F. Restrictions Associated With Applications One way to eliminate or reduce worker exposure to pesticides is to exclude workers from areas being treated and prohibit handlers from applying a pesticide in a way that will expose workers. Present part 170 prohibits the application of any pesticide in a way that directly or through drift will expose workers or other persons not involved in the pesticide application. It also requires unprotected persons to vacate the area. The Agency proposed to continue this provision with some changes. 1. General restriction. The proposal changed the general prohibition on exposure of workers through drift of pesticides from the site of application by substituting the word "contact" for the less precise term "expose." Application may not take place if conditions are such that pesticides may drift beyond the treated area and contact nearby workers. The Agency proposed to clarify the requirement that unprotected workers must vacate the treated area during application by modifying the language to: "no worker shall be allowed or directed to enter or remain in an area during the application of any pesticide to that area, unless the worker is a handler involved in the application of the pesticide." Other workers, even if protected, are not permitted to be in the area. Since these regulations apply only to workers, all references to "other persons" were deleted in the proposal. Only a few comments were received regarding application restrictions. One grower stated that workers should be permitted to remain in the treated area during application under some conditions. For example, planting crews may need to be in a field with the planter (or just ahead of it) during an application of a granular pesticide; field crews may need to be in the same field but may be as much as 1/2 mile away from the area under treatment; and workers should be able to remain in a treated area if they are upwind or if an "adequate barrier" or buffer zone separates them from the application. Some comments expressed concern for protecting the public from agricultural pesticide uses such as in retail greenhouses, at "you-pick" farms, in parks and recreational areas, along roads and rights-of-way, and in schools. Friends of the Earth (Refs. C9,C23) cited a situation where there were children as young as 4 years old in areas being treated with pesticides. Some children were present as workers or handlers; others were there as bystanders or were riding on the application equipment for fun. The Agency is persuaded by the comments to reinsert the clause "and other persons" into the section prohibiting application in a way that will contact workers (Para 170.210). Pesticide applicators must refrain from applying pesticides in areas where any person is likely to be touched by the chemical--either directly or from the drift of the application. EPA intends this provision to protect not only workers on or in farms, nurseries, greenhouses, and forests, but also persons in or near the treated area even if those persons have no reason or privilege to be in that location. The prohibition is consistent with present part 170, which declares that applying pesticides directly on anyone, whether a worker or any other person, is a misuse and is subject to penalty. In the final rule, the language from the NPRM has been modified. Subpart B (Para 170.110) states that "during the application of any pesticide ... the employer shall not allow or direct any person . . .. to enter or to remain in the treated area." The exception found in the proposal for a "worker [who] is a handler involved in the application" has been changed to an exception for "an appropriately trained and equipped handler" (Para 170.110). These changes were made to make it clear that only handlers trained and equipped as required by this part are permitted in an area during application. Other workers, even if protected, are not permitted to be in the area. 2. Application restrictions in nurseries and greenhouses. In greenhouses and nurseries, production areas are often close together. Plants requiring differing pesticide treatments and hand-labor schedules may occupy the same bench or bed. EPA proposed more stringent application restrictions for nurseries and greenhouses than either the general application restriction in present part 170 or those proposed for farms and forests. In the proposal, the application restrictions were listed under the heading of reentry restrictions, but several comments requested clarification of the proposed language. Therefore, in the final rule, EPA is separating the requirements into two sections, restrictions during applications and entry restrictions. In greenhouses, workers often do diverse tasks, including the application of pesticides, close to other activities. EPA recognized that exposure could occur to workers in areas adjacent to the treated area during some types of pesticide applications and with some types of pesticide formulations. The Agency proposed specific requirements for four different types of applications in greenhouses: (a) The entire enclosed area of the greenhouse must be vacated during the application of a pesticide applied as a fumigant, smoke, mist, aerosol, or fog, or whose label requires a respiratory protection device for applicators. (b) The pesticide-treated area plus 25 feet in all directions must be vacated for any application other than those in paragraph (a) if there is no ventilation in the enclosed area during the application, and the pesticide is applied from a height of more than 12 inches from the planting medium, or is applied using fine spray droplets or a spray pressure greater than 40 p.s.i. (c) The entire enclosed treated area in the greenhouse must be vacated during application if ventilation occurs in the enclosed treated area during types of application described in paragraph (b). (d) Only the pesticide-treated area must be vacated during application of pesticides applied from a height of 12 inches or less and applied as a dry formulation, or applied using coarse spray droplets and spray pressure less than 40 p.s.i. Exposure situations in nurseries are similar to those in greenhouses, with three distinctions: (1) Nurseries are not enclosed structures, thus inhalation hazards are reduced; (2) Nurseries do not have ventilation systems that can be turned on and off at will, but are constrained by the direction and speed of the wind; and (3) Nursery applications may include aerial, upward-directed and very high pressure (greater than 150 p.s.i.) sprays. The areas restricted to worker entry during applications in nurseries were defined by three types of applications: (1) For soil-directed applications the restricted area is the treated area; (2) For downward-directed applications the restricted area is the treated area plus 25 feet downwind and 10 feet in other directions; (3) For applications by aerial, upward-directed or high-pressure sprays the restricted area is the treated area plus any moistened or dusted area. The Society of American Florists (Ref. C100) and others concurred with the proposed definitions of areas restricted during applications and entry-restricted areas for greenhouses and nurseries. Some greenhouse operators requested clarification of the terms "reentry- restricted areas" and "entire nonporous enclosed area"; one suggested that the "reentry-restricted areas" be put in a table for clarity. The Maine Audubon Society (Ref. C82) stated that the 25-foot "barrier" zone was too small to be protective, but one comment requested that the 25- foot entry-restricted areas not apply to pesticides in toxicity categories III and IV and that "soil-directed" be redefined as pressure up to 60 psi if water breakers are used. The Agency agrees with the comments that recommended that the greenhouse restrictions be clarified. The restrictions have been summarized in a table containing restrictions associated with applications (Para 170.110(c)). A similar table has been prepared for applications in nurseries (Para 170.110(b)). To provide a more useful description of the area restricted during application for nursery employers and employees, the Agency specifies that an area of 100 feet in each direction around the treated area must be vacated during applications using aerial, upward-directed, or high- pressure sprays instead of "the area dusted or misted." EPA added an area restricted during application of 100 feet beyond the treated area on nurseries during fumigant, smoke, mist, fog, and aerosol applications. The tables listing entry restrictions associated with applications are an attempt to define the minimum area that must be vacated during the application of various pesticide formulations using diverse application methods in greenhouses and nurseries. If an applicator has reason to believe that workers (or other persons) may be contacted by a pesticide during an application in a greenhouse or nursery, even if those workers (or other persons) are in compliance with the minimum distance requirements listed in the tables in the application- restriction sections, that application may not take place until those workers (or other persons) are removed from the area. The Agency is not persuaded to exempt pesticides in toxicity categories III and IV from these provisions. The intent is to reduce occupational exposure to pesticides, regardless of their acute toxicity. The Agency is concerned also about possible subacute, chronic, and reproductive or developmental effects from pesticide exposure. EPA is not persuaded these restrictions would constitute a serious workplace disruption. The Society of American Florists (SAF) (Ref. C100) and other industry personnel requested clarification about the definition of "entire enclosed area." SAF requested that, except in the case of fumigant applications, the "entire enclosed area" include subsections within a greenhouse, such as areas surrounded by nonporous shields, pyramids, or curtains. A few comments requested clarification as to whether the specified 25-foot area restricted during application and entry-restricted zone extended to areas beyond the greenhouse, outside the nonporous enclosed area or, in nurseries, extended off the property. The Agency agrees that, except for fumigant applications, where the entire greenhouse and any adjacent structures that cannot be sealed off from the treated area must be vacated, the use of subenclosures in the greenhouse is permissible and constitutes the area that must be vacated during application. If the entire treated area is enclosed (either the entire greenhouse or a nonporous subenclosure) then no other barriers, such as the 100- or 25-foot zones, are required. The designation of a restricted area that is larger than the treated area pertains to situations where workers are in the same area as the application and where there are no barriers (such as a wall or nonporous curtain) to protect them from drift, overspray, vapors, or splashing. The Agency's interpretation is that the 25-foot or 100-foot areas restricted during application do not extend beyond the greenhouse, or beyond the property line of the nursery. However, the prohibition against spraying workers or other persons does extend beyond such boundaries. A few comments requested clarification as to what constituted "downwind" in a nursery since wind currents tend to be multi-directional over time. The Agency concurs with this observation and has determined that requiring a 25-foot area beyond the treated area in all directions will be more protective for workers and will be easier to understand. 3. Concerns about fumigants. Although a few comments stated that the fumigant entry restrictions were adequate, the Society of American Florists (Ref. C100) stated: In addition, the re-entry area for a fumigant should also be defined as the entire enclosed structure, rather than the enclosed area, to differentiate between the temporary barrier situation and the greenhouse itself. Some comments requested a definition for "fumigant" and stated that fumigants should be distinguished from formulations such as mists and aerosols. Pikes Peak Greenhouse (Ref. C11) requested that the ventilation criteria for defining vapors as dispersed include specifications for the minimum number of air exchanges needed. A few comments stated that the proposed ventilation criteria for defining vapors dispersed may not be adequate for fumigants if only small windows or fans are used for large production areas. These comments recommended that greenhouse employers conduct replicated tests to determine the time necessary to ventilate a specific site using available ventilation methods to achieve permissible exposure levels. The Agency agrees that a definition of fumigant is appropriate and defines a fumigant as "a pesticide that is a vapor or gas or forms a vapor or gas on application and whose pesticidal action is through the gaseous state." Employers will not have the burden of determining which pesticides are fumigants. Part 156 requires pesticide registrants to indicate on the front panel of the label if the pesticide is a fumigant. The Agency has determined that no one, other than an appropriately trained and equipped handler, should be in a fumigant-treated area until the exposure limit listed on the product labeling is achieved. The fumigant continues to disperse throughout the treated area after its release. Persons entering areas being fumigated to measure air concentration levels or to facilitate ventilation either by manipulating ventilation systems in greenhouses or by removing tarpaulins or other coverings from fumigation sites are exposed directly to the fumigant. These persons, therefore, are handlers of the fumigants. The Agency has changed the definition of handlers to include such persons and has extended the prohibition period for fumigants in greenhouses to include the time until the fumigant has dispersed to the level indicated on the label or in the absence of a label-specified level, by meeting one of the ventilation criteria. During this time, only handlers with the protections mandated on the labeling and meeting the other requirements in part 170 may enter the treated area, which is defined as being the entire greenhouse. These handlers should be entering the treated area only to measure the level of the fumigant, remove coverings, or to operate the ventilation system. The gaseous nature of fumigants requires the entire structure, including any adjacent area that cannot be sealed off from the treated area, be vacated during application. Temporary barriers such as curtains or shields are not designed to be air-tight and therefore would not prevent exposure to persons in areas adjacent to those barriers. EPA has reworded the restrictions for fumigant applications in greenhouses to specify that the entire greenhouse and any adjacent structure that cannot be sealed off from the treated area is restricted. The Agency accepted the suggestion that a specific number of complete air exchanges might be specified as constituting sufficient ventilation following a fumigant application (or other airborne application) in a greenhouse. The Agency has concluded that 10 be the minimum number of air exchanges. (If each air exchange removed only 50 percent of the pesticide, 10 exchanges would remove approximately 99.9% of the original volume of pesticide.) In proposing the ventilation criteria, EPA utilized the limited data available and consulted with authorities in greenhouse pesticide application processes to establish appropriate criteria for protecting workers from inhalation exposure following pesticide applications in greenhouses. Roses, Inc.(Ref. C97), the Society of American Florists (SAF) (Ref. C100) and other greenhouse growers requested changes in the provisions regarding ventilation during application. SAF states: The Agency proposes to require that the re-entry area for plant directed applications of pesticides be the entire nonporous enclosed area if applied while ventilation is occurring. This makes sense, if at all, only if EPA clarifies that the ventilation referred to is specifically mechanical ventilation. Since many greenhouses are acres large, workers should be allowed to work in one end of the greenhouse while a spraying operation is going on in the other end of the greenhouse. Many growers use mechanical ventilation during spray operations to cool the greenhouse . . . Workers should be allowed within 25 feet of these operations, while mechanical ventilation is occurring as long as these workers are not directly between the exhaust fan and the application activities. Workers should be permitted to work in one quadrant of a house, while treatment is occurring in another quadrant as long as the mechanical ventilation is drawing the drift in a direction opposite the workers. At the very least, the Agency should specify that if no ventilation occurs, or if passive ventilation occurs, the re-entry area may be within 25 feet of the operation until sprays have dried. Other comments questioned the predictability of greenhouse ventilation patterns and systems. Farmworker Justice Fund, Inc. (Ref. C157) stated: Every greenhouse ventilation system is different. Some have very predictable air patterns. In others the airflow is not predictable and there is more turbulent air. Each greenhouse must determine its own rate at which vapors disperse. The restriction on ventilation was intended to protect workers from airborne vapors, spray, and dusts. The Agency is persuaded that, in most instances, drift from applications, other than fumigant, smoke, mist, fog, or aerosol applications, would not extend to or beyond the 25 foot buffer zone established around the perimeter of the area being treated. Therefore, EPA has eliminated the provision that would exclude workers from the entire greenhouse during these applications if the ventilation system was operating. The Agency emphasizes, however, that the prohibition against applying any pesticide in a manner that would contact workers (or other persons) remains in effect for all applications. If agricultural employers or pesticide applicators have any reason to believe that an application might contact workers, they have the responsibility to take steps to avoid such contact. In the NPRM, EPA listed several criteria for determining when vapors have dispersed after the application of a fumigant. The Society of American Florists (Ref. C100) requested that EPA clarify when vapors are considered dispersed following application of nonfumigant pesticides that require the use of a respirator during application. The Agency concurs and has modified the restrictions associated with applications to include ventilation criteria before workers are allowed to return to work anywhere in the entire enclosed area after pesticide applications of fumigants, smokes, mists, aerosols, or fogs, or pesticide applications that require the use of a respiratory protection device. 3. Contact with handlers handling fumigants and other highly toxic pesticides. The Agency proposed that "visual or voice contact must be made at least every two hours with any person who is mixing, loading, or applying" a product that contains the skull and crossbones symbol on the label. One commenter (Ref. C179) stated that: California has experienced more accidents involving the handling of pesticides at night than during the day. Therefore it prohibits a handler from working alone at night unless contact is made with another person at least once per hour. This regulation should also require hourly contact at night. The Agency is unaware of data that indicate that more frequent monitoring of handlers is necessary to detect accidents that occur at night. In the absence of such a linkage, EPA is not persuaded to increase the frequency of monitoring handlers working alone at night. The Agency also proposed that "visual contact must be maintained by an observer at all times with any person who is applying [a fumigant pesticide] product in a greenhouse or similar structure, or who enters the greenhouse before the REI has expired. The observer must have immediate access to the same personal protective equipment required for an applicator of [the] product." One commenter stated that visual contact was not always feasible in a greenhouse where tall plants might obscure the handler and requested that continuous visual or voice contact be required. The Agency agrees and has modified this requirement accordingly. These provisions are consistent with 29 CFR 1919.134, OSHA regulations discussing the use of respirators, which state that in areas where the wearer, with failure of a respirator, could be overcome by a toxic or oxygen deficient atmosphere, at least one additional person shall be present. The OSHA regulation also stipulates that communications (visual, voice, or signal line) shall be maintained between all persons present, that one person should be unaffected by any likely accident, and that person should have the proper rescue equipment to be able to assist those at risk. The requirement for communication with handlers of highly toxic pesticides, those with "skull and crossbones" on the label, at least every two hours is an extension and modification of the requirement for persons working in toxic or anoxic environments with respirators to be under continuous surveillance. In the case of persons using respirators in closed toxic or anoxic environments, failure of the respiratory protection could be fatal rapidly. Persons working in the open who experience an over exposure to a highly toxic pesticide through a spill, splash or equipment failure are less likely to succumb immediately. The Agency, therefore, has concluded that the requirement to monitor every two hours should be adequate to prevent fatalities in most circumstances and should not represent an unreasonable burden. G. Entry Restrictions The Agency long has recognized the value of limiting agricultural workers' exposure to pesticides through the use of reentry intervals (REI's). Present part 170 established that no worker without the prescribed protective clothing should be allowed to enter a treated area to perform a hand-labor task until the expiration of an REI. In the NPRM, EPA did not change this basic requirement but did extend the scope of this proscription to include any workers on farms or in forests, nurseries, and greenhouses contacting pesticide residues on treated surfaces or in soil, water, or air, not just those performing hand labor tasks. The NPRM required other protections, such as personal protective equipment, training and decontamination facilities, be provided to early-entry workers. As discussed in the section on definitions, the Agency is persuaded to change the term "reentry interval" to "restricted-entry interval" in this final rule, as the latter is more descriptive of the reality. The commonly used abbreviation, "REI", still applies. 1. REI's. Present part 170 established a generic "minimum" REI for pesticides used on agricultural sites covered by that part and specific REI's of either 24 or 48 hours for 12 pesticides; other REI's have been established during the registration, reregistration, and special review processes. Some of these REI's are "permanent" (based on adequate reentry data as required by 40 CFR part 158 or a waiver of data submission); others are interim REI's (not based on part 158 reentry data) pending the generation of adequate data. Under existing Agency policy, the establishment of REI's has been limited to pesticides used on agricultural crops where workers perform "hand-labor operations," involving "substantial contact with treated surfaces." However, workers may have contact with pesticides on treated surfaces from activities such as moving irrigation pipes and scouting, tasks usually not considered as "hand-labor" tasks. Adverse effects on workers may result from a combination of the toxicity of the pesticide and the amount of exposure. Even small amounts of highly toxic pesticides can cause poisoning. For these reasons, the Agency decided that contact with pesticides on treated surfaces through any activity may be harmful to workers. Thus, the Agency proposed that REI's apply to all pesticide products used on agricultural plants as defined by this part, regardless of type of worker activities associated with particular agricultural plants. In proposing to revise part 170, the Agency did not contemplate a change to the part 158 process for establishing "permanent" REI's. Rather, the proposed revision to part 170 represented a change in current Agency policy of setting interim REI's which apply until product-specific REI's could be established, based most often on part 158 reentry data. Therefore, part 156 retains all "permanent" REI's. It also retains all previously established interim REI's that are longer than those that would be established pursuant to this rule making in part 156. These longer REI's have been based on either chronic or delayed health effects or other exposure hazards such as persistence, post-application chemical transformations, or potential for severe skin sensitization. 2. Length of REI's. In the NPRM, the Agency proposed to retain the existing minimum REI of "until sprays have dried, and dusts have settled" for most pesticide applications and to modify it by adding the phrase "or vapors have dispersed" in order to protect workers immediately after applications of fumigants, mists, fogs, aerosols, or smokes. It also proposed specific REI's of 48 hours for pesticides that contain organophosphates or N-methyl carbamates in toxicity category I, and 24 hours for pesticides that contain organophosphates or N-methyl carbamates in toxicity category II and for other active ingredients in toxicity category I. The Agency considered other options which reflect varying acute toxicities. The comments on this issue focussed on the length of the proposed REI's and the bases for selecting the REI's. a. Minimum REI's. Several comments endorsed the concept of "sprays dried, dusts settled, vapors dispersed" as a minimum REI. Some comments requested the Agency to establish a minimum REI of 24 hours for all pesticides; others explicitly opposed a 24-hour minimum REI for all pesticides. Another comment suggested that there be no restricted-entry period less than 12 hours. One comment stated that enforcement of "sprays have dried, dusts have settled or vapors have dispersed" would be difficult. Others stated that determining when "sprays have dried, dusts have settled or vapors have dispersed" is not feasible in some greenhouses because in propagation and misting situations it is difficult to ascertain if sprays have dried because foliage is kept constantly wet. The Agency agrees that in some circumstances it is difficult to determine when the sprays have dried, the dusts have settled, or the vapors have dispersed; judgment is required to assess when such an REI has expired. The rates at which sprays dry, dusts settle, or vapors disperse depend on factors such as temperature, humidity, rainfall, irrigation, dew deposition, wind, crop density, height, leaf configuration, amount of sunshine, and type of pesticide formulation used. Parts of a treated area may be dry while others may not be dry. In dense crops, such as mature corn, the foliage in the center of the stand may be wet while the foliage in the outer areas, where a supervisor is most likely to check, may be dry. Rewetting because of rain, irrigation, or dew may cause confusion and uncertainty whether the sprays have dried and the surface is wet from another source. Wind may make it difficult to determine whether dusts have settled or whether other dusts are wind-blown. Many comments requested that the Agency establish minimum REI's to protect against possible unknown chronic health effects. These comments expressed concern that product-specific health-effect evaluations have taken the Agency a long time to conduct which results in continued exposure of agricultural workers to chemicals whose potential for causing birth defects, cancer, genetic mutations and other systemic damage has not been tested. They recommended that the Agency consider the potential chronic health effects and establish longer REI's. The Agency has decided to establish a minimum REI of 12 hours for all pesticide applications to replace the "sprays have dried, dusts have settled, vapors have dispersed" requirement. This will provide a margin of safety against occupational exposure to all pesticides and eliminate the need for pesticide users to judge how long workers should be kept out of an area. The disruption to agriculture, and thus the cost, should be minimal; pesticides could be applied in the evening, and worker entry would be allowed the following morning. This REI of 12 hours could be modified through the reregistration (or registration) process on a case-by-case basis with submission of full "reentry" data (part 158). The Agency will continue to establish REI's on a case-by-case basis for products where nonacute health effects are concerns. b. Specific REI's. Although most comments supported the REI's proposed and many stated that in most circumstances agriculture would be able to comply, one comment stated that REI's longer than the minimum should be reserved for compounds whose toxicity characteristics or exposure history indicated a need for longer REI's. Some comments supported a 48-hour REI for all active ingredients in toxicity category I and a 24-hour REI for all those in toxicity category II. Other comments requested that REI's not exceed days-to-harvest intervals or noted that 48 hours is the maximum feasible REI under current crop production methods. Many comments supported 72-, 48-, and 24-hour REI's for pesticides in toxicity categories I, II, and III, respectively. Others specifically opposed a 72/48/24 hour scheme or stated that the REI's proposed should be determined on a case-by-case basis when data indicate a need. The Agency's proposal was based on data from California that show that from 1976 to 1985, 90 percent of the systemic poisonings caused by active ingredients in toxicity category I and 70 percent caused by active ingredients in toxicity category II involved either organophosphates or N-methyl carbamates. These data suggested a relationship between the classes of chemicals used and poisonings. A few comments stated that the apparent relationship between chemical class and poisoning in the data is not unexpected; because of the types of crops grown in California, it is likely that 90 percent of the products in toxicity category I and 70 percent of the products in toxicity category II applied were anticholinesterase compounds. Many respondents objected to the distinction made between organophosphate/N-methyl carbamate pesticides and other pesticides in the same toxicity category stating that the subdivision of the toxicity categories I and II by chemical family is not defensible scientifically. These comments asserted that it would be more appropriate to use acute toxicity data as the basis for generic REI's, and to include all compounds in a category. In contrast, some comments requested that only organophosphate and N-methyl carbamate pesticides have REI's. After reevaluating this issue, the Agency agrees that chemical class should not be a criterion for establishing REI's. The Agency has been persuaded that all pesticides in a particular acute toxicity category represent the same acute risk to workers and no distinction should be made among the chemical classes within a toxicity category. The Agency has changed the specific REI's. All pesticides in toxicity category II have REI's of 24 hours, and all pesticides in toxicity category I have REI's of 48 hours in the final rule. All other pesticides (those in toxicity categories III and IV) are subject to the 12-hour minimum REI. Studies have shown that some organophosphates transform into more toxic products in arid conditions. The Agency has been persuaded that in areas receiving rainfall of less than 25 inches per annum, organophosphates in toxicity category I used outdoors should have an REI of 72 hours. Acceptable sources of statistics on average annual rainfall for an area are nearby weather bureaus, such as one located at a local airport or one affiliated with the National Oceanographic and Atmospheric Administration (NOAA). The Agency proposed that REI's be based on the acute toxicity of the technical grade of the active ingredient. Some comments requested that inert ingredients be considered in setting REI's. The Agency believes that the inert ingredients in pesticide products generally are not of a nature, or do not remain in treated areas long enough, to present hazards for reentering workers. Accordingly, REI's established by this final rule will be based on the possible hazards of residues of active ingredients. The Agency is reexamining the hazards of inert ingredients through a separate process. The Agency proposed setting REI's based on the highest toxicity category indicated by available data on acute dermal toxicity or skin and eye irritation potential, determined by the criteria of 40 CFR 156.10(h)(1) of this chapter. If no dermal toxicity data are available, oral toxicity data would be used to set REI's. Workers may have dermal, oral and respiratory exposure to pesticides; for workers entering treated fields, the predominant route of exposure is dermal. The Agency considered using only dermal toxicity to establish REI's, but the potential for eye and skin irritation and for respiratory exposure may be significantly large in some entry situations. Cases of eye or skin irritation are 4 times as common as those of systemic poisonings among early entry workers. Inhalation exposure is a hazard in enclosed areas, such as greenhouses, especially after applications of fumigants or pesticides with high-vapor pressure; it is less important as a hazard for entry into treated areas outdoors, except during removal of barriers, such as tarpaulins, after application of a fumigant. Oral toxicity data are the most widely available data on pesticides, but oral exposure in agriculture is related to the worker's personal habits, such as not washing hands and face before eating, drinking, or smoking. The Agency has determined that entering areas while inhalation exposure remains a hazard is not safe or practical for persons other than appropriately trained and equipped pesticide handlers. Therefore, EPA has modified the entry restrictions in greenhouses to permit only handlers into greenhouses until air concentration levels or ventilation criteria have been met following applications of airborne pesticides and applications of pesticides that require a respirator during application. The Agency has also modified the definition of "handler" to include persons who must enter areas treated with soil fumigants to adjust or remove soil coverings, such as tarpaulins. A few comments recommended that use patterns and mode of action be considered in setting REI's. Another recommended that the duration of the residues should be considered in setting REI's since some injuries such as eye injuries or birth defects, are unrelated to the acute toxicity of the chemical. Basing REI's established by the final rule on particular use patterns, on the mode of action, or on a particular use's potential for exposure is not practical. These considerations are appropriate for establishing "permanent" REI's on a case-by-case basis such as through the reregistration process. 3. Early Entry. Present part 170 allows workers to enter a treated area without personal protective equipment before the expiration of the REI if they are not performing "hand-labor" tasks. a. Entry with no contact. The Agency proposed to modify this requirement by allowing entry into pesticide-treated areas before the expiration of the REI without protective measures only when there is no contact with pesticide residues on treated surfaces or in soil, water, or air. Pesticide would be considered to be in the air, for example, in a greenhouse or other enclosed area before the exposure level listed on the labeling has been reached or one of the ventilation criteria established by ¤Ê170.110(c)(3) or in the labeling has been met. Examples of "no contact" activities listed in the proposal included: i. Operating a closed vehicle equipped with a properly functioning positive-pressure filtration system; ii. Performing tasks that do not involve contact with the soil subsurface after a soil-incorporated or soil-injected pesticide application; iii. Performing tasks that do not involve hand contact with the soil, planting media, or plants after a soil-directed or basal- directed application while wearing chemical-resistant footwear. iv. Operating an open vehicle when the crop is not tall enough to brush against the worker or when pesticide residues could not drop from trees and other plants onto the worker; and v. Walking or riding through a pesticide-treated area on an aisle, a road, or a path, if the pesticide is applied or is directed in a way that would not cause residues to drop on the worker and if the worker cannot brush against treated plants or trees. Many comments opposed any early-entry activities. It is not clear whether some were against early entry in situations where there would be no contact with pesticide residues. The Agency recognizes the need to allow workers access to adjacent benches or adjacent plants in greenhouses and nurseries to carry out other tasks. In the proposed regulation, the Agency intended to allow workers to pass through treated areas (walk around benches, down aisles, etc.) after the sprays and dusts had settled from the air, if no contact with the treated surface would result. The Agency considered that walking down an aisle would result in "no contact" after sprays and dusts have settled if the worker was wearing shoes with chemical- resistant soles, even if the spray or dust has been applied over a large area and the aisle has received some deposit. Although the "sprays and dusts have settled" provision has been deleted, the Agency believes that walking through a pesticide-treated area on an aisle or path would constitute "no contact" as long as residues cannot drop on the worker or the worker does not brush against treated surfaces. The Agency does not intend that workers wearing personal protective equipment would be considered to have "no contact." Therefore, the example listed in the NPRM: "Performing tasks that do not involve hand contact with the soil, planting media, or plants after a soil-directed or basal-directed application while wearing chemical-resistant footwear" is not applicable to the final rule. The following are examples of situations that may be considered no contact after sprays, dusts, and vapors have settled out of the air: i. The worker is wearing footwear and is walking in aisles or on roads, footpaths, or other pathways through the treated areas where the plants or other treated surfaces cannot brush against the worker and cannot drop or drip pesticides onto the worker. ii. The worker is in an open-cab vehicle in a treated area where the plants or other treated surfaces cannot brush against the worker and cannot drop or drip pesticides onto the worker. iii. After a pesticide is correctly incorporated or injected into the soil, the worker is performing tasks that do not involve touching or disrupting the soil subsurface. iv. The worker is in an enclosed cab on a truck, tractor, or other vehicle. The Agency will permit entry to a treated area when the worker will have "no contact" with the treated surfaces. b. Entry to perform routine hand labor tasks. EPA proposed to allow worker entry into treated areas after sprays have dried or dusts have settled, but before the REI has expired, to perform any activity, if the workers are provided appropriate personal protective equipment, training, and decontamination facilities. The Agency anticipated that agricultural producers seldom would require workers to enter treated areas before the REI has expired because of the increased risk to the workers, the cost of providing personal protective equipment, and the problems of heat-related illnesses. It is expected that most agricultural management practices can be carried out after the REI expires; thus, few workers would need these protective measures. Numerous commenters, including farmworker representatives and advocacy organizations, occupational health service organizations, legal service organizations, universities, and State agencies, oppose any early entry. Evergreen Legal Services (Ref. C98) stated: "It is an exercise in fantasy to imagine that whole crews of workers sent in to weed or harvest will be fitted with PPE, receive training, decontamination facilities, etc." The University of Arizona Rural Health Office (Ref. C103) stated: "Given hot weather and cost of equipment, the most viable way to protect farmworkers is by keeping them out of the fields until it is safe." The California Department of Food and Agriculture (Ref. C248) stated in its comments that: The EPA proposal for an additional layer of clothing, rubber boots, goggles, respirator, and carrying individual eyewash bottles is not practical [for field workers]. These measures are not likely to be adhered to in many situations without constant monitoring. The Farmworker Justice Fund, Inc. (Ref. C157) commented: The reentry interval should be treated as a quarantine period so that the concept of routine early reentry workers should be eliminated. . . [T]he agency's proposal undercuts the protective purpose of the reentry interval. . . . Nor has the agency offered any health or safety justification for eliminating this long established modicum of protection. The agency comment that it expects that few workers will be required to reenter before expiration of the reentry interval is ludicrous. Many poisoning incidents occur precisely because workers are required to enter before the reentry interval. . . The Migrant Legal Action Program (Ref. C126) states: The whole purpose of a quarantine period is to keep nonhandlers OUT of the pesticide-treated area until the time period has expired. Dr. Richard Fenske of Rutgers University, in a paper prepared in January 1986 . . . states that, "The use of protective clothing among fieldworkers appears impractical for a number of reasons, including possible heat stress, discomfort, and loss of work efficiency." A few other commenters specifically supported the proposal that early entry be permitted with the use of personal protective equipment. The North Carolina Farm Bureau Federation (Ref c180) commented: . . . we feel that an absolute prohibition to routine hand labor is excessive, and that routine hand labor should be allowed if the worker is wearing such personal protective equipment as may be required by EPA. Most growers and grower organizations did not comment on the issue of allowing workers to enter areas before the expiration of the REI. The National Council of Agricultural Employers (Ref C71) seemed to imply that routine early-entry activities were not probable when they commented: ". . . for some crops 48 hours represents the maximum REI feasible under current crop production techniques." Florida Citrus Mutual (Ref C88) and other growers stated that REI's may be costly to workers because they may be inactive during intervals when other work cannot be scheduled. They also said: "[P]rohibiting worker activities altogether, when weather conditions are such that the required personal protective equipment (PPE) might cause heat stress, creates considerable doubt as to when personal protective equipment will prevent worker activity . . . this type of regulation could result in hardship to workers . . . Workers need some assurance that schedules will be regular and income steady. The implication is that Florida Citrus Mutual foresaw situations where workers might be sent into areas before the expiration of the REI with the required personal protective equipment. Information gathered by the Agency during the process that led to the NPRM and comments that the Agency received in response to the NPRM have convinced EPA that entry during an REI to perform routine hand labor tasks is rarely necessary, especially when the REI is 72 hours or less. The Agency noted in the NPRM that: The Agency anticipates that agricultural producers will seldom require workers to reenter treated areas before the reentry interval has expired, because of the increased risk to the workers; the cost of providing PPE, decontamination water, and training; and the problems related to heat-induced illnesses. Since most agricultural management practices can be carried out after the reentry interval expires, few workers will need these protective measures. Furthermore, comments received in response to the NPRM questioned the feasibility of workers wearing PPE while performing hand labor tasks under normal agricultural field conditions. The Agency has studied the issue of PPE for agricultural field workers who are performing routine hand labor tasks and has concluded that routine use of PPE, such as chemical-resistant gloves, footwear, and headgear, two layers of clothing, and protective eyewear, for such field workers is, in general, not only impractical, but also may be risk-inducing due to heat stress concerns. The Agency has determined that hired agricultural workers, especially harvesters, have a disincentive to wear PPE; because they frequently are paid at a piece rate, they have little tolerance for anything that hinders their speed and efficiency. The Agency concludes that it is likely that the PPE would be removed or would be worn incorrectly if it were required routinely in most hand labor situations. Many comments also observed that routine early entry during the REI was rarely necessary. After consideration of the comments and the available data, the Agency has concluded that, under most circumstances, allowing routine entry for unlimited time to areas under an REI, even with PPE, decontamination, and training, will not reduce adequately the risk of agricultural workers' exposure to pesticides, and that the economic benefits associated with such routine early entry do not justify the risks associated with such early entry. Consequently, the Agency is convinced that routine hand labor tasks should not be allowed before the expiration of the REI, except in rare circumstances based on case-by- case consideration. c. Entry for short-term tasks. EPA proposed to allow worker entry into treated areas before sprays have dried, dusts have settled, or vapors have dispersed: (1) only to perform short-term application, irrigation, or emergency crop management practices and (2) only if the workers are provided the personal protective equipment required for handlers of the pesticide, training, and decontamination facilities. As stated in the NPRM, the Agency considers the risk of exposure for early-entry workers to be comparable to the risk for pesticide handlers. Sometimes, early-entry workers may receive greater exposure than that encountered by an applicator of the pesticide. The Agency believes that there should be no entry to freshly treated areas (except for no-contact entry) until the dusts or sprays have settled and some drying or volatilization of the formulation has taken place; thus it has prohibited entry to treated areas for the first 4 hours after application. After 4 hours have elapsed, 1 hour should be sufficient time to do necessary "short-term" tasks which the Agency is aware must be done and minimize worker exposure. In this final rule, the Agency has prohibited most entry during the REI to perform routine hand labor tasks. However, the Agency will allow necessary short-term activities, such as operating irrigation equipment, in areas remaining under an REI if: (1) there is no entry for the first 4 hours after application and thereafter until any exposure level listed on the labeling has been reached or any ventilation criteria established by Para 170.110(c)(3) or in the labeling has been met; (2) no hand labor tasks are performed; (3) the time in treated areas does not exceed 1 hour in any 24-hour period for a worker; (4) the required PPE is provided, cleaned, and maintained for the worker; (5) the required decontamination and change areas are provided; and (6) the required safety training and labeling-specific safety information have been furnished. As stated in the NPRM, the Agency considers the risk of exposure for early-entry workers to be comparable, in some situations, to the risk for pesticide handlers. Sometimes, early-entry workers may receive greater exposure than that encountered by an applicator of the pesticide. The Agency believes that there should be no entry to freshly treated areas for any reason until the dusts or sprays have settled and some drying or volatilization of the formulation has taken place; thus it has prohibited entry to treated areas for the first 4 hours after application. After 4 hours have elapsed, 1 hour should be sufficient time to do necessary "short-term" tasks, which the Agency is aware must be done, and should minimize worker exposure. d. Early entry for agricultural emergencies. Several comments suggested that early entry be allowed for emergencies on a case-by-case basis. If there are situations in which workers need to enter an area before the expiration of an REI, growers should be able to obtain permission, in advance, from the EPA or the State lead agency. The Agency recognizes there may be a need for workers to enter a treated area before the expiration of an REI to perform tasks, including hand labor tasks, in agricultural emergencies. The Agency regards an agricultural emergency as a sudden occurrence or set of circumstances that the employer could not have anticipated and over which the employer has no control, requiring entry into a treated area, when no alternative practices would prevent or mitigate a substantial economic loss. A substantial economic loss means a loss in profit greater than that which would be expected based on the experience and fluctuations of crop yields in previous years. Only losses caused by the emergency conditions specific to the affected site and geographic area are considered. The contribution of mismanagement cannot be considered in determining the loss. Such emergencies might consist of unexpected and severe adverse weather, such as frost, high winds, tornado, or hurricane, or an unexpected and severe pest outbreak immediately before harvest on a time-sensitive crop such as the soft fruits, soft vegetables, or floral crops. If the emergency is anticipated through a weather forecast, pest outbreak bulletin, or other means, it is not acceptable to apply a pesticide after becoming aware of an impending emergency and then require workers, due to the emergency, to enter the treated area before the REI has expired. The Agency has modified the early-entry restrictions to permit entry to areas under REI's in agricultural emergencies if a State, Tribal, or Federal agency having jurisdiction declares the circumstances for an agricultural emergency exist and the employer determines that the agricultural establishment is subject to the emergency. Entry is permitted if: (1) there is no entry for the first 4 hours after application and no entry thereafter until any exposure level listed on the labeling has been reached or any ventilation criteria established by Para 170.110(c)(3) or in the labeling has been met; (2) the required personal protective equipment is provided, cleaned, and maintained for the worker; (3) the required decontamination and change areas are provided; and (4) the required general training and label-specific information has been furnished; and (5) only tasks related to mitigating the emergency are performed. e. Exceptions to the prohibition on routine early entry. Although the Agency has determined generally not to allow routine early entry even with the use of PPE, the Agency did receive information during the comment period from the cut flower and cut fern industry about the economic hardships that would result in that particular industry if routine hand labor activities were prohibited during REI's. Rose growers (and other cut flower growers) opposed the proposed REI's because of the economic burden that would result to their industry. Several comments emphasized the need to cut the roses twice a day, 365 days a year. They stated that roses are sprayed on a weekly or bi-weekly basis; not cutting flowers 26 to 50 days a year would be an economic disaster. One grower estimated that a 1 to 2 day REI would cause at least a 10 to 15 percent crop loss. Roses, Inc., estimated the crop loss would represent 14 percent of annual sales or on average, over $35,000 loss per year per acre. Several comments suggested that entry for tending floral crops be allowed after sprays dry, in normal work attire for not more than 3 hours per worker per day or requested that entry to treated areas be allowed for not more than 1 hour in 24 hours per worker so that flowers can be tended. In that industry, it appears that the risk-benefit balance might militate in favor of allowing some hand labor activity during the REI. While no information was submitted during the comment period demonstrating that other industries might suffer a significant adverse economic effect if routine early entry during REI's were disallowed, it is certainly possible that other industries, crops, or crop practices may be significantly affected by the prohibition of such routine early entry. The Agency has, therefore, adopted an exception process that would allow interested persons to demonstrate to the Agency that, in a particular industry, crop, or crop practice, an exception should be granted to the general prohibition on routine early entry. Persons wishing to obtain an exception to the early-entry restrictions would submit a request for such an exception to the Agency. The Agency encourages persons who wish to submit such requests to submit the requests as a group or association of affected parties, rather than as individuals. EPA expects that the most efficient and effective request process would ensue when a group or association of growers and/or workers with common interests present a single, consolidated request for an exception. Such a group request would both permit a more efficient review process and lend weight to the case that the exception was necessary to alleviate typical conditions in the commodity or crop-practice situation for which the exception is being requested and was not a highly-specific localized situation. Requests for exceptions that are limited to a narrow geographic area, such as a single agricultural establishment, must be accompanied by persuasive evidence that such a narrow geographic scope is appropriate. The Agency also notes that all of the information pertinent to the specific exception must be submitted with the exception request. The rule states what types of crops and crop production practices might qualify for such an exception and what information must be supplied to the Agency in order for an exception to be considered. If a request for an exception is submitted to the Agency without all of the required information, the Agency shall return the request to the submitter. When a request for an exception that contains all of the required information is submitted to EPA, the Agency will publish a notice in the Federal Register stating that an exception is being considered, describing the nature of the exception, and allowing at least 30 days for interested parties to comment. The Agency will also send a copy of such exception requests to USDA at that time. EPA expects to cooperate with USDA in obtaining information necessary for analysis of the exception requests. If such an exception is approved, the Agency will publish a notice describing the exception and the reasons for it in the Federal Register. The final rule also provides a means for the Agency to withdraw exceptions if the Agency receives poisoning information or other data that indicate that the health risks imposed by the early-entry exception are unacceptable or if the Agency receives other information that indicates that the exception is no longer necessary or prudent. EPA will endeavor to review any requests for exceptions expeditiously. As stated above, requests from registrants or groups/organizations are likely to yield the most efficient review process. Also, the more specific the request, the more readily the Agency can evaluate the full range of impacts. The Agency will consider the economic urgency of the request and the timing of the pest concern, crop, or production practice for which the exception is being requested. To expedite the exception process, EPA intends to establish a formal exception-review procedure that remains outside of the usual registration and reregistration processes. A special organizational unit would be designated as responsible for receiving and processing exception requests, including establishing a mechanism for receiving comments, reviewing all submitted information, and facilitating the decision-making process among the Agency technical experts. EPA believes that this unique strategy will greatly expedite the exception process and allow the Agency to address exceptions in a timely manner. With this process, EPA will endeavor to respond in a timely manner when receiving requests for exceptions that contain all of the required information and will attempt to respond with special urgency to exception requests that are particularly crucial due to unexpected pest problems or crop-season timing. The final rule provides that persons requesting an exception may assume that the exception has been denied if EPA has not published its decision whether to grant the exception within 9 months from the comment-closure date specified in the Federal Register notice in which the Agency announced that it would consider the exception, unless the Agency has taken action to extend its review period for a specified time interval due to the complexity of the exception request or to the number of exception requests concurrently under Agency review. While exception requests may be filed immediately, the Agency is also interested in receiving additional comments and information on both the general prohibition of routine early entry for the performance of hand labor tasks during REI's and the mechanism and criteria for granting exceptions to that general prohibition. EPA is therefore providing an additional 60-day period during which written comments, data, and other evidence concerning these specific topics may be submitted to the Agency for consideration. Upon review of these comments, EPA may modify this final rule where appropriate. This additional comment period should allow for possible refinement of this rule without delaying its implementation and without delaying the consideration of exceptions that may prove to be necessary. Comments that EPA has already received from the cut flower and cut fern industry have convinced EPA that this industry, at least, probably warrants such an exception. The decision that such an exception is probably warranted is based on a balance of the risks and benefits that would result from such an exception (see Notice of Exception Request published elsewhere in this issue of the Federal Register). The Agency is unaware of any specific information indicating that crops or industries other than the cut flower and cut fern industry would qualify for such an exception, but the exception process adopted in this final rule provides interested persons an opportunity to submit relevant information to the Agency if they believe additional exceptions are warranted. 4. Two or more pesticides in combination. Several comments, including the California Department of Food and Agriculture (CDFA), requested that the REI for two or more pesticides applied at the same time be extended to the longest REI of the pesticides applied plus one half the next longest REI of the pesticides applied. CDFA states: We have noted your assessment that there are insufficient data to indicate that synergism can have a significant impact on safe reentry. It has been shown, however, that some organophosphates may potentiate the action of certain others, and that others may have additive effects. In Casarett and Doull's text, Toxicology: The Basic Science of Poisons (Macmillan Publishing Co., Inc., 1980), additive effects and potentiation of toxicity from the simultaneous exposure of mammals, including man, to certain organophosphates are discussed, and several scientific literature references are provided. . . Because of these data and our limited understanding of the relationships between dislodgeable leaf residues, fieldworker exposure and acetylcholinesterase inhibition, it is the position of CDFA that pesticide interactions require consideration in setting reentry intervals. Residue levels that are individually acceptable may be dangerous if they occur simultaneously and the effects are additive or synergistic. The Agency has reviewed the data cited by CDFA and believes that the references cited indicate that some organophosphates used in combination may interact with one another in such a manner as to affect the time required before workers may safely enter treated areas, but the evidence is not sufficient for use in setting interim REI's in this final rule. The Agency believes that its approach to setting REI's in this final rule is prudent and reasonable; but as a temporary and broadly-applied method that does not consider such things as application and degradation rates it does not lend itself to refinements such as that proposed by CDFA. 5. Days to harvest intervals and REI's. Two comments requested that REI's not exceed days-to-harvest intervals (preharvest intervals). Two others questioned why the preharvest interval on some pesticides is shorter than the REI. Preharvest intervals (PHI) and REI's are based on different criteria. REI's are based on the expected skin or eye exposure that workers might receive during an entire workday from exposure to residues on foliage, fruit, other plant parts, and in or on the soil, water, or air. PHI's are based on the expected dietary intake of the edible portion of the crop based on amounts consumed. The Agency believes that field workers often will have a greater opportunity for exposure than the consumers of the crop they pick. No change was made in the final rule. 6. Summary of restricted entry times in the final rule. Dermal exposure to pesticide residues is considered the major reason for pesticide-related illness observed among agricultural workers. The concept of allowing foliar residue to dissipate with time before permitting workers to come in contact with pesticides on treated surfaces was first discussed in 1974 as a means of preventing pesticide related illness in agricultural workers (Ref. 60). Extant studies on the dissipation of residues demonstrate that the dissipation is exponential. The time required to reach a level of residue on treated foliage that will not produce adverse effects in workers depends upon factors such as the toxicity of the product, the formulation of the product, the initial amount of material deposited on the crop, and the climate. Several times have been chosen in the final rule as REI's following pesticide applications, i.e. 4 hours, 12 hours, 24 hours, 48 hours, and 72 hours. These times have been based on an analysis of data from several residue dissipation studies. Current part 170 has a generic minimum REI of "until sprays have dried and dusts have settled." As stated earlier in the discussion of the comments on the minimum REI, determination of when this state has been reached is difficult. The specification of 12 hours as a minimum REI for all pesticide applications is an attempt to assist users in complying by quantifying "until sprays have dried and dusts have settled" and to give some measure of protection from exposure for all pesticides. From available information, EPA is convinced that many moderately toxic pesticides (toxicity category II) require REI's longer than the minimum REI. Thus, it has set REI's of 24 hours for pesticides in toxicity category II. Evidence indicates that 48-hours or longer are necessary to protect workers from the residues of some highly toxic pesticides (toxicity category I). Hence the Agency has set REI's of 48-hours for pesticides in toxicity category I (Refs. 75,76). Studies have shown that some organophosphates transform into more toxic products in arid conditions. The Agency has been persuaded that, in areas receiving rainfall of less than 25 inches per annum, organophosphates that are in toxicity category I and that are used outdoors should have an REI of 72 hours. H. Personal Protective Equipment The level of any toxic effect depends on both toxicity and exposure; if either is very high, toxic effects may result. Conversely, if there is no exposure or if the toxicity is sufficiently low, there will be no effect. The predominant route of pesticide exposure in outdoor agricultural work is through the skin (Refs. 33,84,104). Therefore, any barrier that can be placed between the worker and the chemical to reduce contact with the skin reduces the risk of pesticide poisoning. EPA concluded, in the NPRM, that with the exception of enclosed cockpits, and enclosed cabs with positive-pressure filtration systems, the only other barrier available to pesticide applicators is personal protective equipment. For mixers and loaders, closed systems and technological advances in containers and packaging, such as water-soluble bags, have potential, but work is needed to perfect these approaches. The proposal stated that personal protective equipment was the most viable approach to reducing occupational exposure to agricultural pesticides. Several comments recommended that EPA place less reliance on personal protective equipment and force the development and use of engineering controls. The Occupational Safety and Health Law Center (Ref. C185) stated: [S]tudies . . . have concluded that personal protective equipment is the least desirable method of protection behind removal or system design/ mechanical protection. . . The proposed rule dismisses the mechanical technique of reducing or eliminating exposure as being unavailable and of limited utility. This . . . is in sharp contrast with other regulatory proposals developed by the EPA as well as other federal agencies which `force technology' by providing a lead time for non mechanical solutions and then requiring the application of the `best available technology.' The technology forcing scheme should be applied in this instance. Several comments stated that personal protective equipment should be the last resort for protection and that engineering controls should be explored first. The American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) (Ref. C211) states: It has long been recognized by industrial hygienists and codified by federal OSHA regulations that personal protective equipment should not be permitted as a primary means to control worker exposures to toxic chemicals. Indeed, OSHA regulations require engineering controls or work practices (e.g., ventilation, process design, use of wet materials, etc.) to limit exposures. Personal protective equipment, including respirators, is only permitted while engineering controls are being installed, where engineering controls are not feasible, or in emergencies. EPA agrees that the use of engineering controls is the best way to mitigate worker exposure. But, unlike the industrial environment, which is more controlled and confined, agricultural settings do not lend themselves as easily to engineering controls. The Agency is cognizant of the emergence of engineering controls suitable for agricultural situations, and is considering the adoption of such controls on a product-specific basis during the registration, reregistration, and Special Review processes. Until adequate engineering controls are developed and tested, personal protective equipment will remain the primary means of mitigating exposure for agricultural pesticide handlers. The elimination of routine early entry for hand-labor activities may "force" the development of engineering controls, such as mechanical harvesters, weeders, and pruners, in crops where the timing of such tasks is critical. Some comments requested that closed system mixing and loading and enclosed cab application be required for all toxicity category I pesticides. The Migrant Legal Action Program (Ref. C126) reported that California reduced worker injuries by requiring the use of mechanical controls. The number of injuries caused by liquids in toxicity category I in California was reduced approximately 80% in 10 years (from 75 injuries/year to 16 injuries/year.) Two comments specifically agreed with the proposed personal protective equipment requirements for closed mixing/loading systems. However, the National Farm Workers Health Group (Ref. C179) requested that EPA not reduce personal protective equipment requirements for closed system mixing/loading. They stated: . . . pesticides are highly corrosive, and the Agency has no program to inspect and certify such systems. The efficacy of closed systems has also been impaired by the failure of the Agency or the manufacturers to establish uniform specifications for container openings. Closed systems probes cannot be designed to fit the multitude of containers on the market. Deere & Co. (Ref. C183) stated that the regulation should: . . . contain incentives to develop low risk transfer and cleaning options. The current rule proposal still requires chemical- resistant gloves and aprons to transfer granules without pressure in a closed system. This will cause applicators to stay with more dangerous, but cheaper conventional systems. Similarly, if self- cleaning mechanisms are provided for pesticide equipment, personal protective equipment requirements should be reduced. We agree that repair operations involving the risk of exposure requires the use of personal protective equipment. However, an incentive is necessary to justify research, development, and increased purchase price for safer, closed transfer and cleaning systems. Three comments requested that engineering controls such as wiper wands, low-pressure nozzles, and stream emitters be rewarded with reduced personal protective equipment requirements. EPA considered requiring closed systems for mixing and loading all highly toxic pesticide concentrates. The Agency has decided to continue to "reward" the use of such systems by reducing the amount of personal protective equipment required when closed systems or enclosed cabs are used for mixing, loading, application or other handling activities, but it will not require the use of such systems. The Agency agrees that for closed systems to be safe and effective in reducing exposure, the kinds and types of equipment used in such systems and the maintenance of such equipment must be regulated. Such a program is beyond the scope of part 170 as proposed; the Agency is investigating several engineering control concepts and may require the use of such systems in the future. The Agency also agrees that "rewards" such as a reduction of personal protective equipment requirements are incentives for handlers to use engineering controls. Eliminating all personal protective equipment requirements during the use of closed systems does not seem to be prudent, however. California reports a number of accidents despite the use of closed systems. The Maine Audubon Society (Ref. C82) requested that EPA require state-of-the-art protective clothing for workers where appropriate. The Washington Growers Clearing House Association (Ref. C258) stated that the personal protective equipment as proposed is basically good, but "new methods and protective equipment may be developed and we don't want to be locked into current suggestions." EPA intends to remain attentive to the development of innovative personal protective equipment and to adjust the personal protective equipment requirements as appropriate. 1. Personal protective equipment for early-entry workers. The Agency proposed minimum personal protective equipment requirements, based on the acute toxicity of the active ingredient, for the protection of workers who enter treated areas before the expiration of an REI. Inhalation hazards were not considered a risk after sprays have dried, dusts have settled, or vapors have dispersed. Several comments stated that early-entry personal protective equipment should be the same as the personal protective equipment required for handlers, presumably including respiratory protection. The Commissioner of Agriculture for the State of Texas (Ref. C247) stated: . . . we would like to see a better rationale for excluding inhalation toxicity for workers entering fields after dusts have settled, sprays have dried, or vapors have dispersed. This should not be ruled out unless data conclusively shows that there is no danger. Studies indicate that respiratory exposure for outdoor ground applicators is usually less than 3 percent, and sometimes less than 0.1 percent, of the applicator's total exposure to pesticides (Ref. 23). The Agency intends to eliminate workers' respiratory exposure during application (which is defined as continuing until the pesticide is no longer being dispersed) by prohibiting workers from being in or near the treated area. The Agency has concluded respiratory protection is not needed during the permitted entry after application, because: (1) ventilation criteria have been established for pesticides of concern (airborne or in category I or II for inhalation toxicity) used in enclosed treated areas, and (2) worker entry for any reason into treated areas is prohibited for the first 4 hours after application is complete. Entry to treated areas after an application is complete, but before any ventilation criteria on the label or in the WPS have been met or before the first 4 hours have passed is limited to pesticide handlers, who are required to wear the PPE, including any respirator requirement, specified on the product labeling for handlers. Many comments recommended that no early entry be allowed, because workers will not use the personal protective equipment if the weather is too hot or if they do there is risk of heat stress. They also noted that personal protective equipment is expensive to provide, clean, and maintain. A few comments objected to personal protective equipment other than normal work attire for early-entry workers. The National Cotton Council (Ref. C317) stated, that long-sleeved work shirts and long-legged work pants provide adequate protection for early-entry workers involved in cotton production. One comment requested normal work attire plus chemical-resistant gloves and chemical-resistant footwear be required for all early-entry workers. Another comment objected to chemical-resistant footwear for early-entry workers. Still another comment suggested that the only label-specified early-entry attire for weeders should be chemical- resistant gloves. A few comments requested a minimum early-entry personal protective equipment requirement of coveralls and chemical- resistant gloves for all pesticides. One comment believed the proposed personal protective equipment requirements for early entry were excessive. Several comments, especially those from the rose growing industry, objected to personal protective equipment other than normal work attire for early-entry workers after sprays have dried, dusts have settled, and vapors have dispersed. One comment stated that eye hazards should not be a problem after sprays have dried, dusts have settled, and vapors have dispersed. Other comments expressed dismay that no minimum personal protective equipment was established for early-entry workers in areas treated with pesticides in toxicity categories III and IV. Many of these comments recommended that early-entry personal protective equipment for these pesticides should be normal work attire plus chemical-resistant gloves. The Farmworker Justice Fund, Inc. (Ref. C157) stated: Toxicity III and IV pesticides should require normal work attire and chemical-resistant gloves for all entry before the reentry interval has expired. Given the fact that many of the chemicals are skin irritants, chemical-resistant gloves are important. Dermatitis is the most common occupational disease in agriculture. It can be devastating for a worker's livelihood in terms of lost workdays. Others recommended personal protective equipment other than normal work attire for toxicity categories III and IV without specifying what would be required. In the NPRM, there was a generic REI for pesticides in toxicity categories III and IV of "until the sprays have dried, the dusts have settled, or the vapors have dispersed." The proposal contained a complete ban on hand labor activities during that period; there was no need to specify personal protective equipment for early entry for pesticides in toxicity categories III and IV. The prohibition on most early-entry activities in the final version of part 170 has eliminated the need for most early-entry personal protective equipment. Therefore, the Agency has decided to require early-entry workers to wear the personal protective equipment required for a handler of the pesticide (with the exception of respiratory protection) for pesticides in toxicity categories I and II. The Agency has specified that the minimum attire for early entry for pesticides in toxicity categories III and IV shall be coveralls, waterproof or chemical-resistant gloves, socks and shoes. This minimum attire is based on the Agency's belief that some early-entry workers may receive greater exposure to pesticides through residues in the treated area than may be received by handlers during application. The Agency reserves the right to establish different personal protective equipment requirements for early-entry activities on a case-by-case basis if evidence supports such action. One comment requested that EPA extend the personal protective equipment requirement beyond the REI by specifying that workers should wear at least "normal work attire" (as defined in the proposal) for the entire season and another requested that chemical-resistant gloves and normal work attire be required for the entire season. Another comment requested that there be no personal protective equipment requirements after the expiration of the REI. The Agency does not believe that requiring personal protective equipment or "normal work attire" after the expiration of the REI is warranted. Where data indicate that such protection is needed, the Agency will establish such a requirement; however, it is more likely that the REI would be extended until the personal protective equipment would no longer be needed. 2. Personal protective equipment for pesticide handlers. The Agency has determined that no single personal protective equipment requirement will be adequate to protect agricultural pesticide handlers in all exposure situations. The toxicity of the pesticide, the type of formulation, and the degree of anticipated exposure all influence the kind of personal protective equipment needed to protect handlers. Ideally, each pesticide product labeling should list specific personal protective equipment reflecting the formulation, anticipated exposure level, and toxicity of the product. These determinations are made or are refined as products are registered or reregistered. However, the Agency acknowledges that many pesticide labels require personal protective equipment for handlers that is inadequate by the Agency's present standards. The Agency proposed to establish personal protective equipment requirements until appropriate product-specific requirements can be established. Registrants would be required to list the requirements on the labeling for each pesticide product. In this final rule, the Agency is establishing, through parts 156 and 170, minimum requirements for personal protective equipment for handlers of all agricultural pesticides in various exposure situations. Handlers, such as those mixing, loading, and applying pesticides and those involved in flagging, repairing, adjusting, changing, or cleaning equipment, face potentially dangerous levels of exposure to pesticides unless adequate protection is used. The risk of exposure is especially high for handlers who perform all these tasks and for persons, such as commercial pesticide handlers, who perform these tasks on a frequent and regular basis. Results of numerous studies (Ref. 106) indicate that more than 97 percent of the pesticide to which the body is exposed during handling (especially during spray applications) is deposited on the skin. Exposure to specific parts of the body varies by the type of application or mixing and loading task. The hands and forearms account for the highest percentage of total dermal exposure (Refs. 48, 56). For ground applicators, mixers and loaders, respiratory exposure constitutes a small percentage of total exposure in outdoor handling operations unless highly volatile formulations are involved (Ref. 5). Respiratory exposure cannot be ignored in outdoor situations, however, since nearly 100 percent of any pesticide that enters through the lungs and gastrointestinal tract is absorbed (Ref. 8). When pesticides are used in enclosed structures, the potential for respiratory exposure is greater than when they are used outdoors. (a) Basis for the requirements. The Agency considered whether the toxicity category of the formulated product was the appropriate basis for the personal protective equipment requirements for pesticide handlers. The toxicological characteristics of the formulated product can be linked to the concentrate and to the ready-to-use product diluted by the manufacturer. When the product is diluted by the user, the resulting solution may be less toxic than the concentrated formulated product. When product-specific personal protective equipment requirements are established through the registration or reregistration programs, registrant-supplied data, when available, indicating the acute toxicity of the diluted product may be used to determine the appropriate personal protective equipment for exposure to the diluted product. The Agency proposed to base the requirements established under part 170 on the toxicology of the formulated product, with the provision that registrants could submit data on the toxicity of the diluted pesticide product to reduce the personal protective equipment requirements for handlers other than mixers and loaders. The Oklahoma Department of Agriculture (Ref. C17) and Mauna Kea Agribusiness Co., Inc.(Ref. C42) recommended that personal protective equipment for applicators be based on the toxicity of the dilute product. The Western Agricultural Chemicals Association (Ref. C184) requested that personal protective equipment be based on the type of formulation as well as the acute toxicity. The Commonwealth of Virginia's Department of Forestry (Ref. C36) stated that toxicity should not be the sole determinant of personal protective equipment and that use pattern and mode of action must be considered. Most other comments supported the Agency's proposal to base personal protective equipment requirements on the toxicity of the formulated product and the Agency's use of a table to determine the appropriate attire for a pesticide product. This regulation allows registrants that have data on the toxicity of the dilute product to use that data in establishing the personal protective equipment requirements for handlers exposed to the diluted product. However, basing personal protective equipment on the type of formulation, the use pattern, or the mode of action is best accomplished on a product-specific basis during the case-by-case review of a product. Therefore, the Agency will not consider these factors in establishing the generic personal protective equipment requirements for pesticide handlers in part 156. (b) Personal protective equipment based on concerns about chronic health effects. A few comments requested that personal protective equipment requirements be based, in part, on concern for chronic and sub-chronic health effects. Farmworker Legal Services of New York, Inc. (Ref. C250) said, "The agency's decision to consider the chronic effects of long term exposure on a case by case basis leaves farmworkers in a position of unacceptable risk." The Maine Department of Agriculture, Food and Rural Resources (Ref. C256) stated: In light of the uncertainty surrounding the science of chronic toxicology and risk/exposure assessment, it seems only rational to afford workers more discretion in the level of risk they are willing to accept and more flexibility in their approach to minimizing those risks. The Agency based its requirements for personal protective equipment, in part, on concern for unknown chronic and sub-chronic health effects. The requirement for long-sleeved shirts, long-legged pants, shoes, socks, and chemical-resistant gloves for pesticides in toxicity category III and for long-sleeved shirts, long-legged pants, shoes, and socks for pesticides in toxicity category IV are a reflection of that concern. The Agency believes that the prudent course of action is to reduce occupational exposure to all pesticides through the use of personal protective equipment, training, and availability of decontamination water during handling of all pesticides. (c) Adequacy of personal protective equipment requirements for pesticides in toxicity categories III and IV. The Agency proposed that handlers of pesticides in toxicity category III or IV because of their acute dermal or skin irritation potential be required to wear "normal work attire" (long-sleeved shirt, long-legged pants, shoes, and socks). For toxicity category III, they also would be required to wear chemical-resistant gloves. For pesticides that are in toxicity category III or IV because of inhalation or eye irritation potential, the Agency proposed no minimum personal protective equipment requirements, but reserved the option of requiring personal protective equipment for those hazards on a product-specific basis as warranted by evidence. Many comments praised the proposed personal protective equipment requirements. The North Carolina Farm Bureau (Ref. C180) stated, "We feel that the definition of "normal work attire" which includes, at minimum, long pants, a long-sleeved shirt, shoes, and socks, is reasonable and prudent." But several other comments requested that more than "normal work attire" be required for handlers of pesticides in toxicity categories III and IV. The Migrant Legal Action Program, Inc. (Ref. C126) commented: Protective equipment requirements should be increased for Toxicity Category III and IV pesticides because: (1) of data gaps as to the chronic and subchronic effects attendant on exposure to these products and (2) the high number of injuries they cause. . . [A]ll workers exposed to Toxicity Categories III and IV pesticides should be provided with chemical-resistant gloves. The Industrial Safety Equipment Association (Ref. C186) states: We feel that in Toxicity Categories 3 and 4, at least chemical- resistant aprons should be worn, so that these chemicals are not taken back to the home on garments that are subsequently washed with uncontaminated garments. The Farmworker Legal Services of New York, Inc. (Ref. C252) suggested: By failing to require chemical-resistant gloves for handlers exposed to Tox IV pesticides, . . . the Agency is continuing to place these persons at a known and established health risk when a simple and effective piece of protective equipment could significantly reduce this risk. Farmworker Legal Services of New York also requested that goggles or a face shield be required for handlers exposed to pesticides with toxicity category III or IV eye irritation potential. Two comments requested that goggles, chemical-resistant gloves, chemical-resistant aprons, and chemical-resistant footwear be required so that the contaminated attire would not be taken home. The Agency has considered the comments regarding the personal protective equipment for pesticides in toxicity categories III and IV and has determined that the personal protective equipment proposed is adequate to protect handlers of these pesticides. The Agency has written the personal protective equipment requirements to create an incentive for users to choose less acutely toxic pesticides whenever possible. 3. Types of personal protective equipment required--(a) Body Protection -- (i) Protective suits. In the current regulations "protective clothing" is defined as "at least a hat or other suitable head covering, a long-sleeved shirt and long-legged trousers or a coverall-type garment (all of closely woven fabric covering the body, including arms and legs), shoes and socks." The Agency deems this clothing inadequate to protect either handlers or workers entering treated areas before the expiration of the REI. The Agency proposed minimum personal protective equipment (PPE) requirements that would vary according to the acute toxicity; type of worker activity; route of exposure; and method of application. According to the proposal, all handlers and early-entry workers exposed to pesticides that are in toxicity category I or II because of either dermal toxicity or skin irritation potential would be required to wear a protective suit over normal work attire. Despite the definition of "protective suit" in a footnote to the personal protective equipment charts, comments demonstrated a tendency to confuse "protective suit" with "chemical-resistant suit". One comment requested that chemical-resistant protective suits never be required on pesticide labeling, since they may cause heat stress. Still another comment requested that chemical-resistant protective suits be required for all pesticides in toxicity categories I and II, especially for airblast applications. Two other comments requested chemical- resistant protective suits, such as Tyvek, be required for pesticides in toxicity category I. The Agency has changed the term "protective suit" to "coverall," and changed the definition to state: "Coverall" means any loose-fitting one- or two-piece garment that covers, at a minimum, the entire body except for the feet, hands, and head. The Agency considered requiring a chemical-resistant protective suit for pesticides in toxicity category I (acute dermal), but was persuaded that two layers of clothing provide adequate protection. To minimize dermal exposure to pesticides, protective garments must be worn to cover any body area(s) of concern. Woven cotton or cotton/polyester fabrics, are preferred for work clothing because they often are more comfortable to wear and they can be washed (Ref. A23). Appropriate protective coverings, such as coveralls, can reduce the exposure to pesticide users' trunk area, arms, and legs by 99 percent (Ref. 19). One study (Ref. A9) concluded: "use of rubberized clothing did not provide more protection than the regular work clothing (consisting of standardized cotton shirts, trousers, and long-sleeved coveralls) based on urinary metabolites results." The Agency, however, allows users to wear a chemical-resistant protective suit as an alternative to the two layers of clothing if they choose to do so. The development of various types of disposable chemical-resistant garments made of nonwoven materials, such as Tyvek (spun bonded olefinic fibers), gives pesticide users a wider choice of protective materials. (ii) Work attire worn under the protective suit. One comment specifically supported the provision requiring normal work attire to be worn under a protective suit. Many others implied support by stating that the employer should provide, clean, and maintain the normal work attire for the handler or early-entry worker. Most comments on this provision asked the Agency to reconsider it; the objections centered on the heat-related illness and discomfort problems associated with wearing two layers of clothing in the summer months. Other comments were concerned about possible contamination of the "normal work attire" through a spill or other mishap and questioned whether the employee would then have to wear or take home the normal work attire for cleaning. An owner of a pesticide application business in Wisconsin (Ref. C182) stated: The study cited in establishing this requirement [two layers] was . . . not only unfair but insignificant; since a single layered short sleeved shirt was compared for exposure probability to a long sleeved, double layered one. The Industrial Commission of Arizona (Ref. C130) stated: . . . the more uncomfortable protective clothing becomes, the more likely it is that employees will avoid wearing the protective clothing or not complain to the appropriate authority about the lack of protective clothing in the event the employer fails to furnish such clothing. . . . Because it is entirely possible for normal work attire to become contaminated even though a protective suit may be worn over it, by wearing protective clothing in place of normal work attire, the worker will (1) be less likely to wear contaminated normal work attire home thus exposing family members, (2) be less likely to continue to wear contaminated normal work attire day after day, and (3) be more likely to become aware that a protective suit has become contaminated and take corrective measures. The United States Department of Agriculture (Ref. C189) stated: The use of 2-layers is impracticable and the true need for additional layering is questionable . . . EPA should base such requirements on scientific studies which support the need for such extreme protection. One study on handlers with bare arms is not sufficient to justify the requirement. Some comments, including the Florida Cooperative Extension Service (Ref. C70), stated that convincing handlers to wear a coverall and chemical-resistant gloves would be a major breakthrough in personal protective equipment and that this provision might discourage any compliance. Another comment stated that, in an emergency, stripping the coverall off quickly, washing down, and putting on the extra coverall that is required to be kept at the decontamination area would be more protective than the false sense of security brought by two layers of clothing. The Agency considered the comments on the requirement for handlers and early-entry workers to wear a long-sleeved shirt and long-legged pants under a coverall in activities involving pesticides in toxicity category I or II because of dermal toxicity or skin irritation. A review of the literature revealed a growing support for the concept of layering as an effective protective system. The study by Davies, et al. (Ref. 19) indicated the benefit of layering. Slocum, et al. (Ref. A33) in the discussion of their study state, " These findings are consistent with laboratory studies that indicated additional layers . . . provided a good barrier to pesticide penetration." The results of another study (Ref. A10) revealed that the observed differences in deposition resulted in part from the presence or absence of two layers of clothing over the dermal sampler; the lowest median deposits occurred under two layers of clothing. Laughlin et al. (Ref. 46) state: An undergarment layer offers better protection than does a single layer of clothing. . . . The contamination of the second layer is generally less than 1% that of the contamination of the outer garment layer; thus, the pesticide is not available for dermal absorption. One study (Ref. 38) found that: "Cotton overalls [worn over cotton work shirts and pants] provided excellent protection." The Agency recognizes that the use of personal protective equipment in hot, humid working conditions may lead to heat-stress and discomfort. But the alternative of requiring the use of a single-layered chemical- resistant suit would not solve these problems. The Agency does not consider a coverall without an additional layer of clothing to be protective for pesticides with an acute dermal toxicity value in toxicity category I or II. The Agency does recognize, however, that pesticides in toxicity category I present a greater hazard and risk than those in toxicity category II. Therefore, the Agency will require either a chemical-resistant protective suit or a coverall worn over a long-sleeved shirt and long-legged pants for pesticides classified as toxicity category I for dermal and skin irritation. For pesticides classified in toxicity category II for dermal and skin irritation, a chemical-resistant protective suit or coveralls worn over a layer of clothing that covers the trunk area (i.e. T-shirts and shorts) is specified. (iii) Normal work attire. In the proposal, the Agency defined "normal work attire" as long-legged pants, long-sleeved shirt, shoes, and socks. The proposal specified that normal work attire was not personal protective equipment; therefore, it would not have to be provided, cleaned, or maintained for the worker. Several comments requested that EPA clarify that its intent was to establish normal work attire for pesticide handling activities and not for all work on agricultural establishments. The National Agricultural Chemicals Association (Ref. C311) stated: NACA questions whether the Agency intends to mandate the wearing of long-sleeved shirts and long pants by all workers covered by part 170 at all times, as the definition implies. There needs to be a distinction between personal protective clothing and the clothing which a worker would normally wear around a farm while performing routine duties, other than involving pesticides. To eliminate the confusion, the phrase "normal work attire" is not used in the final rule. Personal protective equipment and other required clothing will be specified on pesticide labeling for each toxicity category. (iv) Chemical-resistant apron. A chemical-resistant apron reduces frontal exposure during mixing and loading and during cleaning of contaminated equipment. An apron prevents contamination of the garment worn under it. A suitable apron can be valuable when liquid formulations are being handled, but it is also useful when handling dry formulations, such as wettable powders. The Agency proposed that mixers and loaders of pesticide formulations in toxicity categories I and II because of acute dermal toxicity or skin irritation potential be required to wear a chemical-resistant apron over a coverall, unless a chemical-resistant suit is worn. EPA also proposed that an apron be worn when contaminated pesticide equipment is being cleaned or repaired. Some comments requested that a chemical-resistant apron be permitted in lieu of the protective suit for applicators. The Agency is not persuaded to allow pesticide applicators to substitute a chemical- resistant apron for coveralls because it would not protect the arms. Other comments expressed concern that an apron is a safety hazard when climbing on spray tanks or when working around mechanical devices. Chemlawn (Ref. C170) stated: We concur that a chemical-resistant apron may afford added protection to a mixer/loader, but disagree with making the wearing of an apron a requirement. Around some equipment, an apron presents a safety hazard from tripping (while bending over or climbing upon equipment) and may also become entrapped in moving mechanical parts. The requirement gives handlers a choice of apparel; in circumstances where the use of an apron is a safety hazard, a chemical- resistant suit could be substituted. One comment stated that since a handler is often the mixer/loader, the applicator, and the person who cleans the contaminated equipment, it is burdensome to switch from one outfit to another. In reality, the burden of switching from one outfit to another is only the putting on and taking off of an apron. If handlers so choose, they can continue to wear the apron during application. Another comment suggested that EPA define an apron as extending from mid-chest to knee. EPA agrees. After considering the comments on this topic, the Agency has decided to make no changes in its proposal to require mixers, loaders, and persons cleaning equipment using pesticides in toxicity category I or II (dermal toxicity) to wear a chemical-resistant apron over a coverall, unless a chemical-resistant suit is worn. (b) Hand protection. Dermal exposure of the hands and forearms is the most significant route of pesticide exposure for hand laborers, applicators, mixers, loaders, and other persons who are exposed occupationally to agricultural pesticides and their residues (Refs. 17,23,48,107,108,109). It has been estimated that appropriate use of chemical-resistant gloves can reduce hand exposure by up to 98 percent (Ref. 31). The Agency proposed to require chemical-resistant gloves for all early-entry and pesticide handling situations, with the exception of toxicity category IV (relatively nontoxic) pesticides. Leather gloves, uncoated cloth gloves, and fingerless gloves are not acceptable for use as protective gloves because liquid and particulate pesticides can penetrate these materials. Such gloves cannot be cleaned adequately, and they are too costly to be considered disposable. The Agency considered an exception for handlers and early-entry workers working with roses, because sturdy, flexible, glove materials such as leather will withstand the wear and tear from thorns while providing sufficient dexterity. A few comments discussed glove materials. California Department of Food and Agriculture (Ref. C248) and the Western Agricultural Chemicals Association (Ref. C184) commented that the preliminary results of their studies indicated that cotton gloves are protective, especially for early-entry workers. Two comments asked for a clarification on whether cotton-lined gloves are acceptable as chemical-resistant gloves. One suggested that cotton-lined gloves be prohibited; the other requested that they be allowed if disposed of after each use. The greenhouse industry asked to be permitted to wear leather gloves while working with roses and other thorny plants. The Agency has determined that multiple-use cotton gloves and cotton-lined gloves are not acceptable for use in pesticide handling or early entry because they are difficult to decontaminate after use and they are too expensive to be disposable. If suitable puncture resistant and chemical resistant gloves cannot be obtained, the Agency will allow the use of leather gloves for working in thorny plants or abrasive crops, with two restrictions. Chemical-resistant glove liners must be worn, and once the leather gloves have been used for early-entry or handling activities, they may not be used for any other activities. A few comments asked how to determine which glove materials are chemical-resistant to specific pesticide formulations. Most stated that either the pesticide registrant or EPA should give more specific guidance on this topic. The Agency concurs and intends to develop a guidance package for pesticide users on the selection, use, and maintenance of chemical- resistant gloves. The final rule will require registrants to list on the product labeling examples of the appropriate type of glove material(s) to use with their product. This regulation requires all agricultural pesticide users to select, use, and maintain these gloves correctly. EPA will continue to cooperate with American Society for Testing and Materials to develop testing criteria for chemical-resistance in gloves and to sponsor research into the chemical-resistance of various glove materials. (c) Head protection. The skin on the back of the neck and the temple area absorb pesticides more readily than other dermal areas usually exposed (Refs. A20,A21). The Agency proposed to require headgear for handlers (and early-entry workers) when exposure from overhead dusts or sprays is possible, such as in airblast spraying and in flagging. Two comments requested that EPA require a chemical-resistant hat or hood for handlers of pesticides in toxicity category I or II in all exposure circumstances. The Agency will continue to require the use of a chemical- resistant hat or hood for pesticides in toxicity categories I and II (dermal/skin irritation) if overhead exposure to the pesticide is likely. (d) Foot protection. The feet may be exposed to pesticides from spills, splashes, downward sprays, and from walking through weeds, grasses, and agricultural plants after application while sprays are still wet. The Agency proposed to require chemical-resistant footgear for handlers and workers entering areas treated with pesticides in toxicity category I or II (dermal/skin irritation). A few comments stated that wearing chemical-resistant footwear can be very uncomfortable and may cause a foot disease similar to trench foot. Because of the problems inherent in decontaminating nonchemical- resistant footwear, the Agency will continue to require the use of chemical-resistant footwear for pesticides in toxicity categories I and II (dermal toxicity or skin irritation). The Agency recognized that forestry workers use leather boots for durability and safety in rough terrain; it sought comment on requiring chemical-resistant footgear for these workers. Many comments from the forestry industry urged the Agency to reconsider the requirement for chemical-resistant footwear for handlers in forests. Oklahoma Department of Agriculture (Ref. C12) stated: Using chemical-resistant footgear over leather boots in rough terrain is impractical and unsafe. . . .In forests, boots are worn mostly for traction on rocks and debris, protection from pests and snakes, as well as durability. If you propose to require some type of protective footwear, we doubt whether it would be taken seriously, unless specifically modified for forestry use. The United States Department of Agriculture (Ref. C189) stated: If a chemical-resistant boot cover is put over a breathable boot, the boot cover cancels out the breathability of the boot. In forestry, most sites are uneven and the terrain is covered with debris, brush, and/or grass. The safety hazard of working in this kind of environment increases if chemical-resistant boot covers are required to be placed over the lug soled, leather boots. The California Department of Food and Agriculture (Ref. C248) stated: . . .several factors . . . need to be addressed: (1) What is the exposure liability via the feet for the job task? (2) What considerations are there other than "exposure" i.e., foot support, traction, etc., that may address other more serious may take precedence over exposure considerations? (3) Is footwear available that will provide exposure protection as well as meet the mechanical requirements for the environment and not induce foot heat stress? On the other hand, the New York State Department of Environmental Conservation (Ref. C298) stated: It is unlikely that forestry workers, as a part of their general duties, would be required to enter a treated area prior to expiration of the period of time required to have elapsed. Therefore, we agree with the requirement that those workers who must re-enter the area early or handlers applying the pesticide be required to wear protective footgear rather than leather boots. The use of durable protective footgear worn over breathable boots is acceptable. The Agency is persuaded by the comments that handlers working away from their base of operations should not be required to wear chemical- resistant footwear in all cases. For physical safety, applicators using pesticides in rough terrain will be permitted to wear leather boots during the application if chemical-resistant boots of sufficient traction and durability are not obtainable. Early-entry workers in similar situations also may wear leather boots if chemical-resistant boots of sufficient traction and durability are not obtainable. These exceptions to the requirements for chemical-resistant footwear do not apply to handlers or workers in other use sites. Leather contaminated with pesticides cannot be cleaned adequately and employees would have a high risk of injury from wearing boots contaminated with highly toxic or concentrated materials. (e) Eye protection. The eyes and face may be exposed whenever there is a chemical splash or a high level of fumes, vapors, or dusts during mixing, loading, and applying pesticides or whenever residues are dislodged from foliar surfaces at or above the head of the worker. The Agency proposed to require the use of goggles or a face shield by all handlers and early-entry workers exposed to pesticides with toxicity category I or II eye irritation potential. Goggles or a face shield also would be required during mixing and loading using pressurized closed systems because of the high risk of exposure and serious eye injury if the system ruptured. Many comments pointed out that goggles and face shields are uncomfortable to wear and they fog during prolonged use. Zieger and Sons, Inc. (Ref. C19), a rose grower, said: . . .we will have a problem wearing any kind of goggles in hot weather. I wear glasses and I am always cleaning my sweat from the lenses in hot weather which means my hands are on my face. How am I to wear two sets of lenses and be able to see anything? This will be dangerous to myself and my workers. The Occupational Health Legal Rights Foundation (Ref. C156) commented: Some provision needs to be made for workers who wear eyeglasses to allow them to have the protection of required goggles and still see their work. . . The solution may be for EPA to consider requiring a protective device designed for wearers of eyeglasses, giving the equivalent protection. A few comments requested that safety glasses with front, brow, and temple protection be allowed for eye protection in addition to goggles and face shields. They indicated that handlers and early-entry workers were more likely to wear the relatively more comfortable safety glasses. The Hawaiian Commercial & Sugar Company (Ref. C115) commented: Eye protection should be based not only upon product toxicity but also on application method. Wiping, or spraying close to the ground with low pressure systems would not expose workers to eye hazards as encountered in orchard situations. Goggles should be required for operations involving exposure from misting or overhead spraying. Safety glasses are sufficient in other situations. Chemlawn (Ref. C170) asked: We would like to know what evidence the Agency has evaluated that precludes the inclusion of safety glasses with eye shields as acceptable eye protection for reentry? . . Safety glasses are an economical alternative for which we believe one can obtain better worker compliance than for a face shield or goggles. . . .Safety glasses contribute more effectively to an overall vision protection program wherein one can encourage regular wearing and protection against foreign body and impact as well as chemical splash. The California Department of Food and Agriculture (Ref. C248) stated: The potential hazard from some pesticides in toxicity category one, primarily corrosive effects, may dictate the need for maximum protection. For most other pesticides and use circumstances there are several styles of eye protection, some of which provide near goggle-level protection at greatly increased levels of wearer comfort and have a lesser tendency for fogging. The Agency is persuaded that safety glasses with protective shields at the eyebrows and temples protection would provide adequate eye protection in most handling and early-entry situations and would be more acceptable to workers and, thus, more likely to be used. The regulation, therefore, has been modified to require the use of "protective eyewear" in handler and early-entry situations involving toxicity category I and II (eye irritation) pesticides. When "protective eyewear" is required, the employer shall provide goggles, a face shield, or safety glasses with side shields and brow guards. A full-face respirator is also acceptable. The Agency is aware that some pesticides in toxicity category I for eye irritation are so hazardous that they require eyewear more protective than shielded safety glasses. For those products, the Agency may require, on a case-by-case basis, the labeling to include a requirement for the use of goggles or a face shield. (f) Respiratory protection. The Agency proposed to require handlers and other workers who enter treated areas before vapors have dispersed to wear respiratory protection devices approved by the National Institute for Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration (MSHA), if the pesticide is in toxicity category I or II for inhalation toxicity. The Agency did not propose to require respiratory protection for handlers of pesticides with inhalation toxicity classified in toxicity category III or IV or for workers entering after pesticide vapors have dispersed. Several comments pointed out that NIOSH does not test respirators for individual pesticides and that to state "a NIOSH-or MSHA-approved respirator" does not indicate whether a dust mask, a canister or cartridge respirator, or an air-supplied respirator is required. Willson Safety Products (Ref. C4) commented: Many times throughout the proposal the need for personal respiratory equipment is cited. The document only gets as specific as calling out NIOSH/MSHA approved devices, and never as specific as detailing type or schedule. As a result of the "generic" specification, Willson feels that potential exists for severe misuse of respiratory equipment which could result in bodily injury. The Industrial Safety Equipment Association (Ref. C186) stated: There are three types of NIOSH/MSHA approved respirators which can be used for protection against pesticides--an air-purifying respirator with pesticide cartridge/filters, an airline respirator, and a self-contained breathing apparatus. Both the air-purifying and airline respirators have limitations on their use depending on the concentration and toxicity of the pesticide. None of the approved respirators is approved for a specific pesticide and, in fact, the NIOSH mandated text for the limitations for air-purifying respirator approval label is "Refer to Pesticide Label for Limitations on Use." . . . NIOSH recognizes that the pesticide manufacturers are the only ones in a position to make recommendations on the type of respirator that will afford proper protection for the user of their products when used according to their instructions. Therefore, it must be mandated that the pesticide manufacturer give respirator instructions on his product label. Most comments urged that before a respirator is used mandatory respirator fit-testing and a physician's approval should be required. The National Agricultural Chemicals Association (Ref. C311) stated: NACA feels that the Agency has inadequately addressed the issue of equipment effectiveness. An improperly fitted respirator will not provide adequate protection . . .Furthermore, the Agency erred in referring to manufacturer's instructions, e.g., specifying the changing of respirator filters, etc., since manufacturers do not provide this information. . . . Where respirator protection is required, its selection, use, and maintenance should be governed by a respiratory protection program as described in 29 CFR 1910.134 [OSHA Standards] The Occupational Health Legal Rights Foundation (Ref. C156) states: Workers should be evaluated by a physician to see if there are any pre-existing cardiopulmonary problems that could kill a worker were he or she to wear a respirator. The National Farm Workers Health Group (Ref. C179) states: A comprehensive respirator program is an essential and accepted requirement of any standard occupational safety program. The lack of such a program will lead to use of poorly fitting, improperly maintained, and contaminated respirators, increasing the risk of overexposure and pesticide poisoning. Moreover, it creates a false sense of security. Safe Alternatives for Farm Laborers (Ref. C195) said that providing workers with forced air (positive-pressure) respirators in lieu of the more traditional negative-pressure respirators would eliminate some of the fitness and fit testing problems. The Occupational Safety and Health Law Center (Ref. C185) questioned the effectiveness of respirators in field applications where the conditions are hot and replacement is difficult. The Agency agrees with the comments regarding the need for a comprehensive respirator-use program encompassing selection, correct use, and appropriate maintenance of respirators. EPA has developed a guidance document on the use of respirators in agriculture. The language in the part 170 offers some guidance on changing filters, cartridges and canisters in the absence of direction from the manufacturer and part 156 requires the registrant to specify what type of respirator should be used with a product that requires respiratory protection for handling. When respirators with dust filters are used, filter elements are to be replaced immediately if breathing resistance becomes excessive, or if the filter element has physical damage, such as tears and holes. In addition, they must be replaced as soon as recommended by the manufacturer or pesticide product labeling, whichever is more frequent. In the absence of any other instructions or indications of service life, they must be replaced at the end of each day's work period. When respirators with gas- and vapor-removing cartridges or canisters are used, the cartridges or canisters are to be replaced immediately if the wearer detects odor, taste, or irritation. In addition, they must be replaced as soon as recommended by the manufacturer or pesticide product labeling, whichever is more frequent. In the absence of any other instructions or indications of service life, they must be replaced at the end of each day's work period (Para 170.240(f)). (g) Exceptions to personal protective equipment requirements-- (i) Aerial applicators. The Agency proposed to allow pesticide applicators in enclosed cockpits of aircraft to wear normal work attire. The Agency is concerned about contamination of the hands when the pilot is entering or leaving the cockpit of an aircraft whose outside surface contains pesticide residues. Contaminated hands could contaminate the air and surfaces in the cockpit and negate the benefit of the enclosed cockpit. Therefore, the Agency proposed to require pilots to use chemical-resistant gloves when entering or exiting an enclosed-cockpit aircraft whose exterior was contaminated by pesticide residues. Representatives of the agricultural aviation industry requested that gloves not be required in this situation. The National Agricultural Aviation Association (Ref. C165) stated: The personal protective equipment requirement for agricultural aircraft pilots, specifically gloves, seems to be without merit. Studies done on the relative health of ag pilots does not indicate that a problem exists due to ingress and egress from the cockpit. Considering the results of ag pilot health surveys and the required annual Federal Aviation Administration medical examinations, current pilot work practices appear to satisfy the intent of the proposed regulation. A few comments were concerned about the possible presence of contaminated gloves in the cockpit. The Association of American Pesticide Control Officials (Ref. C319) states that: "Contamination of cockpit needs to be addressed, contaminated gloves used many times and stored in cockpit could result in increased exposure." The Agency is not persuaded by the comments that the requirement for chemical-resistant gloves for pilots boarding or deplaning from a contaminated aircraft is excessive or superfluous. The Agency does not intend that the pilot store the contaminated gloves unconfined in the cockpit. Between uses, the gloves should be kept in a sealed plastic bag. Both the gloves and the plastic bag should be washed after each day of use or discarded, as is required for all personal protective equipment in subpart B and C of this rule. The Agency proposed to require that pilots in open cockpits wear the personal protective equipment required for other applicators of the pesticide, except that chemical-resistant footwear may be omitted and a helmet with a visor may be worn in lieu of a hat and goggles or face shield. Comments from the agricultural aviation industry requested exemption from personal protective equipment even if flying in open cockpits. They cited years of data indicating no adverse effects from such a practice. The National Agricultural Aviation Association (Ref. C165) stated: Unlike ground equipment, spray materials delivered by aircraft are not likely to enter the cockpit whether it is closed or open. Further, any equipment in the cockpit unnecessary to the safe operation of the aircraft in accordance with the Federal Aviation Regulations seems inappropriate to NAAA. Enclosed cockpits and gloves, in NAAA's opinion, would not contribute to an already outstanding flight safety record for agricultural aircraft. The Butte County Mosquito Abatement District (Ref. C3) stated: [Our] pilot uses coveralls, but no gloves nor respirator and the cockpit is open. We normally fly over 50,000 acres with parathion each year. [Our] records show that our program has been adequate, and there is no need for more requirements. The Agency is convinced that pilots in open cockpits may be exposed to the pesticides they are applying in some circumstances. Under crosswinds and other weather conditions, the pesticide may be hurled back at the cockpit. Also, some types of turns may result in the aircraft flying through the swath of pesticide. Thus, EPA has determined it is prudent to continue to require limited personal protective equipment for aerial applicators in open cockpits. The Agency has decided to retain the requirements originally proposed. Pilots in enclosed cockpits will not be required to wear personal protective equipment. Pilots in open cockpits must wear the personal protective equipment required for a ground applicator of the product in use, except that chemical-resistant footwear is not required, and a helmet with visor may be used in lieu of a hat and goggles or face shield. Pilots in both types of equipment must wear gloves when entering or exiting a plane whose exterior is contaminated by pesticide residues. (ii) Vehicles with enclosed cabs. The Agency proposed that pesticide handlers in the enclosed cabs of ground vehicles should be exempt from personal protective equipment requirements. It proposed that if the enclosed cab does not contain a properly functioning gas- or vapor-removing ventilation system, then any labeling requirement for a respirator is still in effect, but all other personal protective equipment is waived. Fully enclosed cabs without air filtration have been shown to reduce dermal (but not respiratory) exposure substantially for airblast applicators (Ref. 12). The Agency was concerned that heat buildup in unventilated enclosed cabs might lead applicators to open windows for comfort, which would negate the benefit of the enclosed cab. The Agency specifically sought comment on this issue. The Agency also was concerned about the possibility of handlers leaving the enclosed cab in the treated area, becoming contaminated, and then returning to the enclosed cab. Therefore, EPA proposed that all personal protective equipment required for a ground applicator of the pesticide must be available for use any time the handler leaves the cab in the treated area. Most comments were concerned about the tendency of applicators to open the windows of the cab on a warm day, thus negating the protection. Many stated that full personal protective equipment should be required for operators in an enclosed cab without ventilation. Migrant Legal Action Program, Inc. (Ref. C126) states: Persons in enclosed cabs should be required to wear protective clothing in the cab. Otherwise it is likely that such workers will exit the cab to make minor repair without first putting on he protective attire. Moreover, it is likely that such workers would not be able to put on a protective suit while sitting in the cab, even if they wanted to. The United States Department of Agriculture (Ref. C189) wrote: By requiring the operator to wear appropriate clothing while mixing and loading (which in most cases he will do) and anytime the operator leaves the cab, this question is negated. The operator will likely wear the protective clothing during application because of the hassle of removal and storage in the cab. Driscoll Citrus Service, Inc. (Ref. C253) states: There is no way to eliminate workers having to get out of the cab in the treated area. Therefore, I feel growers will say that since the worker must wear the protective clothing anyway there is no reason to spend money on a protective cab. If the same rule that applies to pilots [gloves only when entering or exiting a contaminated aircraft] was applied to cabs, I feel total worker exposure would be reduced. Deere & Company (Ref. C183) commented that it had conducted tests which demonstrated that the largest contribution to chemical contamination inside the cab enclosure was contaminated clothing (gloves on the steering wheel or dash, etc.) The Agency acknowledges the concerns of some comments regarding the possible over-ride of the enclosed cab's protection either through opening the windows of the cab on a hot day or by contaminating the interior of the cab with contaminated clothing or equipment. However, EPA welcomes technological advances that would eliminate or substantially reduce exposure for pesticide handlers and it is clear that an enclosed cab used correctly is protective. Furthermore, the Agency is aware that pesticide applications in many regions of the country take place where discomfort from heat is not a factor, even in enclosed cabs. The Agency is aware also of many situations where the applicator is not the mixer or loader or the person who repairs or adjusts the application equipment, and therefore would not be required to change into or out of personal protective equipment for these activities. Under these conditions, it would be inappropriate to require personal protective equipment in the enclosed cabs. Therefore, the Agency continues to waive the personal protective equipment requirements, with the exception of any respirator requirement, for applicators in enclosed cabs. If the windows of the cab are opened at any time during the application or the enclosure is otherwise breached, the cab is no longer considered enclosed and applicators would be required to wear the personal protective equipment required on the pesticide labeling for applicators of the product. The Agency also wants to clarify that users would need to put on the personal protective equipment when leaving the cab in the area already treated only if they will have contact with pesticide-treated surfaces. They may leave the cab for a rest stop or other reason (other than handling pesticides) without putting on personal protective equipment as long as they are not in the treated area. The driver of a boom sprayer or most airblast equipment may leave the cab and walk forward and away from the just-treated area without personal protective equipment. The Agency is concerned about contamination of the interior of the enclosed cab from pesticide-contaminated clothing worn or taken into the cab. Therefore, the Agency changed the language of the rule to prohibit such an action. The Agency proposed that if the enclosed cab has a properly functioning, positive-pressure ventilation system that removes vapors from the air, all personal protective equipment, including the respirator, would be waived. Studies indicate that positive-pressure, charcoal-filtered ventilation systems on enclosed cabs can remove more than 99 percent of pesticide vapors and sprays during air intake (Ref. 90). A few comments concurred with the proposal not to require personal protective equipment, including a respirator, if the enclosed cab is equipped with positive-pressure ventilation. Dow Chemical Company (Ref. C167) stated: We support the requirement for some type of enclosed cab while orchard air blast spraying, but oppose the need for the cab to be equipped with a positive-pressure charcoal filtered air conditioned system. Even for this means of application [air blast spraying], the major route of exposure is dermal and the added value of an air conditioned cab will be relatively low relative to cost. Furthermore, there are no data to support the need or value of a positive-pressure charcoal-filtered air conditioned system, and data would be needed to define the required maintenance of a filtering system before these are required. Deere & Company (Ref. C183) wrote: Deere believes based on tests that it has conducted, that the basic exclusion for personal protective equipment is desirable. Two other comments stated that enclosed cabs were unproven as protection for airborne hazards and that data are needed to demonstrate the effectiveness of the protection offered by an enclosed cab. Other comments, including Dow Chemical Company, Deere & Company, and Driscoll Citrus Service (Refs. C167,C183, C253) praised EPA for rewarding engineering controls. Deere & Company (Ref. C183) also responded to preamble discussion of a possible requirement for charcoal filters in ventilation systems by stating: Our tests indicate that introducing a charcoal filter into the operator enclosure ventilation system offered no measurable improvement in the overall efficiency of the air cleaning system. The chemicals applied were toxaphene and methyl parathion and the solvent carrier was xylene. All exposure data resulted in less than 7% of acceptable limits. (Miller, et al., 1975 enclosed with Deere comments) . . . Whether charcoal filters are mandated or conventional filters, our current review of the literature did not reveal any practical means for operators to recognize when (or if) the filter becomes saturated with chemicals. In our own studies, no breakout from the filter occurred after 42 spraying applications. Even so, the Agency should consider this a research priority so they can provide guidance on filter change frequency. We would also suggest that if a pesticide is not absorbed by a standard filtration media, it should be the duty of the pesticide formulator to state this concern on the label and the product's MSDS sheet and to define an alternative filter media for the operator enclosure. The Agency agrees with the comments that indicated that EPA should use incentives to encourage the use of engineering controls instead of personal protective equipment when such technology exists. In the final rule, persons occupying an enclosed cab that has a properly functioning ventilation system, which is used and maintained in accordance with that manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a government agency to provide respiratory protection equivalent to or greater than the respirator required by the pesticide labeling, may substitute a long-sleeved shirt, long-legged pants, shoes and socks for labeling-specified personal protective equipment. The Agency is persuaded that the specification of a charcoal filter is not essential to the efficacy of the air cleaning system. 4. Duties relating to personal protective equipment--(a) Providing personal protective equipment. The Agency proposed that employers would provide pesticide handlers and early-entry workers with all personal protective equipment required by the pesticide product labeling for a particular use situation. Safe Alternatives for Farm Laborers (Ref. C195) suggested: The term "provided" might be more clearly spelled out. According to Oregon law, workers are "provided" with certain types of protective clothing, but the cost is docked from their paychecks. Federal rules need to clarify who pays for PPE and who pays for its maintenance. We suggest that the growers can absorb the cost of PPE better than workers. The American Federation of Labor and Congress of Industrial Organizations (Ref. C211) stated: The regulations must also make clear that it is the responsibility of the employer to provide protective clothing and equipment. This means that the employer must pay for the clothing and equipment and be responsible for its cleaning and maintenance. It has been our experience that unless the regulations specify that employers must pay for equipment and clothing, employers will attempt to put this burden on workers. The North Carolina Farm Bureau (Ref. C180) asked whether personal protective equipment owned by the handler can be used. The Farm Worker Justice Fund (Ref. C157) requested that the language be changed to require employers to "provide clean and intact" personal protective equipment so that the equipment will not have holes, abrasions, etc. EPA has changed the wording in the final rule to clarify who is responsible for fulfilling the various requirements and provisions. Thus, this section now specifically states that the employer shall provide the required personal protective equipment. This provision does not prohibit handlers who own personal protective equipment, such as a respirator, from using that equipment. The employer, however, would be required to clean and maintain such equipment, and the employees would not be allowed to wear home or to take home the equipment unless it had been cleaned first. The final rule requires the employer to provide the appropriate personal protective equipment in clean and operating condition, which is, in the Agency's opinion, essentially identical to "clean and intact." The final rule does not require personal protective equipment for employees who are working in the vicinity of a pesticide application but who are not in the area being treated; no one who is not involved in the application may be in the area being treated during the application. A few comments questioned who would provide "normal work attire" and whether "normal work attire" is considered to be personal protective equipment. The Society of American Florists (Ref. C100) suggested: EPA needs to clarify that the Agency only intends to define normal work attire for handling and re-entry activities and that normal work attire is not defined for any other time. By doing this, the Agency will assure that the owner/operator can require his employees to wear long sleeves, pants, shoes and socks as normal work attire during handling and re-entry activities without being required to purchase these things as protective equipment for his employees. The Agency does not include normal work attire in the definition of personal protective equipment; therefore, it is not part of the employer's responsibility and would be provided by the handlers or early-entry workers themselves. (b) Providing a change area. The Agency proposed that a clean place be provided for changing into and out of personal protective equipment and for storing personal clothing. The Agency also proposed to require soap, water, and towels to be available at the end of any exposure period so handlers and early-entry workers could wash themselves. The water would have to be available in sufficient quantity to allow thorough washing of the entire body, if necessary. Many comments misinterpreted the proposed rule as requiring a specific room or rooms, (i.e., a change room and a wash room) to meet the requirement for change areas. These comments indicated that it would be burdensome to provide such a room. One comment asked how many "places" an owner or operator would be required to maintain--pointing out that reference is made to a storage place, a mixing and loading place, a clean place, a personal protective equipment storage place, and a clean place for drying and storing personal protective equipment. Several comments requested that showers be mandatory at the change area where handlers and early-entry workers change out of contaminated personal protective equipment and other attire at the end of the day's exposure period. A few comments specified hot showers be provided for change areas during cold weather. The Occupational Health Legal Rights Foundation (Ref. C156) stated: . . . EPA fails to consider . . .that most of the "surfactants" in soap are not activated by cold water. Where workers are given only cold water from faucets to wash up with, they are less likely to thoroughly wash their entire bodies to remove pesticides. . . EPA should evaluate the technologies available for heating hot water and showers . . . and amend the Proposed Regulations accordingly. The National Agricultural Chemicals Association (Ref. C311) and the New England Chemicals Association (Ref. C160) acknowledged the need for keeping contaminated clothing out of workers' living areas and supported the concept of work clothing, clean change areas, and other personal hygiene practices such as showers, but questioned whether such provisions are practical in an agricultural setting. One comment asked EPA to require that all workers potentially exposed to pesticides have access to the change area, including soap, water, and towels, and that early-entry workers and handlers be guaranteed compensation during the period while they are changing into and out of personal protective equipment and for the time they are washing. Comments representing the forestry industry indicated that providing changing areas in forestry situations is difficult and burdensome. EPA believes that minimizing dermal exposure to pesticides and their residues is a key element in reducing the risks associated with exposure to pesticides. Much of the pesticide exposure in handling activities and early-entry activities is to the skin. To remove residues from the skin as soon as possible after exposure, workers must remove contaminated work clothing and wash themselves. Showers, especially hot showers, would be ideal, but the costs would be prohibitive in some situations. Showers would require running water, a water heater, and separate shower and dressing rooms for males and females. Since the dermal exposure in most handling and early-entry situations is to the hands, forearms, and face, the Agency has concluded that handlers and early-entry workers will be able to wash off pesticide residues adequately without showers. EPA is not requiring a "room" for these activities; any relatively clean area, such as an outdoor area away from the pesticide-treated area, would suffice. The "clean" place need not be the same place for all workers or for each use. For example, an employer may allow workers to leave their unneeded personal items (jackets, lunches, etc.) in a place near where they meet to receive their daily assignments. There may be another place, near the area scheduled to be treated, where handlers put on personal protective equipment. And there may be a third place, perhaps near a source of running water, where handlers take off their contaminated personal protective equipment and wash. The Agency has considered the comments from the forestry industry and has determined that the requirements for a change area are not unduly burdensome, even for those applications that take place away from any vehicular access. These applicators are still required to remove their personal protective equipment and wash at the end of the work shift. EPA has concluded, however, that the requirement that decontamination/eyeflush water be provided in such situations is unduly burdensome. Therefore, in such situations, "clean" water from a stream or lake will be acceptable in lieu of decontamination/eyeflush water. (c) Cleaning and maintaining equipment. The Agency proposed that personal protective equipment would be cleaned and maintained for workers. Employees are not to be allowed to wear home or to take home contaminated personal protective equipment. Normal work attire (long-sleeved shirt, long-legged pants, shoes, and socks) was not considered to be personal protective equipment under the proposal and, therefore, would not have to be maintained by the employer. A few growers commented that they provide, clean, and maintain personal protective equipment for their handlers. Several comments, including the Work Group on Pesticide Health and Safety, Mount Sinai Medical Center, and New Jersey Agricultural Experiment Station (Refs. C193,C297, C308), asked EPA to clarify who must clean and maintain the personal protective equipment. Several comments stated that cleaning and maintaining personal protective equipment is burdensome. Blue Mountain Horticultural Society (Ref. C64) stated: "Employees should be responsible for the cleaning and maintenance of their own PPE." E.I. du Pont de Nemours & Company - Fibers Department; Industrial Safety Equipment Association (Ref. C177) and Texel Industries - Durafab Division (Ref. C285) suggest that EPA encourage or require the use of disposable garments and aprons to eliminate the need for cleaning and maintaining personal protective equipment. However, another comment stated that disposable garments are not an acceptable solution, because of the already burdensome problem of hazardous waste disposal. Rhone-Poulenc (Ref. C287) suggested that a properly trained employee should be able to wear or take home contaminated personal protective equipment. Wailuku Agribusiness Company (Ref. C326) suggested that providing, cleaning, and maintaining personal protective equipment should apply only to highly toxic pesticides. The Agency perceives the appropriate decontamination of personal protective equipment as a major area of concern. Significant levels of some pesticides can remain in clothing or equipment if it is not laundered correctly (Ref. 67) or if prescribed decontamination procedures are not followed. Surveys of pesticide users, especially agricultural workers, indicate that a large percentage do not follow any precautionary procedures when cleaning contaminated clothing and equipment. If protective clothing is reused without laundering, the protective effect may be reduced (Ref. A10). Therefore, the Agency has determined that it is appropriate for the employer to assure that personal protective equipment is cleaned and maintained properly before it is reused. The proposal required that after each use all personal protective equipment be washed thoroughly with detergent and hot water or be cleaned according to the manufacturer's instructions and dried thoroughly before being stored or be placed in a well-ventilated place to dry. The Agency also proposed that personal protective equipment be stored away from pesticide-contaminated places and be stored separately from personal clothing to avoid contamination of either clean personal protective equipment or clean personal clothing. A few comments misinterpreted the proposal as requiring laundry facilities on-site (on the farm, forest, or nursery, or in the greenhouse). Some comments requested that hot water not be required for laundering protective clothing because of the expense of installing water heating equipment and because "toxic vapors" might be produced. A few comments discussed the laundry procedure. Woodmont Orchards, Inc. (Ref. C63) said: Since most farms do not have laundry facilities on the premises, I expect that any laundry that is done will be taken to an ordinary coin-operated laundromat. To be melodramatic, what if the next person to use the machine puts in a load of baby clothes? . . . EPA does not provide sufficient guidance for the implementation of the proposed cleaning and maintenance. Two comments raised the question of appropriate decontamination for chemical-resistant protective clothing and equipment. The New England Fruit Growers' Council on the Environment (Ref. C143) stated: We suggest that the requirement that all protective clothing be laundered daily be changed. This requirement is certainly appropriate for the prescribed "protective suit," which is a simple fabric coverall. However, many growers are accustomed, especially when applying pesticides suspended or dissolved in a large amount of water (dilute applications) to require their applicators to wear outfits of rubber or other impervious material. The inside of a rubber suit is not contaminated by a single use, except under extraordinary conditions. Such suits are expensive, and are damaged by constant laundering in hot water. We fear that a blanket requirement for daily laundering without mention of type of material or degree of contamination will incline some growers to issue only the prescribed fabric overgarments, even in situations where impervious material would provide much better protection. Woodmont Orchards, Inc.(Ref. C63) concurred with the above statements and added: Conventional washing of this type of suit would probably result in low-level contamination of the inside surfaces which would not otherwise occur. . . . I suggest adding "chemical impervious suits, hats, boots, and gloves need not be washed or cleaned daily, but must be kept in a condition of cleanliness consistent with worker safety," or words to that effect. . . . during a normal spray application we might spray from 7 to 9 in the evening, and finish from 5 to 7 the next morning. It is impractical to require cleaning of this type of PPE "after any day on which it is used." Several comments raised the question of who would clean and maintain "normal work attire," i.e., long-sleeve shirts, long-legged pants, shoes, and socks worn during handling or early-entry activities. Many comments requested personal protective equipment be required instead of normal work attire for pesticides in toxicity categories III and IV expressed concerns about employees wearing or taking contaminated attire home. Several comments representing the forestry industry stated that it was awkward to clean and maintain personal protective equipment in typical forestry situations. Some of these requested that personal protective equipment and laundry requirements be eliminated for pesticides in toxicity categories III and IV pesticides and for diluted pesticides in toxicity categories I and II. The Agency has studied the comments on this issue. As stated above, normal work attire is not considered to be personal protective equipment and thus the employer has no responsibility to provide it. However, EPA is concerned about workers' wearing or taking home pesticide-contaminated clothing or equipment regardless of whether the clothing is provided by the employer or by the worker. The Agency therefore, is inclined to require that employers clean and maintain any attire a worker wears while handling pesticides or performing early- entry tasks. However, such an option was not discussed in the NPRM, and the economic impact of such a requirement has not been assessed. The Agency must study the costs and logistics involved in such a requirement and may publish a proposal on this issue for public comment at a later time. Although it would be prudent for employers to clean and to maintain pesticide-contaminated work clothing for their employees, it is not a requirement of this final rule. If a pesticide used in forestry requires the use of personal protective equipment, such equipment must be cleaned and maintained by the employer. This cleaning and maintenance need not be done on the employer's premises or immediately following use. EPA left flexibility in the requirement to allow for employers to collect contaminated personal protective equipment and clean it at their convenience at a location of choice. Therefore, employers of forestry workers could provide their handlers (and early-entry workers) with clean personal protective equipment for each day of handling activities and provide a chemical-resistant container that could be closed securely, such as a sturdy plastic bag, for storing the contaminated personal protective equipment until it is cleaned. EPA's directive to launder personal protective equipment in hot water and detergent was the alternative when there were no directions from the manufacturer on how to clean and maintain equipment. The goal is to remove pesticide residues as completely as possible so that the equipment is clean the next time it is used. Evidence indicates that nonchemical-resistant clothing and equipment, as well as many chemical- resistant items, should be cleaned in hot water and a heavy-duty detergent to remove pesticide residues most efficiently. If manufacturers of chemical-resistant gloves, boots, or suits indicate another method of cleaning and maintaining the equipment, such an alternative is acceptable. EPA proposed that persons responsible for cleaning the personal protective equipment would be informed that the equipment might be contaminated with pesticides. Only a few comments were received on this issue. One comment requested that the person cleaning the personal protective equipment be required to provide written verification that he has been warned of the hazards. The State of Maryland's Occupational Safety and Health agency (MOSH) (Ref. C80) suggests that the requirement state, "Inform . . . any person who cleans or launders protective clothing or equipment of the potentially harmful effects of exposure. . . . " EPA concurs with MOSH regarding the suggested wording change and has rewritten the rule to require the employer to inform persons who clean or launder personal protective equipment or other pesticide- contaminated items that such items may be contaminated with pesticides and of the potentially harmful effects from exposure to pesticides. They also must inform them of the appropriate procedure(s) for handling, washing, drying and storing such items, and warn them that personal protective equipment should be kept, washed, dried, and stored away from any other clothing or laundry. (d) Inspecting personal protective equipment. Some comments requested more specific guidance as to who would be responsible for inspecting the personal protective equipment before each day of use. A few suggested that the inspector be a certified applicator; others suggested that training on the appropriate inspection of personal protective equipment would be beneficial. It is the employer's responsibility to assure that the personal protective equipment is maintained properly, this includes inspecting the personal protective equipment for damage, etc. This may be done by the employer or by the employees if they have been instructed in the care and cleaning of personal protective equipment. The Agency believes that it isn't practical in many agricultural situations to require a certified applicator to inspect all personal protective equipment before each day of use. EPA concurs that pertinent information on procedures for inspecting personal protective equipment would be advantageous. The Agency has developed a guidance brochure on the appropriate maintenance and inspection of personal protective equipment such as goggles, face shields, gloves, boots, chemical-resistant suits, hats or hoods, and coveralls. Information on the inspection and maintenance of respiratory protection devices is also contained in a separate respirator guidance brochure. (e) Disposing of personal protective equipment. Several comments questioned what to do with contaminated personal protective equipment such as a protective suit (coverall) drenched with an undiluted pesticide in toxicity category I or II or with used respirator cartridges and filters. They requested the Agency either to rule that these items are not RCRA waste or to issue directions for their disposal. Two comments suggested that contaminated clothing be disposed of in the same way as empty pesticide containers. One comment asked if the wash water from laundering personal protective equipment is RCRA waste and if so, whether it should be allowed to enter septic systems and other private and public waste water systems. The American Farm Bureau Federation (Ref. C96) wrote: It [contaminated clothing] is recognized as a hazardous waste. What guidelines does the farmer follow for such disposal? Not all pesticides are considered hazardous wastes under RCRA. How does a farmer know which are considered hazardous wastes and which are not? Do the RCRA small quantity generator exemptions apply? One comment suggested that when personal protective equipment becomes drenched with diluted or undiluted pesticides in toxicity category I or II, it should be discarded. Another comment asked whether personal protective equipment drenched with pesticides classified as toxicity category III or IV should be discarded. Still another comment asked what "heavily contaminated" means. Data indicate that nonchemical-resistant materials such as cotton or cotton and polyester coveralls cannot be cleaned by any procedure once they have become soaked with highly toxic pesticides (Ref. 33). Even after being laundered three times, some fabrics contaminated with concentrated pesticides can still contain high levels of pesticide residues (Ref. 34). The Agency has determined that such garments, rags, shoes, gloves, hats, aprons, etc., may not be reused and must be discarded. EPA intends to develop appropriate procedures for disposal of such items. In the interim, each State has laws governing the disposal of pesticide wastes and some such wastes are covered under RCRA. Unusable materials must be handled according to local laws and RCRA. The Agency expects employers to make prudent judgments about whether personal protective equipment can be cleaned adequately or whether it must be discarded. When a fabric is saturated with a highly toxic material, the prudent practice is to discard the item. Drift, and spray or dust fall-out in most cases can be removed by correct washing. (f) Heat-related Illness (Heat stress). Although chemical- resistant suits are not part of the minimum personal protective equipment proposed by this regulation, they are required by the labeling for a few highly toxic pesticides. EPA proposed to prohibit tasks requiring chemical-resistant suits where a combination of temperature, humidity, and length of time required to complete a task might be expected to cause heat-induced illness. The onset of these illnesses depends on a variety of factors and EPA believed that users could be expected to anticipate when work activities might result in heat stress. There were many comments about the heat stress provision. Many expressed concern about the risk of heat stress in agriculture, not only with respect to chemical-resistant suits, but also with respect to protective clothing in general and to the application of pesticides in warm climates. Many comments said that guidance and training were central to enabling growers and workers to prevent heat-related disorders. Nearly every comment on this topic disagreed with EPA's assumption that the employer could ascertain when heat stress was a risk. They asked EPA to develop specific guidance about the conditions that would warrant limiting work because of concerns about heat stress. The National Agricultural Chemicals Association (Ref. C311) stated: The Agency proposes to let the supervisor decide when conditions "might be expected to cause" a heat induced illness and bans the use of required chemical-resistant protective suits in those cases. NACA believes it is inappropriate to ask supervisors to make such determinations a priori. Heat-induced illness is an extremely complicated and potentially life-threatening condition. . . . [T]he worker should be trained to recognize the early signs and symptoms of heat-induced illness, and be permitted to take work breaks, remove chemical resistant suits (in a clean area), seek medical attention, or take other reasonable measures to alleviate those symptoms. The American Farm Bureau Federation (Ref. C96) asked that the entire provision be deleted, because: It would be unfair to make farmers and ranchers who have no training in health, responsible for determining how various individuals may react to different environmental conditions. Many of the comments were based on the mistaken assumption that chemical-resistant suits were synonymous with protective suits, i.e., cotton coveralls, and thus were required for all handlers of pesticides in toxicity categories I and II. Although the proposal did contain new requirements for the use of other types of personal protective equipment, it did not extend existing requirements for the use of chemical-resistant suits. Many others that seemed to understand the distinction also expressed concern over the provision. A few comments interpreted the provision as proposed to mean that the handlers could remove the chemical-resistant protective suit and continue the handling activity without it when conditions might lead to heat-related illness. One comment stated that no personal protective equipment is practical on hot days and requested that workers be allowed to wear none on those days. Three comments requested that the protective suit be permitted to be unzipped during applications when the applicator was upwind of the spray. Some comments stated that environmental conditions in their State or region make the wearing of any personal protective equipment a problem. Florida Citrus Mutual (Ref. C88) said: Data presented to the Polk County Florida Citrus Advisory Committee by Dr. Herb Nigg of the Citrus Research and Education Center, University of Florida, at the Lake Alfred Experiment Station [indicated]. . . that there is no personal protective equipment (PPE) clothing available which is suitable for Florida's climate during summer season when the subject grove applications must be carried out. The Arizona Commission of Agriculture and Horticulture (Ref. C109) indicated that: [I]n some Arizona agricultural areas, there are continuous periods of several days during which the temperature fails to drop below the low nineties for even brief periods of time. .... Arizona has areas in which [the wearing of chemical-resistant suits] would be a problem even during the predawn hours for days at a time. It is not possible to schedule around this as it would in most areas of the country where it is rare to have a day during which there is dangerous heat continuously throughout the 24 hour period. A few comments requested that specific temperature and humidity guidelines be established. Another comment requested that the rule specifically exempt temperature-regulating chemical-resistant suits, i.e. those that contain a self-contained cooling system. The National Institute for Occupational Safety and Health (Ref. C284) recommended procedures to reduce heat stress when personal protective equipment is required. These included: (1) Select the lightest weight protective ensembles and respiratory protective devices that adequately protect the worker. This will minimize the physiological demands placed on the worker by carrying the weight of this equipment. (2) Select protective clothing made of material that will allow evaporation of water vapor, while providing skin protection from the contaminant. (3) Reduce work rate by adjusting the work/rest schedules; using automated procedures and/or mechanical assistance where possible;, and minimizing the work intensity. (4) Educate workers on the symptoms and prevention of heat illness and schedule periodic fluid replacement breaks. (5) Reduce heat stress by scheduling work at night or early morning. After deliberation and analysis, the Agency has determined that the avoidance of heat-related illness is germane not only to chemical- resistant suits, but also to other types of personal protective equipment, and that it would be useful if employers were furnished guidelines regarding the recognition, avoidance, management, and treatment of heat-related illnesses. Therefore, EPA has modified the language in the rule to state that the employer should use appropriate precautions to prevent heat-related illness, Para 170.240(g). EPA has developed a guidance document that addresses recognition, prevention, and treatment of heat stress under agricultural working conditions. That document could be used by employers to determine suitable measures for preventing heat-related illness, as required by the rule. EPA also believes that training handlers and early entry workers to recognize the early warning signs and symptoms and to implement appropriate first-aid measures for heat-related illness will help to minimize the risk of such illnesses. Thus, EPA has modified the requirements for the training programs for handlers and instructions for early-entry workers to include information about heat-related illness. The establishment of specific temperature and humidity limits was determined to be inappropriate, because they are only two of several factors that contribute to the onset of heat-related illness. The Agency is persuaded that employers may be able to complete necessary pesticide handling activities, even in very warm weather, by acclimating handlers and workers, providing plenty of drinking water, modifying work schedules and cycles, and using portable cooling devices.