III. Provisions of the Final Rule A. Restrictions Associated With Applications Present part 170 prohibits the application of any pesticide in a way that directly or through drift will contact workers or other persons who are 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 NPRM proposed changes to the existing general prohibition: ``No owner or lessee shall permit the application of a pesticide in such a manner as to directly or through drift expose workers or other persons except those knowingly involved in the application. The area must be vacated by unprotected persons.'' The Agency proposed to substitute the word ``contact'' for the less precise term ``expose'' and 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 the area, unless the worker is a handler involved in the application of the pesticide.'' Since these regulations apply only to workers, all references to ``other persons'' were deleted in the proposal. There were few comments on these application restrictions. One comment 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 during an application of a granular pesticide; field crews may need to be in the same field but may be distant from the area under treatment; and workers should be able to remain in a treated area if they are upwind from the treatment 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 [38107] parks and recreational areas, along roads and rights-of-way, and in schools. In the final rule, the language from the NPRM has been modified. Section 170.110 states that ``during the application of any pesticide . . . the agricultural 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.'' These changes were made to make it clear that only handlers trained and equipped as required by this rule can be in an area during application. Other workers, even if protected, are not permitted to be in the area. The Agency has been persuaded by the comments to reinsert the clause ``and other persons'' into the section prohibiting application in a way that will contact workers (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 or fallout of the application. This responsibility is irrespective of the relationship of the handler to the person in or near the treated area. This provision is intended to protect workers or other persons on agricultural establishments 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. 2. Application restrictions in nurseries and greenhouses. EPA proposed more stringent application restrictions for nurseries and greenhouses than the general application restriction in present part 170 or those proposed for farms and forests. 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. In the NPRM, the application restrictions were discussed 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 parts, restrictions associated with applications and post-application entry restrictions. In greenhouses, employees 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 pesticide applications and with some 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) above 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 psi. c. The entire enclosed treated area in the greenhouse must be vacated during application if ventilation occurs in the enclosed treated area during the types of application described in paragraph (b) above. 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 psi. Nursery exposure situations are similar to those in greenhouses, except that nurseries: (1) Have lower inhalation hazards, because they are not enclosed structures, (2) 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) sometimes use aerial applications, upward-directed, and very high pressure (greater than 150 psi) sprays. The areas with restricted worker entry during applications in nurseries were defined by the types of applications: i. For soil-directed applications, the restricted area is the treated area, ii. For downward-directed applications, the restricted area is the treated area plus 25 feet downwind and 10 feet in other directions. iii. For applications by aerial, upward-directed, or high-pressure sprays, the restricted area is the treated area plus any moistened or dusted area. Most comments concurred with the proposed definitions of areas restricted during applications for greenhouses and nurseries. One comment stated that the 25-foot ``barrier'' zone was too small to be protective. Another requested that the 25-foot area restricted during applications not apply to pesticides in toxicity categories III and IV. One comment requested that ``soil-directed'' be redefined as pressure up to 60 psi if water breakers are used. A few comments requested clarification of whether the specified 25-foot area restricted during application extended to areas beyond the greenhouse or, in nurseries, extended off the property. The Agency agrees with the recommendations that greenhouse and nursery restrictions be clarified. The restrictions in greenhouses have been summarized in a table containing the restrictions during applications and the entry restrictions after application (170.110(c)). A similar table has been prepared for applications in nurseries (170.110(b)). To provide a more useful description of the area restricted during application for employees in nurseries, 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 modified the area restricted during application to 100 feet beyond the treated area in nurseries during fumigant, smoke, mist, fog, and aerosol applications. The prohibition against applying pesticides in a way that will allow contact with workers or other persons is absolute. If an applicator has reason to believe that workers (or other persons) may be contacted by a pesticide during a pesticide application in a greenhouse or nursery, even if those workers (or other persons) are in compliance with the minimum distance requirements, the application may not take place until those workers (or other persons) leave 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. The Agency concurs that, except for fumigation when the entire greenhouse and any adjacent structures that cannot be sealed off from the treated area must be vacated, subenclosures in the greenhouse are permissible and these subenclosures constitute the area that must be vacated during application. If the treated area is enclosed, the 100- or 25-foot zones are not required. 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 [38108] of the nursery. However, the prohibition against contacting workers or other persons does extend beyond such boundaries. A few comments requested clarification of ``downwind'' in a nursery where wind currents tend to be multidirectional 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. 3. Restrictions with fumigants. Although some comments suggested that the entry restrictions for fumigants were adequate, some stated that the restricted-entry area for a fumigant should be defined as the ``entire enclosed structure'' rather than the ``enclosed area'' to differentiate between an area enclosed by a temporary barrier and the greenhouse itself. Some comments requested that ``fumigant'' be defined to distinguish it from a mist or an aerosol. One comment recommended prohibiting any early entry into a greenhouse following fumigation except to determine fumigant concentration or to facilitate ventilation. A comment requested that the ventilation criteria for defining dispersed vapors specify the minimum number of required air exchanges needed. Other comments stated that the proposed ventilation criteria may not be adequate for large production areas if only small windows or fans are used and recommended that replicated tests be conducted using available ventilation to determine the time necessary to achieve the permissible exposure level for a specific site. In the final rule, the Agency defines a fumigant as ``any pesticide product that is a vapor or gas, or forms a vapor or gas on application, and whose method of pesticidal action is through the gaseous state.'' Final part 156 requires pesticide registrants to identify fumigants on the front panel of the label. The Agency has determined that a fumigant application is complete only when (1) any exposure level listed on the product labeling is reached, or (2) if there is no labeling specified exposure level, when one of the ventilation criteria has been met. The fumigant continues to disperse throughout the treated area after its release. Persons are exposed to the fumigant when they enter fumigated areas to measure ambient concentrations of fumigant or to facilitate ventilation by manipulating ventilation systems in greenhouses or by removing tarpaulins or other coverings from outdoor fumigation sites. These persons, therefore, are handlers of the fumigants. The Agency has changed the definition of handlers to include such persons and has extended the application prohibition for fumigants in greenhouses to include the time needed to reach the exposure level listed in the labeling or to meet one of the ventilation criteria. During this time, only handlers who have the protections mandated on the labeling and who meet the other requirements in part 170 may enter the treated area. These handlers may enter the treated area only to measure the fumigant level, remove coverings, or operate the ventilation system. The gaseous nature of fumigants requires that the entire structure, including any adjacent structure 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 application restrictions for fumigant applications in greenhouses to specify that the entire greenhouse plus any adjacent structure that cannot be sealed off from the treated area, not just the ``entire enclosed area,'' is the treated area and therefore is restricted. The Agency concurs that a specific number of complete air exchanges should be specified as constituting sufficient ventilation following a fumigant application (or other airborne application) in a greenhouse. The Agency has concluded that 10 is the minimum number of air exchanges needed. (If each air exchange removed only 50 percent of the pesticide, 10 exchanges should leave approximately 1/1,024 of the original volume of pesticide.) In proposing the ventilation criteria for ``vapors dispersed,'' EPA used the limited data available and consulted with authorities in greenhouse pesticide application processes to establish appropriate and reasonably conservative criteria for protecting workers from inhalation exposure following fumigation in greenhouses. Several comments noted that many greenhouses are acres large and that workers should be allowed to work in one end of the greenhouse while a spraying application is conducted in the other end of the greenhouse as long as any mechanical ventilation draws the drift away from the workers. The restriction on ventilation was intended to protect workers from airborne vapors, spray, and dusts. Without ventilation, the transport of the pesticide off-site would be minimal and presumably would move in all directions equally. With ventilation (passive or active), air movement in any direction is possible. The amount of drift is dependent on such factors as the size and weight of droplets or particles, the pressure of spray, the distance from application equipment to treated surface, and the force and direction of the ventilation. Even ``passive'' ventilation involves factors such as size of vents, the location of vents, and the outdoor wind currents. The Agency is not persuaded that it is possible to predict the direction or distance that sprays or dusts might drift for all ventilation systems used by the greenhouse industry; therefore, it will continue to prohibit workers from remaining in an area surrounding the application. The dimensions of the area depend upon the type of formulation and the type of application. EPA agrees that after application is completed, the sprays and dusts will settle out of the air and no longer pose an exposure hazard to adjacent workers. Workers may enter the greenhouse after application to work anywhere except in the treated area as defined by Table 2 in 170.110(c)(4). In the NPRM, EPA listed criteria for determining when vapors have dispersed after the application of a fumigant. Some comments requested clarification and guidance on when vapors are considered dispersed following application of nonfumigant pesticides that require the use of a respirator during application or that are applied as smoke, mist, fog, or aerosol. The Agency has modified the application restrictions for pesticides that are applied as fumigants, smokes, mists, aerosols, or fogs, and for applications that require the use of a respiratory protection device, to include ventilation criteria that must be met before workers are allowed to return to work anywhere in the enclosed area, or, in the case of fumigant applications, anywhere in the entire greenhouse plus any adjacent structure that cannot be sealed off from the treated area. B. Entry Restrictions The Agency long has recognized the value of limiting agricultural workers' exposure to pesticides through the use of REIs. 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 farm, forest, nursery, or greenhouse workers who contact pesticide residues on treated surfaces or in soil, water, or air, not just those who are performing hand labor tasks. The NPRM required that other protections, such as PPE, [38109] training, and decontamination facilities, be provided to early-entry workers. 1. Restricted-entry intervals. Present part 170 established a generic ``minimum'' REI for pesticides used on agricultural sites covered by that part, and it set specific REIs of either 24 or 48 hours for 12 pesticides. Other REIs have been established during the registration, reregistration, and special review processes. Some of these intervals are ``permanent'' (based on adequate entry data as required by 40 CFR part 158 or a waiver of data submission); others are interim intervals (not based on part 158 entry data) pending the generation of adequate data. Under existing Agency policy, the establishment of REIs has been limited to pesticides used on agricultural crops where workers perform ``hand labor operations,'' involving ``substantial contact with treated surfaces.'' Workers may have contact with treated surfaces from activities such as moving irrigation pipes and scouting, tasks usually not considered as ``hand labor'' tasks. The shift from routine preventive pesticide applications to the increasing use of pest control on an as-needed basis has resulted in the need for more frequent post-application entry by crop advisors, such as integrated pest management (IPM) scouts, professional pest management consultants, and growers, to determine the status of insect, mite, disease, and weed pests at each stage of crop development. The amount of contact with treated surfaces in these activities depends on variables such as the height and density of the crop, the nature of the activity, the surface that contains the pesticide residue, and whether residues are dry or wet. 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 any activity that results in contact with anything that has been treated with the pesticide to which the REI applies may be harmful to workers. Thus, the Agency proposed that REIs 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 REIs. Rather, the proposed revision to part 170 represents a change in current Agency policy of setting interim REIs which apply until permanent REIs are established on the basis of part 158 entry data. Therefore, part 156 retains all permanent REIs set by EPA on the basis of adequate data. It also retains all previously established interim intervals that are longer than those that would be established pursuant to this rulemaking in part 156. These longer REIs have been based, in general, on either delayed (chronic) effects or other exposure hazards such as persistence, post-application chemical transformations, or potential for severe skin sensitization. 2. Length of restricted-entry intervals. 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'' to protect workers immediately after applications of fumigants, mists, fogs, aerosols, or smokes. It also proposed specific REIs 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 that reflect varying acute toxicities. The comments on this issue focused on the length of the proposed intervals and the bases for selecting the REIs. a. Minimum restricted-entry intervals. 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 are not 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 of foliage because of rain, irrigation, or dew may cause confusion and uncertainty about whether the sprays have dried. Wind may make it difficult to determine whether dusts have settled. Many comments requested the Agency to establish minimum REIs to protect against possible unknown chronic or delayed health effects. These comments expressed concern that because product-specific health-effect evaluations take the Agency a long time to conduct, agricultural workers continue to be exposed 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 and other delayed health effects and establish longer REIs. 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 most often involving submission of full entry data (part 158). The Agency will continue to establish REIs on a case-by-case basis for products where nonacute health effects are a concern. b. Specific restricted-entry intervals. Although most comments supported the REIs proposed and many stated that in most circumstances agriculture would be able to comply, one comment stated that REIs longer than the minimum should be reserved for compounds whose toxicity characteristics or exposure history indicated a need for longer intervals. 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 REIs not [38110] 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 REIs for pesticides in toxicity categories I, II, and III, respectively. Others specifically opposed a 72/48/24-hour scheme or stated that the REIs proposed should be determined on a case-by-case basis when data indicate a need. The Agency's proposal was based on California data showing 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 suggest a relationship between the classes of chemicals used and poisonings. However, 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 and N-methyl carbamate pesticides and other pesticides in the same toxicity category, stating that the subdivision of 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 REIs, and to include all compounds in a toxicity category. In contrast, some comments requested that only organophosphate and N-methyl carbamate pesticides have REIs. After reevaluating this issue, the Agency agrees that chemical class should not be a criterion for establishing REIs. The Agency expects that chemicals in the same toxicity category will pose similar risks of adverse effects from acute toxicity; thus, no distinction should be made among the chemical classes within a toxicity category. The Agency has changed the specific REIs. In the final rule, all pesticides in toxicity category II have REIs of 24 hours, and all pesticides in toxicity category I have REIs of 48 hours. 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 that are in toxicity category I and that are 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 REIs be based on the acute toxicity of the technical grade of the active ingredient. Some comments requested that inert ingredients be considered in setting REIs. 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, REIs 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 intervals 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 REIs. 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 REIs, 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 four times as common as those of systemic poisonings among reentering 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 to enter greenhouses until air concentration levels or ventilation criteria have been met following applications of airborne pesticides or pesticides that require a respirator during application. The Agency also has 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 REIs. Another recommended that the persistence of the residues should be considered in setting REIs since some injuries, such as eye injuries or birth defects, are unrelated to the acute toxicity of the chemical. Basing REIs on particular use patterns, on the mode of action, or on a particular use's potential for exposure is not feasible because of variations in potential exposure related to crop, cultural practices, and application techniques. These considerations are appropriate for establishing permanent REIs on a case-by-case basis such as through the reregistration process. c. Establishing entry restrictions in the future. The REIs established through this final rule are intended to remain in effect until the reregistration process or other comprehensive EPA review process makes definitive REI determinations. In most circumstances, the Agency expects that any REI established as the result of the later Agency review would prohibit early entry to perform routine hand labor tasks. However, such REIs would be based on a risk-benefit judgment that takes into account the prohibition against routine early entry to perform hand labor tasks. The Agency expects to establish appropriate entry restrictions on the basis of several types of data. These may include, as applicable, data on how the residue degradation rate and dislodgeability (amount readily transferable from a surface to persons contacting that surface) are influenced by pesticide formulation type; temperature; humidity; soil type; rainfall, dew, and irrigation practices; sunlight; crop type, height, and density; specific production practices, or worker activity and length of exposure. When feasible, the Agency may establish product-specific REIs that vary depending on one or more of these parameters. For example, the Agency may establish longer REIs for timed-release formulations, which are designed to release the active ingredient over an extended time period. The Agency may determine that, for some tasks, shorter REIs are warranted for ``low crops'' than [38111] for tree crops and other ``high crops,'' such as corn, because workers' exposure levels would be expected to be lower. The Agency may also determine that in areas with characteristically hot, arid conditions and certain soil types, longer REIs are warranted for certain active ingredients because of slower degradation, higher transferability, and transformation of the active into more toxic forms. The Agency may also impose longer REIs for some active ingredients in areas with heavy dew or frequent light rain because those actives are either activated by moisture or transformed by moisture into more toxic forms. On the other hand, if adequate data exist, the Agency may decide that it is feasible to allow a reduction in REIs when a specified amount of rain has fallen or over-the-top irrigation has been applied to the treated area. Another type of product-specific restricted-entry determination might include situations where data indicate that worker contact with the treated surfaces could be acceptably reduced through the use of minimal PPE or mechanical devices that physically separate the worker from the treated surfaces. Such determinations might, for example, allow early entry following soil-directed applications if the worker is wearing chemical-resistant footwear and is performing tasks that do not involve skin contact with the soil surface. Another possible restricted entry adjustment would be to prohibit all routine hand labor tasks for a specified time period, such as 1 or 2 days, and then to allow certain hand labor tasks during the remaining restricted-entry period if certain (perhaps minimal) PPE is worn and other precautions are taken. Still another possible restricted-entry adjustment might allow early entry (with or without minimal PPE) if devices, such as mechanical detasselers or roguers, are used that minimize worker exposure to treated surfaces. The final rule does contain an exception that allows early entry for activities that involve no contact with anything that has been treated with the pesticide to which the REI applies, including, but not limited to, soil, water, air, or surfaces of plants in the treated area. Unfortunately, it is unlikely that such product-specific decisions will be routine, because of their complexity. Conveying such exceptions and restrictions to users in a simple, intelligible manner is difficult. The necessary labeling would be unduly complex. The Agency projects that such adjustments will be most likely in those situations where data indicate that a relatively lengthy REI is necessary under average conditions to adequately reduce risk, but where such a lengthy REI may make the pesticide's use infeasible for certain crops for which hand labor is necessary within tight timeframes after application. Under these circumstances, the Agency will consider alternatives to the prohibition of routine hand labor tasks throughout the REI. In any such deliberations, however, EPA will also consider whether workers can be adequately protected under a more complex set of entry requirements. For the longer run, because of the many factors that affect worker exposure to pesticide residues, the Agency is exploring alternative methods of establishing REIs and alternatives to REIs. One possible approach involves on-site determination as to whether residues have degraded (or are otherwise unavailable) to a degree deemed acceptable for workers to safely enter to perform hand labor tasks involving contact with treated surfaces. One promising technique involves immunoassay-based detection. Immunoassay techniques could provide rapid, simple, and cost-effective methods for determining actual foliar or soil residue levels under field conditions. It is expected that inexpensive kits can be developed that will yield results in a short period of time, thus enabling site-specific determination as to whether residues have decreased to an Agency-established acceptable level for worker entry. This technology would also provide an effective means of signaling to the agricultural employer when residues remain sufficiently high so as to make worker entry unreasonably risky, even if the REI had expired. EPA has determined that more research is required to develop immunoassay and other site-specific monitoring systems for field residues. However, the research data to date indicate that an immunoassay-based system probably could be developed. Immunoassay devices use antibodies as receptors to sample the environment of the exposed surface (persons, foliage, soil, etc). Specific antibodies to many pesticides of concern already have been developed and evaluated, but specific antibodies for other priority compounds need to be identified. The Agency strongly encourages the rapid development of practical and reliable techniques of this kind and welcomes further information on ongoing research and the opportunity to cooperate with developers on the necessary research. To support the goal of improving such technology, the Agency also intends to consider requiring the development of such detection methods for the registration or continued registration of selected pesticides. Furthermore, as product-specific reentry data are generated and analyzed, EPA will investigate the feasibility of adding information on the pesticide labeling that indicates the acceptable residue levels on the specific surfaces of concern for that product. Such information might encourage more rapid development and marketing of site-specific test kits. 3. Entry before a restricted-entry interval expires-- a. Entry for other than hand labor tasks. Present part 170 allows workers to enter a treated area without PPE before the expiration of the REI if they are not performing hand labor tasks. 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. Pesticides 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 170.110(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. 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. [38112] The Agency recognizes the need to allow workers access to adjacent benches or adjacent plants in greenhouses and nurseries to carry out other plant production 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 PPE 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: (a) 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. (b) 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. (c) 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. (d) 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 for short-term 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 PPE, 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 PPE, 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. A few comments supported the proposal that early entry be permitted with the use of PPE or stated that routine hand labor should be allowed if the worker is wearing the PPE required by EPA. Many comments opposed early entry even with the use of PPE. One comment noted that a requirement for the use of PPE by field workers is not practical and is not likely to be adhered to in many situations. A comment stated that the REI should be sufficiently long so that at its expiration there are no further concerns or restrictions on either the field activities or the clothing worn into the field. 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. In this final rule, the Agency has therefore prohibited most entry during the REI to perform routine hand labor tasks. 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 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. c. Exceptions to the prohibition on routine early entry. Although the [38113] Agency has determined, in general, 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 REIs. 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 REIs 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 REIs 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 proposed exception to rule 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. d. 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 [38114] 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 profitability greater than that which would be expected on the basis of 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 an emergency is anticipated through a weather forecast, pest outbreak bulletin, or other means, it is not acceptable to proceed with a pesticide application 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 REIs in agricultural emergencies if a State, Tribal, or Federal agency having jurisdiction declares that 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 170.110(c)(3) or in the labeling has been met, (2) the required PPE is provided, cleaned, and maintained for the worker, (3) the required decontamination and change areas are provided, (4) the required general training and label-specific information has been furnished, and (5) only tasks related to mitigating the emergency are performed. C. Notice of Applications The Agency proposed that workers on an agricultural establishment be notified of pesticide applications and areas remaining under an REI. An exception was proposed for farms, forests, and nurseries--no notification would be necessary if, from the start of application until the end of the REI, the worker would not enter, work in, remain in, or pass through, on foot or in an open vehicle, the pesticide-treated area or any neighboring areas, including growing areas and labor camps that are contiguous or separated only by a roadway from the treated area. A similar exception proposed for greenhouses stated that no notification would be required if, from the start of application until the end of the REI, the worker would not enter, work in, remain in, or pass through the greenhouse. These exceptions were designed to limit the notification requirement to those occasions where the most potential for accidental worker exposure exists and where notification would prove most useful. Notification would not be required when pesticides are applied at times when no workers are employed by the establishment or when pesticides are applied to (or an REI is in effect at) distant areas of the establishment where no work activities are occurring. [38115] Some comments supported these exceptions; some requested that the exceptions be dropped and that workers be notified of any pesticide-treated area on the property, because crews may enter treated areas by mistake. One comment wanted to have information provided to workers about pesticides used in areas contiguous to the area where they will be working. Another noted that since only a small percentage of farms require hand labor for cultivation or harvesting, it seems impractical to post fields when the only one who would be entering is the farmer who caused the field to be treated. A few comments requested a definition of the word ``neighboring,'' and some stated that ``neighboring areas'' should be defined as property controlled and/or owned by the employer. After careful consideration, the Agency has decided to retain but reword the exception to notification on farms and in nurseries and forests. The term ``neighboring area'' has been deleted; the final rule requires notification if workers may be within 1/4 mile of the treated area's perimeter. This distance was chosen for several reasons. First, data from studies show that residue drift from a treated area is negligible beyond 1/4 mile. Second, the Agency believes that 1/4 mile is the farthest distance that workers would be likely to digress from their path or work site for rest or meal breaks. Although the Agency believes that a prudent owner/operator of an agricultural establishment will inform adjacent property owners/operators of pesticide applications at their mutual borders, EPA has determined that such a requirement is beyond the scope of this rule. The exception to notification in greenhouses has not been changed. The Agency has added an additional notification exception that applies to all agricultural establishments. Notice (oral or treated area posting) need not be given to a worker if the worker (1) applied or supervised the application of the pesticide for which the notice would be given and (2) the worker is already aware of the information that would be otherwise conveyed in an oral warning. This exception exempts establishments from having to orally warn or post warning signs at treated areas for an already-informed applicator of the pesticide. This exception would be especially important if the pesticide applicator is the only worker on the establishment for whom notification would otherwise be required. 1. Oral notification. The Agency proposed that workers be given daily oral warnings about pesticide-treated areas on farms and in forests, except as noted above. The warnings would consist of: (1) The location and description of the treated area, (2) the time during which entry is restricted, and (3) instructions not to enter the treated area until the REI has expired. The warnings would be required to be given in a manner the worker can understand. Several comments supported the requirement for mandatory oral warnings on farms and forests because large numbers of agricultural workers would not be able to read material printed in English. Some respondents felt that oral warnings should be required only on the first work day for any worker or when there is a change in the spraying schedules because daily warnings may cause workers to ignore the repetitive message. Some comments stated that oral warnings would be unworkable in some agricultural operations because employees may report to work from different locations at different times of the day, e.g., coming from on-farm camps or local housing or being bused from cities or other farms. Other comments objected to mandatory oral warnings and requested that employers be given a choice of using oral warnings or posting warning signs. One respondent suggested issuing cards containing information about spraying to workers in lieu of oral warnings. Some comments stated that oral warnings are more effective if they include information such as the name of the product or active ingredient, the location of labeling, and/or safety information for the product and the REI. Most comments supported a requirement that oral warnings be communicated in a language the worker can understand. However, a few noted that it would be difficult for growers to find persons who could provide translations into all the languages that might be needed. The Agency has been persuaded that farm and forestry operations should have the choice of notifying workers orally or by posting signs at the treated area. EPA is convinced that for highly diversified farms where different crops would be grown close together or for large agricultural operations where many workers are employed, oral warnings may be impractical and may not be as protective as posting signs at the treated area. However, the Agency believes that most farm and forestry employers will opt to warn employees orally. Signs that employers post must meet the same criteria as the signs for the mandatory treated-area posting. The Agency also has been persuaded to eliminate the requirement that oral notification be given daily. Instead, employers are required to notify workers before the worker's first opportunity for exposure to any treated area. Regardless of whether the employer uses oral notification or posting, the Agency is requiring that application-specific and restricted-entry-specific information be posted at a central location accessible to all workers. This information will remind workers of areas where pesticides are being applied or where an REI is in effect. EPA is convinced that additional information about the pesticide application can be conveyed more effectively through these centrally located notice areas than through oral notification. Providing information about applications on printed cards is not a practical alternative to oral notification because of language problems and the cost of duplicating the information. 2. Posting pesticide-treated areas. Besides oral warnings, the Agency proposed to require the posting of warning signs in areas of farms and forests treated with pesticides having REIs greater than 48 hours, except when no workers would be in the area, as discussed above. The Agency also considered other posting options, such as for pesticides with REIs more than 24 hours. Some comments supported the proposed posting requirements, but some stated that posting must be supplemented with oral notification, particularly on large farms and in forests where posting may be difficult. Many comments advocated daily oral notification supplemented with mandatory posting so that persons working near the area or moving through the area are aware of the application and can avoid contact. Some comments stated that areas treated with pesticides having REIs exceeding 24 hours should be posted because posting is an unequivocal way of communicating to workers their right and duty not to enter a treated field. Some comments said that posting for all pesticides with an REI of greater than 24 hours would be more consistent with the purpose of the proposed rule than posting only for intervals greater than 48 hours. The latter, they said, would exempt nearly all pesticide applications from posting. They stated that oral warnings alone are inadequate for warning workers of the hazards of entry from products in toxicity categories I and II and suggested the requirement might be met by posting a map showing treated areas. Other comments opposed any mandatory field posting requirement. One stated that workers could be notified by a centrally located information board. The Agency has reviewed the comments on mandatory field posting and has decided to modify these requirements. The Agency has defined at least two objectives for posting of treated areas: (1) Warning of areas treated with pesticides that are so toxic that incidental exposure, i.e., contact from brushing against the treated surfaces, could cause an acute illness or injury and (2) warning of areas treated with pesticides for which a short exposure could have the potential for a delayed effect, such as developmental toxicity. The final rule requires posting for all pesticides that contain active ingredients that are classified as toxicity category I because of acute dermal toxicity or skin irritation potential. On a case-by-case basis, the Agency also may require posting for other pesticides that the Agency deems may produce adverse health effects from a short-term exposure. The Agency will require that oral notification also be given to workers when posting is required so that a second tier of warning is provided for these pesticides. Pesticides meeting these criteria will have a statement in their labeling that the treated area must be posted and workers must be notified orally. The Agency proposed that ``When several contiguous areas are to be treated with pesticides on a rotating or sequential basis, the entire area may be posted.'' This would allow posting of a larger area than the treated area when a continuous spraying operation treats alternative rows or areas, rather than the entire area, on a sequential basis. Since posting of individual rows in this case would be difficult and expensive, the Agency would allow the entire area to be posted. However, no part of this entire area may be entered while signs are posted, except under the conditions specified in the regulation for early entry. The Agency has retained this provision in the final rule. 3. Warning sign. The Agency proposed a standard warning sign containing a stern-faced person with an upheld hand containing the words ``DANGER - PESTICIDES - KEEP OUT.'' Although the sign proposed by the Agency received some support, many comments requested modifications to the symbol or the wording. There were suggestions that the sign should contain the skull and crossbones or should use some international symbol. After consideration of the comments, EPA remains opposed to the use of the skull and crossbones symbol for the reasons stated in the NPRM and because posting may be required by the Agency not only for the most acutely toxic pesticides but also for some pesticides in other toxicity categories. Acute toxicity is only one factor in determining what areas should be posted; posting will be required by the Agency on a case-by-case basis during registration, reregistration, or special review for pesticides presenting other types of risks. Furthermore, farm, forest, and nursery establishments may choose to post all pesticide applications, and greenhouse establishments must post all pesticide applications. The Agency did not find an appropriate international symbol that it believed conveyed the desired message. The Agency has not been persuaded that the basic design of the sign should be changed. The Agency is convinced that mandatory worker training will promote worker recognition and understanding of the sign proposed in the NPRM. Some comments expressed concern that the words ``Pesticides'' and/or ``Danger'' make the sign too negative; others recommended that pesticide signal words such as ``DANGER'' or ``CAUTION'' be reserved for use with specific materials that carry relevant toxicity classifications. Some suggested that to use the word ``DANGER'' or the [38116] skull and crossbones symbol on posting signs would be misleading and weaken the meaning of these signals where materials in toxicity categories III or IV might be involved. Some comments requested that the signs be in as many languages as necessary to reflect the composition of the work force; others requested that additional information be required on the signs, such as the name of the pesticide, the date and time applied, and where toxicity information may be obtained. The Agency is persuaded to change the wording of the treated area warning sign. The words ``DANGER/PELIGRO,'' ``PESTICIDES/ PESTICIDAS `` and ``KEEP OUT/NO ENTRE'' will be required. The Agency realizes that Spanish/English signs cannot be read by all workers, but it is impractical to require printing in all the languages used by workers. The Agency believes that removal of the words ``Pesticides'' and ``Danger'' from the signs would defeat the purpose of the signs. Changing the wording to reflect the signal word for the pesticide used would require the employer to have several sets of signs, which would be burdensome. The objective of posting is to keep workers out of an area under treatment, not to inform them of the type or degree of hazard. Because the Agency believes that a generic treated-area sign is the most practical, economical, and reasonable choice, it will not require application-specific information to be listed on the sign. Such information may be added to the sign if the information does not interfere with the other components of the sign. Application-specific information will be required at the centrally located notification area. The Agency proposed that warning signs be visible from all usual points of worker entry to the pesticide-treated areas, including each access road, each border with any labor camp adjacent to the pesticide-treated area, and each foot path and other walking route that enters the pesticide-treated area. When there were no usual points of worker entry, signs were to be posted in the corners of the pesticide-treated area or in any other location affording maximum visibility. Several comments requested that posting also be used to protect other persons, such as persons who live in houses or labor camps adjacent to the fields and persons who may be passing by fields. Some comments advocated posting at specified distances along the perimeter of treated areas in addition to the usual points of access; others noted the difficulty in posting all entries to forested areas. The Agency believes that ``at the usual points of entry'' is the most reasonable requirement for placement of the signs. Posting at specified intervals along the perimeter is unnecessary and burdensome. Labor camps within or adjacent to treated areas must be posted when posting is required for the treated area. Posting a warning sign at a central location is an inadequate replacement for the posting of treated areas. Although posting may be difficult for forestry operations, the Agency believes it is feasible to post at locations that may be considered usual points of access, such as at the place where logging roads enter a treated area. The Agency also recognizes the concerns expressed about warning persons other than workers. While the intent of the rule is to protect agricultural workers, the requirement for posting treated areas will provide warning to other people who might enter the treated area inadvertently. The Agency intends to consider additional actions to deal with exposures not covered by these regulations. These include non-agricultural exposures, agricultural exposures excluded from these regulations, and exposures to the public. 4. Notice of applications in greenhouses and nurseries. In greenhouses and nurseries, the Agency proposed mandatory posting of all entry-restricted areas instead of oral notification, unless there are no workers in the area. Some comments supported the requirement as proposed, stating that the requirement to post pesticide-treated areas seems fair in lieu of oral warnings. Others objected to the requirement because nurseries were singled out for more restrictive posting requirements than forests or farms. The Agency has considered the various comments and has decided to retain the mandatory posting requirement for pesticide applications in greenhouses, but to change the requirement for nurseries. Although some nurseries are much like greenhouses with many crops grown in small areas, others more closely resemble farms. Therefore, the Agency is persuaded that nursery employers, like farm employers, should be permitted to choose between oral notification and posting pesticide-treated areas except when mandatory posting and oral notification are required by the labeling. D. Personal Protective Equipment (PPE) The predominant route of pesticide exposure in outdoor agricultural work is through the skin. Therefore, any barrier that can be placed between the employee and the chemical to reduce contact with the skin reduces the risk of pesticide poisoning. EPA concluded, in the proposal, that except for enclosed cockpits and enclosed cabs with positive-pressure filtration systems, the only other practical barrier available to pesticide applicators is PPE. 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 NPRM stated that PPE was the most practicable approach to reducing occupational exposure to agricultural pesticides. The proposal required the use of PPE appropriate to the pesticide and the work activity. The proposal also required employers to provide, clean, and maintain such equipment. Several comments stated that PPE should be the last resort for protection and that engineering controls should be explored first. Some studies of desirable methods of protection have concluded that PPE ranks below removal of employees from areas where they may be exposed, system design, and mechanical protection. Some comments stated that the proposed rule dismisses mechanical techniques of reducing or eliminating exposure as being unavailable or of limited utility and that this is in sharp contrast with other regulatory proposals developed by EPA and other Federal agencies which ``force technology'' by providing a lead time for nonmechanical solutions and then requiring the application of the ``best available technology.'' Unlike industrial environments, which are more controlled and confined, agricultural settings do not lend themselves as easily to engineering controls. The Agency is aware 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, PPE 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, [38117] 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 to reduce employee injuries. Some comments agreed with the proposed reduction of PPE requirements during use of closed mixing/loading systems. However, another comment requested that EPA not reduce PPE requirements for closed system mixing/loading. It stated that pesticides are highly corrosive and that the Agency has no program to inspect and certify such systems. The comment asserted that the efficacy of closed systems has been impaired by the failure of the Agency or the manufacturers to establish uniform specifications for container openings. One comment stated that the regulation should contain incentives to develop low-risk transfer and cleaning options. Requiring the use of chemical-resistant gloves and aprons to transfer granules in a closed system will cause applicators to stay with more dangerous, but cheaper, conventional systems. Similarly, if self-cleaning mechanisms are provided for pesticide equipment, PPE requirements should be reduced. Several comments requested that engineering controls such as wiper wands, low-pressure nozzles, and stream emitters be rewarded with reduced PPE requirements. EPA considered requiring closed systems for mixing and loading all highly toxic pesticide concentrates. The Agency has decided to encourage the use of such systems by reducing the amount of PPE required when closed systems or enclosed cabs are used for mixing, loading, applying, or other handling activities, but it will not require the use of such systems. The Agency agrees that for closed systems to be most effective in reducing exposure, the kinds and types of equipment used in such systems and the maintenance of such equipment must be standardized. Such a program is beyond the scope of part 170 as proposed; the Agency is investigating several types of engineering controls and may require the use of such controls in the future. The Agency also agrees that ``rewards'' such as a reduction of PPE requirements are incentives for handlers to use engineering controls, but eliminating all PPE requirements during the use of closed systems does not seem to be prudent. A number of accidents are reported despite the use of closed systems. One respondent requested that EPA require state-of-the art protective clothing for employees where appropriate; another was concerned that the Agency not establish excessively rigid requirements that would discourage use of improved knowledge or technology. EPA intends to remain attentive to the development of innovative PPE and to adjust the PPE requirements as appropriate. 1. Personal protective equipment (PPE) for early-entry workers. The Agency proposed minimum PPE 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. Several comments stated that early-entry PPE should be the same as the PPE required for handlers, presumably including respiratory protection. Another stated the Agency should have a better rationale for excluding inhalation toxicity as a hazard for workers entering fields after dusts have settled, sprays have dried, or vapors have dispersed. 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 that respiratory protection is not needed during the permitted entry after application. Many comments recommended that no early entry be allowed, because workers will not use the PPE if the weather is too hot or will risk heat stress if they do wear the equipment. A few comments objected to PPE other than normal work attire for early-entry workers by expressing the belief that, in most cases, long-sleeved work shirts and long work pants provide adequate protection. Several comments expressed dismay that no minimum PPE was established for early-entry workers in areas treated with pesticides in toxicity categories III and IV and recommended that early-entry PPE for these pesticides should be normal work attire plus chemical-resistant gloves because many of these chemicals are skin irritants. Others requested that coveralls and chemical-resistant gloves be the minimum PPE for early entry after all pesticide applications. In the NPRM, there was a generic REI for pesticides in toxicity categories III and IV of ``until sprays have dried, dusts have settled, or vapors have dispersed.'' Since the proposal contained a complete ban on hand labor activities during that period, there was no need to specify PPE for early entry for pesticides in toxicity categories III and IV. In the final rule, the Agency has established a 12-hour REI in lieu of the generic ``until sprays have dried, dusts have settled, or vapors have dispersed'' and specifies minimum PPE for early entry for all pesticides. The prohibition on most early-entry activities in the final version of part 170 has eliminated the need for most uses of early-entry PPE. For those exceptional circumstances when early entry is permitted, the Agency has decided to require early-entry workers to wear the PPE required for an applicator 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 will be coveralls, waterproof or chemical-resistant gloves, socks, and shoes. This minimum attire is based on the Agency's desire to have the body protection (coveralls) provided, cleaned, and maintained for the worker and on the Agency's belief that some early-entry workers may receive greater exposure to pesticides through residues in the treated area than handlers may receive during application. The Agency reserves the right to establish different PPE requirements for early-entry activities on a case-by-case basis if evidence supports such action. The Agency does not believe that requiring PPE 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 PPE would no longer be needed. 2. Personal protective equipment (PPE) for pesticide handlers. Ideally, each pesticide product labeling should list specific PPE 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 PPE for handlers that is inadequate by the Agency's present standards. The Agency proposed to establish PPE 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 PPE for handlers of all agricultural pesticides in various exposure situations. [38118] 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 frequently. Results of numerous studies 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. The hands and forearms account for the highest percentage of total dermal exposure. 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. Respiratory exposure cannot be ignored in outdoor applications, however, since nearly 100 percent of any pesticide that enters through the lungs and gastrointestinal tract is absorbed. When pesticides are used in enclosed structures, the risk of respiratory exposure is greater than when pesticides 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 PPE requirements for pesticide handlers. When the formulated pesticide product is diluted by the user, the resulting solution may be less toxic than the concentrated formulated product. When EPA establishes product-specific PPE requirements during registration or reregistration, it uses any available registrant-supplied data on the acute toxicity of the diluted product to determine the appropriate PPE for exposure to the diluted product. The Agency proposed to base the requirements on the toxicology of the formulated product. By submitting data on the toxicity of the diluted pesticide product, however, registrants could reduce the PPE requirements for handlers, except for mixers and loaders who would be exposed to concentrates. The Agency proposed that handlers of pesticides that are in toxicity category III or IV because of acute dermal or skin irritation potential be required to wear ``normal work attire'' (long-sleeved shirt, long pants, shoes, and socks). For pesticides that are in toxicity category III because of dermal toxicity or skin irritation potential, handlers also would be required to wear chemical-resistant gloves. For pesticides that are in toxicity category III or IV because of inhalation toxicity or eye irritation potential, the Agency proposed no minimum PPE requirements, but reserved the option of requiring PPE for those hazards on a product-specific basis as warranted by evidence. Most comments supported the Agency's proposal to base PPE 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. Some comments recommended that PPE for applicators be based on the toxicity of the dilute product; another requested that PPE be based on the type of formulation as well as the acute toxicity. One comment stated that toxicity should not be the sole determinant of PPE and that use pattern and mode of action must be considered. This regulation allows registrants that have data on the toxicity of the dilute product to use that data in establishing the PPE requirements for handlers exposed to the diluted product. However, basing PPE 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 PPE requirements for pesticide handlers in part 156. b. Types of personal protective equipment (PPE) required--i. Body protection. 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 now deems this clothing inadequate to protect either handlers or workers entering treated areas before the expiration of the REI. In the NPRM, the Agency proposed minimum PPE requirements that would vary according to: (1) The acute toxicity of the pesticide, (2) the type of employee activity, (3) route of exposure, and (4) the presence of engineering controls. Under the proposal, all handlers and early-entry workers exposed to pesticides 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. Some comments requested that chemical-resistant protective suits be required for handling all pesticides in toxicity categories I and II, especially for airblast applications. One comment requested a change in the definition of ``protective suit'' to include suits made of nonwoven materials. The Agency has changed the term ``protective suit'' to ``coverall'' and changed the definition. ``Coverall'' means any loose-fitting one- or two-piece garment that covers, at a minimum, the entire body except the feet, hands, and head. The Agency considered requiring the use of a chemical-resistant protective suit when handling 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. Cotton or cotton and polyester, i.e., woven fabrics, are preferred for work clothing because they are more comfortable to wear, and they can be washed. Appropriate protective coverings, such as coveralls, can reduce the exposure to pesticide users' trunk area, arms, and legs by 99 percent. One study concluded that the use of rubberized clothing did not provide more protection than the regular work clothing (consisting of cotton shirts and trousers worn under long-sleeved coveralls). The final rule, however, allows users to wear a chemical-resistant protective suit as an alternative to the two layers of clothing. The development of various types of disposable chemical-resistant garments made of nonwoven materials, such as Tyvek (spunbonded olefinic fibers), gives pesticide users a wide choice of protective materials. Most comments on the requirement to wear a protective coverall over another layer of clothing asked the Agency to reconsider; objections centered on the problems of heat-related illness and discomfort associated with wearing two layers of clothing in the summer months. One comment stated that if a protective suit is worn and becomes contaminated, it can be discarded and replaced with a clean suit on site, whereas if the normal work attire becomes contaminated, the worker may have to return home in contaminated clothing. Numerous comments stated that the more uncomfortable protective clothing becomes, the more likely it is that employees will avoid wearing the protective clothing or the more likely they will not complain to the appropriate authority about the lack of protective clothing in the event the employer fails to furnish such clothing. Another comment stated that, in an emergency, stripping the coverall off [38119] quickly, washing, and putting on the extra coverall that is required to be kept at the decontamination site would be more protective than a false sense of security brought by two layers of clothing. Some comments stated that convincing handlers to wear a coverall and chemical-resistant gloves would be a major breakthrough in PPE and that a requirement for two layers of protection might discourage any compliance. The Agency considered the comments on the requirement for handlers and early-entry workers to wear a long-sleeved shirt and long pants under a coverall in activities involving pesticides that are in toxicity category I or II because of dermal toxicity or skin irritation potential. A review of the literature revealed several studies supporting the concept of layering as an effective protective system; the protection afforded by protective clothing is proportional to the thickness and the closeness of the weave. The Agency recognizes that the use of PPE 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 pants when handling pesticides classified as toxicity category I for dermal toxicity or skin irritation. For handling pesticides classified in toxicity category II for dermal toxicity or skin irritation, a chemical-resistant protective suit or coveralls worn over a layer of clothing that covers the trunk area (e.g., T-shirts and shorts) is specified. Many comments agreed with the proposed PPE requirements for ``normal work attire,'' which was defined as long pants, a long-sleeved shirt, shoes, and socks, for handlers of pesticides in toxicity categories III and IV. But several other comments requested that more than ``normal work attire'' be required for handlers of pesticides in toxicity categories III and IV. The Agency has considered the comments regarding the PPE required for handling pesticides in toxicity categories III and IV and has determined that the PPE proposed is adequate to protect handlers of these pesticides. The Agency has written the PPE requirements to create an incentive for users to choose less acutely toxic pesticides whenever possible. Several comments requested EPA to clarify that its intent was to establish ``normal work attire'' for pesticide-handling activities and not for all work on agricultural establishments. To eliminate the confusion, the phrase ``normal work attire'' is not used in the final rule. PPE and other clothing required for handling the pesticide will be specified on pesticide labeling. ii. 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. It has been estimated that chemical-resistant gloves can reduce hand exposure by as much as 98 percent. The Agency proposed to require chemical-resistant gloves for all early-entry and pesticide handling situations involving pesticides that are in toxicity categories I, II, or III because of dermal toxicity or skin irritation potential. (No gloves were required for early-entry or pesticide handling situations for pesticides in toxicity category IV). Leather gloves, uncoated cloth gloves, and fingerless gloves are not acceptable, because liquid and particulate pesticides can penetrate them. The Agency considered an exception for early-entry workers handling roses, because sturdy, flexible glove materials such as leather will withstand the wear and tear from thorns while providing sufficient dexterity. Few comments discussed glove materials. 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. If suitable puncture-resistant and chemical-resistant gloves are not obtainable, the Agency will allow the use of leather gloves for working in thorny plants, with two restrictions: (1) Chemical-resistant glove liners must be worn, and (2) leather gloves that have been worn once for protection from pesticide exposure shall thereafter be worn only with chemical-resistant liners. A few comments stated that either the pesticide registrant or EPA should give more specific guidance on how to determine which glove materials are chemical-resistant to specific pesticide formulations. The Agency concurs and has developed a guidance package for pesticide users on the selection, use, and maintenance of chemical-resistant gloves. The final rule requires registrants to specify in the product labeling the appropriate type of gloves to be used with the product. EPA will continue to cooperate with the 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. iii. Foot protection. The feet may be exposed to pesticides from spills, splashes, or downward sprays, and from walking through vegetation 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 uncomfortable and may cause a foot disease similar to trench foot. Many comments urged the Agency to reconsider the requirement for chemical-resistant footwear in forests, stating that leather boots are worn for traction on rocks and debris, protection from pests and snakes, and for durability. The comments stated that the safety hazards of working in this environment increase if chemical-resistant boots or boot covers are required. Because of the problems inherent in decontaminating non-chemical-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). However, the Agency is persuaded by the comments that for physical safety, pesticide handlers and early-entry workers in rough terrain should be permitted to wear leather boots if chemical-resistant boots of sufficient traction and durability are not obtainable. iv. Eye protection. The eyes and face may be exposed whenever there is a chemical splash or a high level of mists, vapors, or dusts during mixing, loading, and applying pesticides or whenever residues are dislodged from foliar surfaces 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 [38120] 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 during prolonged use in hot weather and that there should be some provision for employees who wear eyeglasses. Others commented that for most pesticides and use circumstances, several styles of eye protection provide near goggle-level protection at greatly increased levels of wearer comfort and with less tendency to fog. The Agency is persuaded that safety glasses with protective shields at the eyebrows and temples provide adequate eye protection in most pesticide handling and early-entry situations. Because they are more acceptable than goggles to employees, they would be 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 pesticides in toxicity categories I and II for eye irritation. When ``protective eyewear'' is required, the employer shall provide goggles, a face shield, or safety glasses with side shields and brow guards. For products in toxicity category I for eye irritation, the Agency may, on a case-by-case basis, require the labeling to include a requirement for the use of goggles or a face shield. v. 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 treated areas after pesticide vapors have dispersed. Several comments pointed out that although several types of respirators have NIOSH/MSHA approval for protection against pesticides, NIOSH does not test respirators for individual pesticides. Therefore, requiring ``a NIOSH- or MSHA-approved respirator'' does not assure the use of the most appropriate respirator for a specific pesticide. The comments also noted that the NIOSH instructions that accompany air-purifying respirators refer the user to the pesticide label for limitations of use. Some comments urged the Agency to require pesticide manufacturers to provide respirator instructions in the product labeling. Most comments urged the Agency to require respirator fit-testing before a respirator is used and a physician's approval that the handler's physical condition will permit him/her to use a respirator safely. One comment stated that the use of forced air respirators would eliminate some of the fitness and fit testing problems. Several comments suggested that the selection, use and maintenance of respirators be consistent with the program described in the OSHA standards (29 CFR 1910.134) and/or that the specific recommendations be provided in the Agency's rule. 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 final rule offers some guidance on changing filters, cartridges and canisters in the absence of direction from the manufacturer; part 156 requires the registrant to specify what type of respirator should be used with a product that requires respiratory protection for handling. c. Exceptions to personal protective equipment (PPE) requirements. The Agency has retained the requirements proposed for aerial applicators. Pilots in enclosed cockpits will not be required to wear PPE. Pilots in open cockpits must wear the PPE 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 protective eyewear. Pilots in both types of equipment must wear the protective gloves required by the labeling when entering or exiting a plane whose exterior is contaminated by pesticide residues. The Agency proposed that pesticide handlers in the enclosed cabs of ground vehicles should be exempt from PPE requirements. If the enclosed cab did not contain a properly functioning gas- or vapor-removing ventilation system, any labeling requirement for a respirator would be in effect, but all other PPE would be waived. Fully enclosed cabs without air filtration have been shown to reduce dermal (but not respiratory) exposure substantially for airblast applicators. The Agency was concerned, however, 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 PPE 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 expressed concern that applicators in cabs without ventilation will open the window on a warm day, thus negating the cab's protection. Many suggested that full PPE should be required for operators in an enclosed cab without ventilation. One comment noted that there is no way to eliminate the need for handlers to leave the cab in the treated area; since protective clothing must be worn, employers will use this as an excuse for not providing protective cabs. An equipment manufacturer commented that their studies have shown that contaminated clothing (gloves on the steering wheel or dash, etc.) is a major source of chemical contamination inside cab enclosures. The Agency acknowledges the potential for defeat of the enclosed cab's protection by opening windows or by contaminating the interior of the cab with clothing or equipment containing pesticide residues. However, EPA supports the use of engineering controls in lieu of PPE where feasible; an enclosed cab used correctly is protective. 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 PPE for these activities. Under these conditions, it would be inappropriate to require PPE in the enclosed cabs. Therefore, the Agency continues to waive the PPE 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 PPE required on the pesticide labeling for applicators of the product. Users must wear PPE when leaving the cab only if they will contact pesticide-treated surfaces in the treated area. They may leave the cab for a rest stop or other reason (other than [38121] handling pesticides) without wearing PPE if they will not be in contact with pesticide-treated surfaces in the treated area. The applicator may leave the cab and walk away from the just-treated area without PPE. The Agency is concerned that the interior of the enclosed cab may be contaminated from pesticide-contaminated clothing worn or taken into the cab. Therefore, the Agency changed the language of the rule to prohibit such an action. Once PPE is worn in the treated area, it may not be worn into or taken into the cab. A few comments concurred with the Agency's proposal to waive the use of all PPE, including respirator, if the enclosed cab has a properly functioning, positive-pressure ventilation system that removes vapors from the air. The Agency based its proposal on studies indicating that positive-pressure, charcoal- filtered ventilation systems on enclosed cabs can remove more than 99 percent of pesticide vapors and sprays during air intake. Other comments stated that enclosed cabs were unproven as protection for airborne hazards and that data are needed that demonstrate the effectiveness of the protection offered by an enclosed cab. The Agency believes that incentives should be used to encourage the use of engineering controls instead of PPE 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 pants, shoes and socks for labeling-specified PPE. d. Duties relating to personal protective equipment (PPE). The Agency proposed that all PPE required by the pesticide product labeling for a particular work activity be provided to handlers and early-entry workers and that the employer clean and maintain such equipment. In the final rule, EPA has modified the language to clarify who is responsible for fulfilling the various requirements and provisions. This section now specifically states that the employer shall provide the appropriate PPE in clean and operating condition. This provision does not prohibit handlers who own PPE, such as a respirator, from using that equipment. The employer, however, would be required to assure that such equipment is cleaned and maintained. The employees would not be allowed to wear home or to take home the equipment unless it had been cleaned first. A few comments indicated uncertainty about who would provide ``normal work attire'' (long-sleeved shirts, long pants, shoes, and socks) when it is required by the labeling and whether it is considered to be PPE. The Agency does not include normal work attire in the definition of PPE; therefore, it is not part of the employer's responsibility to provide or maintain this attire. The Agency perceives the appropriate decontamination of PPE as a major area of concern. Significant levels of some pesticides can remain in clothing or equipment if it is not laundered correctly 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 PPE is reused without cleaning or laundering, the protective effect may be reduced or eliminated. Therefore, the Agency has determined that it is appropriate for the employer to assure that PPE is cleaned and maintained properly before it is reused. The proposal required that after each use all PPE be washed thoroughly with detergent and hot water or be cleaned according to the manufacturer's instructions and that it either be dried thoroughly before being stored or be placed in a well-ventilated place to dry. The Agency also proposed that PPE be stored away from pesticide-contaminated places and be stored separately from personal clothing to avoid contamination of either clean PPE or clean personal clothing. A few readers interpreted the proposal as requiring laundry facilities on-site (on the farm, forest, or nursery, or in the greenhouse). It does not. Several comments said EPA did not provide sufficient guidance for the implementation of the proposed cleaning and maintenance provisions. Two comments questioned appropriate decontamination for chemical-resistant protective clothing and equipment; fabric clothing can be laundered daily, but chemical-resistant suits are expensive and are damaged by constant laundering in hot water. One was concerned that conventional washing of chemical-resistant suits may result in low-level contamination of the inside surfaces that might not occur otherwise. It suggested modifying the language to state that chemical-resistant suits, hats, boots, and gloves need not be washed or cleaned daily, but must be kept in a condition of cleanliness consistent with employee safety. Several comments questioned the conditions under which the employee may be permitted to wear or to take home ``normal work attire'' that has become contaminated. To prevent these situations, some comments advocated that the employer should be responsible for cleaning and maintaining ``normal work attire,'' i.e., long-sleeved shirts, long pants, shoes, and socks worn during handling or early-entry activities when it is specified on the labeling. Several comments from the forestry industry asserted that it was awkward to clean and maintain PPE in typical forestry situations. Some of these requested that PPE and laundry requirements be eliminated for pesticides in toxicity categories III and IV 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 PPE; thus, the employer has no responsibility to provide it. However, EPA is concerned about employees' wearing or taking home pesticide-contaminated clothing or equipment, regardless of whether the clothing is provided by the employer or by the employee. The Agency, therefore, is inclined to require that employers clean and maintain any attire an employee 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 PPE, 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 PPE and to clean it at their convenience at a location of choice. Therefore, forestry employers could provide their handlers (and early-entry workers) with a clean set of PPE for each day of handling activities and provide a chemical-resistant container that could be securely fastened, such as [38122] a sturdy plastic bag, for storing the contaminated PPE until it is cleaned. EPA's directive to wash PPE in hot water and detergent is the alternative when there are 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 non-chemical-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 protective suits indicate another method of cleaning and maintaining the equipment, it must be followed. EPA proposed that persons responsible for cleaning the PPE would be informed that the equipment might be contaminated with pesticides. Only a few comments were received on this issue. One comment requested that any person cleaning the PPE be required to provide written verification that he has been warned of the hazards. EPA concurs with the sense of the comment and has rewritten the rule to require the employer to inform persons who clean or launder PPE or other pesticide-contaminated items of the possibility that such items may be contaminated with pesticides and of the potentially harmful effects from exposure to pesticides. The employer must also inform these persons of the appropriate procedure(s) for handling and cleaning such items. Some comments requested more specific guidance as to who would be responsible for inspecting the PPE before each day of use. A few suggested that the inspector be a certified applicator; others suggested that training on the appropriate inspection of PPE would be beneficial. It is the employer's responsibility to assure that the PPE is maintained properly, and this includes inspecting the PPE for damage and other defects. This may be done by the employer, by a designated supervisor, or by the employees if they have been instructed in the care and cleaning of PPE. The Agency believes that it is not practical in many agricultural situations to require a certified applicator to inspect all PPE before each day of use. EPA concurs that information on procedures for inspecting PPE would be useful. The Agency has developed a guidance brochure on the maintenance and inspection of PPE such as protective eyewear, gloves, protective footwear, chemical-resistant protective suits, hats or hoods, and coveralls. e. Heat-related illness (heat stress). Although chemical-resistant suits are not part of the minimum PPE proposed by this regulation, they are required by the labeling for a few pesticides. The NPRM prohibited tasks requiring chemical-resistant suits where a combination of temperature, humidity, and 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 expressed the belief in the NPRM that users could be expected to anticipate when work activities might result in heat stress. Many comments expressed concern about the risk of heat stress in agriculture with respect to the use of PPE when handling pesticides in warm climates, stating that guidance and training were central to enabling employers and employees to prevent heat-related disorders. Nearly every comment disagreed with EPA's assumption that the employer could ascertain when heat-related illness was a risk and asked EPA to give guidance about the conditions that would warrant limiting work due to heat stress concerns. Some comments stated that it is inappropriate and unfair to ask employers to make decisions about heat-induced illness, a complicated and potentially life-threatening condition; farmers and ranchers have no training in health care. The comments stated that the employee 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. A few comments requested that PPE not be used or 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 some States or regions make wearing any PPE a problem because of extreme heat or humidity. A few comments requested that specific temperature and humidity guidelines be established. The National Institute for Occupational Safety and Health offered some recommendations for reducing heat stress when PPE is required. EPA has determined that heat-related illness is a potential problem with the use of many types of PPE. Therefore, the Agency has modified the language in the rule to state that the employer should use appropriate precautions to prevent heat-related illness (170.240(g)). EPA has developed a guidance document that addresses recognition, prevention, and treatment of heat stress under agricultural working conditions. This document can 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 the 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 early-entry workers, providing plenty of drinking water, modifying work schedules and work/rest cycles, and using portable cooling devices. E. Decontamination The Agency proposed that water, soap, and single-use towels be available during any work activity where there is potential employee contact with concentrated or diluted pesticides or with surfaces that have been treated with pesticides. For pesticide handlers and early-entry workers, decontamination facilities would be required at all times since these activities have the greatest risk of exposure. For persons working in treated areas after the REI has expired, the Agency proposed to limit the requirement to activities in areas that have been treated during the current growing season. Many comments questioned the need for decontamination facilities during an entire crop cycle, stating that a time should be specified. The Agency believes that there is a need for decontamination facilities after the end of the REI. The Agency recognizes, however, that some pesticides may have been applied long before workers enter the area. EPA agrees with the comments that suggested that the proposed requirement might be excessive, and it sought to determine what might be a reasonable [38123] time during which decontamination facilities should be available. Knaak, Iwata, and Maddy, in a 1989 investigation of a series of pesticide poisoning incidents that occurred after the expiration of an REI, found that the median time from application in these incidents was 29 days. The Agency has studied more recent data regarding the incidence of multiple-case systemic illnesses of agricultural field workers from exposure to residues of organophosphates in California. Among the 44 incidents for which data were provided, the mean length of time from application to poisoning was 20 days, with a median of 16 days. The range was from less than 1 day to 66 days, although this latter figure was an outlier and did not appear to be well substantiated. Excluding parathion (no longer registered for most crops) and this outlier, the longest period between application and reentry poisoning was 39 days. The Agency believes that poisoning incidents that occur more than 30 days beyond the REI probably stem from a miscalculation in establishing the REI that is listed on the labeling. As part of the Pesticide Hazard Assessment Project funded by EPA in 1985, a computer model was developed to estimate how long hazardous residues might persist. For one of the pesticides studied the hazard was predicted to remain for 30 days after the REI had expired. The Agency is seeking to corroborate and refine this model. In the meantime, the Agency believes it should institute a safety factor in the Worker Protection Standard to compensate for this potential variability. In response to the comments, the Agency has modified the language in the final rule to require decontamination facilities for workers entering a treated area for which an REI is in effect and for workers entering a treated area within 30 days after the expiration of the REI. The NPRM also stated that the water shall be potable, in adequate supply, at a temperature that will not injure the eyes, and reasonably accessible to each worker's place of work. There were many comments about the proposed rule's reference to potable water. Those supporting the requirement for potable water said that OSHA requirements for field sanitation already require potable water in the fields. Comments from representatives of the forestry industry pointed out that potable water might not be available to forestry workers working in areas with no vehicular access. Those opposing the requirement for potable water stated that farm wells are not required to meet the Safe Drinking Water Act requirements, so it is unreasonable to expect water supplied from a farm to meet this standard for quality. In their comments on the draft final rule, under FIFRA section 25(a), the U.S. Department of Agriculture (USDA) stated that the decontamination provisions of the draft final rule would be unreasonably burdensome to employers because of the requirement for potable water for handwashing purposes. They stated that the standard for potable water is higher than necessary for washing purposes and that clean water should be sufficient. Clean water, they suggested, would be readily available from farm and irrigation wells, whereas potable water may not be. USDA believes that changing the decontamination provisions to permit the use of clean water would greatly reduce the burden and expense to farm employers without significantly reducing worker protection. They suggested that an appropriate standard might be the regional or local standard for water safe for swimming. As stated in the NPRM, the Agency proposed the standard of ``potable'' for the quality of water for two primary reasons: (1) ``OSHA's Field Sanitation Standard (29 CFR 1928.110) requires potable water in the fields for hand laborers, intended not only for washing but also for drinking purposes. Even though EPA's proposed requirement was intended to provide water only for washing, in practice the water may be used by workers for drinking as well.'' (2) ``[O]nly 'potable' water can be defined in such a way that noncompliance can be clearly ascertained.'' At the time of the proposal, EPA believed that since OSHA uses the potable water standard for its Field Sanitation Standard, it would be easier for employers to comply with one water standard than with two. However, EPA was reminded by commenters that approximately 89 percent of agricultural establishments are not currently covered by OSHA's Field Sanitation Standard and that EPA should be responsive to the burden to employers on those establishments. EPA has been persuaded by the comments that a standard of ``potable'' may impose a substantial burden to agricultural employers, without a concomitant benefit to workers. EPA believes the goal of this requirement should be to ensure that workers and handlers will be provided with water that will not cause illness or injury when it contacts their skin or eyes and will not cause illness or injury if they should happen to swallow it. Thus, the Agency has been persuaded to eliminate the requirement for ``potable'' water and instead has required the provision of water that meets the stated performance standards. This will permit employers to equip decontamination sites with water which is used for drinking on the agricultural establishment, but which may not meet the standard of potability in the Notice of Proposed Rulemaking. In reexamining the options, EPA considered establishing the quality standard of ``clean'' water defined as water safe for swimming. However, the Agency was unable to ascertain how agricultural employers would be able to apply such a standard. In adopting a standard of water quality different from a potability standard, EPA remains concerned that in practice, some workers may drink the water, especially if no alternative source of drinking water were available in the field. Moreover, the Agency has concluded that water must be of a quality safe for drinking because (1) workers and handlers may accidentally swallow water in the process of washing/flushing their faces or eyes, and (2) workers and handlers may mistake wash water for drinking water. EPA believes that placarding water to indicate that it is not for drinking purposes would be a difficult and unwieldy requirement given the range of languages and degree of illiteracy among workers. EPA concurs with OSHA's stance in the preamble to the Field Sanitation Standard that they ``would like to eliminate the use of signs in several languages to identify different classes of water quality in the same workplace and the errors that occur when water supplies are confused.'' The Agency believes that defining decontamination/eyeflush water, in part, as water that ``will not cause i