IV. Labeling Statements A. Background of Proposal The Agency noted in the NPRM that for part 170 to be enforceable under the misuse provision of FIFRA section 12(a)(2)(G), its requirements must be incorporated onto pesticide labels or labeling. Rather than require that the regulations be printed in their entirety on each product, EPA proposed that part 170 be incorporated by means of a reference statement. In addition to the reference statement, those requirements of part 170 that were product specific, such as personal protective equipment and restricted-entry intervals, and product-specific information necessary for compliance with part 170, such as whether the product is a fumigant, would appear as statements on labeling. Requirements applicable to all products, such as providing decontamination water, would not appear as statements on labeling. The NPRM proposed that the required worker protection labeling statements be consolidated for the convenience of registrants in a new subpart K of part 156, ``Labeling Requirements for Pesticides and Devices.'' The Agency proposed specific regulatory text and labeling statements for part 156, and solicited comment on the labeling aspects of the Worker Protection Standard. The Agency also discussed how it would implement these labeling changes as part of its pesticide registration program. B. Reference Statement The comments were divided evenly in opposing or supporting the proposal to reference part 170 on the label rather than including the full text of all requirements in labeling. Comments that opposed the proposal to reference part 170 gave reasons such as: (1) The problem of availability of the specific requirements of the regulation should it not be incorporated in pesticide labeling in its entirety, (2) the need for information at the use site, and (3) the undermining of the ``read the label'' and the ``label is the law'' message that users have been trained to follow. They suggested that noncompliance is more likely for requirements that are not on the label. Several comments stressed the need for wide dissemination of the requisite information. Two comments suggested that users should not be referred to part 170 but to Agency-generated guides, instructional materials, or popularized versions of the regulations. The Agency acknowledges the need for pesticide users to have access to full information about the legal requirements for use of a pesticide. It also notes that in many cases the quantity of information on pesticide labeling is considerable. Confusion in understanding labeling statements may result in noncompliance as surely as difficulty in obtaining the information may result in noncompliance. The Agency intends to develop and to make available, through its outreach activities and with the assistance of the Cooperative Extension Service, State pesticide-regulating agencies, and the traditional networks of communication with the agricultural community such as commodity organizations and industry associations, information to assist users in understanding and complying with part 170. EPA believes that such information will minimize the need for users to seek out the Code of Federal Regulations (CFR) to understand their duties. The Agency intends to complete the development of basic training materials prior to implementing part 170. The Agency considered requiring registrants to distribute a copy of part 170 with each sale of agricultural pesticides, but concluded that such requirement would result in waste through duplication. However, the Agency encourages any efforts registrants choose to make to communicate part 170 requirements to users. The Agency has retained its approach in the final rule of referencing part 170 on the label, but has changed the language in the reference statement for the purposes of brevity and clarity. C. Other Statements Other changes have been made to part 156 in response to comments. The proposed wording of the labeling statements for restricted-entry intervals, notification, and personal protective equipment have been shortened. One comment suggested that the signal word be required to appear in Spanish for products in toxicity categories III and IV as well as on products in toxicity categories I and II. The Agency believes that for the most toxic products, where there is a significant risk of serious injury by accidental exposure, it is reasonable to require translation of a limited amount of critical information, such as the signal word, into Spanish because it is the primary language for many agricultural workers in the United States. Extending this translation requirement to additional products, information, or languages would add verbiage to already crowded product labels without [38133] increasing the likelihood of avoiding additional pesticide poisonings. EPA permits a product to bear labeling in languages other than English, but it will not require translation as part of the final rule. A number of changes to worker protection statements have been made in the final rule in response to comments. These changes have focused on risk mitigation measures such as the entry restrictions, notification about treated areas, and use of personal protective equipment by handlers and other workers entering treated areas prior to the expiration of a restricted-entry interval. The restricted-entry statements are to be placed in the ``Directions For Use'' section of the pesticide labeling under the subheading of ``Agricultural Use Requirements'' to consolidate most worker protection statements in one place. No comments were received in reference to the proposed notification statements. Several changes to the notification section have been made in the final rule. The wording of the statement was changed to ``notify workers of the application by warning them orally and posting warning signs at entrances to treated areas'' rather than merely ``subject to posting'' to distinguish the statement from other general requirements of part 170 which involve the display of written materials. The subsection related to location of the statement on the labeling has been modified to require that the notification requirement be in the Agricultural Use Requirements section of the labeling with the other required worker protection statements. No comments were received on the proposed personal protective equipment statements. In the final rule the Agency has made a number of administrative and technical changes to these sections. These are reflected in changes in the terminology used in the table for the protective equipment requirements for handling activities in 40 CFR 156.212(e). For example, the term ``coveralls'' has been used instead of ``protective suit'' and ``protective eyewear'' has been used instead of ``goggles or face shield.'' Two differences between the proposed and the final rule relate to PPE labeling statements. Wherever possible throughout the PPE section, the Agency has taken the approach of specifying the exact wording of PPE labeling statements and specifying which products are subject to the statement. The goals of this approach are to reduce the burden on registrants in interpreting part 156 in the process of revising product labeling and to reduce the need for registrants to consult with EPA about PPE labeling language. Another difference between the proposed and the final rule is the way in which information about acceptable types of PPE is conveyed to users. Specific types of glove materials will be recommended on the labeling, and specific types of respirators will be required on the pesticide labeling. Where protection of a certain body area is called for, e.g., eye protection, the labeling will not list all acceptable kinds of protective eyewear. Instead, the labeling statement will list ``protective eyewear,'' and users will refer to the standardized definition of acceptable kinds of PPE for eye protection in 40 CFR 170.240 (the section of the pesticide-handling subpart which covers PPE), in the EPA-prepared guidance brochure on protective eyewear, or in other new EPA training materials dealing with PPE. Through these definitions and through handler training programs, users should become accustomed to the criteria for acceptable types of PPE, and EPA believes this will reduce labeling verbiage related to PPE. EPA has made every effort to minimize the additional labeling language necessitated by the revisions to part 170 and to eliminate excess verbiage. At the same time, EPA recognizes that use restrictions can ordinarily be enforced only through labeling statements. EPA's approach, therefore, has been to put users on notice, via the labeling, of the regulations with which they must comply. One comment suggested requiring the identification of the toxicity category on product labels. Signal words are intended to convey the relative acute toxicity of products in a manner users can understand easily. Since users may not be aware of the criteria on which toxicity categories are based, the Agency believes that the toxicity category would not be useful on labeling and that the signal word is sufficient. In the final rule, EPA has specified the location, or alternative locations, for all required statements. The final rule allows that statements be consolidated, to the extent possible, for the convenience of the reader and that statements be at the beginning of the directions for use to emphasize their importance. V. Statutory Review A. U.S. Department of Agriculture As required by FIFRA section 25(a), a copy of this final rule was provided to the Secretary of Agriculture on June 7, 1991. On March 27, 1992, the Secretary provided written comments on this final rule. The Secretary offered many comments that led EPA to revise the final rule, its cost estimates, and its approach to implementation of the final rule. Following is a summary of the principal comments by the Secretary, together with the Agency's responses. The full texts of the Secretary's comments and EPA's responses are contained in the docket for this rule. Comment 1B1: USDA expressed concern about the impact of restricted-entry intervals (REIs) that exceed 72 hours. Response: USDA's concern is due to two aspects of the draft final rule: (a) A requirement that registrants must retain existing REIs that are longer than those that would be established through the Worker Protection Standard, and (b) a redefinition of ``restricted-entry interval'' -- instead of allowing early entry if minimal protective clothing is worn, the rule now prohibits all early entry to perform hand labor tasks, except for a few narrow exceptions. Therefore, this rule might subject users to considerable costs that were not contemplated when these longer REIs were set. EPA believes that USDA has a valid concern regarding longer REIs established before the promulgation of this rule. EPA has ascertained that REIs exceed 72 hours for only a few currently registered active ingredients--usually for only a few uses of each. EPA is reviewing such uses for each of the few active ingredients in light of current information. The review is based on the availability of reentry data, poisoning incidents, or other evidence that could help determine: (a) Whether routine early entry to perform hand labor tasks must be prohibited for the entire REI to mitigate risk to hand laborers, or (b) whether early entry for hand laborers with personal protective equipment (PPE) and other protections could be permitted on pesticide labeling as an appropriate temporary mechanism to respond to USDA's concerns about disruptions and costs to growers who are using pesticides with REIs longer than 72 hours, or (c) whether another product-specific strategy should be adopted. EPA will notify registrants of this review process and will request that registrants notify EPA of longer REIs that may have been overlooked in the Agency's search. With cooperation from affected registrants, EPA expects to complete the review process in time for those registrants to alter their labeling within the time allotted in this rule. [38134] Comment #2: Activities that entail only slight contact with treated surfaces should be subject to a reduced standard, and provision should be made to permit necessary agricultural worker activities with the use of PPE, particularly when REIs exceed 72 hours. Response: The final rule contains 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. However, when contact with treated surfaces will occur, EPA is unable to predict on a generic basis which activities, crops, and situations will involve only ``slight'' contact. This can be determined only through data review, usually as part of the registration or reregistration process. See preamble discussion in Unit III--establishing entry restrictions in the future. During the formal comment period for this rulemaking, EPA received many comments from the cut flower and cut fern industry about the economic hardship that prohibiting routine hand labor during REIs would cause their industry. The Agency did not receive comments from other industries or commodity organizations that indicated that they would sustain such a hardship and the Agency has no information indicating that any crops or industries other than the cut flower and cut fern industry would be significantly affected by the entry restrictions imposed by this final rule. However, there may be other industries, crops, or crop practices that would bear an unreasonable economic burden under such restrictions. Therefore, the final rule allows the Agency to grant exceptions to the entry restrictions on a case-by-case basis. Comment #3: USDA believes it is imperative that EPA clarify whether the prohibition on early entry to perform hand labor tasks applies to State-established REIs. Response: States determine the restrictions that apply to State-established REIs. The final rule's restrictions on entry apply solely to REIs that appear on federally approved pesticide product labeling. On some occasions, registrants request the addition of a State-established REI to their federally approved product labeling. If EPA approves such an addition, a decision will be made on a case-by-case basis as to whether to prohibit routine early entry to perform hand labor tasks during the entire State-established REI. EPA may chose to create an exception on individual product labeling to allow, after the expiration of the EPA-mandated REI, early entry to perform routine hand labor tasks with certain limited PPE and work clothing. Comment #4: USDA supports the concept of providing training to workers who may be exposed to potentially dangerous pesticides. Response: None required. Comment #5: USDA expressed concern that the manner in which training is required is unreasonably burdensome. Response: USDA's concern is that if EPA requires training before each worker is potentially exposed, then training one or more times daily could be required of employers with frequent employee turnover, as is common in some hand labor crews. Such training might have to be conducted on the spot, such as at the side of the field, and would likely be less beneficial to the worker and onerous to the employer. EPA will continue to require that early entry workers must be trained before entering areas and contacting treated surfaces while an REI is in effect, because their risks are expected to be higher. EPA has made a change, however, in the training requirement for non-early-entry workers. The modified rule continues to require training for all agricultural workers. However, in general, the modified rule requires agricultural employers to assure that when any worker enters any areas on the agricultural establishment where, within the last 30 days, a pesticide has been applied or an REI has been in effect, the worker receives pesticide safety training before their 6th day of entry into such treated areas on any particular agricultural establishment. However, for the first 5 years after the effective date of the rule, workers must be trained before their 16th day of entry into such treated areas on any particular agricultural establishment. Finally, it should be noted that EPA deliberately established a relatively lengthy (about 20 months) lead time before the training provisions of the final rule would be enforceable. This lead time was established, in part, so that a substantial number of workers could be trained in the interim. Once a large percentage of workers have been trained, the concern about repetitive training diminishes, because many new hires already will have received training. This issue does not pertain to handlers' for whom risks are expected to be higher--the rule requires that handlers receive training before they handle pesticides. Comment #6: USDA expressed concern about the absence of a formal mechanism to avoid repetitive training of each new hire on each agricultural establishment. USDA welcomes the opportunity to work with EPA to develop such a verification program. Response: Two changes to the final rule were made. The rule now requires training for workers or handlers to be renewed at least once every 5 years. In addition, the rule now states that if the agricultural employer determines that a worker possesses an EPA-approved Worker Protection Standard training certificate that the employer has no reason to believe is invalid, that determination shall meet the requirements of assuring that the worker has been trained. The revised final rule requires trainers to assure that appropriate Worker Protection Standard training has been given to a worker before the training certificate is issued. Comment #7: Additional funding will be required if EPA anticipates that USDA will meet some of the training requirements of this rule. Response: EPA has not assumed that USDA will be the vehicle to meet the training requirements. The Agency believes that employers will train most workers and handlers. In addition, EPA will promote training by other interested persons and organizations by conducting train-the-trainer courses and by developing suitable training materials and making them available for trainers' use. However, EPA seeks to work closely with USDA in the development of Worker Protection Standard training materials, including materials designed to train workers and pesticide handlers and materials targeted at aiding growers in learning how to comply with the revised rule. EPA also seeks to cooperate with USDA in the development and implementation of the training verification system and other projects designed to inform the regulated audience about the revised rule and how to comply with it. Comment #8: Making agricultural producers responsible for employees' own safety actions is unrealistic. Response: While compliance is primarily a duty of employers under the final rule, enforcement officials have authority to consider the facts of the case before making a determination of whether a violation has occurred. The Agency agrees, for example, that it would be unfair for employers who expend considerable efforts to assure compliance to be treated in the same manner as less conscientious employers who tolerate or encourage noncompliance. However, the Agency believes that it is more appropriate not to intrude by regulation into this area. [38135] Enforcement officials have traditionally based their compliance decisions on the facts of an individual case. Comment #9: USDA questions the requirement that a listing of all pesticides applied must be displayed in a central location until 30 days after the REI has expired. Response: The NPRM, which proposed that the information be provided to workers upon request, generated many comments. The majority of the commenters, including worker organizations, State agencies, and a land-grant university, recommended that the information be provided to workers through posting. The National Agricultural Chemicals Association recommended a requirement that the information be provided with each oral warning. Some commenters cited worker intimidation as the reason for opposing the proposal that information be supplied upon request. Others cited the potential difficulties that employers would have in complying with individual oral requests for such information. EPA was persuaded by the comments to require the posting of this information at a central place. On that basis, in turn, EPA was persuaded to drop the proposed daily oral warnings and require one-time oral warnings instead. EPA believes that most employers would find daily oral warnings more onerous than a one-time posting in a central location. Comment #10: The rule needs to clarify when the employer is responsible for making available to the worker prompt transportation to an appropriate emergency facility. USDA interprets this to be applicable only while the employee is on the employer's property. Response: EPA has clarified in the final rule that the agricultural employer must provide such transportation when a worker is on the employer's property, including in any labor camp located on the property. The Agency has similarly clarified in the final rule that the handler employer must provide emergency transportation when a handler is at the place of employment or at the handling site. Comment #11: The decontamination provisions are unreasonably burdensome to employers because of the requirement for potable water for handwashing purposes. Response: A change to the final rule was made. EPA replaced the requirement for potable water with a requirement for water that is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed. Evidence indicates that the drinking water on many agricultural establishments has not been test for potability. EPA continues to require water of such quality that, if accidently swallowed, would not cause illness or injury, because it is concerned that workers will accidently use decontamination water for drinking purposes. In addition, the Agency recognizes that water used to wash the face may accidently enter the mouth. EPA believes that this is a simple standard that will be easy for employers to understand and comply with. Comment #12: The cost for eyeflush dispensers should be accounted for. Response: USDA's comments on the cost analysis of eyeflush dispensers led, in part, to EPA's reexamination of the requirement. The language of the rule has been altered to change the requirement from ``eyeflush dispenser'' to ``eyeflush water,'' and the requirements for decontamination water and eyeflush water have been combined in the rule to avoid confusion. In addition, the requirement for weekly replacement of nonsterile eyeflush water has been deleted and a performance standard has been added that requires employers to ensure that the decontamination and eyeflush water remains ``of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed.'' Eyeflush dispensers are no longer specifically required at decontamination sites; instead, eyeflush water is required. For example, eyeflush water may be the water in a carboy containing the decontamination water or may be running water from a tap. While special eyeflush dispensers may be used, any source of water that meets the standards for decontamination in the final rulemaking is acceptable for flushing the eyes. Eyeflush dispensers would be required only when handlers or early-entry workers must carry eyeflush water. This would occur only when handlers or early-entry workers are required by the pesticide labeling to wear protective eyewear and when they do not have decontamination water otherwise immediately accessible to them, such as running water nearby or a carboy on a vehicle they are using. Comment #13: USDA questions whether it is reasonable to require decontamination facilities and training for a period of 30 days after the expiration of the REI. Response: EPA reconsidered the 30-day time period due to comments from both USDA and Congress, and remains convinced that pesticide safety training and access to decontamination water are necessary for a considerable time after the REI expires. (Congress requested a time period longer than 30 days.) The final rule continues to require that worker training and decontamination water be provided for 30 days after the expiration of the REI. The 30-day period was an attempt to limit and better define the sometimes open-ended time period in the NPRM that was ``any surface that has been treated with a pesticide during the agricultural crop production cycle in which the task occurs.'' (NPRM 170.38(a)) In addition, it is important to note that this final rule is establishing minimum REIs. These REIs are intended as temporary safeguards until product-specific reviews are conducted. At that time, the Agency anticipates that longer REIs will be established on some of the products, based on restricted-entry-related incidents or on entry data. On the other hand, even permanent product-specific REIs are based on ``average'' conditions. They do not and cannot take into account differences due to temperature and humidity; rainfall, dew, and irrigation practices; degree of sunlight; crop type, height, and density; region-specific production practices; or worker activity and length of exposure. Evidence indicates the importance of washing pesticides off as soon as possible after an exposure to mitigate adverse effects. Retaining decontamination requirements for a period of 30 days after the expiration of an REI minimizes the chances that workers will be harmed by residues, decreases their chronic exposures to pesticides, and lessens the risk of delayed effects that may be unrecognized at present. Studies also indicate the value of training in any program to reduce risk and increase safety. EPA has concluded that providing workers with pesticide safety training and supplying them with water, soap, and towels for routine washing for a period of 30 days after the expiration of an REI is a prudent and inexpensive measure to protect them from a variety of opportunities for exposure to pesticides. Comment #14: EPA should establish regional climate-based restricted-entry intervals, and the need for decontamination provisions and safety training should be based on the pesticide persistence expected in a particular region. Response: When EPA establishes product-specific REIs all available data for the product are considered. All such REIs must be set on a case-by-case basis, after detailed review of the properties and uses of the pesticide. Such a detailed review is not possible in [38136] a regulation of the scope of the Worker Protection Standard. Part 170 establishes only ``interim'' REIs to strengthen deficient existing protections until a more thorough review can be performed. As discussed in response to Comment #13, restricted-entry intervals will, for the most part, be based on ``average'' conditions. Even in the ideal situation, where entry is based on on-site field tests, situations will arise where workers will be exposed to unacceptable levels of residues. These situations include being contacted by drift from nearby applications, mistakes in warnings about areas not yet safe to enter, ``hot spots'' within treated areas from spills, or application mistakes, etc. In addition, the establishment of a residue level that is ``safe'' for entry involves, at this time, only an analysis of exposure to a specific product on a specific occasion, and is often based only upon acute toxicity data. The Agency is also concerned about acute and delayed health effect risks from the cumulative effect of multiple exposures to a single product and multiple exposures to multiple products. Since the opportunities for exposure are so variable, training employees once every 5 years and providing decontamination facilities for a period of 30 days after the restricted-entry interval seem to be prudent, low-cost measures that can reduce the pesticide-related illnesses and injuries that may stem from such exposures. Comment #15: USDA takes exception to the term ``decontamination facilities'' after the expiration of the REI when the risk of pesticide exposure is negligible and suggests ``personal hygiene facilities'' or simply ``handwashing facilities.'' Response: EPA will continue to call the provision ``decontamination facilities,'' because the term best describes the purpose of providing soap, towels, and water to pesticide handlers, early-entry workers, and agricultural workers working in areas that have recently been treated with pesticides. The Agency does not consider the risk of pesticide exposure to be negligible for these employees. Comment #16: USDA is concerned that regulation beyond the harvest interval could be misinterpreted in a manner that would generate unwarranted food safety concerns. Response: Preharvest intervals and entry restrictions are based on different criteria. Entry restrictions are based on the expected skin or eye exposure that workers might receive during an entire workday from exposure to residues on foliage, fruit, other plant parts, and in or on the soil, water, or air. Preharvest intervals are based on the expected dietary intake of the edible portion of the crop based on amounts consumed. The Agency has concluded that field workers often will have a far greater opportunity for exposure than the consumers of the crop they pick. Finally, the uncertainties associated with any REI have already been discussed. This uncertainty has led EPA to require prudent, but economical, worker protections after the REI has expired. Comment #17: In informal discussions between EPA and USDA about this final rule, USDA expressed concern about limiting the access of crop consultants and IPM scouts to treated areas immediately following pesticide applications and during REIs. Response: EPA has changed the final rule to allow persons who are performing duties as crop advisors to have access to treated areas without a time limitation. A crop advisor is defined as any person who is assessing pest numbers or damage, pesticide distribution, or the status or requirements of agricultural plants. The term does not include any person who is performing hand labor tasks. EPA was unwilling to exempt crop advisors from all of the protections provided by this rule, but has defined them as pesticide handlers if they enter an area during a pesticide application or REI. As pesticide handlers, they must receive such protections as handler training (unless already certified applicators), PPE and the availability of decontamination facilities. However, since crop advisors who are employed by commercial establishments (rather than directly for the agricultural establishment) are not workers covered by part 170 protections, their presence in a treated area after the expiration of the REI will not trigger notification requirements, such as oral warnings, treated area posting, or posting of application- specific information, and the operator of the establishment need not supply them with decontamination sites. The Agency bases this change on its conclusion that crop advisors are likely to be particularly well-informed about pesticide risks and how to protect themselves. Comment #18: USDA raised concerns about the Regulatory Impact Analysis. Response: In light of USDA's concerns, EPA reexamined the Regulatory Impact Analysis for this final rule. The Agency used USDA-provided data and data from other sources to update and refine the analyses for the various requirements of the rule. The full text of EPA's responses to USDA's concerns is contained in the docket and in EPA's revised Regulatory Impact Analysis for this rule. B. Congressional Committees As required by FIFRA section 25(a), a copy of this final rule was provided to the Committee on Agriculture, Nutrition, and Forestry of the U.S. Senate and the Committee on Agriculture of the U.S. House of Representatives. Comments were provided by Senator Patrick Leahy and Representative Charlie Rose. Following is a summary of each comment by Senator Leahy and Representative Rose, together with the Agency's response. Comment #1: Supports covering greenhouse, nursery, and forestry workers. Response: None required. Comment #2: Supports prohibiting routine hand labor activities prior to the expiration of the applicable restricted-entry interval. Response: None required. Comment #3: Supports covering all farms regardless of size. Response: None required. Comment #4: Supports training for workers as well as handlers. Response: None required. Comment #5: All field workers should be given crop sheets. Response: The Agency agrees that workers should have access to information about the hazards of the specific pesticides to which they may be exposed during their work activities. Crop sheets provide workers with hazard information for all the pesticides that may be applied to the crops they are working with. The Agency is establishing a system whereby information on the specific pesticide(s) actually used on a crop will be posted at a central location to which workers will have access. The Agency is also proposing to make MSDSs or comparable pesticide-specific fact sheets available to workers. The information posted at the central location, coupled with MSDS-type information, will allow workers to determine the hazards of the specific pesticides they may be exposed to during their work activities. Comment #6: The training for workers and handlers should include information on the workers' rights and the growers' responsibilities. Response: The Agency agrees that workers and handlers should be aware of the protections they are entitled to under the Worker Protection Standard. The Agency has incorporated such a provision into the training requirements for workers and handlers. [38137] Comment #7: All worker and handler training should be ongoing and updated as needed. Response: The Agency supports the concept of ongoing training and the updating of information as needed. A change to the final rule was made. The final rule now requires training for workers or handlers to be renewed at least once every 5 years, measured from the end of the month in which the training is completed. The Agency believes that such renewal of WPS training will be adequate to convey the basic pesticide safety precepts to handlers and to provide timely updates and reinforcement, without undue burden. This final rule requires the continual presence of a pesticide safety poster to serve as ongoing reinforcement of training for workers and handlers on agricultural establishments. The final rule also requires employers to update as necessary the information about the location of the nearest emergency medical facility. In addition, updated information about specific pesticides to which the workers may be exposed will be provided to workers as specified under the notification provisions. Comment #8: Supports establishing a minimum restricted-entry interval (REI) for all pesticides and setting REIs for toxicity category I and II pesticides without distinguishing those of a specific chemical class. Response: None required. Comment #9: In all dry areas, all toxicity category I pesticides should have a 72-hour restricted-entry interval. Response: During the ongoing reregistration of pesticides, the Agency is requiring registrants to supply data about foliar and soil dissipation rates on products for which this information is relevant. When the Agency has the necessary data, it will establish product-specific REIs based on the product, and, as applicable, on the crops or sites where it is used, cultural practices, varying climatic conditions, and application techniques. At present, the Agency has data to indicate that some organophosphates transform into more toxic products in arid conditions. There are no data to indicate that other chemical classes of pesticides undergo similar transformations. Without data to support a longer REI for chemical families other than organophosphates, the Agency has extended the REI to 72 hours for organophosphate pesticides only. The transformation of organophosphates into more toxic products is related to the lack of moisture in the soil and conditions of very low humidity. These conditions are generally found only in areas where rainfall is consistently below 25 inches a year. The Agency believes that defining arid-like conditions, such as a combination of percent humidity, days without measurable dew or rainfall, and percent soil moisture, is unsuitable for establishing these ``interim'' REIs. Comment #10: Generic REIs should be established on the basis of the highest acute toxicity rating, whether dermal or oral. (Methomyl poisoning incidents in California cited as basis.) Response: Studies of fieldworker exposures indicate that the predominant exposures in outdoor situations are to the skin and eyes. Except in those few situations where fieldworkers have eaten fruits or vegetables before the preharvest interval has expired, the Agency is unaware of validated fieldworker poisoning incidents where the primary route of exposure was oral. The worker training materials being developed by the Agency include specific warnings not to eat fruits and vegetables unless a supervisor indicates that it is safe to do so. In this final rule, the Agency intends to establish REIs based on three parameters: dermal toxicity, skin irritation potential, and eye irritation potential. If dermal toxicity data are unavailable, the oral toxicity data will be used. For example, under this strategy, methomyl would be assigned a 48-hour REI because it is a toxicity category I eye irritant. With respect to the methomyl incidents cited by Congress, preliminary reports indicate that, under special environmental conditions, methomyl dissipation is not following the predicted pattern and rate. EPA will adjust REIs for methomyl to reflect these special environmental conditions, if there are indications that the incidents were not unique. The Agency is unaware of data or conclusions by experts that the oral LD50 is a more accurate assessment of the actual hazard to workers than dermal LD50, either in these methomyl incidents or in other fieldworker poisoning incidents. Comment #11: Continue protections for workers for a minimum of 60 days after the expiration of the restricted-entry interval. Response: EPA reconsidered the 30-day time period due to comments from both USDA and Congress. 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. Therefore, EPA decided to continue to require that decontamination water be provided for 30 days after the expiration of the REI. See EPA's response to USDA's Comment #13 for a more complete discussion. Comment #12: Moving or repair of irrigation equipment should be designated as a hand labor task, since workers performing such tasks are likely to come in contact with treated surfaces. Response: EPA concurs that moving and repairing irrigation equipment may cause workers to contact treated surfaces. However, the Agency believes that this contact will be short-term and mostly nonsubstantial. The Agency realizes that moving, adjusting, or repairing irrigation equipment may be necessary while an area remains under a REI. The Agency has, however, placed strict limitations on early entry to perform such tasks. These include: (1) No entry for the first 4 hours after an application, (2) a limit of 1 hour per worker per day for performing such early entry tasks, (3) PPE provided, cleaned, and maintained for the workers, (4) special instructions provided, including information about the hazards of the pesticide(s) to which the workers will be exposed, and (5) special decontamination and change area provisions. Comment #13: A responsible agency should determine whether or not an emergency actually exists before early entry due to an agricultural emergency is permitted. Response: The Agency intends that early entry due to an agricultural emergency be an extremely rare circumstance. Therefore, this final rule requires two separate determinations that an emergency exists: (1) A responsible agency must declare that circumstances exist that might cause an agricultural emergency on an establishment. For example, a State, Tribal, or Federal agency having jurisdiction over the establishment would have to declare that a potentially crop-damaging drought, hail storm, high winds, hurricane, tornado, freeze, or frost has occurred (or is predicted to occur) in the area where the [38138] agricultural establishment is located. (2) In addition, the agricultural employers must declare: (a) That they could not have anticipated the circumstances that led to the emergency when they applied the pesticide, (b) that they had no control over the circumstances that led to the emergency, (c) that no practices other than early entry will prevent or mitigate a substantial economic loss involving the crop in that treated area, and (d) that the loss of profit without early entry will be greater than that which would be expected on the basis of experience and the fluctuations of crop yields in previous years. EPA believes that these rigorous determinations will preclude widespread or improper use of the emergency provisions. Comment #14: Strongly object to the exemption for cut flower and cut fern workers for early entry. Congress notes that California prohibits early entry for hand labor without apparent deleterious effect on the cut flower industry. Response: A change to the final rule has been made. The Agency has adopted an exception process that would allow interested persons to demonstrate to the Agency that, in a particular industry, 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. 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 balancing 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). However, the Agency is interested in a full range of comments and information on this proposed exception and has provided 30 days for interested parties to comment. The Agency particularly welcomes comments supported by information, such as evidence demonstrating whether the risks to workers would be acceptable, whether the use of personal protective equipment in these circumstances would be feasible, and whether there are feasible alternative practices that would make routine early entry unnecessary. The Agency also would welcome any additional information concerning the likely economic impact on this industry of a prohibition of routine hand labor tasks during the restricted-entry intervals. While EPA has concluded that it would be difficult to ensure worker safety during widespread and routine early entry, narrow exceptions, such as this one, can receive adequate management attention to help ensure compliance when such early entry is critical to a crop. The Agency notes that although California law prohibits all early entry work involving hand labor, California does not currently impose REIs beyond ``sprays have dried/dusts have settled'' for many of the pesticides used by the cut flower and cut fern industry. In addition, California has established only a 24-hour REI for toxicity category I pesticides, with longer REIs for specific organophosphate and N-methyl carbamate pesticides. This final rule is establishing a minimum 12-hour REI for all pesticides plus a 24-hour REI for all toxicity category II (dermal and ocular routes) pesticides and a 48-hour REI for all toxicity category I (dermal and ocular routes) pesticides. Thus, while California prohibits early entry, its entry standards for this industry are generally less stringent than those of EPA's final rule. The economic impact of complying with EPA's REIs is likely to be higher than compliance with California's entry limitations, unless an exception is provided. Comment #15: Urge a requirement for cholinesterase monitoring of all commercial and private pesticide handlers who may handle organophosphate or N-methyl carbamate pesticides. Response: The Agency believes that monitoring of employee exposure is a prudent occupational health practice. However, as explained in the preamble (Unit III.I), EPA is concerned about many of the problems of cholinesterase monitoring. EPA intends to reconsider the need for and the appropriate form of exposure monitoring for pesticide handlers after this final rule is implemented. This will give the Agency the opportunity to evaluate more thoroughly the ongoing research in this area and the results of new or existing exposure monitoring programs. The Agency expects to issue a proposed rule in this area in about 3 years. Comment #16: Cholinesterase testing of field workers should be required in poisoning incidents involving organophosphate or N-methyl carbamate pesticides. Response: EPA presumes that treating medical personnel would prescribe such testing when appropriate and that prudent employers would encourage such diagnostic tests. However, the focus of this rule is prevention of poisoning incidents for persons occupationally exposed to agricultural pesticides. It does not address diagnosis or treatment of pesticide illnesses or injuries. Diagnostic testing was not proposed in the NPRM and the Agency deems such a requirement beyond the scope of this rule. Comment #17: Supports evacuation of greenhouse workers during fumigation application and restricted-entry periods. Response: None required. Comment #18: Supports mandatory posting of treated areas in greenhouses. Response: None required. Comment #19: Unrealistic to expect that unprotected workers could reenter treated areas in greenhouses and nurseries without exposure to pesticide-treated surfaces. Response: The Agency is convinced that there are situations in which workers may reenter many areas in nurseries and greenhouses without contacting treated surfaces, and has chosen to permit such entry. An example of such entry is when workers are wearing footwear and are walking through the aisles of treated areas where the plants or other treated surfaces cannot brush against the worker and cannot drop or drip pesticides onto the worker. Under the final rule, worker entry into treated areas is prohibited when contact would take place. Comment #20: Concerned about the adequacy of the ventilation and buffer zone criteria established for greenhouses and nurseries and urge further study of the effectiveness of the standards in practice. Response: The Agency is interested in cooperating in research or evaluations that might be done on this aspect of the regulation and has held some preliminary discussions as to the best design of such a research project. Comment #21: Not requiring notification for workers who are not expected to come within 1/4 mile of a treated area is inappropriate. Response: EPA acknowledges that workers frequently are required to move throughout the field or nursery to accomplish their assigned tasks. This final rule requires employers to notify workers of any pesticide application on the establishment unless the employer makes sure that the worker will not be in the treated area and will not walk within 1/4 mile of the treated area. As a practical matter, if workers move throughout an establishment, their employer must notify them of all treated areas on the establishment remaining under an REI. The exception to the notification requirement is intended to be in effect only when pesticides are [38139] applied at times when workers are not present on the property or when pesticides are applied to distant areas of the establishment where no work activities are occurring. Some farms, nurseries, and forests are vast or noncontiguous; requiring workers to be notified of areas greatly distant from their place of work would be pointless and counterproductive. Comment #22: Concern about EPA's rejection of the skull and crossbones symbol for the restricted-entry sign. Response: The Agency acknowledges that the skull and crossbones is a far more recognized symbol for ``highly toxic'' or ``very poisonous'' than any other pictorial representation. For precisely that reason, FIFRA requires the skull and crossbones symbol on the labels of pesticides that are highly toxic orally, dermally, or through inhalation. EPA prohibits the use of the skull and crossbones symbol on any other pesticide label. The Agency has consistently taught pesticide users that the skull and crossbones is the symbol for the most highly toxic pesticides, i.e. those where only a few drops by mouth could be fatal. For this reason, the Agency is convinced that the skull and crossbones is not appropriate for notifying workers of areas remaining under an REI. While some of these areas may have been treated with highly toxic pesticides, other areas may have been treated with moderately or slightly toxic pesticides. Rather than diluting the impact of the skull and crossbones symbol, EPA has chosen to create a new symbol for restricted entry. The Agency is taking several steps to assure recognition and acceptance of the new symbol: (1) The symbol is mandatory nationwide. States and industries currently using other signs and symbols must use the EPA-mandated sign. (2) Mandatory worker training programs must explain the symbol to workers. (3) The EPA-mandated pesticide safety poster will serve as a reminder to workers by depicting the restricted-entry sign and its meaning. Comment #23: The implementation time frames are too long. All regulations should be mandatory within 8 months. Response: Implementation and enforcement of the revised Rule depends on the misuse provision of FIFRA section 12(a)(2)(G) that states it is unlawful ``to use any registered pesticide in a manner inconsistent with its labeling.'' Thus, the provisions of the Worker Protection Standard must be in the labeling or must be linked to pesticide product labeling as directions for use before they can be implemented or enforced. Although the Agency strongly believes that the protective measures of this final rule should become effective as soon as practicable, it has concluded that a phased and orderly schedule of relabeling, information dissemination and training, and enforcement is needed to facilitate both registrant compliance with the new labeling requirements and user understanding and compliance with the worker protection standard. Therefore, the Agency will require that no revised labels appear in the marketplace for approximately the first 8 months after promulgation so the Agency will have an opportunity to explain the requirements to users. Thereafter, product-specific requirements will be enforceable when they appear on labeling. Twenty months is the latest time that labeling may be revised by the registrants. EPA expects many labeling revisions will occur earlier than the 20-month deadline. Comment #24: The regulatory protections ignore chronic health risks. Response: The Agency is concerned about minimizing both acute and chronic health risks. Several provisions of this final rule are designed, at least in part, to reduce chronic health risks. These include: (1) Incorporating information about chronic risks and how to avoid them into the mandatory worker and handler training programs, (2) providing decontamination sites for 30 days beyond the expiration of the REI, (3) establishing a minimum REI of 12 hours for all pesticides, and (4) establishing for all handlers and early-entry workers minimum PPE and work clothing requirements designed to minimize dermal exposure to all pesticides, regardless of their acute toxicity. EPA believes that these protections against acute risks, if adhered to consistently over time, will protect against chronic risks as well, by reducing exposures that may give rise to chronic effects. On the other hand, the Agency has concluded that more stringent pesticide-specific protections (such as REIs or PPE) based on chronic health risks should more appropriately be set after case-by-case review. Comment #25: No buffer zones are required to protect workers in the field from drift. Response: The Agency recognizes that drift from nearby applications is a common cause of exposure for agricultural workers. This final rule specifically requires that both the pesticide handler and the handler's employer must make sure that the pesticide is not applied so as to contact, either directly or through drift, any worker or other person, other than an appropriately trained and equipped handler. EPA considers this protection so crucial that it is the one situation where a generic requirement from the Standard is listed on each pesticide product label. Comment #26: Toxicological concerns about inert ingredients are ignored. Response: The Agency is concerned about minimizing risks to workers and handlers of any chemicals of toxicological concern, whether they are active or inert ingredients. In establishing PPE requirements for handlers and early-entry workers in the final rule, the Agency considers the toxicity of the formulated pesticide product. The toxicity of the formulated product encompasses the toxicological characteristics of both the active ingredient(s) and the inert ingredient(s). In establishing REIs, however, the Agency has determined that the properties of the active ingredient(s) are the main toxicological concern. Many of the inert ingredients that might otherwise pose a toxicological hazard are volatile and will not remain on the treated surface beyond the first few hours. Similarly, EPA has chosen to consider only the toxicity of the active ingredient(s) in establishing REIs and in determining which products must contain a requirement for both oral warnings and treated area posting. In a process separate from this rule, EPA is evaluating and, where appropriate, reducing the risks posed by inert ingredients. In addition, the Agency will evaluate the risks of all formulations, including their inert ingredients, during its accelerated reregistration program, now underway. The Agency has concluded that further attention to inert ingredients in the final rule is unnecessary. C. FIFRA Scientific Advisory Panel Pursuant to FIFRA section 25(d), a copy of this final rule was provided to the FIFRA Scientific Advisory Panel (SAP). The SAP waived review of the final rule.