II. COMMENTS ON NEED AND SCOPE A. Need For Revisions to Present Standards. Agency concern about the adequacy of present part 170 has grown over the years for at least two reasons: (1) Since the promulgation of part 170, there has been a shift in the types of pesticides used in the production of agricultural plants. Because of their persistence in the environment, the once commonly used chlorinated hydrocarbons largely have been replaced by organophosphorus and carbamate compounds. These chemical families contain pesticides that often are more acutely toxic to humans than the chlorinated hydrocarbons they replaced. (2) Data available to the Agency indicate that pesticide poisonings have persisted among agricultural workers. A few comments stated that the regulation is not necessary because growers are following adequately safe work practices with respect to pesticide use. The Florida Cooperative Extension Service (Ref. C70) said, "Many growers and handlers follow much of what is proposed and would agree with the spirit of what is proposed. There are . . . some details that cause some concern." Some claimed that a nonregulatory approach to worker protection, such as Federal encouragement of worker training programs, would be adequate to address any problems that might exist. A sugar grower stated that his State has a very generous worker's compensation law and that any illnesses due to crop protection chemicals are not evident in this system. The author reasoned that the protection already afforded workers in his industry therefore should be seen as adequate for the industry but offered no data to support the statement. Several comments suggested that more aggressive enforcement of existing regulations is the only action necessary at this time. Among the comments was one that stated that EPA had not presented sufficient data to indicate that pesticide poisoning is increasing among farm workers. One comment expressed concern that health effects with symptoms that mimic pesticide poisoning were being reported as poisonings and being relied upon by EPA as evidence of a problem. Several comments pointed to the difference in agriculture from State to State and questioned whether EPA could or should promulgate rules so heavily influenced by information from pesticide poisonings in California (Refs. C40,C63,C210). Review of the literature on pesticide poisoning indicates that pesticide illnesses in agricultural workers result when safety precautions are not taken. An estimated 3.9 million persons are exposed to agricultural pesticide products or their residues as a result of occupational activities. These agricultural workers and their families are potentially at risk from direct, indirect, or accidental exposure to pesticides. Most comments agreed with the NPRM that part 170 required extensive revision in order to protect agricultural workers from exposure to pesticides and their residues. For example, National Farmers Union (Ref. C290) said that the standards "represent a well-reasoned balance between the economic concerns of farm employers and the needs of their employees to be informed and trained in pesticide use and protected from toxic exposure." Other comments expressing general support were tempered with particular disagreements. Some who supported the revisions said the Agency did not go far enough. Evergreen Legal Services (Ref. C90) stated, the proposed Standards "offer many improvements over existing standards but remain seriously deficient in a number of respects." The Agency acknowledges that some regulated entities are observing worker protection procedures that exceed the current requirements, but it is not convinced that this behavior is universal. Many comments to the contrary were received from worker representatives relating particular pesticide exposure or injury incidents that they had experienced. Other comments contained accounts of cases the authors had encountered in the course of providing medical or legal services to workers. A physician who treats workers that have suffered from exposures to pesticides wrote: Workers are exposed to unknown chemicals about which they have the unfortunate combination of no information and great fear. . . . During the past 5 months I have kept an incomplete list of possible/probable/definite pesticide-related problems. 14 cases of probable or definite pesticide-related illness were documented (5 systemic - none requiring hospitalization, /7 dermatologic and 1 pulmonary) and another 9 possible illnesses occurred (including 2 systemic/ 1 dermatologic and others misc.) for an incomplete total of 23 cases. Numerous cases occurred in which workers suspected that their symptoms (headaches/eye irritation/upper respiratory complaints/chest symptoms as well as depression, fatigue, GI symptoms/ paresthesias, etc...) may be related to residue or spray exposures. Abnormal lab tests . . . occur which are unexplained by any specific disease (Ref. C249). Farmworker Legal Services of New York claimed that while a number of agricultural pesticides have known chronic health effects, many other registered pesticides may have such effects but they have not yet been tested. It noted that although the data on the acute affects are compelling, the effects of continuing term exposure are even more serious and stated: Long term, low level exposure to farm chemicals is believed to cause cancer, particularly, leukemia, and has ill effects on the respiratory system. Cancer studies involving farm workers have consistently revealed a higher incidence of leukemia and higher than normal death rates from prostrate, stomach, skin, lip, pancreatic, kidney, testicular, lymphatic and blood system cancer (Ref. C250). In support of these statements, it cited epidemiological studies that found increased incidence of various cancers among farmworkers and studies which reported various chronic health effects in children of farm workers. Another comment cited many statistics and case reports that demonstrated a need for these revisions. Among the statistics quoted were data from Bureau of Labor Statistics (BLS) for 1987 that suggest that agricultural workers suffer the highest rate of chemical-related illnesses of any occupational group. It also pointed out that exposures to pesticides may cause both acute and chronic illness as well as death, and cited articles that suggest that as many as 300,000 farmworkers become ill each year because of occupational exposure to pesticides. Reliable estimates of the numbers of pesticide poisonings among agricultural workers are difficult to obtain for a variety of reasons: (1) the nature of agricultural labor, as well as economic and social factors hamper data collection; (2) the geographic and seasonal heterogeneity of the population under scrutiny makes estimates of the number of workers at risk elusive; (3) agricultural workers adversely affected by pesticides often do not seek medical attention; and (4) pesticide poisoning incidents often are treated symptomatically without being diagnosed as pesticide-related and may not be reported as such. The Bureau of Labor Statistics's Annual Survey of Occupational Injuries and Illness is the best source of nationwide statistics on the relative magnitude of work related injuries and illness among the various sectors of the work force. This survey samples agricultural employers with more than 10 employees (Standard Industrial Classifications (SIC) 01 and 02) covered by the Occupational Safety and Health Act to obtain data on occupational injuries and illnesses occurring among their employees. In 1974, BLS reported an overall occupational illness rate of 7 cases per 1,000 full-time workers per year in agriculture and 4 per 1,000 full-time workers per year in general industry, a relative risk of 1.75 for agriculture. In 1983, BLS reported occupational illness rates of 1.6 per 1,000 full time employees per year for general industry and 4.8 per 1,000 full-time workers per year for agriculture, a relative risk of about 3 for agriculture. These data suggest that although the overall reported illness rates reported for agriculture and general industry are declining, the rates in agriculture are not being reduced as fast as those in general industry. A more detailed breakdown of the BLS statistics indicates that incident rates for systemic poisoning among agricultural production workers are about 5 times greater than that of all industry and slightly greater than those reported by the pesticide manufacturing industry (Ref. A26). All available evidence indicates that pesticide-related illnesses frequently go unrecognized, and even when recognized, often go unreported. A combination of malaise, weakness, dizziness, sweating, salivation, nausea, vomiting, abdominal pain, diarrhea, blurred vision, headache, dyspnea, and chest tightness when found in an agricultural worker or pesticide handler probably signifies exposure to cholinesterase-inhibiting compounds. Each of these symptoms, however, on its own could suggest other diagnoses and even when grouped together they are not distinctively characteristic of pesticide exposure. The correct cause may be uncovered only by the application of knowledge and skills commonly not taught to general medical practitioners. At least four steps are necessary before a pesticide-related illness can be recorded by counting systems: (1) the worker must perceive he or she is sick; (2) the worker must seek medical attention; (3) the medical care provider must recognize the symptoms are related to pesticide exposure; and (4) the incident must be reported to the right place. There is no reason to believe that the number of pesticide related incidents reported overestimates the problem. All evidence suggests that he numbers of cases reported in any counting system underestimates the problem. Estimates of the extent of under reporting of pesticide-related illnesses vary greatly. There have been estimates that as few as one in a hundred cases are reported (Ref. A12). Data from a recent survey of workers suggest that only 8 to 15 per cent of workers who perceive they may have symptoms related to pesticide exposures seek medical treatment (Ref. A22). Of those who seek treatment, probably only a fraction are recognized as pesticide-related incidents. For further discussion, see the Benefits Assessment section (V) of the Regulatory Impact Analysis for this final rule. The health effects associated with long-term, intermittent exposure to pesticides and their residues have become a major concern for health professionals. As noted in the comments, medical literature links pesticides to a variety of diseases including cancer, birth defects, blood disorders, sterility, abnormalities in liver and kidney function, genetic damage, neurological, psychological, and behavioral effects such as those cited by Farmworker Legal Services of New York, Inc. (Ref. C250). The Agency is convinced that delayed adverse effects are occurring and can be, to a great extent, ameliorated with the protections provided in this final rule. The Agency has analyzed data to provide a representation of the plausible incidence of delayed adverse effects in the agricultural population to which this final rule applies. The analysis and further discussion are contained in the Benefits Assessment section (V) of the Regulatory Impact Analysis for this final rule. EPA relied on data from California's investigations of pesticide poisoning incidents to develop many of the provisions in the NPRM because these are the most detailed data available on pesticide-related incidents. California law requires physicians to report to State and local agencies any injury or illness suspected as being related to pesticide exposure. The incident is investigated by the County Agricultural Commission and classified according to the likelihood that the illness is related to pesticide exposure. Information is sought on the chemical involved, the type of illness or injury, the type of activity the worker was doing, and where he worked. The California Department of Agriculture (CDFA) estimates that in 1986 there were about 800 probable/possible pesticide-related illnesses among fieldworkers on farms in California annually or about 2.7 per 10,000 field workers (Ref. 10). This is close to the "poisoning incident rate" of 3.0 per 10,000 agricultural production workers reported in the BLS survey for the same year (1985) (Ref. A27). EPA is not convinced that State worker protection regulations, in contrast to a national minimum standard, will result in adequate worker protection. There is a dearth of State regulations in this area; few States appear to have the resources to assess this problem and to implement solutions. On this point the New York Farm Bureau commented that differing State regulations tend to create an "uneven playing field" among U.S. farmers. FIFRA section 24(a) permits States to tailor worker protection to fit their needs, without falling below the national minimum. The Agency does not believe that more enforcement of current regulations would protect workers adequately. Some of the agricultural workers at greatest risk, pesticide handlers, are not subject to present part 170 and would not be affected by increased enforcement; some proposed requirements are not found in current regulations; and some portion of reported poisonings have occurred even when current labeling requirements have been followed. Pesticide product labeling gives some pesticide-specific instructions and precautions for handlers of the pesticide to follow. The labeling, however, does not impart the basic pesticide safety concepts necessary to follow the labeling directions correctly. For example, the pesticide labeling may specify the personal protective equipment required for users of the pesticide, but ordinarily would not provide information on how to use the equipment safely and how to maintain the equipment. The Agency considers such guidance crucial to the effectiveness of the personal protective equipment being required, but the Agency does not believe that requiring that such information on each pesticide product's labeling is cost-effective. These provisions would "overload" pesticide labeling if the Agency required them to be repeated on the labeling of every pesticide product. The Agency believes that the data and anecdotes provided in the public comments and the data available from other sources indicate that agricultural workers are at continuing risk of pesticide poisoning. The Agency also believes that these data are sufficient to warrant revising part 170. B. Comments on the Scope Present part 170 covers only farmworkers engaged in hand labor in fields during and after pesticide application. EPA proposed to expand the scope to include workers in greenhouses, nurseries, and forests and persons who handle pesticides used in crop production at these sites and on farms. Comment was requested on whether workers exposed to pesticides at these use sites should be included in part 170. 1. Need for coverage of greenhouses and nurseries. The Agency proposed to extend the scope of part 170 to include greenhouses and nurseries because the cultivation of plants at these sites is labor intensive, often requiring extensive handling of the plants on a daily basis. In addition, in considering FIFRA in 1988, Congress expressed its intent to protect workers in greenhouses and nurseries by including among the priorities for reregistration active ingredients that "are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur." (7 U.S.C. 136b 4(c)(1)(D)). Environmental factors in a greenhouse increase the potential hazards to pesticide applicators and employees working in areas where pesticides have been applied or where they are being applied. Conditions such as high temperature and humidity may affect the degradation of the surface residue, and airborne residues may not dissipate readily from an enclosed, poorly ventilated greenhouse. Some nurseries grow plants in fields where the occupational exposure to agricultural pesticides would be similar to those on farms; others grow plants on benches in semi-enclosed areas that present exposures more like those in greenhouses. Many nurseries have both types of growing areas. Most comments on the proposed extension of the standard to include greenhouses and nurseries were in favor of including these operations under part 170 because the pesticides used in nurseries and greenhouses often are the same as those used on farms, and the volume of pesticides used per acre is often greater than for row-crop agriculture. The New York State Department of Law suggested that there was an increased likelihood of worker hazards in the confined spaces of greenhouses because: Indoor growing environments intensify employee risks by all pathways of exposure, since greenhouse workers may experience saturation of shoes, gloves and clothing with pesticide-laden water, and even, in some situations, ingestion of residue in and on food, cigarettes or other objects placed in or near the mouth. According to credible witnesses, greenhouse workers are often exposed to water- and air-borne pesticides for virtually the full work shift each day" (Ref. C361). Although they contended there could be a significant economic burden from the regulations, the Society of American Florists, the Association of American Nurserymen, the Professional Plant Growers Association, the Florida Foliage Association, and the Colorado Greenhouse Growers Association supported coverage of nursery and greenhouse sites in part 170 if consideration were given to their unique features (Ref. C100). Support for inclusion also came from health professionals, legal services providers, an agricultural chemicals association, and a number of State agricultural agencies. Comments opposed to including greenhouses and nurseries came principally from rose growers and their trade association. Individual rose growers cited the paucity or lack of pesticide poisonings at their facilities, asserted that increased regulation would make them vulnerable to overseas competition, and claimed that their existing safety practices were adequate to protect their workers. A grower from California felt that California's regulations were adequate protection. There are few reports that isolate occupational illness and injuries in nurseries and greenhouses; these statistics are usually included among those for the total agricultural sector. However, in response to the NPRM, Roses, Inc. submitted data collected from its members to support a claim that pesticide poisonings are not a problem in their industry (Ref. C97). Among member establishments that submitted data, there were 81 recognized pesticide incidents over the last 10 years: 75 of these were skin disorders and 6 were systemic poisonings. The respondents reported that 39,839 hours had been worked in their establishments in the 7 days prior to the data submission. Assuming that the hours worked in the week surveyed were representative of the work force over the past 10 years, these data suggest that there are an average of 8.1 incidents per 2,071,628 hours worked per year. In its calculations, BLS considers a work year to be 2,000 hours per person; hence, these data suggest that these rose growers are reporting a pesticide-related incident rate of 7.8 per 1,000 workers (7.24 per 1,000 for skin disorders and 0.58 per 1,000 for systemic symptoms.) The BLS occupational injuries and illness survey for 1986 found there were 4.12 skin disorders and 0.3 poisonings per 1,000 workers in agricultural production (SIC 01-02). The rose growers are observing nearly twice as many systemic poisonings and skin disorders from pesticides as are all other agricultural workers from all chemicals. Although few data exist to show the full extent and cause of pesticide poisonings in greenhouses and nurseries, there is anecdotal evidence, including data submitted by the rose industry in its comments, to show that pesticide-related injuries and illnesses occur at these sites. Since the amount of pesticide use and the likelihood of exposure are at least equal to that on farms, the Agency has concluded that the risk to these workers from occupational exposures to pesticides warrants their inclusion in this worker protection standard. This final rule, therefore, covers greenhouses and nurseries. Pesticide handling in greenhouses and nurseries is subject to the same handling standards as for pesticide handlers at other agricultural sites. Regulations to protect potentially exposed workers are contained in separate subparts for agricultural workers and handlers with special provisions where appropriate for greenhouses and nurseries. Two comments questioned whether the Agency intended to cover the use of pesticides and worker exposure in retail greenhouses and nurseries, and if so, whether such coverage was justified. According to the comments, retail operations, such as floral shops and garden centers, are distinguished by the possible presence of customers in areas of the operation where pesticides have been used. These comments maintain that some of the part 170 requirements, such as entry restrictions and posted warnings, could have an adverse effect on retail operations by limiting public access at times. EPA believes that even though retail nurseries and greenhouses may sell agricultural plants directly to the public, clearly they are engaged in the "production" of the agricultural plants. Employees of retail operations who handle pesticides, or who water, weed, and handle the plants, have the same exposure potential as workers in wholesale or production nurseries and greenhouses, and therefore they should be covered by the provisions of part 170. Retail operations that want to limit the pesticide exposure to customers without changing sales procedures have options such as using pesticides of lower toxicity with shorter restricted-entry intervals, treating when customers are not on the premises, and not using pesticides in selling areas. Another comment questioned whether public botanical gardens, arboretums, and conservatories were covered by part 170. Such operations are similar to traditional agriculture in the pesticides used, application techniques, and plant care practices involving potential pesticide exposure. But there are differences in that small quantities of many different varieties of plants are grown. As a result, the pesticide use patterns, risks, and appropriate practices may differ significantly from those in commercial greenhouses. The Agency believes that it must gather more information on the cultivation practices in botanical gardens before it can promulgate regulations appropriate to these settings. Hence, botanical gardens are excluded from the scope of this rulemaking. The definition of "greenhouse" (Para 170.3) has been revised to exclude these locations. 2. Need for coverage of forestry. The Agency proposed to include forest areas used for the commercial production of wood fiber and timber products in the scope of this regulation. EPA indicated in the NPRM that pesticide use in the management of commercial forests is similar to pesticide use in farm settings, including use of seasonal labor and, on occasion, use of high-intensity crop management practices involving pesticides. The Agency acknowledged that the use of pesticides in forestry is less extensive than in traditional agriculture and specifically sought comment on whether the proposed standards would be applicable to commercial forestry. Many comments favored extending part 170 coverage to include commercial forestry because the similarity between the types of pesticides used with those used in tree-farm and tree-nursery operations. They also stated that workers in these operations face similar risks due to occupational exposure to agricultural pesticides as do other agricultural workers and therefore, should be extended the same protections. Comments opposing inclusion of forestry came primarily from forest products companies, some State forestry departments and divisions (a number of State agencies favored inclusion), and the U.S. Department of Agriculture. Many comments objected to EPA's statement that use of pesticides in forestry was similar to pesticide use in traditional agricultural settings. These comments stated that the use of pesticides in forestry differs from the use on farms in several ways: (1) pesticide use is less frequent; (2) lower application rates are used; (3) most applications are of lower toxicity herbicides used for vegetation management and insecticides are used rarely; (4) application methods are different; and (5) there is a greater reliance on certified commercial applicators for pesticide handling. The State of Washington Department of Forestry (Ref. C315) stated that the primary hand-labor activity in forestry in that State, tree planting, took place 3 months after most herbicide applications took place, so forestry workers are seldom exposed to pesticide residues. The U.S. Department of Agriculture (Ref. C189) stated that forestry workers seldom reenter treated areas immediately after treatment; entry 1 to 10 years after application was more typical. Some comments claimed that the Agency had not demonstrated a need for such requirements in forestry and that they knew of no "problem" that existed. Evergreen Legal Services commented that one study had found that forestry workers are exposed to hazardous herbicides by working near sites being sprayed aerially and by not having proper training and personal protective equipment. It reported that herbicide exposure can occur through drinking water from slow-moving, unprotected and directly sprayed streams; walking with inadequate clothing through heavy brush dripping with just sprayed herbicide; and from inhaling fumes..." (Ref. C98). Many of the pesticides used in forest management are herbicides. As a group, these chemicals are not highly toxic by oral ingestion or dermal absorption but many are irritating to the skin and eyes. The persons at greatest risk in forest vegetation management would be those exposed to the concentrated products, the handlers. The next greatest risk would be to those required to work with treated foliage after application and before environmental degradation has occurred. Because of the type of pesticide most commonly used and the relatively small number of persons employed in forestry, one would not expect to see a large number of acute pesticide poisonings among forestry workers, particularly if much of the pesticide application is done by commercial handlers. Data from the 1985 and the 1986 Bureau of Labor Statistics's Annual Survey of Occupational Illnesses and Injuries indicate that the overall occupational illness incidence rate for forestry is 2.1 to 3 times that of all workers and 1.3 to 1.6 times higher than those employed in the manufacturing of agricultural chemicals (Refs. A27,A28). Forestry workers are 4.2 to 6.7 times more likely to have a skin disorder than all other workers and 2.2 to 3.2 times more likely to have a skin disorder than those employed in manufacturing agricultural chemicals. Although it has not been shown that these skin disorders are pesticide-related, they are of concern since even unrelated breaks in the skin increase the risk associated with dermal exposure to pesticides. These data do not reflect the potential for delayed adverse health effects among forestry workers. As pointed out by several comments, a number of studies in the medical literature suggest that phenoxy herbicides may cause hematopoietic malignancies (Refs. A4,A8,A11,A30). A case-control study in Washington State found that forestry herbicide applicators had an odds ratio of 4.8 for non-Hodgkins lymphoma (Ref. A30) and a mortality study of forest conservationists demonstrated a statistically significant linear trend by duration of employment for increased risk of non-Hodgkins lymphoma (odds ratio = 2.5) (Ref. A1). Although the Agency has not evaluated all of these studies, these findings raise some concern about possible delayed adverse health effects associated with exposure to some pesticides used in forestry. Other comments from the forestry sector asserted that the cost of compliance would be a burden, but they did not elaborate or present data to support their position. Some comments were opposed to some of the proposed requirements but not others; the National Forest Products Association suggested a partial exemption for forestry from some requirements. Other comments favored including forestry, but felt that there should be separate standards tailored to forestry. Several comments pointed out that in noncommercial or recreational forest areas such as public parks, which the Agency proposed to exclude from coverage, pesticides may be used extensively (e.g., brush, weed, right-of-way, and mosquito control uses in a camping area). These comments stated that there was a need to protect workers and the public in such noncommercial forest areas. One comment claimed that the definition of "forest" should not be limited to commercial production of timber products because forests also "produce" livestock, wildlife, and recreation. The Agency agrees that forests may have additional products or values, and that pesticides may be used frequently in noncommercial forests, but it notes that this rulemaking from its inception has been limited to the protection of workers engaged in those forestry operations that most resemble agricultural operations. The Agency believes that it needs more information to ascertain the appropriate measures that should be instituted to protect workers in other forestry operations. The Agency acknowledges that pesticide-use practices and labor activities in forestry differ in some respects from those associated with other types of agriculture. These differences, however, are not sufficient to make the requirements of part 170 inapplicable to forestry. Although worker exposure to pesticide residues may be less frequent in forestry, when exposure does occur, the risk(s) may be comparable to those in other agricultural situations. Therefore, the general protections of part 170 (training, decontamination facilities, etc.) are appropriate. EPA concurs with the comments that stated there are a some special circumstances in forestry where modifications to the general requirements are needed; forestry workers have been included in the scope of the final rule with modifications to some requirements that reflect the unique practices and constraints found in forestry. The Agency anticipates that the requirements will have little economic burden because of the rarity of worker exposure in forestry. If no workers are in or near treated areas within 30 days of an application or a restricted-entry interval, none of the requirements of this rule are triggered. 3. Need for coverage of pesticide handlers. Existing part 170 is directed exclusively to workers performing hand labor tasks in fields that have been treated with pesticides. However, agricultural employees who handle pesticides also may be exposed to pesticides while mixing, loading, applying (including applications from the air), or disposing of pesticides, transporting pesticides in open or previously opened containers, acting as flaggers, moving irrigation equipment, and cleaning, adjusting, or repairing contaminated parts of mixing, loading, or application equipment. EPA's findings indicate that agricultural pesticide handlers may have a poisoning-incident rate several times higher than that for agricultural workers. Data indicate that the poisoning-incident rate for handlers may be more than two times higher than that for workers. EPA proposed specific standards to protect workers engaged in pesticide handling activities (mixing, loading, applying, etc.). Most comments on the Agency's proposal to extend the coverage of part 170 to pesticide handlers on agricultural establishments favored coverage of these activities because the risks from exposure to pesticides during handling activities are potentially greater than the risks for workers exposed to residues in treated areas because these employees are exposed to concentrated formulations of pesticides. A physician cited cases he had seen where sprayers purportedly using personal protective equipment had signs and symptoms of classic organophosphate poisoning -- possibly because of saturated boots or ill- fitting respirators. More vigorous enforcement of existing labeling directions would not address the problem of saturated boots or poorly maintained respirators -- situations that occur because of lack of basic training in the concepts of pesticide safety and safe use and maintenance of personal protective equipment. Most negative comments came from aerial applicators or their representatives. These comments stated that there is little evidence of poisonings among commercial aerial applicators; hence, they need not be covered. The National Agricultural Aviation Association (NAAA)(Ref. C165) cited two studies as indicating that aerial applicators have no higher rate of disease than the general population. One report was on a study of spontaneous abortions, stillbirths, and birth defects among the pregnancies in the families of aerial applicators; the outcome of pregnancies in the families of the applicators' siblings were used as a comparison. No differences were seen. The second paper was a report on a health survey of 125 commercial applicators (57 aerial applicators and 68 structural applicators) who volunteered to participate in a 3-year health screening project. They were compared to persons living in the same geographic area who had no exposure to pesticides. The investigators concluded that, "they could not document any differences in general health between the workers and the controls." In the study of spontaneous abortions, stillbirths, and birth defects among the pregnancies in the families of aerial applicators the authors state: "The group sizes were small and there is no certain basis for concluding that there is a complete absence of pesticide effect in the reproductive data collected and evaluated." Agency review of the study notes that congenital heart defects seemed to be in excess among the children of the applicators (seven among the children of pilots, none among the children of the controls), although the authors did not comment on this point. In the report on a health survey of commercial applicators, 26 percent of the aerial applicators stated they had been made ill at some time from working with pesticides. The aerial applicators were examined twice a year. In the time between the initial health screening and the first follow up, 2 of 47 aerial applicators said they had experienced a possible pesticide-related illness; between the second and third screening exam, 1 of 50 reported a pesticide-related illness. The authors concluded that "aerial pesticide applicators are occupationally exposed to pesticides with potentially negative consequences ... despite the fact that many operators use closed systems to load their aircraft, label specified protective clothing/equipment should be worn to reduce the potential for exposure to pesticides." The number of incidents reported during the course of follow up medical exams in the study indicate that 2 to 4.25 per 100 aerial applicators per 6 months or 4 to 8.5 per 100 applicators per year had possible pesticide-related incidents. This is consistent with the data from California cited above. One employer stated that over a 6-year period he had an average of 20 employees per year but only 3 employees were hospitalized for chemical poisoning, for a rate of (3/(6 x 20)) x 100 or 2.5 per 100 applicators per year (Ref. C28). Since these were hospitalized cases and no mention was made of any non-hospitalized cases, the true incident rate for this establishment could be much higher. The Arizona Agricultural Aviation Association (Ref. C224) stated that there were 15 pesticide-related poisonings in the records of the Arizona Commission of Agriculture and Horticulture for the years 1985 through 1987, a period during which approximately 64,000 aerial applications of pesticides were made. It estimated that three people are involved in each application and each application takes about 1 hour. This means there were (15/(3 x 64,000)) incidents per person hour of exposure. These data yield a rate of 15.65 incidents per 100 full- time workers per year (assuming 200,000 work hours per 100-person work years), a rate several times the rate reported by California for pesticide handlers in an article by Edmiston and Maddy in the "Veterinary and Human Toxicology" journal. Observations were made on four pilots in preparation for a larger study; two were aerial applicators whose activities included the application of ethyl parathion on more than 85 per cent of the acreage they sprayed; the other two were "controls" who did not spray pesticides. Erythrocytic and plasma cholinesterase assays, dark adapted pupil dilation and respiratory sinus arrhythmia were measured on all the pilots. One of the aerial applicators displayed symptoms of organophosphorus toxicosis. Dark adapted pupil dilation and respiratory sinus arrythmia were more indicative of the continuing pesticide exposure than the blood cholinesterase assays. The pilot with indications of exposure cleaned his windshield more often than the other aerial applicator because he used flight patterns more frequently that contaminated his windshield. The author believed that this work practice was responsible for the exposures that led to the observed symptoms (Ref. A7). Several studies of aerial applicators and other pesticide handlers have indicated that although pilots may have less exposure to pesticides than mixers or loaders, they are exposed (Refs. A2,A6,A17). All information available to the Agency suggests that agricultural- pesticide handlers, aerial applicators included, are at risk of acute poisoning incidents from exposure to pesticides. The Occupational Legal Rights Foundation (Ref. C156) cited several studies that suggest that pesticide handlers also may have an increased risk of cancer. The studies are consistent in that all suggest an increased risk of one or more types of cancer, particularly lung cancer. The Florida Agricultural Aviation Association (Ref. C362) recommended that the proposed regulations be rewritten to be consistent with existing certification laws. There are no provisions in the Certification and Training Requirements of 40 CFR part 171 that are inconsistent or in conflict with the proposed revisions to the Worker Protection Standard or this final rule. The provisions of 40 CFR part 171 pertain entirely to the special requirements for people who purchase or use "restricted use" pesticides i.e., those pesticides that may pose a hazard to humans or the environment unless they are used by persons who have demonstrated knowledge to use these pesticides safely. There are many employees who handle pesticides as part of their work in agriculture who are not covered by CFR part 171. In the final rule (Para 170.230), certification is considered a substitute for a handler training program, but all other handler requirements must be followed by commercial certified applicators. In conclusion, the comments received have not led the Agency to alter its original position that part 170 protections should be continued and expanded in scope. A growing body of evidence from many sources points to the reality and the seriousness of the health effects of pesticides in persons who work in agricultural occupations. This evidence is part epidemiological, toxicological, and medical, and part anecdotal. The evidence in this area of which the Agency was aware was referenced and was discussed in the NPRM and expanded upon here and in the Regulatory Impact Analysis. Additional evidence has been cited or entered in the public docket for this rulemaking by those who commented on the NPRM. The Agency believes that, taken as a whole, the evidence indicates that worker exposure continues to occur throughout all agricultural sectors, regions of the country, and worker activities; that acute and chronic poisonings of various degrees continue to occur as a result; and that the basic exposure reduction and emergency response measures contemplated by this rule, if implemented, will reduce the risk of such adverse health effects to workers. C. Exceptions Existing part 170 excluded some agricultural pesticide uses from its scope; the proposed revisions to part 170 retained most of these exemptions and added others for clarity. The possibility of other exemptions was stated in the preamble to the proposal. These included an exemption for small establishments and an exemption for family members. A few comments requested exemptions for specific crops or crop-production practices. 1. Nonagricultural pesticide handlers. The exemptions chosen in the past and in the revisions to part 170 are based on the presumption that part 170 and its revisions, as proposed, are intended to reduce the risk of occupational exposure to pesticides used in the production of agricultural plants on farms, or in forests, nurseries or greenhouses. Some comments stated that the risks associated with pesticide use on non-agricultural sites are as great as those from use on agricultural sites or that continued exemption of nonagricultural plants does not support the purpose of the proposal which was worker protection from agricultural pesticides. The Occupational Health Legal Rights Foundation (Ref. C156) believes that the exemptions of nonagricultural uses "unreasonably" narrows the scope of EPA's duties under FIFRA. Other comments agreed. In the NPRM, the Agency indicated that in considering what standards would be appropriate to protect handlers during handling activities on agricultural sites, the Agency also considered whether to apply such standards to handlers at nonagricultural sites. The Agency had not estimated the economic impact of these options in the Regulatory Impact Analysis and did not propose to cover nonagricultural handlers, but it suggested that the handler requirements might be appropriate for nonagricultural handlers. It discussed three options for broader coverage that it might consider for the final rule: coverage of handling activities at sites similar to agricultural sites (e.g., golf courses or rights-of-way); coverage of full-time handling; and coverage of all occupational handling. Many comments received on this topic that favored extending coverage stated that the health of nonagricultural workers should be considered equally important as that of agricultural workers. Several comments claimed that nonagricultural handling involved many of the same chemicals that are used on agricultural sites. Several growers argued that if agriculture were subject to regulation, then in fairness, other sectors should be subject to regulation also. One comment expressed concern that if these workers were not covered in part 170, EPA had no other plans to address the problem of nonagricultural pesticide exposure. One comment compared the Agency's statements concerning nursery worker exposure with worker exposure in turf management and groundskeeping, compared indoor pesticide hazards in greenhouses with pesticide hazards in structural pest control and grain fumigation activities, and compared pesticide use in commercial forests with pesticide use in parks and picnic areas. The author found few differences among these uses; some of which would be covered while others would not. This comment argued that nonagricultural workers deserved to be protected and that the proposed part 170 measures were appropriate. A majority favored extending coverage to all occupational handling, although several favored covering only use sites that most resembled agricultural sites, because the requirements appeared most applicable to these sites. One comment favored covering all full-time handlers, but another felt that definition of "full-time" would be problematic. Some comments opposed to extending coverage stated that these users are covered by current pesticide labeling requirements and by OSHA's training and information requirements for workers; one referred to "lots" of State and Federal regulations which the comment stated were sufficient. Lawn care companies said that they were training or certifying all their workers in pesticide safety; some said they were doing cholinesterase monitoring. All felt that these practices were adequately protective without additional regulations. One comment asserted that nonagricultural pesticides were similar to consumer products in toxicity. A structural pest control association contended that their members primarily used general use pesticides, followed labeling, trained their workers, and complied with Hazard Communication regulations, actions which they felt were sufficiently protective. Several associations argued that EPA had not examined the safety records of their members for poisoning incidents to prove that a need for regulation existed. Some comments stated that even if a need existed and regulation were appropriate, EPA had not solicited the input of affected interest groups for their views, and that the Regulatory Impact Analysis did not address the impact of extending coverage to nonagricultural handlers so that the public could not comment adequately. One comment suggested that these handlers should be covered by a separate regulation. The Agency will not address the merits of these comments at this time. The Agency has concluded that the NPRM may not have provided sufficient public notice of the issues and options involved in a regulatory proposal to create requirements governing nonagricultural pesticide handling. As a result, EPA has not determined at this time whether regulation would be appropriate and if so, to what extent. The Agency acknowledges that initially its revisions of part 170 did not contemplate a scope of coverage beyond agriculture, and some members of the affected public may not have been alerted to EPA's request for public input in this area. The Agency may use the comments received from the NPRM on this topic as a starting point for developing a regulatory proposal. 2. Public pest control. These uses of pesticides were excluded from the original 40 CFR part 170 and EPA did not propose to change this exemption for mosquito abatement or similar public pest control programs sponsored by governmental entities when this type of pesticide use occurred on land also used for agricultural production. The reasons for the exemption were that such uses were outside the traditional definition of agriculture (53 FR 25977) and that publicly-sponsored programs probably would be used only when necessary and then by trained personnel. The National Cotton Council, stated that public pest control programs, including the boll weevil eradication and containment programs should be exempted from the worker protection standard (Ref. C317). Others disagreed. One comment stated that exemption of public mosquito abatement and similar public pest control programs is not consistent with the purpose of the proposal. Many comments on this exemption expressed concern that those handling public-pest-control pesticides were not going to be covered by the rule. The Butte County Mosquito Abatement District (Ref. C3) supported the exemption but was concerned about how to provide adequate protection for employees without over protecting them from unknown risks. EPA is concerned that this exemption may not be warranted. EPA is reviewing the data with the purpose of assessing the risk and of developing a new notice of proposed rulemaking where warranted. Until then, EPA does not believe it can justify deleting this exemption which has existed since 1974. This exemption, therefore, is retained for the purposes of this rulemaking. 3. Livestock and other animal treatments. EPA proposed to continue the original part 170 exemption for livestock and other animal treatments. Few comments concerned these uses. A rancher (Ref. C203) wrote: I would strongly urge you to include in the coverage persons handling pesticides on livestock. . . Louse control pour-ons for cattle are readily absorbed through the skin. Even though we personally have switched over to the injectable wormers, because of the increased safety, we know from experience how much care and precaution must be exercised so that no pour-on material accidentally splashed on the applicator. The Oregon Department of Agriculture stated that the livestock and animal treatment usually are considered agriculture and supported their inclusion in the coverage of part 170 (Ref. C323). The Occupational Health Legal Rights Foundation, (Ref. C156) and the National Farm Workers Health Group (Ref. C179) also believe these uses should be covered in part 170. Dow Chemical and others recommended that the Agency maintain this exemption, although they did not provide any data to support this request (Ref. C167). The Illinois Farm Bureau stated: We agree with the proposed legislation to exempt livestock and other animal treatment programs. Livestock treatment methods should be explained with instructions on product labels since this area can present unusual situations unlike other forms of agriculture (Ref. C212). EPA recognizes differences between livestock and other agricultural uses and does not believe that it has studied the risks associated with these uses of pesticides sufficiently to address them in these revisions; they too will be included among the uses that will be reviewed in the future. 4. Golf course uses. Original 40 CFR part 170 exempted "treatment of golf courses and similar nonagricultural areas." The Agency proposed to retain this exemption. O. M. Scotts (Ref. C101) and the Golf Course Superintendents Association of America (Ref. C106) support the golf course exemption on the bases that (1) the potential for worker exposure is low, (2) the pesticides used are not acutely toxic and (3) the "exposure to arms, hands, and skin is virtually non existent." Mount Sinai Medical Center took the position that: "Golf-courses make extensive use of pesticides, and their workers need protection" (Ref. C193). The Maryland Occupational Safety and Health Program stated: MOSH has recently received several complaints from employees at different golf courses, concerning pesticide use. As employees become more familiar, through hazard communications programs, with the hazards of other toxic substances, they question the exposure and proper PPE for pesticides they are using. We oppose the exclusion of those workers. (Ref. C80) One State agency cited complaints regarding pesticide application on golf courses, but did not specify whether the complaints concerned exposures to the public or to workers. EPA plans to explore further the risks to workers involved in the application of pesticides on golf-courses. For the present, EPA will continue to exclude pesticide use on golf courses from the requirements of part 170. 5. Sod and turf-grass farms. Sod and turf grass farms are clearly agricultural activities as the American Sod Producers Association's comments pointed out (Ref. C218). The Agency believes that sod and turf-grass farms use pesticides in the production of agricultural plants on farms and nurseries. EPA does not intend to exempt sod and turf growing operations from the requirements of the revised part 170 inasmuch as such sites are covered by the current part 170 and no data were submitted to warrant a change from the present inclusion. Consequently, the definition of "agricultural plant" specifically includes turfgrass. 6. Soil-incorporation. EPA proposed to eliminate the existing exemption for soil-incorporated pesticides. Soil-incorporation involves either injecting pesticides into the soil or applying pesticides and immediately covering them with a layer of soil. The rule would allow entry without constraints if workers would not have contact with the treated surface, i.e., contact with the soil subsurface. Furthermore, if no workers would be within 1/4 mile of the treated area during application or the restricted-entry interval, there would be no requirements for notification. Several comments favored retaining the exemption, claiming that there would be little or no worker exposure to these pesticides using the example of a pre-plant soil-incorporated granular product. Other comments approved of the Agency's position to remove this exemption. Many types of formulations from liquid soil fumigants to preplant granular pesticides may be used as soil-incorporated pesticides. Each poses a different risk to handlers during application and to workers after application is completed. These applications may not present foliar exposure hazards for workers entering the area after the application, but the Agency is concerned about workers who are weeding, suckering, thinning, and cultivating, where there is a possibility for worker contact with treated soils. It is concerned also about spills at turn-rows which may leave granules on the soil surface and about inhalation hazards from volatile soil-incorporated chemicals. After the application of soil fumigants, off-gassing of acutely toxic vapors may occur; even when a tarpaulin is used, significant vapor concentrations may persist until after the tarpaulin is removed. Workers have been injured or killed when tarpaulins have been removed carelessly. The Agency has not been persuaded to exempt soil- incorporated pesticide use from the requirements of part 170. 7. Public areas and residential uses. The Agency proposed to exempt pesticide uses in malls, atria, or office buildings where agricultural plants are present primarily for aesthetic or climatic modifications and in and around habitations or non-commercial crop or ornamental gardens, in non-commercial greenhouses, or on lawns, shrubs, or trees. Although there were no comments that addressed these exemptions specifically, there were many comments that stated that all pesticide handlers should be covered by these regulations. The Agency is concerned that the use of pesticides under such conditions, including use by homeowners, may vary substantially from those in agriculture and therefore require the development of different standards. The Agency will gather information on the worker exposures related to these uses and assess the merits of including these uses in part 170, or in a separate regulation, at a later time. 8. Injection directly into plants. The Agency proposed to exempt pesticides applied by direct injection into agricultural plants from part 170, because of the lack of potential for post-application exposure to workers. Several comments expressed approval for this exemption, including one comment that asked for clarification as to whether the Agency intended chemigation and soil-incorporation application methods be included in the direct-injection exemption. Negative comments came mostly from those expressing opposition to all the exemptions to part 170. Some comments indicated that pesticide handling activities for these applications should not be exempted for this type of application. EPA concurs with the comments that stated that, while post- application worker exposure may be slight, the risk of exposure to pesticide handlers is not substantially different from many other methods of application, especially during mixing and loading activities. Therefore, handling pesticides intended for direct injection into agricultural plants is included in the provisions of subpart C, Standards for Pesticide Handlers. The exemption is continued in subpart B, Standards for Agricultural Workers because the Agency is persuaded that the risk of post-application exposures to these pesticides is slight. EPA did not and does not intend to include such methods as chemigation and soil-incorporation in the direct-injection exemption. The final rule has been modified to make clear that chemigation and soil-incorporation methods are not included in the exemption for direct- injection, Para 170.102(b)(5). 9. Uses not related directly to agricultural production. EPA proposed to exempt in this revision pesticide uses on agricultural establishments that are not related directly to the production of agricultural plants, such as termite control in a barn or brush control along a road. One comment asked for clarification concerning coverage of the use of pesticides in pasture and rangeland. Several other comments requested deletion of this exemption, claiming that worker exposure might occur from this type of use. The Agency regards potential worker exposures from such uses as likely to be different from those encountered in agricultural uses, possibly requiring different standards. EPA will continue the exemption for pesticide uses on pasture and rangeland along with other exemptions not related directly to the production of agricultural plants for the present (Para 170.102(b)(6), 170.202(b)(5)). These uses also will be included in the Agency's evaluation to assess the risks from pesticide uses not related directly to the production of agricultural plants and to determine whether occupational exposure from the use of pesticides on or in these sites should be regulated. 10. Post-harvest uses. EPA proposed to exempt the post-harvest use of pesticides on the harvested portions of agricultural plants. A number of worker representatives did not believe that exemptions for pesticides used in grain storage and seed treatments were justified because these chemicals are highly toxic and are used in enclosed spaces where the exposure risk is increased. The Agency agrees that many of these uses may pose unique risks to workers who handle these pesticides and to workers exposed to their residues. Again, the Agency believes that these potential exposures are likely to require standards different from those required by uses associated directly with agricultural production. The Agency intends to continue this exemption for post-harvest uses and gather information to assess the risks from these uses. 11. Research. EPA proposed to exempt certain research uses of pesticides. A few comments supported the exemption as worded, arguing that researchers are "knowledgeable" about pesticides, and that following part 170 would be a burden because of the many small plots that are sometimes involved in research. Other comments were critical either of the concept of a blanket exemption for research activities or of the way in which the exemption was worded in the proposal. One comment expressed skepticism as to how researchers would protect themselves from numbered products that had no label statements or other information. Another comment argued that if researchers were knowledgeable enough to protect themselves and their assistants, then by the same logic certified applicators should be exempt from part 170. One person questioned whether there was any assurance that researchers would take responsibility for the protection of student assistants or of farmers who allow the research to take place on their land. One comment objected to exempting some kinds of research but not others, and took the position that either all or none should be exempted. Several comments expressed confusion over how the exemption as it was worded would apply in practice. The Agency believes that the risks of exposure to pesticides used on crops for research purposes are similar to the risks of exposure to pesticides used in the production of crops. Therefore, the safety requirements of part 170 are appropriate to the handling of such pesticides. The Agency has concluded that research on registered pesticides used for experimental purposes on agricultural plants will be subject to part 170 in order to protect pesticide handlers and workers from excess exposure to those pesticides. The final rule exempts from part 170 research uses of unregistered pesticides. As in the past, before granting an experimental use permit, the Agency will evaluate the product and will impose appropriate handler and worker protection requirements, based on what is known or what can be predicted about risks to those handlers or workers based on toxicity or exposure patterns. 12. Small establishment exemption. The Agency proposed to cover workers exposed to pesticides used in the production of agricultural plants regardless of the size of the farm, forest, nursery or greenhouse or the commercial applicator operation in which they worked. The Agency solicited comment on whether an exemption for smaller establishments would be appropriate, and if so on what basis. The most frequent comment among those agreeing with the EPA proposal not to exempt small operations was that the health risk to a worker would be the same whether the operation was small or large. A number of farmworker representatives claimed that more poisoning incidents and use violations occurred in smaller operations, drawing the conclusion that these workers faced higher risks. One comment noted that if there were an exemption for farms of ten or fewer workers, then 73 percent of Washington State farms would be exempt. The same comment stated that exemptions based on size are difficult to apply and to enforce in practice, and they may be misunderstood or abused by employers, leading to absence of worker protection. As evidence, the comment cited a study showing that 62 out of 69 growers that claimed they were exempt because of their size from an unemployment insurance law with this type of size exemption were found to be incorrect in their claim. Most comments favoring an exemption pointed to the OSHA practice of exemption from or non-enforcement of regulations affecting farms with 10 or fewer employees and argued for uniformity between the Federal agencies. Some comments claimed part 170 would impose disproportionate financial burdens on small entities, but gave no examples. Many claimed that family members, whom EPA did propose to exempt from many provisions, do most pesticide applications and do much of the work on these farms. One comment stated that in small greenhouses "everyone knows what's going on," so that warnings and other requirements are not needed. Most of these comments favored following the OSHA "ten or fewer" exemption; none favored an exemption based on gross annual payroll; and a few argued for a "five or fewer" exemption without giving reasons for favoring this number. Presumably, the reason for the "OSHA type exemption" from coverage referenced in some comments was an underlying assumption that it would be financially difficult for "small establishments" to comply. It is questionable whether the number of employees employed by a farm is the best indicator of the potential financial burden to the employer in agriculture. The revised final rule exempts owners of agricultural establishments and members of their immediate family from the provisions pertaining to safety training and information, decontamination facilities, notification of pesticide treatments, and emergency assistance. EPA presumes that owners and family members will provide themselves and each other with these protections, and has chosen not to regulate such behavior. This decision represents a significant exemption for small entities, since about 45 percent (251,000 of 560,000) of the agricultural establishments within the scope of the WPS do not hire labor and are, therefore, exempt from all but a few of the final rule's requirements. These establishments use only unpaid employees who, presumably, are the owners and their family members. In terms of acres per establishment, family-operated agricultural establishments (those without hired labor) have an economic base that is one-third to one-sixth the size of agricultural establishments that use hired labor. The size varies according to the primary crop produced. For example, family-operated feed and grain farms average 213 acres per farm, while those with hired labor average 607 acres per farm. For cotton farms, the ratio is 133 acres to 806 acres respectively, and for fruit/vegetable/nut farms the ratio is 16 acres to 121 acres respectively. Recognizing the need to minimize burdens on small family-operated establishments, EPA has reduced the requirements Ñ and therefore the costs Ñ for this sector, which represents approximately 45 percent of the regulated community. The analysis reveals that family-operated agricultural establishments will bear a low cost-burden as compared to agricultural establishments with hired labor. For farms that reported having hired help, the average number of workers per establishment had little relationship to the physical size of the farm for farms of less than 1,000 acres. There was a relationship between the type of farm and the average number of employees per establishment. For example, grain farms with hired employees averaged 3.9 hired workers per farm, whereas fruit/vegetable/nut farms with hired employees averaged 6.9 hired workers per farm. However, grain farms had one of the highest ratios of sales per worker hired and would have one of the lowest costs per worker in implementing part 170. If one bases the definition of small farm on the average number of workers hired, then the majority of agricultural operations are small businesses. From 1982 census data, the Agency estimates that 89 percent of establishments that have hired labor have fewer than 10 workers; these establishments employ about 64 percent of all agricultural workers. For agricultural establishments with hired labor, the economic impact of the WPS is slightly higher per employee for those with only one employee as for those with ten employees. See the "Impacts on Small Entities" section of the Regulatory Impact Analysis for a more detailed discussion and analysis. A number of the requirements in the final rule are designed to allow flexibility in the method of compliance as long as a given standard is met (performance-type standards). This approach will serve to limit costs for all affected entities, and especially for smaller entities that have limited resources for compliance. In summary, the comments presented no evidence that the proposed regulations would present a disproportionate economic burden on small agricultural entities. Without such evidence, the Agency has concluded that denying the benefit of these regulations to workers employed by such establishments would not be justified under the FIFRA risk-benefit standard. EPA has paid close attention to the wording of the final requirements, avoiding high-technology exposure-reduction measures in favor of performance-oriented standards susceptible to cost-effective, employer-specific methods of meeting the requirements. In this manner EPA has allowed flexibility in compliance by agricultural employers without compromising the level of protection afforded workers, or denying some workers any protection at all. 13. Family members. In the NPRM, EPA excluded persons closely related to the owner of the property from the definition of "worker." Family members, therefore, would not be subject to most part 170 requirements, although they would have to comply with labeling-specific restrictions, such as restrictions associated with applications, restricted-entry intervals, and personal protective equipment requirements specified on the product labeling. This approach could be considered a type of "family farm exemption" for agricultural establishments with no workers other than family members. Although many comments approved of this treatment of family members, others claimed that the exemption could not be justified scientifically, and wondered whether EPA "cared" about the risk of pesticide exposure to family members. One comment suggested that such an exemption could "interfere with insurance claims among family members." Some comments approved of the exemption but felt that the proposed definition of family members was arbitrary and that persons in other relationships to the owners, such as in-laws, should be considered family members. The final rule exempts the owners of agricultural establishments and their immediate family from many of the requirements of the Worker Protection Standard. Owners and their families are required to comply with the product-specific instructions, such as personal protective equipment and restricted-entry intervals, but are not required to comply with the more generic requirements, such as training, decontamination, notification, and emergency response. EPA, in reorganizing the final rule, has listed the exceptions to the personal protective equipment requirements (closed systems, enclosed cabs, etc) and exceptions to the prohibition on entry during a restricted-entry interval in Part 170, rather than in Part 156. Therefore, in order to allow owners and their families to take advantage of the exceptions to labeling requirements that are available to agricultural-worker and pesticide-handler employees, the Agency has included owners and their immediate family members in the definition of "worker" and "handler," but added specific exemptions (40 CFR 170.102(c) and 40 CFR 170.202(c)) to all the requirements except those pertaining to labeling-specific statements and the exceptions to those requirements. The Agency believes that it is reasonable to assume that adequate warnings, information, and other protective measures will be provided to family members by the person in charge of agricultural operations. In guidance materials for the implementation of part 170, the Agency expects to encourage the voluntary adoption of specified safety practices for exempted workers and handlers of pesticides. Finally, EPA believes that it is likely that routine compliance inspections on establishments without hired labor would be perceived as intrusive, and unlikely that formal complaints would be received from family members against one another. The Agency has no position on whether its regulations would have any effect on State tort law. EPA used the definition "immediate family" found in the Migrant and Seasonal Agricultural Worker Protection Act (MSPA). 14. Specific crops. The Hawaiian Sugar Planters Association and a number of individual growers requested an exemption from the standards for sugar cane growing stating that they use pesticides of low toxicity, and they have an adequate, self-imposed pesticide safety program in place. One comment proposed an exemption from part 170 for all crops that are "non-labor intensive," giving as examples corn, wheat, and soybeans. EPA commends pesticide safety initiatives, but it does not believe that the existence of such initiatives can be the basis for an exemption from the regulation. No specific crops are exempted in the final rule. However, lower toxicity pesticides are assigned shorter restricted-entry intervals and fewer personal protective equipment requirements. If the precautions required by the final rule are being observed already, compliance with the regulation will have little economic impact on those growers. The Agency believes it would be difficult and arbitrary to attempt to define which crops are "non-labor intensive," since all crops utilize human labor of some type at some stage of production. Pesticide handling activities are virtually indistinguishable among crops. While crops that are not hand-harvested or hand-weeded may have less total worker exposure because fewer workers are involved in the production process, there are some hand labor activities in the production of almost all crops. Furthermore, crop production activities, such as moving, repairing or operating irrigation or watering systems, involve potentially significant worker risk through contact with pesticides on treated surfaces if the activities take place at or near the time of pesticide use. The burden of part 170 for growers of non-labor-intensive crops will be small. If no workers are in or near treated areas, few actions will be required. If, however, workers are present, then part 170 measures are appropriate, and will be required. 15. Persons not engaged in agricultural production. One comment, on behalf of a State irrigation district, stated that in the course of their official duties irrigation inspectors were obliged to go near or into fields which may have been treated with pesticides. On occasion a field had been treated while the inspector was present. The comment objected to the lack of protection under part 170 for such employees. Part 170 is an occupational standard primarily intended to protect workers and handlers engaged in the production of agricultural plants from excessive exposure to pesticides used in the production of those agricultural plants, with the burden of compliance falling on the workers' or handlers' employer. However, there is a specific provision that pesticides may not be applied in a manner that will contact any person either directly or through drift unless they are trained and equipped handlers. Although all persons that may be on the site of an agricultural establishment may not be employees of the grower, some persons such as application contractors and labor contractors can be considered subject to some degree of control and direction by the grower and toward whom the grower, as a pesticide user, has some responsibility. There are other persons who may be in or near agricultural areas and who may be affected by pesticide use, but who are not under the control and direction of the grower; these persons might include trespassers, workers employed by neighboring growers, and irrigation inspectors. The Agency believes that such exposure possibilities are both less common than worker exposure and involve a variety of issues that this rule is not well-suited to address. Such persons may receive some incidental benefit from required actions such as posting, or may wish to make arrangements with the grower to be notified of pesticide applications, but part 170 does not impose duties on agricultural employers toward such persons. Two other provisions in the final rule are designed to provide some protection to persons other than agricultural workers or handlers. One requires instructions for persons cleaning contaminated personal protective equipment and the other requires instructions for persons working with contaminated mixing, loading, or application equipment. 16. The public. Some comments expressed concern for protecting the public from agricultural pesticide uses, for example, in retail greenhouses, at "you-pick" farms, in parks and recreational areas, along roads and rights-of-way, and in schools. The Agency is obligated under FIFRA to concern itself with any exposure to pesticides, and it routinely considers public dietary (e.g., pesticide residues on food) and non-dietary (e.g., home use products) exposure in registration and reregistration actions. The revisions to part 170, however, are intended to address only occupational exposures, although the public may enjoy some incidental benefits from these regulations as, for example, when warning signs are located adjacent to a public right-of-way. As in the case of persons not engaged in agricultural production, the Agency believes that incidental exposures involving the public resulting from agricultural production are likely to be less common and less serious than those affecting workers. D. Comments on Definitions Definitions discussed in this unit include those on which comments were received or those that have been added, modified, or deleted in the final rule as compared with the NPRM. Definitions on which no comments were received and which remain unchanged in the final rule are not discussed. Definitions which have implications for regulatory requirements are discussed in the parts of the preamble addressing those requirements. In particular, definitions in the NPRM that related to personal protective equipment ("personal protective equipment," and "chemical resistant") have been incorporated in the final rule into the regulatory text; they are discussed in the preamble in the discussion of personal protective equipment. Agricultural plant. One comment asked how this term was related to existing EPA definitions of "crop" and "noncrop." There are no definitions of these terms in EPA regulations or in FIFRA, although these terms are occasionally used for internal, nonregulatory reasons unrelated to user compliance, such as grouping of registered use sites for review purposes. Another comment asked if plants found on sites such as pastures, rangelands, and rights-of-way used for grazing or harvesting of forage were intended to be included in this definition. Plants in pastures, rangelands, and rights-of-way are intended to be included within this definition; however, these uses are excluded in the final rule from the scope of subpart B and subpart C. Another comment suggested use of the word "commercial" in order to exclude noncommercial gardens from coverage. This change has been made. Non-commercial gardens are also excluded from coverage in all applicability sections. Commercial pesticide handling establishment. EPA has added a definition of "commercial pesticide handling establishment" to better define the types of establishments where Subpart C pesticide-handler protections must be provided to employees. EPA did not intend to include in the scope of this final rule, persons who are employed by pesticide dealers, hazard waste facilities, or waste disposal operations. These people may be employed to transfer pesticides, dispose of pesticides or pesticide containers, or handle opened containers of pesticides, but would, in many instances, have no way of knowing whether the product was used or to be used in the production of agricultural plants on an agricultural establishment or what labeling precautions to follow if several different products or containers were being handled at one time. The Agency intends to include in the scope of part 170 only those commercial pesticide handling establishments who employ persons to apply pesticides on agricultural establishments for the production of agricultural plants or who employ persons to perform, on an agricultural establishment, tasks as a crop advisor. Crop advisor. EPA received some comments, including oral comments from USDA during their statutory review, that expressed concern about limiting the access of crop consultants and IPM scouts to treated areas during pesticide applications and restricted-entry intervals. The Agency is convinced that 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 timing of these entries is sometimes critical and delays in entering these areas following a pesticide application could decrease the success of the IPM program and result in the need for pesticide applications that could otherwise have been avoided. Therefore, EPA has added a definition for "crop advisor" and 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 a person who assesses 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. The Agency believes that crop advisors are likely to be particularly well-informed about pesticide risks and how to protect themselves. However, EPA is aware that tasks performed by crop advisors may result in substantial contact with pesticides on treated surfaces in pesticide-treated areas. The amount of contact with pesticides 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. Therefore, EPA was unwilling to exempt crop advisors from all of the protections provided by this rule, and has defined them as pesticide handlers if they enter an area during a pesticide application or restricted-entry interval. As pesticide handlers, they must receive such protections as handler training (unless already certified applicators), personal protective equipment, 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 restricted-entry interval 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. If provided with required personal protective equipment and other protections as pesticide handlers, crop advisors may enter without time limitations, areas being treated with pesticides, areas that are restricted until ventilation criteria have been met, and areas that remain under a restricted-entry interval. After an application is complete and any ventilation criteria have been met, crop advisors may wear the personal protective equipment and work clothing required on the pesticide labeling for early entry, instead of that required for applicators and other handlers. Early-reentry worker. The Agency received a number of comments from worker representatives objecting to the use of the term "early reentry worker" because it conveyed the impression that early entry by workers to treated areas was or should be a routine agricultural activity, whereas the authors' position was that no early entry whatsoever should be permissible. One comment suggested including "early reentry workers" in the definition of "handler," since they would be protected in much the same manner as handlers. Since the final rule permits only very limited entry to treated areas before a restricted- entry interval has elapsed, the Agency has deleted this definition, and has made clear under what circumstances entry may occur and what protections must be provided, in those sections of the rule related to entry restrictions. Early entry. The Agency has added a definition of early entry in the final rule to clarify that it refers to entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any restricted-entry interval for the pesticide has expired. Employer. In keeping with the use of the employment relationship to assign primary responsibility for protection of agricultural workers in the final rule, a definition of "agricultural employer" as been added to subpart A. This definition is intended to encompass all employers of workers who may be exposed to pesticides while engaged in agricultural- plant activities. The definition of "handler employer" has also been added to subpart A. The definitions are derived from the definition of "employer" in the NPRM. Persons falling under the definitions of "agricultural employer" are responsible for the requirements of subpart B. In some cases the employer of agricultural workers also will be an employer of workers who handle pesticides ("handler employer") and therefore responsible for the requirements of subpart C (for example, if the same grower hires both fieldworkers and handlers, or if the same worker is hired to handle pesticides and to perform other agricultural activities.) The definition of agricultural employer is intended to include persons who have (1) a position of ownership, management or control within an agricultural establishment, i.e. a farm, forest, nursery or greenhouse; or (2) an employment relationship to agricultural workers. The relevant positions of control identified in the definition include ownership of the establishment (e.g., a farm owner); management of the operation (e.g., a farm operator); and recruiting or furnishing workers for the operation (e.g., a labor contractor). Farm. The American Association of Nurserymen (AAN) and the Society of American Florists (SAF) (Refs. C100, C127), while concurring with the proposed definitions of "nursery" and "greenhouse," asserted that these operations are also types of farms and, therefore, should not be excluded from the definition of farm. The Agency notes that the definitions of farm, forest, nursery and greenhouse found in part 170 function to distinguish which requirements apply to which type of agricultural operation. Since there are some requirements that are specific for nurseries and greenhouses that are different from those for farms, these definitions may not overlap. Overlapping definitions could be confusing for users and for enforcement officials. One comment requested that the Agency clarify that "orchards" were covered as "farms" rather than as "nurseries." EPA intends that outdoor fruit and vegetable production workers be covered under farms and considers the definitions of these terms in the final rule to be clear on this point. A flower growers' trade association commented that under the proposed definition of farm, outdoor cut flower operations would have been covered under proposed subpart for farms and forests, and argued that the requirements for nurseries were more appropriate to outdoor cut flower growing. EPA agrees with the comment and has reworded the definition of nursery and the definitions of nursery plant and farm to treat such operations as nurseries. Some comments wanted to know if "Christmas tree farms" were farms or nurseries. Establishments growing "Christmas trees" that are sold live are considered to be nurseries for purposes of these regulations; establishments that produce harvested (cut) "Christmas trees" are considered to be "farms". Some operations may produce both "cut" and live trees and hence may be subject to requirements for nurseries and farms, depending on the type of production at a given site. In the final rule the definition of farms has been delineated more clearly from greenhouses, nurseries and forests so as to avoid confusion. Forest. One comment asked whether "private" forest land was included, and whether grapevines for wreaths and stump cuts for clocks were considered "timber products." The Agency does not intend to cover land where forest products are used only by the owner of land and not sold, nor does it include grapevines and stump cuts within the meaning of "timber products" for purposes of these regulations. Greenhouse. One comment suggested that the definition of this term should distinguish "private or hobby greenhouses" from commercial operations. In the proposed rule this was done through an exemption for "noncommercial greenhouses"; in the final rule, this language has been changed to an exemption "on plants grown for other than commercial or research purposes, which may include plants in . . . home greenhouses." Another comment suggested that the use of the phrase "enclosed with nonporous covering" in the definition of a greenhouse was ambiguous, since some growing structures have sides or panels that may be opened or removed to such an extent that indoor air circulation would approximate outdoor air circulation conditions. The Agency believes that the risks to workers from some types of pesticide applications, such as fine spray applications, are greater when they are done where there is little ventilation, such as in a greenhouse, or a structure "enclosed with a nonporous covering" than when they are done out-of-doors. When the sides of a structure are removed, the environmental conditions during and after a pesticide application resemble that of a nursery and the application restrictions and entry restrictions in nurseries would apply. Hand-labor activity. One comment asserted that the phrase "activities involving substantial contact" in the definition of hand- labor activities allowed unwarranted judgment by employers as to which activities were or were not permitted. The comment suggested the phrase "any activities leading to contact with treated surfaces" be used in the definition instead. In the NPRM, the Agency listed activities it considers as having the potential for "substantial contact" with treated surfaces in an attempt to limit employer discretion and to clarify the concept. The Agency believes that the phrase "substantial contact" is still necessary in the definition of "hand-labor activities" to define other less common hand-labor activities that may not have been listed. The phrase suggested in the comment, "any activities leading to contact", could include some tasks that EPA believes need not be prohibited during restricted-entry intervals. The Agency has modified this definition in the final rule to identify certain activities that are not considered hand labor activities, so that such activities will be permitted before the expiration of the restricted-entry interval. These activities were identified in the preamble to the NPRM as nonhand labor activities, but the Agency believes that they should be listed in the regulatory text to avoid confusion about compliance. Handler. Two comments stated that application assistants and consultants should be considered handlers so that they would not be prohibited from being present during application, for example, to check for proper spray dispersal. The Agency did not intend to exclude such persons, and has included in the definition of "handler" any person who assists in application in some manner or who performs tasks as a crop advisor. One comment asked for clarification as to whether workers who treat seeds or seedlings by dipping them in pesticides are considered handlers. Such workers would be considered handlers since they are exposed to concentrated or dilute pesticides. EPA has noted in the definition that persons who enter areas recently treated with a pesticide that presents an inhalation hazard in order to ventilate the structure or to measure air levels, or persons who assist in the removal of tarpaulins used in soil fumigation are considered to be handlers, since these activities are related to application and involve exposure to concentrated or dilute pesticides. Several comments suggested that the inclusion of persons who "dispose of pesticides" should be modified to exclude persons who handle empty pesticide containers that have been triple rinsed or adequately decontaminated. The Agency agrees and has added a sentence to this effect. One comment objected to the inclusion of persons who repair mixing, loading or application equipment, asserting that exposure was limited and that it was difficult for growers to assure compliance when repairs were performed by a farm equipment company. The analysis of causes of pesticide-related injuries and illnesses done by California Department of Food and Agriculture has led EPA to believe that equipment repair may involve significant pesticide exposure, depending on how recently the equipment has been used; for example, a field repair or inspection conducted after equipment has broken during use. While this requirement may result in overprotection in some cases, clearly it is necessary in others. When repairs are not done by the owners or operators of the equipment or their employees, the equipment must be cleaned thoroughly before being sent for repair. If such cleaning is not possible, the person doing the repair work must be informed: (1) that such equipment may be contaminated with pesticides; (2) of the potentially harmful effects of exposure to pesticides; and (3) of the correct ways to handle such equipment. The owner or operator of the equipment does not have to supply personal protective equipment, handler training, or other handler protections to a person whom they do not employ, such as someone who works for an independent equipment-repair company. Nursery. The final rule modifies the definition of nursery in order to distinguish nursery operations from farms, forests, and greenhouses. The definition indicates that nurseries are any operation engaged in the outdoor production of any agricultural plant to produce cut flowers and ferns or plants that will be used in their entirety in another location. The definition lists as examples of such plants: flowering and foliage plants or trees; tree seedlings; live Christmas trees; vegetable, fruit, and ornamental transplants; and turfgrass produced for sod. Restricted-entry interval. Several comments objected to the term "reentry interval" because it implied that reentry into the treated area was permissible. Most of these comments suggested the term "quarantine period" as a substitute. The Occupational Safety and Health Law Center (Ref. C185) stated that the use of the term "reentry" is a misnomer and should be clarified and more accurately labeled. The Georgia Department of Agriculture (Ref. C72) stated that EPA must clarify that "reentry intervals" are "no contact intervals" or "must wear protection" intervals. The Agency is persuaded to change the term "reentry interval" to "restricted-entry interval" as the latter is more descriptive of the reality. The commonly used abbreviation, "REI", would still apply. Supervisor. Two comments suggested that the proposed definition was lacking in clarity as to what authority over or relationship to a worker was intended in order that a person be considered a "supervisor" of that worker. Specifically, comments questioned the meaning of "directly or indirectly exercises control." In the final rule, the definition of "supervisor," has been deleted in favor of definitions and appropriate references in the regulatory text to "agricultural employer," or "handler employer" as the responsible person. Treated area. In the NPRM this term was phrased "pesticide treated area." In the final rule the Agency has deleted the word "pesticide" as unnecessary verbiage, but otherwise has not changed the definition. Some comments expressed confusion over the exact boundaries of a "treated area." The definition is meant to make clear that the boundaries of a treated area, for purposes of some part 170 requirements such as entry restrictions and posting, depend on where an applicator intends to direct the pesticide, rather than where the pesticide might come to rest. Because of drift or accidental overspray, pesticides may come to rest on areas beyond the bench, row, or field intended to be treated. In these situations, a hazard could exist beyond the boundaries of the intentionally treated area. In nurseries and greenhouses different plants with differing pesticide treatment patterns may be grown in proximity to each other. In these situations, the final rule recognizes the existence of a hazard beyond the treated area by designating an entry-restricted area that is larger than the "treated areas" in order to protect workers who may be working on plants near areas being treated with pesticides. Another comment asked what the boundaries of the "treated area" would be in the case of application to a very large field which takes several days to complete. An agricultural employer is free to consider any smaller treated portion of a larger area to be the "treated area" -- e.g., those rows treated during one day -- and give warnings to workers about and restrict entry to the smaller area. In the alternative, an agricultural employer may give warnings about and may restrict entry to the entire larger area, even if an application takes a number of days to complete. Worker. One comment suggested that the definition of "worker" be enlarged to include public employees such as irrigation district workers and power line workers, because such workers might be exposed to agricultural pesticides in the course of their employment. Although EPA recognizes that these workers could be exposed to pesticides and their residues in the course of their duties, the Agency does not have enough information at this time to ascertain what would be the most feasible and the most effective way to protect these workers. The Agency will seek such information as it assesses the risks of occupational exposure to pesticides for other nonagricultural workers. One comment asked whether sharecroppers would be considered workers under this definition. Whether a sharecropper would be considered a worker for purposes of part 170 would depend on the terms of the sharecropping arrangement. One comment questioned whether the term "worker" as used in part 170 was compatible with use of the word in other State and federal laws and regulations. EPA believes that the word has no consistent meaning throughout the body of government regulation, and has defined the term so as to make its use of the term in this rule unambiguous. A number of comments expressed confusion because in the NPRM, "handlers" and "early reentry workers" were considered to be types of "workers", and that in subpart B of the NPRM the term "worker" was used to refer to "handlers" and "early reentry workers" (but not to other types of workers). In order to alleviate confusion, in the final rule "handlers" are not defined to be a type of "worker," and language has been added to the definition of worker to make this clear. E. Comments on Duties 1. Responsibility for compliance. The Agency proposed that responsibility for compliance with part 170 would rest primarily with the owner of the agricultural property or, in the case of leased property, with the lessee. In addition, other persons in a position to ensure compliance with the Standards within the scope of their work- related duties would be jointly responsible with the owner/lessee, including operators, supervisors, handlers, workers, and other employees of the owner or lessee, and labor contractors, application contractors, and other contractual agents of the owner or lessee. The responsibility of such persons was specified in terms of a general duty to assure that pesticides were used in accordance with the requirements of part 170 and that workers were protected in accordance with the requirements of part 170. Of the universe of persons potentially subject to enforcement action, enforcement officials would determine, based on the facts of a given case, which persons were in a position to prevent or to mitigate violations. The preamble to the NPRM described factors, such as previous compliance efforts, which might be employed in such determinations. Certain additional factors were proposed for consideration by enforcement officials. These included consideration of evidence of worker noncompliance with relevant work safety instructions, which would be considered in the initiation of enforcement actions and in the determination of penalties, and the limitation of owner/lessee responsibility for violations of a contractor to those occurring on the property of the owner/lessee. In addition, responsible persons would be prohibited from allowing or directing violations to occur and from taking actions, such as retaliatory dismissal, intended to prevent or discourage compliance. Responsible persons would not be prohibited from discharging or disciplining workers for worker noncompliance. Almost all comments addressing the topic of responsibility, including grower organizations and worker representatives, agreed with the Agency's placement of primary responsibility for protection of workers other than commercial handlers on the owner of the farm, forest, nursery or greenhouse. A number of comments specifically supported the proposed shift of responsibility from owner to lessee in the case of leased property. Several comments argued that it was more appropriate to place primary responsibility with the person responsible for day-to-day management decisions, such as a farm operator or manager, claiming that it would be unfair to hold an "absentee owner" responsible who had no involvement in pesticide use or safety decisions. These comments came largely from owners, managers and trade associations associated with forestry operations, where the incidence of "absentee" land ownership appears to be much greater than on farms. Most grower representatives commented that farm owners should not have primary responsibility for the protection of employees of commercial handlers, arguing that growers can exercise little or no control over commercial application operations. Comments from commercial handlers appeared to agree with the proposed responsibility scheme. Worker representatives agreed with the Agency's position that a contractual relationship should not insulate an owner from responsibility for protecting workers. These groups focused their attention on the consequences if owners did not retain responsibility for workers hired through a labor contractor, arguing that owners have more economic resources, often direct the actions of labor contractors by treating them as supervisors, and are usually in a better position to assure compliance. Many comments used the term "employer" apparently interchangeably with the term "owner " when discussing the issues of responsibility. The Agency agrees with the proposition that an on-site operations manager, in most cases, would be the person in the best position to implement worker protection measures and to avert violations. The Agency is persuaded that the proposal as written placed primary responsibility for compliance with that person. The decision to proceed in a particular case against the persons most directly responsible would ensure that persons with no real connection to the violation would not face liability. At the same time, it must be acknowledged that whether an owner, lessee, or operator should be held responsible for pesticide misuse is not related only to whether that person lives or works on the property; nor is it related only to whether the person is the owner of the property on which the agricultural operations take place. In the case of corporate ownership of the agricultural operation, the on-site operator would be subject to the policies and directions of the corporation that could be the primarily responsible party. In the case of misuse by commercial handlers, the incentive and the opportunity for protecting the commercial handlers would appear to rest more with the commercial handlers' employer at the commercial pesticide handling establishment than with the owner or operator of an agricultural establishment. More difficult to assess is the role of agricultural owners and operators in protecting their employees from pesticide use by commercial handlers, although it would seem to depend in part on information communicated from the commercial handler to the owner or operator of the agricultural establishment. As to primary responsibility for workers hired through labor contractors, EPA believes that the owner or operator is in a better position to assure compliance with part 170 for such workers, whose activities are often indistinguishable from those of directly hired workers. The Agency has concluded that it is more appropriate to express responsibility in terms of the employment relationship than in terms of a possessory interest in land. The present rulemaking is fundamentally an occupational exposure standard; the employer-employee relationship is used by OSHA to assign responsibility for worker protection, including the health standards in the agricultural sector such as the Field Sanitation Standard (29 CFR 1928.110) and the Hazard Communication Standard (29 CFR 1910.1200). It is clear from the comments that the term "employer" is used by the regulated community itself, perhaps more commonly than the term "owner." The Agency also believes that appropriate use of employment terminology will create a clearer assignment of responsibility in places where the proposal was more general than necessary as to duties of persons. In the final rule, EPA defines the term "agricultural employer" to indicate who has the primary responsibility for protection of agricultural workers other than handlers. The term "handler employer" is used to refer to those with the responsibility for compliance with pesticide handler requirements. EPA believes that use of these terms will result in an assignment of responsibility roughly equivalent to that in the proposal, because most agricultural employers are either land owners or lessees. For example, land owners who lease their land and retain no personal or corporate involvement in the business operation of agricultural production on the land rarely, if ever, would be subject to enforcement action under either the proposed or final rules. On the other hand, corporate agricultural entities that either own or lease the land used for production, and employ workers to do production-related activities through an on-site corporate manager would be subject to enforcement action under either the proposed or final rules. Agricultural employers would continue to be primarily responsible for the protection of employees hired by labor contractors that work in their operations, with the labor contractor as a "joint employer." They also would be responsible for the protection of their employees from exposure to pesticides applied by commercial handlers (this point is discussed further in the next subsection). The principal difference between the NPRM and the final rule is in the area of responsibility for the protection of commercial handlers and their employees. Although commercial handlers, in many cases, may be considered agents of the agricultural employer within the scope of FIFRA section 14, the Agency agrees with the comments that claimed that agricultural employers may have little direct control over such contractors. This would be true even when contractor's activities occur on the property of the agricultural employer. In the final rule, the employers of commercial handlers have primary responsibility for the protection of commercial handlers (subpart C requirements). Agricultural employers who employ their own handlers retain primary responsibility for such handlers under subpart C, but agricultural employers generally would not be responsible for subpart C violations by commercial handlers or the employers of commercial handlers. This would be true even if violations occur on the property of the agricultural employer, although under some circumstances they may be deemed joint employers. The duties of persons under a "sharecropping" arrangement would be governed by the relationship between land owner and sharecropper. It is the "economic reality" of the relationship, including who controls the manner in which work is done, that is the hallmark of the employment. The more the land owner is involved in the manner in which the sharecropper manages his lands, the more likely it is that EPA would consider the relationship to be one of employer-employee. 2. Other responsible persons. The proposed rule assigned responsibility to owners, supervisors, contractors, workers, and handlers. No comment was received on the topic of responsibility of intermediary supervisory personnel such as crew leaders and foremen, other than the comments discussed previously in support of responsibility for labor contractors, who often function as supervisors. In the final rule, the primary responsibility is on the employer to ensure that his employees comply with the law. A number of comments were received questioning the responsibility of contractors under various types of contractual agreements common in agricultural production, primarily labor contractors and application contractors. As previously discussed, in the final rule labor contractors are included within the definition of "agricultural employer" and have joint responsibility with the owner/operator for assuring that workers in their employ receive the part 170 protections, even if the protections are provided by the owner/operator. As noted above, in the final rule employers of commercial handlers, rather than owner/operators of agricultural establishments on which a pesticide is applied, have primary responsibility for assuring the protection of applicators and other handlers in their employ. Comments by representatives of commercial applicators questioned to what degree they would be responsible for protecting the employees of the agricultural employer on whose land the application occurs, citing their lack of control over these workers and the impracticality of carrying out certain pre-and post-application protective measures such as oral warnings and REI's. The Agency agrees that compliance with most requirements to protect nonhandler workers is more appropriately within the purview of the agricultural employer, with two exceptions. Commercial handlers will have control over their activities that may affect workers (other than handlers) in or near an area under application. Consequently, the final rule requires the handler- employers and the handlers themselves to assure that handlers observe the prohibitions against application so as to contact workers directly or through drift, Para 170.210(a). In addition, commercial handlers will have information concerning the application--such as time and place of application, name of the pesticide, REI, and other labeling information--that will be necessary for the agricultural employer to know in order to protect his or her workers. The final rule therefore requires the commercial handler employer to assure that relevant labeling and application information is communicated to the agricultural employer, Para 170.224. In this manner the Agency has defined the responsibilities of handler employers more clearly than in its proposal. Agricultural employers are assigned a responsibility to protect handlers who are employed by a commercial pesticide handling establishment and who enter an agricultural establishment to perform pesticide handling tasks. The final rule requires that agricultural employers assure that commercial-pesticide-handling-establishment employers are aware of certain pesticide information (Para 170.124): (1) Specific location and description of any areas subject to application or entry restrictions; and (2) Restrictions on entering those areas. A number of comments were received on the subject of EPA's proposal to make workers subject to enforcement action for noncompliance. Grower representatives favored this approach, usually based on notions of fairness and individual responsibility for actions, and the view that without the threat of enforcement action many workers would disregard measures for their protection if it were inconvenient or uncomfortable. Worker representatives objected to this aspect of the scheme of responsibility in part 170, arguing variously that the worker cannot be considered either a pesticide user or an agent of a user within the meaning of the statute; that Congress intended enforcement of occupational laws to be through employer sanctions rather than employee sanctions, and that OSHA generally proceeds on this basis; that growers may allege worker noncompliance merely to exonerate themselves from liability; and that part 170 does not require training of workers such that workers would know the rules. Upon reconsidering, the Agency believes that the statutory questions concerning whether fieldworkers, who are not pesticide handlers, may be considered pesticide users or agents of users for purposes of FIFRA Section 12 misuse violations are such that considerable difficulty could be experienced in bringing enforcement actions against workers. While it may be true that fear of liability might encourage worker compliance with part 170, worker liability might create other enforcement problems. The final rule therefore does not include nonhandler employees among those potentially responsible for compliance. The burden of assuring compliance by employees rests with the employer. The agricultural employer's remedy for noncompliance by employees is nondiscriminatory discipline or discharge, rather than reliance on enforcement officials to coerce worker compliance and possibly to absolve the employer. 3. Specificity of duties. EPA proposed to embody its responsibility scheme in a duties section ("Duties of persons covered under this part") contained in the general requirements subpart of the NPRM. This subpart described, among other things, the general duty of owners and other persons to assure compliance with all part 170 requirements. As to specific requirements, such as decontamination, these sections of the proposed rule were written in the passive voice (e.g., "Water...shall be made available to each worker") without identifying a particular person or persons who were specifically responsible for performing the required actions. In this manner, depending on the circumstances, a range of persons might be jointly responsible for assuring that any specific required action was performed. A number of comments indicated confusion concerning this responsibility scheme. The authors may not have understood that a range of persons must assure compliance jointly. One worker representative claimed that such a scheme would allow unscrupulous persons to avoid responsibility. Several comments suggested specifying, in the active voice, which persons must comply with each requirement. The Agency agrees with these concerns and has made modifications to the responsibility scheme in the final rule. A general duties section has been retained that indicates the general duty of employers to comply with pesticide labeling, including part 170. In addition, substantive requirements are worded in the active voice to specify the appropriate responsible person (either the employer of the agricultural worker or the employer of the handler). At the same time, the definitions of these persons make clear, especially in the case of agricultural employers, that a number of persons may be considered to be employers for purposes of compliance. In this way the overall range of potentially responsible persons has not been modified, except as discussed in the previous sections, while specific obligations should be more understandable to users. 4. Prohibited actions. The proposal stated that no employer "shall allow or direct a worker to violate any requirement" of part 170. One comment argued that the word "allow" in this context was too broad, and would lead to undeserved liability where the responsible person was not aware of a worker's misconduct. The Agency intended that it be considered a violation of part 170 if, for example, an employer told a handler not to wear personal protective equipment that was required, or if the employer was aware that the handler was not wearing the required personal protective equipment and did nothing to deter the violation. Since the employer has the general duty to "assure" compliance with part 170, the Agency is persuaded that this additional language is not necessary to provide clear accountability and effective enforcement. As a result, this language has been deleted from the final rule. The Agency considers that the criminal penalty provisions of FIFRA section 14 ordinarily will be adequate to address any situations in which employers may attempt to evade responsibility by encouraging or tolerating violations of the regulations. The Agency also proposed to consider retaliatory actions by responsible persons against workers to be violations of part 170. No comments were opposed to the anti-retaliation provision. A number of comments by worker representatives agreed with the Agency's statements in the preamble to the NPRM that such a prohibition was necessary to encourage compliance by workers and responsible persons, but argued that this view was not embodied in the regulation adequately. Several of these comments suggested more detailed provisions for protection against retaliation, including specific prohibited actions, administrative remedies, and provision for judicial review. EPA believes that the imposition of detailed procedural protections against retaliation along the lines of these comments would cause a significant drain on Agency resources. The relationship between the prohibition of retaliatory acts and the increased likelihood of compliance with other exposure reduction measures has not been questioned. The final rule retains this section as proposed, with a modification to make the requirement clearer. In the proposed "prohibited actions" subsection, EPA made a statement that employer sanctions for worker noncompliance with part 170 would not be prohibited. Although several comments from growers supported this statement without providing reasons, this language has been deleted from the final rule as redundant. The Agency intended this statement to make clear that disciplinary action by an employer against a worker for failing to comply would not be considered retaliatory, if the worker's noncompliance violated an adequately communicated and uniformly enforced work rule of the employer. Worker noncompliance would not excuse employer violations of part 170 when the employer has not taken adequate steps to prevent worker misconduct. 5. Effect of regulations on State tort law. In the preamble to the NPRM, the Agency noted that it did not intend to create any new civil cause of action through its regulations nor to change any existing common law remedy. A number of grower representatives requested that specific language be added to the regulatory text to emphasize this point. One worker representative asserted that the regulations establish a standard of care for purposes of State tort law, and requested that the Agency make no statements that would undermine this. The Agency must reiterate its position from the NPRM that the regulations are not intended to create a cause of action or to change existing common law remedies, and adds that it has no position on whether the regulations create a standard of care under State tort law. In the final rule no changes have been made with respect to this topic, and the Agency believes none are needed. F. Enforcement 1. Use of a pesticide. In its proposal EPA noted that the Standards would be enforced under FIFRA section 12(a)(2)(g), which makes it unlawful to use a registered pesticide in a manner inconsistent with its labeling. The Agency proposed to determine that the part 170 requirements as specified on labeling were necessary steps to assure the safe use of pesticides and to prevent unreasonable adverse effects on workers. In doing so, EPA relied on its traditional interpretation of "use" for purposes of pesticide regulation, which covers other activities in addition to the actual application of the pesticide, some of which may occur prior to application, some during application, and some following application. The Agency has determined that each requirement in the final rule is necessary to prevent unreasonable adverse effects on workers arising from pesticide use. For each requirement, EPA has examined the potential risk to workers in terms of the available evidence and determined for what period of time before or after application the measure must be provided or performed. This determination is generally embodied in a "trigger" to the requirement, describing the time period during or circumstances under which the requirement is in effect before or after the use of a pesticide. These triggers are addressed in the discussion of each requirement in this document. One comment questioned whether, in defining "use of a pesticide" to include "allowing or arranging for application," the Agency intended to interpret this phrase to include dealers. The Agency does not intend to include dealers for the purposes of this rulemaking, provided that the dealers are not also commercial pesticide handling establishments as defined by this final rule (Para 170.3). For the purposes of the final rule (Para 170.9), EPA interprets the term "use" to include: (1) Preapplication activities, including, but not limited to: (i) Arranging for the application of the pesticide, (ii) Mixing and loading of the pesticide, and (iii) Making necessary preparations for the application of the pesticide, including responsibilities related to worker notification, training of handlers, decontamination, use and care of personal protective equipment, emergency information, and heat stress management. (2) Application of the pesticide. (3) Post-application activities necessary to reduce the risks of illness and injury resulting from handlers' and workers' occupational exposures to pesticide residues during the restricted-entry interval plus 30 days. These activities include, but are not limited to, responsibilities related to worker training, notification, and decontamination. (4) Other pesticide-related activities, including, but not limited to, providing emergency assistance, transporting or storing pesticides that have been opened, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials. In this rulemaking, EPA has not exercised statutory authority with respect to nonagricultural occupational pesticide hazards or agricultural hazards that are not primarily related to pesticide exposure such as general sanitary hazards or other working conditions. These working conditions and hazards may be subject to the Occupational Safety and Health Act and regulations promulgated by OSHA. 2. Joint responsibility. EPA indicated in the NPRM that when more than one person having duties under part 170 was involved in a violation, all such persons would be subject to enforcement action. The extent of the enforcement action would be based on the facts of the case. The Agency has maintained this position in the final rule, and has clarified or has limited the joint responsibilities of certain parties. This clarification occurs primarily between agricultural employers and commercial handler employers, in cases where a pesticide use is arranged by the former and carried out by the latter, and follows upon the use of the term "agricultural employer" and "handler employer" in the final rule to establish primary responsibility. Employers of commercial handlers would be responsible for the protection of their employees (subpart C requirements) and would share responsibility with the employers of agricultural workers for protection of the latter's employees during application ("Restrictions associated with application" in subpart B and "Restrictions during applications" in subpart C). A commercial handler normally would not be considered the agent of an agricultural employer, such that the agricultural employer might be held responsible for part 170 violations by the commercial handler. One exception might be where a specific delegation of duty had occurred; for example, where a commercial applicator had agreed to post warning signs for an application (normally the responsibility of the agricultural employer) and failed to do so. In the proposal, the Agency limited the owner's liability for violations of contractors such as commercial applicators to those violations which occurred on the owner's property. One comment stated that under this section the owner would not be responsible for incidents of pesticide drift caused by a commercial handler. This section has been deleted in the final rule, since it is no longer necessary based on the clarification of duties between the parties as discussed above. The Agency believes that it is most appropriate to hold the handler and the handler's employer responsible for drift incidents. 3. Worker noncompliance. The Agency proposed to state in the regulation that failure by workers to follow instructions by supervisors or owners related to compliance with part 170 "shall not preclude enforcement action..." against the supervisor or owner, but must be taken into account by enforcement officials during any action against the employer. Most growers and grower representatives argued that if workers were properly instructed, warned and equipped as required by part 170, and the grower had done "everything in his power" to ensure the workers obeyed the rules, then they should never be held responsible if the rules were violated by the actions of a worker. Growers focused on the perceived unfairness of holding them responsible for intentional, knowing violations by their workers. One trade association commented that workers might violate part 170 intentionally to "cause problems" for the employer. Worker representatives argued that such an enforcement policy would encourage employers to assert worker noncompliance as a means of avoiding liability. If this happens, the net result will either be a "swearing contest" or, if workers do not contradict such accounts because of fear of job loss, a "cover-up." The New York Department of Labor asserted that such language in the regulation was unnecessary since enforcement officials have discretion to mitigate penalties as appropriate, and that no similar Federal worker protection regulation or New York law or regulation contains such a concept. The Agency agrees that it would be unfair to treat employers who expend considerable efforts to assure compliance the same as less conscientious employers who tolerate or encourage noncompliance. However, it may be difficult to determine, even with thorough investigation, either the degree of effort made by a particular employer to elicit compliance by a worker, or the degree of intentionality of a worker in failing to comply. An example would be the employer who provides personal protective equipment, then "looks the other way" as workers routinely fail to wear it because it is "uncomfortable." Investigators in such situations will be faced with conflicting accounts that will be difficult to resolve and that will be case-specific. The final rule deletes this section. 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 believes that it is more appropriate not to intrude by regulation into this area. Enforcement officials have traditionally based their compliance decisions on the facts of an individual case.