VI. Implementation A. Agency Implementation Strategy 1. Phased implementation. The Agency is establishing different implementation dates for the requirements in part 170 and the changes required in pesticide labeling found in part 156. The first amended labeling under part 156 would be available to users no sooner than April 21, 1993. As pesticide products with amended labeling are used, EPA will begin to enforce the [38140] provisions of part 170 that are related to the new specific requirements on pesticide product labeling for restricted-entry intervals, personal protective equipment, and notification about treated areas. After April 21, 1994, all products covered by this rule must have amended labeling when they are distributed or sold by registrants. After April 15, 1994, EPA will begin to enforce the remaining provisions of part 170. Implementation and enforcement of the revised Worker Protection Standard depend upon the misuse provision of FIFRA section 12(a)(2)(G) that states it is unlawful ``to use any registered pesticide in a manner inconsistent with its labeling.'' Thus, the provisions of this revised standard must be in the labeling or must be linked to pesticide product labeling by reference before they can be implemented or enforced. Currently, changes in directions for use ordinarily are incorporated in their entirety into the labeling of each affected pesticide product. Implementation and enforcement of new directions for use occur when a pesticide product with the changed labeling is used. The Agency has determined that implementation of the Worker Protection Standard through this mechanism would be difficult. Only worker protection requirements that vary from product to product will be placed on the pesticide product labeling as specific directions for use. Part 170 requirements that do not vary among affected products will not be repeated in each product's labeling; the Agency will reference these standards on pesticide product labeling. Placing requirements related to the directions for use in documents that are referenced on the pesticide product labeling, but which do not accompany the product in commerce, is unusual. Although the Agency believes the protective measures of the revised part 170 should become effective as soon as possible, it has concluded that a phased and orderly schedule of relabeling, information dissemination, and enforcement is needed to facilitate both registrant compliance with the new labeling requirements and user understanding and compliance with the Worker Protection Standard. The requirements of the revised Worker Protection Standard related to a product's potential hazard to users and other persons will be on the label or in the product labeling. A registrant of an affected pesticide product will be required to specify: (1) A prohibition from applying the pesticide in a manner that contacts anyone except appropriately trained and equipped handlers, (2) PPE for handling and early-entry activities, (3) a restricted-entry interval, and (4) when appropriate, that workers be notified orally and by posting of signs at the treated areas. Although the concepts of not applying pesticides when workers or other people may be contacted, of using PPE to handle pesticides, of restricting entry to treated areas, and of notification about pesticide-treated areas are familiar to agricultural pesticide users, this rulemaking modifies these requirements in significant ways. Since these product-specific provisions are essential to the safe use of a pesticide, the Agency is unwilling to delay their implementation. Consequently, all product-specific requirements will be effective as soon as they appear on pesticide product labeling. However, the Agency will require that no such labeling changes appear in the marketplace until there has been an opportunity to explain them to users. Other new requirements apply to all pesticide products used in the production of agricultural plants. These include the requirements for training handlers and agricultural workers, for providing pesticide-specific information to employees, and for providing decontamination water and emergency assistance for handlers and workers. It is not practical to describe these requirements fully in the product labeling. Therefore, it will take time to communicate these requirements to the agricultural community and for that community to implement them. As a result, enforcement of the general requirements will be delayed as described below. (Unit VI.A.2.) 2. Implementation of part 170. EPA will implement part 170 in two phases: a. Accelerated implementation of provisions supporting product-specific labeling. Specific requirements related to restricted-entry intervals and notification about treated areas are being added or changed through this revision of part 170. To implement the requirements that will be found on some product labeling for restricted-entry intervals, and the instructions to both orally warn and post treated areas, sections of part 170 that concern these requirements and the exceptions to these requirements must be implemented quickly to prevent unintended burden on the user during the phase-in period of compliance with this regulation. The sections of part 170 that will have accelerated implementation, i.e. that will be enforced as the associated statements appear in pesticide labeling are: i. Sections of part 170 related to entry restriction. Section 170.112(a)(1) through (a)(4) states the general restrictions on worker entry to treated areas prior to the expiration of an REI. Section 170.112(b) describes an exception to the general restrictions and permits entry if the worker will have no contact with anything that has been treated with the pesticide to which the REI applies. Sections 170.112(c)(1) through (3) describe the exemption for early entry to perform short-term tasks and describe the requirements for that exemption which will be implemented on an accelerated schedule. Sections 170.112(d)(1) through (2)(ii) plus 170.112(c)(3) that is referenced in (d)(2)(iii) describe the exemption for early entry due to an agricultural emergency and describe the requirements for that exemption which will be implemented on an accelerated schedule. ii. Sections of part 170 related to requirements about oral warnings and posting of treated areas. Implementation of the requirements to both orally warn and post treated areas in the labeling requires implementation of 170.120(a)(3) and (b)(3), which tell the employer the exceptions to the oral warning and treated-area posting requirements. b. Implementation of part 170 provisions that are generic to all pesticide uses. The enforcement of the remaining or ``generic'' provisions (i.e. those that apply to all pesticides uses) in the final rule will begin April 15, 1994. The phased implementation dates for part 170 are intended to allow time for EPA and cooperating organizations to develop, reproduce, and distribute the training and instructional materials necessary to encourage compliance. If part 170 implementation were to be triggered solely by the appearance of revised labeling, some users would have to comply with part 170 before instructional materials were available to assist them in doing so. 3. Implementation of part 156. The Agency is establishing two separate sale/distribution dates for registrants. The first date regulates the earliest date that a registrant is allowed to sell or distribute a pesticide product with labeling amended to include part 156 statements. This date is the effective date of part 170 (which is 60 days after publication of the final rule) plus 6 months. During this time the Agency will execute an implementation outreach program. The second date, 18 months after the effective date of part 170, is the time by which all affected pesticide products sold or distributed by [38141] registrants would be required to contain the appropriate part 156 statements in their labeling. In the past, EPA has not placed constraints on registrants as to how soon pesticide products bearing Agency-required changes to labeling could be sold or distributed; the emphasis has been on the maximum time registrants would be allowed for changing labeling. However, in the implementation of the Worker Protection Standard, registrants will not be allowed to sell or distribute pesticide products with labeling amended to include part 156 label-specific requirements or the generic part 170 reference statement prior to an established date. This constraint is to prevent pesticide labeling with the new worker protection statements pursuant to this final rule from becoming available to users before EPA and cooperating organizations can disseminate the information necessary to tell users how to comply with the requirements. Otherwise, users could face the dilemma of being required to comply with provisions without the necessary information on how to do so. A summary of the implementation schedule is given in the following Table 1: Table 1.--Implementation Time Table ------------------------------------------------------------------------------ Time Part 156 Activities Part 170 Activities ------------------------------------------------------------------------------ Publication in the Inform registrants of Initiate outreach to Federal Register of required label changes regulated community to part 170 and part 156 (LIP or PR notice). inform affected parties (notice to registrants about the rule, of mandatory labeling particularly the changes). accelerated provisions, i.e. the requirements in the labeling for restricted-entry intervals, treated area posting and oral notification to workers, and use of personal protective equipment. 60 days after Effective date. Effective date, publication. including the process for requesting exceptions to restricted-entry intervals. 6 months after Earliest date that Start compliance efforts effective date of products with amended on new product-specific part 156 and part 170. labeling may be sold or requirements on labeling distributed by registrants. (accelerated provisions of part 170). April 15, 1994. Start enforcement of part 170 ``generic'' provisions whenever a pesticide product with amended labeling is used. 18 months after part All pesticide products 156 and part 170 sold or distributed by effective date registrants must bear (12 months after labeling referencing earliest sale or part 170 and other part distribution date for 156 labeling statements. registrants). 36 months after part Pesticide products sold/ 156 and part 170 distributed by any effective date. person must bear amended labeling. ------------------------------------------------------------------------------ B. Registrant Compliance A large number of products will be affected by the new requirements, and an orderly relabeling process is necessary to avoid confusion, to ensure clear and appropriate labeling to guide users, and to facilitate registrant compliance. Thus, the Agency has included in this preamble instructions to registrants and compliance deadlines for changes to pesticide labeling required by the new subpart K, part 156 (``Worker Protection Statements''). The Agency has tried to make the new labeling requirements as self-explanatory as possible to reduce the need for registrant inquiries. 1. Applicability of part 156, subpart K statements. This section provides guidance to registrants in determining which of their products may be affected by the new part 156 subpart K, whether existing worker protection statements should be retained, and how new part 156 subpart K labeling statements should be determined. a. Scope. Products affected by part 156 subpart K are, with some exceptions, those products registered for use in the production of agricultural plants (40 CFR 156.200(b)). The scope of agricultural pesticides for purposes of subpart K is broad and refers to any product registered for use in the production of agricultural plants on farms, or in forests, nurseries, or greenhouses; these terms are defined in 40 CFR 170.3. Part 156, subpart K applies to products that may be applied directly to agricultural plants or to growing areas. Any such product must bear the subpart K statements, except as noted below. Several types of products that may be registered for application on farms, or in forests, nurseries, or greenhouses need not bear the subpart K statements. These are defined by the exceptions to the handler applicability section of part 170 (40 CFR 170.202(b)). If a product has both exempted uses and covered uses, the subpart K statements must appear on labeling. Under subpart K, a reference statement on the label will direct users to part 170, which contains more specific requirements than those listed in the labeling. b. Existing statements. Various types of worker protection statements currently appear in the labeling of many agricultural products. Most of these statements will be modified or will be replaced by the new subpart K requirements. Several comments on the proposed rule requested clarification of the relationship between subpart K and PR Notice 83-2, which called for certain worker protection statements, based on part 170, to be placed on agricultural product labels. EPA is revoking PR Notice 83-2 effective as of April 21, 1993, and registrants of products subject to PR Notice 83-2 must modify their labeling according to subpart K requirements. Some products within the scope of subpart K were not subject to PR Notice 83-2, including products registered for uses in forests and in greenhouses, for use on nursery ornamentals, and for use on crops whose culture does not involve commonly recognized hand labor tasks. In addition to PR Notice 83-2 statements, some products currently bear statements pertaining to REIs and PPE that were required through registration or a Registration Standard or Special Review decision on an active ingredient contained in the product. The status of existing REI and PPE statements will be governed by the relevant subpart K sections on these topics (40 CFR 156.208 and 156.212). The Agency will issue a PR Notice to registrants with detailed guidelines on [38142] how to evaluate existing labeling statements and on what new labeling statements to adopt. c. New statements. Four types of worker protection statements may apply to products covered by the new subpart K: General statements, REI statements, worker notification statements, and PPE statements. i. General. All products must carry a standard reference statement alerting the user that the product must be used according to part 170 (40 CFR 156.206(b)). A standard statement prohibiting users from allowing a pesticide to contact nonhandlers directly or through drift also must appear on all products (40 CFR 156.206(a)). A different version of this statement was required by PR Notice 83-2; that version must be replaced by the revised version. Products required to use either DANGER or WARNING as signal words (toxicity category I or II products) also must use the Spanish signal word PELIGRO or AVISO on the label, and a phrase in Spanish instructing the reader to have the label explained before using the product (40 CFR 156.206(e)). If the product contains an active ingredient that is an organophosphate or an N-methyl carbamate, this information must be in the labeling either as part of the product name or in the Statement of Practical Treatment (First Aid) section of the labeling (40 CFR 156.206(c)(1)). This information is required in the labeling to aid employers who want to provide cholinesterase monitoring programs for their employees. If the product is a fumigant, its status as a fumigant must be conveyed as part of the product-name or product-type information, placed close to the product name (40 CFR 156.206(c)(2)). ii. Restricted entry. Products covered by subpart K must have a standard REI statement. Fumigants will retain their current entry restrictions, but the statements must be converted to the format of the subpart K restricted-entry statements (40 CFR 156.208(d)). The standard restricted-entry statement (40 CFR 156.208(a)) includes the restricted-entry interval (determined by 40 CFR 156.208(c),(d),(e), or (f)). Some existing labeling bears entry-restriction statements. In determining the appropriate subpart K restricted-entry interval (REI), three situations are possible: First, a product that has a product-specific REI based on foliar or soil dissipation data for the product (or for each active ingredient in the product) that have been submitted to and accepted by EPA, must retain this REI (40 CFR 156.208(e)). The second situation involves products that have an REI that is not product-specific. Here the existing REI must be compared to the REI that would apply using the criteria in 40 CFR 156.208(c); the longer of the two REIs would be the restricted-entry interval. Third, a product that has no REI (this would include products prohibiting entry ``until sprays have dried or dusts have settled'' and other products) must use the criteria of 40 CFR 156.208(c) to determine the appropriate REI unless all data required to set a product-specific interval are submitted to and accepted by EPA and a specific REI is approved. Under the criteria of 40 CFR 156.208(c), REIs are determined by comparing available acute toxicity data for the active ingredients in a product. Registrants must use any obtainable results of toxicity testing (i.e., toxicity category) for the three relevant routes of exposure (dermal toxicity, skin irritation effects, and eye irritation effects) for each active ingredient in the product. If necessary, formulators should seek verification of toxicity category information from their suppliers. In some circumstances, acute oral toxicity or the toxicity of a registered technical product may be used. Among the acute toxicity data used in the comparison, the most toxic toxicity category determines the REI: 48 hours for toxicity category I, 24 hours for toxicity category II, or 12 hours for toxicity category III and toxicity category IV (40 CFR 156.208(c)). When no acute toxicity data are available for one or more of the active ingredients, registrants must use the toxicity category of the formulated product indicated by the signal word in the comparison. When the REI has been determined, the appropriate number of hours is inserted into the restricted-entry statement of 40 CFR 156.208(b), unless the REI varies crop by crop. If a product contains a toxicity category I active ingredient that is a cholinesterase-inhibiting organophosphate ester, a statement must be added requiring a 72-hour REI when the product is applied outdoors in an area where the average annual rainfall is less than 25 inches a year (40 CFR 156.208(c)(2)(i)). EPA reserves the right to modify any subpart K restricted-entry interval for a product in the future. For example, this may occur either at the beginning or end of a Special Review for an active ingredient in the product (40 CFR 156.204(a)) or on evaluation of foliar or soil dissipation data, or other relevant data, showing that a different REI is warranted (40 CFR 156.204(b)). Registrants, or others, may undertake to develop, at their discretion, foliar dissipation or other exposure data that would lead to the establishment of a product-specific REI; until that time, an interim REI will apply to the product. iii. Notification to workers. Each product in toxicity category I for acute dermal toxicity or skin irritation potential, other products designated by EPA, and each fumigant that may be used in greenhouses must carry a standard statement indicating that workers must be given notification of the application both orally and by posting of treated areas (40 CFR 156.210). A definition of a fumigant appears in 40 CFR 156.203. iv. Personal protective equipment (PPE) and work clothing. All products must bear statements specifying minimum PPE or work clothing as determined by subpart K. Appropriate PPE or work clothing is required by subpart K for all handling activities (40 CFR 156.212) and activities in treated areas before the expiration of an REI. If a product has PPE or work clothing statements on the labeling, the registrant must compare these existing statements with the requirements of subpart K, and use the more protective or more specific item of PPE or work clothing for each area of the body to be protected. If product labeling prohibits the wearing of gloves or boots, such a prohibition must be retained on labeling as it is worded. The format of all PPE and work clothing statements should be that described in subpart K, even if a more protective or more specific item is being retained. The following are examples of comparisons of degree of protection or specificity between PPE items in subpart K and PPE items now on product labeling: (1) A coverall is more protective than a long-sleeved shirt and long pants. (2) A chemical-resistant (or liquidproof, waterproof, rubber, etc.) suit, rain gear or rain suit is more protective than a coverall or long-sleeved shirt and long pants. (3) Chemical-resistant gloves are more protective than cotton, cloth, paper, or leather gloves. (4) Chemical-resistant footwear is more protective than shoes and socks. (5) Air-supplied or self-contained respirators are more protective than other classes or types of respirators. (6) A cartridge or canister respirator is more protective than a dust/mist mask or dust/mist respirator. As indicated below, certain words and phrases on existing labeling must be replaced by terms described in subpart K. Unless the registrant has data that indicate a particular type of material(s) [38143] is more chemically resistant to a particular pesticide product or a particular type of pesticide products, the labeling statements for the use of gloves in subpart K must be followed. ``Chemical resistant'' must be used instead of such terms as ``liquidproof,'' ``rubber,'' ``natural rubber,'' ``vinyl,'' ``synthetic rubber,'' ``impervious,'' ``neoprene,'' ``plastic,'' ``impermeable,'' or ``nonporous.'' The term ``waterproof'' must be used in place of ``water-resistant'' or other terms if the pesticide is used dry or as an aqueous solution. Unless the registrant has data indicating that the NIOSH/MSHA approval number prefix listed in subpart K is inappropriate for a particular pesticide product or a particular type of pesticide product, NIOSH/MSHA approval number prefixes indicated in subpart K shall be substituted for the general phrase ``NIOSH/MSHA approved'' in respirator statements on existing labeling. For a dust/mist mask, the NIOSH/MSHA approval number prefix is ``TC-21C.'' For a cartridge respirator, the NIOSH/MSHA approval number prefix is ``TC-23C.'' For a canister respirator, the NIOSH/MSHA approval number is prefix ``TC-14G.'' For a supplied-air respirator, the NIOSH/MSHA approval number prefix is ``TC-19C.'' For a self-contained breathing apparatus (SCBA), the NIOSH/MSHA approval number prefix is TC-13F.'' To determine the appropriate PPE requirements for handling activities, the table in 40 CFR 156.212(e) is used in conjunction with the acute toxicity data on the formulated product for each route of exposure listed in the table. Registrants must determine the toxicity category of the formulated product for acute dermal toxicity, skin irritation potential, eye irritation potential, and acute inhalation toxicity. If the acute toxicity data for dermal or inhalation exposure are not available, the acute oral toxicity may be used as a surrogate. (If acute toxicity data for any of these routes of exposure are not available, the toxicity category of the formulated product as a whole must be used as a substitute for each such route of exposure.) Given the toxicity category for each route of exposure, the table gives the appropriate item or items of PPE or work clothing necessary to protect that part of the body. All such items taken together comprise the basic ``outfit'' to be worn by the handler. This ``outfit,'' in the form of a list of PPE and work clothing items, is inserted into a standardized handler PPE statement (40 CFR 156.212(d)(3)). In addition to the basic handler outfit statement, statements related to exposure pattern are required for products in toxicity categories I and II (40 CFR 156.212(i)). For products that must be mixed or loaded, there must be a statement requiring the use of a chemical-resistant apron unless there is a requirement for a chemical-resistant suit (40 CFR 156.212(i)(1)). If overhead exposure is possible during handling, there must be a statement requiring the use of a wide-brimmed hat or a chemical-resistant hood (40 CFR 156.212(i)(2)). If equipment is used to mix, load, or apply the product, there must be a statement requiring the use of a chemical-resistant apron for persons who clean or repair equipment unless there is a requirement for a chemical-resistant suit (40 CFR 156.212(i)(3)). If a product is sold as a concentrate and diluted for application, registrants may submit to the Agency or cite additional acute toxicity data on the diluted product. The PPE requirements for all handlers except mixer/loaders would then be based upon the data on the product as diluted for application. The appropriate PPE and work clothing requirements for early-entry activities are the same as for applicators, except no respiratory protection device would be needed for early entry to pesticide-treated areas. In addition, the minimum PPE for early-entry activities consists of coveralls, chemical-resistant (or waterproof) gloves, shoes, and socks. The Agency reserves the right to modify the subpart K requirements for PPE and work clothing for a product at some future time. This might occur at the beginning or end of a Special Review, or on review of data showing that different requirements are warranted. d. Labeling format-- i. Language and location of labeling. Specific language for worker protection labeling statements has been employed in subpart K to facilitate registrant compliance and to eliminate unnecessary variation among gricultural product labeling. Each section of subpart K describing a required worker protection statement specifies a location on labeling for that statement. Most worker protection statements are required to be grouped near the beginning of the Directions for Use section of the product labeling under the heading Agricultural Use Requirements. General statements such as the reference to part 170 would appear first. The only statements required to appear elsewhere on labeling are the Spanish signal word and explanatory statement, which must appear close to the English signal word; the identification of the type of product (organophosphate or N-methyl carbamate), which must be associated with the product name or in the Statement of Practical Treatment (First Aid) section; identification of a fumigant, which must appear as part of or close to the product name; and the PPE statements, which must appear in the Hazards to Humans (and Domestic Animals) section of the labeling. At the discretion of the registrant, any existing worker protection statements that are not superseded or modified by subpart K may be relocated under this overall worker protection heading, unless this would reduce existing protection associated with nonagricultural uses. ii. New or amended product labeling. As of April 21, 1993, labeling submitted with applications for new or amended registration must comply with subpart K. The Agency will review and approve labeling for new products under normal Agency procedures. iii. Existing products. Registrants of products that are registered as of the effective date of subpart K and that fall within the scope of subpart K must revise their product labeling to comply with the new requirements in one of the following ways: (1) Subpart K labeling followed exactly. The Agency is specifying precise wording and exact requirements for worker protection labeling so that registrants of existing products will be able to revise product labeling more easily within the timeframes established. If a registrant certifies that the Worker Protection Standard PR Notice wording is followed exactly for a specific product, no Agency approval is required. The registrant must submit the following: (A) An Application for Amended Registration (EPA Form 8570-1). Under ``Subject of Amendment'' in section II of the application, the registrant must identify the subject of the amendment as ``WORKER PROTECTION CERTIFICATION'' and include a certification statement such as, ``All products being sold or distributed after April 21, 1994, will be in compliance with the labeling requirements of 40 CFR part 156, subpart K.'' (B) A copy of the product's revised labeling (draft or final) with the changes highlighted, preferably with a felt-tipped marker. The Agency may choose to review this labeling as a check on the correctness of the registrant's compliance with subpart K. (2) Subpart K labeling not followed exactly. If a registrant wishes to use wording different from that required by the Worker Protection Standard PR Notice, an amended registration must be [38144] approved. The registrant must submit the following: (A) An Application for Amended Registration (EPA Form 8570-1). Under ``Subject of Amendment'' in section II of the application, the registrant must identify the subject of the amendment as ``WORKER PROTECTION LABELING AMENDMENT'' and include a statement such as, ``The applicant requests the Agency to review proposed revised labeling text that differs from 40 CFR part 156, subpart K.'' (B) Five copies of the product's proposed draft labeling with the changes highlighted, preferably with a felt-tipped marker. EPA encourages registrants seeking amendments under section 3(b) to submit their applications as soon as possible after the effective date of this regulation. EPA cannot assure that these amendments to registration will be approved in time to incorporate the revised language on the labeling by the deadlines. As stated above, the Agency intends that the standard and implementing labeling statements be put in place as quickly as possible. Thus, it is unlikely that EPA will grant an extension of time merely because a special labeling amendment has been proposed. This policy does not preclude registrants from requesting special amendments to registration; registrants, however, are required to meet applicable deadlines for labeling changes regardless of the status of any special amendment to registration. iv. Where to send amended application. Applications for amended registration and other labeling must be submitted to the address listed in the Worker Protection Standard PR Notice and must be received on or before April 21, 1994. After this date, no product may be distributed or sold by the registrant (or a supplemental registrant) unless it is in compliance with the new subpart K. After October 23, 1995, all products distributed or sold by any person must bear labeling statements in compliance with the new subpart K. v. Earliest distribution or sale. Finally, it should be noted that no product with the subpart K labeling statements may be distributed or sold by a registrant prior to April 21, 1993, even though the registrant may submit certification and EPA may approve new or amended products with subpart K labeling prior to that date. vi. Failure to comply. If the items listed above, such as a certification statement, and, if applicable, the final printed labeling are not submitted on or before the date specified above, the Agency may issue a ``Notice of Intent to Cancel'' under FIFRA section 6(b). If, after a certification is reviewed, the Agency determines that the registrant has incorrectly labeled the product, the product may be deemed to be misbranded in violation of FIFRA section 12(a)(1)(E) or the Agency may issue a ``Notice of Intent to Cancel'' under FIFRA section 6(b). C. EPA Communication and Training Efforts EPA has been engaged in the promotion of pesticide safety in agriculture for many years. In the course of this program, the Agency has developed working relationships with other Federal, State, and private organizations with similar objectives. It has sponsored the production and distribution of many types of pesticide safety materials. With the promulgation of the revised Worker Protection Standard, the Agency intends to develop appropriate materials to inform pesticide users and agricultural workers of the new requirements and to facilitate compliance. 1. Product labeling. The labeling of each agricultural pesticide product subject to part 170 will indicate, by means of a reference statement, that the product must be used according to these regulations. Requirements that vary from product to product, such as restricted-entry intervals and personal protective equipment, will appear as specific labeling statements, while requirements that do not vary among products, such as provision of decontamination sites, will not be repeated in each product's labeling. 2. Development of materials. To assist agricultural employers and pesticide users in complying with the revised Worker Protection Standard, the Agency intends to develop or to cooperate in the development of new educational materials and to revise some existing educational materials. These materials may be used by agricultural employers, migrant health clinics, Cooperative Extension offices, unions, commodity organizations, and similar groups. a. Compliance materials. In addition to the promulgation of part 170 standard, the Agency intends to develop compliance guides and audiovisual compliance programs for agricultural employers and handler employers. These guides and programs will summarize and explain the regulations and will assist agricultural employers and handler employers to understand their responsibilities under part 170. b. Training programs for handlers and workers. Existing written and audiovisual training programs on pesticide safety are expected to be revised as one source of assistance to agricultural employers and handler employers in training their employees in pesticide safety. The training programs also may be used by others such as migrant health clinics, State agencies, and worker organizations to train agricultural workers and handlers. The training programs that are planned are handbooks, slides/tapes and videos in English and Spanish. They will be designed to meet the pesticide safety training requirements of the new part 170. c. Pesticide safety poster. A bilingual pesticide safety poster for agricultural workers, entitled ``Be Safe With Pesticides/Use Pesticidas Con Cuidado,'' has been developed by the Agency and has been distributed widely with the assistance of cooperating organizations. EPA plans to revise the poster and intends that display of this revised poster will fulfill the pesticide safety poster requirement of part 170. d. Guidelines on the selection and use of personal protective equipment (PPE). Numerous comments from the public addressed the need for more information and guidance on the selection, use, and maintenance of PPE, including the avoidance of heat stress. The Agency has developed informational materials to provide guidance to pesticide users on these topics. The Agency also intends to develop guidance documents on cholinesterase monitoring to assist employers who have or want to have such a program. 3. Liaison with other agencies and organizations. In the past, EPA has had the assistance of a number of governmental agencies, farmworker service organizations, and trade associations in communicating with the agricultural community. The Agency will continue to work with these groups to inform affected persons of their rights and responsibilities under the revised standard, to assist in the reproduction and distribution of educational materials developed by the Agency and to encourage compliance on the part of their members and clients. D. National Compliance Monitoring Strategy The Agency's approach to enforcement of the Worker Protection Standard will be based on development of a National Compliance Monitoring Strategy for worker protection. Pesticide use enforcement under FIFRA is dependent upon two broad authorities, the authority to regulate the distribution and sale of pesticides and the authority to require that registered pesticides be used according to their labeling. In most States, enforcement is [38145] by State regulatory agencies through Cooperative Enforcement Agreements with EPA. EPA intends to assure enforcement of part 170 primarily through these agreements. The National Compliance Monitoring Strategy will be developed in partnership with the State regulatory agencies and will guide all enforcement activities related to this regulation. To achieve maximum compliance, the Agency plans a major communication effort to inform the regulated community of the new requirements. The registrant of a pesticide product subject to part 170 will be governed by the timeframes for product relabeling laid out above. Once a relabeled product is used, it must be used in accordance with its labeling or the user will be in violation of FIFRA section 12(a)(2)(G). The product will bear a reference statement notifying the user that the product must be used in accordance with part 170. The relationship between State and Federal entities in the enforcement of pesticide use regulations is governed by FIFRA section 26(a). With the exception of Nebraska, Wyoming, and (in part) Colorado, all States have primary use enforcement authority and have entered into Cooperative Enforcement Agreements with EPA. EPA regional offices annually negotiate the terms of these agreements with State regulatory agencies. Starting in fiscal year 1990, these agreements have included a specific section on worker protection enforcement activities. EPA expects that individual State compliance monitoring strategies will be developed once the National Compliance Monitoring Strategy is completed. These strategies will describe inspection and complaint response schemes and compliance communication activities to be conducted in each State. Development of interagency coordination agreements among various State agencies concerned with pesticide use and worker safety may be part of each State's strategy. EPA also anticipates that registrant compliance with worker-protection-related registration requirements will be monitored through activities agreed upon under Cooperative Enforcement Agreements. Toward the accomplishment of these goals, money has been allocated to the States in EPA's budget for fiscal years 1990, 1991, and 1992 for the development of worker protection programs and related compliance activities. In States where Cooperative Enforcement Agreements are not in place, EPA regional inspectors will conduct compliance monitoring programs based on the National Compliance Monitoring Strategy for this regulation. VII. Public Docket Documents relied upon by the Agency in the development of this final rule, including public comments submitted on the proposed rule, have been given the document control number OPP-300164A and are available for public inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays, at the Office of Pesticide Programs' Document Control Office, Rm. 1132, CM 1B2, 1921 Jefferson Davis Highway, Arlington, VA. VIII. Regulatory Requirements A. Executive Order 12291 Under Executive Order 12291, a Regulatory Impact Analysis (RIA) has been developed and has been submitted to the Office of Management and Budget (OMB). This document is available for public inspection at the address given at the beginning of this Notice. A summary of the document follows. EPA believes that the benefits that will accrue to agricultural workers and handlers from implementation of the WPS include the reduction in lost time from the workforce, reduced medical expenses, and increased well-being and productivity through being less affected by pesticide poisoning. These and any related benefits cannot be adequately quantified with available data. The Agency is convinced that the benefits to society from avoided incidents of acute, allergic, and delayed adverse effects from occupational exposures to agricultural-plant pesticides exceed the costs attributable to this final rule. The final rule would serve to protect a labor force of 3.9 million exposed either directly or indirectly to pesticides as a result of their occupations on farms, in forests, in nurseries, in greenhouses, or in commercial pesticide-handling operations. This work force includes 1.4 million hired workers and handlers on farms, 92,000 hired workers and handlers in nurseries and greenhouses, and 10,000 hired workers and handlers in forests. There are also 38,000 commercial handlers who handle agricultural-plant pesticides. In addition, 2.36 million agricultural-establishment operators and unpaid workers (presumably family members) handle agricultural-plant pesticides or perform tasks related to the production of agricultural plants on farms, nurseries, and greenhouses. EPA estimates that the incremental costs of this final rule will be about $95 million in the first year and about $50 million annually thereafter. To facilitate comparison with other regulations, EPA has also calculated the incremental costs by annualizing them over 10 years at several illustrative interest rates. Using 3% and 10%, the annualized costs of this final rule would be about $54 and $56 million per year respectively. The annual cost of the rule is therefore expected to be $50 to $60 million dollars, while the estimated annual benefits of this final rule include avoiding 8,000 to 16,000 physician-diagnosed (nonhospitalized) acute and allergic pesticide poisoning incidents, avoiding about 300 hospitalized acute and allergic pesticide poisoning incidents, and avoiding potentially important numbers of cancer cases, serious developmental defects, stillbirths, persistent neurotoxic effects, and nondiagnosed acute and allergic poisoning incidents. B. Regulatory Flexibility Act This final rule has been reviewed under the Regulatory Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164; 5 U.S.C. 601-612) for its impact on small businesses. The results of that review have been incorporated into the Regulatory Impact Analysis and are discussed in more detail in that document (available for public inspection at the address listed at the beginning of this Notice). A summary follows. 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. As a result, the analysis reveals that agricultural establishments without hired labor will bear a low cost-burden as compared to agricultural establishments with hired labor. The incremental continuing annual costs averaged across all establishments without hired labor are about $15 per establishment, whereas the costs averaged across all hired-labor agricultural establishments are about $140 per establishment per year. Non-hired-labor feed and grain farms, which make up the largest crop segment, will incur incremental continuing annual [38146] costs averaging about $10 per farm. Hired-labor feed and grain farms will incur incremental continuing annual costs averaging about $55 per farm. None of the provisions of the regulation provide a direct efficiency of size to establishments with many employees. Most of the provisions are totally or mostly variable (per worker) costs. However, two provisions that contain some fixed (per establishment) cost elements are training and notification. Even these provisions are not directly efficiency-of-size cost factors, due to: (1) The diverse and sporadic nature of pesticide-use and labor-use practices, and (2) the exceptions and options in the rule that allow employers to select the most cost-effective option for their particular circumstance. The variability in the cost-factors due to these exceptions and options is difficult to quantify. Therefore, the analysis of the impact on 1-worker agricultural establishments versus the impact on 10-worker agricultural establishments is a ``worst-case'' analysis that assumes that all costs of training and notification are fixed rather than variable. This results in an overestimate of the impact of this rule to 1-worker agricultural establishments. However, even with the overestimate, results indicate that the burden is not unreasonably higher for such small establishments. The average incremental continuing annual cost due to all provisions for a feed and grain farm with one hired employee is about $25 (or $25 per employee). For a feed and grain farm with 10 hired employees, it is about $115 per year (or $10 per employee). For vegetable/fruit/nut establishments with one hired employee, the average incremental continuing annual cost for all provisions is about $95 per establishment (or $95 per employee). The cost is about $650 (or $65 per employee) for a vegetable/fruit/nut establishment with 10 hired employees. The Agency has determined that the burden on small agricultural businesses does not outweigh the risk to handlers and workers employed in those businesses, and that further exemptions from the regulation for small businesses would not be warranted. C. Paperwork Reduction Act The information collection requirements contained in this rule have been approved by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and have been assigned OMB Control Number 2070-0060. The reporting burden for registrants is estimated to average 5.9 hours per product, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM-223, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460 and to the Office of Management and Budget, Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''