[Federal Register Volume 59, Number 29 (Friday, February 11, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-2969] [[Page Unknown]] [Federal Register: February 11, 1994] _______________________________________________________________________ Part IV Environmental Protection Agency _______________________________________________________________________ 40 CFR Parts 156 and 165 Standards for Pesticide Containers and Containment; Proposed Rules ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 156 and 165 [OPP-190001; FRL-4168-9] RIN 2070-AB95 Standards for Pesticide Containers and Containment AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed Rule. ----------------------------------------------------------------------- SUMMARY: Pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act, EPA is proposing container design requirements for nonrefillable and refillable pesticide containers. EPA is also proposing procedures, standards, and label language to facilitate removal of pesticides from containers prior to disposal. Additionally, this proposal includes standards for containment of bulk pesticide containers and procedures for container refilling operations. These proposed regulations are necessary to implement statutory authority requiring EPA to develop regulations for the safe storage and disposal of pesticides. Also, preliminary issues related to EPA's development of effluent limitations guidelines and standards for the pesticide formulating, packaging, and repackaging industrial category under the Clean Water Act are summarized. DATES: Comments on the proposed rule must be received by EPA on or before May 12, 1994. ADDRESSES: Submit written comments on the proposed rule, bearing the document identification number OPP-190001, by mail to: Public Docket and Freedom of Information Section, Field Operations Division (7506C), Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Deliver comments in person to: Public Docket and Freedom of Information Section, Field Operations Division (7506C), Office of Pesticide Programs, U.S. Environmental Protection Agency, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. Information submitted in any comment concerning the proposal may be claimed as confidential by marking any or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice to the submitter. Comments will be available for public inspection in Room 1132 at the address given above, from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays. FOR FURTHER INFORMATION CONTACT: By mail for the proposed Standards for Pesticide Containers and Containment: Janice Jensen, Pesticide Management and Disposal Staff, Office of Pesticide Programs (7507C), U.S. Environmental Protection Agency, 401 M St. SW., Washington, DC 20460, (703) 305-5288. By mail for the effluent limitations guidelines and standards for the pesticide formulating, packaging, and repackaging (PFP) industrial category: Ms. Janet K. Goodwin, Engineering Analysis Division (4303), U.S. Environmental Protection Agency, Washington, DC 20460, (202) 260-7152. SUPPLEMENTARY INFORMATION: The contents of today's preamble are listed in the following outline: I. Statutory Authority II. Background A. Overview of Amended FIFRA Section 19 B. Phased Implementation of Section 19 C. Container Design, Residue Removal, and Labeling D. The Container Regulations and their Relationship with the Pollution Prevention Act E. Today's Proposal III. Definitions A. Definition of Container B. Definitions for Nonrefillable Container Standards: Container Design and Residue Removal C. Definitions for Refillable Container Standards: Container Design and Residue Removal D. Definitions for Standards for Pesticide Containment Structures IV. Nonrefillable Container Standards: Container Design and Residue Removal A. Background B. Today's Proposal V. Refillable Container Standards: Container Design and Residue Removal A. Background B. Today's Proposal VI. Standards for Pesticide Containment Structures A. Background B. Today's Proposal VII. Labeling Requirements for Pesticides and Devices A. Background B. Today's Proposal VIII. Upcoming Effluent Limitations Guidelines for Pesticide Formulators, Packagers, and Repackagers A. Purpose B. Applicability C. Background D. Expected Approach E. Pollution Prevention F. Schedule IX. Relationship to Other Programs A. Resource Conservation and Recovery Act (RCRA) B. Spill Prevention, Control, and Countermeasures (SPCC) C. Occupational Safety and Health Administration (OSHA) Requirements D. Department of Transportation (DOT) Hazardous Materials Regulations X. Statutory Review Requirements XI. Public Docket XII. References XIII. Regulatory Assessment Requirements A. Executive Order 12291 B. Regulatory Flexibility Act C. Paperwork Reduction Act I. Statutory Authority These proposed rules are issued pursuant to the authority given the Administrator of EPA in sections 3, 8, 19, and 25 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act), 7 U.S.C. 136a, 136f, 136q, and 136w. II. Background FIFRA is the law that authorizes EPA to regulate the sale, distribution, use, and disposal of pesticides in the United States. The Act requires that EPA license by registration (or specifically exempt from registration) each pesticide product sold or distributed in the United States, to ensure that pesticide products will not cause ``unreasonable adverse effects on the environment.'' The term ``unreasonable adverse effects on the environment'' is defined in FIFRA section 2(bb) to mean ``any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.'' As part of registration, EPA requires the submission of data demonstrating that the product will not cause unreasonable adverse effects on the environment. Moreover, EPA reviews and approves the labeling of each product proposed for registration. The labeling is a fundamental tool for enforcement of pesticide use. FIFRA section 12(a)(2)(G) provides that it is unlawful to use a pesticide in a manner inconsistent with its labeling (commonly called the ``misuse'' provision). Currently 40 CFR 156.10(i)(2)(ix) requires storage and disposal statements on pesticide labeling. A. Overview of Amended FIFRA Section 19 Section 19 of FIFRA was amended in 1988, significantly expanding and strengthening EPA's authority in the areas of pesticide storage, disposal and transportation. Among other things, that section of the Act authorizes the Administrator, in conjunction with the registration or reregistration of a pesticide, to establish: (1) Data requirements to determine methods of safe storage and disposal of pesticides [FIFRA sec. 19(a)(1)(A)]. (2) Labeling requirements for the storage, transportation, and disposal of pesticides, excess pesticides, rinsates, and containers [FIFRA sec. 19(a)(1)(B)]. Suspended and canceled pesticides were targeted in the amended Act for specific attention, and EPA was given broad discretionary authority to prescribe storage, transportation, and disposal requirements by order or by regulation. Under FIFRA section 19(b), EPA may require the recall of suspended and canceled pesticides, through either a ``voluntary recall'' by order of the Administrator, or a ``mandatory recall'' implemented by regulation. Section 19(c) establishes a scheme for sharing costs for storing suspended and canceled pesticides with the intent of providing incentives to the manufacturer to expedite safe disposal of the materials. On May 5, 1993 (Ref. 87), EPA proposed regulations covering: (1) Voluntary and mandatory recall plans [FIFRA sec. 19(b)]. (2) Storage and disposal plans; reimbursement of storage costs [FIFRA sec. 19(c)]. (3) Indemnification, which covers financial losses suffered by end users as a result of suspension and cancellation of a pesticide product [FIFRA sec. 15]. Further, section 19 not only authorizes, but mandates the issuance of regulations in two areas of particular concern: (1) Pesticide container design standards [FIFRA sec. 19(e)]. (2) Residue removal standards and procedures [FIFRA sec. 19(f)]. Section 12(a)(2)(S) makes it unlawful to violate any regulation issued under section 19. B. Phased Implementation of Section 19 The preceding summary illustrates the variety of subjects addressed by FIFRA section 19. Because of this variety, EPA is implementing FIFRA section 19 provisions in phases. Phase I of these regulations, addresses the procedural provisions of recall, indemnification of end users, and storage and disposal plans for suspended and canceled pesticides. Today's Phase II proposal addresses the container design and residue removal provisions, as well as associated pesticide labeling requirements necessary to container design and residue removal implementation. In addition, Phase II addresses containment provisions for container refilling operations and refillable bulk containers. In Phase III, EPA plans to address section 19 provisions on data requirements, additional containment concerns, and storage, disposal, and transportation of registered pesticides. C. Container Design, Residue Removal, and Labeling FIFRA sections 19(e) and (f) grant EPA broad authority to establish standards and procedures to assure the safe use, reuse, storage and disposal of pesticide containers. FIFRA section 19(e) requires EPA to promulgate regulations no later than 3 years after the effective date of section 19(e) (by December 24, 1991) for ``the design of pesticide containers that will promote the safe storage and disposal of pesticides.'' The regulations must ensure, to the fullest extent practicable, that the containers: (1) Accommodate procedures used for removal of pesticides from the containers and rinsing of the containers. (2) Facilitate safe use of the containers, including elimination of splash and leakage. (3) Facilitate safe disposal of the containers. (4) Facilitate safe refill and reuse of the containers. EPA must require compliance with regulations issued under section 19(e) no later than 5 years after the effective date of section 19(e) (by December 24, 1993). FIFRA section 19(f) requires EPA to promulgate regulations no later than December 24, 1991 ``prescribing procedures and standards for the removal of pesticides from containers prior to disposal.'' The regulations may: (1) Specify, for each major type of pesticide container, procedures and standards providing for, at a minimum, triple rinsing or the equivalent degree of pesticide removal. (2) Specify procedures that can be implemented promptly and easily in various circumstances and conditions. (3) Provide for reusing, whenever practicable, or disposing of rinse water and residue. (4) Coordinate with requirements imposed under the Resource Conservation and Recovery Act (RCRA) for rinsing containers. Section 19(f) provides that EPA, in its discretion, may exempt products intended solely for household use. The underlying concern of these provisions is to provide appropriate safeguards for activities or processes involving pesticide containers when these activities fall outside the scope of application activities that are addressed through labeling. Therefore, EPA construes the terms ``storage'' and ``disposal'' in the above provisions broadly, to include activities (such as repackaging) that affect the safe storage and disposal of pesticide containers. This broad interpretation is consistent with the legislative history of section 19 that indicates Congress' intent that ``disposal of pesticides include preparation for disposal such processes as packaging, repackaging, recycling, and decanning of pesticide ingredients required to store or dispose of pesticides safely'' (Ref. 81). In addition to the specific authorities in FIFRA sections 19(e) and (f), other FIFRA provisions provide EPA with authority relevant to regulating pesticide containers: (1) Section 19(a)(1)(B) authorizes EPA to require that pesticide labeling contain requirements and procedures for the transportation, storage, and disposal of the pesticide, its container, rinsate, and any material used to contain excess pesticides. (2) Section 19(a)(3) authorizes regulations governing, among other things, storage, transportation, and disposal of containers of a pesticide whose registration has been suspended or canceled. (3) Section 3 provides for registration of pesticides. (4) Section 8 requires producers, registrants, and applicants for registration to keep records. (5) Section 25 provides general regulatory authority. Today's proposal is issued pursuant to the above authorities and implements the mandates in sections 19(e) and (f). Three new subparts to 40 CFR part 165 would be created to implement the statutory mandates in sections 19(e) and (f): subpart F (nonrefillable container standards: container design and residue removal), subpart G (refillable container standards: container design and residue removal), and subpart H (standards for pesticide containment structures). The regulations in 40 CFR part 156 (labeling requirements) would be amended to require new residue removal instructions. In developing this proposed rule, EPA has tended to favor the use of performance-based standards rather than design-specific criteria. Performance-based standards are preferred because they allow for greater flexibility in meeting requirements and can accommodate changes in technology. Specifically, proposed subpart F would establish requirements under sections 19(e) and (f) for nonrefillable containers. The regulations would facilitate safe use and disposal of these containers through requirements relating to container integrity, elimination of leaks and drips during use, and permanent marking of essential information on the container. In addition, the regulations would facilitate the safe use of certain rigid containers by requiring standardized closures to encourage use of closed pesticide dispensing systems. Subpart F also would require that rigid containers used with dilutable (i.e., allowed by the label to be diluted prior to application) pesticides be tested to assure that pesticide residues can be removed from these containers. These residue removal requirements assure that containers accommodate residue removal procedures in a way that promotes safe storage and disposal. To facilitate safe use, disposal, refill, and reuse of the containers, subpart G would establish standards for refillable containers including container integrity and permanent marking. Subpart G also would implement sections 19(e) and (f) by including procedures for removal of pesticide residue from refillable containers, and refilling such containers. These residue removal and refilling procedures would promote safe storage and disposal of pesticides. Proposed subpart H would establish standards for containment of container refilling operations and stationary bulk pesticide containers. The design and operating requirements for bulk containers and containment structures (pads and secondary containment) would promote safe storage by facilitating the safe use, refill, and reuse of these containers. Subpart H would address the concerns underlying sections 19(e) and (f) by providing appropriate controls for activities and processes involving container refill and residue removal that will assure safe storage and disposal. The proposed amendments to 40 CFR part 156 would require that the labeling of dilutable pesticides in rigid nonrefillable containers include specified residue removal instructions, in accordance with the direction in section 19(f) to prescribe residue removal standards. With the exception of the requirements outlined in the preceding paragraph, this proposal would not require registrants to incorporate the proposed requirements into the labeling of pesticide products. EPA recognizes, however, that the pesticide labeling system is generally viewed by the public as the definitive source of regulatory requirements for pesticides. EPA therefore requests comment on whether some or all of the proposed requirements should be referenced by label, including the option of referencing the regulation on the labeling as was done with the Worker Protection Standards published August 21, 1992 (Ref. 92). Additionally, EPA is proposing minor conforming changes to 40 CFR part 165 to reflect the requirements of this proposal. The rule would remove outdated or unnecessary definitions from Sec. 165.1, revise or remove outdated or duplicative material in Sec. 165.2 and Sec. 165.11, and redesignate and transfer the current part 165 regulations into subpart A of part 165. EPA has specified compliance dates in this rulemaking and requests public comment on these proposed compliance dates. Due to the delay in promulgating this rule, the statutory time for compliance under FIFRA section 19(e)(2) (i.e., the 2-year period between December 1991 and December 1993) will not be directly applicable to the final rule. Accordingly, as further specified later in this preamble, EPA is proposing compliance dates which EPA believes are reasonable and reflect the statutory time frames which Congress intended to apply. Similarly, FIFRA section 19(f)(2) sets December 24, 1993 as the deadline for the State programs to ensure compliance with section 19(f). Section 19(f)(2) provides that a State must be carrying out an adequate program to ensure compliance with section 19(f) by December 24, 1993 in order for the State to continue to exercise its primary enforcement authority under section 26, or its certification authority under section 11. Since EPA has not yet promulgated final regulations under section 19(f), EPA recently published a policy statement setting forth criteria for determining, on an interim basis, the adequacy of State programs and a process for States to obtain EPA's interim determination of adequacy (Ref. 86). EPA will make an interim determination of adequacy based on an initial written commitment by a State to conduct several activities that will enable a State to develop an adequate program for assuring compliance with the final rule. EPA will announce in the Federal Register its interim determination of adequacy for the States who submit a written commitment. EPA solicits comments and data on all aspects of the proposed rule, including comments on the alternatives discussed in the preamble, and recommendations (supported by data where appropriate) on alternatives not specifically discussed in the preamble that would improve the proposal and achieve the goals of this rulemaking. Where appropriate, EPA may adopt options other than those included in the regulatory text, based on information submitted by commenters. D. The Container Regulations and their Relationship with the Pollution Prevention Act Congressional passage of the Pollution Prevention Act of 1990 1 (PPA) makes pollution prevention national policy. Section 6602(b) (42 U.S.C. 13101(b)) identifies an environmental management hierarchy in which pollution should be prevented or reduced whenever feasible; pollution that cannot be prevented should be recycled in an environmentally safe manner, whenever feasible; pollution that cannot be prevented or recycled should be treated in an environmentally safe manner whenever feasible; and disposal or other release into the environment should be employed only as a last resort. --------------------------------------------------------------------------- \1\Enacted as Public Law 101-508, sections 6601 through 6611; codified as 42 U.S.C. secs. 13101 et seq. --------------------------------------------------------------------------- In short, preventing pollution before it is created is preferable to trying to manage, treat, or dispose of it after it is created. According to PPA section 6603(5), source reduction reduces the generation and release of hazardous substances, pollutants, wastes, contaminants, or residuals at the source, usually within a process. The term includes equipment or technology modifications, process or procedure modifications, reformulation or redesign of products, substitution of raw materials, and improvements in housekeeping, maintenance, training, or inventory control. Source reduction does not include any practice that alters the physical, chemical, or biological characteristics or the volume of a hazardous substance, pollutant or contaminant through a process or activity that is not integral to or necessary for producing a product or providing a service. Although the PPA focuses largely on industrial pollution prevention, EPA is also bringing to bear the concept of pollution prevention or source reduction in other sectors of economic activity. As EPA's Pollution Prevention Strategy explains, pollution prevention in agriculture can be the ``development and adoption of low input sustainable agricultural practices that eliminate the wasteful use of inputs, such as fertilizers, pesticides, and water,'' and ``soil conservation and land management practices that prevent erosion of sediment and runoff of pesticides and fertilizers'' (Ref. 98). Pertaining to this proposal, section 6604(b)(2) (42 U.S.C. 13103(b)(2)) of the PPA directs EPA to, among other things, ``review regulations of the Agency prior and subsequent to their proposal to determine their effect on source reduction.'' EPA believes that this proposed rule is consistent with the purpose of the PPA's requirement to consider source reduction. EPA's emphasis on source reduction and on evaluating rules in light of the environmental management hierarchy is also entirely consistent with congressional directives in FIFRA section 19. In amending FIFRA in 1988, Congress clearly intended to move the management of pesticide storage, transportation, and disposal further up the environmental management hierarchy toward source reduction. In the context of pesticide containers, EPA believes application of the environmental management hierarchy has several specific characteristics: (1) Improving the design of pesticide containers and enhancing integrity (Sec. 165.102), and facilitating the removal of residues from those containers (Sec. 165.104). (2) Encouraging efficient transfer operations (Sec. Sec. 165.102(b), (d) and (e)) to increase the amount of pesticide reaching the intended target, thereby reducing waste and unwanted environmental releases. (3) Increasing the efficiency of cleaning operations (Sec. 165.104(a) and (b)) to reduce wastes and releases resulting from cleaning. (4) Improving practices of storing pesticides in bulk containers and transferring the pesticides from bulk containers into refillable containers to reduce potential releases of pesticides during storage (Sec. 165.146). (5) Encouraging, whenever feasible, increased use of refillable containers (Sec. Sec. 165.120 through 165.139) to reduce the number of containers needing disposal, and reduce (Sec. 165.130(b)(1) and Sec. 165.134(g)) the pesticide residues commingled with those containers. (6) Reducing worker exposure during handling by encouraging the use of closed pesticide dispensing systems (Sec. 165.102(e)). EPA recognizes that source reduction in the context of pesticides and agriculture generally has other important components. These include improving efficiency in pesticide production and formulating processes, improving application efficiencies, encouraging integrated pest management and low input sustainable agricultural practices, and encouraging the use of safer pesticides when pesticides are necessary. Currently, EPA is pursuing efforts in each of these other areas. For example, see EPA's Notice of Proposed Rule Making (NPRM) on Effluent Guidelines for the Pesticide Manufacturing Industry (Ref. 97), and the Notice relating to Clean Water Act Effluent Limitations Guidelines and Standards for the Pesticide Formulating, Packaging, and Repackaging industrial subcategory included in this preamble in Unit VIII. See also EPA's Notice in the Federal Register on the policy for reduced risk pesticides (Ref. 89). In requesting comment on today's proposal, EPA seeks comment on whether this rule adequately moves pesticide handling ``up'' the environmental management hierarchy set out in PPA section 6602(b), specifically to encourage source reduction, and if there are other options EPA could pursue to further these efforts. E. Today's Proposal EPA examined the problems associated with using and handling containers prior to developing these regulations. Many of the findings may be found in ``Pesticide Containers: A Report to Congress'' (Ref. 65), cited in this preamble as the Report to Congress and ``State of the States: Pesticide Storage and Disposal'' (Ref. 70), cited in this preamble as the State of the States Report. This section gives a brief overview of current pesticide container types and handling practices in order to give the reader an understanding of the scope and nature of container use and handling problems. 1. Numbers of containers. The Report to Congress reported that an estimated 223 million pesticide containers were manufactured in 1986, 90 million of which held agricultural pesticides. This was probably a substantial underestimate, since a 1988 survey conducted by the pesticide industry estimated that 233 million pesticide aerosol containers alone were manufactured that year, more than the previous estimate for the total number of pesticide containers in 1986. A more thorough examination of the diversity of pesticide industries, pesticide formulations, and container types and numbers can be found in the Report to Congress and the regulatory impact analysis for the container design and residue removal regulations (Ref. 67). 2. Types of pesticide containers. Pesticide containers are made from a variety of materials, including stainless steel; several types of plastic, including linear high density polyethylene, low density polyethylene, and cross-linked high density polyethylene; polyvinyl alcohol, in the form of water-soluble packaging; glass; paper; cardboard; aluminum; and various combinations of materials, including teflon, fiberglass, and foil. Pesticides are sold in two general types of containers. Containers not intended for refill or reuse are by far the most commonly used container type. This proposal refers to these containers as ``nonrefillable containers'' (the definition of ``nonrefillable container'' proposed in these regulations is discussed later in this preamble). Containers intended for refill and reuse are used predominantly in the agricultural market, with some applications in industrial and institutional markets, and generally are used to sell and distribute pesticides in larger quantities. This proposal refers to these containers as ``refillable containers'' (``refillable container'' is discussed in Unit III of the preamble and defined in proposed Sec. 165.3). 3. Life-cycle of pesticides and containers. The life-cycle of pesticides sold and distributed in nonrefillable containers differs from that of refillable containers. Pesticides sold in nonrefillable containers pass through the distribution chain, which varies according to the market, until they are purchased by the end user. The end user is generally solely responsible for opening the container, dispensing the pesticide, removing the pesticide residue from the container (``cleaning'' the container), and disposing of the container, rinsates, and excess pesticide. Pesticides sold in refillable containers have a different life- cycle. These pesticides are not prepackaged; rather, they are generally distributed in large, undivided quantities to dealers and retailers, then dispensed into refillable containers, and sold to the end user. The refillable container is returned to a dealer repeatedly for refilling. The sale and distribution of pesticide in this manner, in bulk form, is similar to the way that gasoline is sold. Refillable containers may be owned by registrants, dealers, farmers, and other users. In the mid-1980s, several registrants began providing end users with inexpensive (approximately $50) refillable containers or ``minibulks'' in order to encourage their use. As discussed in Unit III of the preamble and defined in Sec. 165.3, EPA is proposing to define ``minibulk'' and ``bulk'' refillable containers into specific size categories. As documented in the Report to Congress (Ref. 65), registrants and other producing establishments, however, are finding these containers problematic, partly because they do not have much control over the farmer-owned containers, and partly because these containers are not particularly durable. The current trend is toward more durable and better-designed containers that are owned by the registrant. These more durable containers cost an average of about $300. A producing establishment will typically have from 1 to 10 larger stationary refillable containers, ranging from 500 gallons to 12,000 gallons, from which a pesticide is dispensed into smaller refillable containers. 4. Pesticide container integrity. As discussed in the Report to Congress (Ref. 65), the integrity of any container may be compromised if the container is constructed of materials that are not compatible with the pesticide, if the container's design is faulty, if the container is handled inappropriately or if it is stored under adverse conditions. For example, the walls of containers may weaken because of an interaction between the solvent and the container's material of construction. When stored outside, sunlight can cause photodegradation of the resins in plastic containers. Container fixtures (e.g., hoses, valves, sight gauges) may weaken and break at the point where they attach to the container, especially if the container is plastic and the fixtures are metal. The stresses induced from minor collisions with service vehicles, forklifts, and even stresses from normal handling have caused weakened containers to leak and even burst. 5. Spills and leaks from containers. There are many activities related to container handling that present a potential for exposing an end user to pesticides and/or releasing pesticides into the environment. These problems can occur throughout all phases of container handling, including opening, dispensing, and closing or resealing. Certain container design features, such as the position of handles and openings and the size of the openings, promote spilling and leaking through splashing and dripping. The use of closed systems can reduce spills, leaks, and applicator exposure. Although closed systems are becoming more common, the wide variety of container opening sizes and designs has restricted the expansion of their use. Some end users resort to jury-rigging or altering the closed systems to fit the container, with spillage and leakage resulting from unsuccessful attempts. Refillable containers are intended for frequent refill and reuse, and can reduce the number of containers requiring disposal. Unfortunately, spills and leaks can occur throughout all phases of handling minibulk and bulk containers, including cleaning, filling, transportation, dispensing and storage. In the State of the States Report (Ref. 70), several States have reported that costly cleanups have been required at pesticide facilities as a result of fire, failure of refillable containers, and persistent leaking and spilling of pesticides at one place over time. Even in light of potential liability concerns, a significant number of pesticide dealers have not yet placed their larger refillable containers in protective dikes or secondary containment structures. 6. Residue removal from containers. Removing pesticide residue after emptying a nonrefillable container is necessary to minimize human health and environmental risks, and prepare containers for recycling or disposal. Pesticide containers that contain residues, if disposed of improperly, present potential risks to humans and the environment through contamination of surface and groundwater, direct contact by humans (such as trash handlers) and animals, runoff and leaching into sensitive habitats from contaminated soil, contamination of landfills, and other means. In addition, acceptance of empty containers by pesticide recycling programs is highly dependent on the cleanliness of the container. Container design characteristics may interfere with the removal of pesticide residues from the container during the cleaning procedure (residue removal). For example, pesticide can be trapped in the seams along the top, bottom, and sides of the container, as well as in hollow handles and threading in the container's opening. Pesticide may also be adsorbed to the interior walls of the container or absorbed in various amounts into the container material itself. 7. Current residue removal label language. Label directions on storage and disposal, which encompass residue removal, are addressed in 40 CFR 156.10(i)(2)(ix). Today's proposal would add additional requirements to this provision (see Unit VII of this preamble). III. Definitions EPA is proposing to revise the definitions in 40 CFR part 165 by removing a number of the definitions that are outdated or not used in the regulations, by revising some existing definitions, and by adding a number of new terms. The definitions now used in 40 CFR part 167 for ``produce,'' ``producer,'' and ``establishment'' would be included in part 165. In addition, the definitions set forth below, when used in part 165, would have the meanings as explained. Although many of these terms are used in more than one of the proposed subparts, the discussion below is organized according to the subpart that uses the term most extensively. A. Definition of Container EPA proposes to retain the definition of ``container'' that is currently in the 40 CFR part 165 regulations and recommended procedures. This definition would ensure consistency with the existing guidelines on storage and disposal that also will be retained in part 165. The following language would also be added to the definition of container: ``Containers that are used to sell or distribute a pesticide product and that are also spray applicator tanks are considered to be containers for the purposes of this part.'' Vessels that are used to sell or distribute a product and that are also attached to the application equipment, for example, the ``Lock and Load'' system or small volume returnable containers that are a part of a direct injection system, would be considered containers. This language would be added to assure that if these types of equipment are used as containers, they would be regulated as such under section 19. EPA requests comment on whether the definition of ``container'' for purposes of FIFRA section 19 should be broadened to accommodate the containment provisions included in this proposal in light of the new, broader authority granted by Congress in the revisions to section 19. In particular, should the definition of container be expanded to include the secondary containment structure? B. Definitions for Nonrefillable Container Standards: Container Design and Residue Removal EPA proposes that ``nonrefillable container'' be defined as a container that is designed and constructed for one-time filling only. A nonrefillable container cannot be reused or refilled. EPA intends that this definition include, but not be limited to, containers used for the following pesticide products: baits, traps, collars, and bars. The proposed definition of ``agricultural pesticide'' (also used in the other proposed subparts) would apply to pesticides that are labeled for use sites described in the definition of ``agricultural commodity'' [Sec. 171.2(a)(5)] as follows: ``The term 'agricultural commodity' means any plant, or part thereof, or animal, or animal product, produced by a person (including farmers, ranchers, vineyardists, plant propagators, Christmas tree growers, aquaculturists, floriculturists, orchardists, foresters, or other comparable persons) primarily for sale, consumption, propagation, or other use by man or animals.'' The term ``agricultural pesticide'' would also apply to pesticides intended for use in a nursery or greenhouse, in order to more fully include pesticide use sectors that currently use closed systems. EPA intends the proposed definition to include general and restricted use pesticides. A modification of the existing definition of ``triple rinse'' and a new definition of ``pressure rinse'' are proposed in order to better describe the triple and pressure rinsing procedures that are proposed in the amendments to 40 CFR part 156. C. Definitions for Refillable Container Standards: Container Design and Residue Removal The proposed definition of ``design type'' is intended to clarify what constitutes a different container design and applies to both refillable and nonrefillable containers. If any of the parameters listed for defining the design type are different between two containers, the containers would have different designs. This is important in terms of whether a container would need to be tested. The definition of design type is based on the definitions of packaging design type and intermediate bulk container (IBC) design type in the United Nations Recommendations on the Transport of Dangerous Goods (U.N. Recommendations) and the U.S. Department of Transportation (DOT) definition of ``different packaging'' in HM-181 [performance-oriented packaging standards for the Hazardous Materials Regulations] (Refs. 82 and 83). In section 9.7.1.2 of the U.N. Recommendations (Ref. 76), ``a packaging design type is defined by the design, size, material and thickness, manner of construction and packing, but may include various surface treatments. It also includes packagings which differ from the design type only in their lesser design height.'' The definition of IBC design type in section 16.1.4.2.1 is similar. DOT regulations, 49 CFR 178.601(c)(4), state, in part, that: A different packaging is one that differs (i.e. is not identical) from a previously produced packaging in structural design, size, material of construction, wall thickness or manner of construction, but does not include: (i) a packaging which differs only in surface treatment; ...; (iii) A plastic packaging which differs only with regard to additives ...; (v) Packagings which differ from the design type only in their lesser design height. EPA is proposing to adopt a combination of the criteria in the DOT description of different packaging to define a design type. Specifically, Sec. 165.3 would specify that a container design type is defined by certain parameters: structural design, size, material of construction, wall thickness, manner of construction, and, for refillable containers as appropriate, pump fittings. With several exceptions, a change in any one of these parameters would constitute a different design type. The exceptions are that containers with various surface treatments and containers that differ only in their lesser design height may be included in one design type. The term ``structural design'' as used by DOT refers to the general shape and appearance of a container, e.g., cylindrical or cubical, as well as any recessed areas or otherwise distinctive features of the container. ``Manner of construction'' refers to the way the container is made and would distinguish, for example, between plastic containers that are blow molded and those that are rotationally molded. EPA is proposing to add pump fittings to the list of critical parameters, because EPA believes this design feature may have a significant impact on the drop test performance of a container. As an example, a minibulk container design type is characterized by its structural design, size, material of construction, surface treatment, wall thickness, manner of construction, and pump fittings. If any one of these design parameters is different when comparing two containers (except design height or surface treatment), the containers would be considered to be different design types and each container design type would have to be drop tested in accordance with Sec. 165.124(d). The use of ``one-way valves'' is intended to prevent unauthorized persons from placing material into a refillable container. EPA requests comment on whether the definition of one-way valve proposed in Sec. 165.3 is adequate to describe the technology necessary to prevent a person from inserting a substance into a container through that valve. In this proposed rule, a ``refillable container'' is defined as ``a container that is intended to be filled with pesticide more than once.'' A container would be ``intended to be filled with pesticide more than once'' if it is on a registrant's list of acceptable refillable containers for a pesticide product, as specified in proposed Sec. 165.130(b)(2). The regulations propose definitions for four major types of refillable containers: ``liquid minibulk,'' ``liquid bulk,'' ``dry minibulk,'' and ``dry bulk.'' The distinctions are based on the kind of pesticide (i.e., liquid or dry) the container is designed to hold and the size of the container. EPA believes it is appropriate to define different container terms for each of the four major types because each is designed and handled differently, and the appropriate design or performance standards may vary. First, refillable containers are distinguished by whether they are designed and constructed to hold liquid or dry pesticide. The four major types of refillable containers do not include containers for pesticides that are gases or that are in a semi-solid state, such as gels. EPA does not intend to regulate refillable containers for gaseous pesticides at this time because EPA is not aware of problems with this type of container. EPA is not aware of any pesticide gels that are distributed or sold in refillable containers. The second distinction among the types of refillables is based on the size of the container, which is usually a good indicator of whether the container will be portable or stationary. In general, the term ``minibulk'' is intended to identify a container that is considered to be portable. The term ``bulk'' usually refers to a container that is a stationary storage container. However, EPA is proposing a definition based on size rather than portability because size is an objective criterion, while ``portability'' is a more subjective concept that is difficult to describe precisely. The size criteria are different for liquid and dry refillables. For liquid minibulk containers, the proposed rule would define the container as capable of holding up to and including 3,000 liters (793 gallons), which is based on the United Nations (U.N.) definition of intermediate bulk containers (Ref. 76). Section 16.1.2.1 of the U.N. Recommendations defines IBCs, in part, as ``rigid, semi-rigid or flexible portable packagings, other than those specified in Chapter 9, that: (a) have a capacity of not more than 3.0 m3 (3,000 litres), ....'' This proposed definition of liquid minibulk container does not have a lower quantity limit. Therefore, the proposed regulatory definition of liquid minibulk would include those plastic and metal portable containers that are currently referred to as minibulks, as well as the metal 15- and 30-gallon containers that are commonly called small volume returnables, or microbulks. The proposed regulatory definition of liquid minibulk would apply to containers with, for example, a capacity of several ounces if the container could be refilled. The definition of a ``liquid bulk container'' would be similar to that of a liquid minibulk, but with a capacity limit of undivided quantities greater than 3,000 liters (793 gallons). Most portable refillable containers, i.e., those used to transport pesticide products from a dealer to a farm, have capacities of 250 gallons or less. Nearly all the portable containers for pesticides used in the agricultural, institutional, and industrial markets are 600 gallons or less. Most stationary storage tanks have capacities of at least 1,000 gallons. Therefore, EPA believes that the size limit of 3,000 liters (793 gallons) for liquid refillable containers is reasonable and appropriate. The size separation for dry refillable containers is intended to distinguish between minibulk and bulk containers in a similar way. The criterion of 2,000 kilograms (4,409 pounds) is based on the capacity of containers that are commonly used today. To EPA's knowledge, the largest portable refillable container (that is not a transport vehicle) currently used for dry pesticides can hold up to 1 ton (907 kilograms or 2,000 pounds) of product. To account for the possible development of larger minibulk containers through technological advancement, EPA more than doubled this quantity to 2,000 kilograms (4,409 pounds). In other words, the size criterion is intended to accommodate the refillable containers currently used to sell and distribute dry formulations and to allow for the development of larger containers in the future. EPA requests comment on whether this quantity limit is appropriate or whether EPA should base the size criterion for dry refillable containers on the capacities of existing containers. A ``refiller'' is defined as a person who engages in the activity of repackaging pesticide product into refillable containers. A refiller could be a registrant, a person operating under contract to a registrant, or a person operating under written authorization from a registrant. A ``refilling establishment'' is defined in the proposal as ``an establishment where the activity of repackaging pesticide product into refillable containers occurs.'' This definition is intended to include every place where a refillable container is filled or refilled with pesticide product from another refillable container (that is not a transport vehicle). The definition would not include producing establishments that fill only nonrefillable containers for distribution and sale. Refilling establishments are a subset of producing establishments. Refilling establishments must be in compliance with all existing requirements for producing establishments, including FIFRA sections 7 and 8 and EPA's regulations in 40 CFR part 167. The part 165 regulations would place additional requirements on refilling establishments. EPA is proposing a definition for the term ``repackage'' in Sec. 165.3. For purposes of this part, repackage means to transfer a pesticide formulation from one container to another without a change in the composition of the formulation or the labeling for sale or distribution. Transfer of a pesticide from one storage tank to another would not be repackaging. ``Repackaging'' covers a broader range of activities than ``refilling,'' which refers to repackaging into refillable containers, i.e., refilling is a subset of repackaging. For example, a registrant can repackage a product from a 55-gallon drum into nonrefillable 2.5-gallon jugs, which would not be considered to be refilling. Another difference between the two terms is how they are used: pesticide products are repackaged, while pesticide containers are refilled. This proposal focuses on ``refilling refillable containers with pesticide product for distribution or sale'' and ``repackaging pesticide product into refillable containers for distribution or sale,'' which have the same meaning. D. Definitions for Standards for Pesticide Containment Structures Several definitions proposed in subpart A pertain to standards for pesticide containment structures found in subpart H of the proposed rule. These definitions, discussed below, include: appurtenances, containment pad, containment structure, operator, owner, pesticide dispensing area, secondary containment unit, stationary bulk container, and 25-year, 24-hour rainfall event. The proposed definition for ``stationary bulk container'' would include any bulk container that holds pesticide, including transport vehicles such as trucks and rail cars, provided that the container remains in place at a facility for 14 or more days. Containers holding concentrated pesticides or dilute pesticides (e.g., field dilutions or rinsates) could qualify as stationary bulk containers. The proposed definition of ``appurtenance'' is intended to identify the types of conduits that are used when pesticides are dispensed to and from containers. For example, all the pipes and associated valves, pumps, and meters running from a stationary bulk container to the end of the pipe where pesticide is discharged would be considered appurtenances. Certain stationary bulk containers and their appurtenances would be required by subpart H to be protected by a ``secondary containment unit.'' The term ``secondary'' refers to the containment structure's function as a backup in case of leaks or spills from the bulk container or its appurtenances. Such leaks and spills could range from relatively small volumes (e.g., slow drips from a poorly sealed valve) to release of the entire contents of the bulk container, such as during container failure. The term ``pesticide dispensing area'' would include any area where pesticide is transferred out of or into a container and is intended to include direct transfers (e.g., container to container) or indirect transfers (e.g., those involving appurtenances) of pesticides. The vessel from which or into which the pesticide is transferred could be of a wide variety (e.g., container, application equipment, transport vehicle, etc.). The pesticide being transferred could be in a form as sold and distributed or pesticide that has been diluted (e.g., for field application or from container-cleaning operations). As described in subpart H, certain pesticide dispensing areas would be required to be protected by a ``containment pad.'' A containment pad is a structure that provides a means of spill control at a pesticide dispensing area, while a secondary containment unit serves as spill control for stationary bulk containers. As proposed in subpart H, a containment pad could be constructed as an integral component of a secondary containment unit, or vice versa. The more general term ``containment structure'' would be defined in Sec. 165.3 to mean either a secondary containment unit or a containment pad. The term ``operator,'' as it pertains to subpart H, would mean any person in control of, or having responsibility for, the daily operation of a facility at which a containment structure is required. The term ``owner'' would mean any person who owns a facility at which a containment structure is required. Subpart H refers to the term ``25-year, 24-hour rainfall event,'' defined as a rainfall event with a probable recurrence interval of once in 25 years, in describing a design criterion to prevent stormwater run-on at containment structures. The magnitude of such rainfall events is reported as inches of liquid precipitation and can vary geographically. IV. Nonrefillable Container Standards: Container Design and Residue Removal A. Background Proposed subpart F would revise 40 CFR part 165 to facilitate the safe use and disposal of nonrefillable pesticide containers by establishing container design criteria for all nonrefillable containers and residue removal laboratory performance standards for rigid containers containing dilutable pesticides. Nonrefillable containers are the most common type of containers used for the sale and distribution of pesticides. Nonrefillables come in many types and shapes ranging from small aerosols, 1-quart plastic containers, 2.5-gallon jugs, 5-gallon buckets, and bags of all sizes to drums (55 gallons and larger). Nonrefillables are used by pesticide applicators in every market sector, and are especially prevalent in the household market. As will be discussed more fully later in this document, the problems associated with the use of nonrefillable containers include spilling, leaking, and splashing during the handling of the container. Unwanted release of pesticide may occur during the opening, closing, pouring, and emptying of the container. Pesticide residues may be difficult to remove from the inside of containers if the pesticide adheres to the container's walls or is trapped in seams, lips and handles. These residues may be released to the environment and could contaminate surface and groundwater and sensitive habitats as a consequence of poor container handling and disposal practices. Containers with residues may be difficult to dispose of in municipal solid waste facilities or to recycle because facility operators regularly reject dirty containers in response to contamination concerns. A more thorough examination of the spilling and splashing problems associated with current container designs, the impact of residues on container disposal and recycling, the diversity of pesticide industries, pesticide formulations, packaging practices, and quantities and types of containers can be found in the Report to Congress (Ref. 65). B. Today's Proposal Subpart F of today's proposed regulations contains the nonrefillable container design standards, a residue removal performance standard, and certification and recordkeeping requirements. The definition section of proposed subpart A of this NPRM contains definitions of terms used in proposed subpart F and in related subparts of today's proposal. Terms in the proposed definition section that are important to the understanding of subpart F include: Agricultural pesticide, container, design type, and nonrefillable container. 1. Scope and applicability. Section 165.100 would provide that subpart F includes nonrefillable container design requirements and performance standards. These requirements and standards would reduce the risks to users and the environment from pesticide containers that spill and leak during use or retain pesticide residue upon emptying. All nonrefillable containers used for the distribution and sale of pesticides would have to meet these performance standards and requirements. The requirements in subpart F would apply to registrants, which means that containers for unregistered pesticides would not be subject to these requirements. EPA requests comment on whether unregistered pesticides should be subject to these requirements and, if so, whether the requirements should extend to all unregistered pesticides. Proposed Sec. 165.100 would state that subpart F does not apply to manufacturing use products. ``Manufacturing use product'' is defined in 40 CFR 158.153(h) and ``end use product'' is defined in 40 CFR 158.153(b). In order to be excluded from the scope of this rule, a MUP or formulation intermediate would have to be intended solely for formulation into other pesticide products and be labeled for formulation use only. Any product that bears end uses, including industrial products such as cooling towers biocides or paint preservatives, regardless of whether they may also bear manufacturing uses or could under current policies be used for pesticide formulation, would be covered by this rule. EPA is proposing to exclude products that are solely MUPs from subpart F at this time because EPA has a limited amount of information on the kinds of containers used for MUPs and EPA is not aware of any problems that have occurred with containers for MUPs. Because MUPs are handled by registrants and workers who are used to and trained to handle chemicals on a regular basis, it is possible that the stewardship of MUP containers is better than the stewardship of end use product containers at other levels of the pesticide distribution chain. EPA's study of pesticide containers and the resulting Report to Congress (Ref. 65) focused on containers holding end use products. EPA has data and documentation of problems for end use product containers and has drafted these proposed regulations to address these known problems. While EPA is not proposing to include the containers of MUPs in this proposal, EPA is strongly considering expanding the applicability of subpart F to include MUPs in the final rule. Because MUPs generally are more concentrated than end use products, it may be appropriate to require the manufacturing use product containers to meet the requirements of subpart F. EPA requests comments and information on the problems, handling, and disposal of MUP containers, and on whether MUP containers should be subject to the same requirements as end use product containers or should be subject to different standards than end use product containers. 2. Container design standards. Proposed Sec. 165.102(a)(1) would prohibit a registrant from distributing and selling a pesticide product in a nonrefillable container that does not meet the container design standards and requirements of subpart F. Section 165.102(a)(2) would state that information on container failures or other incidents involving pesticide containers that may result in releases of pesticide may be reportable under FIFRA section 6(a)(2). This proposed provision would not establish new reporting requirements; the reference to FIFRA section 6(a)(2) provisions is included to facilitate the reporting of container failures to EPA. Additionally, EPA would delete Sec. 165.2(g), relating to notifying the Regional Administrator, because EPA believes that FIFRA section 6(a)(2) provides for adequate protection. For purposes of regulating under section 19, EPA is interested in receiving reports of container failures and other related incidents in order to evaluate the effectiveness of the regulations, to discover potential problems that may need to be addressed in future rulemakings, to identify container design types that may not meet the proposed requirements, and to determine if certain container design types have a problem with container integrity and strength over time. FIFRA section 6(a)(2) requires registrants to report information on unreasonable adverse effects of a pesticide. EPA published a policy on reporting under section 6(a)(2) in the Federal Register on July 12, 1979. On September 24, 1992, EPA published a proposal for 40 CFR part 159, Reporting Requirements for Risk/Benefit Information (Ref. 91), that specifically addresses reporting container failures under section 6(a)(2). The part 159 proposal includes the following as an example of reportable container failures: ``The registrant receives verifiable reports that five cans of the registrant's product leaked 3 years after the registrant sold them. The registrant has no information regarding incidents of toxic and adverse effects caused by leaks. Nonetheless, the registrant should know that such information about container failures may raise serious questions about the proper terms and conditions of registration of the product, due to the possibility of uncontrolled, unpredictable exposure to the product or its residues, as demonstrated by the series of incidents. Therefore the information would have to be submitted within 30 calendar days of the time the registrant possesses or knows of the information. However, if the registrant investigates, and, within the time permitted, discovers that three cans leaked because they were stored under conditions which were neither in accordance with the labeling or commonly recognized practice (such as the cans were damaged in a warehouse fire), the series of incidents need not be reported unless that registrant has knowledge that EPA is considering terms and conditions of registration to which such information would be relevant.'' EPA believes that FIFRA section 6(a)(2) provides an adequate means of obtaining information about container failures. However, this reporting mechanism is dependent upon registrants being notified about container failures by dealers, refillers, and even end users. EPA believes that there are many market-based reasons for dealers or refillers to notify the registrant of container failures, including: (1) By making the registrant (who would be responsible for the containers meeting the part 165 standards) aware of the problems, the registrant could improve the containers, thus alleviating the dealer's or refiller's problems. (2) The dealer or refiller may try to obtain financial assistance from the registrant to replace the failed container and lost product. (3) If the container failure is associated with a pesticide release, the dealer or refiller might want to obtain guidance and financial compensation on reporting responsibilities, spill remediation, and disposal. Despite these market pressures, EPA is concerned that registrants may not become aware of container failures because it is not mandatory for dealers or refillers to report to registrants. EPA considered other mechanisms for the reporting of container failures, including requiring dealers and refillers to report container failures to the registrant. The registrant, of course, is subject to reporting adverse effects information under FIFRA section 6(a)(2). This option would ensure that registrants receive reports of container failures, thus increasing the potential for reporting to EPA. Another option considered by EPA was to require dealers and refillers to report container failures directly to EPA. This option would ensure that EPA receives reports of container failures in a very timely manner. EPA requests comments on the proposed approach of relying on market forces and the existing FIFRA section 6(a)(2) mechanisms to provide EPA with container failure information and on the other reporting options. EPA particularly requests comments on the burden to the various parties under each of the reporting options. Proposed Sec. 165.102(a)(3) would clarify that compliance with the proposed part 165 regulations would not be an exemption from DOT's Hazardous Material Regulations at 49 CFR parts 171 through 180. If a pesticide is a DOT hazardous material, the pesticide would be required to be packaged in compliance with both DOT and EPA regulations. 3. Container integrity. EPA is proposing in Sec. 165.102(b) to require that all nonrefillable container design types prevent leakage under conditions of normal storage, distribution, sale, and use. In choosing a general performance standard, EPA recognizes that not every possible storage or use condition can be anticipated, but that normal environmental conditions, the effects of long term storage, and container/formulation interactions should be considered by the registrant when choosing packaging for a pesticide product. The risk of exposure to humans, animals, and the environment from concentrated pesticides is greatly increased if the pesticide is not completely and securely confined in its container during storage. Pesticide containers may lose their structural integrity during mishandling or when stored under various conditions (especially long- term storage), including: (1) Storage in extremely high and low temperatures, (2) storage of bags and cardboard containers under humid conditions (damp basements and regions of the country that regularly experience high humidity), and (3) storage of certain plastic containers in direct sunlight, resulting in photodegradation of the plastic. Incompatibility between the pesticide formulation and the construction material(s) may also result in degradation or failure of the container. A discussion of integrity problems of nonrefillable containers may be found in the Report to Congress (Ref. 65). Section 165.102(b) would also require that the container's construction materials be compatible with the formulation. Consideration of any chemical reactions that could occur between the container and the formulation will allow the registrant to choose a container that is made of materials that will not react with the formulation. Compatibility is intended to cover a broad range of potential occurrences. EPA does not consider a pesticide formulation and container to be compatible if, for example, the formulation: (1) Is corrosive to the container, (2) causes softening, premature aging, or embrittlement of the container, or (3) otherwise causes the container to weaken or to create the risk of discharge. A container and formulation are not compatible if there is a significant chemical, electrolytic, or galvanic reaction between the two. Also, a container and formulation are incompatible if there is some interaction between the two, such as the active ingredient permeating the container wall, that would cause the formulation to differ from its composition as described in the statement required in connection with its registration under FIFRA section 3. EPA requests comments on whether this description of compatibility is adequate and/or whether EPA should define compatibility in the regulations. EPA requests comments on the ability of registrants to comply with the nonrefillable container integrity standard as well as the need for additional or alternative requirements, such as a drop test. EPA envisions the nonrefillable container integrity standard being enforced in situations where significant leakage problems occur for a given container design type and formulation. Existing enforcement mechanisms, such as a stop sale, use, or removal order (SSURO), could be used to prevent the further sale or distribution of that container/ formulation combination. EPA is considering the development of a standard for container failure frequency to define what would be considered a violation and to clearly establish a violation of the proposed container integrity standard. Noncompliance would result if containers of a particular design type failed at a frequency greater than that established by EPA. A nonrefillable container that fails at a rate exceeding the failure frequency could be banned from the distribution and sale of pesticide. EPA requests comments on the establishment of a container failure frequency and requests specific suggestions for methods to determine and to set such a standard. 4. Permanent markings. Proposed Sec. 165.102(c) would require certain information, specific to the pesticide sold or distributed in the container, to be marked permanently on every nonrefillable container. Permanent marking includes, but is not limited to, etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding, or marking with durable ink. EPA intends that the information be visible and fixed on the container for the lifetime of the container. This permanent marking would be in addition to the label and labeling, unless the label itself is a permanent part of the container material (e.g., etched, ink jetted, stamped, or molded). Proposed Sec. 165.124(b) of subpart G would require certain information to be permanently marked on refillable containers. (See the discussion in Unit V.B.3 of this preamble.) While permanent marking means the same thing for nonrefillable and refillable containers, EPA anticipates that the containers will be permanently marked using different methods. For example, EPA anticipates that most nonrefillable containers would be permanently marked by ink jetting, embossing, or marking with permanent ink, while refillables would be permanently marked by molding or mechanically attaching a plate. The information proposed to be permanently marked includes the EPA registration number of the pesticide [Sec. 165.102(c)(1)] and the name, symbol, or code of the material(s) from which the nonrefillable container is constructed [Sec. 165.102(c)(2)]. a. EPA registration number. This will allow for the identification of the pesticide even if the label is missing or illegible, facilitating the safe disposal of excess pesticide and containers. When the EPA registration number of the product cannot be confirmed or identified, the current or previous contents of the container and its residue are unknown. Identification of the contents by an analytical chemistry laboratory can be costly and may not provide complete information (for instance, the exact product may not be identifiable). Waste management facilities and municipal collection programs usually consider the cost of identification to be prohibitive, and may refuse to accept unidentified pesticide products because of potential liability under the Resource Conservation and Recovery Act (RCRA) or the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Unidentifiable pesticides have been rejected from pesticide collection programs in several States (for example, Maine, Minnesota, North Carolina, and Virginia) (Ref. 70). Users may keep unidentifiable pesticides and containers in storage indefinitely, or may even resort to open dumping. State authorities who find quantities of pesticide containers with illegible or missing labels in open dumps end up assuming the cost of identification if the user cannot be found. b. Material of construction. This will help recycling programs identify container materials and encourage the recycling of pesticide containers, thereby facilitating safe disposal of containers and furthering EPA's waste minimization goals. EPA is not proposing a system or code to identify the material of construction, because there is no one universally accepted or mandated scheme at this time. The construction material should be identified clearly enough so that persons who are not container manufacturers can determine the material of construction. To EPA's knowledge, there are a limited number of materials currently used to produce pesticide containers. Therefore, EPA does not anticipate identifying the container material in the absence of a specified code to be problematic. Several independent organizations have developed material identification mechanisms. One well-known organization, the Society of the Plastics Industry (SPI), has assigned numbers to certain groups of plastics. The numbers are engraved or embossed directly on the container to aid in the quick identification of the material. Certain beverage can manufacturers print the name of the material (steel, aluminum) on the container. EPA anticipates that most registrants will use either the SPI code or the material name to mark nonrefillable containers with the material of construction. However, there are existing packaging regulations and standards that address identification of the material of construction. Container standards such as the DOT Specifications 56 and 57 for metal portable tanks and the Midwest Agricultural Chemicals Association (MACA) voluntary standards establish conventions for identifying the material of construction for larger, refillable containers, as discussed in Unit V.B.3 of this preamble. 5. Container dispensing capability. EPA believes that a regulation that assures the safe use of containers should apply to all aspects of normal use of the container, including the elimination of splash and leakage during pouring of the pesticide from the container, closing or resealing the container, and storage and cleaning of the container. Proposed Sec. 165.102(d) would require nonrefillable containers containing liquid pesticides to be designed and constructed to: (1) Pour from the container in a continuous, coherent stream (i.e., without glugging and/or splashing) [Sec. 165.102(d)(1)]. (2) Dispense without dripping or leaking down the outside of the container at any time during the dispensing or after the container has been emptied [Sec. 165.102(d)(2)]. (3) Once the container has been resealed, not allow any pesticide or rinsate to escape from the container during storage or while the user is agitating the container during the triple rinse residue removal procedure [Sec. 165.102(d)(3)]. The Report to Congress (Ref. 65) concludes that certain container design features can result in spilling, splashing, glugging, dripping, and leaking during normal use activities, including: (1) Solid handles can promote glugging during pouring because of inadequate air flow back into the container. (2) Handles on top of the container can position the user's hand in likely splash areas. (3) The design and position of the opening can contribute to leakage/drippage of the pesticide down the side of the container during and after dispensing. (4) Once opened, the lid, cap, or other closure mechanism may not securely reclose the container, and may result in leakage and spillage of pesticide during storage, transportation, and container agitation during the triple rinse residue removal procedure. EPA is not proposing specific numerical standards or test methods to verify these design standards. The Report to Congress (Ref. 65) contains a method to demonstrate glugging based on a variation in internal pressure of the container and this method could be adapted for use by registrants. The registrant could use the data from this method or use photographic evidence to demonstrate dispensing capability, as well as for other aspects of the design standards. 6. Standardized closures. The safe use of pesticide containers extends to safe dispensing, and closed systems (also known as closed transfer systems) allow for the safest possible transfer consistent with typical pesticide dispensing procedures. Applicator exposure, spills, leakage, and splashing during the dispensing of pesticide from the container have been shown to be reduced when a closed system is used. To facilitate and encourage the use of closed systems, EPA is proposing in Sec. 165.102(e)(1) to require the standardization of container closures for liquid agricultural pesticides. Pesticide container closures come in a wide variety of sizes and shapes, including pull-off tabs, pop-up funnels, and closures and openings with or without threading. The current nonuniformity among container closures makes it difficult for a user to incorporate closed transfer systems into handling practices. Users may have to purchase or obtain many adapter devices to fit all of the container types to the closed system(s) they own. Lacking a proper adapter, a user may try to secure the closed system to the container using whatever means is available. If this jury-rigging fails, leaking and spilling may result. Moreover, closed systems are not available for many container opening styles. The standardization of the container closure (and therefore the opening also) would encourage and facilitate the use of closed systems by limiting the number of adapters and/or closed systems a user would have to own. Closed systems are used predominantly in the agricultural sector, although they are growing in popularity in the industrial and institutional markets. A growing number of registrants are requiring the use of closed systems as a means of reducing applicator exposure. Some States (California, notably) are also requiring that closed systems be used with certain pesticides in certain application situations. EPA is targeting agricultural pesticides with the standardized closure requirements. EPA has limited information on the use of closed systems in other markets, such as industrial and institutional. EPA requests information on the use of closed systems in other pesticide sectors, including the types of systems, costs, extent of use, and comments on whether a standardized closure requirement would facilitate the use of closed systems. Section 165.102(e)(1) proposes four closure sizes (two bungs and two screw caps) whose design specifications have been adapted from caps and bungs commonly found in the agricultural sector and from current voluntary industry standards (Ref. 90). Section 165.102(e)(1) also proposes that only rigid containers with a capacity greater than or equal to 3.0 liters (0.79 gallons) would have to conform to the closure specifications due to the constraints of adapting the closure specifications to small containers. Also, smaller containers are not used as often in the agricultural sectors. Section 165.102(e)(2) would permit a registrant to request and justify the need for an exemption from the standardized closure requirement. EPA recognizes that the use of a nonstandardized closure with certain pesticide formulations may result in a further reduction of applicator exposure, or may be required for proper mixing, loading, or application. Because EPA believes that most agricultural formulations can be accommodated using the four proposed closures, EPA anticipates a limited number of situations where non-standardized closures might be appropriate. However, EPA would consider any requests for a waiver from the standardized closure requirement and would carefully evaluate them with respect to the criteria set out in Sec. 165.119(b). The proposed requirement for standardized closures should not overlap with the Child-Resistant Packaging requirements for residential use pesticides (40 CFR part 157), unless a pesticide product's labeling allows both the use on agriculture sites and residential use [as defined in Sec. 157.21(e)], and the pesticide is packaged in a container larger than 0.79 gallons (3.0 liters) but less than 5.0 gallons (18.9 liters). EPA would consider the registered use sites when considering a request from a registrant to use a non-standardized closure. Section 165.102(e)(3) proposes to exempt aerosol and pressurized containers from the requirement for standardized closures because the closures are not appropriate for the typical design used to dispense aerosol pesticide from containers. Pesticides packaged in aerosol and pressurized containers are considered to be those products that are sold under pressure where the pesticide cannot be poured or dispensed from the container as a liquid, the container is not designed to allow the opening of the container for dispensing as a liquid, and where the containers are designed to contain pressurized materials. 7. Residue removal-- a. The residue removal problem. FIFRA section 19(e)(1)(B)(i) requires EPA to promulgate regulations that ensure, to the fullest extent practicable, that the design of pesticide containers accommodates procedures used for the removal of pesticides from the containers and the rinsing of the containers. In addition, FIFRA section 19(f)(1)(B)(i) states that the regulation may specify pesticide residue removal standards providing for, at a minimum, triple rinsing or the equivalent degree of pesticide removal. EPA believes it is the intent of Congress to ensure that pesticide containers are capable of being cleaned at least to a level that is equivalent to triple rinsing. In order to fulfill this intent, EPA is proposing to set a residue removal performance standard that certain pesticide products would be required to meet. The performance standard would act as a benchmark for residue removal by specifying the maximum quantity of pesticide active ingredient that can be found in rinsate after a specified residue removal procedure is used. EPA would require that a specified level of pesticide residue removal be achieved in the laboratory before a registrant may distribute or sell a pesticide product in a nonrefillable container. This performance standard would be applicable to all registered products within certain categories of container and formulation combinations. EPA believes that if pesticide containers are capable of being cleaned to a high level, users will be able to achieve a higher degree of container cleanliness prior to disposal or recycling. EPA believes human and environmental exposure and risks are posed by pesticide that is readily available in the container, specifically, the pesticide that can escape from an empty container during storage and transportation to a disposal facility. Pesticide container recycling programs and municipal waste facilities report the frequent rejection of certain pesticide formulation and container combinations because of unacceptable pesticide residues (Refs. 16, 23, 24, 29, 37, 49 and 65). EPA is proposing a performance standard that affords a practicable level of residue removal that is achievable for the majority of pesticide products, while targeting those pesticide/container combinations that have difficulty in achieving an acceptable level of residue removal, such as those frequently rejected from recycling programs. EPA believes that proper residue removal will encourage recycling and reduce human and environmental exposures to pesticide residues from empty, unrinsed containers. Residues from containers can contaminate soil, surface water, and groundwater, posing a risk to wildlife, sensitive habitats, and human health (examples: drinking water and exposure to empty containers by trash handlers and children) (Refs. 20 and 65). The Report to Congress and other sources conclude that residue removal efficiency is a function of the combination of, and interaction between, the container variable(s) and the formulation variable(s) (Refs. 10, 11, 29 and 65). A performance standard approach would not seek to achieve residue removal efficiency through the prohibition of certain container types or formulation characteristics that do not facilitate residue removal, nor would it require the use of a limited set of container types that have been shown to not retain residues; rather, a performance standard would consider the residue removal efficiency of the container and formulation in combination. EPA believes the establishment of a laboratory performance standard is the most desirable strategy, as it provides registrants the greatest amount of flexibility to achieve the standard. A registrant could modify or change the variables of container design and/or formulation characteristics as the registrant so chooses, as long as the performance standard is met. By setting a laboratory performance standard, EPA is laying the groundwork for effective residue removal at the user level. When effective residue removal is fostered by container designs and formulations in conjunction with proper container cleaning procedures, EPA believes that containers will be more readily accepted by pesticide container recycling and collection programs, and by municipal solid waste facilities. EPA believes that promulgation of this proposed laboratory performance standard will: (1) Encourage the use of containers with design features that facilitate residue removal. (2) Encourage the use of formulations that facilitate residue removal. (3) Help to assure those involved with the disposition of the pesticide containers (i.e., farmers, landfill operators, recyclers, etc.) that the containers can be cleaned adequately. (4) Discourage or eliminate those container/formulation combinations that are known to cause problems. b. Rigid/dilutable category targeted for proposed performance standard. At this time, EPA is proposing to establish a residue removal performance standard and laboratory residue removal testing procedures for one type of container/ formulation combination. That container/ formulation combination includes rigid containers with pesticides that are required or allowed by the label or labeling to be diluted prior to application (referred to as ``rigid/dilutable''). By ``rigid containers,'' EPA means containers that have definite retained shape and form and that are self-supporting. EPA is not aware of any regulatory definitions of rigid in DOT regulations or in U.N. packaging standards. For the purposes of subpart F, rigid containers would include containers constructed of metal, molded polyethylene, glass, and paperboard (cardboard). Rigid containers would also include bag-in- a-box containers, because the box is an integral part of the package and bears the label, and the bag or bladder is considered a liner. The bag/bladder liner can and should be rinsed prior to disposal. Water- soluble packages, containing dilutable pesticide, that are sold in cardboard tubes, boxes, or other packaging types would not be considered rigid containers for the purposes of these regulations. The water-soluble film is not a liner and cannot be rinsed because it dissolves to become part of the spray mix. Removal of pesticide residues should not be necessary for the outer packaging because the pesticide is contained within the water soluble packages. EPA requests comments on the proposed description of ``rigid container.'' c. Future inclusion of other categories. EPA ultimately intends to set performance standards for other container/formulation categories. The categories may include non-rigid containers with dilutable and non- dilutable pesticide, rigid containers with non-dilutable pesticide, and aerosols. Standards would be based on what is practicable for the specific type of container and what residue removal procedure is appropriate for the container/formulation combination. Data on residue levels for these categories are being investigated. For example, EPA and the Paper Shipping Sack Manufacturers Association (PSSMA) conducted a study of the residue in paper bags (Ref. 61). d. Rigid/dilutable performance standard. EPA is proposing in Sec. 165.104(b) to establish a residue removal performance standard that represents a practicable level of residue removal for the majority of container/formulation combinations currently in use, based on data available to EPA. To achieve this goal, the proposal would establish a standard through the utilization of a standardized triple rinse procedure, and would require that a minimum of 99.9999 percent removal of pesticide active ingredient be achieved, expressed in terms of reduction of concentration of the pesticide in the residue. In setting the standard, EPA evaluated the residue data produced using a standardized triple rinse methodology. The data analysis indicates that a 99.9999 percent removal standard is practicable for the majority (approximately 70 percent) of rigid/dilutable products tested. The Report to Congress (Ref. 65) examines the container and formulation characteristics that may have resulted in inefficient removal of residues for these products. EPA is proposing that registrants be responsible for assuring that each rigid nonrefillable container design type and dilutable pesticide formulation combination meets the 99.9999 percent residue removal performance standard before the sale or distribution of the pesticide product would be permitted. EPA has gathered a number of studies of the efficiency of triple and/or pressure rinsing. These studies used a variety of protocols and rinsing procedures, making it difficult to compare their results. These documents are included in the docket as background information (Refs. 1, 3, 14, 25, 30, 31, 39, 51, 59). Several different dilutable formulation types in rigid containers with capacities ranging from 1 pint to 5 gallons were tested according to a procedure developed by EPA. The data are summarized in the following Tables 1 and 2 below. In Table 1, 70 percent of the agricultural pesticide products tested met the standard of 99.9999 percent removal, while 86 percent achieved 99.999 percent removal. EPA believes that the container/formulation types tested and presented in Table 1 (including plastic and metal containers ranging from 1 pint to 5 gallons) are representative of pesticide products for the agricultural industry. Table 1.-- Laboratory Standard - Agricultural Products Data Summary.\1\ ---------------------------------------------------------------------------------------------------------------- Total Number Meeting 6- Percent Meeting 6- Number Meeting 5- Percent Meeting 5- Formulation type Number\2\ 9's\3\ 9's 9's\4\ 9's ---------------------------------------------------------------------------------------------------------------- Dry flowable........... 1 1 100 1 100 Emulsifiable concentrate........... 20 15 75 18 90 Aqueous solution....... 3 2 67 3 100 Flowable liquid........ 15 10 67 12 80 Encapsulated........... 4 2 50 3 75 ---------------------------------------------------------------------------------------- Total............. 43 30 70 37 86 ---------------------------------------------------------------------------------------------------------------- \1\ This summary is based on data generated in 1990 by an EPA contractor and the National Agricultural Chemicals Association (NACA). The data are in the Report to Congress (Ref. 65). The procedure followed was a well- defined, thorough, laboratory triple rinse. \2\ The total number of different container/formulation combinations for a given formulation type. \3\ The number of different container/formulation combinations that would meet a standard of 99.9999 percent residue removal (6-9's). Note: container/formulation combinations that were tested in triplicate were considered to meet the standard only if all three data points met the standard. \4\The number of different container/formulation combinations that would meet a standard of 99.999 percent residue removal (5-9's). Note: container/formulation combinations that were tested in triplicate were considered to meet the standard only if all three data points met the standard. In Table 2 below, 59 percent of the containers representative of the industrial, institutional and residential markets that were tested met the standard of 99.9999 percent removal, while 89 percent achieved 99.999 percent removal. EPA believes the container types tested (plastic and metal containers ranging from 1 pint to 5 gallons) are representative of these industries. EPA has received residue removal data from the Chemical Specialties Manufacturers Association (CSMA) on containers and formulations that CSMA claims are representative of household and institutional products (Ref. 77). This information indicated that 2 of the 12 container/ formulation combinations tested would meet a standard of 99.9999 percent removal. These preliminary results do not appear to be consistent with the data in Table 2. EPA requests comments, including additional data, on whether household and institutional pesticide container/formulation combinations have different characteristics than agricultural pesticide containers/formulations or whether there are specific reasons for the difference in percentages meeting a standard of 99.9999 percent such as a smaller sample size in the CSMA testing. Table 2 reads as follows: Table 2.-- Laboratory Standard - Industrial, Institutional, and Household Products Data Summary\1\ ---------------------------------------------------------------------------------------------------------------- Total Number Meeting 6- Percent Meeting 6- Number Meeting 5- Percent Meeting 5- Number\2\ 9's\3\ 9's 9's\4\ 9's ---------------------------------------------------------------------------------------------------------------- Formulation type Emulsifiable concentrate......... 9 8 89 9 100 Flowable liquid...... 9 1 11 6 67 Encapsulated......... 9 7 78 9 100 ---------------------------------------------------------------------------------------- Total.............. 27 16 59 24 89 ---------------------------------------------------------------------------------------- Container size 1 gallon............. 9 5 56 8 89 Less than 1 gal...... 18 11 61 16 89 ---------------------------------------------------------------------------------------- Total.............. 27 16 59 24 89 ---------------------------------------------------------------------------------------------------------------- \1\This is based on data generated in 1991 by an EPA contractor. The procedures followed was a well-defined, thorough, laboratory triple rinse. \2\ The total number of different container/formulation combinations for a given formulation type or container size range. \3\ The number of different container/formulation combinations that would meet a standard of 99.9999 percent residue removal (6-9's). Note: container/formulation combinations that were tested in triplicate were considered to meet the standard only if all three data points met the standard. \4\ The number of different container/formulation combinations that would meet a standard of 99.999 percent residue removal (5-9's). Note: container/formulation combinations that were tested in triplicate were considered to meet the standard only if all three data points met the standard. EPA believes that the most straight forward method of measuring the amount of accessible pesticide is to perform the test on a container that has been -properly cleaned using a standardized triple rinse procedure. After completion of a triple rinsing procedure, an additional rinse of the container (i.e., a fourth rinse) would be performed and the concentration of pesticide active ingredient in the fourth rinse would be determined. The rigid/dilutable performance standard being proposed would require that, at a minimum, a 99.9999 percent reduction of active ingredient concentration in the fourth rinse must be achieved. A 99.9999 percent removal of pesticide from the container is achieved if the concentration of active ingredient in the fourth rinse is less than or equal to 0.0001 percent of the pesticides' original active ingredient concentration. Based on data available to EPA, this percent removal standard represents a practicable level of residue removal for the majority of rigid/dilutable containers currently in use. EPA believes that this standard is preferable to a lower standard (e.g., 99.999 percent removal) because it would provide for a reasonable degree of improvement in the level of residue removal achievable by the currently most inefficient container/ formulation combinations. The purpose of measuring the concentration of pesticide in the fourth rinse is to measure the pesticide that is readily accessible after a triple rinse. This procedure does not measure the total amount of pesticide left in the container after a triple rinse, because it does not include the total amount of pesticide that remains trapped in the container. Small amounts of pesticide can be adsorbed on and/or absorbed into the container (Ref. 65). In order to measure conformance to the residue removal performance standard, Sec. 165.104(b)(1) proposes that the rigid/dilutable residue removal methodology set out in Sec. 165.106 must be followed. The residue removal test methodology is a triple rinse procedure with an additional rinse (fourth rinse) that is conducted under strictly controlled laboratory conditions. EPA developed the methodology through the testing of representative rigid/dilutable products. Some of the test parameters, such as the drain and shake times and the quantity of water used, were based on triple rinse procedures common in many current State regulatory definitions of triple rinsing. Section 165.104(b)(2) proposes that the testing would have to be conducted in accordance with the Good Laboratory Practice Standards (GLP) at 40 CFR part 160. EPA developed the testing and analysis methodologies to provide standardized, uniform, and controlled testing of compliance. In the testing and analysis methodologies, EPA has set out the specific testing elements and standards (such as water temperature) that EPA believes are critical to the accurate determination of residue quantities. EPA plans to issue ``Nonrefillable Container Residue Removal Methodologies: Rigid Containers and Dilutable Pesticide'' in EPA's Pesticide Assessment Guidelines, which will give more detailed information on the methodologies (such as the recommended orientation of the container during the shaking and the draining periods). As part of the general testing methodology, EPA would impose a statistical performance standard to ensure that a specified percentage of containers meet the residue removal performance standard with a predetermined level of confidence. A minimum testing of 19 different containers would be required to ensure with reasonable confidence that the container/formulation combination meets residue removal performance standard. This approach employs an adaptation of a statistical model used in setting ``Tolerance Limits'' for performance criteria (Ref. 8). For pesticide formulations with more than one active ingredient, the registrant would have to calculate the percent removal for each active ingredient, and each active ingredient must meet the residue removal standard. EPA is aware that several different nonrefillable container design types, as defined in proposed Sec. 165.3, may be used with one registered pesticide product (EPA registration number). The regulations would require compliance with the residue removal standard by each nonrefillable container design type that is used with each registered pesticide product. Separate tests must be completed for each nonrefillable container design type and registered pesticide product combination. EPA requests comment on the proposed requirement that all rigid nonrefillable design types used for each registered pesticide product must meet the residue removal standard. EPA requests comments on the reasonableness of the residue removal performance standard as applied to all dilutable pesticide packaged in rigid containers, including types of containers or pesticides for which a different standard may be appropriate, and on alternatives to the proposed standard. EPA believes that a large percentage of products can meet the residue removal standard, and those that do not initially meet this standard may require only a modification of container design in order to comply. Larger nonrefillables, such as drums, may have difficulty meeting the residue removal standard. EPA considered requiring testing at specified intervals during production to ensure continued compliance with the residue removal performance standard, but elected not to propose such a requirement because it did not seem necessary. While the regulations would not prohibit production testing, the registrant would be responsible for all of his product meeting the residue removal performance standards. EPA recognizes that registered pesticide products containing small quantities of active ingredient may encounter difficulties in documenting a 99.9999 percent reduction of active ingredient concentration. Although current laboratory equipment can detect very small concentrations of chemicals, there are detection limitations. When a residue removal procedure is performed on a pesticide product that contains a small initial concentration of active ingredient, the active ingredient concentration in the rinsate could fall below the detection capability of typical laboratory equipment. EPA considered establishing different criteria for those pesticide products where the detection of active ingredient concentration in the fourth rinse (as set out in the proposed methodology) would exceed currently available detection limits. One approach considered was to presume that products with active ingredients that are undetectable after the fourth rinse using approved analytic techniques meet the 99.9999 percent removal standard. Another approach that was considered was to exempt all products that contain active ingredient less than a certain concentration. EPA did not propose these approaches because of insufficient information about how concentration of undetectable amounts of the active ingredient relates to residue risk and due to concerns that other chemical components of a product's formulation may hinder active ingredient removal to such an extent that it can be determined that the product does not meet the proposed 99.9999 percent removal standard. EPA requests comments on the exemption of products with low initial active ingredient concentrations or the establishment of alternative residue removal standards for products with low initial active ingredient concentrations (other than the proposed 99.9999 percent residue removal standard). EPA also solicits comments on how to address setting detection limits for these products. EPA considered, but decided not to propose, an exemption from the residue removal standard for household use (residential use) pesticide products. FIFRA section 19(f)(1)(C) states: ``The Administrator may, at the discretion of the Administrator, exempt products intended solely for household use from the requirements of this section.'' However, EPA is proposing to require rigid/ dilutable household use pesticides to comply with the residue removal standard because many of these products are the same formulation, contain the same active ingredient concentration, and are sold in the same package size as pesticide products used in agricultural, industrial, institutional, and other commercial markets. Additionally, even if a product is packaged or formulated differently for household use than for other uses, it may still pose residue removal concerns. EPA believes it may not be reasonable to exempt products from the proposed residue removal standard just because they are purchased by household users when they may pose residue removal concerns the same as, or similar to, non- household use products. EPA recognizes that there are instances where the risks of human and environmental exposure from pesticide residues remaining in containers may be reduced because of a household or other pesticide product's low active ingredient concentration and low toxicity. EPA requests comments on the inclusion of all household use pesticides in the residue removal requirement, including alternative residue removal standards for low active ingredient concentration and low toxicity household use products, as well as how to regulate products sold to commercial and household users with essentially the same net content. EPA also solicits comment on how ``household use'' would be defined for purposes of exempting them. In addition, many household use products have dual uses in that they can be diluted or used at full strength. EPA solicits comments on whether such products should be considered dilutable for the purposes of the rule. EPA is proposing to allow a waiver of the residue removal requirement under certain circumstances. A registrant could submit a request to EPA to have the residue removal requirement waived for a pesticide product packaged in nonrefillable containers. The waiver proposed in Sec. 165.104(c) is a general standard to accommodate the circumstances under which EPA would grant a waiver from the residue removal standard. EPA is considering several criteria on which to base the evaluation of a waiver request, such as whether a registrant can show that a waiver is necessary for reasons of practicality or feasibility or if a registrant can show that the pesticide residues in the container would not present an unreasonable risk to humans or the environment. EPA requests comments on criteria that would be appropriate to use to evaluate waiver requests. Because EPA's intent in establishing a residue removal standard is to reduce human and environmental risk from pesticide residues, as well as facilitate the reuse and disposal of pesticide containers, EPA believes that a waiver based on no unreasonable risk to humans or the environment would be appropriate. EPA requests comments on the following examples of circumstances in which a waiver could be granted: (1) The registrant can use validated modelling techniques based on the concentration of active ingredients to show that residue levels after triple rinsing would result in very low or undetectable residue levels. (2) The registrant can show that even before triple rinsing the active ingredient in question is low in toxicity and is present in low concentrations. (3) The registrant performs the required triple rinse tests and the resulting residues are undetectable with the use of approved analytic techniques. (4) The registrant has established a returnable container program that collects from users all empty containers of the noncomplying product. Before granting a waiver, EPA would encourage the registrant to switch to smaller nonrefillable containers or refillable containers, as described in subpart G of this proposal. EPA also requests comment on whether there are other circumstances in which a waiver from the residue removal requirement should be granted. e. Other options considered. EPA considered several other possible options for addressing pesticide residue removal before finally electing to propose a laboratory performance standard. Those options included: (1) Prohibiting certain container design features or formulation characteristics that have been proven to exhibit unacceptable cleaning efficiencies, (2) requiring certain container designs that have been proven to exhibit acceptable cleaning efficiencies, and (3) developing residue removal standards according to EPA's established pesticide toxicity categories. EPA requests comments on these options and on other alternatives that would achieve the goals set out in this proposal. EPA does not propose to regulate technical design characteristics of containers or formulation characteristics, as would be required in options 1 and 2, for the following reasons: (1) Not all variables of residue removal would be addressed, (2) technology advances rapidly, rendering some design features obsolete and introducing others, (3) flexibility to the regulated community is reduced, (4) EPA does not have sufficient data supporting benefits or advantages/disadvantages of one design feature over another, and (5) some features offer benefits in other areas that affect their disadvantages for residue removal (for example, while hollow handles on plastic jugs tend to retain pesticide, they also facilitate pouring without glugging). EPA elected not to develop residue removal standards according to EPA's existing categorization of pesticide toxicity [Sec. 156.10(h)(1)] because the toxicity categories are primarily based on the risks of pesticide exposure to humans. EPA's intent in establishing a residue removal standard is to reduce environmental, as well as human exposure to residues remaining in pesticide containers, and the toxicity categories do not factor in environmental risks. EPA requests comments and suggestions on a strategy that could be used to develop residue removal standard(s) based on pesticide toxicity. f. User conformance in the field to the laboratory performance standard is not required. EPA emphasizes that the laboratory residue removal performance standard of 99.9999 percent removal is not an enforcement standard that would be used in the field to check on user compliance with container cleaning instructions set out on the label. The proposed performance standard would apply only to registrants. Users would be required to follow the residue removal procedure(s) specified on the label, as discussed in the proposed amendments to 40 CFR part 156. EPA believes the proposed performance standard should ultimately help users clean containers because certain container design and formulation variables affecting residue removal efficiency will be eliminated. By designing container/formulation combinations that rinse clean to at least a certain minimum level, registrants will increase the likelihood of effective residue removal in the field, even if conditions in the field vary from controlled laboratory conditions. EPA intends to investigate the establishment of field residue removal enforcement standard(s) to measure user compliance with the residue removal label instructions. Options that may be appropriate methods of establishing a field standard include: (1) Adopting the residue removal laboratory performance standard that EPA is proposing to establish for each container/ formulation combination (99.9999 percent removal for rigid/ dilutables). One issue with this option is the possible difficulty users would have in meeting the standard in the field. The laboratory testing would be performed under strictly controlled conditions, whereas field conditions are highly variable and in many cases are out of the control of the user (e.g., water temperature, pH, salinity, etc. may effect the solubility of certain formulations in water). (2) Setting a performance standard less than the laboratory standard. One issue with this option is that it might not be a reasonable measure of user compliance because EPA does not have sufficient information or data to determine whether this standard is achievable under a wide variety of field conditions. (3) Requiring registrants to set the field standard for their pesticide products and submit the data used to support the standard. One issue with this option is the determination of the methods and tests that registrants would be required to submit. Registrants may be unwilling to set a stringent field standard because of potential liability for user compliance. EPA believes it may be appropriate to defer the establishment of a field enforcement standard until more information about the benefits and advantages/disadvantages of such a standard are identified. EPA requests comments on whether to establish field enforcement standard(s). 8. Certification requirements. Section 165.111 proposes to require that all registrants who package pesticide in nonrefillable containers submit a certification stating that the container design and residue removal standards of proposed Sec. Sec. 165.102 and 165.104 have been met. A certification would be required for each registered pesticide product (i.e., each EPA registration number), and the stated compliance must be true for each container design type that is used with the registered pesticide product. Section 165.111(b) proposes that a certification be submitted for all currently registered pesticide products, as well as new pesticide products. Section 165.111(c) specifies that the contents of the certification must include basic information about the registrant and a statement that the registrant is in compliance with the appropriate sections of subpart F. The certification would be based on tests and documentation. The information provided in the certification will identify the pesticide product and allow EPA to check compliance with the requirements of Sec. Sec. 165.102 and 165.104. Under the proposed Sec. 165.114, EPA may perform inspections, and/or require submission, of the data or records required to be maintained in Sec. 165.114. For example, if EPA knows that a particular container/formulation combination has difficulty achieving the residue removal standard, then registrants who submit applications for registration of a pesticide product with this container/formulation may be required to submit the data they are using to support the certification. 9. Recordkeeping and inspections. Section 165.114 proposes to require that registrants maintain certain records showing compliance with subpart F for as long as the nonrefillable container design type is used with the pesticide formulation and for 3 years thereafter. The records would be available for EPA (or its authorized representative) or States for inspection and copying, but would have to be submitted to EPA only if EPA specifically requested their submission from the registrant. The records proposed to be kept are as follows: (1) Section 165.114(a) and (b). A copy of the certification statement and some basic information identifying the pesticide product. (2) Section 165.114(c). Records showing compliance with the container dispensing capability requirements of Sec. 165.102(d), including documentation of any testing performed. The test data or documentation could include data generated through a testing method or photographic evidence that demonstrates dispensing capability. (3) Section 165.114(d). Records showing compliance with the standardized closure requirements of Sec. 165.102(e). In ordering and purchasing containers from a container supplier, the registrant could require the proposed closure design specifications in the purchase contract. Alternatively, the container supplier may have literature demonstrating that a certain container design type conforms to the proposed specific closure design specifications, or may provide relevant information or data in a letter to the registrant. (4) Section 165.114(e). Records showing compliance with the residue removal requirements of Sec. 165.104, including documentation or testing. EPA anticipates that many pesticide products will not require residue removal testing to determine compliance with the residue removal standard because registrants will acquire data that is acceptable to EPA from other registrants and sources. Section 165.114(e)(1)(ii) would allow a registrant to use residue removal test data that have been generated for a different pesticide product. The registrant may demonstrate that a product shares the same formulation characteristics as the one that has met the residue removal standard, and is packaged in the same container that has been documented as meeting the standard with this type of formulation. The registrant would be required to submit a written explanation of why the data for the other pesticide product should be allowed to substitute for data that would otherwise be generated for his pesticide product. EPA requests comments on the circumstances under which submission of residue removal data from pesticide products with substantially similar container/formulation characteristics would be sufficient in lieu of data generation for every pesticide product. EPA also requests comments on the factors to be considered in determining when container and formulation characteristics should be considered ``substantially similar'' for the purposes of this requirement. Section 165.114(e)(1)(iii) would allow the registrant to submit a letter from the facility or the container manufacturer that conducted the testing to provide the registrant with some flexibility. The letters would be required to contain information about the specific test type, a description of the container, a description of the pesticide formulation, and the test results, as well as specify the location of the original test data. EPA reserves its right, on a case by case basis, to require the registrant to submit the residue removal data. The certification that the container/formulation combination meets the residue removal standard, having been tested by the proposed methodology, is information that would be required to be submitted under FIFRA section 19. The certification, as well as the underlying residue removal data, are data necessary to maintain a registration under FIFRA section 3. If the registrant has only a letter from the testing facility in its records instead of the actual residue removal data as would be allowed by Sec. 165.114(e)(1)(iii), the registrant would be responsible for assuring that it could obtain the data so that it could submit the data to EPA, if required to do so. Testing must be conducted in accordance with the Good Laboratory Practice Standards (GLP) at 40 CFR part 160. Section 160.15 requires the testing facility to permit an authorized employee or duly designated representative of EPA to inspect and copy the test data, at reasonable times and in a reasonable manner. If the facility denies EPA access to the test data, EPA would not consider the data to be reliable for purposes of supporting the registration. Proposed Sec. 165.114(e)(2) would specify that the registrant would have to keep a statement of compliance or noncompliance with respect to GLP, as described by 40 CFR 160.12, with the residue removal records. Section 160.12 requires a statement of compliance or noncompliance to accompany all testing and studies submitted to EPA. However, the proposed 40 CFR part 165 regulations would not require registrants to submit data as a routine practice; registrants would only have to keep the residue removal data or related documentation in their records. Therefore, EPA believes that it is appropriate to require registrants to keep a copy of the GLP statement of compliance or noncompliance with the residue removal data. EPA is considering requiring registrants to submit the GLP statement of compliance or noncompliance to EPA as part of the certification in Sec. 165.111. Receiving the GLP compliance statements would provide EPA with information that could be helpful in determining which data to request registrants to submit. In addition, the GLP compliance statements would give EPA a list of the laboratories that have done the residue removal testing, so the laboratories could be inspected. EPA requests comments on whether the GLP statement of compliance or noncompliance should be kept with the residue removal records as proposed, or submitted to EPA. 10. Compliance dates. In section 19(e) of FIFRA, Congress directed EPA to promulgate container design regulations by December 24, 1991 and required compliance with these regulations by December 24, 1993. However, the compliance dates in the statute no longer apply directly because EPA did not meet the statutory deadline for promulgating the final rule. EPA is therefore proposing in Sec. 165.117(a) to provide a period of 2 years after the date of publication of the final rule in the Federal Register before registrants would have to be in compliance with subpart F. As a matter of policy, EPA believes some lead time is necessary for compliance with these regulations, and a 2-year implementation period would provide adequate time for registrants to perform the testing and analysis necessary to comply with the requirements of subpart F. Additionally, 2 years reflects the time frame established in the statute. EPA does not believe Congress would have intended to impose major additional compliance burdens on the regulated community as a result of EPA's delay in issuing this rule. Accordingly, EPA believes it is reasonable to provide a compliance date of 2 years after the date of publication of the final rule in the Federal Register. All pesticides sold or distributed by registrants in nonrefillable containers would have to be in compliance at that time. Proposed Sec. 165.117(c) would specify that certifications for pesticide products registered as of the date of publication of the final rule would be required to be submitted to and received by EPA within 2 years after the date of publication of the final rule in the Federal Register. In addition, EPA is proposing in Sec. 165.117(b) that as of 5 years after the date of publication of the final rule in the Federal Register, persons other than registrants may only sell or distribute pesticide packaged in nonrefillable containers that are in compliance with the requirements of subpart F. Persons other than registrants include, but are not limited to, dealers, retailers, grocery and pet stores, veterinarians, garden centers, and merchandise catalog companies. 11. Waiver requiring EPA approval. Section 165.119 contains the procedures to be followed when applying for exemption from the standardized closure requirement of Sec. 165.102(e) of subpart F. Section 165.119(a) would specify the general information that must accompany the requests and directions on where to submit the requests. Section 165.119(b) would specify the general information that must accompany the request for an exemption from the requirements for standardized closures of Sec. 165.102(e) of subpart F. V. Refillable Container Standards: Container Design and Residue Removal A. Background This proposal would revise 40 CFR part 165 to facilitate the safe refill, reuse, and disposal of refillable containers by establishing container design criteria and refilling responsibilities and practices. Refillable containers are most commonly used in the agricultural pesticide market, but are also used in industrial and institutional applications and by pest control operators. Refillables come in a variety of types and shapes, ranging from 15-gallon ``keg-like'' containers called small volume returnables to huge, 12,000-gallon stationary storage tanks. Portable refillable containers, generally larger than 100 gallons, were introduced into the agricultural pesticide industry in the late 1970s and early 1980s. Fostered by EPA's Bulk Pesticides Enforcement Policy which, under certain conditions, allowed repackaging without a registration for the repackaged product, the use of these containers at first grew exponentially. Although the rate of growth has slowed, the use of these portable refillable containers continues to grow. A National Agricultural Chemicals Association (NACA) survey showed a 3 percent increase in liquid capacity sold in minibulks between 1988 and 1989, with a similar increase projected for 1990 (Ref. 18). The use of minibulks is most common in the Midwest and other regions where many acres of the same crop are farmed. It has been predicted that the use of minibulks will continue to increase for several years and level off when most of the potential monoculture crop markets have been tapped. This may be occurring already, because relatively few users need 100 or more gallons of a pesticide product at any one time. The problems and concerns associated with the use of refillable containers are different from nonrefillable container problems such as spilling, leaking, and splashing because pesticide transfer equipment is generally an integral part of refillable containers. Pesticide product usually is pumped from a refillable container, forming a closed or semi-closed system, instead of being poured from the container, as often occurs with nonrefillables. The two major concerns posed by refillable containers are the potential for a large release of pesticide and the possibility of contamination of the product being sold or distributed in the refillable containers. Large releases of pesticide to the environment can contaminate surface and ground water and sensitive habitats. Contaminated product could cause crop damage, illegal tolerances, and possibly unhealthy exposure. A more thorough examination of the current practices and problems associated with using, cleaning, and disposing of refillable containers can be found in the Report to Congress (Ref. 65). B. Today's Proposal Subpart G of the proposed part 165 regulations contains the refillable container standards, which can be categorized into two major types: container design standards and procedural requirements for refilling. The design standards describe the minimum design and construction requirements that EPA believes are necessary for the safe use and reuse of refillable containers. The refilling requirements set out the responsibilities of both registrants and refillers. These refilling requirements include the procedures and practices that EPA believes are necessary for refillers to follow to ensure the safe refill and reuse of these containers. EPA considered three different regulatory options for subpart G. The options differ mainly in the designation of parties who would be responsible for the containers meeting the design standards. The option proposed in the regulatory text, option 1, would make the registrants responsible for containers meeting the container design standards. The general philosophy of the three options and a detailed description of each are presented in Unit V.B.8 of this preamble. The definition section of proposed subpart A contains definitions of terms used in proposed subpart G and in related subparts of today's proposal. Terms that are key to the understanding of subpart G include: (1) Container. (2) Design type. (3) Dry bulk container. (4) Dry minibulk container. (5) Liquid bulk container. (6) Liquid minibulk container. (7) One-way valve. (8) Refillable container. (9) Refiller. (10) Repackage. (11) Tamper-evident device. (12) Transport vehicle. 1. Scope and applicability. Section 165.120 would cover the scope of subpart G, which would set forth design and construction standards for refillable containers and would establish standards and requirements for refilling such containers. Section 165.122 would describe the applicability of the subpart G regulations. The subpart in general would apply to three different entities: (1) Registrants who distribute or sell a pesticide product to refillers for repackaging into refillable containers, (2) registrants who distribute or sell a pesticide product in refillable containers (i.e., registrants who are refillers), and (3) refillers. As described below, however, different sections of subpart G would apply to specific subgroups of these three categories. Registrants are divided into two categories to distinguish between the two scenarios for repackaging pesticide into refillable containers. In the first and more common situation, registrants distribute or sell product to refillers, generally in large, undivided quantities, and the refillers transfer the product into smaller refillable containers that go to the end user. In the second situation, the registrant packages the product directly into a portable refillable container that is then distributed or sold by a refiller or dealer to the end user, or the registrant delivers its pesticide product directly to the end user's bulk tank. In either of these situations, the registrant is the refiller. The key to the distinction is the party who actually transfers the pesticide product into the refillable container. The container design and construction standards and requirements of Sec. Sec. 165.124, 165.126, and 165.128 would apply to: (1) Registrants who distribute or sell pesticide product to refillers that, in turn, repackage the product into refillable containers, and (2) registrants who distribute or sell pesticide product in refillable containers. Unit V.B.8 of this preamble discusses in detail the reasons EPA is proposing to hold registrants solely responsible for compliance with the container design standards and how refillers can determine that refillable containers comply with these standards. The standards and requirements in Sec. 165.129 would apply to registrants allowing transfer of their registered pesticide product into refillable containers by refillers for distribution or sale. Section 165.130 would establish the responsibilities of registrants in terms of the refilling of refillable containers. Section 165.132 would prescribe related recordkeeping requirements. Sections 165.134 and 165.136 would establish comparable responsibilities, procedures, and recordkeeping for refillers. Section 165.139 would establish a compliance date for the requirements to be met by all registrants and refillers. Several general exemptions would be included in Sec. 165.122(b). Subpart G would not apply to containers that contain manufacturing use products or to transport vehicles that contain pesticide. Similar to subpart F (see Unit IV.B.1 of this preamble), EPA is proposing to exclude manufacturing use products from subpart G because EPA has a limited amount of information on the kinds of containers used for manufacturing use products and the problems with these containers. EPA requests comments and information on the problems, handling practices, and disposal of manufacturing use product containers. As with subpart F, EPA is strongly considering expanding the applicability of subpart G in the final rule to include manufacturing use products. EPA's ``Enforcement Policy Applicable to Bulk Shipments of Pesticides'' (Ref. 63) dated July 11, 1977 and the subsequent amendment to the policy dated March 4, 1991 (Ref. 62) apply to manufacturing use products as well as end use products. EPA intends to rescind the Bulk Pesticides Enforcement Policy when subpart G goes into effect. As a result, manufacturers and distributors that are not registrants of a manufacturing use product would no longer be able to repackage that manufacturing use product for distribution or sale under the terms of the Bulk Pesticides Enforcement Policy. EPA is unsure of the extent to which registrants currently are allowing other manufacturers or distributors to sell or distribute their manufacturing use products under the terms of the Bulk Pesticides Enforcement Policy. Therefore, EPA is uncertain about the potential effect of the proposed regulations on manufacturing use products. EPA welcomes comments on the impact that exclusion from subpart G would have on the distribution of manufacturing use products. The other exclusion in subpart G is for transport vehicles that contain pesticide. Without the exemption, transport vehicles would be subjected to the requirements of subpart G because they would be included in the proposed definition of refillable container (see subpart A). However, EPA does not intend to address the design of transport vehicles. EPA's intent with the provision in proposed Sec. 165.122(b)(2) is to exempt transport vehicles with pesticide-holding tanks that are an integral part of the transport vehicle and that are the primary containment for the pesticide. For example, EPA would like to exclude tank cars and tank trucks used in the distribution of bulk pesticides from the container design standards of this subpart. However, EPA is concerned that there are situations where the distinction between a container and a transport vehicle may not be clear. For example, EPA is aware that pesticide product may be sold or distributed in minibulk containers on small trailers. In this case, EPA would consider the vessel to be a container and therefore subject to the standards of this subpart. EPA requests commenters to describe other examples of unusual container and/or transport vehicle situations that may cause confusion regarding the transport vehicle exclusion in Sec. 165.122(b)(2). 2. Container design standards. Section 165.124 proposes container design standards for refillable containers. EPA is concerned about the structural integrity, strength, and durability of refillable containers. During repeated refill and reuse, refillable containers may be subjected to rough conditions, such as being dropped, bumped, left in the sunlight, or subjected to temperature extremes. Even under the best circumstances and the most careful handling, a certain amount of ``wear and tear'' is expected. Therefore, EPA believes that refillable containers should have a minimum degree of integrity to provide for the safe use, reuse, and refill of these containers. Proposed Sec. 165.124(a)(1) would prohibit the distribution or sale of a pesticide product in a refillable container unless the container meets the standards of Sec. 165.124. Therefore, a container could not be refilled with a pesticide product for distribution or sale unless it met the standards required by this section. Refillable containers in which pesticide product is distributed or sold would include minibulk containers and bulk containers at refillers. As also specified in Sec. 165.124(a)(1), the registrant would be responsible for assuring that the refillable containers in which the registrant's product is distributed or sold meet the standards of this section. Section 165.124(a)(2) would state that information on container failures or other incidents involving pesticide containers that may result in releases of pesticide may be reportable by registrants under FIFRA section 6(a)(2). This requirement is the same as that in Sec. 165.102(a)(2) for nonrefillable containers. As discussed in Unit IV.B.2 of this preamble, EPA is relying on market forces to ensure that dealers and refillers notify registrants of container failures and similar incidents. As a matter related specifically to refillable containers, EPA expects that refillers would notify registrants of failures of any container that the registrant has identified as acceptable under proposed Sec. 165.130(b)(2), and not just the containers that the registrant owns. Proposed Sec. 165.124(a)(3) would clarify that compliance with the proposed part 165 regulations would not be an exemption from DOT's potentially applicable Hazardous Materials Regulations (HMR) at 49 CFR parts 171 through 180. The same provision is proposed in Sec. 165.102(a)(3) for nonrefillable containers. If a pesticide is a DOT hazardous material, the pesticide would be required to be packaged in compliance with both DOT and EPA regulations. For specific proposed part 165 requirements that may overlap with DOT requirements, such as some of the permanent marking requirements and the drop test, EPA is proposing that compliance with the DOT requirement would satisfy the part 165 requirements. Such compliance would prevent duplicative standards or testing. 3. Permanent marking. Section 165.124(b) proposes permanent marking of certain information on refillable containers. The markings would provide information to the user and refiller; facilitate the safe reuse, handling, and disposal of the container; and facilitate enforcement of the regulations. Permanent marking means the same thing as it does for nonrefillable containers, although EPA anticipates that different permanent marking methods will be used depending on the container type, as discussed in Unit IV.B.4 of this preamble. EPA is proposing that the following information be permanently marked on each refillable container: (1) The name of the container manufacturer, (2) the model number assigned to the design type of the container, preceded by the phrase ``Model No.:'', (3) the month and year (last two digits) of manufacture of the container, (4) the rated capacity of the container, in appropriate units of weight or volume, (5) the name, symbol, or code of the material(s) from which the container is made, (6) a serial number or other identifying code that will distinguish each individual container from all other containers, and (7) the phrase ``Meets EPA standards for refillable pesticide containers.'' This type of information is typical of that required by DOT, recommended by the United Nations, and recommended by the Midwest Agricultural Chemicals Association (MACA), a regional trade association, to be marked on refillable containers for chemicals and substances. MACA's Bulk Pesticide Task Force Committee has developed specifications, called the MACA-75 standards, in consultation with technical, regulatory, and legal experts. The MACA-75 standards are voluntary manufacturer specifications and user guidelines for refillable containers for liquid pesticides and other agri-chemicals not subject to DOT specification packaging (Ref. 38). The following table summarizes the markings representing each of the packaging standard schemes. DOT standards listed are those for the Specification 57 containers (metal portable tanks). The U.N. Recommendations specify certain markings for all intermediate bulk containers (IBCs) and additional markings for each individual type of IBC; e.g., metallic, rigid plastic, flexible, etc. (Ref. 76). The table includes the information that would be on a metallic IBC, including the markings common to all IBCs. The table also lists the information specified by the MACA-75 standards and proposed by the part 165 standards. Permanent Marking Required by Representative Packaging Standards ------------------------------------------------------------------------ U.N. metal Type of marking DOT 57 IBC MACA 75 Part 165 ------------------------------------------------------------------------ Container manufacturer....... X X X X Volumetric capacity. X X\1\ X X\2\ Rated gross weight.. X X X X\2\ Materials of construction....... X X\1\ X X Serial number....... X X\1\ X X Date of manufacture. X X X Specification identification..... X X Code identifying IBC type............... X Code identifying packaging group.... X Model number........ X Design pressure..... X X\1\ X Tare weight......... X X\1\ X Original (or leakage) test date. X Date of last leakproofness test. X\1\ State authorizing mark............... X Stacking test load.. X U.N. packaging symbol............. X Minimum thickness... X\1\ Date of last inspection......... X\1\ Test pressure....... X ``Meets EPA standards''........ X ------------------------------------------------------------------------ \1\ These are standards for metallic IBCs only. The other markings identified in this column are for all IBCs. \2\ The proposed part 165 standards would require either the volumetric capacity or the rated gross rate. The information EPA is proposing to be marked on refillable pesticide containers is a subset of the three examples. Different pieces of information are intended to be used for different purposes. The name of the container manufacturer and model number are necessary for registrants, refillers, and EPA and State inspectors to be able to identify acceptable containers. Under this proposed rule, registrants would be responsible for refillable containers meeting the container design standards. A registrant would also be required to develop and provide to refillers a list of containers that are acceptable for refilling with the registrant's product(s). Marking the container with the container manufacturer and the container model number would provide registrants with a way to identify the acceptable containers to refillers. Each model number should identify one and only one design type. This would facilitate EPA's ability to trace a particular minibulk container (with a model number) to a design type and then to the relevant drop test data. EPA is considering adding a regulatory requirement that would prohibit a model number from identifying more than one design type. EPA requests comments on the necessity and feasibility of this potential requirement. Additionally, identifying the container manufacturer, the model number, the date of manufacture, and the serial number would help registrants or refillers to determine the source of a faulty container or batch of containers. The container's date of manufacture and material(s) of construction are intended to facilitate safe disposal of the containers. The date of manufacture is necessary on plastic liquid minibulk containers so a refiller could determine if a container's maximum lifetime of 6 years after the date of manufacture (as described in Sec. 165.134(f)) has expired. While other types of refillable containers do not have a maximum lifetime specified in the regulations, the date of manufacture would still be useful to manage a container throughout its life. The phrase ``Meets EPA standards for refillable pesticide containers'' is intended to provide a quick way for registrants, refillers, and inspectors to identify a container as one that meets the standards of subpart G. Although further inspection would be necessary to determine if the container is acceptable for a particular product, the phrase could serve as a useful initial check. Also, this phrase would provide an easy means for EPA inspectors to identify pesticide containers. Proposed Sec. 165.124(b)(2) would state that if any of the information, such as the date of manufacture, the rated capacity, the material of construction, or the serial number, is required by DOT regulations or by the terms of a DOT exemption, then compliance with DOT's requirement would satisfy the corresponding requirement of this paragraph. DOT exemptions are product-specific and include a series of container specifications and requirements. ``By the terms of a DOT exemption'' means according to the standards contained in an exemption approved by DOT under the provisions of 49 CFR part 107. Section 165.124(b)(2) is included to prevent duplicative requirements between the proposed part 165 regulations and the DOT regulations. 4. Minibulk containers. Section 165.124(c) would establish a general integrity standard for minibulk containers under conditions of normal storage, distribution, sale, and use. With one exception, this standard is the same as the nonrefillable container integrity standard proposed in Sec. 165.102(b) and discussed in Unit IV.B.3 of this preamble. The difference between the two standards is that compatibility between the minibulk container and the pesticide product sold or distributed in the container is not included in the integrity standard for minibulks because it is addressed by the registrant's written list of acceptable containers. One goal of the container design standards is to ensure that refillable containers have a minimum degree of durability and strength. To facilitate this goal, Sec. 165.124(d) would require a drop test for minibulk containers (for both dry and liquid formulations). The drop test standard proposed in this rulemaking is intended to serve as a benchmark indicator of the strength and durability of containers. The standard does not serve as a guarantee that a minibulk container will be able to withstand the ``wear and tear'' associated with repeated refilling and reuse. Liquid minibulk and dry minibulk containers generally are portable containers that are transported from refillers to the field and back. EPA has data on a number of spills that have occurred when minibulk containers were damaged when they fell out of vehicles during transportation. For example, the Illinois Environmental Protection Agency investigated at least four incidents of this type in 1989 (Ref. 55). Also, 11 incidents involving spills from minibulk containers during transportation were reported between 1985 and 1989 to the National Response Center (NRC) (Ref. 60). The NRC, administered by the U.S. Coast Guard, provides a Federal mechanism to receive and refer for action and/or investigation reports of oil, chemical, biological, and etiological releases into the environment in the United States and its territories. Some incidents involving releases of certain hazardous substances or materials listed under several statutes, including the Comprehensive Environmental Response, Compensation, and Liability Act, secs. 101(14) and 102 (42 U.S.C. 9602) and the Transportation Safety Act of 1974 (49 U.S.C. 1802 and 1803), are required to be reported to the NRC. These statutes, however, include only some pesticides on their list of hazardous substances or materials. Thus, only a portion of the incidents involving pesticides must be reported to the NRC, and the actual number of spills is probably larger. The above data show that minibulk containers can and do fall off transportation vehicles. Minibulks also can be dropped while being loaded into or out of vehicles or while being handled with forklifts. Therefore, EPA believes that minibulk containers should be designed to minimize the potential for container damage that could result in a pesticide release. Portable containers must be durable enough to withstand potential stresses and strains that may be encountered during repeated transportation, rinsing, and refilling. While this handling is difficult to simulate, certain performance tests and criteria can be established to ensure that the containers are sturdy enough to withstand some potential abuse, such as sudden impacts, jars, or drops. Most packaging standards, such as the DOT Hazardous Materials Regulations (HMR) and U.N. Recommendations, specify a series of tests, which may include bottom lift, top lift, stacking, leakproofness, hydraulic pressure, drop, and vibration tests. EPA considered a number of different tests as indicators of minibulk container durability and integrity, including leakproofness, pressure, drop, vibration, stacking, and lift tests. In this proposed rule, EPA has chosen to focus on the drop test. EPA's intent is to set a minimum number of standards to address the problems specific to pesticide containers and to have these standards apply to all pesticide minibulk containers, regardless of the hazard classification of the pesticide in the container. The drop test was selected because the data available to EPA indicate that the drop test best simulates the type of incidents that commonly result in pesticide releases from minibulk containers. As EPA gains experience and knowledge of the problems with pesticide containers, EPA may reconsider the necessity of some of the other tests. EPA would like to be consistent with existing packaging requirements, which would minimize the potential for duplicative testing. EPA considered adopting a drop test standard from three different organizations -- U.N., DOT, and MACA. EPA has chosen to incorporate U.N. drop tests into the proposed regulations because U.N. tests are the most universally accepted and used of the three drop tests discussed in this preamble. Additionally, DOT has published a proposed rule that would incorporate U.N. standards for IBCs into the HMR (Ref. 84). Therefore, proposing the U.N. standard is consistent with EPA's goal of minimizing the potential for duplicative testing. In the DOT regulations, the drop tests are designated for each individual type of container. For example, the Specification 57 metal portable tank must be capable of passing a 2-foot drop test (49 CFR 178.253-5). A Specification 34 container, a reusable polyethylene drum for use without overpack, must be capable of passing two different 4- foot drop tests, where one is at a low temperature (49 CFR 178.19-7). In December 1990, DOT published HM-181, a significant revision of the previously existing HMR. One of the goals of HM-181 is to align the HMR with U.N. Recommendations (Ref. 82). The performance standards in HM-181 apply to non-bulk packagings with liquid capacities of 450 liters (119 gallons) or less or, for solids, capacities of 400 kilograms (882 pounds) or internal volumes of 450 liters or less. These requirements could apply to minibulk containers that are smaller than 400 kilograms or 450 liters. HM-181 will not change the testing requirements for minibulk containers with capacities of greater than 450 liters or 400 kilograms. In other words, HM-181 does not incorporate U.N. standards for IBCs. As mentioned above, however, DOT recently published a NPRM that would incorporate the standards for IBCs in Chapter 16 of U.N. Recommendations into the HMR (Ref. 84). EPA estimates that about one-third of all pesticide active ingredients are classified as DOT hazardous materials. Specification 57 metal portable tanks often are used for pesticides that are DOT hazardous materials. However, any plastic minibulk that currently is being used for a pesticide classified as a DOT hazardous material must receive an exemption from DOT, because there are no specifications established by regulation for plastic portable tanks. For plastic portable tanks, the specifications and requirements set out in the exemptions are generally based on the requirements in Specification 34. EPA chose not to incorporate any of DOT's drop tests, because the tests were too specific to certain containers. EPA's goal is to set one drop test standard for all minibulks for all pesticides. Incorporating the DOT drop tests and ensuring consistency would require making the same quantity, material of construction, and hazard class distinctions that are in the HMR. EPA believes this would be too complicated and inconsistent with the goal of establishing minimum standards applicable to all pesticide containers. In addition, many of the detailed specifications are being phased out over the next several years, according to the schedule set out in HM-181. EPA also considered the drop test recommended in the MACA-75 standards. The MACA-75 standards detail a 2-foot drop test and specify that nonmetallic tanks be tested at a low temperature. While this drop test has the benefit of being developed by a segment of the agricultural industry and having industry support, EPA has decided not to propose the MACA-75 drop test because it would not be consistent with either the DOT regulations or U.N. standards. Also, while the MACA-75 standards are well known and commonly used in the agricultural pesticide market, they are virtually unknown in other markets, such as the institutional and industrial segments, and the part 165 requirements would apply to containers for pesticides used in all of these markets. U.N. Recommendations specify drop tests for each type of IBC [containers with capacities greater than 450 liters (119 gallons) but less than or equal to 3,000 liters (793 gallons)], including metallic, flexible, rigid plastics, composite with plastic inner receptacles, fiberboard, and wooden containers. Many minibulk containers would be classified as IBCs. Many dry minibulk containers are refillable bags and therefore have flexible bodies, although EPA is aware of at least one dry minibulk design type with a rigid plastic body. Liquid minibulk containers have metal or rigid plastic bodies. Therefore, EPA has incorporated U.N. drop tests for IBCs with flexible, metal, and rigid plastic bodies into the proposed rule. Section 165.124(d)(1) would require each liquid and dry minibulk container design type to pass successfully the appropriate drop test. In addition, Sec. 165.124(d)(2) would require that each minibulk container be capable of passing the appropriate drop test, even though each minibulk container would not have to be tested. Section 165.124(d)(3) would require the drop tests to be conducted in accordance with the Good Laboratory Practice Standards in 40 CFR part 160. Proposed Sec. 165.124(d)(4) would state that if a pesticide product is required to be packaged according to DOT standards and the DOT requirements include a drop test, then compliance with the DOT drop test would satisfy the part 165 minibulk drop test requirement. However, the registrant still would have to comply with the certification and recordkeeping requirements concerning the drop test in Sec. Sec. 165.126 and 165.128. The registrant would not necessarily have to conduct the drop test; the container manufacturer or another entity could actually conduct the testing. However, the registrant would be responsible for ensuring that the container meets the drop test standard. The actual methodology for the drop tests is proposed in Sec. 165.125 and discussed in Unit V.B.7 of this preamble. 5. Apertures. Section 165.124(e) would address the potential problem of contamination in liquid minibulk containers by requiring each aperture of a liquid minibulk to have a one-way valve and/or a tamper-evident device. EPA's concern about contamination of pesticide product in liquid minibulks arises partly because refillers and registrants have little or no control over what happens to these containers when they are in the field. EPA has received anecdotal evidence of end users removing pumps from minibulks in efforts to remove all of the pesticide from the containers (Ref. 74). This situation is problematic for the refiller, because the refiller has no assurance about whether the end user simply tried to remove all of the product or used the container to store a substance other than the pesticide product. EPA believes that tamper-evident devices are needed on all liquid minibulk container openings unless access into the container is prevented by other design features, such as one-way valves. One-way valves and tamper-evident devices (both terms are defined in proposed Sec. 165.3) would not prevent pumps and closures from being removed from containers. However, EPA believes that one-way valves and tamper- evident devices would give refillers reasonable indication about whether substances other than the pesticide product for which the containers are labeled may have been introduced into the containers. These design requirements would be an important part of ensuring the safe refilling and reuse of liquid minibulk containers. Many liquid minibulk containers have several openings, or apertures, including a vent, an opening used for filling and/or cleaning the container, and an opening used for withdrawing products. However, some of the smaller liquid minibulk containers (small volume returnables) have a single opening that serves as a filling and withdrawal port and may also provide a venting mechanism. Many liquid minibulk containers that are currently being produced, particularly those that meet MACA-75 standards, already have tamper- evident devices. Many of the liquid minibulk containers that are currently used have one-way valves on the withdrawal port, because container manufacturers and registrants are concerned with preventing users from introducing foreign materials into the opening from which pesticide is dispensed. EPA believes that all minibulks should have these minimal protective measures. The most common type of tamper-evident device currently used in the agricultural pesticide industry is a wire that is attached to the closure and then hooked through a slot, like the eye of a needle. The refiller seals the wire to form a loop after the container is refilled. The wire loop is broken if anyone attempts to remove the closure from the container. Other types of tamper-evident devices include cables, heavy tape, or plastic rings that are broken or removed if the closure is removed from the container. One issue regarding one-way valves is the location of the valve. Specifically, would the valve have to be part of the container, or could the one-way valve be part of the equipment attached to the container to withdraw pesticide? This is an important consideration for small volume returnable containers, because there is often only one opening on the container. If a one-way valve allowing pesticide withdrawal were placed in the container, this valve would have to be braced open to fill the container, which is difficult to accomplish. Instead, many small volume returnables are designed with the one-way valve in the coupler that must be used to withdraw product from the container. EPA's intent with the requirement for one-way valves is to prevent any person other than the refiller from placing material into the container. Therefore, it would be acceptable to have the one-way valve in a coupler that attached to the container if the coupler is the only reasonably foreseeable way to withdraw pesticide from the container. EPA requests comment on the issue of locating the one-way valve. Another question regarding tamper-evident devices and one-way valves is whether these requirements should apply to dry refillable containers as well. EPA encourages the incorporation of tamper-evident devices and one-way valves into the design of dry minibulk containers. However, EPA does not believe it is appropriate to require them at this time. EPA has no information indicating that there is a problem with contamination caused by dry minibulk containers being used to store or transport substances other than pesticide and then being returned for refilling. EPA requests comments on whether a requirement for tamper- evident devices and one-way valves should apply to dry minibulk containers. 6. Bulk containers. Section 165.124(f) proposes standards for liquid and dry bulk containers at refilling establishments of refillers operating under contract to or written authorization from a registrant. EPA is interested in the integrity, strength, and durability of bulk containers, which are generally used for stationary storage of large quantities of pesticides. Bulk containers are often located outside and therefore may be subjected to rough weather conditions, including direct sunlight, precipitation, and temperature extremes. Because bulk containers are larger than minibulk containers, the potential for a large release exists if container integrity is breached. Because of the possible costs and inherent dangers associated with large volumes of pesticides, bulk containers usually are designed and constructed to be strong and durable. However, some refillers have experienced problems with leakage from the fittings on liquid bulk containers, particularly when corrosive pesticides are being stored. As stated earlier, subpart G does not apply to the design of transport vehicles. In this proposal, EPA intends to regulate the design of large, stationary containers that are used for the distribution or sale of pesticide. Specifically, the opening paragraph in Sec. 165.124(f) would specify that the standards in Sec. 165.124(f) would apply only to bulk containers at the refilling establishments of refillers operating under contract to or written authorization from a registrant. The standards for bulk containers in Sec. 165.124(f) would not apply to bulk containers at a registrant's facility. A bulk container at a registrant's facility could be used for many purposes, including storing raw materials (active ingredients or inerts), formulating a product, storing a product before it is packaged into nonrefillable containers, and storing a product that will be transferred into tank trucks. Without limiting the applicability of Sec. 165.124(f), the proposed container design standards for bulk containers would apply to registrants' bulk containers used for storing a pesticide product that will be transferred into tank trucks or directly into portable refillable containers. EPA does not have enough information at this time on whether there are bulk container problems at registrant facilities. EPA believes that many of the registrants' bulk containers are located indoors, and therefore are not subjected to the deteriorating effects of the weather. As discussed in Unit IV.B.1 of this preamble regarding manufacturing use products, it is possible that the stewardship of containers at registrant facilities is better than that at other levels of the pesticide distribution chain, because containers at registrant facilities are handled by workers who are used to and trained to handle chemicals on a regular basis. Additionally, EPA believes that economic considerations would push registrants to having containers of sufficient integrity to hold the product. However, EPA is considering applying the standards of Sec. 165.124(f) to registrants' bulk containers that are used to sell or distribute a pesticide product, because there is an inherent risk associated with bulk containers due to the quantity of product they hold. EPA requests comment on whether it is appropriate to apply the standards in Sec. 165.124(f) to those bulk containers at registrants' facilities that are used to sell or distribute pesticide products in refillable containers. Also, the standards of Sec. 165.124(f) would not apply to bulk containers at custom blenders or independent custom applicators if these facilities are not refilling establishments where a refiller is operating under contract to or under written authorization from a registrant. However, proposed subpart H would require bulk containers at independent custom applicators and custom blenders to be secondarily contained. EPA believes that the number of bulk containers at custom blenders and custom applicators that would be subject to subpart H but not subpart G is limited -approximately 340 containers. However, since EPA has no reason to believe that the bulk containers at refilling establishments are different from those at the facilities of independent custom applicators or custom blenders, EPA is considering expanding the scope of subpart G to apply the standards in Sec. 165.124(f) to all bulk containers used to store or to sell or distribute a pesticide product at independent custom applicators and custom blenders in the final rule. EPA requests comments on any reasons why the standards should not be expanded. Many current State regulations for bulk pesticide storage address the integrity of the containers used to store pesticide (Ref. 70). Generally, these State specifications are performance standards that address the stresses and conditions that a container most likely would have to withstand. EPA is proposing to regulate the integrity of bulk containers in a manner similar to that of many States. In fact, the language that EPA is proposing for the container integrity of dry and liquid bulk containers in Sec. 165.124(f)(1) is based, in part, on bulk pesticide storage regulations in Wisconsin and Minnesota (Refs. 40 and 79). Proposed Sec. 165.124(f)(1)(i) would specify that bulk containers would have to meet the integrity standards except during a civil emergency or an act of God. By act of God, EPA means any unanticipated grave natural disaster or other natural phenomenon of an exceptional, inevitable, and irresistible character, the effects of which could not have been prevented or avoided by the exercise of due care or foresight. This proposal incorporates the definition of act of God from section 101(1) of the Comprehensive Environmental Response, Compensation, and Liability Act [92 U.S.C. 9601(1)]. Proposed Sec. 165.124(f)(1)(ii) would require all bulk containers and their appurtenances to be resistant to extreme changes in temperature. Also, all bulk containers and their appurtenances would have to be constructed of materials that are adequately thick to not fail and that are resistant to corrosion, puncture, and cracking. Under Sec. 165.124(f)(1)(iii), the containers would have to be capable of withstanding all operating stresses, taking into account static head, pressure buildup from pumps and compressors, and any other mechanical stress to which the containers may be subjected in the foreseeable course of operations. In addition to the containers' integrity, EPA is concerned about the potential development of high internal pressures in liquid bulk containers. Because the bulk containers are often located outside, they may be subjected to direct sunlight and high temperatures. Many States with bulk pesticide storage regulations require the storage containers to be equipped with vents. In Sec. 165.124(f)(2), EPA is proposing that each liquid bulk container be equipped with a vent or other device designed to relieve excess pressure, prevent losses by evaporation, and exclude precipitation. This proposed requirement is similar to that in Minnesota's bulk pesticide storage regulations (Ref. 40). One kind of vent that would meet this requirement is a conservation vent. Such a vent is normally closed, but will open under either vacuum or internal pressure. Wisconsin's bulk pesticide storage regulations require each fixed storage container used for liquid bulk pesticide to be equipped with a conservation vent (Ref. 79). EPA also is proposing to prohibit external sight gauges on liquid bulk containers. As described in Sec. 165.124(f)(3), external sight gauges are pesticide-containing hoses or tubes that run vertically along the exterior of the container from top to bottom. External sight gauges are vulnerable to damage and could cause all of the contents of a container to be released if they are broken. Therefore, EPA believes it is necessary to prohibit external sight gauges to ensure the safe use, reuse, and refilling of liquid bulk containers. There are other ways to determine the volume of liquid pesticide in a container, including float gauges, calibrations on the side of translucent plastic containers, calibrated dip sticks, and electronic devices (Ref. 79). In Sec. 165.124(f)(4), EPA proposes to require all connections on liquid bulk containers, except for vents, to be equipped with shutoff valves that can be locked closed. A shutoff valve is a valve that allows the flow of pesticide from the container connection to be stopped. EPA believes it is necessary to have shutoff valves to decrease the potential for a large spill. For example, if a hose broke during the transfer of pesticide from a container in the absence of a shutoff valve, pesticide would continue to be released from the container until the container was empty or until the hose could be replaced, which could be a very risky mechanical intervention. However, if the connection had a shutoff valve, a person could stop the flow of pesticide simply by closing the valve. EPA is proposing that the shutoff valve has to be able to be locked to prevent releases due to vandalism. Many currently available valves can be locked closed with a simple padlock. EPA is not currently proposing to regulate the location of the shutoff valve. The Wisconsin pesticide bulk storage regulations, however, specify that the shutoff valve be ``located on the storage container or at a distance from the storage container dictated by standard engineering practice'' (Ref. 79). In a guidance document explaining the regulations, Wisconsin clarifies that ``the valve should be no farther from the container than 3 times the diameter of the plumbing being used to connect the valve to the container. For cone bottom tanks the first valve can be located within three pipe diameters of the tank skirt or frame, provided the pipe is rigidly connected to the skirt or frame'' (Ref. 79). EPA believes it may be necessary to specify the location of the shutoff valve to ensure that it is located within the secondary containment structure, if containment is required. EPA requests comments on whether it is necessary to regulate the location of shutoff valves, and if so, what the location should be. 7. Minibulk container drop test methodology. Proposed Sec. 165.125 would prescribe the drop test methodology for flexible, metal, and rigid plastic minibulk containers. Wherever possible, EPA has used the exact wording in U.N. Recommendations. Significant changes and additions are discussed below. Section 165.125(b) describes the preparation and general requirements that would be necessary for all of the specific drop tests. A difference between the proposed tests and U.N. tests is the requirement in Sec. 165.125(b)(2) that any pump, valve, meter, hose, or other hardware that is attached to the container during transportation, storage, or use would also be attached during the test. EPA is proposing this requirement because, as discussed previously, minibulk containers usually are transported from the dealer to the field with the associated hardware attached to the containers. Unless minibulk containers are designed to provide protection, the appurtenances can be damaged or sheared off of the containers in the case of sharp blows or jolts to the containers. As a result, the pesticide could spill from the ruptured container. Preventing a spill when a container is dropped with hardware attached can be achieved in several ways. The pump can be recessed; e.g., the liquid minibulk can be designed with a depression or area in which the pump fits without protruding from the contour of the container. Another type of protection is a 10- to 12-inch lip or ridge on the top of the container that extends above the level of the pump. An alternative design with the same purpose is a spring-loaded check valve in the connection between the pump and the minibulk. If the pump is sheared off or jolted out of place, the spring automatically closes the valve and leakage is prevented. Both of these options -- hardware protection and the use of a spring-loaded check valve -- offer equal environmental protection, although the extent to which pumps are damaged may vary considerably. Sections 165.125(b)(4) through (b)(6) would set out the conditions under which a container could be drop tested with a test material other than the pesticide product that will be transported in the container. The registrant would be responsible for selecting an appropriate test substance. Section 165.125(b)(4) would allow a substance to be substituted for a dry pesticide if it has the same physical characteristics, such as mass and grain size, as the pesticide to be carried. Section 165.125(b)(4) also would allow the use of additives such as lead shot to achieve the requisite total package mass, as long as they are placed so that the test results are not otherwise affected. Section 165.125(b)(5) would allow a container for a liquid pesticide to be tested with another substance, if the other substance's relative density and viscosity are similar to those of the pesticide to be carried. Section 9.5 of the U.N. Recommendations states that relative density and specific gravity are considered to be synonymous (Ref. 76). Section 165.125(b)(6) would set out the conditions where water could be used as the test substance. EPA is not proposing numerical standards to define ``similar relative density and viscosity.'' Instead, EPA is placing the responsibility for determining the similar relative density and viscosity of a test substance on the registrant. EPA anticipates that most registrants will test their containers using water as the test substance, in accordance with Sec. 165.125(b)(6), and therefore won't have to determine whether a test substance has similar relative density and viscosity. EPA requests comments on whether ``similar'' relative density and viscosity should be defined. Sections 165.125(b)(4) through (b)(6) propose requirements based on the relative density or another characteristic of the pesticide to be sold or distributed in the container. In other words, the testing would be specific to a single formulation and container combination, which could be problematic if the minibulk container is not going to be dedicated to a specific product. However, the tests in Sec. Sec. 165.125(c) through (e) are written to allow a test done at a drop height higher than the required minimum to satisfy the drop test conducted at the minimum height. Therefore, a registrant could drop test a minibulk container based on the most dense pesticide product to be sold or distributed in the minibulk container and satisfy the drop test requirement for any of its products to be sold or distributed in the container. For example, a test for a pesticide with a relative density of 1.4 that is conducted with water as the test substance would require a drop height of 1.4 meters, according to proposed Sec. 165.125(b)(6)(ii). (Drop height = 1.4/1.2 x 1.2 meters = 1.4 meters). A container that passed this 1.4-meter test could also be used to package a pesticide product with a relative density of 1.3, because the testing height of 1.4 meters would be greater than the required height (1.3 meters). Therefore, if a registrant intends to use a container to sell or distribute several products, the container would only have to be tested (with water) at a drop height based on the pesticide product with the largest relative gravity. Section 165.125(b)(7) would require the test records to include the number of containers of each particular design type that were tested for the design type to successfully pass the drop test. This would indicate whether a registrant simply continued to test a container design type until one container passed. EPA believes that there are market incentives to prevent registrants from continuing to test containers of a design type that fails more than once or twice, including the cost of the minibulk containers and, more importantly, the liability and associated problems of containers failing in the field. However, EPA is considering establishing a regulatory limit on how many times a design type could be tested. For example, EPA could set a standard such that if two containers of a design type fail the drop test, the entire design type would fail and would have to be modified. This would ensure that a maximum of two containers would be tested unsuccessfully for a given design type. EPA requests comments on whether it is necessary to limit the number of containers of each design type that can be tested before one container passes and, if so, whether the approach discussed above is appropriate. Sections 165.125(c) through (e) would provide specific details for the drop tests. These specifications would mandate the capacity to which the container is to be filled, the type of surface to receive the drop, the drop height, and the criterion for passing the test. Section 165.125(c) would apply to dry minibulk containers with flexible bodies, but not to liquid minibulk containers, because EPA is assuming that liquid pesticides would not be transported in refillable containers with flexible bodies. EPA requests information on any liquid pesticide products that are distributed or sold in flexible refillable containers. As proposed in Sec. 165.125(c)(1), EPA considers a minibulk container with a flexible body to consist of a body constituted of film, woven fabric, or any other flexible material or combination thereof. This description of flexible bodies is based on the U.N. definition of flexible IBCs in section 16.3.2.1 of the U.N. Recommendations (Ref. 76). Section 165.125(d) would apply to minibulk containers (for either liquid or dry product) with metal bodies. Different filling requirements and drop heights would be used for testing containers for liquid or dry formulations. Similarly, Sec. 165.125(e) would apply to minibulks (for either liquid or dry product) with rigid plastic bodies, with different filling requirements and drop heights for liquid or dry minibulk containers. The different filling requirements in Sec. Sec. 165.125(d) and (e) -- to 95 percent of the capacity for dry minibulks and to 98 percent of the capacity for liquid minibulks -- are the same as specified in U.N. Recommendations. Proposed Sec. Sec. 165.125(d)(4) and (e)(5) would require the container to be dropped ``on that part of the base considered to be the most vulnerable.'' EPA anticipates that this would require the containers to be dropped onto a corner or edge of the base rather than flat on the base of the container to fulfill this requirement. The drop heights in U.N. specifications vary according to the hazard level (packing group number) of the substance to be transported in the container (Ref. 76). The drop height is 1.2 meters (3.9 feet) for packing group II substances and 0.8 meters (2.6 feet) for packing group III. EPA is proposing different drop heights, depending on whether the pesticide formulations to be sold or distributed in the containers are dry or liquid. For liquid minibulks, EPA is proposing the packing group II test -- a drop of 1.2 meters. For dry minibulk containers, EPA is proposing the packing group III test, which is less stringent - a drop of 0.8 meters. EPA is proposing a higher drop height for liquid minibulks to ensure environmental protection. EPA believes that a higher drop height for liquid minibulk containers is appropriate because it is more difficult to contain and recover a release of liquid material than a release of dry material. In some ways, U.N. drop tests are not as rigorous as some of the DOT and MACA drop tests. The orientation in which the container is dropped in the drop tests in the DOT Specification 57 and MACA-75 standards is more demanding than the orientation in U.N. IBC drop tests. For example, Specification 57 requires a ``free drop onto a flat unyielding horizontal surface, striking the target surface in the position and attitude from which maximum damage to the tank (including piping and fittings) is expected'' [49 CFR 178.253-5(a)(2)]. In order to comply with this requirement, the container generally would be dropped on its top -- either on the fittings or a corner -- which would cause the force of the container contents to impact directly on the closures. The closures are often on the top of the container and are one of the container parts most likely to fail. On the other hand, the drop test for IBCs with metal or rigid plastic bodies in U.N. standards (section 16.2.8.6.3) specifies a drop ``in such a manner as to ensure that the point of impact is on that part of the base of the IBC considered to be the most vulnerable'' (Ref. 76). In this orientation, the initial force of the container contents would impact upon the bottom of the container. The base of the container is generally less likely to fail than a closure, given similar conditions (wall thickness, container material, etc.) Considering the difference in severity between the orientation of the U.N. IBC drop test (also the proposed part 165 test) and the DOT Specification 57 drop test, EPA believes it is appropriate to propose a drop height of 1.2 meters (3.9 feet) for liquid minibulk containers instead of 2 feet, like the DOT Specification 57. EPA requests comments on whether the drop tests being proposed are appropriate. 8. Container design responsibility. A significant issue regarding these proposed regulations is who should be held responsible for ensuring that the refillable containers would meet the standards in Sec. 165.124. This proposal includes three different regulatory options for who would be held responsible for doing so. The parties that potentially could be held responsible include registrants, refillers, container owners, and container manufacturers. However, before these options are presented, it is necessary to provide background information on the pesticide registration regulations in 40 CFR part 152, the usual distribution chain for products that are repackaged into refillable containers, and the way in which refillable containers enter the distribution chain. A registrant must submit, among other things, formulation information, data, and labeling to EPA to obtain a registration for a pesticide product. A ``pesticide product,'' as defined at 40 CFR 152.3(t), includes the composition, packaging, and labeling of the pesticide in the form in which the pesticide is, or is intended to be, distributed and sold. In the typical nonrefillable chain of commerce, the registrant produces the pesticide formulation, packages it or contracts for the packaging, labels it, and releases it for distribution or sale. The package is not opened until it reaches the end user. If a second producer wishes to repackage that pesticide, that producer must obtain a separate registration for the product that includes the formulation and the second registrant's package and label. In the refillable chain of commerce, pesticide products distributed or sold in refillable containers and the containers themselves often enter the pesticide distribution chain separately. As discussed in Unit V.B.1 of this preamble, there are at least two ways for product sold in refillable containers to enter the pesticide distribution chain. First, some registrants package the products initially into the refillable containers for distribution or sale. In this case, the refillable containers and the products enter the pesticide distribution chain together, much as a pesticide product in a nonrefillable container would. Second, and more commonly, pesticide products that are distributed or sold in refillable containers are sold or distributed in ``bulk form'' (large undivided quantities) by a registrant to a dealer who has obtained written authorization to repackage the registrant's product and to use the registered product's label. Such dealers are refillers as defined in this proposal. The pesticide product is transferred from tank cars or trucks to bulk containers at the dealer's facility. The dealer then transfers the pesticide formulation from the bulk containers into minibulk containers, generally for sale to end users. In these situations, the containers and products may enter the distribution chain at different times. Containers can be purchased from container manufacturers by any party in the pesticide distribution chain, including registrants, distributors, dealers, and end users. While EPA has not been able to determine accurately the number of liquid minibulk containers that are owned by each group nationwide, a survey of refillers (dealers) in Iowa during the 1990 Iowa less-than- 56-gallon pilot project reported the following data: (1) Seventy-five percent to 85 percent of liquid minibulk containers were dealer-controlled (owned by registrant, owned by dealer, owned by registrant and leased by dealer, etc.). (2) Fifteen percent to 25 percent of liquid minibulk containers were owned by farmers (Ref. 17). In general, the minibulk containers that are purchased by registrants and then loaned, leased, or sold to refillers are of significantly better quality than other minibulks, including those owned by end users or purchased directly by dealers. Most liquid bulk containers are owned by refillers. Refillers may purchase liquid bulk containers independently. Alternatively, a registrant might give a refiller a liquid bulk container as part of an incentive program to buy and sell the registrant's products in bulk. For example, some pesticide manufacturers provide bulk storage tanks to dealers, who then ``earn'' the cost of the container by meeting a certain obligation for the volume of pesticide sold. Refillers also may lease liquid bulk containers from pesticide registrants. Dry minibulk and dry bulk containers generally are purchased and owned by registrants, because currently, refillers repackage predominantly liquid pesticide products. However, the number of refillers that handle dry pesticide in large quantities is increasing. Therefore, the number of refillers who purchase dry minibulk and dry bulk containers also may increase. a. Introduction to the options considered by EPA. As previously discussed, any person in the pesticide distribution chain may provide the container for refilling. The question is ``Who should be responsible for assuring that refillable containers meet the container design standards of part 165?'' EPA is proposing that registrants be held responsible for meeting the container design standards for minibulk and bulk containers. In making the choice, EPA considered the following three regulatory options. (1) Registrants would be responsible for containers meeting the proposed design standards. Registrants would identify the acceptable containers to refillers and EPA by specifying the container manufacturer and model number. In a variation to this option, registrants would identify the acceptable containers to refillers and EPA by specifying design type parameters. (2) Anyone could request EPA's approval to use a certification seal. This could be container manufacturers, but it also could be registrants, refillers, or even end users. The seal would indicate that a person had certified to EPA that the container meets the part 165 standards. Registrants would address container/formulation compatibility by identifying design type parameters to refillers and EPA. (3) Container manufacturers would be responsible for containers meeting the proposed design standards. Registrants would address container/formulation compatibility by identifying design type parameters to refillers and EPA. In evaluating the options for container design responsibility, EPA considered the differences among the options in terms of seeking the least burdensome approach that is also effective, practicable, and easily enforceable. EPA believes that Option 1 is more effective, more practicable, and significantly more easily enforceable than the other two options. EPA also considered whether the proposed regulations would encourage refillable containers. For the following reasons, EPA considers it desirable to encourage the use of refillable containers with the proposed part 165 container regulations: (1) FIFRA section 19(e)(1)(B)(iv) encourages the use of refillable containers; it directs EPA to promulgate regulations on container design to facilitate safe refill and reuse. (2) Refillable containers are consistent with the concept of pollution prevention and waste minimization. (3) The demand from end users for refillable containers is strong and growing. EPA believes there may be a difference among the options in terms of whether the regulations would encourage refillable containers. EPA requests comments on whether each option would encourage refillable containers, as well as the reasons why or why not. On the other hand, EPA does not believe there would be a significant difference among the containers that are designed and produced under the various options. EPA anticipates that container manufacturers will make containers that meet the standards in order to fulfill a market demand, regardless of who is responsible under EPA's regulations. Similarly, there may not be a big difference among the options in terms of the costs to design complying containers. The containers likely would be designed similarly regardless of who was responsible. Also, the recordkeeping requirements and the associated costs would be similar for all of the options. However, the party responsible for recordkeeping varies, which may alter the burden of the proposed regulation. EPA requests comments on the differences in the risks, benefits, and costs among the options, and on ways in which these options could be improved. b. Option 1-- Registrants, model numbers. In option 1, which is preferred by EPA, registrants would be responsible for the containers meeting the proposed design standards. The containers would be marked with the phrase ``Meets EPA standards for refillable pesticide containers.'' The phrase would not imply any degree of review or acceptance by EPA. In proposed Sec. 165.126, registrants would be required to certify to EPA that the refillable containers that are refilled with their products meet the design standards. Under Sec. 165.128, registrants would be responsible for maintaining records on the refillable containers used to distribute or sell their products. Registrants would be required by Sec. 165.130(b)(2) to develop a written list of acceptable containers for each product. This list would identify those refillable containers that could be used for selling or distributing the registrant's product. Acceptable containers would be those that the registrant has determined meet the standards of Sec. 165.124 and are compatible with the pesticide formulation to which the list applies. As described in Sec. 165.130(b)(2)(ii), the containers would be required to be identified by, at a minimum, the container's manufacturer and model number. Section 165.130(c) would require registrants to provide this written list of acceptable containers to refillers. Under the proposed Sec. 165.132, registrants would be required to keep a copy of the list of acceptable containers. EPA would have access to this list because the registrant would be required to make the records available for inspection and copying and to submit them upon request. Refillers would be required by Sec. 165.134(c)(1)(i) to refill product only into refillable containers that are identified on the registrant's list of acceptable containers. The refiller would know that the registrant had ensured that the containers on the list met the standards of Sec. 165.124 and were compatible with the formulation. Option 1 is sensible for several reasons. Under FIFRA, registrants are responsible for the containers as part of the registered pesticide product. Registrants already submit data and other information as required to show that their pesticide products do not cause unreasonable adverse effects on the environment. Registrants are in the best position in terms of technical knowledge to determine which containers are most suitable for their products. Also, between registrants and nonregistrant refillers, registrants are generally larger organizations and thus financially more capable of being responsible for container testing. Refillers would be able to identify allowable containers because they could only repackage products into containers specified on the lists of acceptable containers. It would be easy for refillers to recognize the acceptable containers because the containers would be identified by model numbers. EPA inspectors easily would be able to determine whether a product was refilled into a container meeting the requirements of part 165 because they would know (or have access to) the acceptable model numbers. Similarly, EPA inspectors would be able to determine that containers had been properly tested by inspection of registrants' records. Requiring registrants to be responsible for container design standards may not encourage the use of refillable containers. The regulatory approach of holding registrants responsible for container design standards could have the effect of encouraging registrants to dedicate containers to a specific pesticide product. With dedicated containers, the number of minibulk and bulk containers needed by each refiller could increase, which could place an increased storage, handling, and maintenance burden on refillers. Another possible effect could be to discourage farmer-owned containers, which may represent about 15 percent to 25 percent of the current number of liquid minibulk containers. EPA specifically requests comments on whether option 1 would encourage refillable containers. The specific requirements of this option are discussed in greater detail in Units V.B.9 through V.B.13 of this preamble. As a variation to option 1, EPA considered requiring containers to be identified by design type parameters rather than by the container's manufacturer and model number. Under this variation, registrants would still: (1) Be responsible for the containers meeting the proposed design standards, (2) certify to EPA that the refillable containers meet the design standards, and (3) maintain records for the refillable containers. Refillers would be required to refill product only into refillable containers that the registrant identifies as acceptable. Similar to option 1, this variation has the potential to discourage the use of generic refillable containers obtained independently by refillers or users. Another disadvantage of this variation is that refillers and EPA inspectors may have difficulty identifying acceptable containers if they are given only a description of the design type parameters instead of a definitive list of acceptable models. EPA rejected this variation partly because of this potential difficulty in identifying acceptable containers. In addition, EPA does not believe the container design parameters could be described so that refillers would know what to look for in determining acceptable containers. Therefore, EPA also rejected this variation because it doesn't appear practicable or easily enforceable. c. Option 2.-- Certification seal. Under option 2, any person would be allowed to produce a container meeting EPA's design standards. In addition, any person would be allowed to certify to EPA that the container meets the part 165 standards. EPA would grant the person permission to mark the container permanently with a seal (``the certification seal''). The seal, which would indicate that a person had certified to EPA that the container meets the part 165 standards, could be a phrase such as ``Meets 40 CFR part 165 container standards.'' This statement would be the only one that could be used as the seal. EPA envisions that principally container manufacturers or registrants would avail themselves of this option, but refillers or end users could also. The submission to EPA would include a certification that the container meets the part 165 container design standards, a description of the container (including its design parameters, the container manufacturer, and the container model number), and a citation to the location of the test data and records. Use of the seal would be denied if the owner of the data and records did not provide EPA access to inspect and copy the data and records. The person who certifies compliance with the standard would be required to maintain a copy of the certification submission. EPA would grant permission to mark refillable containers permanently with the seal if all of the certification submission criteria were met. EPA would notify the person making the certification of EPA's approval or disapproval to use the seal. EPA would not be approving the refillable container, but rather, allowing the seal to be used based on the certification. EPA could compile a list of the model numbers for which approval to use the seal was granted. This option could include persons other than registrants or refillers. Section 19(e) of FIFRA does not restrict its applicability to any particular persons, and there is no express statement of an intent to limit applicability of FIFRA section 19(e) to registrants. Refillers and registrants would be required to repackage product only into containers that had the certification seal. With this option, registrants would be required to address compatibility between the containers and the pesticide formulations. Compatibility depends to a great extent on the container's material(s) of construction. Therefore, the registrant would be required to develop, for each product, a list of container construction materials that would be acceptable for the containers in which its product could be distributed or sold. This would be similar to the list of acceptable containers in option 1. Registrants would be required to provide this written list of acceptable container construction materials to refillers and to keep a copy of it. Refillers would be required to repackage a pesticide product only into refillable containers that are marked with the certification seal and that are made from materials identified as acceptable by the registrant. Option 2 has several advantages. It allows more flexibility than option 1, because refillers wouldn't be bound to specific container models selected by the registrant, unless the registrant required its pesticide to be sold or distributed in dedicated containers. This flexibility might help encourage refillable containers because, in not being limited to specific manufacturers and model numbers, it may be easier for parties in the distribution chain to obtain acceptable containers. It would be easy for refillers to identify allowable containers, because they would look for the seal and also ensure the container is made from a material the registrant has identified as acceptable. Similarly, EPA inspectors could determine if a pesticide had been repackaged into an improper refillable container by looking for the seal and reviewing the registrant's list of acceptable container materials. The inspectors would know or would have access to a list of the model numbers of containers that have been certified to meet the standard through the information supplied to EPA. EPA also would have a list of the locations of the data and records. This approach to data and recordkeeping would be similar to the inspection of laboratories under the Good Laboratory Practice Standards in 40 CFR part 160. As a condition for using the certification seal, permission would have to be given for EPA to inspect testing facilities and the data. A disadvantage of this option is that the need to certify and to obtain EPA permission to mark a container permanently with the certification seal may discourage some persons from seeking approval of a wide number of containers or from seeking improvements in existing containers. Moreover, the disadvantage to EPA is the need to establish and maintain what is, in essence, a licensing program for pesticide containers with its accompanying costs and administrative requirements. EPA believes an option that creates such administrative burdens for the industry and EPA is a less desirable option. Also, it could be more difficult to enforce this option because the records and data could be held by container manufacturers, testing facilities, registrants, refillers, or end users. EPA routinely inspects registrants and registered establishments. EPA's enforcement program, which is carried out in cooperation with the States, is directed to registrants, producers, and users. In other words, EPA has a framework for and experience in regulating registrants and producers, but not for handling container manufacturers or other parties. d. Option 3-- Container manufacturers. Under option 3, container manufacturers would be responsible for containers meeting the design standards in the proposed Sec. 165.124. The container manufacturer would mark the containers permanently with a seal, which would be a certification that the container meets the standards of part 165. As in option 2, the seal could be a phrase such as ``Meets 40 CFR part 165 container standards.'' The container manufacturer would be responsible for keeping records for the containers. Refillers would be required to repackage product only into containers that were marked with the seal. Similar to option 2, registrants would be required to address compatibility between the containers and the pesticide formulations. The registrant would be required to develop, for each product, a list of construction materials that would be acceptable for the refillable containers and provide this list to refillers. Registrants would keep the requisite list of acceptable container materials, and would make the list available to EPA and the states. Refillers would be required to repackage pesticide product only into refillable containers that are marked with the seal and that are made from materials identified as acceptable by the registrant. Option 3 makes sense for several reasons. It allows more flexibility than Option 1, mainly because refillers wouldn't be bound to specific container models selected by registrants, unless the registrant required specific containers for its pesticide products. This flexibility might help encourage the use of refillable containers because it may be easier for parties in the pesticide distribution chain to obtain acceptable refillable containers. Refillers could identify allowable containers by looking for the seal and checking to be sure that the container is made from a material the registrant has identified as acceptable. Similarly, EPA inspectors could determine if pesticide has been repackaged into an improper refillable container by looking for the seal and reviewing the registrant's list of acceptable container materials. Because this option assigns responsibility for container design standards to container manufacturers, it departs from the traditional FIFRA regulatory scheme that places the burden of registrability of pesticides on pesticide registrants. However, section 19(e) of FIFRA does not restrict its applicability to any particular person. Neither FIFRA section 19 nor the legislative history for the 1988 amendments to FIFRA indicate Congress intended to preclude regulation of container manufacturers for container design. Under option 3, EPA would be entering an industry sector it has never regulated before under FIFRA. The disadvantage and the main reason this option was rejected is that EPA lacks information and experience in this industry, and has no regulatory infrastructure in place. Also, EPA's enforcement capability could be limited because there is no link between responsibility for container design and sale or distribution of the pesticide. Again, EPA welcomes comments on the merits and drawbacks of these options. 9. Certification, recordkeeping, and inspection. As discussed regarding option 1, registrants would be required to certify that the containers meet the container design standards and to maintain records regarding these standards. Proposed Sec. 165.126(a) would require registrants to certify, for each product sold or distributed in refillable containers, that all refillable containers in which that product is distributed or sold meet the standards of Sec. 165.124. This would apply both to registrants who distribute or sell pesticide product to refillers for refilling and to registrants who distribute or sell pesticide product in refillable containers. Section 165.124(b) would specify the contents of the certification, including an acceptable certification statement. Proposed Sec. 165.126(c) would specify that a certification be submitted with each application for a new registration. For currently registered pesticides, as proposed in Sec. 165.139, a certification would be required to be submitted no later than 2 years after the date of publication of the final rule in the Federal Register. Section 165.128 would specify the container design recordkeeping requirements for registrants. This section would apply to registrants who distribute or sell pesticide product to refillers for refilling and to registrants who distribute or sell pesticide product in refillable containers. The records would have to be maintained for as long as the registrant allows the container to be used; that is, for as long as the container is identified on the registrant's list of acceptable containers, and for 3 years thereafter. Registrants would be required to make the records available for inspection and copying and to furnish them upon request. Section 165.128(a) would require that a description of the container be a part of the records for all refillable containers. A description of the container is necessary to link the records to the actual containers. Specifically, the description would be required to include, but not be limited to, the kind of refillable container (liquid minibulk, liquid bulk, etc.), the model number of the container, the container manufacturer, and the container's design type parameters, including the structural design, size (capacity and dimensions), material of construction, wall thickness, manner of construction, and (for minibulks) pump fittings. Proposed Sec. 165.128(b) would specify the records pertaining to the drop test that would be required for dry minibulk or liquid minibulk containers. For minibulk containers, the records would be required to include at least one of three different kinds of records. The first kind of record, as described in Sec. 165.128(b)(1)(i), would be a copy of the test data, including a description of the test, a description of the container tested, the test results, the date and location of the test, and the test operators' names. ``A description of the test'' would include the exact details of the drop test that was performed, including which procedure was followed [i.e., the test specified in Sec. 165.125(c), (d), or (e)], the drop height, and the characteristics of the material that was used to fill the container for the tests, such as the relative density of the material. The description of the container is necessary to verify that the correct container was tested. The rest of the information in proposed Sec. 165.128(b)(1)(i), i.e., the test result, the date and location of the test, and the test operators' names, is similar to the type of information included in the recordkeeping specified by DOT's HM-181, specifically in 49 CFR 178.601(k). As discussed in Unit V.B.7 of this preamble, the test records would have to include the results of failed tests of the same design type. Two other kinds of records are included to allow the registrant flexibility. EPA does not expect that all registrants will do the drop test themselves. Therefore, Sec. 165.128(b)(1)(ii) would specify that a letter from the container manufacturer would be acceptable. Similarly, Sec. 165.128(b)(2)(iii) would specify that a letter from the facility that conducted the test would be acceptable. The letters would be required to contain much of the same information as that specified for the first kind of record, including the specific test type, a description of the container, and the test results. Instead of including the date and location of the test and the test operators' names, the letters would be required to specify the location of the original test data. Section 165.128(b)(3) would specify that EPA reserves the right, on a case by case basis, to require submission of the drop test data. EPA considers these data necessary to maintain a registration under FIFRA section 3. Therefore, while registrants would not be required to maintain a copy of the test data, registrants would still be responsible for assuring that they could obtain the data so that they could submit the data to EPA, if required to do so. Since the testing must be done according to the GLP standards, EPA would also have the right to inspect the testing facility and copy the data under 40 CFR 160.15. If EPA were denied access to the testing facility or the data, then EPA would not consider the test data reliable for supporting the registration. Proposed Sec. 165.128(b)(2) would require that the registrant keep a statement of compliance or noncompliance with respect to the GLP standards, as described by 40 CFR 160.12, with the drop test records. Similar to the approach for the residue removal data (as discussed in Unit IV.B.9 of this preamble), EPA is considering requiring registrants to submit the GLP statement of compliance or noncompliance for the drop testing. As in Unit IV.B.9 of this preamble, EPA requests comments on whether the GLP statement of compliance or noncompliance should be kept with the drop test records as proposed, or submitted to EPA. 10. Transfer of registered pesticide products into refillable containers. FIFRA section 3(a) provides in pertinent part that ``... no person ... may distribute, sell, offer for sale, hold for sale, ... to any person any pesticide which is not registered with the Administrator.'' Registration is the principal means of ensuring that a product is brought under the FIFRA regulatory scheme. The registrant must demonstrate to EPA's satisfaction that the product meets the statutory criteria for registration with respect to composition, labeling, and the lack of unreasonable adverse effects. The registrant must take responsibility for quality control of the product's composition and for adequate labeling describing the product, its hazards, and its uses. Repackaging of a pesticide produces a new pesticide product that must be registered before it can be distributed or sold. In 1977, EPA issued an enforcement policy for bulk shipments of pesticides. The policy describes certain conditions in which EPA allows the transfer and repackaging of bulk pesticides to occur without requiring registration of the repackaged pesticides (Ref. 63). The 1977 Bulk Pesticides Enforcement Policy (the Policy) defined ``bulk'' for the purposes of the Policy as ``any volume of pesticide greater than 55 gallons or 100 pounds held in an individual container.'' EPA developed the Policy to accommodate business practices of manufacturers and distributors who handle pesticides in large undivided quantities rather than in small individual containers because EPA believed: (1) The need to properly dispose of excess numbers of containers would be reduced. (2) Less warehouse space would be required. (3) Labor and handling costs would be reduced. (4) Inventories could be more accurately controlled. EPA also recognized that encouraging the use of refillable containers would aid in minimizing waste. In the Policy, EPA determined that repackaging of bulk pesticides could occur without a separate registration if certain conditions were met that would assure that the purposes of registration would be satisfied. The conditions are that repackaging of the registered bulk pesticides could involve nothing more than changing the product container; i.e., no change in: (1) The pesticide formulation, (2) the pesticide's labeling except to add an appropriate statement of net contents and a registered establishment number, and (3) the identity of the party accountable for the product's integrity. The Policy elaborated on the accountability requirement. The pesticide has to be: (1) Transferred at an establishment owned by the registrant, (2) transferred at a registered establishment operated by a person under contract with the registrant, or (3) transferred at a registered establishment owned by a party not under contract to the product registrant, but who had been furnished written authorization for use of the product label by the registrant. The requirement for written authorization assures that the registrant remains responsible for quality control of the product's composition and adequate labeling describing the product, its hazards, and its uses. The 1977 Policy only addressed the transfer of a volume of pesticide greater than 55 gallons or 100 pounds held in an individual container. In March 1991, the Policy was amended to allow repackaging of any quantity of pesticides into refillable containers, provided: (1) The container is designed and constructed to accommodate the return and refill of greater than 55 gallons of liquid or 100 pounds of dry material. (2) Either: (a) the containers are dedicated to and refilled with one specific active ingredient in a compatible formulation, or (b) the container is thoroughly cleaned according to written instructions provided by the registrant to the dealer prior to introducing another chemical into the container, in order to avoid cross-contamination. (3) All other conditions of the July 11, 1977 Policy are met (Ref. 62). Container disposal is a growing problem in some areas of the country. The 1991 amendment to the Policy that allowed refillers to repackage less than 55 gallons of product into containers with capacities greater than 55 gallons was envisioned as a step toward encouraging greater use of refillable containers and thus reducing the number of containers for disposal. In FIFRA section 19(e), Congress directed EPA to promulgate container design regulations that facilitate safe reuse of containers, thus indicating that Congress considered encouraging the use of refillable containers important. Now that EPA is proposing container design standards for refillables and requirements for refillers, EPA believes it should expand the practice permitted by the Policy to allow repackaging into any refillable container that meets the part 165 standards. Accordingly, EPA intends to replace the Bulk Pesticides Enforcement Policy with Sec. 165.129. The proposed Sec. 165.129 provides that a registrant may allow a refiller to repackage the registrant's pesticide product into any size refillable container and to distribute or sell such repackaged product under the registrant's registration, provided all conditions set out in the rule are met. In other words, the refiller would not have to obtain a separate registration to distribute or sell the repackaged product. One of the proposed conditions is that the transfer of the pesticide product into refillable containers must be done at a registered establishment. This is based on the regulations at 40 CFR part 167, governing registration of establishments, which require that repackaging of pesticides occur at registered establishments. Registrants, distributors, or dealers who deliver pesticides to farmers or other end users are responsible for assuring that the site where the transfer occurs is a registered establishment. The proposed rule would not change the existing law; the Bulk Pesticides Enforcement Policy would be replaced by a regulation. The registrant would remain responsible for the integrity, labeling, and packaging of the repackaged product. Both the registrant and refiller may be held liable for violations pertaining to the repackaged pesticide. For example, the registrant and the refiller both would be responsible if the product was adulterated. Both the refiller and the registrant would be the ``person'' who distributed or sold an adulterated product. The registrant would be responsible because the registrant authorized the refiller to repackage the pesticide. The proposed requirements in Sec. Sec. 165.130 and 165.134 would address the responsibilities of registrants and refillers for labeling, container inspection, and residue removal. In order to assure the registrant's accountability for the repackaged product, EPA is considering adding to Sec. 165.129 a requirement that registrants submit to EPA an acknowledgement that: (1) They have entered into a repackaging agreement with a refiller and (2) they are responsible for the integrity of the repackaged product. The Bulk Pesticides Enforcement Policy would remain in effect until the date specified for compliance in Sec. 165.139, at which point it would be rescinded. Proposed Sec. 165.129 would apply to registrants authorizing distributors and/or dealers (refillers) to repackage the registrants' registered pesticide products into refillable containers. Refillers operating under contract to a registrant and refillers operating under written authorization by a registrant would be regulated the same under subpart G. Section 165.129 would not apply to registrants repackaging their own pesticide products solely at their own establishments. Under 40 CFR 152.46(b), the registrant can modify the package size and label net contents statement without notifying EPA. This would be an amendment to the registration not requiring EPA notification or approval. As a result of recent compliance monitoring efforts, EPA has received information that indicates there may be a significant contamination problem with repackaged products. Despite considering it desirable to encourage the use of refillable containers as outlined in Unit V.B.8.a of this preamble, EPA may consider the alternative of not allowing the practice of bulk repackaging to continue, and invites comments and information on contamination incidents or other problems associated with bulk repackaging. If registrants could not authorize repackaging of their pesticides by refillers, then refillers would have to obtain a registration to sell or distribute the repackaged product. As producers, registrants and refillers are required to comply with the section 8 recordkeeping and section 7 reporting regulations in 40 CFR parts 169 and 167, respectively. 11. Registrant responsibilities concerning refilling activities. Section 165.130 would prescribe the requirements for registrants to promote safe refilling and reuse of containers. These requirements would include providing refillers with written authorization or a written contract, developing a written refilling residue removal procedure for each product, developing a written list of acceptable containers for each product, and ensuring that the label and labeling, residue removal procedure, and acceptable container list are available at the establishments where the registrant's product is repackaged into refillable containers. Note that registrants also would be subject to the proposed requirements in Sec. 165.134 for all refilling operations they conduct. Additionally, repackaging by the registrant must be done at a registered establishment, as required by 40 CFR part 167. Currently, the Bulk Pesticides Enforcement Policy provides an exemption from the requirement for the transfer of pesticides to be conducted at registered establishments for registrants that deliver bulk pesticides directly to commercial applicators, if the pesticides are metered off into the applicator's tanks without being put into a dealer's holding tank. EPA sees no reason to continue this exception from the registered establishment requirement. Accordingly, when the Bulk Pesticides Enforcement Policy is rescinded, this practice will no longer be allowed. EPA requests comments on the effect of discontinuing this exception. The proposed Sec. 165.130(a) would set out the general responsibilities of a registrant. Under Sec. 165.130(a)(1), a registrant would be required to provide a written contract or a written authorization to a refiller prior to distribution or sale of the pesticide product to the refiller. The requirement for the written contract or written authorization would not apply if the registrant of the repackaged product is the sole refiller. Proposed Sec. 165.130(a)(2) would hold the registrant responsible for product integrity of the pesticide product repackaged by the refiller under written authorization or contract. Product integrity means that the pesticide product is not adulterated or different from the composition as described in the statement submitted by the registrant in connection with registration under section 3 of FIFRA. This proposed requirement reflects current law. Under FIFRA section 12(a)(1), it is unlawful for any person to distribute or sell to any person a pesticide which is adulterated or whose composition differs from the composition described in the statement required in connection with registration. Both the registrants and the refillers are selling or distributing the product. The registrant is responsible because the registrant has authorized the refiller to repackage the registrant's pesticide product and to use the registrant's label according to the terms of the written authorization or contract. The registrant remains accountable for its repackaged product which is distributed or sold in the refillable container. Registrants have raised the issue of whether there should be an exception from liability for adulteration or contamination of the pesticide product if registrants can show that the adulteration or contamination occurred solely because of actions or lack of actions by the refiller. EPA believes it is appropriate for registrants to be held responsible for acts by the refillers because the repackaging is being done under the registrant's registration and the refillers are agents of the registrants for purposes of carrying out the written authorization or contract. Proposed Sec. 165.130(b) would require registrants to develop written procedures for residue removal from refillable containers in preparation for refilling (the refilling residue removal procedure) and written lists of acceptable containers. Both the residue removal procedures and acceptable container lists would be product-specific. Section 165.130(b) would apply to registrants who distribute or sell pesticide products to refillers for repackaging into refillable containers and to registrants who distribute or sell pesticide products in refillable containers. Under Sec. 165.130(b)(1), registrants would be required to develop a written refilling residue removal procedure for each pesticide product. The refilling residue removal procedure would describe the procedures for removing pesticide residues from a container before it is refilled with the registrant's product. Proposed Sec. 165.130(b)(1)(i) would set the performance standard for residue removal before refilling a container. Specifically, Sec. 165.130(b)(1) would require the refilling residue removal procedure to be adequate to ensure that the composition of the pesticide does not differ at the time of its distribution or sale from its composition as described in the statement required in connection with its registration. To obtain a registration, applicants must submit a statement of formula and product chemistry data that includes, among other things, certified limits for active ingredients, inerts, and impurities of toxicological significance (40 CFR part 158). Additionally, any impurity that exceeds 0.1 percent by weight of the active ingredient must be identified and the nominal concentration of the impurity in the product must be furnished [40 CFR 158.155(d)]. If any impurity were to be introduced into the pesticide formulation from some external source, such as the previous product in the container, the result could be adulteration of the pesticide product. Contamination from previous pesticide formulations is a concern with refillable containers. Contamination of pesticides from failure to clean out previously held pesticides properly can lead to crop damage, residues exceeding the tolerances, or illegal applications of pesticides to foods for which there are no tolerances. This could lead to unanticipated risks from the use of the pesticide. Also, such contamination from mismanagement of refillable containers could be very costly, due to reimbursing growers for crops that have been damaged and/or cannot be sold. In 1990, Iowa ran a pilot project in which dealers were allowed to repackage less than 56 gallons of product into containers with capacities of 56 gallons or larger (Ref. 32). As part of the project, the Iowa Department of Agriculture and Land Stewardship sampled representative minibulks to test the product repackaged into the container for the presence of the active ingredient(s) previously in the container. Twelve minibulk containers were tested and 4 of the 12 were determined to be contaminated (i.e., they contained active ingredients other than those specified on the containers' labels). No contamination from the previous active ingredient was detected in six samples. Contamination of the active ingredient could not be determined in two other samples, because the second pesticide product contained the same active ingredient as the previous product. Of the four contaminated samples, the active ingredient previously contained in the minibulk was detected in two. The other two samples, both from the same dealer, were contaminated with an active ingredient other than that of the previously held product. Despite the limited number of containers sampled, the Iowa project shows that there can be a problem with contamination and product integrity with refillable containers. As a result of recent compliance monitoring efforts, EPA has received information that indicates there may be a significant contamination problem with repackaged products. The results of sampling pesticides in refillable containers in Region 7 indicated that about 60 percent of the samples from bulk storage tanks contained contamination and about 80 percent of the samples from minibulk containers contained contamination (Ref. 7). Contamination of a pesticide in the refillable container that results from the container not being properly cleaned before refilling would be a violation of FIFRA section 12(a)(1)(E) if the pesticide is adulterated, or section 12(a)(1)(C) if the product composition differs from the registered product. Another possible source of contamination is the use of common piping, pumps, meters and discharges hoses to distribute pesticide product from bulk tanks. The Minnesota Department of Agriculture conducted a survey of 40 refillers in Minnesota and found that 29 of these facilities had dedicated (separate) plumbing systems, while 11 had common plumbing systems (Ref. 35). If the pipes, pumps, meters and hoses are not properly purged between transfers, the residue from the first product can contaminate the second product. EPA requests comments on the potential contribution of common plumbing systems to contamination and whether EPA should address plumbing systems in the final rule. Under proposed Sec. 165.130(b)(1)(ii), if the refilling residue removal procedure requires the use of a solvent other than the diluent used for application of the pesticide as specified on the label under ``Directions for Use,'' or if there is no diluent used for application (examples: granules, some ultra-low-volume concentrates), the refilling residue removal procedure would be required to describe how to manage the rinsate resulting from the procedure in accordance with applicable Federal and State regulations. The rinsate management instructions are intended to encourage the reuse of rinsates by application in accordance with label instructions, rather than having to dispose of them. In situations where registrants recommend or require cleaning with a solvent that would result in rinsate that could not be applied to any labeled site, registrants would have to describe how to manage that rinsate. An example of acceptable rinsate management instructions for a solvent that can be reused to rinse containers would be: ``Collect the solvent solution in a designated container and reuse it to clean other containers. After using the solvent to clean 25 containers, contact the registrant for disposal instructions.'' The requirement for a residue removal procedure in proposed Sec. 165.130(b)(1) would apply only to cleaning the containers before they are to be refilled. Residue removal prior to disposal (by users or refillers) is addressed in the proposed modifications to labels in part 156 of this chapter (see the discussion in Unit VII.B.7 of this preamble). Proposed Sec. 156.144(e)(2) would require registrants to provide a label statement giving instructions on cleaning refillable containers prior to disposal. Proposed Sec. 156.144(e)(2) would allow the registrant a number of options for a residue removal label statement, as long as the chosen procedure is appropriate for the characteristics and formulation of the pesticide product and is adequate to protect human health and the environment, as provided in Sec. 156.144(e)(2)(ii). One option under Sec. 156.144(e)(2)(iii)(A) would be the refilling residue removal procedure developed by the registrant. EPA anticipates that in most cases registrants would be able to use the same procedure for residue removal both before refilling and prior to disposal, although the language placed on the label for cleaning prior to disposal would most likely be a condensed and simplified version of the refilling residue removal procedure. EPA believes that residue removal procedures sufficient to ensure that the product subsequently sold in a container would not differ from its composition as described as a condition of registration most likely would clean containers well enough to be safely disposed, whether that would be recycling, incinerating, landfilling, or another management option. EPA anticipates that the procedures proposed by registrants for the label would generally provide for triple rinsing or the equivalent degree of pesticide removal from refillable containers. Under Sec. 156.144(e)(2)(iii)(B), registrants also could base their label language on standard industry practices that they use to prevent adulteration during refilling, as long as the general standard is met. Proposed Sec. 156.144(e)(2)(iii)(C) includes a potentially acceptable label statement for residue removal from refillable containers prior to disposal. EPA developed this statement by compiling key components of current industry practices. The residue removal procedure described in Sec. 156.144(e)(2)(iii)(C) would include filling the container 10 percent full with water, agitating the container vigorously or recirculating the water with the pump, emptying the container and repeating the process two more times. This procedure involves rinsing the refillable container three times, although it is different from the description of triple rinsing for nonrefillable containers as proposed in Sec. Sec. 156.144(d)(1)(ii)(A) and (iii)(A). EPA believes that the procedure for cleaning refillable containers in proposed Sec. 156.144(e)(2)(iii)(C) would provide for triple rinsing or the equivalent degree of pesticide removal from the refillable container. Finally, the registrant could propose a different residue removal statement that the registrant considers appropriate. The proposed approach for cleaning refillable containers before disposal is different from that of nonrefillable containers. At this time, EPA is not proposing to set a numerical performance standard for the amount of residue that can remain in a refillable container. EPA does not have sufficient information on the amount of residue remaining after refillable containers are cleaned. Also, currently there are no established, standardized refillable container cleaning procedures which would assist in developing the data to set a laboratory performance standard. The situation with refillable containers does not parallel that with nonrefillables because of the larger range of sizes for the refillable containers that may be used to distribute or sell the pesticides. The effectiveness of cleaning a container, if measured by the concentration of pesticide in the rinsate, depends on the amount of product retained when the container initially is emptied. The amount of product retained depends, in part, on the internal surface area of the container, which is related to the container size. Different procedures may be necessary or appropriate, depending on the size of the containers. For example, residue removal procedures for cleaning a 110- gallon liquid minibulk container may not be appropriate for a 10,000- gallon liquid bulk container. Similarly, a given residue removal standard may be appropriate for a limited range of container sizes. For example, EPA expects that larger nonrefillable containers, such as drums, may have difficulty meeting the residue removal standard in Sec. 165.104. (See the discussion in Unit IV.B.7 of this preamble). EPA also anticipates that, unlike nonrefillable containers, many plastic refillable containers will be incinerated rather than recycled. Metal refillables can be recycled at steel reclamation facilities. Because the incineration of plastic containers and the recycling of metal containers occur at high temperatures that offer a high degree of pesticide destruction, the amount of pesticide remaining in the containers may not be as crucial. Unit VII.B.4.a of this preamble discusses the proposed label statement that would require end users to rinse nonrefillable containers immediately after emptying out the useful contents of the container. EPA is not proposing to require cleaning refillable containers immediately upon emptying the useful contents. It may not be practical to require refillables to be cleaned immediately since the refillers, the parties required to clean the refillable containers, are generally not the people emptying the containers. In addition, EPA is not as concerned about pesticide product drying inside a refillable container because the container should remain closed until the refiller is ready to clean and/or refill it. Therefore, EPA believes it is appropriate to regulate residue removal from refillable containers differently than residue removal from nonrefillable containers, and specifically, not to set a performance standard for refillable containers at this time. However, EPA also believes that refillable containers, like nonrefillables, should be designed to facilitate draining and residue removal. To accomplish this, EPA is considering the development of a laboratory residue removal procedure and a numerical standard for refillable containers. EPA requests comment on the appropriateness of the proposed approach to regulating residue removal from refillable containers before disposal. EPA also solicits comments on the possibility of setting a numerical residue standard for refillable containers and suggestions for developing such a standard. Proposed Sec. 165.130(b)(2) would require registrants to develop a written list of acceptable containers (bulk and minibulk) for each registered product. Proposed Sec. 165.130(b)(2)(i) would specify that acceptable containers would be those that the registrant has identified as meeting the standards in Sec. 165.124 and being compatible with the pesticide formulation to which the written list of acceptable containers applies. Registrants would have to determine which containers would be compatible with each formulation so as to reduce the possibility of an adverse interaction between the formulation and container. Product-specific lists of acceptable containers would be required because of the requirement for the container and formulation to be compatible. The concept of compatibility between a container and formulation is the same for refillable and nonrefillable containers and is discussed in Unit IV.B.3 of this preamble. Section 165.130(b)(2)(ii) would require the registrant to identify the containers by specifying, at a minimum, the container's manufacturer and model number. This scheme of specifying containers would provide a relatively simple way for registrants, refillers, and inspectors to identify containers. The proposed definition of container in Sec. 165.3 would include some spray applicator tanks. EPA has received reports that some refillers transfer product directly into farmers' spray applicator tanks. Under the proposed regulation, this practice could take place only if a farmer's spray applicator tank was included on a registrant's written list of acceptable containers. EPA believes that it is unlikely that a registrant would include spray applicator tanks on a list of acceptable containers. EPA is considering prohibiting registrants from including spray applicator tanks on their written list of acceptable containers because EPA does not believe that having a refiller repackage product directly into a farmer's spray applicator tank is a safe practice. EPA requests comments on whether the regulations should be revised to prohibit registrants from including spray applicator tanks on their list of acceptable containers. Proposed Sec. 165.130(c) would require registrants to provide certain documentation to refillers. Specifically, a registrant whose pesticide product is repackaged by a refiller into refillable containers would be required to provide refillers with all of the documentation described in Sec. 165.130(c)(2). A registrant would be required to provide the documentation before or at the time of sale or distribution of the pesticide product to the refiller. By proposed Sec. 165.130(c)(2), a registrant would be required to provide a refiller with: (1) The written refilling residue removal procedure for the pesticide product; (2) the written list of acceptable containers for the product; and (3) the pesticide product's label and labeling. The requirement for the registrant to provide labels and labeling to refillers would help ensure that the end user receives relevant product information. The refiller would attach the label to the container into which the product is repackaged. Refillers would need a copy of the label and labeling for each container used to distribute or sell the registrant's product. The other documentation, i.e., the refilling residue removal procedure and the list of acceptable containers, would be required to be provided to refillers to ensure that the refillers have the information necessary to refill and reuse the containers safely. 12. Registrant recordkeeping and inspection. Section 165.132 would specify the recordkeeping requirements for registrants. The specific recordkeeping requirements would be different for registrants who distribute or sell pesticide products in refillable containers (i.e., those who refill themselves) and registrants who distribute or sell pesticide products to refillers for repackaging into refillable containers. A distinction is made between these two groups because different records and different lengths of time for record retention are appropriate for each group. However, in both cases, the registrants would be required to make the records available for inspection and copying and to furnish them to EPA upon request. By Sec. 165.132(a), a registrant who distributes or sells a pesticide product to a refiller for repackaging into refillable containers would be required to maintain the records for as long as the pesticide is distributed or sold to a refiller, and for 3 years thereafter. These registrants would be required to maintain copies of: (1) Each written authorization or written contract provided to a refiller for repackaging the registrant's pesticide product into refillable containers, (2) the written refilling residue removal procedure for the pesticide product, and (3) the written list of acceptable containers for the pesticide product. Section 165.132(b) would require a registrant who distributes or sells a pesticide product in refillable containers to maintain the records for as long as the registrant distributes or sells the product in refillable containers, and for 3 years thereafter. These registrants would maintain the same records, except for the written authorizations. 13. Refiller responsibilities and procedures. Section 165.134 would set out the responsibilities of a refiller that are intended to ensure a sufficient degree of product and container integrity. EPA is proposing these procedural requirements for refillers because the refillers are actually doing the refilling and container handling. The requirements of Sec. 165.134 would apply to all refilling operations, which could include any of the following situations: (1) A registrant refilling a container for a refiller who is operating under contract to or authorization from that registrant, (2) a refiller operating under contract to or authorization from a registrant refilling a container for an end user (regardless of the establishment where that refilling takes place), and (3) a registrant refilling a container for an end user (regardless of the establishment where that refilling takes place). EPA requests comments on whether the proposed requirements are appropriate in all of these situations. Custom blenders provide the service of mixing pesticides with fertilizer, feed, or another pesticide to a customer's specification. (See 40 CFR 167.3). Custom blenders that fill refillable containers at the end user's request with a blended mixture of pesticide would be refillers under subpart G and subject to the refiller responsibilities and procedures in Sec. 165.134. Although EPA has limited information about the practices of custom blenders, EPA recognizes that some of the proposed requirements in Sec. 165.134 may cause problems for custom blenders. For example, custom blenders may blend a pesticide that they obtained in nonrefillable containers, and therefore the registrant may not have developed a list of acceptable containers or written residue removal procedures. For the final rule, EPA is considering two options: (1) Issue a regulation on refilling practices that is tailored specifically to custom blenders that distribute pesticide mixtures, or (2) exempt custom blenders from the requirements of subpart G. The latter option would be consistent with EPA's past practice. Currently, custom blenders are exempted from the establishment registration requirements and the production reporting requirements in part 167. However, custom blenders that fill refillable containers with blended pesticides for an end user are performing activities very similar to dealers that are repackaging pesticides into smaller refillable containers for end use. EPA has the same concerns about contamination of the repackaged pesticide, and the integrity of the container for custom blends as for other pesticides being repackaged in refillable containers. Additionally, custom blenders would be subject to the secondary containment requirements being proposed in subpart H. EPA requests that commenters provide information on how the requirements of Sec. 165.134 could be revised to address the specific practices of custom blenders. If the final rule regulates the refilling practices of custom blenders and requires that the repackaging of the pesticide by custom blenders occur only at registered establishments, Sec. 167.20, which exempts custom blenders from the establishment registration requirement, would be amended to be consistent with the part 165 requirements. Section 165.134(a) would require a refiller to possess certain items from a registrant before repackaging the registrant's pesticide product into refillable containers. These items include the written authorization or contract and other information that the registrant would be required to provide to the refiller as specified in Sec. 165.130. Registrants and refillers would be jointly responsible for the exchange of these items; registrants would be responsible for providing them and refillers would be responsible for obtaining them. By proposed Sec. 165.134(a), a refiller would be required to possess: (1) The written authorization or contract from the pesticide product's registrant, if required, (2) the product's label and labeling, (3) the registrant's written refilling residue removal procedure for the pesticide product, and (4) the registrant's written list of acceptable containers for the pesticide product. The written authorization or contract would be required if the refiller is repackaging the pesticide product for the registrant under the conditions of Sec. 165.129. A written authorization or contract would not be required if the registrant of the product is the refiller, as discussed in Unit V.B.11 of this preamble. These items are necessary for different reasons. As discussed earlier, a written authorization or a written contract is necessary for the refiller to be able to rely on the registrant's registration to repackage the registrant's pesticide product for distribution or sale. Requiring the refillers to obtain the product's labeling would assure that the label for the registered products would be available for the refilled container. The written refilling residue removal procedure for the pesticide product would provide instructions so that the refiller would know how to clean the containers. The written list of acceptable containers is necessary so the refiller would know which containers could be used for repackaging a registrant's product. Section 165.134(b) would clarify that a refiller is responsible for the product integrity of the pesticide product that the refiller repackages into refillable containers. By product integrity, EPA means that the pesticide product must not be adulterated or differ from the composition as described in the registrant's statement submitted in connection with registration under section 3 of the Act. Refillers would be responsible for product integrity in addition to the registrants, as specified in Sec. 165.130(a)(2). EPA considered exempting refillers from responsibility for the product integrity under a narrow range of conditions. Specifically, EPA considered an exemption from responsibility for product integrity if the refiller could show that it repackaged the product into a container on the registrant's list of acceptable containers for the product, followed the registrant's refilling residue removal procedure for the product, and complied with the requirements of Sec. 165.134, including the container inspection procedure at Sec. 165.134(e). If these conditions were met, the refiller would have done everything according to the registrant's instructions. However, EPA rejected this idea. Even if the refiller followed the registrant's instructions and complies with the regulations, there could be other actions a refiller should have taken or refrained from taking to avoid contamination. Additionally, EPA believes that holding refillers responsible for product integrity for all repackaged product would improve product and container stewardship. EPA requests comments on the refiller's proposed responsibility for product integrity and on the exemption therefrom considered by EPA. Proposed Sec. 165.134(c) would set out several general conditions that a refiller must meet. Section 165.134(c)(1)(i) would require refillers to repackage a pesticide product only into a refillable container that is identified on the registrant's list of acceptable containers for that product. This requirement is included for enforcement purposes. If a refiller repackages a registrant's product into a container that is not on the list of acceptable containers, the refiller would violate proposed Sec. 165.134(c)(1)(i). Proposed Sec. 165.134(c)(1)(ii) would prohibit refillers from changing the pesticide formulation, unless the refiller has a registration for the new formulation. Refillers operating under written authorization or contract from a registrant would not be allowed to change the formulation, which is consistent with proposed Sec. 165.129(a). Section 165.134(c)(2) would refer refillers to the potentially applicable standards for secondary containment units and containment pads located in proposed subpart H of part 165. EPA believes that secondary containment structures and containment pads are necessary for the safe reuse and refill of containers, as described in Unit VI.A of this preamble, the background discussion for subpart H. As discussed briefly in Unit V.B.6 of this preamble, the scope and applicability of subpart G (refillable containers) and subpart H (containment structures) are different. For example, the requirements of proposed Sec. 165.134 would apply to refillers, which include both registrants and pesticide retailers. However, proposed Sec. 165.141(b) would specify that subpart H applies to refilling establishments whose principal business is retail, i.e., only a subset of refillers' facilities. Section 165.134(d) would require a refiller to identify the pesticide product previously contained in the refillable container. The refiller could identify the previous product by reference to the label or labeling. The purpose of this requirement is to determine whether a residue removal procedure would have to be conducted according to Sec. 165.134(g). Section 165.134(e) would require refillers to inspect each refillable container before repackaging a pesticide product into that container. Container inspections would promote the refilling of sound containers, which is necessary for safely refilling and reusing containers. The container design standards, such as the drop test for minibulks, would ensure that the containers had a certain minimum degree of strength. However, having a container design type that passes the relevant drop test does not ensure that a container will remain sound after years of use. The condition and integrity of a refillable container may be affected by factors specific to that container and its history, such as the original design, the material(s) of construction, storage and handling conditions, and exposure to sunlight, precipitation, and temperature extremes. Industry representatives and container users have expressed concern regarding the effect of ultraviolet light on the integrity of plastic refillable containers that are exposed to sunlight for extended periods of time. Ultraviolet light can cause stress cracking on the surface of plastic containers and can cause the containers to become brittle. EPA believes that the inspection of containers each time they are refilled is necessary to detect problems with each specific container. Section 165.134(e) would specify the conditions under which a container would fail an inspection. The inspection primarily would be to make sure the container does not have any major structural problems. The person doing the inspection would not need to be a packaging expert. The visual inspection would be expected to consist of at least the following three steps. First, the exterior and interior (if possible) of the refillable container and the exterior of the appurtenances would be visually inspected for signs of corrosion or ultraviolet light damage; structural defects, such as cracks, holes, dents, defective welds, or weakened welds; and damage to the fittings, valves, tamper- evident devices, or other appurtenances that could affect the integrity of the container. Second, the exterior of the container would be visually inspected to determine if the information proposed to be marked permanently on the container in Sec. 165.124(b) is present and legible. Third, liquid minibulk containers would be visually inspected to determine if each appurtenance has an intact and functioning one-way valve and/or a tamper-evident device. Proposed Sec. 165.134(e) would prohibit a refiller from repackaging product into a refillable container that fails the inspection. Paragraphs 165.134(e)(1)(i) through (e)(1)(iii) set out the conditions that define how a container fails the inspection. By proposed Sec. 165.134(e)(1)(i), a container would fail the inspection if there is significant corrosion or ultraviolet light damage. The term ``significant'' is included to differentiate between small rust spots and an amount of corrosion or ultraviolet light damage that could cause the container to leak under a reasonably expected jolt, such as a drop of several inches on its base. Under proposed Sec. 165.134(e)(1)(ii), a container would fail the inspection if there are structural defects including, but not limited to, significant cracks, visible holes, bad dents, defective welds, or weakened welds. Again, ``significant'' is included to differentiate minor surface stress cracks from cracks that compromise the ability of the container to hold the product. ``Visible holes'' could cause product to leak from the container; these are different from tiny pinholes that are not visible. ``Bad'' is included to differentiate between minor indentations and dents that may indicate that the container may not be able to contain the product. A similar criterion, i.e., whether or not the container could hold product under reasonably foreseeable conditions, can be applied to determine if welds are ``defective'' or ``weakened.'' By Sec. 165.134(e)(1)(iii), a container would fail the inspection if there is damage to any of the fittings, valves, tamper-evident devices, or other appurtenances that could affect the integrity of the container. The criterion of whether or not the container could hold product under reasonably foreseeable conditions can be applied to determine if there has been damage that would cause the container to fail the inspection. By Sec. 165.134(e)(2), a container would fail the inspection if the information required in Sec. 165.124(b) to be permanently marked on the refillable container is not legible or is not permanently marked on the refillable container. This criterion for failing the inspection is included because if this information is not readily available, the refiller may not have the information necessary to refill and reuse the container safely. This part of the inspection also would affirm that the container meets the Sec. 165.124 container design requirements. Under Sec. 165.134(e)(3), a container would fail the inspection if the refillable container is a liquid minibulk container and it does not have an intact and functioning one-way valve or a tamper-evident device on each aperture. EPA understands that many of the proposed criteria for defining when a container fails the inspection, such as ``significant corrosion or ultraviolet light damage,'' ``significant cracks,'' and ``bad dents'' are subjective. EPA requests comment on whether the proposed criteria are appropriate and whether they are written in a manner that can distinguish between containers that are and are not acceptable to be refilled. A part of the container inspection procedure would include looking at the date of manufacture of the container, which would be required as permanent marking. Under proposed Sec. 165.134(f), a refiller would be prohibited from repackaging pesticide product into a plastic liquid minibulk container more than 6 years after the date of manufacture of the container, which would limit the lifetime of these containers. The 6-year limit is intended to give plastic liquid minibulks a year to get into the pesticide distribution chain and a 5-year lifetime. EPA is concerned about the long-term durability of plastic minibulk containers. From many discussions with industry representatives, 5 years is generally accepted as a ``safe'' lifetime of one of these containers. As discussed in the Report to Congress (Ref. 65), many minibulk containers have been in the field successfully for 5 years (since the late 1980s). However, after that point, the integrity of the container is questionable. Several registrants have instituted programs to pull the 1980s models from the field and replace them with new minibulks. Limiting the lifetime of plastic minibulks is consistent with the recommendations in both the MACA-75 voluntary industry standards and U.N. Recommendations for rigid plastic IBCs. For example, section 16.4.11.1 (regarding specific requirements for rigid plastic IBCs) of the U.N. Recommendations (Ref. 76) states, ``Unless otherwise approved by the competent authority, the period of use permitted for the transport of dangerous liquids should be five years from the date of manufacture of the receptacle except where a shorter period of use is prescribed because of the nature of the liquid to be transported.'' EPA is considering incorporating into the regulations a waiver that would allow plastic liquid minibulk container design types to be used for longer than 6 years. The waiver would be for a specific time period based on information submitted by the registrant. It is possible that future plastic liquid minibulk containers may be significantly better than current designs due to improvements in technology, such as a new resin or a different manufacturing method. To EPA's knowledge, nearly all plastic liquid minibulk containers are constructed of linear high density polyethylene (HDPE) or cross-linked HDPE and are manufactured by either a blow molding process or a rotational molding process. It is possible that a change in either the plastic resin used and/or the manufacturing process could lead to a significant change in the sturdiness and durability of the containers. Some of the potential criteria EPA could use for evaluating requests for waivers from the 6-year lifetime limit include whether the container design type: (1) is constructed of a plastic resin other than linear HDPE or cross-linked HDPE that can be shown to be more durable and sturdy; (2) is manufactured by a process other than blow molding or rotational molding that can be shown to be more durable and sturdy; or (3) utilizes some other advance that contributes to a significant increase in the sturdiness and durability of the containers. In addition, EPA would expect the registrant to provide data, a revised container lifetime expectancy and a justification for the different life span. EPA would have to review and approve the waiver before the design type could be added to the registrant's list of acceptable refillable containers. EPA requests comments on whether such a waiver should be included in the final rule and, if so, whether the approval criteria discussed above are appropriate or if they should be modified. EPA is also considering an option of allowing plastic liquid minibulk containers to be tested after the 6-year lifetime has expired in order to extend the useful life of the container. EPA realizes that a container that is handled carefully and protected from detrimental conditions (such as extremely hot temperatures, freezing conditions, precipitation and sunlight) may be able to continue to be used safely for more than 6 years. Specifically, EPA is considering incorporating a test procedure similar to the DOT retest procedure set out in 49 CFR 173.32(e). Section 173.32(e) of the DOT hazardous materials regulations specifies that a pressure test and a visual inspection of the container under pressure be conducted at a specified time interval (every 1, 2 or 5 years depending on the container type). The pressure test specified in the DOT regulations is a relatively simple and inexpensive test that utilizes a small air compressor (if air is to be used) or the existing water line (if water is to be used) to increase the pressure inside the container. The person who conducts the test must mark the test data on the container and maintain records of the test until the next test date. EPA requests comments on whether a similar test procedure should be incorporated into the final rule as a means to extend the life of individual plastic liquid minibulk containers. EPA also requests comments on the details of the test, such as: (1) Who should be allowed to conduct the testing (registrants and/or refillers?); (2) how long should the life of a container be extended if it passes the test (e.g., one or two years?); and (3) how should the extension of the container lifetime be indicated on the container? (e.g., should the test date be marked on the container or should a notation that specifies the ``new'' expiration date be marked on the container?). Section 165.134(g) would require the refiller to follow appropriate refilling residue removal procedures. This section describes the situations in which a refiller would have to clean containers before using them for repackaging pesticide products. Refillable containers would not always have to be cleaned before they are refilled. However, EPA is concerned that the pesticide product being repackaged into the container could become contaminated with impurities from previously contained products. EPA believes that specifying the conditions under which a refillable container needs to be cleaned would help minimize the potential for contamination. Also, specifying these conditions would set out consistent ground rules for when the refilling residue removal procedures would need to be conducted, which would benefit refillers. EPA also would like to minimize the amount of rinsate that is generated, which is consistent with EPA goals of waste minimization and pollution prevention. Management or disposal of the rinsate can be burdensome to a refiller. EPA believes that minimizing the cleaning of containers may help encourage refillable containers because it would be less burdensome for refillers in terms of rinsate management and handling costs. On the other hand, a desire to minimize container cleaning is secondary to maintaining the integrity of the products. When EPA amended the Bulk Pesticides Enforcement Policy in 1991 to allow repackaging of any quantity of pesticide product, EPA was concerned about contamination of the products sold in refillable containers (Ref. 62). To address this concern, the policy allows the repackaging of any quantity of a pesticide product into refillable containers, provided that either: (1) The containers are dedicated to and refilled with one specific active ingredient in a compatible formulation, or (2) The container is thoroughly cleaned according to written instructions provided by the registrant to the dealer prior to introducing another chemical to the container in order to avoid cross- contamination. EPA proposes to follow this approach in Sec. 165.134(g), with some expansion. Section 165.134(g)(1) would specify that a refiller would have to conduct the pesticide product's refilling residue removal procedures before repackaging the pesticide product into a refillable container, except under the conditions specified in Sec. Sec. 165.134(g)(1)(i) - (iii). In general, refillers would be required to clean containers in situations other than those where a container previously held a product with a single active ingredient and is being used to repackage a product with the same active ingredient. If the three conditions specified in Sec. Sec. 165.134(g)(1)(i)- (iii) are met, a refiller could repackage product into the container without conducting the refilling residue removal procedure. The first condition would be that each tamper-evident device is intact, if the refillable container has a tamper-evident device. An intact device would provide reasonable assurance to the refiller that the container had not been tampered with, and had contained only the product identified on the label. The second condition would be that the container previously held a product with a single active ingredient and is being used to repackage a product with the same single active ingredient. The third condition would be that there is no reaction or interaction between the product being repackaged and the residue remaining in the container that would cause the composition of the product being repackaged to differ from its composition as described in the statement required in connection with its registration under section 3 of the Act. Under the second and third conditions, a container could be refilled with the same product as it previously held or with a product that has the same active ingredient ``in a compatible formulation,'' as specified in the 1991 amendment to the Bulk Pesticide Enforcement Policy. EPA considered specifying other situations in which the refilling residue removal procedure would not have to be conducted. For example, if the original product contains one active ingredient and the container is to be refilled with a product with two active ingredients, including the one in the original formulation, there should be no contamination of the active ingredients. In this case, if the conditions in proposed Sec. Sec. 165.134(g)(1)(i) and (iii) were met, it may be that the container would not need to be rinsed. Nevertheless, to ensure product integrity, EPA is proposing a limited universe of situations where refilling is allowed without cleaning the container. In particular, EPA is concerned about the effect the inert ingredients may have in causing the product being sold in the refillable container to differ from the registered product. Proposed Sec. 165.134(g)(2) would state that in addition to conducting the refilling residue removal procedure, in all cases where the container has a broken (not intact) tamper-evident device, other procedures may need to be taken to assure that product integrity is maintained. EPA is concerned that the refilling residue removal procedure may not be thorough enough, because with broken tamper- evident devices, a refiller would have no reasonable assurance about the identity of the container's previous contents. The container may have been used to store a substance other than a pesticide, such as gasoline or motor oil. EPA anticipates that refilling residue removal procedures developed by registrants will not be designed to account for situations such as these. EPA considered another option for cleaning containers with broken tamper-evident devices. EPA considered requiring the refiller to identify the container contents by sampling the residue remaining in the container, to clean the container if necessary, and to verify that the container has been sufficiently cleaned by sampling the residue in the container. EPA rejected this option because the refillers may not have the expertise to conduct the testing of the samples drawn from the residue and the testing could be costly. In addition, EPA does not have sufficient information to set a standard for what would be considered ``sufficiently clean.'' EPA requests comments on whether additional procedures beyond those set out in Sec. 165.134(g) are needed to clean containers with broken tamper-evident devices. Regardless of whether the container would be required to be cleaned or not, the product distributed or sold in the refillable container must not be contaminated so that it differs from the composition of the registered product, as discussed earlier. EPA is concerned that there may be a problem with the conditions proposed in Sec. 165.134(g) if a container previously holding a product with a high concentration of one active ingredient is to be refilled with a product having a significantly lower concentration of the same active ingredient. Such a container would not be required to be cleaned under the proposal (if the formulations were compatible and the container's tamper-evident devices were intact). The second formulation could differ from its composition defined in the registration statement not by a different active ingredient, but by the higher concentration that may result. In this case, the active ingredient may exceed its certified limits and could be subject to enforcement. EPA requests comments on the potential problem of significantly different concentrations of the same active ingredient. EPA also requests comments on whether the proposed conditions for conducting the refilling residue removal procedures are appropriate. The proposed conditions in Sec. 165.134(g) would apply to all types of refillable containers, as specified in the proposal. EPA requests comments on whether it is appropriate to subject liquid bulk containers to the same conditions as liquid minibulk containers. Section 165.134(h) would allow a refiller to repackage any quantity of pesticide product into a refillable container up to the rated capacity of the container. Currently, under the Bulk Pesticides Enforcement Policy, refillers can only repackage registered pesticide products into containers with capacities greater than 55 gallons liquid or 100 pounds of dry material. EPA believes that any container that meets the requirements of Sec. 165.124 can be safely refilled and reused, regardless of the capacity of the container. Smaller refillable containers are desirable for the many applications that do not require 55 gallons of pesticide, such as treatments of small fields and uses of pesticides that are applied at low rates. Smaller refillables may become increasingly important if the trend toward selling more highly concentrated pesticide formulations continues. The provision to allow the repackaging of any quantity of product into a refillable container should lead to increased use of refillable containers, thereby decreasing the number of nonrefillable containers requiring disposal. EPA believes that by allowing any quantity of product to be repackaged into acceptable containers and not defining a minimum capacity for refillable containers, EPA will encourage the use of refillable containers. EPA requests comment on whether this is an accurate assessment of the effect of loosening the quantity restrictions involved with refilling. Section 165.134(i) would require a refiller to label the refilled container properly. A refiller would be required to securely attach the new label. The label would have to be attached in such a manner that the label can reasonably be expected to remain affixed during the foreseeable conditions and period of use. EPA expects that a refiller would first remove the previous label and labeling, if any, to ensure that the pesticide product is not misbranded. The refiller would be attaching labels provided by the registrant of the pesticide product which is being repackaged. To comply with the labeling requirements of Sec. 156.10, the refiller would include the EPA assigned establishment number and the net contents statement. A pesticide product is considered misbranded if its label does not bear the registration number, assigned under section 7, of the establishment in which it was produced [FIFRA sec. 2(q)(1)(D)]. Also, it is misbranded if the net weight or measure of the contents is not affixed to the container [FIFRA sec. 2(q)(2)(C)(iii)]. The proposed blank spaces on the label would accommodate this information. 14. Refiller recordkeeping and inspection. Section 165.136 describes the records that a refiller would be required to maintain. Section 165.136(a) would require a refiller to maintain copies of the agreement and information obtained from each product's registrant. These records would be required to be maintained for as long as the refiller distributes or sells a pesticide product in refillable containers, and for 3 years thereafter. By proposed Sec. 165.136(a), a refiller would be required to maintain copies of: (1) The written contract or written authorization from the registrant of the pesticide product, as described in Sec. 165.129(a), (2) the registrant's written refilling residue removal procedure for the pesticide product, and (3) the registrant's written list of acceptable containers for the pesticide product. Section 165.136(b) describes the records that a refiller would be required to maintain each time a refillable container that has been used to distribute or sell a pesticide product is delivered to the refiller to be refilled. By proposed Sec. 165.136(b), the information would include the name and address of the person providing the refillable container, the serial number of the container, the date the container was received, and the name and EPA registration number of the pesticide that was last distributed or sold in the refillable container. These records would create a link between the container and the previous formulation sold in the container. These records, in addition to the records specified in proposed Sec. 165.136(c) which would link the container to the next product repackaged into it, would help assure the safe refill and reuse of containers. EPA believes the records in proposed Sec. Sec. 165.136(b) and (c) would minimize the potential for contamination of the product sold or distributed in the container and make the regulations more easily enforceable. For example, whether or not a refillable container needs to be cleaned depends on both the previous product and the product to be repackaged in that particular container. In general, the records in Sec. Sec. 165.136(b) and (c) are intended to ensure that a refiller effectively manages, handles, and tracks containers within its own facility by making available a minimum amount of information regarding the container's history. The records in Sec. 165.136(b) would have to be kept only for those containers that the refiller is going to refill; i.e., only those containers delivered to the refiller to be refilled. A refiller would not have to keep records for those refillable containers that the refiller returns to a registrant. In other words, this section would not establish a nationwide container tracking system. A log that includes the specified information would be sufficient to satisfy the requirements of proposed Sec. 165.136(b). Section 165.136(c) specifies the information a refiller would have to record and maintain each time a product is repackaged into a refillable container for sale or distribution. One record would be required for each container for each instance of filling or refilling. The records specified in proposed Sec. 165.136(c) generally are intended to verify that the refiller is complying with the Sec. 165.134 requirements regarding containers, including repackaging, inspection, and residue removal. The first three pieces of information specified in proposed Sec. 165.136(c) would identify the specific sale or distribution of a pesticide product. These records would include: (1) The name, EPA registration number, and amount of the pesticide product distributed or sold in the refillable container, (2) the date of the distribution or sale, and (3) the name and address of the consignee. Section 165.136(c)(4) would require a refiller to record the serial number of the container, which would link the specific pesticide formulation to a specific container. The connection between the specific product and the container in which it is sold or distributed is important in several ways. The records in proposed Sec. 165.136(c) would help substantiate that the refiller took proper steps in refilling containers. While the refiller would be required by proposed Sec. 165.134(i) to place its EPA establishment number on the label, the Sec. 165.136(c) records would provide a connection between the container, the product, and the refiller, in case the refiller did not put its EPA establishment number on the label or if the label fell off the container. In addition, the information required in Sec. 165.136(c)(1) through (c)(4) would allow an inspector to spot check whether the refiller is repackaging product only into refillable containers identified on the list of acceptable containers provided by the registrant, as required by proposed Sec. 165.134(c)(1)(i). An inspector could compare the refillable container (which would be permanently marked with the serial number and the model number) at the refiller's facility with the Sec. 165.136(c) records and the registrant's list of acceptable containers to determine compliance or noncompliance with proposed Sec. 165.134(c)(1)(i). Refillers may already be required to keep some of the information specified in Sec. 165.136(c) -- the identity and amount of the pesticide product, the date of distribution or sale and the identity of the consignee -- under 40 CFR part 169 or 40 CFR part 171. Section 169.2(d) requires that this information be kept for the shipment of all pesticides, devices, and active ingredients used in producing pesticides; and, in states where EPA administers the certification plan, Sec. 171.11(g) requires restricted use pesticide dealers to maintain this information, for each transaction involving a restricted use pesticide. In general, a log that includes the specified information would be sufficient to satisfy the requirements of proposed Sec. 165.136(c). As specified in Sec. 165.136(c)(5), a refiller would be required to record that the container inspection procedure was conducted and the results of the inspection, which would indicate compliance with Sec. 165.134(e). Refillers would be required under Sec. 165.136(c)(6) to record whether a refilling residue removal procedure was conducted and if not, the reasons why the container was not cleaned. This information, in addition to the records specified in Sec. Sec. 165.136(b) and 165.136(c)(1) through (c)(4), could be used to indicate whether the refiller cleans containers when necessary, as specified in Sec. 165.134(g). In addition, the information specified above -- whether a refilling residue removal procedure was conducted, the container identification, the previous product identification, and the repackaged product identification -- is important in case the product in the container is determined to be contaminated. This information could aid in determining who is responsible for contaminated product and how the product got contaminated. 15. Compliance date. In section 19(e) of FIFRA, Congress directed EPA to promulgate container design regulations by December 24, 1991 and required compliance with these regulations by December 24, 1993. For the reasons set out in Unit IV.B.9 of this preamble for proposed subpart F, Sec. 165.139(a) would provide a period of 2 years after the date of publication of the final rule in the Federal Register before compliance with subpart G would be required. This would apply to both the container design and the refilling requirements. In other words, within 2 years of the publication date of the final rule, pesticides could only be distributed or sold in containers that meet the requirements of subpart G. Also, within 2 years of the publication date, registrants and refillers would have to meet the refilling and recordkeeping requirements of subpart G. The Bulk Pesticides Enforcement Policy will be in effect until the compliance date; i.e., 2 years after the final rule promulgating subpart G is published in the Federal Register. Proposed Sec. 165.139(b) would specify that certifications for pesticide products registered as of the publication date of the final rule would be required to be submitted to and received by EPA within 2 years of the date subpart G is published as a final rule. EPA believes that a 2-year implementation period would provide enough time to comply with the procedural requirements of subpart G including the exchange of information between the registrant and the refiller. Container and equipment (e.g., pump and meter) manufacturers have indicated that it takes about a year for the designing and testing that is necessary to go from a set of specifications to a final product. Therefore, EPA does not anticipate a problem with the availability of acceptable containers and appurtenances. Additionally, EPA believes that many containers currently being used meet the proposed requirements, with the possible exception of some of the proposed permanent marking. EPA believes that existing containers that meet most of the standards (such as the drop test) can be retrofitted; e.g., permanently marked with information such as a serial number. EPA is concerned that there may be containers that could not be used after the 2-year phase-in period, although the containers may be structurally sound. For example, a sound minibulk container may not be permanently marked with the phrase ``Meets EPA standards for refillable pesticide containers'' and, for some reason, may not be able to be retrofitted. EPA is aware that prohibiting the use of containers such as these may create a disposal problem and cause a financial burden to the owners of these containers. One option EPA considered was a ``grandfather'' provision, which would allow existing containers to be used for a specified period of time, such as 5 years. However, the proposed regulatory scheme clearly makes registrants responsible for the containers in terms of both meeting the proposed standards of Sec. 165.124 and ensuring compatibility with the pesticide formulation. Extending an automatic regulatory exemption for existing refillable containers could allow a refiller to repackage a product into a container other than a container on the registrant's list of acceptable containers, if the registrant allowed its product to be distributed or sold in such containers. Therefore, EPA rejected the option of a grandfathering provision for all refillable containers because of the potential problems with incompatibility and substandard containers, as well as the possible confusion caused by inconsistency between the regulations and the registrant's list of acceptable containers. EPA also considered an option where registrants could ``grandfather'' existing containers that met minimum standards. Under this option, EPA would allow registrants, under certain conditions, to have containers on their list of acceptable containers that don't meet all of the standards in Sec. 165.124. Some conditions that EPA might consider appropriate include: (1) The container is currently in use in the field, i.e., it is an ``existing'' container, (2) EPA approves a date suggested by the registrant, such as 5 years after the date the regulations are published, after which the container cannot be used. (Plastic minibulk containers could not be used after they are more than 6 years old), and (3) the container meets a set of standards, that would have to be approved by EPA. While this option would provide a registrant some flexibility, it could still cause confusion for refillers who are trying to comply with the regulations. For example, if an existing container without a serial number was allowed to be used, the refiller could not comply with the recordkeeping requirements. In addition, this option could impose a considerable burden on EPA resources for administering an approval program for each registrant. EPA requests comment on whether a 2-year phase-in period for compliance with subpart G is appropriate or whether an alternative, such as the option described above, should be incorporated into the final rule. EPA requests commenters to be as specific as possible about suggesting alternatives, including information on the number of existing containers that might need to be grandfathered, suggestions for the standards that might be appropriate for the grandfathered containers, and the potential confusion and conflicts the use of the grandfathered containers might have on other parts of the regulations and the regulated community. VI. Standards for Pesticide Containment Structures A. Background 1. Introduction. Subpart G of this proposed rule introduces container design and residue removal standards for pesticide refillable containers, including liquid bulk containers and dry bulk containers. In subpart H, EPA proposes standards for containment structures to intercept and contain spills and leaks from stationary bulk containers, areas where pesticides are dispensed from and into stationary bulk containers, and areas where containers are refilled. These containment standards would apply to facilities of agricultural pesticide refilling establishments and custom blenders (as defined in Sec. 167.3), and to facilities of businesses that apply agricultural pesticides for compensation (also referred to as for-hire applicators in this preamble). The proposed requirements include criteria for design, maintenance, and operation of containment structures. They are intended to introduce basic safeguards in States that currently lack containment regulations and to harmonize with containment requirements in States where adequate containment safety programs already exist. EPA believes that the proposed Federal containment standards, together with proposed requirements for container design and residue removal, are essential for ensuring the safe use, reuse, and refill of containers as required by FIFRA section 19. These proposed standards are intended to prevent pesticide contamination of soil and water resources at pesticide bulk container storage facilities and at facilities where container refilling operations occur. Although spills can occur throughout the chain of pesticide commerce (from manufacturer to user), the accumulated evidence points to agrichemical dealerships, custom blenders, and for- hire applicators as facilities where pesticide contamination of ground and water is most frequently documented. Bulk pesticide containers are located at many of these facilities, and agrichemical dealerships often serve as refilling establishments for refillable agricultural pesticide containers. Failure of stationary bulk containers at such facilities can result in significant environmental contamination, but so too, can failures of hoses and pipes (appurtenances), operational errors (e.g., overfilling), improper containment systems, improper disposal of pesticide rinsates, and vandalism. These findings lead EPA to conclude that unless storage of bulk containers and refilling operations are addressed as integrated systems, the FIFRA section 19 mandate for regulations that ensure safe reuse and refill of pesticide containers cannot be satisfied. These proposed standards are designed to supplement the proposed subpart G standards addressing design, structural, and residue removal standards for refillable containers. EPA believes that additional standards are necessary for containment structures because the safety of use, reuse, and refill depends on a number of factors that affect the refilling activity, particularly in situations where pesticides are stored in large refillable containers and where refilling operations routinely occur. The remainder of Unit VI.A of this preamble describes pesticide bulk container storage facilities and refilling operations and characterizes their sources of pesticide leaks and spills. The nature of environmental problems for such operations is also discussed, as are efforts by States to prevent further environmental problems. 2. Pesticide bulk containers and refilling operations: sources of leaks and spills. Bulk containers are used at many levels in the pesticide distribution network -- from registrants, formulators, distributor tank farms, and dealerships to for-hire and private applicators. The categories of bulk pesticide container facilities for which EPA has accumulated the most substantial evidence of soil and ground-water contamination, and thus the focal point of the proposed containment regulations, are the facilities of refilling establishments and for-hire applicators of agricultural pesticides. Facilities where agricultural pesticides are custom blended from bulk containers are also proposed for regulation. Typically, bulk containers for agricultural pesticide refilling establishments, for-hire application services, and custom blending operations are maintained at the facilities of agrichemical dealerships. However, bulk containers are also used at the facilities of independent for-hire applicators and may also be used at the facilities of independent custom blenders, though EPA believes that independent custom blenders are likely to be rare. Refilling establishments whose principal business is retail, custom blenders and for-hire applicators of agricultural pesticides (referred to collectively as ``commercial agrichemical facilities'' in this preamble) may use pesticide bulk containers for many purposes. For example, they may refill minibulk pesticide containers for sale and distribution or for use as shuttles to transport pesticides from the dealership to the field for their for-hire application services. They may also use bulk containers to supply pesticides to custom blending services where pesticide is mixed with material such as fertilizer, another pesticide, or seed on a customer-order basis. Commercial agrichemical facilities may also use bulk containers to store fertilizers, but unless such fertilizers are mixed with and therefore labeled as pesticides, they are not subject to FIFRA. Pesticide bulk containers at these facilities usually hold herbicides. Liquid bulk containers typically range in capacity from 1,000 to 5,000 gallons, though some dealers may have containers with a capacity of 30,000 or more gallons. Dry bulk containers that hold as much as 90,000 pounds can be found at dealerships. At commercial agrichemical facilities, pesticides generally are transferred to and from bulk containers via appurtenances (pipes, hoses, pumps, and/or meters) that terminate at a dispensing area. This dispensing area may serve as a site to clean or refill containers, nurse tanks, or application equipment, and it may also be used to transfer pesticides from delivery vehicles into bulk containers. In some cases, pesticide rinsates resulting from cleaning operations are collected and stored in bulk containers. Depending on State and local regulations and registrant requirements, bulk containers and dispensing areas may or may not be located inside a protective containment structure. A number of potential sources of pesticide spills exist at refilling operational sites and facilities that store or dispense pesticides from bulk containers. Available information suggests that chronic small leaks from containers and appurtenances or recurrent improper pesticide waste disposal are responsible for environmental contamination in many cases (see later discussion). Larger, sudden releases of concentrated product probably occur less frequently, but perhaps due to their more dramatic nature and to existing release reporting requirements such as CERCLA section 403 and EPCRA section 304, their occurrence is better documented than chronic spills. Causes for such major spills include: (1) Bulk container failure (due to structural defects, corrosion of the containers by incompatible pesticides, improper installation, fire, collisions with equipment, etc.), (2) failure of pipes, hoses, valves, or pumps, (3) operator errors (e.g., neglecting to shut off valves, overfilling, leaving transfer operations unattended), and (4) vandalism. Insight into the causes of these mishaps can be gained from Federal and State spill incident reports and from comments by industry. The National Response Center (NRC, administered by the U.S. Coast Guard) provides a Federal mechanism to receive and refer for action and/or investigation reports of oil, chemical, biological, and etiological releases into the environment in the United States and its territories. Some incidents involving releases of certain hazardous substances or materials listed under several statutes, including the Comprehensive Environmental Response, Compensation, and Liability Act, secs. 101(14) and 102 (42 U.S.C. 9602) and the Transportation Safety Act of 1974 (49 U.S.C. 1802 and 1803), are required to be reported to the NRC. These statutes, however, include only some pesticides on their list of hazardous substances or materials. Although only a portion of the incidents involving pesticides are reportable, the NRC database does include a number of incidents in which significant quantities of pesticides were released. In analyzing incident data provided by the NRC for a reporting period of 1982 through May 1991, EPA identified 40 incidents in which spills appeared to be associated with bulk pesticide containers (Ref. 60). Transportation incidents, other than those involving mishaps during transfers into or from delivery vehicles, were excluded from this analysis. Seventy percent of the spills (28 of 40) involved herbicides. The reported quantities of pesticide released ranged from 2 gallons to an estimated 1,000 gallons. The most frequently listed causes of spills, in descending order, were: (1) Transfer mishaps (hoses or couplings failing or dislodging during load-in or load-out, etc.) (38 percent). (2) Appurtenance failure (leaks or breaks in pipes or valves, valves left open, sight gauge failure, etc.) (30 percent). (3) Container failure (corroded, collapsed) (12 percent). (4) Overfilling (13 percent). (5) Vandalism (5 percent). (6) Unspecified (2 percent). The Nebraska Department of Environmental Control also maintains a spill incident database that includes reports of pesticide spills. During a 10-year reporting period (May 1981 through March 1991), 20 incidents were reported that appeared to involve bulk pesticide operations. The quantities of pesticides reported spilled (all herbicides) ranged from a few gallons to 1,400 gallons. Failure of appurtenances was the most commonly encountered cause of discharge (six cases; 30 percent). Vandals were reported responsible for spillage in four incidents and operator errors (e.g., overfilling containers and allowing hoses to become dislodged during transfers) caused four incidents. Container failures (e.g., container tipped over and burst) accounted for three other spills. The causes of incidents were not reported in three cases (Ref. 34). In documenting the need for containment regulations for large pesticide containers, the Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) cited nine pesticide spills that occurred from 1981 to mid-1984. Volumes released ranged from a few gallons to 1,700 gallons. Causes included four transfer mishaps (hose and valve failure), four container-related incidents (valve failure, container rupture, overflow from rain into an open container) and one fire (Ref. 78). Subsequently, the WDATCP noted several additional bulk-related spills of herbicides, including (Ref. 42): (1) A 4,600-gallon spill when ice sheared off a container valve. (2) A 550-gallon loss when a hose outside of containment ruptured. (3) A 3,000-gallon release into a warehouse (cause not specified). (4) A 40-gallon spill due to a plumbing failure (containment allowed recovery and use of the herbicide). The WDATCP also indicated that installation of containment structures enabled many commercial operations to detect small spills that previously eluded notice (Ref. 42). Some pesticide registrants whose agricultural pesticides are sold and distributed from bulk containers at refilling establishments cite appurtenance failure as a leading cause of leaks and spills. Other common causes they identify are hoses/couplings dislodging during load- out, human error (e.g., leaving valves open on unattended equipment), and overfilling. Pinhole leaks in bulk containers, sight gauge failure, vandalism, and fire also have been noted as sources of spills. Spills from bulk containers or appurtenances that were reported to companies range from 1 gallon to 5,000 gallons, but quantities of several hundred gallons are typical (Ref. 66). The above information from Federal, State and industry sources consistently indicates that in addition to container failures, leading causes of sudden spills at bulk pesticide storage and dispensing operations are failures of appurtenances and/or human errors during pesticide transfers, vandalism, and fire. In addition to these larger and more noticeable spills, small chronic leaks of pesticide concentrate and improper management of pesticide rinsates also can occur and contribute to environmental contamination. These findings underscore that regulations promoting safe container reuse and refill should address not only the structural integrity of bulk containers, but also should include safeguards for appurtenances, dispensing operations, and container refilling operations. 3. Frequency of leaks and spills. Although several databases on chemical spill incidents are available, none provides a comprehensive outlook on pesticide-related incidents. As mentioned previously, a Federal reporting mechanism is in place at the National Response Center, but as this applies only to releases of specified substances above a threshold quantity, many incidents involving pesticides could be exempt from reporting. Chronic small spills may go unnoticed and uncontrolled discharges of dilute pesticide rinsates may not be recognized as a significant source of environmental contamination by facility owners and operators. Reluctance of operators to bring spills to the attention of environmental or other authorities also may lead to under-reporting. Despite reporting limitations, EPA has obtained independent rough estimates of the frequency with which spills are noted at facilities that store pesticides in bulk containers or conduct loading/refilling operations. These estimates pertain only to spill incidents that were clearly noticeable, i.e., relatively large quantities of pesticides were involved; many of the cases were reported as a result of complaints. They were not derived from environmental sampling surveys of facilities for pesticide contamination. The Michigan Department of Agriculture has compiled a summary of agriculture-related pollution emergency incidents (such as reported spills of agrichemicals and improper disposal of farm wastes, including pesticide rinsates) from 1987 through early 1991. Based on reports of 180 incidents, EPA estimates that about 1 of every 75 Michigan pesticide dealers (1.3 percent) experiences a reported release each year (Ref. 68). The Nebraska Department of Environmental Control requires the reporting of spills of threshold quantities of CERCLA hazardous substances, as well as spills of 10 pounds or more of pesticide active ingredients. Based on Nebraska's 1984 through 1990 data, calculations suggest that noticeable leaks occur annually at nearly 1 percent of the State's 350 bulk storage and refilling establishments (Refs. 34 and 68). The Michigan and Nebraska figures agree with those offered by some registrants, who estimate that 1 percent to 1.5 percent of agricultural pesticide bulk storage sites report spill incidents each year (Refs. 66 and 68). 4. Soil and ground-water contamination. Many States have documented soil and ground-water contamination problems resulting from pesticide spills at commercial agrichemical facilities that engage in pesticide storage and transfer operations. Two of the most comprehensive reports to date on this subject were jointly authored by the Wisconsin Department of Agriculture, Trade and Consumer Protection and the Wisconsin Department of Natural Resources. Their 1989 study (Ref. 20) of 20 for-hire agricultural pesticide applicator facilities was prompted by the detection of pesticide residues in private wells at or near 18 facilities and by reports of pesticide spills at two other such facilities. Fourteen of the sites studied were facilities that handled liquid pesticides in containers larger than 55 gallons. The survey revealed that pesticide contamination of soil was commonplace at these facilities. The greatest total concentrations of pesticides occurred at acute spill areas (where relatively large accidental spills had occurred), areas where containers were burned, mixing and loading sites, and pesticide storage areas. Soil sampling data obtained after implementation of soil remediation actions at these sites showed that chronic spillage continued to be a problem and even increased in several cases, because the users continued to engage in improper disposal practices (Refs. 20 and 80). Pesticide residues were detected in drainage-ways and temporary ponds adjacent to pesticide handling areas. The residues subsequently may have dispersed into ground water through leaching and via movement of surface waters: pesticide residues were reported in ground water at concentrations that often exceeded Wisconsin health advisory levels. In four cases, ground water up-gradient from the facility also contained pesticide residues, suggesting additional sources of contamination (Ref. 20). The report concluded that the most effective approach toward preventing further environmental problems would be to develop long- range management practices and install proper secondary containment for bulk containers and containment pads for pesticide transfer operations (Ref. 20). In 1991, the same Wisconsin agencies reported the results of an environmental survey of 27 randomly selected agricultural pesticide application business sites (Ref. 45). (This study was designed to assess operations representing the industry as a whole.) The investigation revealed the presence of pesticides in soil at 25 of the 27 locations. Soil at 18 (66 percent) of the sites may eventually require remediation; these sites had pesticide concentrations exceeding those that would have been expected had pesticide been applied at labeled field rates. Pesticides also were found in ground water at more than half (55 percent) of the sites. At nine of these locations (33 percent of total sites) pesticide levels exceeded Wisconsin ground- water standards. Given these results, the Wisconsin agencies estimate that between 45 percent and 75 percent of the State's commercial agrichemical sites may require soil remediation and that 29 percent to 63 percent potentially exceed the State's ground-water standards for pesticides. Many of the latter also may require remediation (Ref. 45). A study of commercial agrichemical facilities in Utah found pesticide contamination resulting from a variety of handling activities such as spills of pesticide in bulk container storage and dispensing operations, mixing and loading into application equipment (for facilities that engaged in for-hire application), and equipment cleaning activities. Residues were detected in pesticide handling areas and adjacent areas to which they drained, as well as in gravel driveways and parking lots (Ref. 47). Much of the contamination found in the Utah study appeared to be associated with spills of custom blended pesticide/fertilizer mixtures. Pesticide-impregnated fertilizer loading areas have been identified by the National AgriChemical Retailers Association as being associated with elevated concentrations of pesticide contamination (Ref. 46). Case studies of Iowa commercial agrichemical facilities revealed pesticide levels approximating formulation concentrations in pools of water and soil in areas where pesticides were loaded and handled or where containers and equipment were rinsed (Ref. 21). The Iowa Fertilizer and Chemical Association estimates that 40 percent to 50 percent of the sites in Iowa may require remediation for existing or potential ground-water contamination (Ref. 15). In Kansas, 70 percent to 80 percent of the detections of pesticide in ground water could be traced back to pesticide dealerships (Ref. 46). Minnesota identified ground-water contamination in 20 of 100 active spill incident cases at commercial agrichemical facilities in 1991 (Ref. 41). Between 1984 and 1989, complaint-generated investigations in Illinois confirmed several incidents of pesticide contamination of private well water. Thirteen of these instances were attributed to the handling of pesticides at agricultural pesticide retail facilities. Likely causes of this contamination included pesticide runoff and waste-water discharges into surrounding areas, and chemical spills resulting primarily from leaking storage containers and handling mishaps (Ref. 57). In 1987 and 1988, the Illinois Department of Public Health surveyed wells at 81 commercial agrichemical facilities (randomly selected from a statewide pool of over 1,500 licensed facilities). The survey detected pesticides in 65 percent of these sites, with multiple pesticide residues detected in many of the wells (Ref. 33). By contrast, various public water supply monitoring projects conducted by the Illinois Environmental Protection Agency (IEPA) typically reveal pesticides in only about 1 percent of samples (Ref. 19). A recent joint study by the Illinois Department of Agriculture and the Illinois State Geological Survey (Ref. 26) revealed that soils from all of 49 randomly selected agrichemical facilities contained pesticides at levels that exceeded draft IEPA site-specific soil cleanup objectives. One or more pesticide residues also were detected in 25 percent of the 52 water-supply wells sampled at the sites, however, concentrations of pesticides in water samples generally were less than those encountered in the 1987-1988 Illinois Department of Public Health survey (Ref. 33). These recent findings led the authors of the joint report (Ref. 26) to suggest that although ground water below many currently active agrichemical facilities does not appear to have been extensively impacted by past facility practices, concern for ground water is warranted. Other studies point to pesticide contamination of public or private drinking water wells located near commercial agrichemical facilities. For example, Hallberg (Ref. 22) cites 10 Iowa case studies in which pesticide concentrations in ground water near dealerships were a hundredfold or more concentrated than background levels. In more than 80 percent of the instances in which herbicides other than atrazine have been detected in Iowa's public wells, the wells were located near commercial agrichemical facilities (Ref. 13). In a 1989 survey, the Michigan Department of Agriculture sampled well water from 50 commercial agrichemical bulk storage sites. Pesticides were detected and confirmed in well water from eight (16 percent) of the sites; health advisory levels for pesticides were exceeded in three of the wells. Pesticide concentrations in soils were not determined. The report concluded that commercial agrichemical bulk storage operations located on hydrogeologically vulnerable sites pose a threat to ground-water quality (Ref. 36). Other types of users/operations with practices similar to commercial agrichemical facilities may cause environmental contamination, but for these there is less evidence available. A survey conducted by the Association of American Pesticide Control Officials (Ref. 2) responded to by 28 States revealed 826 commercial agrichemical facilities with documented environmental degradation, but also 121 private sites. Of the 121 private sites, 32 were associated with agricultural research sites. In water quality surveys of farm wells, detections of the highest levels of pesticides sometimes have been attributed to factors such as improper pesticide storage or handling near the well (Refs. 9, 27, and 54). 5. Contamination remediation costs. Remediation of contamination resulting from inadequate pesticide containment and poor waste management practices can be very costly. For example, one registrant spent $207,714, $51,300 and $184,440 for clean up of three separate spills from bulk containers between 1981 and 1983 (Ref. 50). While most States have not begun to assess systematically the degree to which commercial agrichemical facilities require remediation, information from midwestern States indicates a substantial problem. Based on results of samples taken from 50 sites and on files of other open cases, the Minnesota Department of Agriculture estimates that virtually all of the 1,000 commercial agrichemical facilities active in the State will need to conduct contamination assessments and that some degree of remediation will be required for at least half of the sites. Cost estimates derived from the Department's experience with approximately 100 cases suggest that 50 percent to 60 percent of the contaminated sites will be remediated for at least $20,000 to $50,000, not including certain costs (such as attorney fees); 20 percent for $50,000 to $200,000; and 20 percent for more than $200,000, with costs occasionally exceeding $1 million (Ref. 6). The Illinois Environmental Protection Agency notes that while conclusive data do not yet exist, some two-thirds of the State's 1,500 commercial agrichemical sites eventually could be found to warrant some degree of remediation for contamination ``hot spots.'' Typical costs for assessment and remediation for such facilities would average between $15,000 and $50,000. Another 15 percent of the facilities are projected to require more extensive cleanup (cost range $50,000 to $250,000); 2 percent to 5 percent more could require even more expensive remediation (Ref. 56). A recent Illinois study of site contamination at agrichemical facilities (Ref. 26) estimates that statewide costs for soil remediation will range from $8 million to $96 million, with the most realistic estimate thought to be $42 million. These estimates do not include costs for site assessments or for remediation of contaminated ground water. A study conducted by the WDATCP indicates that 45 percent to 75 percent of Wisconsin's commercial agrichemical facilities are likely to require soil remediation. Many also may need to remediate ground-water contamination (Ref. 45). Typical costs for soil remediation range from $10,000 to $50,000. If ground-water contamination is encountered, especially if municipal water supplies are affected, the costs can be much higher. For example, a Wisconsin agrichemical facility recently spent $350,000 to characterize the extent of pesticide contamination in a municipal drinking water supply and install ground-water remediation equipment, and further significant expenses are anticipated (Ref. 43). In Iowa, where roughly half of the commercial agrichemical facilities will require remediation, direct costs for site assessments, monitoring, and remediation of pesticide dealerships could reach $50 million to $100 million (Ref. 15). 6. State bulk containment regulations. As of December 1992, 27 States had implemented or were drafting containment regulations for pesticides (Ref. 71). In the State of the States Report (Ref. 70), EPA learned that pesticide containment regulations vary considerably among the States. Requirements range from relatively minimal standards to comprehensive rules governing construction of bulk containers, secondary containment for storage containers, containment pads for various operations (such as refilling, mixing and loading, washing, rinsing), spill response, recordkeeping, and rinsate and precipitation accumulation management. Some States also include standards for facility location and abandonment and requirements to notify the State of various activities. Some critical areas in which State pesticide containment regulations (implemented or draft) differ include (Ref. 70): a. Applicability of regulations to persons, quantities, and identities of materials. State bulk regulations vary with respect to facilities/operators to whom containment requirements apply. Rules may pertain to manufacturers, distributors, or users of pesticides or may apply more specifically, such as to repackagers, dealers, commercial applicators, and/or farmers. Some States apply secondary containment requirements to any pesticide container with a volume exceeding 55 gallons; others use 210- , 300- or 500-gallon criteria. Containment rules may apply to technical grade, formulation grade, or similar grade pesticides or may extend to rinsates and use solutions. b. Capacity of secondary containment for bulk containers. States commonly set the minimum holding capacity of secondary containment structures according to the volume of the largest container within the structure plus a margin for safety. The safety margin generally requires compensation for volume displaced by containers and equipment and requires additional capacity for structures exposed to precipitation. Some variations among States in safety margin include (separately or in combinations): (1) Ten percent of the volume of the largest container. (2) Twenty five percent of the volume of the largest container. (3) The volume of rainfall from a 25-year, 24-hour storm. (4) Six inches of freeboard. c. Materials for secondary containment. Most States allow concrete, steel, or solid masonry, provided the material is impermeable to pesticide. Several permit soil containment. Others allow various synthetic materials, if they are compatible with pesticides. d. Specifications for containment pad. States typically require paved, curbed and/or sloped containment for pesticide handling operations. Most specify construction with concrete, although some allow asphalt. e. Permitting and notification. Several States require permits prior to construction or, for existing facilities, procedures and permits must be followed to phase facilities into compliance with new regulations. Several also require notification to the State annually prior to initial delivery. In summary, most States do not currently have pesticide containment regulations. Some States are delaying development of containment rules until Federal standards appear. Among the States that have rules, there exists considerable variation in the scope and stringency of requirements. The Federal containment requirements proposed today would establish basic standards which are generally similar to State standards, although they may be more rigorous than some and less stringent than others. These Federal standards would not preclude States from adopting more rigorous State requirements. 7. Conclusions. There is considerable evidence that the routine storage and dispensing of large quantities of pesticides at commercial agrichemical facilities is associated with significant environmental contamination by pesticides. Although it is not always possible to relate specific incidents of contamination at such facilities to particular activities, it is clear that improvements in containment and related management practices for pesticide bulk storage and container refilling operations can help prevent environmental contamination. As discussed further in Unit VI.B.1 of this preamble, EPA proposes to require containment structures at refilling establishments, custom blenders, and for-hire applicators where agricultural pesticides are stored and dispensed. Containment requirements for bulk container storage and container refilling operations, in conjunction with container design standards and adequate procedures for residue removal, would provide an integrated system of environmental safeguards. Each of these three regulatory components is considered essential to ensure the safe refill and reuse of pesticide containers. B. Today's Proposal Subpart H of the proposed regulations is organized into three general categories: general standards for containment structures, secondary containment for bulk containers, and containment for pesticide dispensing areas (where the contents of bulk containers are dispensed and/or containers are refilled). Performance standards for containment materials and design are proposed, as are requirements for operation, maintenance, and recordkeeping. Certain containment requirements for facilities with existing structures are proposed as interim standards to allow sufficient time for retrofitting and to provide a phased approach to meeting new requirements. The definition section of proposed subpart A of this proposed rule contains definitions of terms used in proposed subpart H and related subparts. Terms that are key to the understanding of subpart H include: (1) Agricultural pesticide. (2) Appurtenances. (3) Container. (4) Containment pad. (5) Containment structure. (6) Dry bulk container. (7) Dry pesticide. (8) Liquid bulk container. (9) Pesticide dispensing area. (10) Owner. (11) Operator. (12) Refillable container. (13) Refilling establishment. (14) Secondary containment unit. (15) Stationary bulk container. (16) Transport vehicle. (17) 25-year, 24-hour rainfall event. 1. Scope and applicability. Section 165.140 sets out the scope and purpose of subpart H. The regulations would establish requirements for containment of stationary bulk containers and requirements for containment of pesticide dispensing areas. These requirements are intended for two purposes: to protect human health and the environment from exposure to pesticides from spills and leaks, and to reduce wastes produced when pesticides are stored and handled in bulk containers and during container refilling operations. Descriptions of the applicability of subpart H would appear in two tiers in Secs. 165.141 and 165.142. Section 165.141 identifies facilities and persons that would be responsible for meeting the requirements of subpart H. For those facilities included, Sec. 165.142 would then delineate the universe of stationary bulk containers and pesticide dispensing areas to which the containment requirements apply. a. Facilities and persons covered. Section 165.141 would apply the requirements of subpart H to the following three types of facilities that contain a stationary bulk container or a pesticide dispensing area for an agricultural pesticide (as defined in subpart A): (1) Pesticide refilling establishments (as defined in subpart A) whose principal business is retail sale, (2) custom blenders as defined in 40 CFR 167.3, and (3) the facilities of businesses that apply an agricultural pesticide for compensation (other than trading of personal services between agricultural producers). Facilities that refill an agricultural pesticide into refillable containers and whose principal business is retail sale would be encompassed whether or not they used a stationary bulk container to supply the refilling operation. Retail-oriented establishments would be included because EPA has obtained significant evidence of environmental contamination from pesticide leaks and spills at such establishments (as documented in Units VI.A.2 through VI.A.4 of this preamble). EPA intends to defer consideration of containment requirements at refilling establishments whose primary function is formulation or manufacturing of pesticides, since EPA does not possess sufficient information regarding the practices and environmental problems of these facilities. Moreover, EPA believes that such facilities may warrant containment requirements considerably different from those in today's proposal. If formulation and manufacturing activities are conducted at a refilling establishment whose principal business is retail sale, EPA intends that containment requirements would be applicable at the facility. Also encompassed in Sec. 165.141 would be facilities of businesses that apply an agricultural pesticide for compensation (other than trading of personal services between agricultural producers). This is intended to include the facilities of those pesticide applicators who provide a service of controlling agricultural pests, whether or not they are part of a refilling establishment. The facilities of such for- hire applicators may store and handle large quantities of agricultural pesticides on a routine basis. As discussed in Unit VI.A.4 of this preamble, there is substantial evidence of soil and ground-water contamination by pesticides at such facilities. Among potential sources of pesticide releases are areas where pesticides are stored and dispensed from bulk containers into application equipment and areas where containers are rinsed. EPA does not intend Sec. 165.141(b)(3) to include the facilities of farmers who apply agricultural pesticide for other farmers on a for- hire basis when such service is a minor component of the farm's operation and when it is conducted only on an occasional basis. EPA does not believe that these facilities necessarily will have the same environmental impacts as refilling establishments because their for- hire activities constitute only a small part of the facilities' activities. However, comments are requested to address this assumption and to identify the number and characteristics of farm facilities that would be affected by extending the requirements for containment of bulk storage/dispensing areas to such for-hire farm facilities. EPA intends that the requirements of subpart H should apply to the facilities routinely used by for-hire applicators, but not to field application sites, since different requirements may be appropriate in locations that are used on a temporary basis. Pesticide transfers at temporary sites in the field may be addressed in future rulemaking. Section 165.141 would apply the requirements of subpart H to the facilities of custom blenders (as defined in 40 CFR 167.3) who blend an agricultural pesticide on a customer-order basis with materials such as fertilizers and other pesticides. Based on the available evidence (see Unit VI.A.4 of this preamble), EPA believes bulk pesticide storage and dispensing in custom blending operations pose environmental risks similar to those encountered at refilling establishments. Since most custom blenders are thought to operate as a part of the business of refilling establishments, containment requirements would be applicable by the previously mentioned sections in Sec. 165.141. However, because some custom blenders may operate independently, Sec. 165.141 also would include a separate statement of applicability to custom blenders. (Note that the scope of proposed subpart H differs somewhat from the scope of proposed subpart G with respect to custom applicators and custom blenders. Refer to Unit V.B.6 of this preamble for a discussion of this issue). In addition to identifying applicable facilities, Sec. 165.141 would stipulate that the owners and operators of the containment structure are jointly responsible for assuring that the facility complies with the requirements of subpart H. As defined in subpart A of the proposed rule, the term ``owner'' means any person who owns a facility at which a containment structure is required; ``operator'' means any person in control of, or having responsibility for, the daily operation of a facility at which a containment structure is required. The intent of Sec. 165.141 is to hold the owner and operator jointly liable. EPA requests comments as to whether both the owner and operator or only one of these parties should be held responsible, or whether other parties also should be held responsible. Although commercial agrichemical facilities represent only a subset of the realm of facilities/operations where containment requirements might be appropriate, EPA is not proposing at this time that Sec. 165.141 extend the requirements of subpart H to other types of facilities that store and dispense pesticides in bulk containers or conduct refilling operations. EPA is giving priority to rulemaking for commercial agrichemical facilities because these are the facilities for which the clearest pattern of soil and ground-water contamination by pesticides has been established. However, because EPA intends to consider further containment-related rulemaking for other elements of the pesticide industry, commenters are invited to address relevant problem areas encountered industry-wide. Specifically, some form of containment provisions may be appropriate for bulk storage facilities of registrants and distributors. These operations generally maintain and handle very large stocks of pesticides year-round; thus, EPA believes requirements different from those proposed today may be appropriate. Specific comments are requested that will assist EPA in characterizing the scope, operating practices, environmental risks, and structural and operational safeguards appropriate for these establishments. EPA believes that containment requirements also may be necessary for pesticide bulk containers and certain dispensing operations at the user level. EPA believes that if bulk-related spillage occurs frequently at commercial agrichemical facilities, it probably also occurs at least as frequently at farm sites where pesticides are stored and dispensed from bulk containers. EPA assumes that pesticide storage and dispensing activities can be similar whether conducted at the facilities of a for-hire applicator or the facilities of a large farm. In addition, it is assumed that commercial facilities generally are subject to more frequent inspections by regulatory authorities and that refilling establishments are more likely to receive registrant guidance on containment than are farm facilities. Therefore, EPA is strongly considering expanding the applicability of Sec. 165.141 of the rule to include agricultural users with bulk pesticide containers. EPA requests comments specifically on whether it would be reasonable to so broaden the final rule. EPA also requests specific comments regarding whether Sec. 165.140 and Sec. 165.141 should be extended to apply containment requirements to facilities where non-agricultural pesticides are stored or dispensed from bulk containers. EPA believes that some facilities that handle non-agricultural bulk pesticide containers (e.g., roadside weed control operations, mosquito control operations) are sufficiently similar to agricultural commercial facilities to cause similar environmental problems. To determine whether it would be appropriate to extend the proposed requirements to such facilities, EPA requests comments and data on the scope of such establishments, their practices, state of containment structures, and evidence of spillage or environmental damage. EPA also requests similar information on the wood preservative industry, structural pest control operations, and other institutional and industrial pesticide operations for which containment provisions may be appropriate. EPA does not intend to subject facilities to dual regulation, and in cases where facilities are regulated under other Federal statutes (e.g., regulation of wood preserving facility drip pads under RCRA), comments are requested on how or whether existing requirements could be supplemented. However, EPA notes that some pesticides, if discarded, would be listed or characteristic wastes, regulated under Subtitle C of RCRA. In such cases, RCRA requirements would continue to apply. EPA assumes that many of the facilities covered in Sec. 165.141 will also store and dispense fertilizers in large quantities. Unless fertilizers are mixed with pesticides and therefore labeled as such, they are not subject to FIFRA nor would they be directly subject to the proposed regulations. However, EPA is aware that a number of States have proposed or implemented containment regulations to protect against uncontrolled releases of fertilizers to the environment. While the requirements proposed today have been developed for containment of pesticides and not fertilizers, they may contain some elements that would be of use to States or other entities that are interested in fertilizer containment or spill prevention measures. b. Stationary bulk containers covered. Section 165.142 identifies the types of stationary bulk containers and pesticide dispensing areas to which the requirements of subpart H would apply. Section 165.142(a) would apply secondary containment requirements to stationary liquid and dry bulk containers at facilities encompassed in Sec. 165.141. Two key characteristics of stationary bulk containers (as defined in subpart A) are their holding capacity and the duration of time for which they remain at a facility. EPA would define a liquid bulk container or a dry bulk container by the respective volume or weight of pesticide that it is rated to hold. Bulk containers for liquid pesticides would be refillable containers designed to hold liquid pesticide in undivided quantities of greater than 3,000 liters (793 gallons); bulk containers for dry pesticides would have a capacity of greater than 2,000 kilograms (4,409 pounds). Containers of less than these volume/weight capacities would not be required to be protected with a secondary containment unit. The definition would include any bulk containers, including transport vehicles, that are fixed or remain at a facility for at least 14 consecutive days. Thus, Sec. 165.142 applies requirements for secondary containment to large, stationary pesticide containers. The capacities for liquid and dry bulk containers are proposed as criteria to trigger secondary containment requirements on the premise that container design requirements, as proposed in subpart G of this notice, will help assure that smaller containers do not cause a significant problem in the event they are used for stationary storage. (See discussion of pesticide dispensing operations below for situations in which containment would also be required for smaller containers). The container capacities for bulk containers are substantially greater than volume criteria adopted by States with containment regulations. The States use ``bulk'' criteria ranging from 55 to 500 gallons to trigger secondary containment requirements for liquid pesticides. For dry pesticides, a typical containment trigger is 300 pounds. In proposing larger volume/weight criteria, EPA is attempting to target containers that pose the greatest risk of catastrophic consequences in the event of failure. Although most bulk containers used at commercial agrichemical facilities will be fixed in one position, EPA anticipates that some pesticide bulk containers may not. For example, some facilities may use or be visited by pesticide bulk delivery trucks or rail cars. EPA believes it necessary to require that containment pads, but not secondary containment units (with potentially greater capacity requirements), be used for transport vehicles during customary short- term visits at applicable facilities. However, when such vehicles are used at one location for prolonged storage or repeated on-site dispensing of pesticide, the primary function of the vessels shifts from pesticide transport to pesticide storage or handling. Given the attendant increase in risks of accumulated leakage and unsafe use in such situations, EPA reasons that full holding capacity of secondary containment provisions are warranted. Therefore, Sec. 165.142 would apply the same containment requirements to fixed bulk containers as to non-fixed bulk containers that remain at an applicable facility for at least 14 days. EPA believes that 13 days would adequately accommodate the on-site tenure of transport vehicles under normal circumstances. An option EPA considered but decided not to propose would apply secondary containment requirements only to bulk containers from which pesticides were dispensed for container refilling operations. This limited option was discarded because no evidence was found to suggest that pesticide bulk containers used for refilling operations inherently are more likely to suffer leaks and spills than bulk containers used for other purposes (e.g., dispensing to application equipment or delivery vehicles). As proposed in Sec. 165.142, a stationary bulk container would be exempt from the requirements of subpart H if it satisfied any one of the following conditions: (1) The container has been cleared of all pesticide that can be removed by customary methods such as draining, pumping, or aspirating (whether or not residues have been removed by washing or rinsing). (2) The container holds pesticide rinsates or wash waters and is so labeled. (3) The container holds only pesticides which would be gaseous when released at atmospheric temperature and pressure. (4) The container is dedicated and labeled for non-pesticide use. Section 165.142(a)(2)(i) would allow certain bulk containers that are out of service to remain at the facility without containment. The exemption applies even if some pesticide residues remain in the bulk container, provided that all pesticide that can be removed by customary methods such as draining, pumping or aspirating has been removed. However, EPA expects that in most cases, stationary bulk containers will actually be equipped with secondary containment. EPA also considered a more stringent criterion; namely, that unless residues remaining in such containers were further removed by washing or rinsing, containment would be required. EPA rejected this measure because it was not clear that the benefit derived from the additional cleaning would outweigh the rinse-water disposal problems it could create. The exemption of Sec. 165.142(a)(2)(ii) for stationary bulk containers holding pesticide rinsates and wash waters is based on the fact that EPA currently does not possess sufficient information on the risks of storage of such dilute pesticides. As discussed in Unit VI.A.4 of this preamble, contamination of soil and ground water has been associated with improper management and disposal of pesticide rinsates and wash waters, but the extent to which storage of such materials in bulk containers has been problematic is not clear. EPA requests comments to assist in determining conditions under which secondary containment is appropriate for bulk containers of dilute pesticides and to help in estimating the numbers of facilities and bulk containers that may need to be protected. Today's proposal would exempt from containment requirements bulk containers that hold pesticides that would be gaseous if released at atmospheric temperature and pressure. This exemption is based on the fact that the preponderance of EPA's information on environmental contamination at commercial agrichemical facilities pertains to soil and water contamination, not to releases to air. Comments are requested to clarify whether and the extent to which aerial releases of pesticides from bulk containers warrant containment measures to protect human health and the environment. c. Pesticide dispensing areas covered. Section 165.142(b) sets out the applicability of containment pad requirements for pesticide dispensing areas at facilities covered in Sec. 165.141. The term ``pesticide dispensing area'' is defined to include an area in which pesticide is transferred out of or into a container. Section 165.142(b)(1) would identify four specific conditions under which the requirements for containment pads in subpart H would apply to pesticide dispensing areas. These four areas are as follows: (1) As proposed in Sec. 165.142(b)(1)(i), an area in which pesticide is dispensed from a stationary bulk container would be required to meet the containment pad requirements of subpart H. Containment requirements would apply regardless of the purpose of dispensing. For example, containment requirements would apply whether pesticide dispensing is done to refill refillable containers, service containers, transport vehicles, or application equipment, or to empty the bulk container prior to cleaning. The intent of this portion of Sec. 165.142 is to require that at a minimum, containment pad requirements apply to the area where material is transferred from the appurtenance of a stationary bulk container into a receiving vessel, including the area physically covered by the receiving vessel. Containment pad requirements also would be intended to apply even if there is no receiving vessel on the pad, such as might occur when rinsate is discharged from the appurtenance of a stationary bulk container during container cleaning. EPA is proposing that containment requirements apply to these areas because large volumes of pesticides are transferred there and are subject to spillage from operating practices and mishaps, as well as equipment failures (see Units VI.A.2 through VI.A.4 of this preamble, for discussion). (2) Section 165.142(b)(1)(ii) would apply containment pad requirements to pesticide dispensing areas in which pesticide is dispensed from any container other than a stationary bulk container for purposes of refilling a refillable container for sale or distribution. The area where pesticide is dispensed into the refillable container, including the area physically covered by the refillable container, would be required to meet requirements for a containment pad. EPA believes that containment is warranted in refilling areas for the same reasons described above for Sec. 165.142(b)(1)(i). Containment requirements would not apply if pesticide is dispensed from small containers for purposes other than refilling. EPA requests comment on whether containment requirements should be broadened to include dispensing from small containers for other purposes (see further discussion below). (3) An integral component of container refilling operations is the emptying, cleaning, and rinsing of refillable containers in preparation for refill. During this process, significant quantities of pesticide concentrates and rinsates may be generated or transferred. Section 165.142(b)(1)(iii) would apply containment requirements to areas where such activities occur. EPA believes that without structures to intercept and collect pesticide spills in such areas, safe refill cannot be assured. Evidence presented in Unit VI.A.4 of this preamble indicates that environmental contamination can occur not only where pesticide concentrates are spilled, but also in areas where pesticide rinsates are routinely dispensed. (4) Section 165.142(b)(1)(iv) also would apply containment pad requirements to areas at a facility where pesticides are dispensed from transport vehicles into stationary bulk containers. This requirement is predicated on EPA's finding (documented in Unit VI.A.2 and Unit VI.A.3 of this preamble) that mishaps can result in pesticide spills during dispensing both from (load-out) and into (load-in) stationary bulk containers. EPA believes that in most situations, pads used for dispensing pesticide from stationary bulk containers also will be able to be used as containment pads to accommodate dispensing from transport vehicles. (See discussion on Sec. 165.152(b)(1) in Unit VI.B.5 of this preamble for size considerations of pads used for such transport vehicles.) EPA considered but rejected two other options pertaining to the applicability of containment pad requirements. One option would require containment pads wherever any pesticide container routinely is stored, emptied, filled, cleaned, or handled at a facility. This broad approach was not adopted because EPA lacked sufficient data to determine what type of containment was warranted in different situations. A second, much more narrow option would apply containment pad requirements only to pesticide container refilling operations at refilling establishments. However, environmental data, discussed in Units VI.A.2 and VI.A.4 of this section, suggested that refilling operations are not likely to be the sole cause of contamination at facilities covered; activities such as dispensing pesticides from bulk containers into spray equipment and improper disposal of pesticide rinsates could also be contributing factors. Thus, this narrow approach was rejected in favor of the approach proposed in Sec. 165.142. As proposed in Sec. 165.142(b)(2), a pesticide dispensing area would be exempted from the containment pad requirements of subpart H under any of the following three conditions: (1) If the only pesticides handled in the pesticide dispensing area are pesticides which would be gaseous if released at atmospheric temperature and pressure. EPA proposes to defer action on containment requirements for gaseous pesticides, pending further collection of information. (2) If the only pesticide containers refilled within the pesticide dispensing area were stationary bulk containers protected by a secondary containment unit that complied with the requirements of this subpart. This exemption stems from the fact that the portion of a stationary bulk container where pesticide is dispensed into the container could fall under the definition of a ``pesticide dispensing area,'' triggering containment pad requirements. Because the act of refilling a stationary bulk container will occur only infrequently, but storage of pesticide in stationary bulk containers will occur on a prolonged or continuing basis, EPA believes the safeguards of a secondary containment unit would be more appropriate than the safeguards of a containment pad. Although the exemption for containment pad requirements pertains to the stationary bulk container, the area where pesticide is dispensed out of the appurtenance of the stationary bulk container (e.g., for filling containers, application equipment, etc.) would be required to be protected by a containment pad. (3) If the pesticide dispensing area is used solely for dispensing pesticide from a rail car that is not a stationary bulk container. EPA believes that operations involving dispensing from rail cars typically will involve brief visits to off-load into bulk containers. It is not clear that containment pads are warranted in such temporary situations, especially since such pads would be less likely to be able to serve multiple purposes than would pads where trucks are off-loaded. However, if a rail car is used as a stationary bulk container, secondary containment would be required. Under this proposal, a facility required to install a containment pad for transfers to and from bulk containers would not be required to use the pad for filling of application equipment from containers smaller than bulk containers; nor would it be required to use the pad for application equipment washing operations. However, it clearly would be in the facility's interest to use the pad if such operations are conducted on-site, since spills, leaks, and improper disposal of wash waters could result in environmental contamination. EPA believes that requirements for the use of containment pads when cleaning equipment or when dispensing pesticide from small containers into application equipment merits further consideration. EPA requests comments on useful criteria to determine to whom or under what situations containment pad requirements should apply for containers smaller than bulk containers and whether the standards proposed today for containment pads would be appropriate. EPA also requests data reflecting the numbers of facilities that could be affected by so extending containment standards. 2. General requirements for containment structures. EPA is proposing general requirements for containment structures in Sec. 165.146. Both containment pads and secondary containment units would be required to meet the standards for materials, design, construction, operation, inspection, and maintenance proposed in this section. The proposed standards would apply to structures for dry pesticides as well as for liquids, since the former can routinely become exposed to rainfall, wash water or other liquids. The proposal also would provide a phase-in period, establishing certain interim standards for existing containment structures and full requirements for new containment structures. Section 165.144 would identify existing containment structures as those for which installation commenced on or before the date 3 months after the date of publication of the final standards for pesticide containers and containment in the Federal Register; new containment structures would be those for which installation commenced after that date. Section 165.144 would also provide criteria to distinguish between new and existing structures. These criteria derive from EPA's Hazardous Waste Management System regulations issued under the Resource Conservation and Recovery Act (Ref. 93) and from EPA's Prevention of Significant Deterioration regulations issued under the Clean Air Act (Ref. 85). EPA requests comment on whether alternative or supplementary criteria should be used to define existing and new containment structures. (See also discussion of compliance dates for new and existing structures in Unit VI.B.7 of this preamble.) a. Rigid structures. Section 165.146 would require that the containment structure be constructed of rigid material, capable of withstanding the full hydrostatic head (dynamic or static), load, and impact of any pesticides, precipitation, other substances, equipment, and appurtenances placed within the structure. Rather than specifying a list of acceptable construction materials, Sec. 165.146 would leave open the choice of materials (with a few exceptions), as long as rigidity performance standards were satisfied. Containment structures for pesticides and other chemicals such as petroleum products, solvents, and fertilizers have been constructed with a variety of materials. Some examples of rigid systems are reinforced concrete dikes, stainless steel pans, and basins cast from synthetic polymers. Examples of non-rigid materials are asphalt or earthen dikes, unfired clay, and portable synthetic materials which can be rolled up or folded. Key technical guidance documents (Refs. 28 and 58) recommend that rigid materials, especially reinforced concrete, be used for structural support in pesticide containment facilities. Many State pesticide containment regulations require construction with concrete (Ref. 70). EPA believes that rigid materials are best able to withstand the full force of contained materials and any vehicles or other equipment that might be used on the structure. Although flexible, portable containment structures may be appropriate in certain other situations, EPA believes that durable, rigid materials should be required for containment at facilities covered in this proposed rule. In Sec. 165.146(a)(2) of today's proposal, EPA would prohibit the use of earthen materials, unfired clay or asphalt as structural materials for containment structures. Such materials are not recommended in technical guidance documents for pesticide containment systems (Refs. 28 and 58). For containment of very large containers of chemicals (e.g., tanks with a holding capacity of 100,000 gallons or more), engineers may seek less expensive alternatives to rigid containment materials, such as clay-lined earthen berms. However, a number of significant failures of earthen containment structures have been documented (Ref. 12). The level of protection afforded by earthen liners can be degraded by exposure to sunlight and cold cracking and may be vulnerable to damage from animal activity. Costs associated with cleanup of pesticide spills inside clay containment structures can be high, given the likely need to excavate and reconstruct the liner, and test and dispose of contaminated soil (Ref. 44). Since the overwhelming majority of the containment systems affected by today's proposal is anticipated to involve storage and dispensing of relatively small volumes of pesticides (as opposed to 100,000-gallon systems), EPA believes that rigid materials would be appropriate. Comments are requested regarding whether these prohibitions would subject facilities to undue hardship, and if so, what alternative safeguards could be proposed to ensure that containment structures constructed of these materials would function effectively. b. Hydraulic conductivity. Containment structures must be sufficiently resistant to penetration by pesticides to prevent the leaching and release of harmful quantities of pesticide. Section 165.146 proposes that containment structures must meet specific quantitative criteria for hydraulic conductivity. Section 165.146(a)(3)(i) would specify a standard for hydraulic conductivity of less than or equal to 1 x 10-6 centimeters per second (cm/sec) for existing containment structures during an interim period that would begin 2 years after the final rule is published and would end 8 years later; thereafter, a more stringent standard of 1 x 10-7 cm/sec or less would apply to existing structures. (Further discussion of a proposed interim phase-in schedule for existing structures appears in this section and in Unit VI.B.7 of this preamble). As proposed in Sec. 165.146(a)(3)(ii), new containment structures would be required to achieve a hydraulic conductivity that is less than or equal to 1 x 10-7 cm/sec 2 years after the publication date of the final rule. These standards could be attained by using structural materials; surface sealants and coatings; liners beneath the structure; or combinations thereof. The hydraulic conductivity standards would apply for the entire pesticide-bearing portion of the structure. The proposed hydraulic conductivity criteria pertain to the rate of water movement through containment material. EPA believes that although it would be preferable to base the criterion directly on the permeability of the containment material to the pesticide, manufacturers of containment materials frequently will not have available information on permeability performance of their products for a wide variety of pesticides. However, EPA believes that the rate of movement of water through the containment material is customarily measured by manufacturers of containment materials and would provide a reasonable index for the rate of movement of liquid pesticide. A hydraulic conductivity standard of less than or equal to 1 x 10-7 cm/sec proposed in Sec. 165.146(a)(3)(ii) was selected for many of the same reasons it was proposed under RCRA subtitle C for surface protection (sealants and coatings) of wood preservative drip pads [see Notice of Proposed Rulemaking in 56 FR 63848, December 5, 1991 (Ref. 95)]. EPA believes that concrete is the material chosen by most owners of pesticide containment structures. Well-designed and constructed concrete, when unfractured, has been demonstrated to have a hydraulic conductivity of 10-7 cm/sec or less. Thus, a hydraulic conductivity standard of 10-7 cm/sec is essentially a proxy standard for well-constructed, unfractured, common concrete. EPA believes that well-constructed, unfractured concrete generally could serve as an adequate containment material for pesticides. When suitable materials are used and properly installed, concrete offers the advantages of structural strength, durability and economy. EPA believes that when well-constructed concrete is unfractured, it will adequately retard migration of pesticide through the structure and reduce the risk of harmful releases of pesticides to the environment. To illustrate the amount of liquid that could pass through an unfractured concrete containment structure with a hydraulic conductivity of 10-7 cm/ sec, a 25 ft2 sump that is continually wetted would release 0.05 gallons of material per day. When exposed to field conditions, concrete is susceptible to fracturing, and even microscopic cracks can diminish its ability to retain liquids. Microfractures could allow liquids to permeate many times more rapidly than material that is on a crack-free structure; therefore, EPA believes that concrete exposed to field conditions is unlikely to meet the proposed standard of less than or equal to 1 x 10-7 cm/sec and is unlikely to provide an adequate level of protection. In addition, recent preliminary findings by the Tennessee Valley Authority (Ref. 5) indicate that concrete alone may not be an adequate barrier to prevent the penetration of some agricultural pesticides. For these reasons, EPA believes that new containment systems constructed of concrete would require additional protection in the form of treatment with sealers or coatings, and/or protection from below with a liner. EPA believes materials are available that can meet or exceed (i.e., have a lesser hydraulic conductivity value than) 1 x 10-7 cm/sec, although some additional research and technology transfer may be needed to facilitate the matching of containment materials to different pesticides and field conditions. Although a hydraulic conductivity standard of 1 x 10-7 cm/sec is proposed today for pesticide containment structures as well as in the rule for wood preservative drip pads, it should be noted that the two rulemaking initiatives differ regarding the containment materials to which these standards would apply. For wood preservative drip pads, the standard applies to surface protection treatments for concrete pads (i.e., sealants, coatings, covers) but not to liners. Rather than a hydraulic conductivity standard, liners for wood preservative drip pads must meet various design, construction, and installation requirements. In today's proposal, compliance with the hydraulic conductivity standard could be attained by sealants, by coatings, by structural materials in the containment structure, or by a liner beneath the structure. Under Sec. 165.146(a)(3)(i) of today's proposal, during an interim period, existing containment structures could be composed of materials meeting a less stringent hydraulic conductivity standard, namely less than or equal to 1 x 10-6 cm/sec. This provision is intended to allow operators to derive up to 10 years additional service (until the end of the interim period) from existing, concrete containment structures without applying a coating or sealant, provided that visible cracks are repaired and that the structure otherwise will be inspected, maintained, and operated in compliance with requirements proposed in this section. There is a precedent in the States (Illinois) for using a hydraulic conductivity standard of 1 x 10-6 cm/sec for pesticide containment structures. In selecting a hydraulic conductivity standard for existing structures, EPA attempted to identify a criterion that would comport with hydraulic conductivity standards that have been set forth in state regulations on pesticide containment. Most state regulations do not cite hydraulic conductivity construction standards, but those that do typically specify values no less stringent than 10-6 cm/sec (this value usually applies to liners). EPA is therefore proposing a hydraulic conductivity standard of 10-6 cm/sec in an effort to harmonize with state regulations governing existing structures. In essence, the 10-6 cm/sec standard is intended to serve as a surrogate standard to represent a containment structure that is composed of well constructed concrete but that has been exposed to fracturing conditions in the field. EPA requests comments on whether hydraulic conductivity standards are appropriate for existing containment structures or if other types of criteria should be used to indicate the ability of existing containment structures to retain pesticides. For example, in place of a hydraulic conductivity standard, should EPA require that during the interim period, existing containment structures must be maintained free of visible cracks and other defects? If this or similar qualitative standards are proposed, would such requirements be applicable to concrete as well as to other appropriate containment materials? EPA believes that less stringent hydraulic conductivity standards are not appropriate for the long term, since more rapid rates of penetration may result in significant releases of pesticides to the environment and also may lead to costly disposal problems when contaminated concrete structures are decommissioned. Therefore, EPA is proposing today that for new structures, the effective date for compliance with the 1 x 10-7 cm/sec hydraulic conductivity standard would be 2 years after publication of the final rule. EPA believes it would be prudent for operators of existing concrete structures to coat or seal their structures as soon as possible with material meeting the 1 x 10-7 cm/sec standard; however, EPA realizes that coating or sealing existing structures may not be a simple task. Bulk containers would need to be removed from secondary containment units and the containment structures would require thorough preparation either by scarifying, grinding, or sandblasting, and vacuuming or a wet treatment involving degreasing, acid treatment, and neutralization (Ref. 28). Because this may be a significant undertaking, EPA is proposing to require compliance with the more stringent hydraulic conductivity standard in synchrony with schedules for other standards requiring significant structural changes. Therefore, for existing structures, compliance with the standard of 1 x 10-7 cm/sec would not be required until after an additional 8-year interim period. EPA assumes that manufacturers of sealers, liners, and coatings can provide documentation to verify that their products meet hydraulic conductivity criteria [see proposed recordkeeping requirements in Sec. 165.157(b)]. A typical method for measuring the infiltration rate of water vapor into a synthetic coating or liner is ASTM E96 Procedure E. EPA would consider this form of verification acceptable and requests comment on whether other procedures such as ASTM E96 Procedure H should be considered. EPA does not believe that it would be practicable to require routine hydraulic conductivity tests of installed materials. In fact, EPA is unaware of any generally accepted test methods for determining the permeability of a surface sealer, coating, or cover once it has been applied. EPA requests comments as to whether owners or operators of existing containment structures will be able to and should be required to document that installed containment materials can meet a standard of 1 x 10-6 cm/sec. EPA invites other comments regarding the proposed hydraulic conductivity standards. In particular, commenters are requested to discuss whether all containment structures (new and existing) should meet the more stringent standard of 10-7 cm/sec within 2 years of publication of the final rule. Comments are also solicited on whether hydraulic conductivity criteria should apply to all types and parts of containment structures, or whether they should be tailored to match relative risks of releases. For example, should the hydraulic conductivity standard for pesticide containment pads be more stringent than the standard for secondary containment units, since the former are likely to be subjected more frequently to pesticide spills and rinsate discharges? Should sumps or other areas where pesticides can routinely accumulate meet a more stringent standard than other parts of the containment structure? EPA also requests comments regarding whether the proposed hydraulic conductivity values of 10-6 and 10-7 cm/ sec are appropriate as standards for containment structures, or, if not, what factors should EPA consider in proposing alternative hydraulic conductivity values. Although a hydraulic conductivity standard is applicable to concrete and other porous or easily fractured materials, it may be less applicable to certain other materials (e.g., steel) that may inherently meet the conductivity standard. EPA requests comments as to whether alternative language is needed to clarify the acceptability of other materials in meeting the proposed standard. Comments also are requested to assist EPA in determining if a hydraulic conductivity standard is appropriate for liners used beneath containment structures, or whether alternative design, construction, and installation criteria should apply to such liners. For example, when synthetic liners are used for wood preservative drip pads, regulations at 40 CFR part 264 subpart W and part 265 subpart W [55 FR 50450, December 6, 1990 (Ref. 94) require that they prevent leakage from the drip pad into adjacent soil and water. Liners for wood preservative pads must also be constructed of materials that will prevent drippage/leachate from being absorbed into the liner; the materials also must have appropriate chemical properties and sufficient strength and thickness to prevent failure due to pressure gradients, physical contact with the drippage/leachate to which they are exposed, climatic conditions, and stresses of installation and daily operation. The liners also are required to be placed on a foundation or base capable of providing support to the liner and resistance to pressure gradients above and below the liner to prevent failure of the liner due to settlement, compression, or uplift. EPA requests comments to clarify whether design, construction, and installation standards such as those applying to liners for wood preservative drip pads should apply to liners for pesticide containment structures, in lieu of or as a supplement to the proposed hydraulic conductivity standard. EPA considered several other approaches to specify the ability of containment materials to resist penetration by pesticides. One alternative was the use of specific design criteria (e.g., specifying type and thickness of concrete, spacing of reinforcement bars, etc.). Another approach was to require that the structure be constructed of material that is impermeable or impervious to the pesticide being stored or handled. Another option was to set a specific length of time over which the containment structure would be required to retain spilled material. For example, a spill retention period of 72 hours was recently proposed by EPA as a standard for secondary containment of large, aboveground oil tanks under section 311(j)(1)(c) of the Clean Water Act (Ref. 88). EPA requests comments on whether these or other qualitative criteria should be used as an alternative or supplement for hydraulic conductivity. c. Resistance to pesticides. Section 165.146(a)(4) would require that containment structures be composed of materials that are resistant to the pesticide that is being stored or dispensed. Unless containment materials are resistant, exposure to pesticide could cause them to become weakened or corroded, or to otherwise deteriorate. EPA believes that manufacturers of containment materials routinely will be able to provide documentation to verify that materials are resistant to particular pesticides. EPA requests comments on whether the term ``resistant to the pesticide'' is clear and/or whether EPA should define this phrase in the regulations. Comments also are requested to assist EPA in determining appropriate qualitative or quantitative criteria for resistance to pesticides. d. Stormwater control. Precipitation may enter a containment structure either directly or through stormwater run-on from surrounding land or structures. The presence of this water on the containment structure can be undesirable because it diminishes the holding capacity of the structure and may eventually flush pesticide residues from the structure to adjacent lands and waters. Even if the structure does not overfill, if pesticide residues mix with the water, the water may need to be managed as pesticide. This can create a disposal management problem if an operator is not prepared to use the pesticide-containing water according to the appropriate label or if there is not adequate storage to hold the material until it can be properly used. In later sections of this preamble (Units VI.B.3, VI.B.4, and VI.B.5) capacity requirements for containment structures are discussed. These sections include discussions of requirements that would allow for retention of direct rainfall and/or the possibility of roofing to protect containment structures from direct rainfall. In contrast, the present section of the preamble describes proposed construction and design requirements to prevent stormwater from entering containment structures via run-on from adjacent areas. As stipulated in Sec. 165.146(b)(1), EPA is proposing that at a minimum, any containment structure must be designed and constructed to prevent water and other liquids from seeping into it or flowing onto it from adjacent land or structures during a 25-year, 24-hour rainfall event. EPA is concerned that operators will find it difficult to properly manage pesticide-containing stormwater or prevent pesticide releases from containment structures that are located on poorly drained areas. A 25-year, 24-hour rainfall event is commonly used as a design benchmark for the capacity of secondary containment structures. For example, the National Pollution Discharge Elimination System (NPDES) Best Management Practices Guidance Document (Ref. 75) indicates that containment structures should be designed to retain precipitation from a 25-year, 24-hour storm to prevent run-off from being released to the environment. EPA believes that, just as a 25-year, 24-hour storm is a reasonable criterion for stormwater retention, it would also serve as a reasonable standard to which pesticide containment structures should be built to prevent stormwater seepage and run-on from entering the structure from adjacent lands or structures. EPA requests comments as to the utility of this specific requirement and whether containment designers will be able to translate information on 25-year, 24-hour storm values into appropriate siting/design specifications. Alternatively, EPA requests comments on whether other flood criteria, such as a 100-year flood level, would be more appropriate. EPA is proposing a requirement for stormwater control that is performance-based rather than design-based. Thus, the proposed approach would not stipulate that containment walls be constructed to some minimum height, such as 3 inches or 6 inches. EPA believes that a performance-based stormwater control requirement will allow owners/ operators flexibility to comply under varying site-specific conditions. For example, all other things being equal, containment structures built on well-drained, elevated areas may be constructed with lower curbs/ walls than structures built in depressions. Structures sited on drainage ways may rely on higher curbs/walls, may install stormwater- diverting structures (such as berms) uphill, or both. Structures built in arid areas (and, hence, with less precipitation during a 25-year, 24-hour storm) may generally need lower walls or less elevation than structures located in regions with more rainfall. Sites with porous soils and low water tables will drain better than sites with compact soils and high water tables, and containment structures design can vary accordingly. If stormwater can drain into the containment structure from the overhanging roofs of adjacent buildings, gutters or other methods could be used to divert the stormwater away from the structure. EPA requests comments on alternative approaches to stormwater control for containment structures. For instance, rather than specifying that stormwater run-on must be prevented from entering a containment area during a 25-year, 24-hour rainfall event, the rule could provide that, at a minimum, no discharge may take place from a containment structure during a 25-year, 24-hour rainfall. This approach would generally comport with typical NPDES requirements; however, because it would essentially impose capacity requirements on containment structures, readers should refer to the discussions on capacity requirements in Units VI.B.3, VI.B.4, and VI.B.5 of this preamble. e. Site preparation. This proposal does not include specifications for site preparation. For example, there is no proposed requirement for testing the proposed construction site for soil and ground-water contamination prior to construction. There is also no requirement that contaminated sites be properly cleaned prior to construction. However, because recent evidence points to widespread pesticide contamination of soil and ground water at commercial agrichemical facilities, EPA strongly urges any person who is contemplating constructing or purchasing a containment structure, especially at a site with a history as an agrichemical facility, first to conduct an environmental assessment of the site. If construction proceeds and significant contamination is found later, the effectiveness of the structure would be questioned and the structure may have to be removed in conjunction with remediation efforts. f. Support of containers and appurtenances. Section 165.146(b)(2) would require that containers and appurtenances on containment structures be protected from damage by personnel and moving equipment. The need to protect equipment against accidents is supported by EPA's finding that spills and leaks at pesticide bulk storage and handling facilities are often related to operator error and equipment failure. The proposed language would provide several choices in securing protection, including measures such as the use of supports to prevent sagging, flexible joints in the event that connections are jarred or dislocated, and the use of guard rails, barriers, and protective cages. A number of State pesticide containment regulations require similar protective measures. As a variation of this requirement, EPA considered requiring that all appurtenances used to dispense pesticides to or from containers be protected by containment. For example, a pipe running from a distant pesticide bulk container to a containment pad would itself require containment. EPA is not proposing this alternative due to a lack of information on the practicability of containing all appurtenances. g. Configuration of drains and appurtenances. Section 165.146(b)(3) proposes that for new structures (and existing structures after 8 years), pipes or drains through the walls or base of the containment structure would not be allowed. An exception would be granted for pipes through walls separating adjacent containment structures, provided the structures meet all applicable proposed requirements. EPA believes that areas in which containment structures are penetrated by plumbing fixtures are difficult to keep sealed. Moreover, leaks in drains beneath structures are difficult to detect. The proposed interim period of 8 years would provide existing facilities the opportunity to continue operating prior to upgrading. EPA is concerned that appurtenances that are buried or otherwise inaccessible to inspection may be sources of significant undetected leakage. This problem frequently has been documented for buried appurtenances of petroleum product containers. For example, an EPA study, ``Causes of Release from UST Systems,'' (as discussed in Ref. 96) concludes that faulty piping, loose fittings and vents cause 84 percent of test failures for ``tightness'' of underground storage tank systems. (``Tightness'' tests measure changes in product volumes over time to determine if tank systems are leaking.) External corrosion is a common source of damage to such underground piping, but natural forces and accidents also cause piping failures. Piping near the surface is subject to damage from overloading and from soil heaving during freeze/ thaw cycles. EPA believes that the problem of undetected leakage is generic to buried appurtenances, regardless of their contents. Therefore, Sec. 165.146(b)(3) of today's proposal would require that appurtenances be configured in such a way that if leaks and spills occur, they can easily be observed. EPA considered implementing this requirement for all structures (existing and new) 2 years after the rule is published, but chose to defer the requirement for existing systems for 8 additional years due to the possibility that compliance with this provision may require substantial remodeling costs for existing systems. Thus, Sec. 165.146(b)(3) of today's proposal would defer for an interim period of 8 years the requirement that appurtenances be configured in such a way that any leakage that might occur can be readily observed. Comments are requested to assist EPA in determining whether leak detection systems, hydrostatic testing, or other methods would better assure the integrity of appurtenances. h. Operations. Section 165.146(c) proposes general standards for the operation of containment structures. As discussed in Units VI.A.2 through VI.A.4 of this preamble, operational problems such as overfilling containers or equipment, allowing hoses to become dislodged, leaving pesticide transfer operations unattended, and improperly disposing of spills and rinsates have contributed to contamination of soil and ground water. Indeed, even after remediation of commercial agrichemical facilities and installation of new containment systems, contamination often recurs because operators apparently continue to engage in improper pesticide handling and disposal practices (Refs. 20 and 80). The protection offered by containment structures is intended to address spills or leakage after it occurs, but cannot alone ensure that pesticide storage or transfer operations will not result in environmental contamination. EPA believes that structural safeguards must be coupled with sound operational procedures to ensure safe refill and reuse of containers. Section 165.146(c)(1) would require any containment structure (secondary containment unit or containment pad) to be operated in a manner that prevents pesticides, including residues in rinsates and rainwater, from escaping the structure to surrounding areas. This section would also require that all materials containing pesticide residues be handled in accordance with label directions and applicable regulations. Section 165.146(c)(2) would require the owner or operator to ensure that an individual be present whenever pesticides are being transferred at the containment structure. This proposed requirement is based on information gathered by EPA suggesting that significant spills can occur at agrichemical bulk storage facilities when pesticide transfer operations are left unattended (see Units VI.A.2 and VI.A.3 of this preamble). EPA also believes that the person in attendance should be trained in the proper methods of pesticide storage and dispensing and versed in the facility's spill control and recovery procedures. EPA is not proposing that such training be mandatory and formally certified, but invites comments as to whether such a measure should be required. Because vandalism has caused major pesticide spills at agrichemical facilities, Sec. 165.146(c)(3) would require that lockable valves on stationary bulk containers (as proposed by subpart G for bulk containers at refilling establishments) be locked closed when the facility is not attended. Section 165.146(c)(4) would require that the owner or operator ensure that contained spills and leaks are collected and recovered to the maximum practicable extent and in a manner that ensures protection of human health and the environment. Certain technical guidance documents recommend immediate cleanup of spills and leaks at containment structures (Refs. 28 and 58). Timely cleanup of the containment structure can increase its service life by preventing long- term corrosive conditions, can reduce the volume of pesticide- containing rainwater that needs to be disposed (in unroofed structures); and can minimize the potential for human or animal exposure to pesticides. In addition, long-term retention of spilled materials in a containment structure would displace some of its holding capacity, increasing the probability of releases during periods of heavy rainfall or other unanticipated events. As proposed, Sec. 165.146(c)(4) would require that spills or leaks be cleaned up as soon as practicable and no later than by the end of the day in which pesticides have spilled or leaked in the containment structure. EPA requests comments on alternative provisions to require immediate cleanup of spills, or to allow a set period of time (e.g. 24 hours) until cleanup. Section 165.146(c)(5) would require the owner or operator to ensure that recovered materials containing pesticides be handled as prescribed by label instructions and applicable Federal, State, and local regulations. EPA also requests comments on any alternatives to the proposed containment requirements that would reduce the likelihood of spills and leaks, and thus reduce the potential quantity of material that would have to be recovered and managed. i. Inspection and maintenance. General requirements for inspection and maintenance of containment pads and secondary containment units are proposed in Sec. 165.146(d). Without vigilance and regular upkeep, even relatively small defects can lead to hazardous and costly uncontrolled releases of pesticides. Since the proposed rule does not set forth environmental monitoring or leak detection requirements that would warn operators of containment defects, EPA believes that requirements for regular inspections and maintenance are crucial for ensuring safe bulk storage and refill operations. Section 165.146(d)(1) would require the monthly inspection of all stationary bulk containers and their appurtenances and containment structures for external signs of damage or leakage. This requirement would apply during periods in which pesticides were being stored or handled in the containment area. Regular inspections are proposed to facilitate the timely detection and correction of containment flaws and thereby prevent pesticide discharges to the environment. The proposed monthly inspection schedule for containment structures generally comports with inspection requirements of applicable State regulations. Since weekly inspection schedules were recently proposed by EPA for wood preservative drip pads (Ref. 95), EPA considered whether weekly inspection schedules also would be appropriate for containment structures for agricultural pesticides. EPA assumes that pesticide containment structures addressed in today's proposal generally will be smaller and (during operating hours) will have a greater frequency of personnel visits per unit area than will wood preservative drip pads. Additionally, pesticide spillage would be required to be cleaned up sooner after it occurred on containment structures for agricultural pesticides than it would for wood preservative pads. EPA believes that these factors would lead to defects being noted more quickly in containment structures for agricultural pesticides than in drip pads for wood preservatives. Therefore, EPA is proposing a monthly rather than a weekly inspection schedule for containment structures covered in today's proposal. EPA requests comments as to whether a monthly frequency of inspection is appropriate, or whether a different inspection schedule should be established. Section 165.146(d)(2) proposes that any cracks and gaps in a containment structure or appurtenance must be sealed with material that is resistant to the pesticide being stored or handled and that also satisfies applicable requirements for hydraulic conductivity. Expansion cracks and joints are said to be the biggest sources of releases from concrete secondary containment structures (Ref. 53). Cases of uncontrolled releases of agrichemicals (sometimes involving thousands of gallons of product) have been attributed to poorly sealed joints and cracks in containment structures (e.g., Ref. 52). EPA requests comments as to whether manufacturers of caulking, waterstops, and other types of sealing materials readily can document that their products conform to the proposed standards for hydraulic conductivity and pesticide- resistance. Section 165.146(d)(3) would prohibit the storage of pesticides on a containment structure that fails to meet the requirements of subpart H. Dispensing of pesticides would also be prohibited, unless the dispensing is done to remove pesticides promptly until suitable repairs could be effected. By the provision for ``prompt removal,'' EPA intends that the owner or operator would be required to remove all of the pesticide as promptly as practicable. At some facilities, such removal may be achieved immediately by transferring the pesticide from a flawed containment structure to one that is intact. In other cases, it may be necessary to dispatch a transport vehicle to remove pesticide until repairs are completed. However, EPA believes that most repairs will be relatively minor and should be able to be completed in less time than would be required to remove pesticide from the defective structure. EPA solicits comments as to whether there should be additional inspection and maintenance requirements, such as a criterion that containment structures be inspected annually (or every 3 or 5 years) by a registered professional chemical, civil, industrial, or petroleum engineer and be certified to meet all applicable material, structural, and design criteria. j. Detection of leaks from containment structures. Even well- designed containment structures may develop leaks. For example, failed caulking, small fractures, pinhole leaks, and related structural flaws may develop unnoticed and lead to unanticipated release of pesticide through the containment structure. EPA considered two options to address such problems. One approach would require the installation and regular monitoring of leak detection systems beneath the containment structures and of ground-water monitoring wells nearby. The second option would not require leak detection systems, provided the structures were subjected to regular visual inspections and proper maintenance. EPA believes that certain proposed requirements would lessen the need for rigorous containment leak detection requirements. For example, prohibitions on drains and buried appurtenances and a proposed requirement that stationary bulk containers be elevated so that any leaks can readily be observed (discussed in Unit VI.B.3 of this preamble) would reduce the possibility of containment leaks escaping notice. The use of structural materials, surface sealants and coatings to meet hydraulic conductivity standards would also reduce the need for leak detection systems, since EPA believes that all these materials would be relatively amenable to visual inspection for defects. Although the proposed rule adopts this second approach, EPA requests comments as to whether leak detection systems and ground-water monitoring requirements would be more appropriate in some or all instances. For example, if a containment structure meets the requirement for hydraulic conductivity through the use of an underlying liner, should leak detection/ground-water monitoring systems be required because the liner cannot be visually inspected? Should leak detection systems be required preferentially for containment pads over secondary containment units, since the former more routinely come into contact with spilled pesticides? Should leak detection systems be required for outdoor containment structures rather than indoor structures, since outdoor structures are subject to more damaging exposure to the elements? Should leak detection systems be installed under the entire containment structure, or only under the sump, since this is the area of the structure with the greatest exposure to spilled materials? 3. Containment for stationary liquid bulk containers. A containment structure that is designed and constructed to contain pesticide spills from stationary bulk containers is referred to in the proposal as a secondary containment unit. Stationary bulk containers may hold either liquid pesticide or dry pesticide. As proposed in subpart H, secondary containment units would be required to satisfy general requirements for containment structures in Sec. 165.146, and additional requirements specific to containment of stationary bulk containers in Sec. 165.148 (for liquid pesticides) or in Sec. 165.150 (for dry pesticides). Section 165.148 would specify standards for the capacity of secondary containment units for liquid bulk containers, as well as certain construction, design, inspection, and maintenance requirements. a. Capacity. EPA believes that any secondary containment unit should have sufficient holding capacity to retain not only the small leaks and spills encountered in routine conditions, but also major spills from bulk containers. To develop quantitative standards for capacity, EPA evaluated various factors, especially capacity requirements in State containment rules. Two capacity requirements for secondary containment units protecting containers with liquid pesticides are set forth in today's proposal in Sec. 165.148(a): the first would cover existing structures for an interim period of 8 years; the second would cover new structures (and existing structures after the interim period had lapsed). The interim standard for existing structures [in Sec. 165.148(a)(1)] would require a minimum capacity of 100 percent of the volume of the largest stationary bulk container in the existing secondary containment unit, plus an additional 10 percent (110 percent, total) of the capacity of the largest container if the storage area is not protected from rainfall, plus the volume displaced by containers and appurtenances. This interim capacity standard for existing secondary containment units in Sec. 165.148(a)(1) is proposed on the basis of general conformance with current or proposed State containment regulations. The standard in Sec. 165.148(a)(2) for new containment structures, and for existing structures after the interim period in Sec. 165.148(a)(3), would require a minimum capacity of 110 percent of the volume of the largest bulk container, plus an additional 15 percent (125 percent, total) of the capacity of the largest container if the storage area is not protected from rainfall, plus the volume displaced by containers and appurtenances. (This capacity requirement is referred to hereafter as the 110/125 standard.) The 110/125 standard for capacity should prove adequate to contain most spills. The 110 percent criterion for storage areas under a roof provides sufficient capacity to hold the contents of a full container, plus a margin of safety to accommodate sloshing from sudden releases or other unforeseen displacement events. The 125 percent criterion for storage areas without roofing adds an extra margin of safety for retention of precipitation. EPA has considered the following rainfall-based alternative to the proposed 110/125 standard for new containment structures: 110 percent of the volume of the largest bulk container, plus an additional capacity adequate to contain precipitation from a 25-year, 24-hour rainfall event if the storage area is not protected from rainfall, plus the volume displaced by containers and appurtenances. (This option is also described in the discussion on stormwater run-on control requirements, in Unit VI.B.2 of this preamble.) With this option, required containment capacity would vary according to local rainfall patterns. EPA believes that either the rain-based standard or the proposed 110/125 standard would provide adequate protection, although most States with containment regulations do not use a 25-year, 24-hour storm criterion for containment capacity. Comments pertaining to the relative advantages and disadvantages of these capacity criteria are requested. Comments are requested to aid EPA in characterizing the procedures involved in retrofitting existing structures to meet more stringent capacity requirements. Discussion of the feasibility of either modifying the containment facility or the configuration of containers or other approaches to meet more stringent capacity requirements would be particularly helpful. In developing the proposed capacity requirements, EPA also considered but elected not to propose a requirement that secondary containment units be protected from the direct introduction of precipitation by a roof or similar cover. EPA believes that in many cases, the advantages of keeping rainwater out of containment structures will significantly outweigh the costs of installing a roof. However, in arid regions, a roof may not be cost-effective. EPA requests comments as to whether, and under what circumstances, a roof or similar cover should be required to protect secondary containment units from the direct introduction of precipitation. b. Ability to observe leaks from containers. Stationary bulk containers that rest flush upon containment structures are exposed at the base to increased moisture, which may make them more susceptible to corrosion and failure. The outside base of such containers cannot be inspected readily for flaws, and they also hinder inspection, cleanup, and maintenance of the covered portion of the containment structure. In the event that both the bulk container and the covered area of the containment structure develop defects, pesticide could leak to the environment undetected. In Sec. 165.148(b)(1), EPA proposes to require that stationary bulk containers be positioned to allow for the observation of leakage from the base of the containers. This requirement would help alert operators that containers are leaking, allowing them to make timely cleanups and repairs. However, EPA believes that design constraints of certain existing containment structures and bulk containers may necessitate major retrofitting efforts to meet this requirement. Thus, for existing secondary containment units, EPA is proposing in Sec. 165.148(b) to defer this requirement for an interim period of 8 years. Section 165.148(c) would require that during the interim period, monthly inventory and reconciliation be conducted for the contents of bulk containers that are not elevated. The proposed method of inventory and reconciliation would help to determine if the container was leaking by comparing the quantity of material actually measured in the bulk container versus the quantity that would be expected (as determined by adding or subtracting deposits or withdrawals from the container to the quantity measured in the bulk container at the previous month's inventory). However, EPA believes that variables that can also influence container volume, such as thermal expansion, container deformation, and evaporation and condensation within the container, will make this method inadequate for indicating small leaks. EPA requests comments on the suitability of other means of checking non- elevated containers for leaks, such as periodic volumetric tests that can compensate for the effects of thermal expansion. c. Anchored bulk containers. Liquids from spilled pesticides, rainwater, water from fire suppression, and other sources can accumulate in containment structures. As the level of liquid rises inside the structure, it can exert significant floatation forces against partially filled or empty containers (Refs. 4 and 28). Floatation can cause stationary bulk containers to become uprooted, collide with other containers and equipment, and spill. For these reasons, Sec. 165.148(b)(2) would require any stationary bulk container that is protected by a secondary containment unit either to be adequately elevated or anchored to prevent floatation in the event that the secondary containment unit fills with liquid. The intent of this provision is to allow facilities the choice of either elevating containers sufficiently to avoid floatation, or to anchor the containers (or both, if desired). EPA believes that the need to anchor bulk containers will be greatest for flat-bottomed containers that are not elevated. Since non-elevated bulk containers would be permissible at existing structures during the interim period, EPA is proposing that the provision for anchoring become effective during the interim period (and thereafter) and apply to both new and existing secondary containment units. 4. Containment for stationary dry bulk containers. Section 165.150, would require that, in addition to meeting the general requirements for containment structures posed in Sec. 165.146, containment structures for stationary dry bulk containers must have a capacity of at least 100 percent of the volume of the largest stationary dry bulk container within the containment structure, compensating for any volume displaced by containers and appurtenances. This requirement would apply to new containment structures, but would be deferred for an 8-year interim period for existing structures. EPA believes that secondary containment for dry bulk containers is appropriate because spills of dry pesticides could mix with rainwater, fire suppression water, or other liquids to reach and contaminate soil and water supplies. Therefore, the proposed rule would require that secondary containment units for dry pesticides be designed to hold 100 percent of the capacity of the largest bulk container in the containment unit. This proposed approach differs from the requirements established in the few State rules that address storage of large quantities of dry pesticide. States generally define dry ``bulk'' quantities as 100 pounds to 300 pounds of material. They also require storage under a roof and, if outdoors, on pallets or raised concrete platforms. While 100-pound to 300-pound quantities may be addressed by roofing and flooring requirements, EPA believes that larger quantities defined as bulk in this proposal (more than 2,000 kilograms) pose potentially greater risks of serious environmental contamination if a release associated with exposure to water occurs, and therefore warrant protection similar to that proposed for liquid bulk containers. Rather than require that secondary containment units for dry bulk containers be designed to contain a specific volume, EPA considered requiring that secondary containment units for dry pesticides be designed to extend a specified distance beyond the perimeter of the bulk container. However, EPA lacked sufficient information to determine what would constitute an adequate distance for containment. EPA requests comments regarding factors that could be considered for setting the dimensions of secondary containment units for dry bulk containers. Comments are also solicited as to whether secondary containment units for dry bulk pesticide containers should be protected by roofing or similar cover from the direct introduction of precipitation (see related discussion in Unit VI.B.3. of this preamble). 5. Containment for pesticide dispensing areas. Section 165.152 proposes standards for the capacity, design, and construction of containment pads at pesticide dispensing areas. As proposed, containment pads would be required to meet the requirements of Sec. 165.152 in addition to the general requirements for containment structures set forth in Sec. 165.146. Because undersized pads can allow pesticide spills and leaks to escape, holding capacity is a key element of containment pad design. EPA is proposing in Sec. 165.152(a) a minimum containment pad capacity of 1,000 gallons, or, if no container or pesticide holding equipment on the pad exceeds a capacity of 1,000 gallons, the proposed minimum capacity of the pad would be at least 100 percent of the capacity of the largest container or pesticide holding equipment on the pad. This proposed minimum standard is based primarily on a review of current or proposed containment pad regulations in the States. EPA believes that this standard could be met by most, if not all, existing State- regulated containment pads and that it affords an adequate level of environmental protection. EPA considered, but is not proposing, a requirement that pesticide containment pads be protected by roofing or similar cover from the direct introduction of precipitation (see related discussion in Unit VI.B.3. of this preamble). EPA requests comments as to whether, and under what circumstances protection from the direct introduction of precipitation should be required for containment pads. Section 165.152(b) would require containment pads to meet certain design and construction requirements. By proposing in Sec. 165.152(b)(1) that the containment pad be designed and constructed to intercept leaks and spills of pesticides that may occur in a pesticide dispensing area, EPA intends that the containment pad be of sufficient dimensions to cover areas where pesticides are transferred into or out of containers or their appurtenances, including the container itself. EPA recognizes that at some facilities, tanker trucks delivering pesticide for sale or distribution to the facility will be considerably larger than containers or equipment normally used on the containment pad. Because such deliveries are not expected to be frequent, EPA is proposing in Sec. 165.152(b)(1) that the pad be at least large enough to protect the area where the pesticide delivery hose or device connects to the vehicle, but not necessarily large enough to accommodate the entire vehicle. This size exception for containment pads is not intended to apply to those transport vehicles that are used routinely in the day-to-day operation of the facility, such as trucks with nurse tanks. Container refilling and cleaning and similar operations are likely to result in routine exposure of containment pad surfaces to pesticides. To facilitate the collection of pesticides, Sec. 165.152(b)(2) would require that the base of the containment pad be sloped toward a liquid-tight sump. EPA believes that a graded surface will lessen the time that pesticides remain on the pad and facilitate pesticide collection, which in turn will reduce the likelihood of pesticide escaping the pad. The requirement for sloped surfaces and liquid-tight sumps would be deferred for 8 years for existing containment pads. This interim period would allow operators of facilities that currently do not meet the proposed requirement to derive further use of their systems before retrofitting. The structural integrity of the sump is critical because it is the portion of the pad with the greatest exposure to spilled pesticide and rinsates. EPA requests comments on whether, and the extent to which, performance criteria for the sump should differ from general containment requirements. For example, should sumps be constructed of double-walled stainless steel with observation ports to check the annular space for leaks? Section 165.152(b)(3) would require a means, such as manually activated pumps, of removing collected materials from the sump. Pumps that are automatically activated would not be allowed if they lack an automatic mechanism to prevent overflows at the receiving vessel. 6. Integrated systems. Section 165.153 of the proposal would permit facilities to design containment structures that would combine secondary containment units and containment pads. EPA believes that such combined systems would be acceptable, provided that the separate requirements for each of the component structures are satisfied. Thus, a secondary containment unit could include within its boundaries a pesticide containment pad, as long as the integrated system complied with all applicable standards. Conversely, a pesticide containment pad could include as a component a secondary containment unit for a stationary bulk container. Section 165.153 would also allow for multiple stationary bulk containers to be protected within a single secondary containment unit. EPA requests comments as to whether the storage of multiple pesticide products within a common containment structure should be restricted in some situations. For example, should integrated systems be prohibited if spills could result in mixtures of pesticides whose labels do not allow application to the same crop? 7. Compliance dates. Section 165.156 identifies the dates on which compliance with requirements in this proposal would take effect, distinguishing compliance dates for new versus existing structures. As noted in Unit VI.B.2 of this preamble, Sec. 165.144 would define a new containment structure as a containment structure for which installation has commenced more than 3 months after publication of the final rule in the Federal Register. An existing containment structure would mean a containment structure for which installation has commenced earlier than the reference date (i.e., on or before 3 months after the date of publication of the final rule in the Federal Register). Section Sec. 165.144 would also describe criteria under which installation would be considered to have commenced. Section 165.156(a) would require that as of 2 years after publication of the final rule, new containment structures would comply fully with all applicable requirements of subpart H. EPA believes that 21 months between the reference date for new structures (3 months after publication) and the compliance date (24 months after publication) would provide a reasonable period of time for new structures to be planned and built in compliance with the full requirements of subpart H. EPA believes that further shortening the period before compliance is required may not provide ample time for facilities to be constructed in locales with significant seasonal constraints on construction. Conversely, a longer period before compliance would unnecessarily prolong the environmental risks of spills and leaks at commercial agrichemical facilities. Section 165.156(b) would establish an interim period that would commence 2 years after the date of publication of the final rule and would end 10 years later (net interim duration: 8 years). During the interim period, existing containment structures would be required to meet those requirements identified in subpart H as interim requirements for existing containment structures, and to fully meet all other applicable requirements. As proposed in Sec. 165.156(c), after the interim period, interim requirements for existing facilities would no longer apply and all facilities would be required to meet the requirements of new containment structures. In proposing this phase-in approach for existing structures, EPA believes that certain structural standards are crucial to safe containment. These critical standards include: (1) Construction with rigid materials. (2) Use of pesticide-resistant materials. (3) Hydraulic conductivity no greater than 1 x 10-6 cm/sec. (4) Stormwater run-on protection for a 25-year, 24-hour storm. (5) Protection of appurtenances and containers. (6) Sealed joints and cracks. (7) Pad capacity requirements. (8) Minimum secondary containment capacity of 100/110 percent (indoors/outdoors) of the volume of the largest container. (9) Anchoring stationary bulk containers that are susceptible to floatation. If an existing structure does not already comply with these standards, EPA believes that appropriate modifications can be readily implemented at existing structures within 2 years. Certain other standards are proposed to be deferred for a total of 10 years for existing structures because many existing structures that have been constructed at considerable expense may have design or structural features that are not amenable to upgrading without major modification. EPA believes that the cost of immediate retrofitting of such structures may outweigh incremental gains in protection and may place undue burdens on owners of such structures. EPA has concluded that these standards should be phased in over time for existing structures. Standards that EPA proposes to defer for an interim period include: (1) Hydraulic conductivity less than or equal to 1 x 10-7 cm/ sec. (2) Plumbing configured to facilitate leak detection. (3) No drains or pipes penetrating the containment structure. (4) Minimum secondary containment capacity based on 110/125 percent (indoors/outdoors) of the largest liquid container and on 100 percent of the largest dry bulk container. (5) Bulk containers elevated for leak observation. (6) Pads sloped and with sumps. The 10-year compliance period proposed in Sec. 165.156(b) is estimated to represent roughly one-half to two-thirds of the 15- to 20- year service life of an average well-built and well-maintained containment structure. The expected service life of containment structures is difficult to predict as it can vary with the quality of materials used, construction practices, operational practices, exposure and maintenance practices. EPA believes that 15-20 years may be a reasonable estimate for most existing structures, although some may last considerably longer and others may need replacement or renovation sooner than this time frame. EPA also believes that the majority of existing structures will have been constructed considerably more than 10 years before the interim compliance period expires. It is believed that by allowing structures 10 years to complete upgrades, EPA would minimize impacts on owners of existing structures who have invested large capital expenditures to meet state requirements and those who voluntarily upgraded structures. The 10-year time frame would allow owners to recoup the benefits from the depreciation of the capital investment and financially prepare to upgrade their aging structure to meet the full requirements of new structures. EPA believes that the proposed maximum time limit would allow owners/operators of existing structures a variety of ways to plan for and accomplish an orderly transition toward compliance with the standards for new structures. Although 10 years would be the maximum time period allowed, EPA encourages a more rapid transition where possible, so that the benefits of these improvements can be realized sooner. EPA requests comments and information as to whether an interim time different from the proposed 10-year period (2 years + 8 years) would be more appropriate. EPA considered but is not proposing a requirement that standards for new structures would apply when existing structures are repaired or renovated, as well as when they are replaced. EPA requests comments on the advisability of such a requirement and on how to define when it would apply. EPA considered other strategies to address existing structures. One option, based on containment structure age rather than a fixed 10-year period, would have allowed existing structures to operate under certain minimal standards until they were 15 years old, when the full requirements would apply. Existing structures that were cited for spill violations or that expanded in size by 50 percent or more would be required to meet the full requirements. An underlying assumption for this option is that older containment structures are more likely to result in releases of pesticides than are newer structures. Under this option, a containment structure that is 15 years in age or older (as well as those of unknown age) at the 2-year compliance date would be required to meet the standards of a new structure by the 2-year compliance date. A structure that is 10 years old at the 2-year date would be required to retrofit 5 years later. The major difference between this approach and the proposed fixed-interim period approach is that under the age-based system, older existing structures would be required to upgrade to comply with new structure standards much sooner than under the fixed interim period approach. On the other hand, under the age-based schedule, very recently built existing containment structures would be required to comply with standards for new structures later than would such structures under the proposed approach. EPA solicits comments and information pertaining to the benefits that could be obtained by phasing in containment standards based on age rather than on a fixed interim period. Information is also requested that may further reveal whether, and to what extent, older containment structures may pose significantly more of a threat to human health and the environment than more recently built containment structures. Another option would have applied the full requirements (i.e., those proposed today for new structures) to all structures, regardless of whether the structures were new or existing. Another option would have left intact the interim standards for existing structures, but would require that some or all upgrades be completed sooner than 10 years after the publication date of the final rule. Under this option, a time-tiered compliance schedule would be possible, with some interim standards being replaced with full standards earlier than others. EPA requests comments regarding whether these or other options would provide cost-effective approaches for containment. EPA also requests comments on whether the proposed reference date to distinguish new from existing structures (3 months after the date of publication of the final rule in the Federal Register) is appropriate. For example, EPA considered an option that would move the reference date to coincide with the compliance date, effectively allowing any facility that commenced construction prior to the 2-year compliance date to be designated as existing structures. EPA discarded this option because the interim standards for existing structures were developed for structures that would otherwise need to retrofit extensively. EPA reasoned that structures for which installation had not commenced until 3 months after the publication of the final rule in the Federal Register should be able to be built to comply with the full set of requirements. 8. Recordkeeping. Section 165.157(a) would require retention of records for a 3-year period to verify the facility's compliance with applicable requirements of the proposed rule. Section 165.157(a)(1) would require that records be retained to document inspections and maintenance of containment structures, stationary bulk containers, and their appurtenances. Information to be recorded would include the name of the person performing the inspection or maintenance activity, the date of the activity, conditions noted, and maintenance performed. Section 165.157(a)(2) proposes recordkeeping requirements for monthly inventory and reconciliation of pesticides in stationary bulk containers that do not readily allow for inspection for possible leakage (see also discussion on Sec. 165.148(c), in Unit VI.B.3 of this preamble). Information proposed to be logged for each applicable container would include the name of the product stored, quantity reported from previous inventory, quantities dispensed, measured quantity remaining, and reconciliation. These logs would need to be recorded only during the interim period. Proposed Sec. 165.157(a)(3) would require that records be kept to document the duration over which pesticide remains in one location at the facility in any bulk container not protected by a secondary containment unit that meets the requirements of subpart H. This proposed requirement is intended to assist in determining whether the bulk container has exceeded the 13-day residence criterion that triggers requirements for secondary containment of stationary bulk containment. Section 165.157(b) would require the retention of written confirmation of hydraulic conductivity and pesticide-resistance, as applicable, for as long as the containment structure is in use, and 3 years thereafter. VII. Labeling Requirements for Pesticides and Devices A. Background The provisions of 40 CFR 156.10(i)(2)(ix) require that the labeling of a pesticide product bear the directions for storage and disposal of the pesticide and its container required by part 165, and that these directions be grouped under the heading ``Storage and Disposal.'' The current part 165 does not contain specific labeling directions. EPA's Pesticide Regulation Notice 83-3 (cited in this preamble as PR Notice 83-3) (Ref. 64) provides that the requirements of Sec. 156.10(i)(2)(ix) may be satisfied if the registrant provides on each pesticide label certain statements instructing the user on pesticide residue removal procedures and container disposal. PR Notice 83-3 sets out statements for a variety of pesticide products and container types. B. Today's Proposal 1. Amendments to part 156. EPA proposes to amend 40 CFR part 156 to add Sec. 156.140, Identification of container type, and Sec. 156.144, Residue removal instructions, under new subpart H entitled ``Container Labeling.'' To accommodate the requirements of these proposed additions as well as the proposed amendments to 40 CFR part 165, the following amendments to Sec. 156.10 would be necessary: (1) Section 156.10(i)(2)(ix) would refer to the new additions to part 156 (Sec. 156.140 and Sec. 156.144). (2) Section 156.10(d)(7) would require that a space be reserved on labels intended for use on refillable containers so the net weight or measure of content can be marked in by the refiller prior to distribution or sale of the pesticide. (3) Section 156.10(f) would require that a space be reserved on labels intended for use on refillable containers so the refiller can mark in its EPA-assigned establishment number prior to distribution or sale of the pesticide. A pesticide product is considered misbranded if its label does not bear the registration number, assigned under FIFRA section 7, of the establishment in which the pesticide was produced [FIFRA sec. 2(q)(1)(D)]. Also, it is misbranded if the net weight or measure of the contents is not affixed to the container [FIFRA sec. 2(q)(2)(C)(iii)]. The proposed blank spaces on the label would accommodate this information. 2. Identification of container categories. EPA is proposing in Sec. 156.140 to require statements to be placed on the container label or the container itself that would identify the container for the user as either a nonrefillable or refillable container. Placement would be limited to the container label or the container because labeling that is not attached to the container may become separated from the product and thus unavailable to the user. EPA believes this statement is necessary because of reports of the reuse of existing containers in ways that pose unacceptable risks, or actual harm, to humans, livestock, and the environment. These reports include the reuse of pesticide containers as water jugs and flotation devices, and the reuse of larger containers that have been cut in half to serve as animal feed troughs and barbecues. The intent of the label language would therefore be to make clear that nonrefillable containers cannot be refilled with anything and refillable containers can be refilled only with pesticide. Two statements are proposed for pesticides in nonrefillable containers. The first statement would prohibit the reuse or refilling of the container. Nonrefillable containers would not be allowed to be refilled or reused because they would not have to meet the proposed refillable container integrity standards. (Today's proposal would require that refillable containers be designed and constructed to facilitate safe refill and reuse.) The statement also would recommend that the user offer the container for recycling. EPA does not consider recycling to be a direct ``reuse'' of the container for the purposes of this requirement. For example, the container could be recycled by having its physical form demolished, and the materials from which it was made could be reused to manufacture new containers. The second statement proposed in Sec. 156.140(a)(2) for pesticides in nonrefillable containers would require that a lot number or other identification code to identify the batch of pesticide product be marked permanently on the container label or the container itself by the registrant or the producer. The usefulness of this batch code depends on its availability to enforcement personnel, and because labeling that is not securely attached to the container may become separated from the product, EPA would limit the placement of the code to either the container label or the container. While EPA is not proposing to require a mandatory recordkeeping or tracking system for these batch codes/lot numbers, EPA believes batch codes/lot numbers would facilitate the safe use of containers by allowing EPA to identify and trace pesticides that are found to be adulterated, unstable, off specification, or otherwise defective. When used in conjunction with the EPA establishment number (currently required by EPA in Sec. 156.10(f) to appear on the label or the immediate container), the batch codes/lot numbers would allow for the tracing of defective products back to the place of manufacture, and identification of other products packaged during the same time. Registrants would be able to choose the type of identifying code they wish to use for this purpose. Several manufacturers already place (stamp or ink jet) batch codes, lot numbers, or other identifying codes on containers voluntarily to aid in quality control, production assessment, and identification of the time and date of manufacture. The statement for refillable containers would identify the container as a refillable pesticide container and prohibit the user from refilling the container with substances other than pesticides. EPA's PR Notice 83-3 (Ref. 64) does not distinguish between refillable and nonrefillable containers. As discussed later in this preamble, the label statements of PR Notice 83-3 will be amended as necessary to reflect changes made by this rule. 3. Residue removal statements. Section 156.144(a) would require that all labels bear instructions for removal of pesticide residues prior to container disposal. EPA realizes that the residue removal requirements proposed today may not be appropriate for every pesticide product and is therefore proposing in Sec. 156.144(b) that registrants may request modifications and waivers from the residue removal label language. Section 156.144(c) would require residue removal statements to appear under ``Container Cleaning,'' a proposed subheading under the Storage and Disposal heading of the Directions for Use. The addition of this subheading would standardize the organization of the ``Storage and Disposal'' section, thereby increasing the ease of compliance with label requirements. The proposed Sec. 156.144 segregates the requirements for residue removal label statements into Sec. 156.144(d) for nonrefillable containers and Sec. 156.144(e) for refillable containers in order to decrease any confusion that may ensue from establishing different requirements for the two container categories. 4. Residue removal statements for nonrefillable containers. Section 156.144(d) proposes that the labels of all pesticides packaged in nonrefillable containers must bear instructions for residue removal prior to disposal. EPA intends to establish specific label language for each container/formulation category at the same time as the corresponding laboratory residue removal standards are established in Sec. 165.104. Accordingly, proposed today in Sec. 156.144(d)(1) are label instructions for the rigid/dilutable category (as discussed in Unit IV.B.7.b. of this preamble. This category includes products that are meant to be diluted prior to application and that are packaged in rigid containers, i.e., those containers constructed of materials such as glass, metal, and rigid plastics). Because PR Notice 83-3 (Ref. 64) also specifies container disposal instructions, EPA intends to amend PR Notice 83-3 to reflect the establishment in regulation of these rigid/ dilutable statements and instructions. At this time, EPA does not intend to change the residue removal language that is specified in PR Notice 83-3 for the other container categories. Additional changes will be made to PR Notice 83-3 as new container/formulation categories have their residue removal standards and instructions established in regulation. Although allowable by FIFRA section 19(f)(1)(C), EPA does not propose to exempt products intended solely for household use that are rigid/dilutable from the residue removal label language requirements of Sec. 156.144(d)(1). In many instances, the same pesticide product in the same container is sold for agricultural or industrial use, as well as for use in the home, yard, or garden. The current PR Notice 83-3 (Ref. 64) states that all products intended solely for household use packaged in rigid containers (e.g., bottles, cans, jars) must bear the statement, ``Rinse thoroughly before discarding in trash.'' The proposed container rinsing label statements would require the user to use a specific residue removal procedure. EPA specifically requests comments on whether rigid/dilutable products that are distributed and sold for household use by consumers should be exempted from Sec. 156.144(d)(1) and on any other exemptions that may be appropriate and, if so, what alternative residue removal procedure should be provided for these containers. It is possible that household pesticide users might experience some difficulty properly adding the container cleaning rinsate to the use mixture or using the rinsate itself as a use solution. EPA believes that an educational outreach program addressing proper rinsate management may alleviate many potential problems. Another option would be to require registrants to include on the label detailed instructions on how to properly add the rinsate to the application mixture or to use the rinsate as a use solution. EPA requests comments on the appropriateness and feasibility of such an educational program and/or requiring rinsate management directions on the labels of household products. If the rinsate can't be added to the use solution or used directly for some reason, the disposal methods available to the household pesticide user include disposing of the rinsate in the trash and pouring the rinsate down the drain. EPA requests comments on the appropriateness of these two potential methods for managing the rinsate from household pesticide containers. In addition, EPA requests comments on whether there are circumstances in which it would be more appropriate to not create rinsate from household pesticide containers by requiring that the label include directions to wrap the container in newspaper and discard in the trash instead of rinsing instructions. The proposed label statements pertaining to the rigid/dilutable category consist of two elements: a statement on timing of the residue removal and a statement that includes at least one residue removal (rinsing) procedure. a. Timing of the residue removal procedure. EPA considers the timing of the residue removal procedure to be a critical factor in residue removal effectiveness. EPA therefore proposes in Sec. 156.144(d)(1)(i) that users be required to clean containers immediately after emptying out the useful contents of the container. The Report to Congress (Ref. 65) identifies the timing of the rinsing procedures as a critical element of effective residue removal. When rinsing is not performed immediately after the emptying of the useful contents of the container, the residue dries on the inside and outside of the container. Many liquid formulations are particularly difficult to remove once they have dried. Container disposal becomes more difficult when pesticide residues cannot be removed. This is especially true for pesticide container recycling and collection programs where pesticide residues are a major concern. For example, three letters to EPA from the Minnesota Department of Agriculture (Ref. 23) summarizing pesticide container recycling programs reported the rejection of containers with visible pesticide residues and that the residues were a greater problem for the containers that were not rinsed immediately after emptying. A plastic pesticide container collection program in Iowa (Ref. 16) reported that 50 percent of the containers collected were rejected by landfill operators because of the presence of colored or dried residues in the containers as a result of improper rinsing. Surveys conducted in various States show that many users are not aware of the importance of the timing of their container rinsing practices. One example is a survey, conducted in Ohio, that reported that 14 percent of the applicators surveyed indicated they did not, or they only sometimes, rinsed their containers after emptying them (Ref. 48). Additionally, 45 percent of the users surveyed strongly agreed and 48 percent agreed that ``It is not necessary to rinse used containers if they are locked up away from others.'' Users may not be aware of the importance of timing because label statements generally do not require rinsing to be performed at any specific time, nor do any of the residue removal statements found in PR Notice 83-3 (Ref. 64) specify the timing of residue removal. User compliance with this proposed label statement should increase the number of containers that can enter container collection and recycling programs, thereby reducing the difficulties now experienced by users seeking disposal options for their empty containers. b. Establishing detailed residue removal statements. The current Sec. 156.10 does not require registrants to place specific residue removal instructions on their labels. PR Notice 83-3 (Ref. 64) instructs registrants to add triple rinse requirements to their labels for rigid containers (metal, plastic, glass) but does not set out the triple rinse or equivalent procedures. Triple rinsing as a means of cleaning containers was originally derived from dilution principles used in laboratories and was adopted as a practical procedure for pesticide users. EPA is proposing to establish detailed triple rinse and pressure rinse procedures to clearly communicate to the user the elements of the cleaning procedure that are critical to rinsing efficiency. Today's proposal would require the placement of either procedure on the label, with the option of including both. EPA requests comments on whether registrants should be required to place both triple and pressure rinsing statements on the label to allow users to use either container cleaning procedure. The critical elements of the triple rinse statement are based on the laboratory triple rinse methodology that EPA is proposing in Sec. 165.106. By requiring users to follow a similar methodology, EPA hopes to assure a high level of cleaning efficiency under typical field conditions where the variables of water (varying pH, salinity, temperature, etc.), air temperature, and relative humidity are less controllable. Section 156.144(d)(1)(ii)(A) proposes the triple rinse procedure for dilutable liquid pesticide formulations, whereas Sec. 156.144(d)(1)(iii)(A) proposes the triple rinse procedure for dilutable dry pesticide formulations. The statements differ only by a phrase in the first sentence, which instructs users to empty the remaining pesticide concentrate from the container prior to rinsing. The phrase ``and continue to drain for 30 seconds'' that is found in the statement for liquid formulations is not part of the dry formulation statement because dry materials do not ``drain'' as liquids do. The proposed pressure rinse instructions are modeled after rigorous procedures currently used in the field, and are generally considered to result in a degree of residue removal efficiency equivalent to triple rinsing (Refs. 31 and 65). The results of the studies in the Report to Congress generally indicated comparable residue removal for the two methods. EPA concludes that pressure rinsing is at least as efficient as triple rinsing in removing pesticide residues from containers (Ref. 65). Section 156.144(d)(1)(ii)(B) proposes the pressure rinse procedure for dilutable liquid pesticide formulations, whereas Sec. 156.144(d)(1)(iii)(B) proposes the pressure rinse procedure for dilutable dry pesticide formulations. As with the triple rinse statements, these two statements differ only by a phrase in the first sentence pertaining to the emptying of pesticide concentrate from the container prior to rinsing. EPA considered proposing an additional pressure rinse procedure that specified recirculation via a pump for larger nonrefillables, such as drums. EPA requests comments on whether the proposed pressure rinsing procedure is appropriate for larger nonrefillable containers. EPA estimates that the triple rinsing instructions proposed today will take approximately 5 minutes to perform, whereas the pressure rinsing procedure would take approximately 2 minutes. EPA is evaluating the efficiency of shorter triple rinse procedures (Ref. 69). EPA requests comments on the time burden of the proposed rinsing procedures, and the voluntary submission of data on residue removal, including in particular the cleaning efficiency of any suggested shorter triple rinse and pressure rinse procedures. EPA also requests comments and data on alternative residue removal procedures. No field residue removal standard is proposed today. The laboratory residue removal standard proposed in Sec. 165.104 is to ensure that container design and formulation characteristics would facilitate residue removal. Registrants -- not users--would have to meet the laboratory standard. By establishing a requirement in Sec. 165.104 that a pesticide product must meet a laboratory residue removal performance standard, EPA believes a high level of residue removal from containers will be achieved when the user follows the label instructions, even under less than optimal field conditions. A field experiment conducted on existing pesticide products using triple rinse procedures less stringent than those proposed today reported levels of 99.9 percent removal from several container types, showing that this triple rinse procedure can remove a significant amount of residue (Ref. 3). 5. Non-water diluents. The laboratory residue removal procedure proposed in Sec. 165.104 uses water as the diluent. Even if a product has complied with Sec. 165.104, it is possible that a registrant may request EPA to allow modification of the label instructions to require users to clean the container with a nonwater diluent. Under proposed Sec. 156.144(d)(1)(iv), EPA may grant the request if certain conditions are met. Handling of the rinsate generated during residue removal must be in accordance with the label. Reuse of the rinsate cannot be accomplished unless the non-water diluent is permitted by the label to be used in application. If reuse in application is not permitted, then the rinsate must be collected and stored for eventual disposal. EPA is proposing in Sec. 156.144(d)(1)(iv) to allow the use of non- water diluents to clean containers if the registrant shows that the use of a non-water diluent is necessary and proposes appropriate instructions. The residue removal instructions would have to be modified to identify the diluent. The instructions may allow the rinsate to be added to the application equipment if the label ``Directions for Use'' permit application of the resulting rinsate. If the ``Directions for Use'' do not identify the non-water diluent as an allowable addition to the pesticide, the label would have to specify collection and storage of the rinsate in lieu of use. EPA must have approved, in writing, the modification of the residue removal instructions before the pesticide product can be distributed or sold. 6. Future addition of residue removal statements. EPA is proposing to hold Sec. 156.144(d)(2) in reserve for the residue removal statements of other container/formulation categories. EPA acknowledges that the residue removal procedures proposed for rigid/dilutables may not be appropriate for all container and package types (such as paper bags) or formulations (e.g., ant/roach/fly traps, baits, and other non- dilutable or ready-to-use pesticide products). EPA requests comments and data on alternative residue removal procedures for container/ formulation types other than rigid/dilutable. 7. Label statements for refillable containers. Section 156.144(e) would require that the labels of all pesticides packaged in refillable containers bear statements and instructions for residue removal prior to disposal. EPA is proposing in Sec. 156.144(e)(1) a statement to require users to clean refillable containers prior to disposal. In Sec. 156.144(e)(2), EPA is proposing to require the registrant to develop and place on the label a cleaning procedure to be used prior to disposal of the container. See Unit V.B.11 of this preamble for a discussion of this provision. In Sec. 165.124, EPA is proposing to require liquid minibulk containers to be equipped with tamper-evident devices to minimize the potential of pesticide product becoming contaminated. EPA considered but decided not to propose a label statement informing users that if they present a liquid minibulk container with a damaged tamper-evident device for refilling, the container could not be refilled with pesticide unless it was cleaned and a new tamper-evident device was installed. Cleaning and installing a new device may incur a cost to the user. A possible label statement that might suffice to alert the user to this issue is ``If the tamper-evident devices on this container are damaged, then the container must be cleaned and new devices must be installed before refilling.'' EPA requests suggestions and comments on the need for a label statement concerning tamper-evident devices. 8. Compliance dates. EPA is considering three options for compliance schedules and requests comments on these schedules, as described below, or on alternatives to these schedules: (1) Compliance with the proposed part 156 amendments would be required no later than the compliance date of the proposed part 165 residue removal requirements. (2) Compliance with the proposed part 156 amendments would be required the next time a label amendment of any type is requested by the registrant (voluntary request) or required by EPA, or by the compliance date of the proposed part 165 residue removal requirements, whichever is earliest. (3) Compliance with the proposed part 156 amendments would be required the next time a label amendment of any type is requested by the registrant (voluntarily request) or required by EPA, but would not be postponed longer than 1 year past the compliance date of the proposed part 165 residue removal requirements. VIII. Upcoming Effluent Limitations Guidelines for Pesticide Formulators, Packagers, and Repackagers A. Purpose The goal of the Clean Water Act (33 U.S.C. 1251 et seq.) is to achieve zero discharge of wastewater pollutants to the waters of the United States. Under the Clean Water Act (CWA), EPA is developing Effluent Limitations Guidelines and Standards (effluent guidelines) for the Pesticide Formulating, Packaging, and Repackaging (PFP) industrial category. EPA expects that the effluent guidelines will affect, among other facilities, the same refilling establishments as are affected by today's bulk containment proposal (40 CFR part 165, subpart H). EPA seeks to develop a regulatory approach to the effluent guidelines for PFPs that is consistent with the bulk containment requirements proposed today. The purpose of this part of today's Notice is to inform interested parties that EPA is developing these CWA regulations for scheduled proposal in January 1994, to describe EPA's anticipated approach to these regulations, and to provide advanced notice to parties who are interested in the opportunity to comment on the January 1994 proposed rulemaking. B. Applicability The PFP effluent guidelines will apply to facilities engaged in pesticide formulating, packaging, and repackaging; this includes refilling establishments (considered a type of ``repackager''). The EPA database (see Unit VIII.D of this preamble) established to support the PFP effluent guidelines currently includes refilling establishments. It does not include the other types of facilities covered by today's bulk containment proposal; i.e., commercial applicators and custom blenders. Therefore, EPA expects that the effluent guidelines being developed for PFPs will not apply to commercial applicators or custom blenders. C. Background Pesticide formulating and packaging operations currently are regulated by the Best Practicable Technologies (BPT) Effluent Guidelines for the Pesticide Chemicals Point Source Category, promulgated in 1978 (40 CFR part 455 subpart C). This effluent guideline set a BPT limitation of ``no discharge for process wastewater pollutants'' for PFP facilities that discharge directly to lakes, streams, rivers, or other waters of the United States (``direct dischargers''). Facilities that discharge to publicly owned treatment works (POTWs) (``indirect dischargers''), are not covered by the BPT limitations. D. Expected Approach Effluent guidelines establish limitations on the pollutants discharged into waters of the United States from industrial point sources. Pollutant limitations are based on the best performance achievable by appropriate control technologies, including in-process and wastewater treatment technologies. EPA surveyed a sample population of the pesticide formulating and packaging industry in 1990. Included among the facilities surveyed were companies that repackage pesticide products, many of which are refilling establishments. EPA obtained responses from 188 refilling establishments. Of those refilling establishments, 135 reported generating wastewater or rinsate from rinsing their bulk tanks and associated equipment or rinsing the other refillable containers. Forty-two companies also reported having to manage and dispose of some pesticide- containing stormwater. The most frequently reported means of managing these pesticide-containing rinsates and stormwaters was through application according to label requirements. This management practice was reported by 149 companies. The management of pesticide-containing rinsates and stormwaters by application in accordance with the label is currently practiced by most refilling establishments in the eastern and midwestern United States. The most common practice in California is to treat the pesticide- containing rinsates and stormwaters and reuse the treated water. California's practices are different due to the diversity of agriculture and number of pesticides used during the year. Since most of California's agricultural region experiences net evaporation, there is apparently not any problem associated with an excess or accumulation of water needing management or disposal. The bulk containment system requirement for refilling establishments proposed in today's Notice (40 CFR part 165, subpart H) provides for the containment of rinsates, spills, or leaks and stormwater that may contain pesticides. EPA preliminarily believes that these proposed requirements are consistent with the control technologies the Agency is considering as the basis for the PFP effluent guidelines and standards for pesticide refilling establishments. EPA data appear to show that zero discharge to surface waters is technically feasible at refilling establishments, since 98 percent of these establishments are now achieving it. Through the construction of bulk containment as proposed today, pesticide- containing waters could be contained and held for reuse according to the label, thus achieving zero discharge to surface waters. Therefore, EPA anticipates that zero discharge may be the basis for the proposed effluent guideline for refilling establishments. This zero discharge requirement would apply to the rinsates and stormwater falling within the contained area. The zero discharge requirement would prohibit discharges by refilling establishments both to surface waters and to POTWs. E. Pollution Prevention EPA is exploring source reduction opportunities and applications of the environmental management hierarchy in developing effluent guidelines (see Unit II.D of this preamble). While today's bulk containment proposal (subpart H) focuses on preventing the pesticide product from becoming a source of pollution, the effluent guidelines effort focuses on identifying opportunities to eliminate or reduce the volume of pesticide-containing wastewaters discharged to surface waters by refilling establishments. EPA is looking at ways to reduce these discharges by reducing the generation of wastewater and/or reusing these wastewaters. Historically, the effluent guidelines program has based its limitations and standards on the best performance of control technologies demonstrated within the industry or transferred from other industries. This has included pollutant reductions achieved through: (1) Process changes. (2) Recycling or reuse at the production process stage. (3) Recycling or reuse following treatment. (4) Treatment only. EPA notes that some refilling establishments currently apply the principles of source reduction as follows: (1) Avoid creating a contaminated stormwater stream by enclosing pesticide bulk storage tanks and loading pads under a roof. (2) Prevent the stormwater from being contaminated through better housekeeping, such as prompt cleanup of spills and leaks, and increased inspection and maintenance to avoid leaks. (3) Recover product value contained in rinsates through reuse when applying pesticides. At the time of the proposal of the PFP effluent guidelines, EPA will request comment on a number of issues related to refilling establishments, including the technical practicality and feasibility of the practices listed above and their economic achievability at refilling establishments. EPA will also solicit information on whether other source reduction practices should be considered. F. Schedule EPA's proposed effluent guidelines regulation for the pesticide formulators and packagers industry (40 CFR part 455), which would include the effluent guidelines regulation for refilling establishments, is scheduled to be issued in January 1994. Promulgation of the effluent guidelines regulation is scheduled for August 1995. IX. Relationship to Other Programs Certain laws administered by EPA and other agencies may affect the design of pesticide containers or procedures and standards for removal of residue from pesticide containers. This section identifies the laws that EPA considers to have the most significant impact on pesticide containers. The description of these laws is for informational purposes only; no changes are being proposed in the laws described below. Nothing in this proposal, if ultimately implemented, is intended to alter obligations under other statutes. However, EPA solicits comment on any changes that should be made to this proposal to aid in coordinating with these or other applicable laws and regulations. A. Resource Conservation and Recovery Act (RCRA) Requirements under RCRA may affect the handling of pesticide containers under certain circumstances. RCRA Subtitles C and I are described briefly below. FIFRA sections 19(f)(3) and 19(h) specify that FIFRA section 19 does not affect the requirements or authorities of RCRA. Accordingly, this proposal does not alter any existing RCRA requirements, and any applicable RCRA provisions will apply in addition to the provisions of any final rule issued under FIFRA section 19. In addition, FIFRA section 19(f)(1)(B)(iv) specifies that the residue removal regulations may be coordinated with requirements for container rinsing under RCRA. As outlined below, this proposal would provide for coordination in this area. 1. Hazardous waste requirements. Subtitle C of RCRA creates a cradle-to-grave system for managing hazardous wastes. RCRA Subtitle C regulations include requirements for generators, transporters, and others who handle hazardous wastes. The regulations cover any ``solid waste'' (defined at 42 U.S.C. 1004 and 40 CFR 261.2) that is listed as a hazardous waste or exhibits a characteristic of hazardous waste, as set out in part 261. Pesticides and pesticide containers that are discarded or intended to be discarded may qualify as hazardous wastes if they are listed under Sec. 261.33 (discarded commercial chemical products, off-specification products or manufacturing intermediates, container residues, and spill residues), or if they exhibit a characteristic of hazardous waste as described in part 261 subpart C, and are not otherwise exempt from regulation. A hazardous waste remaining in a container is not subject to Subtitle C regulation if, among other things, the container is ``empty'' as defined in Sec. 261.7. A container is ``empty'' if the wastes are removed pursuant to Sec. 261.7(b)(1) or (b)(2), or, in the case of an acute hazardous waste, the container has been triple rinsed or otherwise cleaned pursuant to Sec. 261.7(b)(3). It is EPA's intent that triple rinsing as provided in this proposal would meet the requirements of Sec. 261.7(b)(3), thus meeting the directive in FIFRA section 19(f)(1)(B)(iv). 2. Underground storage tanks. RCRA Subtitle I provides for the development and implementation of a comprehensive regulatory program for ``underground storage tanks'' (USTs), defined at 42 U.S.C. 6991 and 40 CFR 280.12 as tanks that are used to contain an accumulation of ``regulated substances'' and whose volume (including underground pipes connected thereto) is 10 percent or more below ground. Regulated substances include petroleum or substances defined as hazardous under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) (except hazardous wastes regulated under RCRA Subtitle C). CERCLA hazardous substances, enumerated at 40 CFR part 302, include a number of pesticides. UST requirements at 40 CFR part 280 include standards for new tanks as well as requirements for leak detection, closure, corrective action, and financial responsibility. EPA is not aware of the extent of industry use of USTs to store agricultural pesticides, and therefore has not made specific provision in subpart H of this proposal for containers that may be subject to UST requirements. EPA specifically solicits comment on the use of underground tanks to store agricultural pesticides and on the preferred means of coordinating UST and FIFRA requirements (e.g., by exempting containers regulated under the UST program from the FIFRA requirements for bulk containers). B. Spill Prevention, Control, and Countermeasures (SPCC) Under section 311(j)(1)(C) of the Clean Water Act (CWA), EPA has promulgated regulations at 40 CFR part 112 (known as the SPCC regulations) for the prevention of oil spills into navigable waters and adjoining shorelines. The regulations apply to facilities that, because of their location, could reasonably be expected to discharge oil into navigable waters or adjoining shorelines. Part 112 includes spill prevention procedures, methods, and equipment requirements for non- transportation related facilities with total aboveground oil storage capacity greater than 1,320 gallons (or greater than 660 gallons aboveground in a single tank) or buried underground oil storage capacity greater than 42,000 gallons. On October 22, 1991 (Ref. 88), EPA proposed revisions to these regulations clarifying the mandatory nature of the rule requirements governing SPCC plans. Because the definition of ``oil'' under CWA section 311 is very broad (including oil ``of any kind and in any form''), it could potentially include pesticides that contain oil or are oil-based. EPA expects that comparatively few of the facilities covered by today's proposal would be subject to SPCC requirements. For those few, however, both today's proposed rule and the SPCC requirements would apply. C. Occupational Safety and Health Administration (OSHA) Requirements The Occupational Safety and Health Act (U.S.C. 2601 et seq.) addresses occupational safety and health hazards by establishing requirements for employers and employees and authorizing OSHA to establish mandatory occupational safety and health standards. Tanks and containers that are used to store flammable and combustible liquids in occupational settings are subject to OSHA requirements under 29 CFR 1910.106. For storage tanks, Sec. 1910.106(b) contains design and construction requirements, including standards for materials, spacing, venting, drainage and diking, fire and flood resistance, and testing for strength and tightness. Section 1910.106(c) contains specifications for piping, valves, and fittings. Section 1910.106(d) sets out design and construction requirements for containers and portable tanks, and also contains specifications for storage areas. D. Department of Transportation (DOT) Hazardous Materials Regulations The Hazardous Materials Transportation Act of 1974, (49 U.S.C. 1801 et seq) authorizes DOT to designate as hazardous materials those materials that may pose unreasonable risk to health and safety or property, and regulate the handling and transportation of such materials. DOT regulates the transportation of hazardous materials at 49 CFR parts 171 through 180 (Hazardous Materials Regulations) by prescribing rules for, among other things, the manufacture, marking, and testing of the packaging or container for the hazardous material. A hazardous material is defined at 49 CFR 171.8 as a substance that has been determined by the Secretary of Transportation to be capable of posing an unreasonable risk to health, safety, and property when transported in commerce. DOT lists specific hazardous materials at 49 CFR 172.101 and 172.102, and also defines several categories of hazardous materials in 49 CFR part 173. Some pesticides classify as hazardous materials. For such pesticides, the containers would have to comply with DOT's requirements (if the pesticide is being transported in commerce) as well as the container design rules being proposed today. There would be some overlap between DOT's hazardous materials regulations and EPA's container design regulations. More specifically, DOT's testing requirements for non-bulk packaging at 49 CFR part 178 include drop- test requirements similar to EPA's proposed drop-test regulations for refillable minibulk containers. EPA does not intend to subject pesticide containers to two sets of drop test requirements. If a registrant is required to package its pesticide in containers that meet these DOT testing requirements, then such containers will be considered to satisfy EPA's proposed drop test requirement. Additionally, EPA believes that containers manufactured to DOT specifications would meet EPA container integrity requirements. Thus, if a pesticide is required to be transported in a particular DOT specification container, then that container would be likely to meet EPA's proposed container integrity requirements for nonrefillables at Sec. 165.102(b), for minibulk containers at Sec. 165.124(c), or for bulk containers at Sec. 165.124(f)(1), whichever applies. X. Statutory Review Requirements As required by FIFRA 25(a), this proposal was submitted to the U.S. Department of Agriculture (USDA) for review and comment. USDA elected not to comment officially on this proposal. This proposal was submitted to the Committee on Agriculture of the U.S. House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the U.S. Senate. EPA did not receive comments on this proposal. The FIFRA Scientific Advisory Panel (SAP) waived its review of this proposal. XI. Public Docket EPA has established a public docket (OPP-190001) containing the material used to develop this proposed rule, as well as all of the material referenced in the References section below. The public docket is open from 8 a.m. to 4 p.m. Monday through Friday, and is located in Rm 1132, Cyrstal Mall #2, 1921 Jefferson Davis Highway, Arlington, Virginia. XII. References and Support Documents 1. Archer, T., ``Removal of 2,4-Dichlorophenoxyacetic Acid (2,4-D) Formulations from Noncombustible Pesticide Containers,'' Bulletin of Environmental Contamination and Toxicology, 13, 44-51 (1975). 2. Association of American Pesticide Control Officials. ``SFIREG Survey Report Regarding Agrichemical Site Remediation and Disposition of Certain Agrichemical Containing Materials,'' (1992). 3. Braun, H.E., et. al. ``Efficiency of Water Rinsing for the Decontamination of Used Pesticide Containers,'' Archives of Environmental Contamination and Toxicology, 12, 257-264 (1983). 4. Broder, M. Tennessee Valley Authority, ``Containment of Fertilizers and Pesticides at Retail Operations,'' TVA/NFERC-91/3. Circular Z-291. Muscle Shoals, AL (1991). 5. Broder, M., D. Nguyen, and A. Harner. Tennessee Valley Authority, ``Effects of Fertilizer and Pesticide on Concrete,'' presentation to American Society of Agricultural Engineers, International Summer Meeting, Charlotte, NC, (1992). 6. Buzicky, G. Minnesota Department of Agriculture, [Costs for cleanup of agrichemical dealerships in Minnesota], Personal communication to U.S. EPA, summarized in memorandum by D. Howard, November 11 (1991). 7. Callier, D. U.S. EPA, Region 7, [Information on bulk repackaging and cross-contamination], Personal communication to attendees of Technical Meeting on Bulk Repackaging Issues, May 4 (1993). 8. Conover, W.J. Practical Nonparametric Statistics, 2nd edition, New York, Wiley and Sons (1980). 9. Dade County Environmental Resources Management. ``Agrichemical Mixer-Loader Wells in Dade County, Florida: Potential for Groundwater Pollution,'' Miami, Florida (1989). 10. Dwinell, S. Florida Department of Environmental Regulation, ``Final Report: Jackson County Pesticide Container Recycling Demonstration Project,'' (1991). 11. Dwinell, S. Florida Department of Environmental Regulation, ``Final Report: South Florida Pesticide Container Recycling Demonstration Project,'' (1991). 12. Elsner, G. Minnesota Department of Agriculture, ``Earthen Dikes as Secondary Containment for Fertilizers,'' (1991). 13. Fawcett, R.S. ``Big Spring Revisited,'' Agrichemical Age, (October, 1989). 14. Frank, R., et. al. ``A System for Rinsing Herbicide Residues from Drums During Highway Right-of-Way Spray Operations,'' Bulletin of Environmental Contamination Toxicology, 39, 680-687 (1987). 15. Frieberg, D. Iowa Fertilizer and Chemical Association, ``Environmental Cleanup of Fertilizer and Agricultural Chemical Dealer Sites,'' (1991). 16. Frieberg, D. Iowa Fertilizer and Chemical Association, ``Final Report on Iowa Pesticide Container Recycling Project'' (1990). 17. Frieberg, D. Iowa Fertilizer and Chemical Association, ``Iowa Pilot Project: Less than 56 Gallon Repackaging,'' (1990). 18. Gilding, T. National Agricultural Chemicals Association, [Results of NACA pesticide container survey], Personal communication to U.S. EPA, October 12 (1989). 19. Good, G. and A.G. Taylor. Illinois Environmental Protection Agency, ``A Review of Agrichemical Programs and Related Water Quality Issues,'' Illinois Environmental Protection Agency Report, Springfield, Illinois (1987). 20. Habecker, M. A. Wisconsin Department of Agriculture, Trade Consumer Protection, ``Environmental Contamination at Pesticide Mixing/ Loading Facilities: Case Study, Investigation and Remedial Action Evaluation,'' (1989). 21. Hallberg, G. Cooperative Extension Service, ``Agricultural Chemicals and Groundwater Quality in Iowa: Status Report, 1985,'' Iowa State University, Ames, IO (1985). 22. Hallberg, G. ``Overview of Agricultural Chemicals in Ground Water. Agricultural Impacts on Ground Water: A Conference,'' National Well Water Association (1986). 23. Hansen, R. Minnesota Department of Agriculture, [Results of pesticide container collection programs], Personal communications to U.S. EPA, October 4, 1990, November 1, 1990, January 28, 1991 (1990- 1991). 24. Hansen, R. and L. Palmer. Minnesota Department of Agriculture, ``Pesticide Container Collection and Recycling in Minnesota,'' Pesticide Waste Management: Technology and Regulation, American Chemical Society, Washington, DC (1992). 25. Hsieh, D., et. al., ``Decontamination of Non-combustible Agricultural Pesticide Containers by Removal of Emulsifiable Parathion,'' Environmental Science and Toxicology, 5, 826-829 (1972). 26. Illinois Department of Agriculture and Illinois State Geological Survey, ``Agrichemical Facility Site Contamination Study'' (1993). 27. Jennings, G.D. North Carolina Cooperative Extension Service, ``Pesticides in Private Wells in Moore and Hoke Counties,'' Draft report, North Carolina State University (1991). 28. Kammel, D., R. Noyes, G. Riskowski, and V. Hofman. ``Designing Facilities for Pesticide and Fertilizer Containment,'' MidWest Plan Service-37, Iowa State University, Ames, Iowa (1991). 29. Kelleher, K. Houston County Recycling Coordinator, [Observations from a pesticide container collection program], Personal communication to U.S. EPA, October 24 (1990). 30. Lamberton, J., et. al., ``Pesticide Container Decontamination by Aqueous Wash Procedure,'' Bulletin of Environmental Contamination and Toxicology, 16, 528-535 (1976). 31. Leasure, J.K. ``Triple Rinsed -- Or Equivalent,'' Southern Illinois University, unpublished report (1978). 32. Lohafer, Iowa Department of Agriculture and Land Stewardship, [Results of minibulk sampling], Personal communication to U.S. EPA, December 7 (1990). 33. Long, T. ``Groundwater Contamination in the Vicinity of Agrichemical Mixing and Loading Facilities,'' Illinois Agricultural Pesticides Conference [includes updated and supplemental data] (1989). 34. MacDonald, B. Mitchell Systems Corporation, ``Summarization of Nebraska Agrichemical Spill Data,'' memorandum to U.S. EPA, July 17 (1991). 35. Magnusson, M. Minnesota Department of Agriculture, [Summary of the Minnesota Bulk Pesticide Repackaging Survey], Personal communication within the Minnesota Department of Agriculture, January 15 (1993). 36. Michigan Department of Agriculture. ``Agricultural Chemicals in Michigan Groundwater Pilot Survey of 1989,'' Pesticide and Plant Pest Management Division (1989). 37. Michigan Department of Agriculture. ``Environmental Stewardship and the Michigan Department of Agriculture: A Report to Governor John Engler'' (1993). 38. Midwest Agricultural Chemicals Association, Inc. ``Revised MACA-75 Manufacturer Specification and User Guidelines for Portable Agri-Chemical Tanks,'' June (1992). 39. Miles, J., et. al., ``Assessment of Hazards Associated with Pesticide Container Disposal and of Rinsing Procedures as a Means of Enabling Disposal of Pesticide Containers in Sanitary Landfills,'' Journal of Environmental Science and Health, B, 305-315 (1983). 40. Minnesota Department of Agriculture. ``Bulk Pesticide Storage Regulations,'' Chapter 1505.3010, Subpart 2. 41. Minnesota Department of Agriculture. ``Minnesota Superfund: A Report on Use of the Minnesota Environmental Response, Compensation, and Compliance Fund During Fiscal Year 1991'' (1991). 42. Morrison, P. Wisconsin Department of Agriculture, Trade and Consumer Protection, ``Bulk Pesticide Facility Spills,'' Personal communication to Mitchell Systems, Arlington, VA (1991). 43. Morrison, P. Wisconsin Department of Agriculture, Trade and Consumer Protection, [Costs for cleanup of agrichemical dealerships in Wisconsin], Personal communication to U.S. EPA summarized in November 12 memorandum by D. Howard (1991). 44. Morrison, P. Wisconsin Department of Agriculture, Trade and Consumer Protection, [Explanation of certain portions of Wisconsin's bulk pesticide rules], Personal communication to U.S. EPA (1991). 45. Morrison, P. and S. Kefer. Wisconsin Department of Agriculture, Trade, and Consumer Protection and Wisconsin Department of Natural Resources, ``Report on Wisconsin Pesticide Mixing and Loading Site Study,'' (1991). 46. Myrick, C. National AgriChemical Retailers Association, [Brief summarization of contamination characteristics associated with agrichemical dealerships], Personal communication to U.S. EPA, July 21 (1992). 47. Novak, M. Utah Department of Environmental Quality, ``Survey of Potential Soil and Groundwater Contamination at Licensed Pesticide Dealers in Utah,'' (1991). 48. Ozkan, H. Ohio State University, ``Proper Rinsing and Disposal of Pesticide Containers,'' February 14 (1991). 49. Palmer, L. and R. Hansen. Minnesota Department of Agriculture, [Information on pesticide container collection programs], Personal communication to members of the Minnesota Pesticide Container Advisory Committee, September 30 (1991). 50. Paulson, D. Ciba-Geigy, ``Why Containment - Industry's Perspective,'' Conference Proceedings, National Symposium on Pesticide and Fertilizer Containment: Design and Management, MidWest Plan Service (1992) 51. Peck, D. ``The Determination of Residue of Certain Pesticides After Triple Rinsing,'' August (1985). 52. Read, D. Minnesota Department of Agriculture, ``Agricultural Containment Failures,'' Personal communication to U. S. EPA. January 28 (1992). 53. Sausville, P. New York Department of Environmental Conservation, ``The Pros and Cons of Concrete,'' Aboveground Tank Update, July, pp. 13-14 (1991). 54. Stumpf, K. Ciba-Geigy, [Examples of point source contamination involving pesticides], Personal communication to U.S. EPA, July 24 (1992). 55. Taylor, A. Illinois Environmental Protection Agency, ``Field Investigation Reports of Seven Agrichemical Transportation Spills in Illinois,'' (1990). 56. Taylor, A. Illinois Environmental Protection Agency, [Costs for cleanup of agrichemical dealerships in Illinois], Personal communication with U.S. EPA summarized in November 15 memorandum by D. Howard (1991). 57. Taylor, A. Illinois Environmental Protection Agency, ``Testimony in Support of Regulatory Proposals Regarding Agrichemical Storage and Handling Facilities,'' (1989). 58. Tennessee Valley Authority. ``Environmental Handbook for Fertilizer and Agrichemical Dealers,'' editor: J. Parker, TVA/NFERC-91/ 11. Circular Z-303. Muscle Shoals, AL (1991). 59. Tiernan, T. Wright State University, ``Assessment of Rinsing Procedures for Removing Pesticides from Containers Used by Agricultural Applicators,'' Quarterly Progress Report submitted to U.S. EPA, February 1 (1990). 60. U.S. Coast Guard. National Response Center [selected spill data with summary notes by U.S. EPA Office of Pesticide Programs] (1982 through 1991). 61. U.S EPA and Paper Shipping Sack Manufacturers Association, ``EPA/PSSMA Paper Bag Residue Study'' (1993). 62. U.S. EPA, Office of Compliance Monitoring. ``Amendment to the July 11, 1977 Enforcement Policy Applicable to Bulk Shipment of Pesticides,'' March 4 (1991). 63. U.S. EPA, Office of Compliance Monitoring. ``Enforcement Policy Applicable to Bulk Shipment of Pesticides,'' July 11 (1977). 64. U.S. EPA, Office of Pesticide Programs. ``Label Improvement Program -- Storage and Disposal Label Statements,'' Pesticide Regulation Notice 83-3 (1983). 65. U.S. EPA, Office of Pesticide Programs. ``Pesticide Containers: A Report to Congress,'' EPA publication number EPA 540/09-91-116, May (1992). 66. U.S. EPA, Office of Pesticide Programs. ``Registrant information on bulk-related spills,'' September 25 (1992). 67. U.S. EPA, Office of Pesticide Programs. ``Regulatory Impact Analysis: Proposed Container Design and Residue Removal Regulations Under the Federal Insecticide Fungicide and Rodenticide Act as Amended 1988,'' (1993). 68. U.S. EPA, Office of Pesticide Programs. ``Regulatory Impact Analysis: Standards for Pesticide Containment Structures Under the Federal Insecticide Fungicide and Rodenticide Act as Amended, 1988,'' (1993). 69. U.S. EPA, Office of Pesticide Programs. Research conducted by Formulogics, Inc., ``Triple Rinsing of Containers, Rinsing Variables'' (1991). 70. U.S. EPA, Office of Pesticide Programs. ``State of the States: Pesticide Storage, Disposal and Transportation,'' prepared for EPA by Mitchell Systems Corporation, EPA publication number EPA 734-R-92-012 (1992). 71. U.S. EPA, Office of Pesticide Programs. ``Status of State Regulations for Containment of Pesticide Bulk Containers,'' December 31 (1992). 72. U.S. EPA, Office of Pesticide Programs. ``Supporting Statement for SF-83 Container Design and Residue Removal Regulations (40 CFR part 165),'' prepared for EPA by Mitchell Systems Corporation (1993). 73. U.S. EPA, Office of Pesticide Programs. ``Supporting Statement for SF-83 Containment Structure Regulations (40 CFR part 165),'' prepared for EPA by Mitchell Systems Corporation (1993). 74. U.S. EPA, Office of Pesticide Programs. ``Trip Report to Missouri,'' May 25 (1990). 75. U.S. EPA, Office of Research and Development. ``NPDES best management practices guidance document,'' EPA publication number EPA- 600/9-79-045, December (1979). 76. United Nations. ``Recommendations on the Transport of Dangerous Goods,'' 6th revised edition, New York (1989). 77. Vieira, K. Clorox, [Data from container rinsing tests conducted by Chemical Specialties Manufacturers Association], Personal communication to U.S. EPA, July 13 (1993). 78. Wisconsin Department of Agriculture, Trade, and Consumer Protection. ``Background Report on Proposed Chapter Ag 163, Wisconsin Administrative Code (pesticide bulk storage),'' (1985). 79. Wisconsin Department of Agriculture, Trade, and Consumer Protection, Agricultural Resource Management Division. ``Explanations and Interpretations of Ag 163, Wisconsin Administrative Code, Pesticide Bulk Storage,'' (1989). 80. Zuelsdorff, N. Wisconsin Department of Agriculture, Trade, and Consumer Protection, ``Pesticide Storage and Spill Containment; State Initiatives,'' Proceedings, National Symposium on Pesticide and Fertilizer Containment: Design and Management, MidWest Plan Service, Iowa State University, Ames, IO (1991). Legislative/Administrative References. 81. Leahy, P., 134 Congressional Record S13454, daily edition September 28 (1988). 82. U.S. DOT. ``Performance-Oriented Packaging Standards; Changes to Classification, Hazard Communication, Packaging and Handling Requirements Based on UN Standards and Agency Initiative,'' 55 FR 52402, December 21 (1990). 83. U.S. DOT. ``Performance-Oriented Packaging Standards; Revisions and Response to Petitions for Reconsideration,'' 56 FR 66124, December 20 (1991). 84. U.S. DOT. ``Intermediate Bulk Containers for Hazardous Materials,'' 57 FR 36694, August 14 (1992). 85. U.S. EPA, Office of Air. ``Approval and Promulgation of State Implementation Plans: Clean Air Act Amendments to Prevent Significant Deterioration, 43 FR 26395, June 19 (1978). 86. U.S. EPA, Office of Compliance Monitoring. ``Interim Determination of Adequacy of State Pesticide Residue Removal Programs,'' 58 FR 43994, August 18 (1993). 87. U.S. EPA, Office of Compliance Monitoring. ``Pesticide Management and Disposal,'' 58 FR 26856, May 5 (1993). 88. U.S. EPA, Office of Emergency and Remedial Response. ``Oil Pollution Prevention; Non-transportation Related Onshore and Offshore Facilities; Proposed Rules,'' 56 FR 54612, October 22 (1991). 89. U.S. EPA, Office of Pesticide Programs. ``Incentives for Development and Registration of Reduced Risk Pesticides,'' 57 FR 32140, July 20 (1992). 90. U.S. EPA, Office of Pesticide Programs. ``Notice of Voluntary Packaging Standardization Scheme for Liquid Agricultural Pesticide Formulations,'' 49 FR 212, October 31 (1984). 91. U.S. EPA, Office of Pesticide Programs. ``Reporting Requirements for Risk/Benefit Information,'' 57 FR 44290, September 24 (1992). 92. U.S. EPA, Office of Pesticide Programs. ``Worker Protection Standard,'' 57 FR 38102, August 21 (1992). 93. U.S. EPA, Office of Solid Waste. ``Hazardous Waste Management System: General,'' 45 FR 33066, May 19 (1980). 94. U.S. EPA, Office of Solid Waste. ``Wood Preserving; Identification and Listing of Hazardous Waste; Final Rule,'' 55 FR 50450, December 6 (1990). 95. U.S. EPA, Office of Solid Waste. ``Wood Preserving; Identification and Listing of Hazardous Waste; Standards and Interim Status Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities; Proposed Rulemaking,'' 56 FR 63848, December 5 (1991). 96. U.S. EPA, Office of Underground Storage Tanks. ``Underground Storage Tanks; Technical Requirements and State Program Approval; Final Rules,'' 53 FR 37082, September 23 (1988). 97. U.S. EPA, Office of Water. ``Pesticide Chemicals Manufacturing Effluent Limitations Guidelines and Standards,'' 57 FR 12560, April 10 (1992). 98. U.S. EPA. ``Pollution Prevention Strategy,'' 56 FR 7849, February 26 (1991). XIII. Regulatory Assessment Requirements A. Executive Order 12291 Under Executive Order 12291, EPA must determine whether a rule is ``major'' by performing a Regulatory Impact Analysis (RIA). EPA has determined that this is not a major rule because it is not likely to have: (1) An annual effect on the economy of $100 million or more, (2) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions, or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic or export markets. Two RIAs -- one for the container and labeling requirements and one for the containment requirements -- have been developed and submitted to the Office of Management and Budget (OMB) for review (Refs. 67 and 68). These documents are available for public inspection at the address given at the beginning of this Federal Register notice. In addition, this proposed rule was submitted to OMB for review as required by E.O. 12291. Unless otherwise specified, the discussion below represents a summary of the two RIAs together. In developing the proposed regulations, EPA analyzed three regulatory options in each of the RIAs. Regulatory Option 2 represents EPA's proposed rule, Regulatory Option 1 represents a less stringent option and Regulatory Option 3 represents a more stringent option. The proposed rule would primarily affect registrants (formulators) who package formulated pesticide products (formulating industry), refillers/refilling establishments (generally agrichemical dealers) who refill refillable containers (refilling industry), independent (for- hire) aerial and ground applicators who apply agricultural pesticides for compensation, and household and certain institutional end users who will be affected by a triple rinse requirement for the first time. Representative facilities were developed for each of the groups (except end users) according to size and, for formulators, the pesticide market segment served. The costs of compliance were estimated on an individual facility and a total industry basis, resulting in uneven cost streams representing capital, initial, intermittent, compliance period and operational and maintenance (annual) costs of compliance. Such compliance streams were converted to an equivalent, constant-level cost per year (an annualized cost) using an annual revenue requirement (ARR) methodology. The annualized cost or ARR for each representative facility was then compared to that facility's sales and profits before tax to estimate the impacts of compliance. Any facility with an ARR to sales ratio greater than 1.0 percent and an ARR to profits before tax ratio of greater than 20 percent would be considered significantly affected. The total combined estimated costs of compliance for the proposed rule would be $27.2 million to $37.7 million under Regulatory Option 1; $38.7 million to $49.9 million under Regulatory Option 2 (EPA's proposed option); and $102.6 million to $113.8 million under Regulatory Option 3. Under Regulatory Option 2 (the proposed rule), the total costs to each of the industry sectors would be $19.9 million to $27.2 million for the formulating industry, $11.2 million for the refilling industry, $1.6 million for the independent (for-hire) applicator industry, and $6.0 million to $9.9 million for end users. The formulating industry would be most affected, bearing at least 50 percent of the total costs of these proposed regulations. The container RIA analyzes each of the regulatory options in two scenarios, based on the number of container/formulation combinations that are assumed would be tested for the nonrefillable container residue removal standard. Scenario 1 assumes 50 percent of all rigid container/dilutable formulation combinations would be tested for residue removal, and Scenario 2 assumes 100 percent of all such combinations would be tested. In general, formulating facilities would not be significantly affected under Scenario 1 of Regulatory Option 2. However, under Scenario 2 of Regulatory Option 2, the following representative formulating facilities would be affected significantly: small formulating facilities in all of the pesticide sectors, one of the model large agricultural facilities, and medium representative industrial facilities. Refilling facilities would not incur significant impacts as a result of either the container standards or the containment standards. Some independent (for-hire) aerial and ground applicators (less than 20 small and less than 80 medium aerial applicators) would be significantly affected by the proposed rule. The number of small applicators projected to be significantly affected as a result of the costs of compliance does not represent a substantial number of small aerial applicators. EPA believes that rinsates and runoff from pads will not be required to be treated as hazardous wastes. According to an Office of Water survey, 98 percent of facilities surveyed are able to recycle rinsates as reusable pesticide. The remainder of facilities will be accounted for under water effluent guidelines. Thus EPA estimates that the additional costs imposed by the proposed containment rule for disposal of runoff and rinsates are zero. The combined direct benefits of the rule have been estimated in a range of $11.1 million to $16.0 million, with the midpoint at $13.6 million, as well as 1,650 to 2,250 acute illness incidents avoided annually. The proposed container design/residue removal regulations are expected to generate direct health and environmental benefits due to fewer incidents of container failure, better ``usability'' of containers, and less human and environmental exposure to insufficiently rinsed containers. These benefits are expected to range from $4.1 to $5.0 million and 1,650 to 2,250 acute illness incidents avoided annually. The proposed containment regulations are expected to generate direct environmental and health benefits due to fewer uncontrolled releases of pesticides into the environment. These benefits are evaluated in terms of avoided costs for remediating contaminated sites and are estimated to range from $7.0 to $11.0 million annually. In addition, indirect benefits are estimated based on the expected shift from nonrefillable to refillable containers. All of these indirect benefits ($106.1 million) are attributable to the shift from nonrefillables to refillables. It is possible that all of this shift could occur without this regulation over time. Therefore, it is assumed that 25 to 75 percent of this shift is due to this rule. In this case, total indirect benefits would be estimated at $26.5 to $79.6 million annually. EPA solicits comments on the extent to which the indirect benefits as characterized in the Container Design/Residue Removal RIA properly reflect the percentage of indirect benefits that would be attributable to the rule. B. Regulatory Flexibility Act This rule was reviewed under the provisions of section 3(a) of the Regulatory Flexibility Act (RFA) [5 U.S.C. 605(b)]. The results of that review have been incorporated into the regulatory impact analyses. The RFA requires that regulatory agencies consider the potential impacts of regulations on small businesses. A significant adverse impact exists if one of the following criteria is met: (1) Annual compliance costs increase total costs of production for small entities, for the pertinent process or product being regulated, by more than five percent, (2) compliance costs as a percent of sales for small entities are at least ten percent higher than compliance costs as a percent of sales for large entities, (3) capital costs of compliance represent a significant portion of capital available to small entities, considering internal cash flow plus external financial capabilities, and (4) the requirements of the regulation are likely to result in closure of small entities. In developing these regulations, EPA has considered impacts on small businesses by analyzing different stringency levels of regulations (Regulatory Options 1, 2, and 3). Further, as indicated in Unit XIII.A of this preamble, sensitivity analysis was evaluated on the residue removal testing issue through the inclusion of scenarios 1 and 2 under each regulatory option in the container RIA. Scenario 1 assumes 50 percent of all rigid container/dilutable formulation combinations would be tested for residue removal, and Scenario 2 assumes 100 percent of all such combinations would be tested. The analysis indicates small facilities would not be significantly impacted under Regulatory Option 1 and Scenario 1 of Regulatory Option 2. Scenario 1 reflects EPA's anticipation that many container/ formulation combinations will not require residue removal testing. This is because registrants (formulators) would acquire data that is acceptable to EPA from other registrants and sources. If formulators can demonstrate that a product shares the same formulation characteristics as one that has met the residue removal standard and is packaged in the same container that has been documented as meeting the standard with that type of formulation, the burden on small formulators is smaller. While it is not known just what percentage of container/ formulation combinations would ultimately be tested, analysis clearly indicates that if all rigid/dilutable combinations were tested, small formulating facilities in all of the pesticide sectors would likely experience significant impacts under two regulatory options. Neither the container RIA nor the containment RIA indicate that the representative refillers/refilling establishments would be adversely affected by compliance with the proposed regulations. Some small for-hire applicators, primarily aerial application businesses, (1) may experience increases in total costs of production that are greater than five percent, (2) may have compliance costs at least ten percent higher than those for large entities, and (3) may face closure as a result of the proposed rule. However, the number of small aerial applicators adversely impacted cannot be considered ``substantial,'' and such entities could avoid the costs of compliance with the containment portion of the proposed rule by working from smaller, nonbulk containers. C. Paperwork Reduction Act The information collection requirements contained in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Two Information Collection Requests (ICRs) -- one for the container and labeling requirements and one for the containment requirements -- have been prepared by EPA (Refs. 72 and 73) and copies may be obtained from Sandy Farmer, Information Policy Branch (2136), EPA, 401 M St., SW., Washington, DC 20460 or by calling (202) 260-2740. According to the container ICR, the total annual burden to respondents and EPA is estimated to be 573,425 hours. In addition, total annual costs to respondents and EPA are estimated to be $16,869,059. Public respondent burden for this collection of information (for the container standards) is estimated to average 93.90 hours per response, including the time for: reviewing instructions; planning and coordinating compliance activities; creating new and gathering existing data; compiling and reviewing data; completing paperwork and submitting the required data to EPA; and maintaining data in company files. According to the containment ICR, the total annual burden to industry and EPA is estimated to be 15,519 hours. Total annual costs to respondents and EPA are estimated to be $473,263. Public respondent burden for this collection of information (for the containment standards) is estimated to average 2.72 hours per response, including the time for: reviewing instructions; planning and coordinating compliance activities; creating new and gathering existing data; compiling and reviewing data; completing paperwork; and maintaining data in company files. Send comments regarding these burden estimates or any other aspect of these collections of information, including suggestions for reducing the burden, to Chief, Information Policy Branch, 2136, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, D.C. 20503, Attn: Desk Officer for EPA. The final rule will respond to any OMB or public comments on the information collection contained in this proposal. List of Subjects 40 CFR Part 156 Environmental protection, Labeling, Pesticides and pests. 40 CFR Part 165 Environmental protection, Packaging and containers, Pesticides and pests, Waste treatment and disposal. Dated: February 2, 1994. Carol M. Browner, Administrator. Therefore, it is proposed that 40 CFR chapter I, subchapter E, be amended as follows: PART 156--[AMENDED] 1. In part 156: a. The authority citation would continue to read as follows: Authority: 7 U.S.C. 136-136y. b. In Sec. 156.10 by adding paragraph (d)(7), and by revising paragraphs (f) and (i)(2)(ix) to read as follows: Sec. 156.10 Labeling requirements. * * * * * (d) * * * (7) For pesticide packaged in a refillable container, an appropriately sized area on the label shall be left blank to allow the net weight or measure of content to be marked in by the refilling establishment prior to distribution or sale of the pesticide. * * * * * (f) Producing establishments registration number. The producing establishment registration number preceded by the phrase ``EPA Est.'', of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container. It must appear on the wrapper or outside container of the package if the EPA establishment registration number on the immediate container cannot be clearly read through such wrapper or container. For pesticide packaged in a refillable container, an appropriately sized area on the label shall be left blank after the phrase ``EPA Est.'' to allow the EPA establishment registration number to be marked in by the refilling establishment prior to distribution or sale of the pesticide. * * * * * (i) * * * (2) * * * (ix) Specific directions concerning the storage, residue removal and disposal of the pesticide and its container, in accordance with Sec. Sec. 156.140 and 156.144 and part 165 of this chapter and other Agency instructions. These instructions shall be grouped and appear under the heading, ``Storage and Disposal.'' * * * * * c. By adding subpart H entitled ``Container Labeling,'' consisting of Sec. Sec. 156.140 and 156.144, to read as follows: Subpart H - Container Labeling Sec. 156.140 Identification of container types. 156.144 Residue removal instructions. Subpart H-- Container Labeling Sec. 156.140 Identification of container types. The following statement(s) shall be placed on the label or container. The information may be located on any part of the container except the closure. If the statements are placed on the container, they shall be permanently marked on the container. (a) Nonrefillable container -- (1) Statement identifying a nonrefillable container. The following statement is required: Nonrefillable container. Do not reuse or refill this container. Offer for recycling if possible. (2) Batch code. A lot number, or other code used by the registrant or producer to identify the batch of the pesticide product which is distributed and sold. (b) Refillable container. The following statement is required: Refill this container only with pesticide. Do not reuse this container for any other purpose. Sec. 156.144 Residue removal instructions. (a) General. Except as provided by paragraph (b) of this section, each pesticide product must bear on the label instructions pertaining to the removal of pesticide residues from the container prior to container disposal that are specified in this section. The residue removal statements and instructions are required for both nonrefillable and refillable containers. (b) Modification. EPA may, on its own initiative or based on data submitted by any person, modify or waive the requirements of this section, or permit or require alternative labeling statements. (c) Placement and subheading of residue removal statements -- (1) Placement. All residue removal statements and instructions shall be placed under the `Directions for Use' portion of the label, under the heading ``Storage and Disposal.'' (2) Subheading. All residue removal statements and instructions shall be grouped together under the subheading `Container Cleaning'. (d) Residue removal statements for nonrefillable containers. The label of each pesticide packaged in a nonrefillable container shall bear the following residue removal statements and instructions as appropriate. (1) Rigid container containing a liquid or dry dilutable pesticide. The statement in paragraph (d)(1)(i) of this section and the instructions of either paragraph (d)(1)(ii) or (d)(1)(iii) of this section, as appropriate, shall appear on the label of liquid or dry dilutable pesticides packaged in rigid containers. (i) Timing of the residue removal procedure. (A) The following statement must immediately precede the instructions required in paragraph (d)(1)(ii) or (d)(1)(iii) of this section: Clean container immediately after emptying. (B) When both triple and pressure rinse procedures will be allowed, the statement of paragraph (d)(1)(i)(A) of this section may be substituted with the following statement: Triple rinse or pressure rinse container immediately after emptying. (C) When only a triple rinse container cleaning procedure will be required, the statement of paragraph (d)(1)(i)(A) of this section may be substituted with the following statement: Triple rinse container immediately after emptying. (D) When only a pressure rinse container cleaning procedure will be required, the statement of paragraph (d)(1)(i)(A) of this section may be substituted with the following statement: Pressure rinse container immediately after emptying. (ii) Residue removal instructions for dilutable liquid pesticides. One of the following instructions shall appear on the label of dilutable liquid pesticide products, but both instructions may be used. (A) Triple rinse. For triple rinse, use the following label instruction: Triple Rinse as follows: Empty the remaining contents of this container into application equipment, and drain for 30 seconds after the flow begins to drip. Fill the container 1/4 full with water and recap. Agitate for 30 seconds. Pour rinsate into application equipment or store rinsate for later use or disposal. Drain for 30 seconds after the flow begins to drip. Repeat this procedure two more times. (B) Pressure rinse. For pressure rinse, use the following label instruction: Pressure rinse as follows: Empty the remaining contents of this container into application equipment, and continue to drain for 30 seconds after the flow begins to drip. Hold container over application equipment or collect rinsate for later use or disposal. Insert pressure rinsing nozzle, and rinse at 40 PSI for 30 seconds. Drain for 30 seconds after the flow begins to drip. (iii) Residue removal instructions for dilutable dry pesticides. One of the following instructions shall appear on the label of dilutable dry pesticide products, but both instructions may be used. (A) Triple rinse. For triple rinse, use the following label instruction: Triple Rinse as follows: Empty the remaining contents of this container into application equipment. Fill the container 1/4 full with water and recap. Agitate for 30 seconds. Pour rinsate into application equipment or store rinsate for later use or disposal. Drain for 30 seconds after the flow begins to drip. Repeat this procedure two more times. (B) Pressure rinse. For pressure rinse, use the following label instruction: Pressure rinse as follows: Empty the remaining contents of this container into application equipment. Hold container over application equipment or collect rinsate for later use or disposal. Insert pressure rinsing nozzle, and rinse at 40 PSI for 30 seconds. Drain for 30 seconds after the flow begins to drip. (iv) Non-water diluent. (A) A registrant who wishes to require users to clean a container with a diluent other than water (e.g., solvents) must submit to the Agency a written request to modify the residue removal instructions of paragraph (d)(1)(ii) or (iii) of this section, as applicable. The registrant may not distribute or sell the pesticide until the Agency approves the request in writing. (B) The registrant must indicate why a non-water diluent is necessary for efficient residue removal, and must propose residue removal instructions that are appropriate for the characteristics and formulation of the pesticide product and non-water diluent. The proposed residue removal instructions must identify the diluent. If the Directions for Use permit the application of a mixture of the pesticide and the non-water diluent, the instructions may allow the rinsate to be added to the application equipment. If the Directions for Use do not identify the nonwater diluent as an allowable addition to the pesticide, the instructions must require collection and storage of the rinsate in a rinsate collection system. (C) The Agency may approve the request if the Agency finds that the proposed instructions are necessary and appropriate. (2) [Reserved] (e) Residue removal statements for refillable containers. The label of pesticide packaged in refillable containers shall bear the following statements and instructions. (1) Timing of the residue removal procedure. (i) The following statement must immediately precede the instructions required in paragraph (e)(2) of this section: Clean container before disposal. (ii) The statement in paragraph (e)(1)(i) of this section may be substituted with the following statement or another phrase that more precisely describes the cleaning procedure: Pressure rinse container before disposal. (2) Residue removal instructions prior to container disposal. (i) A statement giving instructions on cleaning each refillable container prior to disposal is required. Instructions shall be given for all pesticide products, including those that do not require dilution prior to application. (ii) The statement on residue removal instructions shall be appropriate for the characteristics and formulation of the pesticide product and must be adequate to protect human health and the environment. (iii) Subject to meeting the standard in paragraph (e)(2)(ii) of this section, the statement on residue removal instructions could include any one of the following: (A) The refilling residue removal procedure developed by the registrant for the pesticide product. (B) Standard industry practices for pesticide refillable containers. (C) For pesticides that require dilution prior to application, the following statement: Empty the remaining contents from this container. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this rinsing procedure two more times. (D) Any other statement the registrant considers appropriate. (f) Compliance date. As of [2 years after the date of publication of the final rule in the Federal Register] the labels of all pesticide products distributed or sold by the registrant in nonrefillable and refillable containers shall be in compliance with the requirements of this part. PART 165-- [AMENDED] 2. In part 165: a. By revising the authority citation to read as follows: Authority: 7 U.S.C. 136a, 136f, 136m, 136q and 136w. Sec. 165.11 [Removed] b. By removing Sec. 165.11 Sec. Sec. 165.1-165.10 [Redesignated] c. By redesignating Sec. Sec. 165.1 through 165.10 as set forth in the table below, and by transferring all of the newly redesignated sections to subpart A of part 165: Redesignation Table ------------------------------------------------------------------------ Old New ------------------------------------------------------------------------ 165.1.......................................................... 165.3 165.2.......................................................... 165.1 165.3.......................................................... 165.5 165.4.......................................................... 165.7 165.5.......................................................... 165.8 165.6.......................................................... 165.10 165.7.......................................................... 165.12 165.8.......................................................... 165.11 165.9.......................................................... 165.14 165.10......................................................... 165.16 ------------------------------------------------------------------------ SUBPARTS B-D [Reserved] d. By removing and reserving the designations for subparts B through D. e. By revising newly redesignated Sec. 165.1 to read as follows: Sec. 165.1 Authorization and scope. (a) The regulations and recommended procedures in this part address management of excess pesticides, management of pesticide containers, and acceptance by the Administrator of pesticides for safe disposal. The following provisions apply only to subpart A of this part: (1) Regulations for acceptance for safe disposal of pesticides canceled under section 6(c) and recommended procedures for disposal or storage of pesticides, pesticide containers, and pesticide-related wastes are those which the Administrator judges as necessary, with an adequate margin of safety, to protect public health and the environment. Such procedures are subject to addition and revision as the Administrator deems necessary. (2) The recommended procedures for the disposal of pesticides and pesticide containers apply to all pesticides, pesticide-related wastes (and their containers) including those which are or may in the future be registered for general use or restricted use, or covered under an experimental use permit, except those single containers discussed in paragraph (a)(4) of this section. These disposal procedures are mandatory only for the Agency in carrying out its pesticide and container disposal operations. (3) The recommended procedures and criteria for the storage of pesticides and pesticide containers apply to all pesticides and excess pesticides and to used empty containers and containers which contain pesticides. These procedures and criteria apply to all sites and facilities where pesticides that are classed as highly toxic or moderately toxic, and bear the signal words DANGER, POISON, or WARNING, or the skull and crossbones symbol, on the label are stored. Pesticides covered by an experimental use permit should also be stored in accordance with these procedures. These procedures are mandatory only for the Agency in carrying out its pesticide and container storage operations. Temporary storage by the user of the quantity of the pesticide needed for a single application may be undertaken in isolated areas in accordance with the procedures and criteria given in Sec. 165.16(a). (4) Recommended pesticide and pesticide container disposal procedures shall not apply to containers of pesticides registered for use in the home and garden if securely wrapped in several layers of paper and disposed of singly during routine municipal solid waste disposal, nor to containers of pesticides used on farms and ranches where disposal by an open-field burial of single containers is undertaken with due regard to the protection of surface and sub-surface waters. (b) As a general guideline, the owner of excess pesticides should first exhaust the two following avenues before undertaking final disposal: (1) Use for the purpose originally intended, at the prescribed dosage rates, providing these are currently legal under all Federal, State, and local laws and regulations. (2) Return to the manufacturer or distributor for potential re- labeling, recovery of resources, or reprocessing into other materials. Transportation must be in accordance with all currently applicable U.S. Department of Transportation regulations. Sec. 165.3 [Amended] f. Newly designated Sec. 165.3 is amended by removing paragraphs (a), (d), (e), (g), (h), (i), (l), (p), (s), (u), and (y). g. Section 165.3 is further amended by removing the remaining paragraph designations, arranging the remaining definitions in alphabetical order, revising the definitions for ``Container,'' and ``Triple rinse,'' and by adding alphabetically the other terms and definitions set forth below to read as follows: Sec. 165.3 Definitions. * * * * * Act means the Federal Insecticide, Fungicide and Rodenticide Act. * * * * * Agricultural pesticide means any pesticide product labeled for use in a nursery or greenhouse or for use in the production of any agricultural commodity, including any plant, plant part, animal, or animal product produced by persons (including farmers, ranchers, vineyardists, plant propagators, Christmas tree growers, aquaculturalists, horticulturists, orchardists, foresters, or other comparable persons) primarily for sale, consumption, propagation or other use by man or animals. Appurtenances means equipment or devices which are used for the purpose of transferring pesticides from a bulk container or to any refillable container, including but not limited to, hoses, fittings, plumbing, valves, gauges, pumps and metering devices. Container means any package, can, bottle, bag, barrel, drum, tank, or other containing-device (excluding spray applicator tanks) used to enclose a pesticide or pesticide-related waste. Containers that are used to sell or distribute a pesticide product and that are also spray applicator tanks are considered to be containers for the purposes of this part. Containment pad means any structure that is designed and constructed to intercept and contain pesticides, rinsates, and equipment wash water and prevent them from running off or leaching from a pesticide dispensing area. Containment structure means either a secondary containment unit or a containment pad. Design type means the characteristics of design and construction of a container that render it distinguishable from other containers. A container design type is defined by the following parameters: structural design, size, material of construction, wall thickness, manner of construction, and, for refillable containers as appropriate, pump fittings. A change in any one of these parameters constitutes a different design type, except that a design type may include containers with various surface treatments and containers that differ only in their lesser design height. Dry bulk container means a refillable container designed and constructed to hold only dry pesticide formulations with the capacity to hold undivided quantities of greater than 2,000 kilograms (4,409 pounds). Dry minibulk container means a refillable container designed and constructed to hold only dry pesticide formulations with the capacity to hold undivided quantities of less than or equal to 2,000 kilograms (4,409 pounds). Dry pesticide means any pesticide that is in solid form and that has not been combined with liquids; this includes formulations such as dusts, wettable powders, dry flowable powders, granules, and dry baits. * * * * * Establishment means any site where a pesticidal product, active ingredient, or device is produced, regardless of whether such site is independently owned or operated, and regardless of whether such site is domestic and producing a pesticidal product for export only, or whether the site is foreign and producing any pesticidal product for import into the United States. * * * * * Liquid bulk container means a refillable container designed and constructed to hold liquid pesticide formulations with the capacity to hold undivided quantities of greater than 3,000 liters (793 gallons). Liquid minibulk container means a refillable container designed and constructed to hold liquid pesticide formulations with the capacity to hold undivided quantities of less than or equal to 3,000 liters (793 gallons). Nonrefillable container means a container that is not a refillable container and that is designed and constructed for one time containment of a pesticide. * * * * * One-way valve means a valve that is designed and constructed to allow the withdrawal of material from, but not the introduction of material into, a container. * * * * * Operator means any person in control of, or having responsibility for, the daily operation of a facility at which a containment structure is required. Owner means any person who owns a facility at which a containment structure is required. Pesticide dispensing area means an area in which pesticide is transferred out of or into a container. * * * * * Pressure rinse means the flushing of the container to remove pesticide residue by using a pressure method. Produce means to manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant the section 5 of the Act, and any active ingredient or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device. Producer means any person, as defined by the Act, who produces any pesticide, active ingredient, or device (including packaging, repackaging, labeling and relabeling). Refillable container means a container that is intended to be filled with pesticide more than once. Refiller means a person who engages in the activity of repackaging pesticide product into refillable containers. This could include a registrant, a person operating under contract to a registrant, or a person operating under written authorization from a registrant. Refilling establishment means an establishment where the activity of repackaging pesticide product into refillable containers occurs. * * * * * Repackage means, for the purposes of this part, to transfer a pesticide formulation from one container to another without a change in the composition of the formulation or the labeling content, for sale or distribution. * * * * * Secondary containment unit means any structure, including rigid diking, that is designed and constructed to intercept and contain pesticide spills and leaks and prevent runoff or leaching from stationary bulk containers. * * * * * Stationary bulk container means a liquid bulk container or a dry bulk container that is fixed at a single facility or establishment or, if not fixed, remains at the facility or establishment for at least 14 consecutive days, during all of which time the container holds pesticide. Tamper-evident device means a device which can be visually inspected to determine if a container has been opened. Transport vehicle means a cargo-carrying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transportation of cargo by any mode. Triple rinse means the flushing of the container three times to remove pesticide residue by using a non-pressurized method. * * * * * 25-year, 24-hour rainfall event means a rainfall event with a probable recurrence interval of once in 25 years, as defined by the National Weather Service in Technical Paper Number 40, ``Rainfall Frequency Atlas of the United States'', May, 1961, and subsequent amendments, or equivalent regional or State rainfall probability information developed therefrom. Technical Paper Number 40 may be obtained from the National Climatic Data Center, Federal Building, Ashville, NC 28801-2696; telephone 704-259-0682. * * * * * * h. By adding and reserving subpart E and adding new subparts F, G, and H to part 165 to read as follows: Subpart F-- Nonrefillable Container Standards: Container Design and Residue Removal Sec. 165.100 Scope and applicability. 165.102 Container design standards. 165.104 Residue removal standards. 165.106 Rigid/dilutable residue removal methodology. 165.111 Certification. 165.114 Recordkeeping and inspections. 165.117 Compliance dates. 165.119 Waiver from standardized closures requiring Agency approval. Subpart G -- Refillable Container Standards: Container Design and Residue Removal 165.120 Scope. 165.122 Applicability. 165.124 Container design standards. 165.125 Minibulk container drop test methodology. 165.126 Certification. 165.128 Container design recordkeeping and inspection. 165.129 Transfer of registered pesticide products into refillable containers. 165.130 Registrant responsibilities concerning refilling activities. 165.132 Registrant recordkeeping and inspections. 165.134 Refiller responsibilities and procedures. 165.136 Refiller recordkeeping and inspections. 165.139 Compliance dates. Subpart H -- Standards for Pesticide Containment Structures 165.140 Scope and purpose. 165.141 Applicability to facilities and persons. 165.142 Applicability to stationary bulk containers and pesticide dispensing areas. 165.144 Existing and new containment structures. 165.146 Containment structures: general requirements. 165.148 Specific requirements for containment of stationary liquid bulk containers. 165.150 Specific containment requirements for stationary dry bulk containers. 165.152 Specific containment requirements for pesticide dispensing areas. 165.153 Integrated systems. 165.156 Compliance dates. 165.157 Recordkeeping requirements and inspections. Subpart F -- Nonrefillable Container Standards: Container Design and Residue Removal Sec. 165.100 Scope and applicability. This subpart establishes design and construction standards and requirements for nonrefillable containers used for the sale or distribution of pesticide products. This subpart applies to registrants. This subpart does not apply to containers that contain manufacturing use products, as defined in Sec. 158.153(h) of this chapter. Sec. 165.102 Container design standards. (a) General. (1) A registrant shall not sell or distribute a pesticide product in a nonrefillable container unless the nonrefillable container meets the standards of this section. (2) Information on container failures or other incidents involving pesticide containers that may result in releases of pesticide may be reportable under section 6(a)(2) of the Act. (3) Compliance with part 165 container design requirements does not exempt registrants from compliance with the Department of Transportation's (DOT) Hazardous Materials Regulations at 49 CFR parts 171 through 180, if DOT's requirements are applicable. (b) Container integrity. Each nonrefillable container design type shall prevent leakage under conditions of normal storage, distribution, sale, and use, and shall be compatible with the pesticide formulation it contains. (c) Permanent marking. Each nonrefillable container shall be permanently marked with the information listed in this paragraph. The information shall be visibly located on the outside part of the container except on a closure. Placement on the label or labeling is not sufficient unless the label is an integral, permanent part of or permanently stamped on the container. The information shall include: (1) The EPA registration number of the pesticide. (2) The name, symbol, or code of the material(s) from which the container is constructed. (d) Container dispensing capability. Each nonrefillable container design type for liquid pesticide shall: (1) Allow the contents of the nonrefillable container to pour in a continuous, coherent stream. (2) Eliminate dripping so that no pesticide is visible on the outside of the nonrefillable container during the use of the container or after the closure (cap) is removed and the container is emptied. (3) Reclose securely so as not to allow the escape of any pesticide or rinsate during storage or the triple rinse residue removal procedure. (e) Standardized closures -- (1) Requirement. A liquid agricultural pesticide that is packaged in a rigid nonrefillable container greater than or equal to 3.0 liters (0.79 gallons) shall be packaged in a container having one of the following standardized closures: (i) Bung, 50.0 millimeters (2.0 inches), external threading, 11.5 threads per 25.4 millimeters (11.5 threads per inch) National Pipe Threading (NPT) standard. (ii) Bung, 50.0 millimeters (2.0 inches), external threading, 5 threads per 25.4 millimeters (5 threads per inch). (iii) Screw cap, 63.0 millimeters (2.5 inches), at least one thread revolution at 6 threads per 25.4 millimeters (6 threads per inch). (iv) Screw cap, 38.0 millimeters (1.5 inches), at least one thread revolution at 6 threads per 25.4 millimeters (6 threads per inch). Cap to fit on separate rigid spout or on flexible pull-out plastic spout designed to crimp-on container with a 63.0 millimeter (2.5 inch) orifice. (2) Non-standardized closure. A registrant may request approval to use a non-standardized closure by following the procedures established in Sec. 165.119. (3) Exemptions. Aerosol and pressurized containers are exempt from the requirements for standardized closures in this paragraph. Sec. 165.104 Residue removal standards. (a) Residue removal standard. Each nonrefillable container design type and pesticide formulation combination shall meet the applicable residue removal standard of this section. (b) Standard for rigid containers with dilutable pesticide -- (1) Requirement. If the nonrefillable container is rigid and the pesticide product labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application (dilutable), then the registrant shall demonstrate for each container/formulation combination that at least 99.9999 percent removal of each active ingredient is achieved using the rigid/dilutable residue removal methodology of Sec. 165.106. Percent removal represents the percent of the original concentration of the active ingredient when compared to the concentration of that active ingredient in the fourth rinse. (2) Good Laboratory Practice Standards. The testing shall be conducted in accordance with the Good Laboratory Practice Standards in part 160 of this chapter. (c) Modification. The Agency may, on its own initiative or based on data submitted by any person, modify or waive the requirements of this section. Sec. 165.106 Rigid/dilutable residue removal methodology. (a) General. The rigid/dilutable residue removal methodology of paragraphs (b), (c) and (d) of this section shall be adhered to in demonstrating compliance with the residue removal standard of 99.9999 percent removal of Sec. 165.104. (b) General testing methodology. The methodology used in conducting testing under paragraph (c) of this section shall adhere to the following: (1) The number of containers tested shall be adequate to meet the residue standard specified in Sec. 165.104(b) in a statistically valid manner, with the minimum requirements being as follows: A minimum of 19 containers shall be selected at random and tested, with at least a 95 percent confidence that at least 85 percent of containers tested will meet the minimum residue removal standard. (2) The temperature of the distilled water used to rinse the containers in each rinse cycle shall be 233 degrees Celsius (73 5 degrees Fahrenheit). (3) The volume of distilled rinse water used in each rinse cycle shall be 25 1 percent of the rated volume of the container. The volume of distilled rinse water added to the container in each rinse cycle shall be recorded. (c) Test methods. The testing shall be conducted by following the steps in paragraphs (c)(1) through (c)(4) of this section in sequence. (1) Step 1. The container shall be filled to its rated capacity with the pesticide formulation, capped and then shaken vigorously in order to expose the entire inside of the container to the pesticide. (2) Step 2. The cap shall be removed from the container. The contents of the container shall be emptied by inverting it over a suitable collection vessel and, if a liquid formulation, allowed to drain for 30 seconds after the flow begins to drip. The container shall be recapped to prevent the residue from evaporating. The rinse cycle of paragraph (c)(3) of this section shall begin within 30 minutes. (3) Step 3. Distilled rinse water, according to paragraphs (b)(2) and (b)(3) of this section, shall be added to the drained container. The cap shall be placed back on the container and the container shall be shaken vigorously for 30 seconds. The cap shall be removed from the container. The container shall be inverted over a clean collection vessel and allowed to drain for 30 seconds after the flow begins to drip. (4) Step 4. The rinse cycle of paragraph (c)(3) of this section shall be repeated three more times, i.e., conducted a total of four times (four rinse cycles). The rinsate from the fourth rinse cycle shall be analyzed following the methods in paragraph (d) of this section. (d) Analysis methods. The analysis of the test shall adhere to the following steps: (1) The rinsate from the fourth rinse cycle shall be analyzed for each active ingredient using any validated analytical procedure suitable for the analysis of the active ingredient in water. (2) The temperature of the fourth rinsate when tested shall be 23 3 degrees Celsius (73 5 degrees Fahrenheit). (3) The rinsate ratio and percent removal shall be calculated as follows below, and both calculations shall be recorded. (i) The rinsate ratio is the ratio of the concentration of active ingredient found in the fourth rinse to the formulation's original active ingredient concentration. This rinsate ratio quantity shall be calculated as follows: ![]()
TP11FE94.011 (ii) The percent removal compares the active ingredient concentrations in the fourth rinsate and the original formulation, measuring how much the concentration of active ingredient found in the fourth rinsate has been reduced from the formulation's original active ingredient concentration. The percent removal shall be calculated as follows: percent removal = [1.0 - A] X 100.0. Sec. 165.111 Certification. (a) Certification. The registrant shall certify to the Agency that all nonrefillable container(s) used for each registered pesticide product meet the standards of Sec. 165.102 and Sec. 165.104. (b) Submission of certification. Certification shall be submitted with each application for a new registration. For pesticide products registered as of [date of publication of the final rule in the Federal Register], a certification shall be submitted according to the compliance schedule in Sec. 165.117. The certification shall be submitted to the address given in Sec. 165.119(a)(2). (c) Contents of certification. The certification shall contain the following information: (1) The name and EPA registration number of the pesticide product to which the certification applies; the registrant's name and address; the date; and the name, title, signature, and telephone number of the company official authorized to make the certification. (2) A written statement that the nonrefillable container(s) in which the pesticide product is distributed or sold meet the standards of Sec. 165.102 and Sec. 165.104. The statement, ``I certify that the nonrefillable container(s) that are used for the distribution or sale of this pesticide product meet the standards of 40 CFR 165.102 and 165.104.'' will satisfy this requirement. Sec. 165.114 Recordkeeping and inspections. The registrant shall maintain the records required by this section for as long as the nonrefillable container design type is used with the registered pesticide product, and for 3 years thereafter. The registrant, upon request of any officer or employee of the Agency or of any State or political subdivision duly designated by the Agency, shall furnish and make available for inspection and copying the records specified in paragraphs (a) through (e) of this section. (a) General information. The registrant shall keep the name and EPA registration number of the pesticide product, and description of the design type of the nonrefillable container(s) in which the pesticide product is distributed or sold. (b) Certification. The registrant shall keep a copy of the certification described in Sec. 165.111 for each pesticide product. (c) Container dispensing capability. The registrant shall keep at least one of the following records pertaining to the requirements of Sec. 165.102(d) for each nonrefillable container design type for each pesticide product: (1) Test data or documentation demonstrating that the nonrefillable container with the pesticide product meets the standard in Sec. 165.102(d). (2) Test data or documentation showing a different nonrefillable container with the same or a different pesticide product meets the standard in Sec. 165.102(d), together with a written explanation of why such data or documentation demonstrates that the container meets the standard in Sec. 165.102(d). (d) Standardized closures. The registrant shall keep at least one of the following records pertaining to the requirements of Sec. 165.102(e) for each nonrefillable container design type for each pesticide product: (1) A letter or literature from the container supplier. (2) A specification in the contract between the registrant or applicant and the container supplier. (3) A copy of the Agency approval of any non-standardized closure. (e) Residue removal. (1) The registrant shall keep at least one of the following records pertaining to the residue removal standard of Sec. 165.104 for each nonrefillable container design type for each pesticide product: (i) Test data showing that the container design type and pesticide formulation combination meets the standard in Sec. 165.104 and that residue removal methodology in Sec. 165.106 was followed. (ii) Test data showing a different nonrefillable container with the same or a different pesticide formulation meets the standard in Sec. 165.104, together with a written explanation of why such data demonstrates that the container design type and pesticide formulation combination meets the standard in Sec. 165.104. (iii) A letter from the facility that conducted the test describing the specific test type, a description of the container design type, a description of the pesticide formulation, the test results, and the location of the original data. (2) The registrant shall keep with the residue removal records a statement of compliance or noncompliance with respect to Good Laboratory Practice Standards as described at Sec. 160.12 of this chapter. (3) The Agency reserves the right to require, on a case by case basis, submission of the residue removal test data for any pesticide product registered or proposed for registration. Sec. 165.117 Compliance dates. (a) As of [2 years after the date of publication of the final rule in the Federal Register], all pesticide products distributed or sold by the registrant in nonrefillable containers shall be distributed or sold in compliance with this subpart. (b) As of [5 years after the date of publication of the final rule in the Federal Register], all pesticide products distributed or sold by persons other than the registrant in nonrefillable containers shall be distributed or sold in compliance with this subpart. (c) Certifications for pesticide products registered as of [date of publication of the final rule in the Federal Register] shall be submitted to and received by the Agency by [2 years after the date of publication of the final rule in the Federal Register]. Sec. 165.119 Waiver from standardized closures requiring Agency approval. (a) General. Requests for a waiver from the standardized closure requirement of Sec. 165.102(e) shall be submitted in writing to the Agency. (1) The Agency must have approved in writing the request for the waiver before the registrant is allowed to distribute or sell the pesticide product in the nonconforming nonrefillable container. (2) Requests shall be submitted to the following address: U.S. Environmental Protection Agency, Office of Pesticide Programs, Registration Division (7505C), 401 M St., SW., Washington, DC 20460. (3) Requests shall be accompanied by two copies of the following information, which may be part of an application for registration or amended registration: (i) The name and address of the registrant; the date; and the name, title, signature, and phone number of the company official making the request. (ii) The name and EPA registration number of the pesticide product for which the waiver is requested. (iii) A statement indicating that the request is for a waiver from the standardized closure requirement of Sec. 165.102(e). (iv) A description of the design type of the nonrefillable container for which the waiver is requested. (v) Documentation or justification to demonstrate that the non- standardized closure meets one of the criteria in paragraph (b) of this section. (b) Approval of waiver. The Agency may approve a nonstandardized closure when the Agency is satisfied that: (1) The non-standardized closure is necessary for the proper mixing, loading, or application of the pesticide product. (2) The non-standardized closure will offer exposure protection to handlers during mixing and loading that is the same or greater than that provided by the standardized closures. Subpart G -- Refillable Container Standards: Container Design and Residue Removal Sec. 165.120 Scope. (a) Container design. This subpart sets forth design and construction standards and requirements for refillable containers used for the distribution or sale of pesticide products. (b) Refilling requirements. This subpart establishes the standards and requirements for repackaging pesticide products into refillable containers. Sec. 165.122 Applicability. (a) The requirements of this subpart apply as follows: (1) Registrants who distribute or sell pesticide products in refillable containers shall comply with: (i) Section 165.124 with respect to container design of refillable containers, Sec. 165.125 with respect to the minibulk container drop test methodology, Sec. 165.126 with respect to certification of containers, and Sec. 165.128 with respect to recordkeeping pertaining to container design. (ii) Section 165.130 with respect to registrant responsibilities concerning refilling activities and Sec. 165.132 with respect to recordkeeping pertaining to these responsibilities. (iii) Section 165.134 with respect to refiller responsibilities and procedures and Sec. 165.136 with respect to recordkeeping pertaining to these responsibilities and procedures. (iv) Section 165.139 with respect to compliance dates. (2) Registrants who distribute or sell pesticide products to refillers for repackaging into refillable containers shall comply with: (i) Section 165.124 with respect to container design of refillable containers, Sec. 165.126 with respect to certification of containers, and Sec. 165.128 with respect to recordkeeping pertaining to container design. (ii) Section 165.129 with respect to the transfer of pesticide products into refillable containers. (iii) Section 165.130 with respect to registrant responsibilities concerning refilling activities and Sec. 165.132 with respect to recordkeeping pertaining to these responsibilities. (iv) Section 165.139 with respect to compliance dates. (3) Refillers shall comply with: (i) Section 165.134 with respect to refiller responsibilities and procedures and Sec. 165.136 with respect to recordkeeping pertaining to these responsibilities and procedures. (ii) Section 165.139 with respect to compliance dates. (b) The requirements of this subpart do not apply to: (1) Containers that contain manufacturing use products, as defined in Sec. 158.153(h) of this chapter. (2) Transport vehicles that contain pesticide in pesticide holding tanks that are an integral part of the transport vehicle and that are the primary containment for the pesticide. Sec. 165.124 Container design standards. (a) General. (1) A pesticide product shall not be distributed or sold in a refillable container unless the container meets the standards of this section. The registrant is responsible for assuring that the refillable containers in which the registrant's product is distributed or sold meet the standards of this section. (2) Information on container failures or other incidents involving pesticide containers which may result in releases of pesticide may be reportable under section 6(a)(2) of the Act. (3) Compliance with part 165 container design requirements does not exempt registrants from compliance with the Department of Transportation's (DOT) Hazardous Materials Regulations at 49 CFR parts 171 through 180, if DOT's requirements are applicable. (b) Permanent marking. (1) Each refillable container shall be permanently marked with the information listed in this paragraph. The information shall be visibly located on the outside part of the container except on a closure. Placement on the label or labeling is not sufficient unless the label is an integral, permanent part of or permanently stamped on the container. The information shall include: (i) The name of the container manufacturer. (ii) The model number assigned to the design type of the container, preceded by the phrase ``Model No.''. (iii) The date of manufacture of the container in the order of the month (two digits) and year (last two digits). (iv) The rated capacity of the container, in appropriate units of weight or volume. (v) The name, symbol, or code of the material(s) from which the container is constructed. (vi) A serial number or other identifying code that will distinguish each individual container from all other containers. (vii) The phrase ``Meets EPA standards for refillable pesticide containers.'' (2) If any of this information, such as the date of manufacture, the rated capacity, the material of construction, or the serial number, is required by the DOT Hazardous Materials Regulations at 49 CFR parts 171 through 180 or by the terms of a DOT exemption issued under 49 CFR part 107, then compliance with DOT's requirement will satisfy the corresponding requirement of paragraph (b). (c) Minibulk integrity. Each minibulk container design type shall prevent leakage under conditions of normal storage, distribution, sale, and use. (d) Drop test for minibulk containers. (1) The applicable drop test specified in Sec. 165.125 shall be successfully performed on each minibulk container design type before a container of the design type is used for the sale or distribution of the pesticide product. Section 165.125 prescribes the drop test methodology for flexible, metal, and rigid plastic minibulk containers. (2) Each minibulk container shall be capable of passing the appropriate drop test. (3) The testing shall be conducted in accordance with the Good Laboratory Practice Standards in part 160 of this chapter. (4) If a pesticide product is required to be packaged according to the DOT Hazardous Materials Regulations at 49 CFR parts 171 through 180 or by the terms of a DOT exemption issued under 49 CFR part 107 and the DOT requirements include a drop test, then compliance with DOT's drop test requirements will satisfy the requirements of this paragraph. (e) Apertures. Each aperture of a liquid minibulk container shall have a one-way valve, a tamper-evident device, or both. (f) Standards for bulk containers. The standards in Sec. 165.124(f) apply only to bulk containers at the refilling establishments of refillers operating under written contract to or written authorization from a registrant. (1) Container integrity. (i) Except during a civil emergency or an act of God (any unanticipated grave natural disaster or other natural phenomenon of an exceptional, inevitable, and irresistible character, the effects of which could not have been prevented or avoided by the exercise of due care or foresight), each liquid bulk and dry bulk container and its appurtenances shall meet the following standards: (ii) Each liquid bulk and dry bulk container and its appurtenances shall be resistant to extreme changes in temperature and constructed of materials that are adequately thick to not fail and that are resistant to corrosion, puncture, or cracking. (iii) Each liquid bulk and dry bulk container shall be capable of withstanding all operating stresses, taking into account static head, pressure buildup from pumps and compressors, and any other foreseeable mechanical stresses to which the container may be subjected in the course of operations. (2) Vent. Each liquid bulk container shall be equipped with a vent or other device designed to relieve excess pressure, prevent losses by evaporation, and exclude precipitation. (3) Gauge. External sight gauges, which are pesticide containing hoses or tubes that run vertically along the exterior of the container from the top to the bottom, are prohibited on liquid bulk containers. (4) Shutoff valve. Each liquid bulk container connection, except for vents, shall be equipped with a shutoff valve which can be locked closed. Sec. 165.125 Minibulk container drop test methodology. (a) General. This section prescribes the drop test methodology for flexible, metal, and rigid plastic minibulk containers. (b) Preparation. (1) The test sample shall consist of at least one minibulk container taken at random. (2) The test shall be carried out on minibulk containers prepared for transport. Any pump, valve, meter, hose, or other appurtenance that would be attached to the container during transportation, storage, or use shall be attached during the test. (3) The pesticide to be transported in the minibulk container may be replaced by other substances, as specified in paragraph (b)(4), (b)(5), or (b)(6) of this section. The registrant is responsible for selecting an appropriate test substance. (4) For dry pesticides, when another substance is used it shall have the same physical characteristics (mass, grain size, etc.) as the pesticide to be carried. It is permissible to use additives, such as bags of lead shot, to achieve the requisite total package mass, so long as they are placed so that the test results are not affected. (5) For liquid pesticides, when another substance is used, its relative density and viscosity shall be similar to those of the pesticide to be carried. The registrant is responsible for determining whether a test substance has a relative density and viscosity similar to the pesticide to be carried. (6) Water may be used for the liquid drop test under the following conditions: (i) Where the pesticide to be carried has a relative density not exceeding 1.2, the drop height shall be that specified in paragraph (d)(6) or (e)(7) of this section for that minibulk container. (ii) Where the pesticide to be carried has a relative density exceeding 1.2, the drop height shall be that specified in paragraph (d)(6) or (e)(7) of this section for that minibulk container multiplied by the ratio of the relative density of the pesticide to be carried, rounded off to the first decimal, to 1.2, i.e., relative density x specified drop height. (7) If the minibulk container passes the test, the test records shall include the number of containers of that particular design type that were tested. (c) Dry minibulk containers that consist of flexible bodies. (1) Minibulk containers with flexible bodies are those that consist of a body constituted of film, woven fabric or any other flexible materials or combinations thereof. (2) The dry minibulk container shall be filled to not less than 95 percent of its capacity and to its maximum permissible load, the load being evenly distributed. (3) The dry minibulk container shall be dropped on its base on to a rigid, non-resilient, smooth, flat, and horizontal surface. (4) The dry minibulk container shall be dropped from a height of at least 0.8 meters (2.6 feet). (5) The dry minibulk container shall pass the test successfully if there is no loss of contents after one drop. A slight discharge, e.g., from closures or stitch holes, upon impact shall not be considered to be a failure of the dry minibulk container provided that no further leakage occurs after the dry minibulk container has been raised clear of the ground. (d) Minibulk containers that consist of metal bodies. (1) A dry minibulk container shall be filled to not less than 95 percent of its capacity. (2) A liquid minibulk container shall be filled to not less than 98 percent of its capacity. (3) Pressure relief devices shall be removed and their apertures plugged, or shall be rendered inoperative. (4) The minibulk container shall be dropped on to a rigid, non- resilient, smooth, flat, and horizontal surface, in such a manner as to ensure that the point of impact is on that part of the base of the minibulk container considered to be the most vulnerable. (5) A dry minibulk container shall be dropped from a height of at least 0.8 meters (2.6 feet). (6) A liquid minibulk container shall be dropped from a height of at least 1.2 meters (3.9 feet). (7) The minibulk container shall pass the test successfully if there is no loss of contents after one drop. A slight discharge from a closure upon impact shall not be considered to be a failure of the minibulk container provided that no further leakage occurs. (e) Minibulk containers that consist of rigid plastic bodies. (1) A dry minibulk container shall be filled to not less than 95 percent of its capacity. (2) A liquid minibulk container shall be filled to not less than 98 percent of its capacity. (3) Arrangements provided for pressure relief may be removed and plugged or rendered inoperative. (4) This test shall be carried out when the temperature of the test container and its contents have been reduced to -18 degrees Celsius (0 degrees Fahrenheit) or lower. Test liquids shall be kept in the liquid state, if necessary by the addition of anti-freeze. (5) The minibulk container shall be dropped on to a rigid, non- resilient, smooth, flat, and horizontal surface, in such a manner as to ensure that the point of impact is on that part of the base of the minibulk container considered to be the most vulnerable. (6) A dry minibulk container shall be dropped from a height of at least 0.8 meters (2.6 feet). (7) A liquid minibulk container shall be dropped from a height of at least 1.2 meters (3.9 feet). (8) The minibulk container shall pass the test successfully if there is no loss of contents after one drop. A slight discharge from a closure upon impact shall not be considered to be a failure of the minibulk container provided that no further leakage occurs. Sec. 165.126 Certification. (a) Certification. Each registrant who distributes or sells a pesticide product to a refiller for repackaging into refillable containers and each registrant who distributes or sells a pesticide product in refillable containers shall certify to the Agency that all refillable containers in which the pesticide product is distributed or sold meet the standards of Sec. 165.124. (b) Contents of the certification. The certification for each pesticide product shall contain the following: (1) The name and EPA registration number of the pesticide product to which the certification applies; the registrant's name and address; the date; and the name, title, signature, and telephone number of the company official making the certification. (2) A written statement that the refillable container(s) in which the pesticide product is distributed or sold meet the standards of Sec. 165.124. The statement, ``I certify that the refillable container(s) used for the distribution or sale of this pesticide product meet the standards of 40 CFR 165.124.'' will satisfy this requirement. (c) Submission of certification. Certification shall be submitted with each application for a new registration. For pesticide products registered as of [date of publication of the final rule in the Federal Register], a certification shall be submitted according to the compliance schedule in Sec. 165.139. (d) Address. Certifications shall be submitted to the following address: U.S. Environmental Protection Agency, Office of Pesticide Programs, Registration Division (7505C), 401 M St., SW, Washington, DC 20460. Sec. 165.128 Container design recordkeeping and inspection. Each registrant who distributes or sells a pesticide product to a refiller for repackaging into refillable containers and each registrant who distributes or sells a pesticide product in refillable containers shall maintain the records in this section for the refillable containers which are listed as acceptable for the sale or distribution of the product. The records shall be maintained for as long as the registrant authorizes the container to be used and for 3 years thereafter. The registrant, upon request of any officer or employee of the Agency or of any State or political subdivision duly designated by the Agency, shall furnish or make available for inspection and copying the records as specified in paragraphs (a) through (c) of this section. The records in paragraphs (a) and (b) of this section shall be maintained for each design type. (a) Description of container. The registrant shall keep, for all refillable containers, a description of the container, including but not limited to the kind of refillable container (liquid minibulk, liquid bulk, etc.), the model number of the container, the container manufacturer, and its design type parameters. (b) Minibulk containers. (1) The registrant shall keep at least one of the following records pertaining to the drop test requirement in Sec. 165.124(d) for minibulk containers: (i) A copy of the test data, including a description of the test, a description of the container tested (including all of the information specified in paragraph (a) of this section), the test results (including the results of any failed test(s)), the date and location of the test, and the names of the test operators. (ii) A letter from the container manufacturer that verifies that the container design type has been tested according to the methodology in Sec. 165.125 and that includes a description of the test, a description of the container tested (including all of the information specified in paragraph (a) of this section), the test results (including the results of any failed test(s)) and the location of the original test data. (iii) A letter from the facility that conducted the test that verifies the container design type has been tested according to the methodology in Sec. 165.125 and that includes a description of the test, a description of the container including all of the information specified in paragraph (a) of this section, the test results (including the results of any failed test(s)) and the location of the original test data. (2) The registrant shall keep with the drop test records a statement of compliance or noncompliance with respect to Good Laboratory Practice Standards, as described at Sec. 160.12 of this chapter. (3) The Agency reserves the right to require the registrant, on a case by case basis, to submit the drop test data for any pesticide product registered or proposed for registration. (c) Certification. The registrant shall keep a copy of the certification described in Sec. 165.126 for each pesticide product. Sec. 165.129 Transfer of registered pesticide products into refillable containers. (a) A registrant may allow a refiller to repackage the registrant's pesticide product into refillable containers and to distribute or sell such repackaged product under the registrant's existing registration if the following conditions are met: (1) The repackaging results in no change to the pesticide formulation. (2) The pesticide product is repackaged at a producing establishment registered with EPA as required by Sec. 167.20 of this chapter. (3) The registrant has made one of the following arrangements, if applicable. (i) The registrant has entered into a written contract with the refiller to repackage the pesticide product at a registered establishment and to use the registrant's pesticide product label. (ii) The registrant has provided written authorization to the refiller to repackage the pesticide product at a registered establishment and to use the registrant's pesticide product label. (4) The pesticide product is repackaged only into refillable containers that meet the container design standards of Sec. 165.124. (5) The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the EPA establishment number. (b) Repackaging a pesticide product for distribution or sale without either obtaining a registration, or meeting all of the conditions in paragraph (a) of this section is a violation pursuant to section 12 of the Act. (c) Both the registrant and the refiller that is repackaging the pesticide product under contract to or written authorization from the registrant may be liable for violations pertaining to the repackaged product. Sec. 165.130 Registrant responsibilities concerning refilling activities. (a) General responsibilities. (1) If a registrant is allowing a refiller to repackage the registrant's product under a written contract or a written authorization as specified in Sec. 165.129(a), the registrant shall provide the written contract or written authorization to the refiller before the registrant distributes or sells the pesticide product to the refiller. (2) The registrant is responsible for the pesticide product repackaged and distributed or sold by a refiller operating under written contract or written authorization not being adulterated or different from the composition as described in the statement required in connection with registration under section 3 of the Act. (b) Developing information. Each registrant who distributes or sells a pesticide product to a refiller for repackaging into refillable containers and each registrant who distributes or sells pesticide product in refillable containers shall develop the following: (1) The registrant shall develop, for the pesticide product, a written refilling residue removal procedure, which describes the procedures for removing pesticide residues from a container before it is refilled. (i) The refilling residue removal procedure shall be adequate to ensure that the composition of the pesticide does not differ at the time of its distribution or sale from its composition as described in the statement required to be submitted by the registrant in connection with registration under section 3 of the Act. (ii) If the refilling residue removal procedure requires the use of a solvent other than the diluent used for application of the pesticide as specified on the label under ``Directions for Use'', or if there is no diluent used for application, the refilling residue removal procedure shall describe how to manage the rinsate resulting from the procedure in accordance with applicable Federal and State regulations. (2) The registrant shall develop a written list of acceptable refillable containers (minibulk and bulk) which can be used for the sale or distribution of the registrant's pesticide product. (i) Acceptable containers are those which the registrant has determined meet the standards in Sec. 165.124 and are compatible with the pesticide formulation to which the written list of acceptable containers applies. (ii) The registrant shall identify the containers as acceptable by specifying, at a minimum, the manufacturer of the container and the model number of the container. (c) Providing information. (1) Each registrant whose pesticide product is repackaged by a refiller into refillable containers shall provide the refiller with all of the information and documentation described in paragraphs (c)(2)(i) through (c)(2)(iii) of this section before or at the time of sale or distribution of the pesticide product to the refiller. (2) The registrant shall provide the refiller with: (i) The written refilling residue removal procedure for the pesticide product. (ii) The written list of acceptable containers for the pesticide product. (iii) The pesticide product's label and labeling. Sec. 165.132 Registrant recordkeeping and inspections. (a) Each registrant who distributes or sells a pesticide product to a refiller for repackaging into refillable containers shall maintain the records listed in paragraphs (d)(1) through (d)(3) of this section for that pesticide product. The records shall be maintained for as long as the registrant distributes or sells the pesticide product to a refiller and for 3 years thereafter. (b) Each registrant who distributes or sells a pesticide product in refillable containers shall maintain the records listed in paragraphs (d)(2) through (d)(3) of this section for that pesticide product. The records shall be maintained for as long as the registrant distributes or sells the pesticide product in refillable containers and for 3 years thereafter. (c) The registrant, upon request of any officer or employee of the Agency or of any State or political subdivision duly designated by the Agency, shall furnish or make available for inspection and copying the records specified in paragraphs (d)(1) through (d)(3) of this section. (d) The registrant shall keep the following records: (1) Each written contract entered into with a refiller and each written authorization provided to a refiller for repackaging the registrant's pesticide product into refillable containers. (2) The written refilling residue removal procedure for the pesticide product. (3) The written list of acceptable containers for the pesticide product. Sec. 165.134 Refiller responsibilities and procedures. All refilling operations by a refiller shall be conducted in accordance with this section. (a) Items in possession of refiller. Before repackaging a pesticide product into any refillable container for distribution or sale, a refiller shall have in its possession the following items: (1) The written contract or written authorization, as described in Sec. 165.129(a), from the product's registrant for the pesticide product. A written contract or written authorization is not required if the registrant of the product is the refiller. (2) The pesticide product's label and labeling. (3) The registrant's written refilling residue removal procedure for the pesticide product. (4) The registrant's written list of acceptable containers for the pesticide product. (b) Product integrity. A refiller is responsible for the pesticide product which the refiller repackages into refillable containers and distributes or sells not being adulterated or different from the composition as described in the statement required in connection with registration under section 3 of the Act. (c) Refilling conditions. (1) A refiller shall: (i) Repackage a pesticide product only into a refillable container that is identified on the list of acceptable containers provided by the registrant. (ii) Not change the pesticide formulation, unless the refiller has a registration for the new formulation. (2) Standards that may be applicable for secondary containment units and containment pads are located in subpart H of this part. (d) Identification of pesticide previously contained in refillable container. A refiller shall identify the pesticide product previously contained in the refillable container to determine whether a residue removal procedure must be conducted in accordance with paragraph (g) of this section. The refiller can identify the previous pesticide product by reference to the label or labeling. (e) Container inspection. Before repackaging a pesticide product into any refillable container, a refiller shall visually inspect the exterior and interior (if possible) of the container and the exterior of appurtenances to determine whether the container meets the necessary criteria with respect to continued container integrity, required markings, age of the container, and tamper-evident devices. The container shall fail the inspection, and shall not be refilled, if: (1) The integrity of the container is compromised in any of the following ways: (i) There is significant corrosion or ultraviolet light damage. (ii) There are structural defects including, but not limited to, significant cracks, visible holes, bad dents, or defective or weakened welds. (iii) There is damage to the fittings, valves, tamper-evident devices or other appurtenances that could affect the integrity of the container. (2) The container does not bear the permanent markings required by Sec. 165.124, or such markings are not legible. (3) The container does not have an intact and functioning one-way valve or tamper-evident device on each aperture, if required. (f) Age of plastic liquid minibulk containers. A refiller shall not repackage a pesticide product into a plastic liquid minibulk container more than 6 years after the date of manufacture of the container. (g) Residue removal procedures. (1) A refiller shall conduct the pesticide product's refilling residue removal procedures before repackaging the pesticide product into a refillable container, unless all of the following conditions are met: (i) Each tamper-evident device is intact, if the refillable container has one or more tamper-evident devices. (ii) The container previously held a product with a single active ingredient and is being used to repackage a product with the same single active ingredient. (iii) There is no reaction or interaction between the pesticide product being repackaged and the residue remaining in the container that would cause the composition of the product being repackaged to differ from its composition as described in the statement required to be submitted by the registrant in connection with registration under section 3 of the Act. (2) In addition to conducting the refilling residue removal procedure, in all cases where the container has a broken (not intact) tamper-evident device, other procedures may need to be taken to assure that product integrity is maintained. (h) Quantity that may be refilled. A refiller may repackage any quantity of a pesticide product into a refillable container up to the rated capacity of the container. (i) Relabeling procedures. A refiller shall securely attach the new label (such that the label can reasonably be expected to remain affixed during the foreseeable conditions and period of use). The new label and labeling shall comply in all respects with the requirements of Sec. 156.10 of this chapter. In particular, the refiller shall ensure that the net contents statement and EPA establishment number appear on the new label. Sec. 165.136 Refiller recordkeeping and inspections. Each refiller shall maintain the records listed in this section. The refiller, upon request of any officer or employee of the Agency or of any State or political subdivision duly designated by the Agency, shall furnish or make available for inspection and copying the records listed in this section. (a) Recordkeeping for each pesticide product. The following records shall be maintained for as long as the refiller distributes or sells a pesticide product in refillable containers, and for 3 years thereafter. The refiller shall maintain copies of the following: (1) The written contract or written authorization, as described in Sec. 165.129(a), from the product's registrant for the pesticide product. (2) The registrant's written refilling residue removal procedure for the pesticide product. (3) The registrant's written list of acceptable containers for the pesticide product. (b) Return of refillable containers. For each refillable container that has been used in the distribution or sale of a pesticide product and delivered to the refiller to be refilled, the following information shall be recorded and maintained for 3 years after the date of receipt: (1) The name and address of the person providing the refillable container. (2) The serial number of the refillable container. (3) The date the refillable container was received. (4) The name and EPA registration number of the pesticide product that was last distributed or sold in the refillable container. (c) Refilling of refillable containers. Each time a refiller repackages a pesticide product into a refillable container and distributes or sells the product, the following records shall be generated and maintained for at least 3 years after the date of repackaging: (1) The name, EPA registration number, and amount of the pesticide product distributed or sold in the refillable container. (2) The date of the distribution or sale. (3) The name and address of the consignee. (4) The serial number of the refillable container. (5) A record that the refiller has conducted the container inspection procedure and the results. (6) A record of whether a refilling residue removal procedure was conducted, and if not, why not. Sec. 165.139 Compliance dates. (a) As of [2 years after the date of publication of the final rule in the Federal Register] all pesticide product distributed or sold in refillable containers shall be distributed or sold only in compliance with this subpart. (b) Certifications for pesticide products registered as of [date of publication of the final rule in the Federal Register] shall be submitted to and received by the Agency by [2 years after the date of publication of the final rule in the Federal Register]. Subpart H -- Standards for Pesticide Containment Structures Sec. 165.140 Scope and purpose. (a) Scope. This subpart prescribes the requirements for containment of stationary bulk containers and pesticide dispensing areas at pesticide refilling establishments and at certain other facilities that store bulk quantities of pesticide products. (b) Purpose. The purpose of this subpart is to protect human health and the environment from exposure to pesticides resulting from spills and leaks and to reduce the generation of wastes associated with the storage and handling of bulk quantities of pesticide products and with pesticide container refilling operations. Sec. 165.141 Applicability to facilities and persons. (a) General applicability. The requirements of this subpart apply to each facility identified in paragraph (b) of this section which contains a stationary bulk container or a pesticide dispensing area used for an agricultural pesticide. (b) Facilities covered. The requirements of this subpart cover: (1) Refilling establishments whose principal business is retail sale. (2) Custom blenders, as defined in Sec. 167.3 of this chapter. (3) Facilities of businesses which apply an agricultural pesticide for compensation (other than trading of personal services between agricultural producers). (c) Responsibilities of owners and operators. The owners and operators of the facility are responsible for assuring that the facility complies with the requirements of this subpart. Sec. 165.142 Applicability to stationary bulk containers and pesticide dispensing areas. (a) Stationary bulk containers. (1) Unless exempted by paragraph (a)(2) of this section, each stationary bulk container at a facility shall be protected by a containment structure which shall meet: (i) The general requirements of Sec. 165.146. (ii) The secondary containment requirements of Sec. 165.148 for liquid bulk containers or, as applicable, of Sec. 165.150 for dry bulk containers. (2) A stationary bulk container is exempt from the requirements of this subpart if any of the following conditions exists: (i) All pesticide that can be removed from the container by customary methods such as draining, pumping or aspirating has been removed (whether or not residues have been removed by washing or rinsing). (ii) The container holds only pesticide rinsates or wash waters, and is so labeled. (iii) The container holds only pesticides which would be gaseous if released at atmospheric temperature and pressure. (iv) The container is dedicated to non-pesticide use, and is so labeled. (b) Pesticide dispensing areas. (1) Unless exempted in paragraph (b)(2) of this section, each pesticide dispensing area where any of the following activities are conducted must be protected by a containment structure which meets the general requirements of Sec. 165.146 and the specific requirements for containment pads of Sec. 165.152: (i) The dispensing of pesticide from a stationary bulk container for any purpose, including, but not limited to, refilling refillable containers, service containers, transport vehicles or application equipment, or emptying prior to cleaning. (ii) The dispensing of pesticide from any container other than a stationary bulk container for the purpose of refilling a refillable container for sale and distribution. Containment requirements do not apply if pesticide is dispensed from such containers for purposes other than refilling. (iii) The emptying, cleaning or rinsing of any refillable container. (iv) The dispensing of pesticide from a transport vehicle for purposes of filling a stationary bulk container. (2) A pesticide dispensing area is exempt from the requirements of this subpart if any of the following conditions exist: (i) The only pesticides in the pesticide dispensing area are pesticides which would be gaseous when released at atmospheric temperature and pressure. (ii) The only pesticide containers refilled or emptied within the pesticide dispensing area are stationary bulk containers and the area is protected by a secondary containment unit meeting the requirements of this subpart. (iii) The pesticide dispensing area is used solely for dispensing pesticide from a rail car which does not remain at a facility long enough to meet the definition of a stationary bulk container. Sec. 165.144 Existing and new containment structures. (a) Existing containment structures. For purposes of this subpart, existing containment structure means a containment structure for which installation has commenced on or before [3 months after the date of publication of the final rule in the Federal Register]. Installation is considered to have commenced if: (1) The owner or operator has obtained all Federal, State, and local approvals or permits necessary to begin physical construction of the containment structure; and if (2)(i) Either a continuous on-site physical construction or installation program has begun; or (ii) The owner or operator has entered into contractual obligations, which cannot be canceled or modified without substantial loss, for physical construction or installation of the containment structure, to be completed within a reasonable time. (b) New containment structures. For purposes of this subpart, new containment structure means a containment structure for which installation has commenced after May 12, 1994. Sec. 165.146 Containment structures: general requirements. Each stationary bulk container and each pesticide dispensing area shall be protected by a containment structure which meets the requirements of this subpart. (a) Material. (1) The containment structure shall be constructed of reinforced concrete or other rigid material which will withstand the full hydrostatic head (dynamic or static), load and impact of any pesticides, precipitation, other substances, equipment, and appurtenances placed within the structure. (2) The containment structure shall not be constructed of natural earthen material, unfired clay, or asphalt. (3)(i) During the interim period as specified in Sec. 165.156(b), each existing containment structure shall have a hydraulic conductivity less than or equal to 1 x 10-6 centimeters per second. This standard may be satisfied by the use, separate or combined, of any of the following materials: (A) Structural materials. (B) Surface sealants or coatings. (C) A continuous liner at the bottom of the containment structure. (ii) Each new containment structure shall have a hydraulic conductivity less than or equal to 1 x 10-7 centimeters per second. After the expiration of the interim period specified in Sec. 165.156(b), each existing containment structure also shall meet this requirement. The standard for hydraulic conductivity may be satisfied with materials in the manner specified in paragraph (a)(3)(i)(A) through (a)(3)(i)(C) of this section. (4) The containment structure shall be constructed of materials that are resistant to the pesticide. (b) Design and construction. (1) The containment structure shall, at a minimum, prevent water and other liquids from seeping into or flowing onto it from adjacent land or structures during a 25-year, 24- hour rainfall event. (2) Appurtenances and pesticide containers shall be protected against damage from operating personnel and moving equipment. Means of protection include but are not limited to supports to prevent sagging, flexible connections, the use of guard rails, barriers, and protective cages. (3) No new containment structure shall have an appurtenance, discharge outlet or gravity drain through the base or wall, except for direct interconnections between adjacent containment structures which meet the requirements of this subpart. Appurtenances shall be configured in such a way that spills or leaks readily can be observed. After the expiration of the interim period as specified in Sec. 165.156(b), each existing containment structure also shall meet this standard. (c) Operation. (1) The owner or operator shall operate the structure in a manner that prevents pesticides or materials containing pesticides from escaping from the containment structure. This includes, but is not limited to, pesticide residues washed off the containment structure by rainfall or liquids used for cleaning the area within the containment structure. All materials containing pesticide residue shall be handled in accordance with label directions and applicable Federal, State and local laws and regulations. (2) The owner or operator shall ensure that transfers of pesticides between pesticide containers or between transport vehicles and containers are attended at all times. (3) The owner or operator shall ensure that each lockable valve, if required by Sec. 165.124(e)(4), on a stationary bulk container shall be locked closed whenever the facility is unattended. (4) The owner or operator shall ensure that spills and leaks of pesticide on or in any containment structure are collected, and recovered in a manner that ensures protection of human health and the environment (including surface water and ground water) and ensures the maximum practicable recovery of the pesticide spilled or leaked. At a minimum, cleanup shall occur no later than the end of each day on which pesticides have been spilled or leaked in or on the containment structure. (5) The owner or operator shall ensure that all materials resulting from spills and leaks are managed in accordance with label instructions and applicable Federal, State and local laws and regulations. (d) Inspection and maintenance. (1) At least monthly during periods when pesticides are being stored or dispensed on the containment structure, the owner or operator shall inspect each stationary bulk container and its appurtenances and each containment structure for visible signs of wetting, discoloration, blistering, bulging, corrosion, cracks or other signs of damage or leakage. (2) The owner or operator shall repair any areas showing visible signs of damage and seal any cracks and gaps in the containment structure and appurtenances with material that is resistant to the pesticide being stored or dispensed and that meets the standard for hydraulic conductivity set forth in Sec. 165.146(a)(3)(i) or (a)(3)(ii), as applicable. (3) No pesticide shall be stored or dispensed on a containment structure if the structure fails to meet the requirements of this subpart, until suitable repairs have been made. Prompt removal of pesticides, including emptying of bulk containers, in order to effect repairs or recovery of spilled material is acceptable. Sec. 165.148 Specific requirements for containment of stationary liquid bulk containers. Each stationary liquid bulk container shall be protected by a secondary containment unit which meets the requirements of Sec. 165.146 and of this section. (a) Capacity. (1) During the interim period as specified in Sec. 165.156(b), each existing secondary containment unit shall have, at a minimum, the following capacity, in addition to compensating for any volume displaced by containers and appurtenances: (i) At least 110 percent of the capacity of the largest stationary bulk container within a secondary containment unit that is not protected from precipitation. (ii) At least 100 percent of the capacity of the largest stationary bulk container within a secondary containment unit that is protected from precipitation. (2) Each new secondary containment unit shall have, at a minimum, the following capacity, in addition to compensating for any volume displaced by containers and appurtenances: (i) At least 125 percent of the capacity of the largest stationary bulk container within a secondary containment unit that is not protected from precipitation. (ii) At least 110 percent of the capacity of the largest stationary bulk container within a secondary containment unit that is protected from precipitation. (3) After the expiration of the interim period as specified in Sec. 165.156(b), each existing secondary containment unit shall meet the requirements of paragraph (a)(2) of this section. (b) Design and construction. (1) Each new secondary containment unit shall allow for the observation of leakage from the base of any enclosed stationary bulk container. This requirement may be achieved by elevating the stationary bulk container on structures such as legs, skids, raised beds of rounded gravel, or by other methods, provided that leaked material readily can be observed and the integrity of the secondary containment unit is preserved. After the expiration of the interim period as specified in Sec. 165.156(b), each existing secondary containment unit also shall meet this standard. (2) Any stationary bulk container protected by a secondary containment unit shall be adequately elevated or anchored to prevent floatation in the event that the secondary containment unit fills with liquid. (c) Inspection and maintenance. Each month during the interim period as specified in Sec. 165.156(b), the owner or operator shall inventory and reconcile the contents of any stationary bulk pesticide container which is protected by an existing secondary containment unit but not elevated (as described in paragraph (b)(1) of this section) so as to allow for observation for leakage beneath the container. Inventory and reconciliation shall compare the quantity of material measured in the bulk container versus the quantity expected (as calculated by adjusting the quantity of pesticide measured in the bulk container at the previous month's inventory for subsequent amounts dispensed into and from the container). Sec. 165.150 Specific containment requirements for stationary dry bulk containers. (a) Each stationary dry bulk container shall be protected by a secondary containment unit which meets the requirements of Sec. 165.146 and of this section. (b) Each new secondary containment unit shall have, at a minimum, the capacity to contain 100 percent of the volume of the largest stationary dry bulk container within the containment structure, in addition to compensating for any volume displaced by containers and appurtenances. After the expiration of the interim period as specified in Sec. 165.156(b), each existing secondary containment unit also shall meet this requirement. Sec. 165.152 Specific containment requirements for pesticide dispensing areas. Each pesticide dispensing area shall be protected by a containment pad which meets the requirements of Sec. 165.146 and this section. (a) Capacity. The containment pad shall have, at a minimum, a holding capacity of 1,000 gallons or, if no container or pesticide- holding equipment on the containment pad exceeds a capacity of 1,000 gallons, the minimum capacity of the containment pad shall be at least 100 percent of the capacity of the largest pesticide container or pesticide-holding equipment used on the pad. (b) Design and construction. (1) The containment pad shall be designed and constructed to intercept leaks and spills of pesticides which may occur in the pesticide dispensing area. The surface area of the containment pad shall be sufficient to extend completely beneath any container on the pad except transport vehicles which are dispensing pesticide for sale or distribution to a facility's stationary bulk container. For such vehicles the surface area of the containment pad, at a minimum, shall accommodate the portion of the vehicle where the delivery hose or device couples to the vehicle. (2) The surface of each new containment pad shall be sloped toward a liquid-tight sump where liquids can be collected for removal. After the expiration of the interim period as specified in Sec. 165.156(b), each existing containment pad also shall meet this requirement. (3) The containment pad shall have a means of removing and recovering spilled, leaked, or discharged material and rainfall such as by a manually activated pump. Automatically activated pumps lacking automatic overflow cutoff switches for the receiving container are prohibited. Sec. 165.153 Integrated systems. Containment pads and secondary containment units may be combined into integrated systems provided the requirements of Sec. 165.146 and, as applicable, Sec. Sec. 165.148, 165.150, and 165.152 are satisfied separately. If more than one stationary bulk container is located at a facility, the requirements for secondary containment units may be applied individually to each stationary bulk container or collectively, at the option of the facility. Sec. 165.156 Compliance dates. (a) As of [2 years after the date of publication of the final rule in the Federal Register] each new containment structure shall be in compliance with all applicable requirements of this subpart. (b) The interim period of this subpart begins on [2 years after the date of publication of the final rule in the Federal Register] and ends on [10 years after the date of publication of the final rule in the Federal Register]. During this interim period, each existing containment structure shall be in compliance with those requirements identified as interim and shall be fully in compliance with all other applicable requirements. (c) As of [10 years after the date of publication of the final rule in the Federal Register] each existing facility shall be in compliance with the full requirements of this subpart. Interim requirements shall no longer apply to any facility or containment structure. Sec. 165.157 Recordkeeping requirements and inspections. Each owner or operator shall maintain the records listed in this section. The owner or operator, upon request of any officer or employee of the Agency or of any State or political subdivision duly designated by the Agency, shall furnish or make available for inspection and copying the records listed in this section. (a) The following records shall be maintained for at least 3 years: (1) Records of inspection and maintenance for each containment structure and for each stationary bulk container and its appurtenances, including the name of the person conducting the inspection or maintenance, date, conditions noted, and maintenance performed. (2) During the interim period referenced in Sec. 165.156(b), monthly records of inventory and reconciliation, including for each stationary bulk container applicable under the provisions of Sec. 165.148(c), the name of product stored, the quantity measured at previous inventory, the quantities dispensed from or added to container, and reconciliation with the quantity measured at the most recent inventory. (3) For any dry or liquid bulk container that holds pesticide but is not protected by a secondary containment unit that meets the requirements of this subpart, records of the duration over which the container remains at the same location at the facility. (b) Each owner or operator shall maintain written confirmation of hydraulic conductivity as required in Sec. 165.146(a)(3) and (d)(2) and statements of resistance to the pesticide as required in Sec. 165.146(a)(4) and (d)(2). The owner or operator shall maintain these records for as long as the containment structure is in use, and 3 years thereafter. [FR Doc. 94-2969 Filed 2-10-94; 8:45 am] BILLING CODE 6560-50-F