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.

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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.

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\1\Enacted as Public Law 101-508, sections 6601 through 6611;

codified as 42 U.S.C. secs. 13101 et seq.

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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 a

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