EPA container Regs

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EPA’s Pesticide Container Regulations

Requirements for Portable

Refillable Containers &

Repackaging

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Outline

1. Overview of Container-Containment

Regulations

2. Requirements for Portable Refillable

Containers (“Minibulks”) and Repackaging

3. Implications/Issues

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1. Overview of

Container-Containment

Regulations

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Overview: Purpose of the Rule

Containers

Minimize human exposure during container

handling

Facilitate container disposal and recycling

Encourage use of refillable containers

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Schedule of Compliance Dates

August 16, 2009

Nonrefillable containers: Registrants ensure that their nonrefillable

containers comply with container standards

Containment: Retailers, commercial applicators & custom blenders must

have secondary containment around large stationary tanks and containment

pads for dispensing areas

August 16, 2010

Labels: Registrants ensure that labels have required statements and

pesticide users follow container-related directions on label

August 16, 2011

Refillable containers: Registrants ensure that their refillable containers

comply with container standards

Repackaging: Registrants authorize refillers to repackage product and

develop & provide certain info to refillers. Refillers obtain & follow registrant

info; also inspect, clean & label refillable containers

Scope – Which Products? All pesticide products

other than manufacturing use products, plant-incorporated protectants, and exempt antimicrobials must comply with the refillable container (Subpart C) and repackaging (Subpart D) regulations.

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Scope – Partial Exemption

Partial exemption -

Antimicrobial pesticides used in swimming pools (if not totally exempt) are exempt from certain requirements:

Marking

One-way valve/tamper-evident device

Repackaging recordkeeping

Inspection and cleaning criteria related to marking, one-way valve, and tamper-evident devices.

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Scope - Exemptions

The refillable container & repackaging regulations do not apply to:

Transport vehicles that contain pesticide in pesticide-holding tanks that are an integral part of the transport vehicle and that are the primary containment for the pesticide.

Containers that hold gaseous pesticides.

Custom blending.

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2. Requirements for Portable

Refillable Containers &

Repackaging

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Refillable Containers

Applicability

DOT standards

Marked with serial

number/code

Tamper-evident device

or one-way valve on

each opening

“Bulk” tanks: vent and

shut-off valve; no sight

gauge

The first question will pertain

to: Applicability

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1. Which company/companies do the refillable container regulations identify as being responsible for ensuring that a minibulk meets the standards in the refillable container regulations?

[§165.40(b)(1)]

A. The registrant of the pesticide product sold in the minibulk

B. The refiller who repackaged the pesticide product into the minibulk

C.A and BD.None of the above

Answer to Question 1

A. The registrant of the pesticide product sold

in the minibulk.

165.40(b)(1) states that

registrants must comply

with all of the refillable

container requirements

and that their products

must be sold or distributed

in refillable containers (including minibulk and

bulk containers) that meet the standards of

these regulations.13

Answer to Question 1 (cont.)

The refiller does have related

responsibilities, including repackaging pesticide

only into a refillable container identified on the

registrant’s description of acceptable containers

(which the registrant has identified as complying

with the regulations).

FIFRA: Registrant is responsible for pesticide

product, which includes the formulation, label and

container. So, ultimately the registrant is

responsible.

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The following slides will

pertain to: Applicability

DOT Requirements

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DOT Requirements: Background

The pesticide container regulations refer to

and adopt some of the Department of

Transportation (DOT) Hazardous Materials

Regulations.

Some - not all - pesticide products are DOT

hazardous materials.

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DOT Requirements: Background

DOT defines 9 classes of hazardous

materials. Common ones for pesticides are:

Class 3 – flammable or combustible liquids

Class 6.1 – poisonous materials

Class 8 – corrosive materials

DOT also defines 3 different packing groups

(PGs) within the classes.

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DOT Requirements: Background

DOT’s Hazardous Materials Regulations

cover many topics and requirements that the

container regulations do not adopt, such as:

Shipping

papers, labeling, placarding, emergency

response info, carrier requirements

(rail, aircraft, vessel, air)

Pesticide container regulations focus on

packaging, marking and continued

qualification/maintenance requirements.

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DOT Requirements and Refillable

Container Regulations If a pesticide product is a DOT hazardous

material, it must comply with applicable DOT regulations.

If a pesticide product is not a DOT hazardous material, it must be packaged in a refillable container that is designed, constructed, and marked to comply with the basic integrity, testing, and other cross-referenced DOT regulations at packing group III level.

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DOT/United Nations Marking

In DOT regulations, marking with UN symbol:

Can only be used if package fully conforms with

requirements - 49 CFR 178.3(b)

Certifies that all requirements are met –

49 CFR 178.2(b)

A limited number of refillable containers comply

with the DOT packing group III standards but are

not required to have marking

The following questions will

pertain to: Applicability

DOT Requirements

Marking

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2a. Does this minibulk meet the marking requirement in 165.45(d)? Why or why not?

2b. If the number was not included in the bottom photo, would this marking comply with the requirement in

165.45(d)? Why or why not?

Answer to Question 2a

The marking includes a serial number. The issue is whether this sticker counts as durable marking. The examples of durable marking in the reg text are: etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding and marking with durable ink. Durable is “able to withstand wear and tear or decay; lasting.” EPA will have to issue an interpretation this. The sticker is different than the examples provided but probably meets the definition of durable.

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Answer to Question 2b

Yes, this marking would still comply.

165.45(d) requires “a serial number or

other identifying code…” A bar code counts

as an “other identifying code,” although

there is still the issue about whether this is

durable marking.

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The next set of questions will

pertain to: Applicability

DOT Requirements

Marking

Tamper-Evident Device/One-Way Valve

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3. What is the definition of tamper-evident device? (See 165.3.)

Answer to Question 3

A tamper-evident device is a device which

can be visually inspected to determine if a

container has been opened.

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4. These photos show several openings on minibulk containers. Do these comply with 165.45(e)?

Answer to Question 4

Yes, each opening (other than a vent) has a

tamper-evident device. So the containers

comply with the requirement to have a

tamper-evident device, a one-way valve, or

both.

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5. What is the definition of one-way valve? (See 165.3.)

Answer to Question 5

A one-way valve means a valve that is

designed and constructed to allow virtually

unrestricted flow in one direction and no

flow in the opposite direction, thus allowing

the withdrawal of material from, but not the

introduction of material into, a container.

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6. The valve at the bottom of this minibulk is not a one-way valve. (There is a tamper-evident device on the valve.) Does this minibulk comply with the requirement in

165.45(e)?

Answer to Question 6

Yes, the opening has a tamper-evident

device, so it complies with the requirement

to have a tamper-evident device, a one-way

valve, or both.

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7. The end user has to break the tamper-evident device to remove pesticide from the minibulk through this valve. When the minibulk is returned, would the refiller have to clean the minibulk before refilling it with the same pesticide product? (See 165.70(g) and (h).) Why or why not?

Answer to Question 7

Yes, the refiller would have to rinse the

container even if he refills it with the same

product. The container does not meet the

criterion in 165.70(g)(1): “If required, each

tamper-evident device and one-way valve is

intact.” The user could have put another

material in the container, which could cause

cross-contamination.

.

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8. This refillable container has a tamper-evident device on the “fill” opening near the front of the container. For the large opening in the center, the end user has a

specially-designed device that connects to this opening, which is the only way to remove pesticide product from this opening. The device has a one-way valve in it. Does this container comply with 165.45(e)?

Answer to Question 8

Yes, 165.45(e) says that the one-way

valve may be located in a device or system

separate from the container if the device or

system is the only foreseeable way to

withdraw pesticide from

the container.

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Repackaging

Registrants

Authorize refillers to repackage their product;develop and provide certain information

Refillers

Obtain and follow registrant info

Inspect, clean, and label containers

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Bulk Policy vs. Repackaging

Regulations

The conditions for a registrant to allow an independent refiller to repackage its product are set out in 165.67(b) for registrants and in

165.70(b) for independent refillers. These conditions are intended to assure that the purposes of registration would be satisfied, as in the 1977 Bulk Policy.

In addition, other requirements in the repackaging regulations revise or change criteria in the Bulk Policy.

The Bulk Policy will be rescinded when the repackaging regulations go into effect in August 2011.

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Repackaging Regs vs. Bulk Policy9. For each of the conditions for

allowing repackaging by an independent refiller (see 165.67(b) & 165.70(b)),

assess whether the condition is the same as, similar to or different than the Bulk Policy.

A. The repackaging results in no change to the pesticide formulation.

B. The pesticide product is repackaged at a refilling establishment registered with EPA as required by 167.20 of this chapter OR the product is repackaged by a registered refilling establishment at the site of a user who intends to use or apply the product.

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Repackaging Regs vs. Bulk Policy

9. (cont.) For each of the conditions for allowing repackaging by an independent refiller, assess whether the condition is the same as, similar to or different than the Bulk Policy.

C. The registrant and independent refiller have entered into a written contract to repackage the pesticide product and to use the product’s label.

D. The pesticide product is repackaged only into refillable containers that meet the refillable container standards.

E. The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the refiller’s EPA establishment number.

Answer to Question 9

A. No change in formulation – same

B. At or by a registered establishment –

same

C. Entered into a written contract – similar;

Bulk Policy allows “written authorization”

D. Refillable container that complies with

regs – different (new)

E. Labeled appropriately - same

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New Repackaging Requirements

The repackaging regulations require a registrant to provide two new items to a refiller before the refiller repackages a pesticide product into any refillable container for distribution or sale:

1. The registrant’s written refilling residue removal procedure for the pesticide product.

Describes how to remove residue from a refillable container before it is refilled

Adequate to ensure product integrity

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New Repackaging RequirementsThe repackaging regulations require a registrant to provide two new items to a refiller before the refiller repackages a pesticide product into any refillable container for distribution or sale:

2. The registrant’s written description of acceptable containers for the pesticide product. Acceptable container = registrant has determined

meets the refillable container standards and is compatible with the pesticide formulation

Must identify container(s) by specifying materials of construction that are compatible & information to confirm compliance with refillable container regs

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3. Implications/Issues

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Implications

There are many minibulks currently being

used that do not meet the refillable

container requirements:

DOT PG III standards

Marking

Tamper-evident device/one-way valve

Registrant’s description of acceptable

containers

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Implications

Can those minibulks be used after August

16, 2011?

If minibulk does not comply with DOT PG III

standards – No, it cannot be used.

Can the tank be retrofitted to comply with

marking (serial number) and tamper-evident

device/one-way valve requirement?

Is the container included on the registrant’s

list of acceptable container?

Will the container pass the visual inspection?

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Implications If containers cannot be used, they should

be safely recycled or disposed of.

While outside the scope of the regs, EPA

wants to support minibulk recycling to the

extent possible:

EPA HQ: Education, provide information,

answer questions, on-going discussions, etc.

Region 5: Project to develop guidance for

properly preparing minibulks for recycling

Region 9: Project to support minibulk

recycling program48

Issues

Outstanding questions:

Clarify “durable marking” for serial number

Definition/standards for one-way valves

Is a pump an opening and, if so, do

existing pumps comply with the

requirement for one-way valves and

tamper-evident devices?

Many questions about DOT requirements

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Contact Information

EPA web site: http://www.epa.gov/pesticides/regulating/containers.htm

Nancy Fitz, 703-305-7385

Jeanne Kasai, 703-308-3240

David Stangel, 202-564-4162

Email: last name.first name@epa.gov,

e.g., fitz.nancy@epa.gov

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