epa container regs
TRANSCRIPT
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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 [email protected],
e.g., [email protected]
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