Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment
[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Rules and Regulations]
[Page 47379-47428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au06-26]
[[pp. 47379-47428]]
Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment
[[Continued from page 47378]]
[[Page 47379]]
limitation is that the products that are exempt from the refillable
container and repackaging regulations must be repackaged by the
registrant or a person under written contract to the registrant. EPA
believes this constraint will not be a problem for MUPs and exempt
antimicrobials because we have received information that these products
are repackaged by the registrants if they are sold or distributed in
refillable containers. In addition, refillable containers are not
appropriate for distributing plant-incorporated protectants, so these
products will also not be adversely affected.
One issue that has been raised is whether registrants and
independent refillers can comply with the regulations (and specifically
the conditions for repackaging pesticide products for distribution or
sale) before the compliance date. This is appealing to registrants and
independent refillers because the regulations allow pesticides to be
repackaged under written contracts into refillable containers of any
size (compared to the 55 gallon container size limit established in the
Bulk Policy and maintained in the 1991 amendment). EPA believes that it
is acceptable for registrants and independent refillers to repackage
pesticide products under the regulations before the 5 year compliance
date as long as they are in full compliance with the refillable
container and repackaging regulations. In other words, registrants can
enter into contracts with independent refillers to refill containers
only if: (1) The containers comply with the refillable container
regulations, i.e., they meet the specified DOT standards, have a
durable serial number or other identifying code, and have one-way
valves and/or tamper-evident devices; (2) the registrant meets the
repackaging conditions and develops and provides the necessary
information, including a description of acceptable containers and a
cleaning procedure; (3) the refillers meet the repackaging conditions
and comply with the operational procedures, including inspecting,
cleaning (if necessary), and labeling the containers; and (4) all other
requirements specified in the refillable container and repackaging
regulations are followed.
H. Product Integrity
1. Background. The Bulk Pesticides Enforcement Policy and both the
proposed and final rules hold the registrant and the refiller (if
different than the registrant) responsible for product integrity of the
pesticide product repackaged by the refiller. ``Product integrity''
means that the pesticide product is not adulterated or different from
the composition described in its confidential statement of formula that
is required under FIFRA section 3. This requirement reflects current
law. Under FIFRA section 12(a)(1), it is unlawful for any person to
distribute or sell to any person a pesticide which is adulterated or
whose composition differs from the composition described in its
confidential statement of formula.
FIFRA Section 12(a)(1) applies to pesticide distributed or sold in
nonrefillable containers and in refillable containers. For pesticides
distributed or sold in nonrefillable containers, it is clear that the
registrants are responsible for product integrity because there are no
other parties involved (except for supplemental registrants, as
regulated by 40 CFR 152.132, and parties acting as agents under
contract to the registrant). Similarly, when a registrant repackages a
product directly into a refillable container for distribution or sale,
it is also clear that the registrant is responsible for product integrity.
The situation is less clear when a registrant distributes or sells
a product to an independent refiller for repackaging into refillable
containers. Both the registrants and the independent refillers are
selling or distributing the product, so both parties are responsible
for product integrity. The registrant is responsible because the
registrant has authorized the independent refiller to repackage the
registrant's pesticide product and to use the registrant's label
according to the terms of the written contract (or authorization under
the Bulk Policy). The registrant remains accountable for its repackaged
product which is distributed or sold in the refillable container. EPA
believes it is appropriate for registrants to be held responsible for
acts by independent refillers because the repackaging is being done
under the registrant's registration and the independent refillers are
agents of the registrants for purposes of carrying out the written
contract. The independent refiller is responsible for product integrity
because the refiller is the person who physically places the product
into the container for sale or distribution.
In 1996, EPA established a policy on ``Toxicologically Significant
Levels of Pesticide Active Ingredients'' in PR Notice 96-8. (Ref. 58)
This document describes EPA's interpretation of the term
``toxicologically significant'' as it applies to contaminants in
pesticide products that are also active ingredients. The policy
provides risk-based concentration levels of such contaminants that are
generally considered to be toxicologically significant (and therefore
must be reported and accepted as part of product registration according
to 40 CFR 158.167). The concentrations are defined according to the
type of pesticide that is contaminated (insecticide, herbicide, low
dose herbicide, etc.) and the pesticide category of the contaminant.
While PR Notice 96-8 applies to all pesticide products in nonrefillable
and refillable containers, a driving force in developing the policy was
the cross-contamination found in refillable containers in the early 1990's.
2. Final regulations. The repackaging regulations clearly hold all
parties subject to the repackaging standards to be responsible for
product integrity. This includes:
(1) Registrants who distribute or sell a pesticide product in
refillable containers (in Sec. 165.65(b));
(2) Registrants who distribute or sell pesticide products to
independent refillers for repackaging into refillable containers (in
Sec. 165.67(e)); and
(3) Refillers of a pesticide product that are not the registrants
of the pesticide product (in Sec. 165.70(d)).
Specifically, all of these businesses are responsible for the
pesticide product that they distribute or sell not being adulterated or
different from the composition described in the product's confidential
statement of formula that is required under FIFRA section 3.
3. Changes. The language in the final regulation is nearly
identical to the text in the proposed regulation. One slight
modification is that the phrase ``described in its confidential
statement of formula that is required under FIFRA section 3'' is used
in the final regulations because it is more straightforward than the
proposed phrase ``described in the statement required in connection
with registration under section 3 of the Act.'' EPA considers these two
phrases to mean exactly the same thing.
However, one thing that has changed since the proposed rule is
EPA's policy on toxicologically significant levels of pesticide active
ingredients. PR Notice 96-8 defines risk-based concentration levels of
contaminants that are generally considered to be toxicologically
significant. Active ingredient contaminants that are present at lower
concentrations do not have to be reported by registrants and accepted
by EPA as part of product registration. For example, if an herbicide
active ingredient is detected at less than 1,000 ppm in any pesticide
where the contaminant is accepted for use on all
[[Page 47380]]
sites for which the product is labeled, the herbicide active ingredient
is not considered to be toxicologically significant. As described in PR
Notice 96-8, the purpose of this policy is to: (1) Recognize that
cross-contamination is a reality, and that not all cross-contamination
is problematic; (2) set a clear standard that can be readily applied by
EPA, States and the regulated industry; (3) ensure that allowable
cross-contamination does not pose unreasonable adverse effects; (4)
minimize the paperwork burden for EPA and registrants; (5) maintain
accountability for the product from the registrant to the end user; and
(6) not preclude marketplace or private solutions to correct problems
that do arise.
I. Delivery and Repackaging at End User Locations
1. Background. The 1977 Bulk Policy (Ref. 75) provided the
following two examples of acceptable practices for shipping ``bulk''
pesticides to end users:
? A registrant ships a bulk pesticide directly to an end
user (custom applicator, farmer, etc.). The label accompanies the
shipment and is placed on the user's tank. No new establishment or
product registration is needed for the bulk container since the labeled
product is fully registered and has been sold intact to the user.
? A tank car of pesticide from which commercial applicators
meter off into their own tanks, without being put into a dealer's
holding tank, would be exempt from new producer establishment
registration. It is considered that the original container has not been
changed in delivery to the applicator and the tank car label (placard)
will bear the producer's establishment number.
In the preamble to the 1994 proposed rule, EPA stated that
repackaging by the registrant must be done at a registered
establishment, as required by 40 CFR part 167. In addition, EPA stated
that we saw no reason to continue the exemption from the registered
establishment requirement described in the second bullet in Unit I.1.,
above. We requested comments on the effect of discontinuing this exception.
On February 3, 1994, EPA released the ``Bulk Pesticide Repackaging
Question & Answer Document'' (Ref. 63) which included the following
question and answer that address the issue of making a bulk delivery
directly to an end user.
18. May a registrant deliver pesticides in bulk directly to a
farm, even if the farm is not registered as a producing
establishment? May someone other than the registrant do this?
Under the bulk pesticide repackaging policy, a registrant may
deliver pesticides directly to a farm, even if the farm is not
registered as a pesticide producing establishment. Someone other
than the registrant could not deliver pesticides in bulk to a farm
unless the farm was registered as a pesticide producing
establishment and that person has received written authorization
from the registrant to deliver the pesticide to the specific farm.
The registrant of the establishment (i.e., the farmer) would also be
required to submit annual production reports. Please note that some
States and most registrants require containment structures for the
storage of bulk pesticides. Most farmers do not have these
containment structures and delivery to these farms may not be
allowed under State law.
After discussion and debate on this question among the regulated
community and regulatory agencies, EPA reconsidered and revised our
position in a memo titled ``Bulk Pesticide Transfers'' dated March 22,
1995. (Ref. 59) The new question 18 supersedes the question in the 1994
Bulk Policy Question & Answer document and is:
18(a). May a registrant deliver pesticides in bulk directly to a
farm, even if the farm is not registered as a producing
establishment? May someone other than the registrant do this?
A registrant, dealer, or other authorized person pursuant to the
``Enforcement Policy Applicable to Bulk Shipments of Pesticides''
(July 11, 1977) may transfer pesticides in bulk at a farm, even if
the farm is not registered as a pesticide producing establishment.
18(b). May a registrant deliver pesticides in bulk directly to
end use sites other than a farm, even if such site is not registered as a
producing establishment? May someone other than the registrant do this?
Yes. See answer to question 18(a) above. However, the Agency
will continue to pursue enforcement actions against all end users
that use any registered pesticide in a manner inconsistent with its
labeling pursuant to FIFRA 12(a)(2)(G).
The March 22, 1995 memo explained that this revision was made
because end users are not the persons repackaging shipments of bulk
pesticides at the farm and other end use sites. The memo further stated
that the terms and conditions of the 1977 Bulk Policy and 1991
amendment are unchanged. Since the pesticide that is transferred at the
farm or other end use site is not being transferred and held for
further sale, final accountability for meeting the terms of the Bulk
Policy remains with the registrant and the last establishment making a
transfer associated with a pesticide sale, the dealer. Registrant and
dealer establishments are responsible for reporting repackaging as
production pursuant to 40 CFR 167.85. In the memo, EPA recommended (but
did not require) that pesticides be transferred into stationary bulk
containers protected by a secondary containment structure at end user sites.
2. Final Regulation. One of the requirements specified in
Sec. Sec. 165.67(b) and 165.70(b) for when a registrant may allow a
refiller to repackage its pesticide product into refillable containers
and to distribute or sell such repackaged product under the existing
registration is:
One of the following conditions regarding a registered refilling
establishment is satisfied:
(1) The pesticide product is repackaged at a refilling
establishment registered with EPA as required by Sec. 167.20.
(2) The pesticide product is repackaged at the site of a user who
intends to use or apply the product by a refilling establishment
registered with EPA as required by Sec. 167.20.
3. Changes. The first condition listed above (Unit I.2.(1)) (the
product is repackaged at a registered refilling establishment) is the
same as the proposed regulation. The second condition--the product is
repackaged at the site of a user who intends to use or apply the
product by a registered refilling establishment--was added to the final
rule to be consistent with EPA's revised policy as described in the
March 22, 1995 ``Bulk Pesticide Transfers'' memo. The final regulation
is consistent with EPA's 1995 position that final accountability for
meeting the terms of the Bulk Policy remains with the registrant and
the last establishment making a transfer associated with a pesticide
sale (an independent refiller in this case), because the pesticide that
is transferred at the farm or other end use site is not being
transferred and held for further sale.
EPA has received anecdotal evidence that the practice of refilling
containers (bulk containers, minibulks, application tanks, nurse tanks,
etc.) at end user sites has increased over the past few years and may
continue to increase in the future. Therefore, EPA is concerned about
the potential for spills, leaks and other releases during transfers at
end user sites to cause soil and water contamination. As described in
the preamble to the proposed rule, EPA decided to require containment
structures at dealers, commercial applicators and custom blenders with
bulk storage tanks, largely because these were the kinds of sites where
contamination had been documented. EPA did not and still does not have
documentation of end user site contamination due to repackaging
pesticide product. Therefore, the final pesticide container and containment
[[Page 47381]]
regulations do not require repackaging at end user sites to be done
within a containment structure. However, EPA strongly recommends that
repackaging at end user sites be conducted over some kind of
containment--whether it is a permanent concrete containment pad or a
portable containment structure. In the future, EPA may revise the
repackaging regulations to require all repackaging (including at end
user sites) to occur over a containment structure if we become aware of
a pattern of end user site contamination being caused by repackaging.
J. Registrants Who Distribute or Sell Pesticide Products in Refillable
Containers - Overview (Sec. 165.65)
1. Final Regulation. The regulations in Sec. 165.65 apply to
registrants who distribute or sell pesticide products in refillable
containers. This means that the registrant conducts all of the
repackaging for the product and does not distribute or sell the product
to a refiller that is not part of its company for refilling.
Of course, a registrant may repackage a product directly into
refillable containers for sale or distribution and distribute or sell
that same product to an independent refiller for repackaging. In this
case, the registrant must comply with both sets of requirements: the
standards in Sec. 165.65 for those quantities the registrant
distributes or sells directly in refillable containers and the
requirements in Sec. 165.67 for those quantities that the registrant
distributes or sells to independent refillers for repackaging.
A registrant who distributes or sells a pesticide product directly
in refillable containers:
? Is responsible for the integrity of the product, as
discussed in Unit VII.H.;
? Must develop a refilling residue removal procedure, as
discussed in Unit VII.M.;
? Must develop a description of acceptable containers, as
discussed in Unit VII.N.;
? Must comply with the requirements for refillers (including
having certain information and inspecting, cleaning, and labeling the
refillable containers), as discussed in Unit VII.O. through VII.R.;
? Must keep records, including copies of the refilling
residue removal procedure and the description of acceptable containers
and certain information about each instance of repackaging. The
recordkeeping requirements are discussed in Unit VII.S.
2. Changes. All of these requirements for registrants who
distribute or sell pesticide products directly in refillable containers
were included in the proposed regulation. Some of the requirements were
modified based on comments and the change to refer to and adopt some of
the DOT standards. The specific changes to these requirements are
discussed in other sections of Unit VII.
K. Registrants Who Distribute or Sell Pesticide Products to Refillers
for Repackaging - Overview (Sec. 165.67)
1. Final Regulation. The regulations in Sec. 165.67 apply to
registrants who distribute or sell pesticide products to refillers that
are not part of their companies for repackaging into refillable
containers. This is the more common form of repackaging, where the
registrant ships in bulk to a refiller (normally a retailer) who
repackages the product into portable pesticide containers.
As mentioned above, a registrant may repackage a product directly
into refillable containers for sale or distribution and distribute or
sell that same product to an independent refiller for repackaging. In
this case, the registrant must comply with both sets of requirements:
the standards in Sec. 165.65 for those quantities the registrant
distributes or sells directly in refillable containers and the
requirements in Sec. 165.67 for those quantities that the registrant
distributes or sells to independent refillers for repackaging.
A registrant who distributes or sells a pesticide product to an
independent refiller for repackaging:
? Must comply with the conditions for allowing a refiller to
repackage his product, as discussed in Unit VII.G.;
? Must provide the refiller with the written contract to
repackage before distributing or selling the product to the refiller;
? Is responsible for the integrity of the product, as
discussed in Unit VII.H.;
? Must develop a refilling residue removal procedure, as
discussed in Unit VII.M.;
? Must develop a description of acceptable containers, as
discussed in Unit VII.N.;
? Must provide the refilling residue removal procedure,
description of acceptable containers, and the product's label and
labeling to the refiller before or at the time of distribution or sale
to the refiller;
? Must keep records of the contracts, the refilling residue
removal procedure, and the description of acceptable containers. The
recordkeeping requirements are discussed in Unit VII.S.
The requirements that are specific to registrants who distribute or
sell pesticide products to independent refillers for repackaging are
the two that establish standards for the timing of when the registrant
provides documents to the refiller. Under Sec. 165.67(d), the
registrant must provide the written contract to repackage the product
before selling or distributing the product to the refiller. Section
165.67(g) specifies that the other information (cleaning procedure,
description of acceptable containers, and label/labeling) can be
provided earlier but must be provided to the refiller at the time of
sale or distribution at the latest. These two provisions are identical
to the proposed regulations.
2. Changes. All of these requirements for registrants who
distribute or sell pesticide products to refillers for repackaging were
included in the proposed regulation. Some of the requirements were
modified based on comments, modifications to some EPA policies, and the
change to refer to and adopt some of the DOT standards. The specific
changes to these requirements are discussed in other sections of Unit VII.
L. Refillers Who Are Not Registrants - Overview (Sec. 165.70)
1. Final Regulation. The regulations in Sec. 165.70 apply to
refillers who are not registrants of the products that they repackage
for sale or distribution.
A refiller who repackages a product for distribution or sale and is
not the registrant of the product:
? Must comply with the conditions for allowing him to
repackage the registrant's product, as discussed in Unit VII.G.;
? Is responsible for the integrity of the product, as
discussed in Unit VII.H.;
? Must comply with the requirements for refillers (including
having certain information and inspecting, cleaning, and labeling the
refillable containers), as discussed in Unit VII.O. through VII.R.;
? Must keep records, including copies of the contract from
the registrant, refilling residue removal procedure, and description of
acceptable containers, and certain information about each instance of
repackaging. The recordkeeping requirements are discussed in Unit VII.S.
2. Changes. All of these requirements for independent refillers
were included in the proposed regulation. Some of the requirements were
modified based on comments, modifications to some EPA policies, and the
change to refer to and adopt some of the DOT standards. The specific
changes to these requirements are discussed in other sections of Unit VII.
[[Page 47382]]
3. Comments - whether or not to include custom blending in this
rule. In the preamble to the proposed rule, EPA discussed whether or
not the requirements for independent refillers should apply to custom
blenders, who provide the service of mixing pesticides with fertilizer,
feed, or another pesticide to a customer's specification. The preamble
provided two options for the final rule: (1) Issue a regulation on
refilling practices that is tailored specifically to custom blenders
that distribute pesticide mixtures, or (2) exempt custom blenders from
the repackaging requirements. EPA requested comments on these options.
A few commenters showed lukewarm support for applying the
repackaging regulations to custom blenders. A registrant was unaware of
pressing reasons to exclude custom blenders and pointed out that custom
blenders are usually custom applicators. A State regulatory agency
stated that custom blenders should be required to meet the refilling
requirements if the criteria apply to them. This commenter also pointed
out that custom blends are generally placed into a spreader, not a
container.
A registrant group stated that custom blenders provide valuable
service in reducing pesticide container use and applicator exposure.
This respondent recommended developing standards that are specific to
custom blenders and that address items such as container integrity and
cleaning procedures.
A registrant distinguished between custom blending and selling a
pesticide product in a refillable container with a registrant's label
on it as two different activities. A few dealer groups strongly urged
EPA to exclude custom applicators from the refiller requirements. The
retailer-related commenters believe it is inappropriate to address
custom blenders in a section that focuses on maintaining the original
integrity of repackaged pesticides. They also described current custom
blending practices in the Midwest, including the following points:
? Midwest dealers with bulk pesticides are mostly all custom
blenders and custom applicators and have become repackagers recently.
? It is common for the volume of bulk pesticides that goes
into custom blends to exceed the volume that is repackaged into
refillable containers.
? Custom blends may be loaded into custom application and nurse
vehicles of that dealer, another for-hire custom applicator, or a customer.
? On the other hand, registered bulk pesticides are: (1)
Repackaged into minibulk containers; (2) moved in portable service
containers from the bulk container to supply the dealer's custom
application operation in the field; and (3) loaded into tanks that are
an integral part of application or nurse vehicles for field nursing or
to supply injection systems.
4. EPA response - whether or not to include custom blending in this
rule. In the final rule, EPA decided to exempt custom blending from
having to comply with the repackaging requirements. As stated by
several of the commenters, EPA determined that there is an inherent
difference between custom blending and repackaging pesticide products
for sale or distribution. When a product is repackaged for sale or
distribution, it must maintain the characteristics of the product and
meet the ingredient contents identified on the label and in the
product's registration. On the other hand, a custom blend intentionally
mixes a pesticide with another substance. While the product's labeling
must be consistent with the custom blend (i.e., the labeling directions
do not prohibit the use of the product in such a blend) and the
product's label must be delivered to the end-user, the material in the
custom blend is no longer just the pesticide product identified on the
label. In fact, the custom blender must deliver a statement specifying
the composition of the mixture.
The exemption for custom blending was added to Sec. 165.63(h) of
the final regulation, which asks ``Are there any other exceptions?''
Paragraph (h) in Sec. 165.63 was added to state that custom blending
is exempt from the regulations in this subpart. In addition, Sec.
165.3 of the regulations define custom blending as ``Custom blending
means the service of mixing pesticides to a customer's specifications,
usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a
pesticide-animal feed mixture, when:
(1) The blend is prepared to the order of the customer and is not
held in inventory by the blender;
(2) The blend is to be used on the customer's property (including
leased or rented property);
(3) The pesticide(s) used in the blend bears end-use labeling
directions which do not prohibit use of the product in such a blend;
(4) The blend is prepared from registered pesticides; and
(5) The blend is delivered to the end-user along with a copy of the
end-use labeling of each pesticide used in the blend and a statement
specifying the composition of the mixture.''
This description is based on the definition of ``custom blender''
in 40 CFR 167.3, but was modified to reflect the practice of custom
blending rather than the establishment at which it takes place. The
Sec. 167.3 definition focuses on the establishment, because the part
167 regulations then exempt custom blenders from the requirements to
register their establishments (in Sec. 167.20(a)(1)) and to report
production (in Sec. 167.85(a)). The Sec. 167.3 definition of custom
blender includes a sixth condition--that no other pesticide production
activity is performed at the establishment--because these other
activities would subject a custom blender to the establishment
registration and production reporting requirements. However, this sixth
condition is not relevant to the pesticide product repackaging
requirements in 40 CFR part 165 subpart D because the subpart D
regulations are tied to the process or action of repackaging. As
reported by several commenters, a facility may conduct several
different activities, including repackaging pesticide products into
refillable containers and custom blending. In this case, the
repackaging must be conducted in accordance with the regulations in
this subpart, while the custom blending is exempt from the regulations
in this subpart.
It is worth noting that the containment regulations in subpart E
apply to some custom blenders, specifically ``custom blenders of
agricultural pesticides.''
5. Comments - mixing diluent with pesticides. Several commenters
(dealer groups and a dealer) urged EPA to allow water as a blend
component. One retailer described the awkwardness of the situation when
such mixing is not permitted -- a dealer can put pesticide in a
farmer's application equipment at its facility (with a containment
pad), but the farmer has to return to his own location to add water and
finish preparing the application mixture. The two dealer groups
suggested or stated that using water as a custom blend component is
currently practiced in the Midwest. The two dealer groups also
recommended deleting condition #6 in the Sec. 167.3 definition
of custom blender which specifies that ``no other pesticide production
activity is performed at the establishment.''
6. EPA response - mixing diluent with pesticides. EPA disagrees
with the comment to delete condition #6 in the Sec. 167.3
definition of custom blender that specifies ``no other pesticide
production activity is performed at the establishment.'' As described
above, this condition is intended to distinguish between custom
blenders - who are exempt from the part 167 establishment registration
requirements - and
[[Page 47383]]
producing establishments, who are required to register their
establishments. Condition #6 does not prevent a facility from
conducting custom blending and repackaging (producing). These
facilities must register as establishments because they are producing
establishments. Instead, condition #6 is intended to describe
the facilities that are exempt from the establishment registration
requirements, i.e., facilities that custom blend and do not repackage
or otherwise produce pesticides.
However, EPA considered the request from commenters to allow custom
blends to be diluted with water. Various offices and Regions within
EPA, as well as the States, have not had a consistent policy about
whether custom blends can be diluted with water or another diluent.
After reviewing this issue, it is appropriate to clarify our position
on diluting custom blends. EPA believes that the definition of custom
blender in Sec. 167.3 provides flexibility. Custom blenders are
defined as ``any establishment which provides the service of mixing
pesticides to a customer's specifications, usually a pesticide(s)-
fertilizer(s), pesticide-pesticide, or a pesticide-animal feed mixture,
when'' the six conditions described above are met. In particular, the
word ``usually'' in this definition provides flexibility and allows
water (or other diluents when specified by the labeling of the
pesticide[s] in the blend) to be added to custom blends.
EPA believes that the language of Sec. 167.3 allows custom blends
to be diluted with water or a diluent specified on the labels of all
pesticides in the blend. In many ways, it is more efficient and
possibly more accurate for the facility that is measuring and blending
pesticides, fertilizers and/or animal feed to also measure and blend
the diluent into the custom blend. In addition, custom blends (with
diluents) that are delivered to an end user as a use-dilution (usually
in refillable containers) offer worker exposure and environmental
protection benefits including eliminating the need for end users to
mix, handle and potentially spill the pesticide in the field;
eliminating the need for the end user to rinse containers in the field;
allowing the use of closed systems; and reducing the number of
nonrefillable containers that must be disposed or recycled. However,
EPA wants to clarify that custom blends with a diluent added still must
comply with all five conditions in the definition of custom blend in
Sec. 165.3: ``Custom blending means the service of mixing pesticides
to a customer's specifications, usually a pesticide(s)-fertilizer(s),
pesticide-pesticide, or a pesticide-animal feed mixture, when:
(1) The blend is prepared to the order of the customer and is not
held in inventory by the blender;
(2) The blend is to be used on the customer's property (including
leased or rented property);
(3) The pesticide(s) used in the blend bears end-use labeling
directions which do not prohibit use of the product in such a blend;
(4) The blend is prepared from registered pesticides; and
(5) The blend is delivered to the end-user along with a copy of the
end-use labeling of each pesticide used in the blend and a statement
specifying the composition of the mixture.''
EPA will monitor the practices and procedures that develop and
proliferate in the field with this interpretation. If problems develop,
EPA will consider options, including revising its interpretation,
adding protective conditions if diluents are added to custom blends,
and subjecting custom blending to the repackaging requirements in part 165.
In addition, EPA does not view a difference between custom blending
and custom mixing from a regulatory point of view. A custom mixer is a
facility that stores materials previously purchased by end-users and
that custom mixes the products just prior to application. A custom
mixer does not own, sell or apply the product, although the conditions
in the Sec. 165.3 definition of custom blending are met. Over the
years, there have been different interpretations of whether or not
there is a difference between custom blending and custom mixing. At
least a few businesses have been established as custom mixers under the
determination that they are not custom blenders. This final rule does
not distinguish between custom blenders and custom mixers. Similarly,
the policy of allowing diluents to be added to custom blends applies to
both custom blenders and custom mixers. As discussed above, custom
blending is excluded from the subpart D repackaging requirements.
However, custom blenders (including custom mixers) would be subject to
the subpart E containment standards if they blend (mix) agricultural
pesticides.
7. Comments - service containers. A few dealer groups noted that
the proposed rule does not address service containers, which are used
to move pesticides from bulk storage to end-use applications in the
field, e.g., the tanks that are an integral part of application or
nurse vehicles. These commenters pointed out some advantages of service
containers including: reducing the number of nonrefillable containers
used, keeping pesticides separate from water or fertilizers during
transportation, accommodating on-board injection systems and allowing
the applicator to adjust pesticides in the field. These commenters
urged EPA and industry to consider providing for the expanded use of
service containers, with some exclusions from the refillable container
requirements, to increase the use of bulk pesticides. A State
regulatory agency supported keeping the Bulk Policy because they don't
want to register each facility where bulk pesticides are metered, such
as where pest control operators place pesticides into service
containers.start here
8. EPA response - service containers. The pesticide container and
repackaging regulations do not regulate service containers, because the
container and repackaging regulations only apply to containers that are
used to sell or distribute pesticide products and to the repackaging of
products for sale or distribution. For the purposes of this discussion,
a service container is defined as ``any container used to hold, store,
or transport a pesticide concentrate or a pesticide use-dilution
mixture, other than the original labeled container in which the product
was distributed or sold, the measuring device, or the application device.''
EPA does not currently regulate service containers. In 1976, EPA
issued a Pesticide Enforcement Policy Statement (PEPS) on ``Structural
Pest Control: Use and Labeling of Service Containers for the
Transportation or Temporary Storage of Pesticides,'' which defined
minimal labeling requirements and several other limitations for the
acceptable use of service containers by structural pest control
operators. (Ref. 76) However, this PEPS was later rescinded. EPA
continues to believe that it is a good management practice to ensure
that the contents of service containers are identified and that the
label of a pesticide product that is in a service container is
available to the person handling and/or applying the pesticide. EPA may
consider developing a separate policy on service containers while the
pesticide container and containment regulations are being phased in.
M. Registrant Refilling Residue Removal Procedure (Sec. 165.65(c)(1)
and 165.67(f)(1))
1. Final Regulation. Registrants who sell or distribute pesticide
products directly in refillable containers and registrants who sell or
distribute products to independent refillers for repackaging must
develop a refilling
[[Page 47384]]
residue removal procedure that describes how to remove pesticide
residue from a refillable container (portable or stationary pesticide
container) before it is refilled. Registrants must specify a cleaning
procedure for each product sold or distributed in refillable
containers, although the same procedure can be used for multiple
products. The refilling residue removal procedure must provide
instructions for removing residues from all refillable containers. The
same procedure can apply to portable and stationary pesticide
containers, or the registrant can describe different procedures if it
is appropriate and necessary. Finally, the refilling residue removal
procedure describes how to remove residue from a refillable container.
While this generally involves rinsing the container with water, the
regulations do not specifically require rinsing with water. If a
different procedure is appropriate for a given formulation, it can be
used as long as it meets the following performance standard.
The refilling residue removal procedure must meet the performance
standard of being adequate to ensure that the composition of the
pesticide product does not differ at the time of its distribution or
sale from the composition described in its confidential statement of
formula. This standard ensures that the products distributed and sold
in refillable containers meet the existing product integrity
requirements, as described in Unit VII.H.
The refilling residue removal procedure must describe how to manage
any rinsate resulting from the procedure in accordance with applicable
Federal and State regulations if: (1) The procedure requires the use of
a solvent other than the diluent used for applying the pesticide, or
(2) there is no diluent used for application. This information is
necessary to help refillers manage rinsate that cannot easily be used
as make-up water in future applications.
2. Changes. This requirement is the same as it was in the proposed
rule. Several minor editing change have been made to improve the
clarity and the different refillable containers are described as
portable and stationary pesticide containers because the definitions of
minibulk and bulk are not being finalized. These modifications have not
changed the requirement or intent of the requirement.
N. Registrant Description of Acceptable Containers (Sec. Sec.
165.65(c)(2) and 165.67(f)(2))
1. Final regulation. Registrants who sell or distribute pesticide
products directly in refillable containers and registrants who sell or
distribute products to independent refillers for repackaging must
develop a description of acceptable refillable containers (portable and
stationary pesticide containers) that can be used for distributing or
selling that pesticide product. An acceptable container is one which
the registrant has determined meets the refillable container standards
in subpart C and is compatible with the pesticide formulation intended
to be distributed and sold using the refillable container. The
registrant must identify the containers by specifying: (1) The
container materials of construction that are compatible with the
pesticide formulation; and (2) information necessary to confirm
compliance with the refillable container requirements in subpart C. The
refillable container requirements include the adopted DOT standards,
being marked with a serial number or other identifying code, having a
one-way valve or tamper-evident device on each opening (other than a
vent) of a portable pesticide container designed for liquids, and the
stationary pesticide container requirements.
Similar to the refilling residue removal procedure, registrants
must specify a description of acceptable containers for each product
sold or distributed in refillable containers, although the same
description can be used for multiple products if it meets the standards.
2. Changes. This requirement was changed significantly from the
proposed rule. The proposal would have required registrants to develop
lists (not descriptions) of acceptable containers, which would have
been identified by specifying the container manufacturer and model
number of the container. This was proposed because registrants are
responsible for ensuring that the refillable containers used to sell
and distribute their products meet the requirements in the container
regulations. When EPA proposed the rule, specifying the container
manufacturer and model number seemed like a relatively easy way for
registrants to identify acceptable containers for their refillers.
However, the final rule's approach of referring to and adopting
some DOT requirements provides an even easier way for registrants to
identify acceptable containers to the refillers. Rather than citing
specific model numbers, the registrants can provide refillers with a
much less prescriptive approach by identifying characteristics, such as
the material of construction, how to determine if the container meets
the applicable DOT standards, how to comply with the serial number
requirement, how to obtain and apply one-way valves and/or tamper-
evident devices to the openings of portable pesticide containers for
liquids and information for complying with the stationary pesticide
container standards.
3. Comments. Several commenters (registrants and a registrant
group) recommended that instead of a list of acceptable containers, the
registrants should identify acceptable containers by providing the
compatible materials of construction and the necessary information to
apply the DOT standards. The registrant group and a distributor
commented that this requirement will be helpful to ensure that
formulators and subregistrants know and obtain information about the
proper packaging.
4. EPA response. In the final rule, EPA changed the requirement for
identifying acceptable containers so registrants can describe
acceptable containers by specifying compatible materials of
construction and the information necessary to comply with the
refillable container requirements. This includes information for
complying with the adopted DOT standards, but also the other
requirements in subpart C.
O. Requirements for All Refillers (Sec. Sec. 165.65(d) and 165.70(e))
1. Final regulation. All refillers, including those at registrant's
facilities and those who are not part of a registrant's company must
comply with the following provisions regarding repackaging a pesticide
product into refillable containers:
*(1) The establishment must be registered with EPA as a producing
establishment as required by Sec. 167.20 of this chapter.
*(2) The refiller must not change the pesticide formulation unless
he has a registration for the new formulation.
(3) The refiller must repackage a pesticide product only into a
refillable container that is identified on the description of
acceptable containers for that pesticide product.
(4) The refiller may repackage any quantity of a pesticide product
into a refillable container up to the rated capacity of the container.
In addition, there are no general limits on the size of the refillable
containers that can be used.
(5) The refiller must have all of the following items at the
establishment
[[Page 47385]]
before repackaging a pesticide product into any refillable container
for distribution or sale:
*(A) The written contract from the pesticide product's registrant.
[Subparagraph A applies only to independent refillers.]
*(B) The pesticide product's label and labeling.
(C) The written refilling residue removal procedure for the
pesticide product.
(D) The written description of acceptable containers for the
pesticide product.
(6) Before repackaging a pesticide product into any refillable
container for distribution or sale, the refiller must identify the
pesticide product previously contained in the refillable container to
determine whether a residue removal procedure must be conducted in
accordance with the cleaning requirements described in Unit VII.Q. The
refiller may identify the previous pesticide product by referring to
the label or labeling.
(7) The refiller must inspect each refillable container as
discussed in Unit VII.P.
(8) The refiller must clean each refillable container, if required,
as discussed in Unit VII.Q.
*(9) The refiller must ensure that each refillable container is
properly labeled as discussed in Unit VII.R.
(10) The refiller's establishment must maintain records, as
discussed in Unit VII.S.
*(11) The refiller's establishment must maintain records as
required by 40 CFR part 169.
*(12) The refiller's establishment must report as required by 40
CFR part 167.
(13) Stationary pesticide containers (that meet the specified size
criteria) at the establishments of independent refillers must meet the
standards in Sec. 165.45(f). [Paragraph 13 is only included in the
regulations in Sec. 165.70(e) for independent refillers. The
refillable container regulations state that both the registrant and
independent refillers are responsible for complying with the stationary
pesticide container requirements.]
(14) Refillers may be required to comply with the containment
standards in subpart E. [Paragraph 14 applies only to independent
refillers.]
These requirements, except for items 5(A), 13 and 14 which apply
only to independent refillers, apply to any refiller that repackages a
product subject to the regulations regardless of the main business of
the refiller (registrant, retailer, etc.). Some of these conditions
(indicated by an asterisk) simply refer to or reinforce key
requirements in existing regulations, including 40 CFR parts 156, 167
and 169 or incorporate existing standards of the Bulk Policy (having a
copy of the registrant's contract). These provisions are included here
for the sake of completeness and as a reference for refillers.
In other words, the new provisions for refillers are that each refiller:
? Must repackage a product only into a container identified
on the registrant's description of acceptable containers;
? May repackage any quantity of a product into a refillable
container (up to its rated capacity) and there are no general limits on
the size of the refillable containers;
? Must have certain documents before repackaging;
? Must identify the product previously in the container by its label;
? Must inspect and, if necessary, clean the container; and
? Must maintain certain records.
EPA believes that these provisions are good management practices
that are intended to ensure product and container integrity. The second
provision actually removes a condition on container size from the bulk
policy. In other words, it provides more flexibility to registrants and
refillers than currently exists.
2. Changes. Regarding the list of requirements for refillers, the
final regulations are very similar to the proposed rule. However, the
structure and order of the final rule was revised to list these
requirements in one section. EPA believes this makes the regulations
more clear, which should facilitate compliance. The items that refer to
existing requirements in 40 CFR parts 167 and 169 were added to the
list to provide a more complete reference for refillers. However, these
statements simply refer to existing requirements; they don't add new ones.
Adjustments were made to a few of the provisions. Specifically, the
requirements in the proposed rule that referred to the registrant's
list of acceptable containers were changed to refer to the registrant's
description of acceptable containers (see items 3 and 5 above), to
accommodate the changes described in Unit VII.N. Also, the proposed
regulatory text did not explicitly allow any size refillable container
to be used, although the preamble discussed removing the size limit in
the Bulk Policy in some detail. Therefore, a sentence clarifying that
there are no general limits for the size of refillable containers was
added to the statement allowing any quantity of pesticide (up to the
container's rated capacity) to be repackaged. (See item 4.)
Specific modifications made to the inspecting, cleaning, labeling
and recordkeeping requirements and comments on these standards are
discussed in detail in Units VII.P. - VII.S.
The refillable container regulations were modified to clarify that
both registrants and refillers are responsible for complying with the
stationary pesticide container requirements in Sec. 165.45(f). The
final repackaging rule includes this provision in the list of
requirements as a reminder for independent refillers.
P. Inspecting Refillable Containers (Sec. Sec. 165.65(e)and 165.70(f))
1. Final regulation. Before repackaging pesticide products into
refillable containers, refillers must visually inspect the exterior and
(if possible) the interior of the container and the exterior of
appurtenances. The purpose of the inspection is to determine whether
the container meets the necessary criteria with respect to continued
container integrity, required markings and openings (tamper-evident
devices or one-way valves). As with the proposed regulations,
inspecting the containers is the responsibility of the refillers, since
they are the ones who are actually handling and refilling the
containers. If any of the failure conditions in this section are
observed during the inspection, the container cannot be refilled unless
the problems are rectified and the associated acceptability criterion
(either reconditioning according to DOT's requirements or coming into
compliance with the refillable container standards in subpart C) is
satisfied.
The container fails the inspection and must not be refilled (unless
the applicable DOT standards for reconditioning are met) if the
integrity of the container is compromised in any of the following ways:
? The container shows signs of rupture or other damage which
reduces its structural integrity. [Based on the criterion in 49 CFR
173.28(a)]
? The container has visible pitting, significant reduction
in material thickness, metal fatigue, damaged threads or closures, or
other significant defects. [Based on the criterion in 49 CFR
173.28(c)(1)(iii)]
? The container has cracks, warpage, corrosion or any other
damage which might render it unsafe for transportation. [Based on the
criterion in 49 CFR 180.352(b)(2)(iii)]
? There is damage to the fittings, valves, tamper-evident
devices or other appurtenances that may cause failure of the container.
[Similar to the criterion in
[[Page 47386]]
49 CFR 180.352(b)(2)(ii) for service equipment.]
If either of the following conditions exists (or both), the
container fails the inspection and must not be refilled until the
container meets the refillable standards specified in subpart C. The
conditions are:
? The container does not bear the markings required by
subpart C or such markings are not legible.
? The container does not have an intact and functioning one-
way valve or tamper-evident device on each opening other than a vent,
if required.
Note that these two conditions are written so refillers of
antimicrobial products used in swimming pools and related sites would
not have to inspect for a serial number (because it's not a marking
required by subpart C for these products) or for an intact and
functioning one-way valve or tamper-evident device on each opening,
because neither is required for these products.
2. Changes. The general obligation to inspect refillable containers
before repackaging pesticide products into them is the same as the
proposed rule. However, EPA made several changes to the details of the
inspection. First, we based the conditions for failing the inspection
on conditions specified in the DOT regulations in 49 CFR 173.28 and
180.352(b)(2). A commenter suggested this change and EPA believes it is
an appropriate modification and is consistent with other changes in the
regulation to refer to and adopt the DOT standards for container
design, construction and marking. While we don't think the criteria in
the final rule are necessarily more stringent than those in the
proposed rule, we believe that consistency with DOT is beneficial.
Second, the inspection requirement was modified to clarify that if
problems found during the inspection are fixed and certain criteria are
met, the container can be refilled. Under the proposed standard, it was
not clear that a container could be reconditioned or brought into
compliance with the refillable container standards and then refilled.
Several other minor modifications were made to account for changes in
the regulations, including: (1) removing the reference to a standard
for the age of the container and (2) clarifying that vents do not need
to have one-way valves or tamper-evident devices. Because the
refillable container regulations in subpart C exempt antimicrobial
products used in swimming pools and related sites from the serial
number requirement and the standard requiring a one-way valve or
tamper-evident device, the final rule was written so that refillers of
these products are not subject to the failure criteria that address
serial numbers, one-way valves, or tamper-evident devices.
Q. Cleaning Refillable Containers (Sec. Sec. 165.65(f) - (g) and
165.70(g) - (h))
1. Final regulation. Refillers must clean refillable containers by
conducting the pesticide product's refilling residue removal procedure
before repackaging the product into the refillable container, unless
condition #1 and either condition #2 or #3 are satisfied:
(1) Each tamper-evident device and one-way valve is intact (if
required).
(2) The refillable container is being refilled with the same
pesticide product.
(3) Both of the following conditions are satisfied.
(A) The container previously held a pesticide product with a single
active ingredient and is being used to repackage a pesticide product
with the same single active ingredient.
(B) There is no change that would cause the composition of the
product being repackaged to differ from the composition described in
its confidential statement of formula that is required under FIFRA
section 3. Examples of unallowable changes include the active
ingredient concentration increasing or decreasing beyond the limits
established by the confidential statement of formula or a reaction or
interaction between the pesticide product being repackaged and the
residue remaining in the container.
If a tamper-evident device or one-way valve is not intact, the refiller
must clean the container according to the product's refilling residue
removal procedure. In addition, the final regulations state in Sec.
165.65(g) for registrants who refill and in Sec. 165.70(h) for
independent refillers that other procedures may be necessary in this
case to assure that product integrity is maintained.
The first condition is written so it would not apply to refillers of
antimicrobial products used in swimming pools because neither a one-way
valve or tamper-evident device is required.
2. Changes. The biggest change from the proposed regulations is
adding the condition where the container is being refilled with the
same pesticide product as a case for not needing to clean the
container. Some commenters pointed out that the conditions in the
proposed regulation and the 1991 amendment to the Bulk Pesticides
Enforcement Policy (Ref. 71) would require a refillable container
holding a product with multiple active ingredients to be cleaned even
when it was refilled with that product. This is true because the
proposed rule, based on the 1991 amendment to the Bulk Policy,
specified a product with a single active ingredient in a compatible
formulation as an acceptable condition for refilling without cleaning.
EPA corrected this oversight in the final rule, because refilling with
the same product (regardless of how many active ingredients there are)
is certainly the most clear way to ensure product integrity and should
be allowed (assuming any tamper-evident devices and one-way valves are
intact).
Several other minor changes include:
(1) Changing the first condition so it includes one-way valves and
not just tamper-evident devices like in the proposal;
(2) Adding ``if required'' to the first condition, since one-way
valves or tamper-evident devices are only required on portable
pesticide containers for liquids and are not required on the containers
of antimicrobial products used in swimming pools;
(3) Using the phrase ``described in its confidential statement of
formula that is required under FIFRA section 3'' because it is more
straightforward than the proposed phrase as described in Unit VII.H.;
(4) The condition in criterion 3(B) was modified to be more general
to account for situations other than reactions or interactions between
the two products such as very different active ingredient
concentrations that could cause the repackaged product to differ from
the confidential statement of formula; and
(5) Splitting the situation of a broken tamper-evident device or
one-way valve into a separate paragraph for clarity.
R. Labeling Refillable Containers (Sec. Sec. 165.65(h) and 165.70(i))
1. Final regulation. Before distributing or selling a pesticide
product in refillable containers, refillers must ensure that the label
of the product is securely attached to the refillable containers such
that the label can reasonably be expected to remain affixed during the
foreseeable conditions and period of use. The label and labeling must
comply in all respects with the requirements of 40 CFR part 156. In
particular, refillers must ensure that the net contents statement and
EPA establishment number appear on the label. This part of the
regulations simply re-states requirements from 40 CFR part 156 and
FIFRA for clarity.
2. Changes. The major change to the labeling requirement was to
change it
[[Page 47387]]
from an ``active'' standard (i.e., the refiller must securely attach
the label) to a ``passive'' standard (i.e., the refiller must ensure
that the label is securely attached). Also, the regulatory text was
modified to state that the net contents and EPA establishment number
appear on the label (rather than the new label as proposed). Both of
these changes account for situations where the label is embossed on the
container or the container already has an intact label that meets all
the requirements. For example, a commenter said that 1-gallon
refillable containers for the swimming pool market are embossed with
label information because they are refilled automatically at a rate of
100-120 bottles per minute.
S. Recordkeeping (Sec. Sec. 165.65(i), 165.67(h), 165.70(j))
1. Final regulation. All of the companies subject to the
repackaging standards must keep certain records, although the specific
records vary according to who the company is and what it does. These
records must be furnished and made available for inspection and copying
upon request of EPA or our designee, such as a State or Tribe.
Informational records (listed in the first few rows of Table 16) must
be maintained for the current operating year and for 3 years after
that. The repackaging records (listed in the last three rows of Table
16) must be generated each time a product is repackaged into a
refillable container for distribution or sale and must be maintained
for at least 3 years after the date of repackaging. All of the records
are product-specific. In other words, this information must be kept for
each product distributed or sold in refillable containers. The same
cleaning procedure or description of containers can be used for
different products, but there must be a record documenting a procedure
and a description for each product distributed or sold in refillables.
Table 16.--Recordkeeping Requirements in the Repackaging Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrants who d/s directly in refillables\1\ Registrants who d/s Refillers who aren't registrants
------------------------------------------------ to refillers for ---------------------------------------------
repackaging into
Product-Specific Record refillables \1\
Swim pool products\2\ All other products ----------------------- Swim pool products\2\ All other products
All products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informational Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contract to repackage No No Yes Yes Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refilling residue removal procedure Yes Yes Yes Yes Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Description of acceptable Yes Yes Yes Yes Yes
containers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repackaging Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPA registration number of the No Yes No No Yes
product distributed or sold in the
container
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of the repackaging No Yes No No Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Serial number of the container No Yes No No Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ ``d/s''= distributed or sold.
\2\ Swim pool products = antimicrobial products used in swimming pools and closely related sites, that are subject to the pesticide container-related
regulations.
EPA reminds registrants and refillers that the records identified
in Sec. Sec. 165.65(i), 165.6(h) and 165.70(j) of the repackaging
regulations do not change other recordkeeping requirements that
currently apply to them, such as restricted use product records or
applicable records required in 40 CFR parts 167 and 169.
2. Changes. EPA made the following significant changes in the
recordkeeping requirements in the final regulations:
? The informational records must be kept for the current
operating year and for 3 years after that rather than the proposed time
period of as long as the pesticide product is distributed or sold in
refillable containers and for 3 years thereafter. The specific
informational records kept by each of the three categories of
businesses is the same in the final rule as in the proposal, although
the list of acceptable containers was changed to the description of
acceptable containers.
? The repackaging records in the final rule are a subset of
what was included in the proposed rule. The final regulations do not
include the name or quantity of the product, the name and address of
the consignee, a record that the refiller has inspected the container
(and the results), and a record of whether a refilling residue removal
procedure was conducted (and, if not, why not). Additionally, the date
of the distribution or sale (in the proposal) was changed to the date
of the repackaging in the final rule.
? Refillers that repackage antimicrobial products used only
in swimming pools or closely related sites would not have to comply
with the repackaging recordkeeping. However, these refillers would have
to comply with the informational recordkeeping.
? The proposed regulations would have required refillers to
maintain certain records of containers that were received by them to be
refilled, including the name and address of the person providing the
container, its serial number, the date it was received and the name and
EPA registration number of the product that was last distributed or
sold in the refillable container. These records are not being finalized
in today's final regulations.
[[Page 47388]]
3. Comments - refiller records. Many commenters (registrants,
registrant groups, State regulatory agencies, a dealer, a dealer group,
and an equipment manufacturer) opposed the recordkeeping requirements
for refillers. Most of these respondents commented that the proposed
recordkeeping requirements were too burdensome and several stated that
these standards will discourage the use of refillable containers. A
registrant group recommended requiring refillers to maintain records of
the serial number, the amount of product placed in the container and
the date the refilling took place.
4. EPA response - refiller records. EPA modified the refiller
recordkeeping requirements to minimize the paperwork burden of
maintaining these records. However, EPA believes that some records are
necessary to ensure safe repackaging and compliance with these
requirements. First, the refiller must have the informational records,
including the registrant's contract (if applicable), the refilling
residue removal procedure and the description of acceptable containers.
These records are necessary so the refiller has the information needed
to properly repackage a product into refillable containers and to
ensure that an independent refiller has the proper approval from a
registrant to repackage the product.
Second, certain information about when a product is repackaged into
a refillable container is needed in case there is a problem with a
product sold in refillable containers, i.e., it is adulterated or
contaminated or it causes damage to the site after application.
However, EPA pared the repackaging records down to the minimum amount
of information that would allow the refiller and investigators to
identify the product, the container, and the date of the repackaging.
All of this information is readily available at the time the pesticide
product is repackaged into the refillable container, unlike in the
proposed rule where the information also included the name and address
of the person receiving the container. EPA deleted the requirement to
record the results of the inspection and whether the container was
cleaned because these records would probably not be useful in
enforcement cases. We will be able to determine that a container was
not inspected if a container in poor condition (that did not just
sustain recent damage) is found and, similarly, we'll be able to tell
if a container was not properly cleaned if we find high levels of
contamination in the product in that refillable container.
5. Comments - sodium hypochlorite. Several respondents from the
sodium hypochlorite industry commented on the proposed rule and stated
that the refiller recordkeeping requirements would be especially
burdensome for this market. One registrant group described a typical
sodium hypochlorite delivery, where a truck holding up to 4,000, 1-
gallon refillable containers stops at several locations, delivers
various volumes of product, and picks up empty containers. This
commenter estimated all the recordkeeping standards could triple the
time for deliveries and increase the cost of the product by 100
percent. An association representing many businesses involved with
swimming pools commented that the requirement for individual serial
numbers and the recordkeeping requirements attendant to the serial
number marking would be completely unworkable for refillable pool
chemical containers. These respondents and a swimming pool supply
company stated that the recordkeeping would discourage the use of
refillables in the pool chemical industry.
When commenting on the supplemental notice, the registrant group
representing the sodium hypochlorite industry reiterated its estimate
of the increase in time and costs that could be attributed to the
proposed recordkeeping. In addition, a sodium hypochlorite manufacturer
requested EPA to exempt all refillable plastic containers of sodium
hypochlorite from the requirements for serial numbers, one-way valves,
tamper-evident devices and burdensome recordkeeping that would
negatively impact the currently used refillable container system.
6. EPA response - sodium hypochlorite. EPA was persuaded by the
arguments from the companies who repackage sodium hypochlorite into
refillable containers for use in swimming pools. Because of the huge
number of small (1- and 2.5-gallon) refillable containers used in this
market segment, EPA acknowledges that compliance with this
recordkeeping would be burdensome. Therefore, the final rule exempts
refillers of antimicrobials used in swimming pools and similar sites
from the repackaging recordkeeping, although they must comply with the
informational recordkeeping.
T. Proposed Standards That Are Not Being Finalized
Final regulation/changes. The following proposed requirements
relating to repackaging are not being finalized in today's final rule:
? Sec. 165.134(f): Age of plastic liquid minibulk containers; and
? Sec. 165.136(b): Records on the return of refillable
containers to refillers.
The proposed rule would have prohibited a refiller from repackaging
a product into a plastic liquid minibulk container more than 6 years
after the container's date of manufacture. EPA decided not to finalize
this provision to be consistent with the DOT regulations, which do not
establish a life limit for plastic nonbulk containers (which may be
portable pesticide containers under our regulations) or for plastic
intermediate bulk containers (which also may be portable pesticide
containers under our regulations).
As discussed in Unit VII.S., EPA is not finalizing the requirement
for refillers to keep records on the return of refillable containers to
minimize the burden on refillers. Also, this information would have
been of limited use because it would not have been sufficient to
conclusively identify where a container had been and who had had
possession of it.
VIII. Containment
A. Introduction
1. Regulatory background. In 1994, EPA proposed standards in
subpart H of 40 CFR part 165 for containment of large pesticide
containers and procedures for container refilling operations. Standards
for pesticide containers, including large storage containers, are
covered in Units III. through VII. of this notice, and apply to all
pesticides unless specifically exempted. The requirements for a
secondary containment unit (either a containment structure around a
stationary container, or a containment pad under a container refilling
operation) only apply to agricultural pesticides. The requirements are
intended to protect human health and the environment from contamination
by spills and leaks which may occur during container filling or when a
stationary container fails. Affected facilities are required to have
structures which intercept and contain spills and leaks of agricultural
pesticides in areas where stationary containers are stored and
agricultural containers are refilled or cleaned.
Secondary containment means a structure, such as rigid diking,
berms or walls, designed to intercept and contain leaks and spills from
the enclosed containers. Some States define bulk quantities as a
pesticide container with a volume exceeding 55 gallons; others use 210,
300, or 500 gallon criteria. EPA's proposed definition of bulk
quantities was 3,000 liters (793 gallons)
[[Page 47389]]
for liquid pesticides and 2,000 kilograms (4,409 pounds) for dry
pesticides. The final rule establishes quantities of 500 gallons (1,890
liters) for liquids and 4,000 pounds (1,818 kilograms) as the threshold
for requiring secondary containment. Thus, EPA's regulations cover only
relatively large containers which pose the greatest risk of
catastrophic contamination in case of failure.
EPA believes the Federal containment standards, together with
requirements for container design and residue removal, are essential
for ensuring the safe use, reuse and refill of containers as required
by FIFRA section 19. The regulations promulgated today will be located
in 40 CFR part 165 in Sec. Sec. 165.80 - 165.97.
2. Summary of proposed and final containment standards. The
proposed and final standards include criteria for design, maintenance
and operation of containment structures (units and pads) at certain
facilities. The design criteria include standards for material of
construction, capacity, and protection from stormwater and
precipitation. The facilities subject to the requirements are
agricultural pesticide refilling establishments and custom blenders (as
defined in Sec. 167.3), and facilities of businesses that apply
agricultural pesticides for compensation (also referred to as for-hire
applicators in this preamble). In the preamble to the proposal, the
Agency explained its rationale for choosing these facilities. Although
spills can occur throughout the chain of pesticide commerce (from
manufacturer to user), the accumulated evidence points to agrichemical
dealerships, custom blenders, and for-hire applicators as facilities
where pesticide contamination of soil and water is most frequently
documented. (See 59 FR 6750 (Ref. 66) and Unit VIII.C. for a detailed
discussion.) The agricultural chemical distribution system has the most
potential for spills and a requirement for reporting spills, and is
uniquely characterized by the use of large tanks and container
refilling operations, often outdoors, while other sectors generally use
smaller containers, pre-packaged indoors by a manufacturer.
Standards which are considered critical are required for all
existing and new containment units and pads, and some additional
criteria are imposed for new containment structures. For this final
rule, the criteria identified as critical reflect the comments received
and new information, and are not necessarily the same criteria used in
the proposed rule. For example, hydraulic conductivity criteria were
considered critical in the proposed rule, but, as a result of comments
we received on hydraulic conductivity, are not being finalized in the
final rule (see discussion in VIII.H).
Many respondents provided comments on specific provisions of the
containment regulations. EPA has made certain revisions to the proposed
regulations based on these comments. The following units of the
preamble discuss the comments received on each of the major issues
raised in the proposed rule, any differences between the proposal and
the final rule, and the Agency's reasons for making the changes.
Costs and benefits of the rule have been revised from those
projected at the time of the proposed rule. Total costs are predicted
to be less than estimated in the proposal, due to the changes made as a
result of comments and new information.
3. State secondary containment regulations. At least 19 States have
already promulgated and begun implementing their own secondary
containment regulations for bulk storage of pesticides. The 1992 State
of the States Report (Pesticide Storage, Disposal and Transportation,
Ref. 70) cited in the proposed rule showed the wide variety of
containment regulations among States. There are variations in the
facilities affected, the container volume triggering the requirement
for secondary containment, etc. The economic assessment for the
proposed rule estimated the number of facilities with bulk pesticide
storage in each State based on commercial, State and government
business census data. EPA estimated that a total of 5,214 agrichemical
dealers in all States and the District of Columbia have containers of a
size defined in the proposed rule as bulk (greater than 3,000 liters
liquid or 2,000 kilograms dry). (Ref. 21) EPA has reviewed the
secondary containment regulations in all 19 States and has found that
they are generally comparable to or more stringent than the
requirements in today's final rule. These 19 States contain 81 percent
(4,220) of the agrichemical facilities regulated by this final rule.
EPA received many comments on the negative impact of the proposed
regulations on facilities in States with preexisting regulations.
Today's containment standards are intended to introduce basic
safeguards in States that currently lack containment regulations and to
harmonize with containment requirements in States where adequate
containment safety programs already exist. While EPA believes a
national standard must provide baseline environmental protection, a
mechanism is being provided to accommodate States that are already
successfully implementing pesticide containment programs.
4. Key terms for understanding the requirements of subpart E. The
following terms, defined in Sec. 165.3 of subpart A, are key to
understanding the containment standards in subpart E:
(1) Agricultural pesticide.
(2) Appurtenances.
(3) Container.
(4) Containment pad.
(5) Containment structure.
(6) Dry pesticide.
(7) Establishment.
(8) Facility.
(9) Owner.
(10) Operator.
(11) Pesticide compatible.
(12) Pesticide dispensing area.
(13) Refillable container.
(14) Refilling establishment.
(15) Rinsate.
(16) Secondary containment unit.
(17) Stationary pesticide container.
(18) Transport vehicle.
(19) Washwater.
i. Changes. Based on commenters' suggestions and additional
research, the definitions of the following terms were added to the
final rule to clarify the requirements: facility, pesticide compatible,
and rinsate.
ii. Comments. A regulatory agency in a State with many bulk
containment facilities commented that the definition of a stationary
bulk container uses the words ``facility'' and ``establishment,'' but
only defines the latter. The State agency advised that those trying to
avoid the costly container and containment requirements might choose to
view this as a legal loophole, and that the term facility should also
be defined.
Several State agencies requested that EPA clarify the phrase
``resistant to pesticide,'' because its meaning could be either
compatible or unreactive and could be difficult or burdensome to
enforce. Alternatives were proposed, including ``chemically
compatible,'' defined as the ability of the containment structure
materials to withstand anticipated exposure to stored or transferred
materials without losing the ability to provide the required secondary
containment of the same or other materials within the containment area.
Several State regulatory agencies commented that their regulations
require containment of rinsate, and recommend containment for wash
waters, because hazardous waste violations at pesticide facilities are
often linked to problems with rinsate/wash waters. One State agency
asked if a 300-
[[Page 47390]]
gallon spill mixed with 600 gallons of cleanup water can be considered
rinsate. Another State agency has an expanded definition of rinsate to
include recovered sedimentation, washwater, contaminated precipitation,
or other contaminated debris.
iii. EPA response. The word facility has been added to the list of
definitions. The Agency agrees that the phrase pesticide compatible is
clearer than pesticide resistant and has changed the regulation
accordingly. For the purpose of this regulation, rinsate is being
defined as the liquid (usually water) used to rinse the interior of any
equipment or container that has come in direct contact with any
pesticide. The Agency agrees that it is a good management practice to
place rinsate tanks within containment and is recommending that
practice, but does not have information on the risks of storage of such
dilute pesticides.
B. Purpose (Sec. 165.80(a))
1. Final regulations. The purpose of the containment standards is
to protect people and the environment from exposure to agricultural
pesticides from spills and leaks, and to reduce wastes produced during
pesticide storage, handling or refilling of pesticide containers.
2. Changes. This is the same as the proposed purpose in Sec. 165.140.
C. Who Must Comply (Sec. 165.80(b))
1. Final regulations. You must comply with these regulations if you
are the owner or operator of a facility that stores pesticides in a
stationary pesticide container or conducts any of the regulated
pesticide transferring activities and if you are a retailer, for-hire
applicator, or custom blender (as defined in 40 CFR 167.3) of
agricultural pesticides.
2. Changes. This is the same approach and scope that we proposed in
Sec. 165.141. The proposed regulations included only retailers, for-
hire applicators, and custom blenders because they are the three
categories for which EPA has accumulated the most substantial evidence
of soil and groundwater contamination by pesticides. The final rule
maintains the same scope. These facilities represent only a subset of
the realm of operations where containment requirements might be
appropriate. The Agency may consider further containment rulemaking for
other elements of the pesticide industry if further information
indicates that such requirements are needed. In addition, the final
rule revises the regulatory language to clarify that the containment
regulations only apply to agricultural pesticides. (See Unit VII.L. for
a discussion of custom blending and custom mixing.) Also, a description
of ``principal business is retail sale'' -- more than 50% of total
annual revenue comes from retail operations -- was added to the final
regulation for clarity.
3. Comments. Many commenters (dealer groups, dealers, State
regulatory agencies, and a distributor/registrant) responding to both
the 1994 proposal and the 2004 reopening of the comment period argued
for a level playing field and urged EPA to expand the scope of the
containment standards to include manufacturing plants, distributors,
farms, and non-agricultural facilities. Commenters argued that there
are similar potential risks of environmental contamination at any
facility that meets the volume, time or activity criteria, regardless
of the location of the facility or the type of pesticide, Many
commenters (State regulatory agencies, a dealer, a dealer group, an
aerial applicator and an aerial applicator group) stated that there are
some farms which store and handle more pesticides than some small
retailers, and that the regulations should focus on the activity and/or
the quantity stored, not the individual storing it.
Commenters to the 2004 Federal Register Notice reopening the
comment period stated that there have been changes in pesticide use
patterns in the 11 years since the regulations were proposed. They
stated that equipment technology developments in the handling and
application of bulk agricultural chemicals have advanced dramatically,
and that these new technologies coupled with the increase in the number
of farms with large acreage have led to end users becoming a dramatic
growth sector of purchasers of commercial application equipment. A
dealer association stated it had surveyed chemical equipment dealers in
Kansas and that 20 to 25 percent of all new large commercial
application rigs and 80 percent of all used application equipment is
currently purchased by end users, most of whom are farmers. The
commenter said that using such equipment requires large quantities of
chemicals on site and concluded that on-farm bulk storage is growing.
Another dealer association commented in 2004 that by the end of
2006, 70 percent of all crop protection products, mainly herbicides,
will be off-patent, creating a marketing opportunity for non-
traditional suppliers and chemical brokers. They noted that end users
could become direct crop protection customers without appropriate
facilities, resulting in increased environmental incidents. The
association also stated that at least 58 percent of U.S. farmland is
not farmed by the landowner, countering the belief that farmers are
better stewards because they have a vested interest in protecting their
farmland from contamination. They commented that retailers are
professionals trained in handling hazardous materials compared to end
users, who tend to have less knowledge and training in safety,
containment, and cleanup procedures. A dealer stated that some farmers
have become tool shed dealers who store bulk without containment and
repackage for neighboring farmers. This point was reinforced by
retailers during a meeting in 2004 following the reopening of the
comment period (Ref. 31), where the dealer associations and individual
dealers reiterated their submitted written comments and cited a growing
problem of cash and carry dealers who repackage product on farms
illegally without a license.
Several commenters opposed expanding the scope to include farmers.
In 2004, the Farm Bureau and associated grower groups opposed any
change in the proposed scope. A registrant group recommended that EPA
work jointly with State pesticide regulatory officials and industry to
devise a method for obtaining reliable data on the number of farmers
storing bulk nationwide. The Association of American Pest Control
Officials recommended that EPA not expand the scope to farmers without
first researching the number, volumes and other pertinent data
regarding on-farm bulk practices, an assessment of the risks of on-farm
operations, and an analysis of the costs and benefits of on-farm bulk
containment.
Several commenters specifically supported requiring non-
agricultural pesticides stored in bulk to be subject to the rule. They
state that bulk pesticide storage presents potential hazards regardless
of use or activity, and that risk may be even higher due to greater
population density compared to rural agricultural settings.
EPA response. Due to the large number of commenters in 1994 and
2004 from all sectors who supported requiring farms to have containment
for stationary container pesticide storage, the Agency considered the
option of expanding the scope of the rule to include farms and other
entities. Although the Agency had solicited data on bulk pesticide
storage on farms and at non-agricultural facilities in both the 1994
proposed rule and the 1999 supplemental notice, only anecdotal
information was received alleging an
[[Page 47391]]
increase of stationary container pesticide storage on farms. (Ref. 27)
The Agency therefore researched the issue of whether pesticide
storage on farms is a significant problem. The Agency contacted several
commenters to the rule for clarification and was unable to confirm that
the use of larger spray equipment relates to increased bulk pesticide
storage or only to fertilizer storage and application. In cases where
bulk storage of pesticide most likely occurs on large farms, such as
with metam-sodium, it is not clear that pesticide remains in the tank
for 30 days or more. The Agency asked the USDA to contact its sources
in the extension network, and Agency staff contacted regulatory
representatives and dealers in several States, particularly those with
large areas under field crops. In general, the persons contacted knew
of few, if any, farms with bulk pesticide storage, with the definition
of bulk as 500 gallon containers or greater.
USDA contacted Colorado, where less than 1 percent of farmers
potentially store pesticides in bulk, and where minibulks up to 660
gallons are exempt from the requirement for containment if they are
approved by DOT or MACA. USDA also contacted Illinois, Kansas and
Nebraska. Illinois has implemented new regulations which require
farmers to have secondary containment if they meet the volume criteria,
so any farmers with large tanks are taking them out of service. They
learned that Kansas has three to six farms with bulk pesticides, and
most farmers are using 250 gallon minibulks. Nebraska representatives
could not estimate how many farms have bulk pesticide, but the most
commonly used containers are 85 to 250 gallon minibulks. The only State
with hard data was Indiana, which has 65 farmers with bulk storage
(defined as larger than 55 gallons), of which 31 reportedly had tanks
larger than 500 gallons.
EPA has no data on the existence of bulk storage in non-
agricultural facilities. EPA assumes that at such facilities,
pesticides are often stored indoors, where the building itself affords
some measure of containment. EPA is aware of some isolated mosquito-
control facilities which may store pesticides in large stationary tanks
during the treatment period, but does not have any way to estimate the
existence of such facilities nationwide.
In short, EPA has not received sufficient evidence of contamination
at manufacturing plants, distributors, farms and non-agricultural sites
to justify regulating them. In the proposed rule, we outlined the data
available to the Agency documenting contamination at agricultural
retailers, refilling establishments and commercial applicator sites. At
least 30 of the references to the proposed rule were State monitoring
studies showing contamination at such sites. Data documenting
widespread contamination at other facilities were not submitted, and
have not been identified.
The consensus, even from commenters who support expansion of the
scope to include farmers, is that on-farm bulk storage is still rare.
The Agency does not wish to regulate in anticipation of a potential
problem, particularly since it is questionable that such a regulation
could be enforced on an equitable basis. We recognize the staff and
resource restrictions of State agencies, and do not wish to add to
their burden in anticipation of a problem which may or may not occur in
the future.
The Agency recognizes that all large, stationary tanks have the
potential to leak or burst, and considered requiring all stationary
tanks, regardless of location, to conform to the containment standards.
However, the Agency also believes that the volume through-put of tanks
used for retail sale or commercial application of pesticides is higher
than that expected for individual farms, resulting in a higher
potential risk associated with their usage. The Agency further believes
that an end-user who is not significantly involved in resale of product
has less opportunity and motivation to finance the purchase of large
tanks and the construction of secondary containment.
EPA added a description of the phrase ``principal business is
retail sale'' to the final rule so Sec. 165.180(b)(1) states that
refilling establishments who repackage agricultural pesticides and
whose principal business is retail sale (i.e., more than 50% of total
annual revenue comes from retail operations) must comply with the
containment regulations. EPA's intent of including the phrase principal
business in the 1994 proposed rule was to distinguish between refilling
establishments whose principal business is retail sale and refilling
establishments whose primary function is formulation or manufacturing
of pesticides. The description of principal business was added to the
final rule to provide clarification on how to make this distinction. In
addition, the information we received during the 2004 comment period
about some farmers reportedly repackaging pesticides for sale further
supported the need to clarify the meaning of principal business is
retail sale. For the reasons discussed in this section, EPA decided not
to apply the final containment regulations to farmers. We believe that
adding the clarification of principal business to the final rule will
help identify the retail facilities that we intend to regulate with
Sec. 165.180(b)(1). However, EPA wants to clarify that anyone
including a farmer - who is repackaging pesticides for sale or
distribution must comply with the existing requirements in 40 CFR part
167 to register their establishments and report their production
(repackaging) to EPA and must also keep records of pesticide production
according to 40 CFR part 169. In addition, such facilities would be
regulated as refillers under this final rule and would have to comply
with the refiller requirements in subpart D, Standards for Repackaging
Pesticide Products into Refillable Containers. These facilities would
have to comply with the containment requirements in subpart E if they
repackage agricultural pesticides and if more than 50% of their total
annual revenue comes from retail operations.
The Agency is willing to amend the regulation to include such sites
if a pervasive pattern of contamination or other handling problems
appear at other sites in the future. It is recommended that State and
local agencies regulate such facilities at the local level as needed.
D. Compliance Dates (Sec. 165.80(c))
1. Final regulations. All containment structures subject to today's
rule must comply with all applicable containment regulations for new
and existing structures within 3 years of today's date.
2. Changes. The proposed rule required new structures to comply
with the containment standards beginning 2 years after publication of
the final rule. Existing structures would have been required to comply
with interim standards for a period of 8 years, beginning 2 years after
publication of the final rule, and then existing structures would have
to comply with the same standards as new structures. The interim
standards were defined as critical to safe containment, and considered
readily implemented within 2 years. The interim period was intended to
allow existing structures which have design or structural features not
amenable to upgrading without major modification to phase in those
modifications over time. The final rule has no provision for an interim
period; the final rule applies only one set of requirements to existing
structures over their life spans. Both new and existing structures must
comply with applicable standards beginning 3 years after publication of
the final rule.
[[Page 47392]]
3. Comments. Many commenters had objections or changes to propose
on the interim period. Several respondents commented specifically on
the length of the interim period. A registrant thought it should be
longer and a State regulatory agency said it should be shortened to 5
years and be based on the structure's age and performance. A State
regulatory agency said that the nine critical standards were sufficient
and that the only distinction between new and existing facilities
should be the compliance date. A dealer opposed the interim period
because States already have containment standards and would have to
learn two new sets of standards above and beyond existing State rule.
Several respondents commented on the different possibilities for an
interim period discussed in the preamble. A State regulatory agency
supported an age-based approach of setting the compliance date on a
formula using 20 years minus the existing containment facility's age.
Many commenters (dealers, a dealer group and a State regulatory agency
group) opposed setting any standards that are more stringent than
existing State standards. A principal reason for opposition was that
interim requirements would comprise an extra, unnecessary set of
requirements to be learned by regulators and regulated parties,
particularly in States with containment programs in place. It would
also be costly for existing structures to have to retrofit,
particularly in States where facilities had already been constructed to
conform with State requirements. Several commenters (State regulatory
agencies, a dealer, and a grower group) recommended that EPA
grandfather existing containment facilities that are already in
compliance with State standards. A State regulatory agency group
requested EPA to seriously consider accepting small discrepancies in
some standards due to differences in existing State rules and
legislation. This commenter said that national uniformity in regulation
is desirable, although progress toward this goal should not be at the
expense of States that have already enacted rules and statutes that
vary slightly from the proposed Federal regulations. A dealer group
suggested that EPA set the Federal standards as a baseline, which would
allow the proactive work of some States to stand. Many dealers
recommended that EPA adopt the Iowa standards in lieu of those in the
proposal. A dealer said that making States enforce standards different
from their own would cause difficulties for enforcing agencies,
distributors, retailers and end users, and a State regulatory agency
elaborated, stating that States with containment requirements would
have to reinitiate their compliance efforts and would lose credibility
and trust of the regulated community. A few State regulatory agencies
suggested adding a provision that would use the time during the interim
period to collect data about the adequacy of State regulations. If the
collected information indicated a State's requirements weren't
adequate, EPA could justify compliance with the Federal standards.
4. EPA response. The interim period was intended to allow
substandard facilities sufficient time to retrofit and come into full
compliance with the regulations and for owners to recoup the benefits
from the depreciation of their capital investment and financially
prepare to upgrade their structure. EPA has maintained a dialogue and
information exchange with States and the regulated community
(facilities and their associations) since the rule was published in
1994. EPA has decided not to finalize the most onerous and contentious
standards from the requirements for existing facilities, such as a
hydraulic conductivity standard, thereby significantly reducing the
effort and expense needed to comply. EPA believes that 33 months
between the reference date for new structures (3 months after
publication) and the compliance date (36 months after publication)
would provide a reasonable period of time for new structures to be
planned and built in compliance with the full requirements of subpart
E. If an existing structure does not already comply with the standards
for existing structures, EPA believes that the remaining modifications
can be readily implemented at existing structures within 3 years. The
proposed period of 2 years before compliance may not have provided
ample time for facilities to meet the requirements, particularly
facilities in locales with significant seasonal constraints on
construction. In addition, allowing 3 years as a compliance date for
both new and existing structures will allow one year for States with
their own containment regulations to apply for an equivalency
determination, and still avoid confusion by retaining the same
compliance date for all facilities. EPA believes that allowing one more
year before implementation will not have a significant adverse impact
on the environment, particularly given the many State regulations that
are already in effect. This is a shorter time frame than the 5-year
phase-in period allowed for the refillable container and repackaging
regulations, but given that most States with dealerships have already
implemented containment regulations, the Agency considers 3 years
sufficient time for facilities to comply. The Agency is allowing 5
years for compliance with the refillable container standards because
registrants need to phase out existing containers without recalling
them prior to the completion of their normal usable life. The
transition period helps distribute costs over time and improve
regulatory compliance.
The critical standards cited in the preamble of the proposed rule
(59 FR 6765, February 11, 1994) for implementation during the interim
period have been modified based on comments, additional research, and
evaluation of existing State regulations. The modified standards for
existing structures are considered crucial to safe containment and
comprise the basic standards demonstrated to be effective for existing
structures in States with containment regulations. The following table
compares standards in the proposed rule to today's final standards for
existing structures. New structures are subject to these standards plus
additional standards representing further protectiveness.
Table 17.--Comparison of Standards for Proposed and Final Rule
------------------------------------------------------------------------
Additional
Standard in Proposed Rule for Standard in Final Standard in Final
Existing Structures Rule for Existing Rule for New
Structures Structures
------------------------------------------------------------------------
Construction with rigid Same. NA
materials.
------------------------------------------------------------------------
Use of pesticide-resistant Use of pesticide- NA
materials. compatible
materials.
------------------------------------------------------------------------
[[Page 47393]]
Hydraulic conductivity no None. Liquid- NA
greater than 1 x 10-6 cm/sec tight.
during interim, 1 x 10-7 cm/sec
after 10 years.
------------------------------------------------------------------------
Withstand full hydrostatic head. Same. NA
------------------------------------------------------------------------
Stormwater run-on protection for Sufficient NA
a 25-year, 24-hour storm. freeboard to
contain
precipitation and
prevent water and
other liquids
from seeping into
or flowing onto
it.
------------------------------------------------------------------------
Protection of appurtenances and Same. Appurtenances
containers. configured so
leaks can be
observed.
------------------------------------------------------------------------
Seal joints and cracks and Same. NA
repair any visible damage.
------------------------------------------------------------------------
Inventory reconciliation of None. NA
liquid remaining in tank during
interim only.
------------------------------------------------------------------------
Pad capacity 1,000 gallons. Pad capacity 750 Sloped to liquid-
gallons. tight sump.
------------------------------------------------------------------------
Liquid stationary containers - Liquid stationary Liquid stationary
unit capacity 100 percent/110 containers - unit outdoor capacity
percent indoor/outdoor minimum capacity 100 110 percent
during interim, 110 percent/125 percent indoor/ minimum.
percent indoor/outdoor after 10 outdoor minimum.
years.
------------------------------------------------------------------------
Anchoring liquid stationary Anchoring or NA
containers. elevating liquid
stationary
containers.
------------------------------------------------------------------------
Prevent pesticide-containing Seal Appurtenances must
material from escaping from appurtenances, be configured in
containment. discharge outlets such a way that
and gravity spills or leaks
drains through are easy to see.
base or wall of
containment unit,
including sump.
Containment pads
may drain to a
watertight sump
with method of
removing
accumulated
liquids, such as
a pump, which
transfers
contents to
aboveground
container.
------------------------------------------------------------------------
Dry product stationary container Dry product NA
- no capacity requirement stationary
during interim, 100% after 10 container
years. protected from
wind/rain with 6-
inch berm at
least 2 feet from
container.
------------------------------------------------------------------------
Attended transfers; locked Same. NA
valves; cleanup by the end of
day of spill; monthly
inspection.
------------------------------------------------------------------------
E. Stationary Containers Included (Sec. 165.81)
1. Final regulations. Stationary pesticide containers designed to
hold undivided quantities of agricultural pesticides equal to or
greater than 500 gallons (1,890 liters) of liquid pesticide or equal to
or greater than 4,000 pounds (1,818 kilograms) of dry pesticide are
subject to the containment regulations. Containers of less than these
volume/weight capacities are not required to be protected with a
secondary containment unit. The definition of stationary pesticide
container includes transport vehicles that are fixed or remain at a
facility for at least 30 consecutive days.
A stationary pesticide container is subject to the containment
regulations and must have a secondary containment unit unless it
satisfies any one of the following conditions:
? The container is empty, which means that it has been
cleared of all pesticide that can be removed by customary methods such
as draining, pumping, or aspirating (whether or not residues have been
removed by washing or rinsing).
? The container holds pesticide rinsates or wash waters and
is so labeled.
? The container holds only pesticides which would be gaseous
when released at atmospheric temperature and pressure.
? The container is dedicated and labeled for non-pesticide use.
2. Changes. This is not the same subset of stationary containers
proposed in Sec. 165.142(a) as subject to, or exempt from, the
standards. The three differences are that the: (1) Liquid container
size subject to the rule is 500 gallons rather than 793 gallons; (2)
dry container size subject to the rule is 4,000 pounds rather than
4,409 pounds; and (3) period of time that a container can remain fixed
or at a single facility in order to be considered stationary is 30
days, rather than the 14-day period in the proposed rule.
3. Comments - holding capacity. Many commenters (State regulatory
agencies, dealer groups, and another government agency) urged EPA to
reduce the capacity threshold for containers for which secondary
containment is required. Specific alternative suggestions included: (1)
300 gallons for liquids or 100 pounds for dry products; (2) 300 gallons
for liquids or 500 pounds for dry products; (3) 500 gallons for liquids
or 2,000 pounds for dry products. A registrant group commented in 2004
that packaging experts believe plastic containers larger than 330
gallons would not meet DOT
[[Page 47394]]
Packing Group III standards, which they cite as further evidence that
containers that size and larger need secondary containment. A State
agency stated that they are already seeing a shift in container size
(below the regulatory cut-off) in order to be exempt from the State's
containment regulations. Another State agency suggested that States
have geographical differences and that perhaps EPA should allow
individual States to mandate storage limits based on their individual
situation. A dealer group and a registrant group jointly commented that
containers with a liquid capacity of greater than 330 gallons should be
protected by containment. There were no commenters who thought the
container size of 793 gallons was appropriate or that it should be larger.
4. EPA response - holding capacity - liquids. The Agency recognized
that the liquid capacity proposed was substantially greater than volume
criteria adopted by many States with containment regulations. These
States use lower limit ``bulk'' criteria ranging from 55 to 500 gallons
to trigger secondary containment requirements for liquid pesticides.
The reasoning for the proposed definition (793 gallons) of liquid bulk
container was to be consistent with the DOT definitions in
distinguishing between intermediate bulk containers and bulk
containers. Since the final containment regulations do not use
definitions of bulk or intermediate bulk, the DOT definitions are
irrelevant here. As discussed in Unit VI.A., EPA is not finalizing the
definitions of minibulk and bulk containers in the final rule. The
Agency's intent for the secondary containment requirement is to prevent
the most catastrophic spills, and the larger the container, the greater
the risk of contamination. The Agency believes contamination from
failure of a 500-gallon container would be significant, and agrees with
commenters that a 330-gallon container is generally considered the
largest size container that can be moved by a fork lift and can be
considered mobile. The next most common size used in the field is 500
gallons. The Agency agrees with States that those 500 gallon tanks
should be required to have secondary containment, and is lowering the
size cut off to capture those tanks and harmonize with existing
regulations. The Agency has confirmed by personal communication with
some State regulators and extension staff (Ref. 28) that there are few,
if any, containers between the sizes of 500 and 793 gallons, (the next
most common size after 500 gallons is 1,000 gallons) and expects that
today's rule will discourage demand for container sizes in that range
in an attempt to be exempt from the containment regulations. The Agency
confirmed that 500-gallon tanks are common in the field, and recognizes
that the regulations may prompt some demand for tanks slightly smaller
(e.g., 450 gallons) in order to be exempt from the Federal requirement.
There may always be facilities which try to skirt the law in such ways,
but the Agency intended the containment regulations to prevent the
environmental consequences from the most catastrophic spills. The
smaller the tank size, the less contamination will result from leaks or
spills. The Agency also reviewed containment regulations in the 19
States which have them, and determined that the size cut-off which
triggers the requirement for secondary containment varies from 55 to
550 gallons, with many states selecting 300- or 330-gallon tanks as the
cut-off size. The Agency believes that selecting a volume cut off
between 55 and 500 gallons would conflict with some State regulations
at a cost to both States and facilities, with no measurable benefit to
the environment (Ref. 25) and has therefore selected 500 gallons as a
realistic, practical and protective size which triggers the need for
secondary containment.
5. EPA response - holding capacity - dry pesticides. As with liquid
pesticides, the Agency's goal in proposing larger weight criteria for
dry pesticides, was to target containers that pose the greatest risk of
catastrophic consequences in the event of failure. The proposed size
criterion for dry pesticide containers was 4,409 pounds (2,000
kilograms). There were many comments on the size criterion for dry
pesticide containers in 1994. Those comments objected specifically to
the proposed standard for 100 percent containment capacity for such
containers based on the physical nature of a dry spill. The Agency has
confirmed with the packaging industry (Ref. 29) that dry pesticides are
not packaged in containers between the sizes of 4,000 and 4,409 pounds.
Therefore, EPA is lowering the size of the container for which
containment is required to 4,000 pounds (1,818 kilograms) for
simplicity and clarity, since 4,000 is an easier number to remember for
compliance and enforcement purposes, and there is no functional
difference between 4,000 and 4,409 pounds for refillable dry bulk
containers, since neither size exists. In addition, EPA has replaced
the requirement for 100 percent containment capacity for dry pesticides
with a requirement for a 6-inch berm in the final rule.
6. Comments - 14-day residence. Several commenters suggested
increasing the time criterion to 30 days to account for factors beyond
the control of the facility. One commenter questioned the associated
recordkeeping as burdensome and unclear as to what was required. A
registrant requested that EPA exempt packaged product in nonrefillable
containers from the 14-day time trigger because it would burden small
facilities.
7. EPA response - 14-day residence. Although most large containers
used at commercial agrichemical facilities are stationary, some
containers are actually vehicles (such as tank trucks) used for
prolonged storage or repeated on-site dispensing of pesticide at one
location. In this case, the primary function of the vessels shifts from
pesticide transport to pesticide storage or handling, and therefore
containment is required. Since monthly inspection is required at such
facilities, EPA believes that it would be reasonable to allow a 30-day
maximum residence time without containment requirements, since any
transport vehicles temporarily stored would have to be inspected by the
owner or operator within that period. The recordkeeping required for
stationary containers which do not have secondary containment could
simply be a signature of the driver and/or facility owner/operator on a
paper listing the driver's arrival date. The regulation is not intended
to impose burdensome recordkeeping. The regulations will not affect
packaged pesticide in small quantities used by small entities, since
the quantities required that would trigger containment requirements are
500 gallons liquid or 4,000 pounds dry pesticide.
F. Pesticide Dispensing Areas Included (Sec. 165.82)
1. Final regulations. Dispensing areas are subject to the
requirements for a containment pad if one of the following activities
is conducted in the dispensing area:
? Emptying, cleaning, and rinsing of refillable containers
that hold agricultural pesticides.
? Dispensing of an agricultural pesticide from a stationary
pesticide container of a size holding 500 gallons or more of liquid or
4,000 pounds or more of dry pesticide for any purpose.
? Dispensing of an agricultural pesticide from a transport
vehicle to fill a refillable container.
? Dispensing of an agricultural pesticide from any other container for
[[Page 47395]]
the purpose of refilling a refillable container for sale or
distribution.
A dispensing area is exempt from subpart E requirements for a
containment pad if it satisfies any of the following conditions:
(1) The only pesticides handled in the pesticide dispensing area
are pesticides which would be gaseous if released at atmospheric
temperature and pressure.
(2) The only pesticide containers refilled within the pesticide
dispensing area are stationary pesticide containers protected by a
secondary containment unit that complies with the requirements of this
subpart.
(3) The pesticide dispensing area is used solely for dispensing
pesticide from a rail car that is not a stationary pesticide container.
However, if a rail car is used as a stationary pesticide container,
secondary containment is required.
2. Changes. This is the same approach and scope that was proposed
in Sec. 165.142(b) for including and exempting pesticide dispensing
areas from the requirement for a containment pad. The language in Sec.
165.82(a)(2) has been slightly revised to reflect the lower container
sizes, and all of the conditions have been slightly revised to be clearer.
3. Comments. As with the scope of facilities subject to the
containment requirements above, many commenters responding to both the
1994 proposal and the 2004 Notice (State regulatory agencies, a few
dealer groups and a registrant) urged EPA to expand the scope to all
permanent areas where the transfer of pesticides from any container
occurs, regardless of container size or pesticide type. In particular,
they argued for requiring containment pads for mixer/loader activities
by farmers or for-hire applicators, citing significant soil and
groundwater contamination in agricultural States, and equivalent risk
whenever large quantities of pesticides are handled. They noted the
possibility that farmers are less well-trained in pesticide management
than commercial dealers. State agencies supported including farmer
mixer/loader pads in order to strengthen their own regulations.
Arguments by State regulatory agencies, user groups, a registrant,
and a registr ![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}