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
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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 registrant group against including farmers in the scope cited the
difficulty of monitoring numerous individual farms and lower quantities
of pesticides used. Two user groups opposed including farmers because
the costs would be significant to farmers and could not be passed on;
the costs of monitoring the large number of farm sites would be
burdensome; and farm sites generally handle less material, which should
result in fewer spills.
4. EPA response. As discussed above in Unit VIII.C., Who Must
Comply, EPA focused on commercial agrichemical facilities because these
have the clearest pattern of soil and ground water contamination by
pesticides. EPA did not include farms because farms conduct operations
on an occasional basis and would not have the same environmental
impacts as refilling establishments. Containment on a farm would also
be expensive and require year-round maintenance but only be needed on a
seasonal basis. EPA does not have a good estimate of the number of
farms with stationary bulk storage, nor evidence that significant
contamination is occurring at farm sites. Although it follows logically
that any area where pesticides are transferred between containers and
application equipment may become contaminated, the quantities
transferred at dealer and commercial sites for sale to multiple
customers are expected to far exceed quantities transferred at
individual farms.
EPA noted that the language in Sec. 165.82(a)(4) did not fit the
plain-English standard for simplicity and revised it to clarify that
the activity of refilling refillable containers for sale or
distribution, even if the source container is smaller than the size
requiring secondary containment, requires a secondary containment pad.
For example, refilling a 15-gallon minibulk from a 400-gallon
stationary tank would still require a containment pad if the product
was intended to be sold or distributed.
G. Definition of New and Existing Structures (Sec. 165.83)
1. Final regulations. A new containment structure is one whose
installation begins more than 3 months after the final rule is
published. Installation is considered to have begun if:
(1) You, as the owner or operator, have obtained all Federal,
State, and local approvals or permits necessary to begin physical
construction of the containment structure; AND
(2) You have either begun a continuous on-site physical
construction or installation program OR you have entered into
contractual obligations for physical construction of the containment
structure. The contract must be such that it cannot be canceled or
modified without substantial loss, and must be for the physical
construction or installation of the containment structure within a
specific and reasonable time frame.
An existing containment structure is one whose installation began
on or before the date 3 months after the final rule is published.
2. Changes. This is identical to the definitions of new and
existing containment structures proposed in Sec. 165.144. However, the
general structure of the final rule is different from the proposal, as
explained in more detail in Unit VIII.K. The proposed rule would have
required existing structures 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 had to comply with the
same standards as new structures. Instead, the final rule establishes
critical design standards for both new and existing structures, and
several additional standards for new structures. In other words,
certain standards in the final rule apply to all existing structures
for their lifetimes. Similar but slightly different standards apply to
all new containment structures. As noted earlier, these standards would
not apply in States that show that their regulations afford environmental
protection at least equivalent to that provided by EPA's regulations.
Also, EPA reorganized the regulatory text so all the design and
capacity standards for new structures are grouped together in Sec.
165.85. (See Unit VIII.H.) All the design and capacity standards for
existing structures are grouped together in Sec. 165.87. (See Unit
VIII.I.) The regulations that follow these two groupings of standards,
including but not limited to operational, inspection, maintenance and
recordkeeping requirements, apply to both new and existing structures.
EPA believes this format is clearer and should facilitate compliance
compared to the structure of the proposed rule, which intermingled
requirements for the interim period and for new structures.
H. Design and Capacity Requirements for All New Structures (Sec. 165.85)
1. Construction materials for new containment structures (Sec.
165.85(a))--i. Final regulations. New containment structures must be
made of steel, reinforced concrete or other rigid material which will
withstand the full hydrostatic head, load and impact of any pesticides,
precipitation, other substances, equipment and appurtenances placed
within the structure. The construction material must not be natural
earthen material, unfired clay, or asphalt, and must be compatible with
the stored pesticide.
ii. Changes. The proposed rule stated that the construction
material had to be
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resistant to pesticide. The final rule states that the material must be
compatible with the pesticide. The proposed rule also had the following
additional requirement for new structures, which is not being finalized
in the final rule:
Each new containment structure must have a hydraulic conductivity
less than or equal to 1 x 10-7 centimeters per second.
During the interim period, each existing structure must have a
hydraulic conductivity standard less than or equal to 1 x
10-6 centimeters per second.
iii. Comments - rigid structures. A few State regulatory agencies
supported requiring rigid structures. One recommended allowing flexible
synthetic liners in the base. A university and a registrant supported
the use of steel structures. A few State regulatory agencies and a
containment materials supplier supported portable rigid or non-rigid
structures.
iv. EPA response - rigid structures. EPA does not believe that
flexible, portable, or non-rigid structures can adequately ensure the
permanent and continuous liquid-tight containment of large quantities
of agricultural pesticides or of areas where pesticides are transferred
and handled regularly. Years of State experience with secondary
containment has shown that structures of concrete, steel or other rigid
material are effective in containing spills and leaks. Furthermore, as
stated in the proposed rule, key technical guidance documents recommend
that rigid materials, especially reinforced concrete, be used for
structural support in pesticide containment facilities. Industry
guidance (Ref. 11) indicates that water-tight concrete can be achieved
with nonporous aggregate, high-quality cement paste, proper curing,
etc., and that maintenance plays an important role in keeping the
structure impermeable to liquids. Although flexible, portable
containment structures may be appropriate in certain other situations,
EPA believes that durable, rigid materials should be required for
stationary pesticide containment at facilities covered in today's final
rule.
v. Comments - hydraulic conductivity. Several State regulatory
agencies supported the hydraulic conductivity standard as proposed.
Many commenters (including State regulatory agencies, another agency,
registrants, a registrant group, dealer groups, and a dealer) commented
that a hydraulic conductivity standard would be difficult to implement,
generally citing a lack of methods to verify compliance with such a
standard. Some respondents (dealers, State regulatory agencies,
registrants and a registrant group) commented that there are no on-
site, non-destructive tests to verify hydraulic conductivity.
Respondents from a variety of commenter categories opposed the standard
as too restrictive, unnecessary, unachievable, and too costly. Some
commenters (registrants, a registrant group, and State regulatory
agencies) pointed out that RCRA-mandated wood preservative drip pads
serve as primary containment, whereas the proposed regulations apply to
secondary containment, arguing that the same standard should not apply
in both cases. A few State regulatory agencies expressed concern that
construction modifications of existing structures to comply with the
capacity and hydraulic conductivity standards may not be technically
feasible and could penalize proactive States. A few State regulatory
agencies and a dealer group commented that there is no evidence of
pesticide moving through concrete slabs or unsatisfactory performance
by existing concrete structures, and one commenter observed that most
releases from secondary containment are through unsealed cracks and
installed drains.
Respondents commented on the methods needed to achieve a hydraulic
conductivity standard, such as use of coatings, sealants, and liners. A
State regulatory agency supported the use of sealants and coatings and
a few dealer groups acknowledged that coatings on concrete would extend
the useful life of the structure and make it less permeable. Many
commenters expressed concerns about the use of coatings and sealants on
containment structures, for reasons such as: coatings can cover cracks
and problems that would not be visible (dealer, dealer association and
a State regulatory agency); abrasion from traffic (State regulatory
agency) and deterioration of sealants due to ultraviolet light
(registrant group and several registrants) could prevent a structure
from maintaining compliance; and high cost of maintenance and
replacement. Some commenters (dealer groups, State regulatory agencies)
suggested qualitative alternative ways to implement an impermeability
standard: liquid-tight with cracks, seams and joints sealed; spill
retention; leakproof, coupled with permit and other requirements;
leakproof and constructed with materials resistant to pesticides. A
State regulatory agency observed that most releases from secondary
containment are through unsealed cracks or installed drains.
vi. Comments - hydrostatic head. A few State regulatory agencies
argued that a requirement for construction to withstand full
hydrostatic head would require dike walls to be unreasonably thick in
order to withstand a very rare but not impossible tidal wave impact of
a large tank rupture. A dealer group urged EPA to replace the standard
with the following language from the Association of American Pest
Control Officials (AAPCO) model rule: ``Secondary containment shall be
constructed of sufficient thickness, density, and composition so as to
contain any discharged material...''
vii. EPA response - hydraulic conductivity and hydrostatic head.
Based on the comments and additional research, EPA agrees that the
proposed hydraulic conductivity requirements would be unnecessarily
burdensome, and that rigid walls of chemically compatible material have
been proven effective in controlling accidental spills. The 1 x
10-7 cm/sec standard was based on the hydraulic conductivity
requirement found in current RCRA requirements for wood preservative
drip pads in subpart W of 40 CFR parts 264 and 265. EPA agrees that
secondary containment structures are intended to catch and briefly
retain spills and releases, not store them indefinitely, and recognizes
the difficulty in verifying hydraulic conductivity. The Agency has
therefore decided not to finalize the standards for hydraulic
conductivity. The Agency disagrees that the requirement to withstand
full hydrostatic head is unreasonable. It is a requirement in many
State containment regulations. The final rule was modified slightly to
delete the phrase (dynamic or static) because that phrase adds more
confusion than clarity. However, EPA believes that the standard of
being ``capable of withstanding the full hydrostatic head, load and
impact of any pesticides, precipitation...'' requires the secondary
containment unit to be able to contain a catastrophic spill. EPA
believes that using industry construction guidance on concrete quality
and reinforcement bars will ensure that containment structure's
integrity in the case of a catastrophic spill of a large tank.
2. General design requirements for all new containment structures
(Sec. 165.85(b))--i. Final regulations. These are the general design
requirements for new containment structures:
(1) You must protect appurtenances and pesticide containers against
damage from operating personnel and moving equipment. Means of
protection include, but are not limited to, supports to prevent
sagging, flexible connections, the use of guard rails, barriers, and
protective cages.
(2) Appurtenances, discharge outlets, or gravity drains must not be
configured
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through the base or wall of the containment structure, except for
direct interconnections between adjacent containment structures which
meet the requirements of this subpart. Appurtenances must be configured
in such a way that spills or leaks are easy to see.
(3) The containment structure must be constructed with sufficient
freeboard to contain precipitation and prevent water and other liquids
from seeping into or flowing onto it from adjacent land or structures.
(4) Multiple stationary pesticide containers may be protected
within a single secondary containment unit. The volume of the largest
container determines the capacity requirement of the unit.
ii. Changes. Requirements in Sec. 165.85(b)(1) and (2) are
identical to those proposed in Sec. 165.146(b). Paragraph (4) is added
to clarify a statement in the proposed rule under Sec. 165.152. The
requirement in Sec. 165.85(b)(3) has been changed. In the proposed
rule, the requirement was to prevent storm water run-on from seeping
into or flowing onto it from adjacent land or structures during a 25-
year, 24-hour rainfall event.
iii. Comments - storm protection. Several respondents (a registrant
and two State regulatory agencies) supported the stormwater control
provision. Several others (a dealer group and two State regulatory
agencies) suggested alternative language, such as diverts water, no
discharge, or constructed to prevent any surface water from moving onto
or across the structure. Several commenters (a dealer group, a
registrant group and two State regulatory agencies) noted that it would
be difficult to comply because (1) a watershed runoff study would be
needed; (2) the 25-year, 24-hour criterion would be difficult to
determine at different sites; (3) rainfall varies substantially from
year to year. A few State regulatory agencies commented that the
stormwater control standard doesn't adequately address precipitation
and stated that the containment capacity requirements must be based on
rainfall volume, such as a 25-year, 24-hour rainfall event. A few
dealers recommended the example of the Illinois pesticide containment
rule, which requires that stormwater be diverted from containment
structures.
iv. EPA response - storm protection. A 25-year, 24-hour storm is
commonly used as a benchmark for the capacity of secondary containment
structures, and is recommended in the National Pollution Discharge
Elimination System (NPDES) Best Management Practices Guidance
Document.(Ref. 74) EPA believes that, just as a 25-year, 24-hour storm
is a reasonable criterion for stormwater retention (prevention of run-
off), it would also serve as sufficient freeboard and a reasonable
standard for prevention of stormwater seepage and run-on from adjacent
lands or structures. Such a standard allows flexibility for varying
climatic conditions. It is also the standard required for certain tank
systems storing or treating hazardous waste. See, for example, 40 CFR
265.1(e)(1)(ii) and (e)(2)(ii). However, the Agency has decided not to
require a 25-year, 24-hour storm criterion here in order to be
consistent with the final EPA rule on Oil Pollution Prevention and
Response: Non-Transportation-Related Onshore and Offshore Facilities
(67 FR 47042, Ref. 47). The Oil Prevention Rule states that while a 25-
year, 24-hour storm event standard is appropriate for most facilities
and protective of the environment, it may be difficult and expensive
for some facilities to secure recent information concerning such storm
events at this time. Recent data do not exist for all areas of the
United States, or may be costly for small operators to secure. Should
recent and inexpensive information concerning a 25-year, 24-hour storm
event become easily accessible for every part of the United States, we
will reconsider proposing such a standard. Instead, at this time, we
are requiring, as a few commenters suggested, that the containment
structure have sufficient freeboard to contain precipitation and
prevent water and other liquids from seeping into or flowing onto it
from adjacent land or structures. Most States with containment
regulations do not use a 25-year, 24-hour storm criterion, and have
indicated that, in their experience, requiring a numerical capacity
(110 percent) or sufficient freeboard to accommodate local
precipitation conditions provides adequate protection.
3. Capacity requirements for new stationary liquid pesticide
containment units and new containment pads in pesticide dispensing
areas (Sec. 165.85(c))--i. Capacity for new stationary liquid
pesticide containment units--Final regulations. These are the capacity
requirements:
? New secondary containment units for stationary liquid
containers, if protected from precipitation, must have a capacity of at
least 100 percent of the volume of the largest stationary container
plus the volume displaced by other containers and appurtenances within
the unit.
? New secondary containment units for stationary liquid
containers, if exposed to or unprotected from precipitation, must have
a capacity of at least 110 percent of the volume of the largest
stationary container plus the volume displaced by other containers and
appurtenances within the unit.
a. Changes. The proposed rule required higher capacity of 110
percent for units protected from precipitation and 125 percent for
units exposed to precipitation.
b. Comments. Several State regulatory agencies supported the
proposed standards, stating that adjusting the standard to reflect
variable rainfall would add confusion. Many commenters (dealers, dealer
groups and a State regulatory agency) supported instead the standard
that EPA had proposed for the interim period for existing structures,
namely 100 percent/110 percent capacity (indoor/outdoor). Reasons cited
included: (1) Many dikes that meet this standard have been in place for
years with no overflows; (2) EPA provides little or no justification
that capacity in excess of 100 percent of the volume of the largest
container is necessary; (3) modifying a dike to add additional capacity
would be expensive; and (4) many Midwestern States have adopted the 100
percent/110 percent standard from the AAPCO model rule.
c. EPA response. EPA agrees with comments based on practical field
experience and has reduced the volumes needed to 100 percent and 110
percent, respectively for indoor and outdoor units. The 110 percent
criterion for storage areas without roofing adds an extra margin of
safety for retention of precipitation. An extra 10% is not needed
indoors as long as the displaced volume or other containers is added.
However, the Agency recognizes that, for enforcement purposes, it may
be difficult to reconcile capacity with climatic conditions. For
example, in the case of a 2-inch rain, capacity at a new outdoor liquid
pesticide facility could be temporarily reduced to less than 110
percent of the largest tank if that tank were full, and the facility
would no longer be in compliance. To avoid disputed calculations of
capacity, the Agency recommends that facilities make allowances for
additional capacity beyond the 110 percent required, such as 125
percent, to build in a margin of error.
ii. Capacity for new containment pads in pesticide dispensing
areas--i. Final regulations. These are the capacity requirements:
? New containment pads in pesticide dispensing areas subject
to the regulations in this subpart which have a pesticide container or
pesticide-holding equipment with a volume of
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750 gallons or greater must have a holding capacity of at least 750 gallons.
? New containment pads in pesticide dispensing areas subject
to the regulations in this subpart which do NOT have a pesticide
container or pesticide-holding equipment with a volume of at least 750
gallons must have a holding capacity of at least 100 percent of the
volume of the largest pesticide container or pesticide-holding
equipment used on the pad.
ii. Changes. The proposal required that pads have a minimum holding
capacity of 1,000 gallons, or, if no equipment used on the pad exceeded
1,000 gallons, at least 100% of the capacity of the largest container
or equipment used on the pad. Today's rule reduces the minimum pad
holding capacity to 750 gallons in the most likely scenario where large
(greater than 750 gallon) containers or pesticide-holding equipment
will be on the pad. Additionally, the capacity requirement refers to
gravity capacity, as defined in oral comments by Wisconsin state
regulatory officials (Ref. 46) in 2003. The gravity capacity of a sump
or containment structure is the capacity before any method of removing
or transferring the contained liquid by pump or other means is
employed. For example, a facility is prohibited from claiming a
capacity of 750 gallons if the sump or containment structure has an
actual capacity of less than 750 gallons but is serviced by a pump
which transfers accumulated liquid into holding tanks such that the
effective capacity would be 750 gallons. Since achieving 750-gallon
storage capacity under those circumstances relies on the proper and
dependable functioning of a pump as well as a continual supply of fuel
or electrical current to run the pump, this is not an acceptable way of
achieving the required capacity because if these conditions are not
met, a spill is more likely.
iii. Comments. Indiana state regulators argued that the state had
spent three difficult years and had invested considerable resources in
implementing its regulations, which require a pad capacity of 750
gallons. They stated that to get the cooperation and voluntary
compliance of the impacted industries, they had to suggest to those
making the investment that there would be no significant changes in
requirements. To reverse themselves now, they stated, would jeopardize
their credibility. Illinois, a state with over 1,000 bulk facilities,
suggested that the pad capacity requirement should take into account
the additional volume of a 6-inch rainfall (the volume expected from a
24-year, 25-hour storm). A few State regulatory agencies did not object
to EPA's proposed pad capacity requirements, although their State
regulations are slightly more stringent. A State regulatory agency
noted that the difference between 750 gallon and 1,000 gallon capacity
would do little to accommodate a spill from a 3,000 gallon delivery truck.
iv. EPA response. The Agency did not have a technical basis for
choosing the 1,000 gallon capacity in the proposed rule, but based it
on a review of proposed and actual State containment regulations. Based
on comments and subsequent research, we determined that the criteria of
750 gallons used in some States has proven adequate. We believe that in
most actual situations of spillage on a pad, 750 gallons would be
adequate, especially since product transfers must be attended under the
requirements of this subpart. In a catastrophic event, neither 750
gallons nor 1,000 gallons would be sufficient to contain a large spill,
and the added cost of increasing capacity to 1,000 from 750 would
exceed any marginal environmental benefit. The Agency also agrees with
Wisconsin State regulators that a 750-gallon pad may be as small as 12
feet square, and that a top-loaded tank may risk splashing during the
refilling process. Consequently, while we are lowering the gallon
capacity to 750 gallons of gravity capacity, we are recommending that
the pad have a minimum size of 15 feet by 15 feet (or 225 square feet).
Additionally, for new operational pads unprotected from precipitation,
we recommend constructing a pad with a gravity capacity of 1,000 gallons.
4. Specific requirements for new stationary liquid pesticide
containment units (Sec. 165.85(d))--i. Final regulations. In addition
to meeting the requirements of Sec. 165.85(a), (b) and (c), each new
stationary liquid container protected by a secondary containment unit
must either be anchored or elevated to prevent flotation in the event
that the secondary containment unit fills with liquid.
ii. Changes. The proposed rule required that the containment unit
had to allow for observation of leakage from the base of any enclosed
stationary pesticide container. Thus, a flat-bottomed container would
have had to be elevated so that leakage would be visible. In addition,
the proposed rule required that flotation of the container, in the
event the containment filled with liquid, be prevented by either
elevating or anchoring the container. The final rule requires either
elevation or anchoring in response to comments that argued that
elevating containers is not necessary to detect leaks and may engender
risks from inadequate support devices.
5. Specific requirements for new containment pads in pesticide
dispensing areas (Sec. 165.85(e))--i. Final regulations. In addition
to meeting the requirements for Sec. 165.85(a), (b) and (c), each new
containment pad in a pesticide dispensing area must:
? Be designed and constructed to intercept leaks and spills
of pesticides which may occur in the pesticide dispensing area.
? Have enough surface area to extend completely beneath any
container on it, with the exception of transport vehicles dispensing
pesticide for sale or distribution to a stationary container. For such
vehicles, the surface area of the containment pad must accommodate at
least the portion of the vehicle where the delivery hose or device
couples to the vehicle. This exception does not apply to transport
vehicles that are used for prolonged storage or repeated on-site
dispensing of pesticides.
? Allow, in conjunction with its sump, for removal and
recovery of spilled, leaked, or discharged material and rainfall, such
as by a manually activated pump. Automatically activated pumps which
lack automatic overflow cutoff switches for the receiving container are
prohibited.
? Have its surface sloped toward a liquid-tight sump where
liquids can be collected for removal.
ii. Changes. These requirements are identical to those in Sec.
165.152(b) of the proposed rule. The proposed rule noted that tanker
trucks are considerably larger than containers or equipment normally
used on the containment pad, but that such deliveries are not expected
to be frequent, and did not propose that the pad had to be large enough
to accommodate the entire vehicle. This exception does not apply to
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides, since the primary function of such a
vehicle would be pesticide storage rather than transport. EPA reasons
that the full containment requirements imposed on fixed containers
would also apply to non-fixed containers that remain at an applicable
facility for at least 30 days.
6. Specific Requirements for new stationary dry pesticide
containment units (Sec. 165.85(f))--i. Final regulations. In addition
to the requirements in Sec. 165.85(a) and (b), each new stationary dry
pesticide containment must meet the following requirements:
? The stationary dry pesticide containers within the containment unit
[[Page 47399]]
must be protected from wind and precipitation.
? Stationary dry pesticide containers must be placed on
pallets or a raised concrete platform to prevent the accumulation of
water in or under the pesticide.
? The stationary dry pesticide container storage area must
be enclosed by a curb that is a minimum of a 6 inches high and that
extends at least 2 feet beyond the perimeter of the container.
ii. Changes. The proposal required that dry bulk secondary
containment units have a capacity of 100 percent of the largest
container plus the volume displaced by other containers and
appurtenances within the containment. The Agency was concerned that dry
pesticide could still mix with rainwater, fire suppression water, etc.,
to reach and contaminate groundwater and soil. The proposed rule did
not have any provisions for protection from wind and precipitation, nor
for elevated storage to prevent water accumulation under the pesticide,
but did request comment on such options. The final rule does not have a
numerical capacity requirement.
iii. Comments. Several commenters (State regulatory agencies and a
dealer group) opposed the 100 percent proposed capacity as excessive,
since dry materials do not spread and disperse like liquid materials.
Several State regulatory agencies suggested that dry bulk secondary
containment should be protected by roofing or similar cover from wind
and precipitation, which would make 100 percent capacity unnecessary.
One State noted that it already has dry bulk containment regulations
which require that the containers be raised off the floor, and several
States require at least a 6-inch curb around an area extending at least
2 feet beyond the perimeter of the bulk tank. A registrant stated that
the typical practice is to store dry pesticides under a roof. Some
commenters offered alternative strategies, generally based on existing
State regulations, including a curb 6 inches high at least 2 to 3 feet
beyond the perimeter.
iv. EPA response. EPA has reviewed State bulk storage regulations
and best management practices for storing dry bulk pesticides and has
noted that States require storage under a roof and, if outdoors, on
pallets or raised concrete platforms, and that the most common
requirement for dry bulk is a 6-inch berm at least 2 to 3 feet from the
container. (Ref. 34) Given that the States with the most experience
with dry bulk storage have the most practical experience with dry spill
containment, EPA agrees with the common sense arguments of commenters
regarding protection from precipitation, elevation, and the flow
properties of dry material, and has changed the dry containment
requirement accordingly. In regard to roofing, EPA believes that the
advantages of keeping rainwater out of containment will outweigh the
cost of installing a roof. However, in arid regions, a roof may not be
cost-effective, and if EPA provided roofing specifications, it is
possible that they would conflict with local construction requirements
and building codes. Therefore, the final rule requires protection from
wind and precipitation rather than specifically requiring a roof to
allow some flexibility. The Agency agrees that 100 percent capacity,
given that dry materials spread differently that liquids, would be
excessive. We also recognize that significant quantities of dust may be
generated during the refilling process, where the dry product is a
dust, granules or flowable formulation. While today's rule makes no
requirement for dust minimization or collection, we recommend that
every effort be made to contain the dust generated, both for the
respiratory protection of the persons attending the transfer and for
the preservation of air and soil quality in the vicinity of the facility.
I. Design and Capacity Requirements for Existing Structures (Sec. 165.87)
1. Construction Materials for all existing containment structures
(Sec. 165.87(a))--i. Final regulations. Existing containment
structures must be made of steel, reinforced concrete or other rigid
material which will withstand the full hydrostatic head, load and
impact of any pesticides, precipitation, other substances, equipment
and appurtenances placed within the structure. The construction
material must not be natural earthen material, unfired clay, or
asphalt, and must be compatible with the stored pesticide.
ii. Changes. The requirements in Sec. 165.87(a) for existing
structures are identical to the requirements for construction materials
for new containment structures in Sec. 165.85(a). The proposed rule
stated that the construction material had to be resistant to pesticide,
while the final rule requires the material to be compatible with the
stored pesticides. In addition, the following proposed standard for
existing structures is not being finalized:
During the interim period, each existing structure must have a
hydraulic conductivity standard less than or equal to 1 x
10-6 centimeters per second. After the interim period, each
new containment structure must meet the hydraulic conductivity standard
for new structures of less than or equal to 1 x 10-7
centimeters per second.
iii. Comments. General comments and EPA's response on construction
material are discussed in Unit VIII.H.1. EPA believes that existing
structures should easily meet these requirements based on the
information we have gathered. We are not aware of secondary containment
units being constructed of any of the prohibited materials. We are
aware of the existence of some asphalt containment pads, but we believe
these are mostly used by aerial applicators that probably are not
subject to these regulations because they do not have large stationary
pesticide containers.
2. General design requirements for all existing containment
structures (Sec. 165.87(b))--i. Final regulations. These are the
general design requirements for existing containment structures:
(1) Protect appurtenances and pesticide containers against damage
from operating personnel and moving equipment. Means of protection
include, but are not limited to, supports to prevent sagging, flexible
connections, the use of guard rails, barriers, and protective cages.
(2) Seal (permanently close) all appurtenances, discharge outlets
and gravity drains through the base or wall of the containment
structure, except for direct interconnections between adjacent
containment structures which meet the requirements of this subpart.
(3) Construct the containment structure with sufficient freeboard
to contain precipitation and prevent water and other liquids from
seeping into or flowing onto it from adjacent land or structures.
(4) Multiple stationary pesticide containers may be protected
within a single secondary containment unit.
ii. Changes. Requirements are similar to those proposed in proposed
Sec. 165.146, except that (4) is added to clarify a statement in the
proposed rule under Sec. 165.152. The requirement in paragraph (2) was
proposed for existing structures 10 years after the publication date of
the rule (at the expiration of an interim period that was proposed for
existing units. See discussion on compliance dates in Unit VIII.D.
above.) In addition, at the end of the interim period, existing
structures had to meet the requirements for new structures, including
configuring appurtenances in such a way that leaks and spills could be
readily observed. The final rule requires facilities with existing
structures to seal appurtenances, discharge outlets and gravity drains
at the base and walls. EPA believes it is
[[Page 47400]]
necessary for existing structures to comply with this requirement
because some studies cited in the proposed rule estimated that 30
percent of the reported pesticide spill incidents resulted from
appurtenance failure, and many releases were reported from discharge
outlets and gravity drains. Requirements in paragraph (3) have also
been changed. In the proposed rule, the requirement was to prevent
storm water run-on from seeping into or flowing onto it from adjacent
land or structures during a 25-year, 24-hour rainfall event. The
requirement has been changed to ensuring sufficient freeboard to
prevent run-on. The comments on general design requirements and EPA's
responses are discussed in Unit VIII.H.2.
3. Capacity requirements for existing stationary liquid pesticide
containment units and existing containment pads in pesticide dispensing
areas (Sec. 165.87(c))--i. Capacity for existing stationary liquid
pesticide containment units--a. Final regulations. Each existing
stationary liquid pesticide containment unit must have a capacity of at
least 100 percent of the volume of the largest stationary pesticide
container plus the volume displaced by other containers and
appurtenances within the unit.
b. Changes. The proposed rule required a capacity of 100 percent
for existing liquid bulk containment units protected from precipitation
and 110 percent for units exposed to precipitation for the 8-year
interim compliance period. At the expiration of the interim period, the
capacity requirements would be the same as those proposed for new
structures, that is, 110 percent for units protected from precipitation
and 125 percent for outdoor, unprotected units. The approach of having
an interim period is not being finalized. The final rule requires
existing liquid pesticide containment units to have capacities of 100
percent whether protected from precipitation or not.
c. Comments. The comments on capacity requirements for new and
existing stationary liquid pesticide containment units are discussed in
the comment section under Unit VIII.H.3.a. In addition, many commenters
noted that changes in capacity requirements for existing structures
would require major modification, re-certification by an engineer and
significant costs. A few State regulatory agencies noted that little if
any additional benefit will be afforded by requiring extra capacity,
and that they had never experienced a breach of containment structure
based on existing laws.
d. EPA response. As discussed in Unit VIII.H.3., EPA agrees, based
on field experience, that the proposed capacity requirements were
excessive and has reduced the capacity requirements in the final rule.
In addition, the Agency is not requiring a numerical standard of 110
percent for existing unprotected units (in contrast to the requirements
for new unprotected units) in order to harmonize with existing State
containment regulations which have chosen to require unprotected units
to have 100 percent capacity plus either a 6-inch freeboard or capacity
to withstand a 25-year/24-hour storm. The Agency understands that some
existing units would need to retrofit to meet a 110 percent capacity
requirement, and that the burden of adding the extra capacity appears
to outweigh any benefit of the extra capacity. The Agency recognizes
that States may have existing structures in low-precipitation areas,
and is allowing them the flexibility to define capacity requirements
above 100 percent according to local conditions.
ii. Capacity for Existing containment pads in pesticide dispensing
areas-- a. Final regulations. Existing containment pads with pesticide-
holding equipment with a volume of 750 gallons or greater must have a
holding capacity of at least 750 gallons. Pads which do not have a
pesticide container or pesticide-holding equipment with a volume of at
least 750 gallons must have a holding capacity of at least 100 percent
of the volume of the largest pesticide container or pesticide-holding
equipment used on the pad.
b. Changes. The proposal required that existing pads have a minimum
holding capacity of 1,000 gallons or 100 percent of the capacity of the
largest container or equipment used on the pad. The final rule reduces
the minimum pad holding capacity to 750 gallons in the most likely
scenario where large (greater than 750 gallon) containers or pesticide-
holding equipment will be on the pad. Comments and EPA responses apply
as discussed in Unit VIII.H.3. for new containment pads.
4. Specific design requirements for existing stationary liquid
pesticide containment units (Sec. 165.87(d))--i. Final regulations. In
addition to the requirements in Sec. 165.87(a), (b) and (c), each
existing stationary liquid pesticide container protected by a secondary
containment unit must be adequately elevated or anchored to prevent
flotation in the event that the secondary containment unit fills with
liquid.
ii. Changes. This requirement is identical to that proposed in
Sec. 165.148(b)(2). In the proposed rule, existing secondary
containment units would have had to allow for the observation of
leakage from the base of all stationary bulk containers after the
interim period expired. As explained in Unit VIII.H.4., the standard
for observing leakage from the base of stationary bulk containers is
not being finalized.
5. Specific design requirements for existing containment pads in
pesticide dispensing areas (Sec. 165.87(e))--i. Final regulations. In
addition to meeting the requirements for Sec. 165.87(a), (b) and (c),
each existing containment pad in a pesticide dispensing area must:
? Be designed and constructed to intercept leaks and spills
of pesticides which may occur in the pesticide dispensing area.
? Have enough surface area to extend completely beneath any
container on it, with the exception of transport vehicles dispensing
pesticide for sale or distribution to a stationary container. For such
vehicles, the surface area of the containment pad must accommodate at
least the portion of the vehicle where the delivery hose or device
couples to the vehicle. This exception does not apply to transport
vehicles that are used for prolonged storage or repeated on-site
dispensing of pesticides.
? Allow, in conjunction with its sump, for removal and
recovery of spilled, leaked, or discharged material and rainfall, such
as by a manually activated pump. Automatically-activated pumps which
lack automatic overflow cutoff switches for the receiving container are
prohibited.
ii. Changes. The requirements in the final rule are identical to
those in the proposal. The proposed rule noted that tanker trucks are
considerably larger than containers or equipment normally used on the
containment pad, but that such deliveries are not expected to be
frequent, and did not propose that the pad had to be large enough to
accommodate the entire vehicle. This exception does not apply to
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides, since the primary function of such a
vehicle would be pesticide storage rather than transport. In addition,
the proposed rule required that, at the expiration of the interim
period, each existing containment pad would be sloped to a liquid-tight
sump where liquids can be collected for removal. The interim period has
been deleted, and the requirement for sloped pads is not being
finalized for existing containment pads. The requirement for sloped
pads applies only to new containment pads in the final rule.
6. Specific design requirements for existing stationary dry pesticide
[[Page 47401]]
containment units (Sec. 165.87(f))--i. Final regulations. In addition
to the requirements in Sec. 165.87(a) and (b), each existing dry
stationary pesticide containment must meet the following requirements:
? The containment must protect stationary dry pesticide
containers within it from wind and precipitation.
? Dry stationary pesticide containers must be stored on
pallets or a raised concrete platform to prevent the accumulation of
water in or under the pesticide.
? The container storage area must be enclosed by a minimum
of a 6-inch high curb that extends at least 2 feet beyond the perimeter
of the container.
ii. Changes. The proposal required that dry bulk secondary
containment units have a capacity of 100 percent of the largest
container plus the volume displaced by other containers and
appurtenances within the containment. The proposed rule did not have
any provisions for protection from wind and precipitation, nor for
elevated storage to prevent water accumulation under the pesticide. The
final rule does not have a numerical capacity requirement. All
modifications must now be made within 3 years instead of the 10 years
in the proposed rule, but the requirements are modified and simplified
such that the Agency believes they are feasible within the 3-year
period. See Unit VIII.H.6. for a summary of the significant comments
and EPA's responses.
J. Operational, Inspection and Maintenance Requirements (Sec. 165.90)
1. Operating procedures for all new and existing pesticide
containment structures (Sec. 165.90(a))--i. Final regulations. An
owner or operator of a new or existing pesticide containment structure
must:
? Manage the structure in a manner that prevents pesticides
or materials containing pesticides from escaping from the containment
structure (including, but not limited to, pesticide residues washed off
the containment structure by rainfall or cleaning liquids used within
the structure.)
? Ensure that pesticide spills and leaks on or in any
containment structure are collected and recovered in a manner that
ensures protection of human health and the environment (including
surface water and ground water) and maximum practicable recovery of the
pesticide spilled or leaked. Cleanup must occur no later than the end
of each day on which pesticides have been spilled or leaked.
? Ensure that all materials resulting from spills and leaks
and any materials containing pesticide residue are managed according to
label instructions and applicable Federal, State and local laws and
regulations.
? Ensure that transfers of pesticides between containers, or
between containers and transport vehicles are attended at all times.
? Ensure that each lockable valve on a stationary pesticide
container, if it is required by Sec. 165.45(f), is closed and locked
whenever the facility is unattended.
ii. Changes. These requirements are substantially the same as those
proposed in Sec. 165.146(c). The order of the standards and several
minor wording modifications were made to improve the clarity of the
requirements.
2. Inspection and maintenance of all new and existing pesticide
containment structures (Sec. 165.90(b))--i. Final regulations. The
owner or operator of each pesticide containment structure must:
? Inspect each stationary pesticide container and its
appurtenances at least monthly during periods when pesticides are being
stored or dispensed on the containment structure. Your inspection must
look for visible signs of wetting, discoloration, blistering, bulging,
corrosion, cracks or other signs of damage or leakage.
? Immediately repair any areas showing visible signs of
damage and seal any cracks and gaps in the containment structure or
appurtenances with material compatible with the pesticide being stored
or dispensed.
? Not store any pesticide on a containment structure if the
structure fails to meet the requirements of this subpart until suitable
repairs have been made. Prompt removal of pesticides, including
emptying of stationary containers, in order to effect repairs or
recovery of spilled material is acceptable.
ii. Changes. These inspection and maintenance requirements are
substantially the same as those proposed in Sec. 165.146(d). A few
minor modifications were made to improve the clarity of the language.
In addition, several changes were made to be consistent with other
changes in the regulations. In particular, EPA decided not to finalize
the hydraulic conductivity standard, so the corresponding inspection
and maintenance requirement is also not being finalized. Also, the
final rule specifies that the containment structure be compatible with
the pesticides, rather than resistant as proposed. The corresponding
inspection and maintenance standard was changed accordingly.
K. Combined Pads and Units (Sec. 165.92)
1. Final Regulation. Facility owners and operators may combine
containment pads and secondary containment units as an integrated
system provided the requirements set out in this subpart for pads and
units in Sec. Sec. 165.85(a) and (b), 165.87(a) and (b) and 165.190,
and as applicable, Sec. Sec. 165.85(c)-(f) and 165.87(c)-(f) are
satisfied separately.
2. Changes. This provision for allowing integrated containment
systems is substantially the same as that proposed in Sec. 165.153.
L. Recordkeeping (Sec. 165.95)
1. Final regulations. Facility owners and operators subject to the
requirements of this rule must maintain the following records, and must
furnish these records for inspection and copying upon request by any
employee of EPA or any entity designated by EPA, such as a State,
another political subdivision or a Tribe:
? Records of inspection and maintenance for each containment
structure and for each stationary pesticide container and its appurtenances
must be kept for 3 years and must include the following information:
? name of the person conducting the inspection or maintenance;
? date the inspection or maintenance was conducted;
? conditions noted;
? specific maintenance performed.
? Records for any non-stationary container 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 that holds
pesticide but is not protected by a secondary containment unit meeting
today's regulations must be kept for 3 years. Records on these non-
stationary pesticide containers must include the time period that the
container remains at the same location.
? Records of the construction date of the containment
structure must be kept for as long as the pesticide containment
structure is in use, and for 3 years afterwards.
2. Changes. The proposed rule required additional recordkeeping of
inventory reconciliation for existing bulk liquid containers that were
not elevated during the interim period. The proposed rule also required
owners and operators to maintain records of written confirmation of
hydraulic conductivity and statements of resistance to pesticide for as
long as the structure was in use,
[[Page 47402]]
and for 3 years thereafter. These requirements are not being finalized,
so the corresponding recordkeeping requirements are also not being
finalized. Since the standards differ depending on whether the facility
was considered existing or new at the time of this final rule, a new
recordkeeping requirement has been added: each facility must maintain
records of the construction date of the containment structure for as
long as the pesticide containment structure is in use, and for 3 years
afterwards.
M. States With Existing Containment Programs (Sec. 165.97)
1. Final regulations. States that have promulgated containment
regulations effective prior to August 16, 2006, and which also have
primary enforcement responsibility and/or certification programs, have
the option of continuing to implement their own programs in lieu of
today's Federal regulations under certain conditions.
A State that wishes to continue implementing the State's
containment regulations must request the authority to do so by August
16, 2007 in the following manner:
? The State must submit a letter and any supporting
documentation to EPA. Supporting documentation must demonstrate that
the State's program is providing environmental protection equivalent to
that expected to be provided by the Federal regulations in 40 CFR
subpart E.
? The State must identify any significant changes to State
regulations which would be necessary in order to provide environmental
protection equivalent to the EPA regulations, and develop an estimated
timetable to effect these changes. The letter must be signed by the
designated State Lead Agency (SLA).
EPA's Office of Pesticide Programs (OPP), in collaboration with the
EPA Regions and other EPA offices, will review the State's
correspondence and determine whether the State's program is adequate to
provide environmental protection equivalent to or more protective than
these Federal regulations for new and existing containment structures.
OPP will inform the State of its determination through a letter
authorizing or declining to authorize the State to continue
implementing its containment regulations and will detail any reasons
for declining authorization.
Any State that has received authorization to continue implementing
its State containment regulations must inform EPA by letter signed by
the designated State Lead Agency within 6 months of any revision to the
State containment regulations. EPA will inform the State by letter if
it determines that the State's containment regulations are no longer
adequate based on the revisions. The State containment regulations will
remain in effect, unless and until EPA sends the State a letter making
this determination.
2. Changes. The proposed rule made no provision for States to
implement their own containment regulations in lieu of EPA's rule.
3. Comments. Many commenters to the 1994 proposed rule (dealers, a
dealer group, a State regulatory agency group and individual State
regulatory agencies) opposed setting any Federal standards that are
more stringent than existing State requirements. They requested that
EPA accept current State rules and statutes where the discrepancies are
not significant from Federal standards. The State regulatory agency
group requested EPA to seriously consider accepting small discrepancies
in some standards due to differences in existing State legislation, and
said that while national uniformity in regulation is desirable, it
should not be at the expense of States that have already enacted rules
that vary slightly from the Federal rule. A dealer group suggested that
EPA set the Federal standards as a baseline, which would allow the
proactive work of some States to stand and would preclude dealers from
incurring the same economic burdens twice (i.e., to build and then
rebuild containment structures).
Several commenters (State regulatory agencies, a dealer, and a
grower group) recommended that EPA grandfather existing containment
facilities that are in compliance with State standards or that are
comparable in function, design, and construction. Similarly, a grower
group said that State rules for bulk containment should take precedence
over this proposal. A State regulatory agency elaborated on these
difficulties, stating that States with containment requirements would
have to reinitiate their compliance efforts and would lose credibility
and the trust of the regulated industry, with whom they worked closely
to develop and implement the State rules.
A dealer commented that forcing States to enforce different rules
from their own would cause difficulties for the enforcing agency,
distributors, retailers and end users who will have to learn an extra
set of requirements. A few State regulatory agencies commented that
millions of dollars have been spent by industry on compliance with
State regulations, some of which have been in place since 1985, and
that containment structures have not had failures when built to State
standards. They recommended that the final rule be crafted to harmonize
with State or other environmental statutes, and that it should not
penalize States which have spent years building effective relationships
with the regulated community for safe pesticide handling.
Similarly, many commenters to the 2004 Notice reiterated these
arguments and said States have taken a pro-active role and have enacted
pesticide containment regulations which have proven to be protective of
the environment and which EPA should accept by a grandfather clause. A
few commenters in 2004 pointed out that in some States it is not the
State lead pesticide regulatory agency (usually, department of
agriculture) that has authority for regulating the storage of hazardous
materials/pesticides, but instead the State environmental protection or
pollution control agency. They argued that situations where one State
agency does the comprehensive pesticide regulatory work but another is
charged with the containment regulations begs questions about
responsibilities for and resources necessary to accomplish expected
compliance monitoring and enforcement response.
4. EPA response. The Agency agrees that Federal regulations should
reinforce, rather than undermine or conflict with the efforts of
proactive States. While the Agency believes in the need for national
standards, EPA does not want to burden proactive States and facilities
in those States with additional expenditures to revise their regulatory
implementation system if the differences between their containment
regulations and today's rule are minimal, and especially where State
standards are more stringent than Federal standards. EPA has evaluated
the pesticide containment regulations in those States that have
promulgated them, and believes that the regulations in those States
have generally brought facilities into compliance with today's
regulations, with some potential deficiencies in certain States. EPA
recognizes that simply reading regulations without awareness of the
field reality, State enforcement discretion, and policy and guidance
directives provided to inspectors may provide a less accurate reading
of the equivalency of regulations. Consequently, EPA expects that
States will be able to readily document their equivalency by providing
existing information or pre-existing documents. EPA does not anticipate
a significant paperwork burden for States, and is
[[Page 47403]]
offering this opportunity in response to States' requests in comments
to be allowed to continue to implement their own regulations. EPA
believes that in States where the lead pesticide agency is not
responsible for enforcing containment regulations, collaboration
between the State's agencies will be feasible. State regulators are
encouraged to consult with EPA prior to preparing their submission.
IX. Labeling Requirements for Pesticides and Devices
A. Overview
1. Final regulations. Today's final rule changes the requirements
for labeling pesticides in 40 CFR part 156 in several ways. First,
these regulations add a new subpart H, entitled Container Labeling to
part 156. The new container labeling regulations include the following
requirements:
? A statement identifying the container as nonrefillable or
refillable is required on all pesticide labels. In addition,
nonrefillable container labels must include several statements
providing basic instructions for managing the container and a batch
code for the product. (See Units IX.B. - IX.D. for more details.)
? Cleaning instructions for some nonrefillable containers,
specifically for dilutable products that are sold or distributed in
rigid containers and that are not household/residential. (See Units
IX.E. - IX.K. for more details.)
? Instructions for cleaning all refillable containers before
disposal. (See Units IX.E. and IX.L. for more details.)
In addition, today's final rule modifies several existing
requirements in 40 CFR 156.10 to allow for blank spaces on the labels
of some refillable containers for the net contents and EPA
establishment number. In addition, the paragraph in 40 CFR 156.10 that
requires storage and disposal statements is being changed to be
consistent with the label requirements added to 40 CFR part 156 in
subpart H and the container regulations being added to 40 CFR part 165
in today's rule. (See Unit IX.M.)
Container-related labeling instructions for plant-incorporated
protectants will be determined on a case-by-case basis until specific
labeling guidance for plant-incorporated protectants are promulgated
under 40 CFR part 174.
Existing EPA guidance on label statements for cleaning, recycling
and disposing of pesticide containers, includes:
? The Label Review Manual (Ref. 44);
? PR Notice 83-3, Label Improvement Program -- Storage and
Disposal Label Statements (Ref. 73);
? PR Notice 84-1, Clarification of Label Improvement Program (Ref. 72);
? PR Notice 94-2, Recycling Empty Aerosol Pesticide
Containers (Ref. 65);
? PR Notice 98-10, Notifications, Non-Notifications and
Minor Formulation Amendments (Ref. 56); and
? PR Notice 2001-6, Disposal Instructions on Non-
Antimicrobial Residential/Household Use Pesticide Product Labels (Ref. 49).
This guidance will be revised, if necessary, to be consistent with
the requirements in today's final regulation.
2. Changes. The final labeling regulations in today's rule cover
the same statements and topics that were included in the proposed rule.
However, a number of changes have been made to the regulations,
including but not limited to modifying specific statements, adding
alternative statements, restructuring the regulations based on the
plain language format, and exempting household/residential pesticide
products from the requirements for cleaning instructions on
nonrefillable container labels. The specific changes are described in
the section-by-section discussion below.
B. Identification of Container Types (Sec. 156.140)
1. Final regulations. This section applies to all pesticide
products and requires statements that, among other things, identify the
container as nonrefillable or refillable. These statements must be
placed on the label or container. The regulations in 40 CFR
156.10(a)(4)(i) require the label to ``appear on or be securely
attached to the immediate container of the pesticide product.''
Therefore, the statements required by Sec. 156.140 cannot be placed
only on labeling that is not attached to the container, because it may
become separated. The information may be located on any part of the
container except the closure. If the statements are placed on the
container, they must be durably marked on the container. Durable
marking includes, but is not limited to etching, embossing, ink
jetting, stamping, heat stamping, mechanically attaching a plate,
molding, or marking with durable ink.
2. Changes. In the final rule, EPA has changed the word
``permanent'' to ``durable'' to describe the required container
marking. In addition, the language from the preamble of the proposed
rule that lists acceptable formats of the marking was added to the
regulations to clearly establish our intent. Finally, the phrase ``as
applicable'' was added to the first sentence to accommodate the fact
that the statements in paragraph (a) apply only to labels on
nonrefillable containers and the statements in paragraph (b) apply only
to the labels on refillable containers.
C. Statements Required for Nonrefillable Containers (Sec. 156.140(a))
1. Final regulations. The final rule requires all nonrefillable
containers to have the following four items on the label or the container:
? The phrase ``Nonrefillable container;''
? A statement regarding reuse;
? A statement about recycling or reconditioning; and
? A batch code.
If the first three items are placed on the label, they must be put
under an appropriate heading under the heading ``Storage and
Disposal.'' If any of the first three items are placed on the
container, an appropriate referral statement, such as the statement in
Sec. 156.140(a), must be placed on the label under the heading
``Storage and Disposal.''
2. Changes. These statements were reorganized by separating each
phrase or statement into a different regulatory paragraph to
accommodate the addition of alternative statements. The proposed rule
included all four items, but included the first three as one statement:
``Nonrefillable container. Do not reuse or refill this container. Offer
for recycling if possible.'' Also, the final rule specifies that if the
first three statements are placed on the label (rather than on the
container), they must be placed under the ``Storage and Disposal''
heading on the label. EPA added this language to reinforce the
requirement in Sec. 156.10(i)(2)(ix) for the instructions in subpart H
to appear under the ``Storage and Disposal'' heading. These three
statements must be under an appropriate heading under the storage and
disposal heading, although they may be in any order. EPA believes it is
better to provide registrants flexibility in where to place these
statements. Some registrants may choose to place them all together,
while others may choose to place the recycling statement after the
cleaning (residue removal) instructions.
The final rule was revised to require a referral statement on the
label if any of the statements except the batch code are placed on the
container. Examples of appropriate referral statements are ``See
container for handling and recycling statements.''; ``Recycling
information is located on the container.''; and ``See the container for
refill limitations.'' The
[[Page 47404]]
referral statement will provide information to allow users who look for
refill prohibitions or recycling statements in the storage and disposal
section of the label to find the information.
i. Statement identifying a nonrefillable container--Final
regulations and changes. The identifying phrase ``Nonrefillable
container'' is identical to the identifying phrase in the proposed
regulations.
ii. Reuse Statement--Final regulations. Registrants must choose to
use one of the following reuse statements, as appropriate. Products
with labels that allow household/residential use must use the statement
in item (1) or (3). All other products must use one of the three
statements.
(1) ``Do not reuse or refill this container.''
(2) ``Do not reuse this container to hold materials other than
pesticides or dilute pesticides (rinsates). After emptying and
cleaning, it may be allowable to temporarily hold rinsate or other
pesticide-related materials in the container. Contact your state
regulatory agency to determine allowable practices in your state.''
(3) The following statement may be used if a product is ``ready-to-
use'' and its directions for use allow a different product (that is a
similar, but concentrated formulation) to be poured into the container
and diluted by the end user: ``Do not reuse or refill this container
unless the directions for use allow a different (concentrated) product
to be diluted in the container.''
iii. Changes. The proposed rule required the first statement, ``Do
not reuse or refill this container.'' The second statement was added to
address a common practice where pesticide applicators use plastic jugs
to hold rinsate that contains the pesticide on the label, which could
be interpreted as a violation of a ``Do not reuse'' statement. While
EPA has some concerns about the widespread storage of rinsate or other
pesticide-containing materials in pesticide containers (without proper
management practices such as marking the contents and date on the
container), we acknowledge the day-to-day reality of pesticide
operations that sometimes there are materials such as rinsates or
leftover tank mix that must be dealt with. While temporarily storing
these materials in pesticide containers can create disposal problems if
the material is not managed properly and promptly, temporary storage is
better than most of the other low-cost, practical alternatives such as
dumping the rinsate or leftover material. Therefore, the second
statement was added to provide some flexibility while still prohibiting
the reuse of nonrefillable containers for materials other than
pesticides, including but not limited to water, food, feed and oil.
However, EPA does not believe that household/residential pesticide
users are likely to be able to properly manage rinsate and other
pesticide-containing materials in this way, so this statement cannot be
used on household/residential use products.
The third statement was added in response to comments describing
ready-to-use products in containers that are intended to be sold or
distributed only once, but that can be refilled by the end user with a
concentrate (a different product) and then diluted. The third statement
gives registrants the option to continue distributing products in this
way, but still provides end users with the message that these
containers should generally not be reused or refilled.
iv. Comments - refill with concentrate. Several commenters noted
that a prohibition on reuse or refill would make a common practice
illegal. Specifically, some ready-to-use products are distributed or
sold in containers that are intended to be sold or distributed only
once (and therefore meet the definition of nonrefillable containers).
However, these containers can be refilled by the end user (generally a
household user) with a concentrate and then diluted. A few respondents
suggested not requiring the reuse statement on ready-to-use product
containers and several others offered an alternative statement for
these products.
v. EPA response - refill with concentrate. EPA agrees that the use
of containers of ready-to-use products to be refilled with a different
product (that is a similar, but concentrated formulation) and diluted
by the end user should be allowed to continue. In a relatively quick
search of product labels, EPA found a number of household/residential
use herbicides with label directions that allowed this practice. This
environmentally beneficial practice reduces the amount of packaging
used and packaging waste produced, since a smaller container can be
used to distribute the concentrate. Therefore, the final regulation
includes an alternative statement that allows this practice to
continue. Currently, we believe this situation is most commonly used
for household products, although the final regulations were written to
allow any products (not just household/residential use products) to be
able to use the appropriate refill/reuse statement on their labels.
3. Recycling or reconditioning statement--i. Final regulations.
Registrants must use at least one of the following statements:
(1) ``Offer for recycling if available.''
(2) ``Once cleaned, some agricultural plastic pesticide containers
can be taken to a container collection site or picked up for recycling.
To find the nearest site, contact your chemical dealer or manufacturer
or contact [a pesticide container recycling organization]
at [phone
number]
or [web site]. For example, this statement could be ``Once
cleaned, some agricultural plastic pesticide containers can be taken to
a container collection site or picked up for recycling. To find the
nearest site, contact your chemical dealer or manufacturer or contact
the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free)
or http://www.acrecycle.org.'' 
(3) A recycling statement approved by EPA and published in an EPA
document, such as a Pesticide Registration Notice.
(4) An alternative recycling statement that has been reviewed and
approved by EPA.
(5) ``Offer for reconditioning if appropriate.''
ii. Changes. The final rule includes options for container
recycling statements to account for differences in the process for
recycling different kinds of containers (e.g., aerosol cans or plastic
jugs) and differences in recycling among markets (agricultural or
household). In addition, the proposed rule specified the statement
``Offer for recycling if possible.'' In the final rule, EPA changed the
word possible to available. Finally, EPA added a statement ``Offer for
reconditioning if appropriate'' as an alternative.
iii. Comments - recycling. Several commenters addressed the issue
of recycling. A user group supported the continued development of
container collection and recycling programs. A registrant endorsed
recycling but commented that the language must comply with Federal
Trade Commission (FTC) guidance. A registrant group requested that the
terms of PR Notice 94-2 ``Recycling Empty Aerosol Pesticide
Containers'' as amended by letter on June 9, 1994, be codified into
regulation. A State regulatory agency urged EPA to specifically direct
users to agricultural pesticide container collection programs to
prevent agricultural pesticide containers being offered for household
recycling collection. Another State regulatory agency suggested a label
statement requiring small rinsed containers to be delivered to State-
authorized container collection programs. This commenter stated that
use of the word ``possible''
[[Page 47405]]
would be problematic because while it is possible for farmers to travel
more than 100 miles to a recycling center, it would be unreasonable to
expect that. A group of people involved with pesticide container
recycling in Washington State submitted suggestions for changing the
storage and disposal statements on pesticide containers. These comments
specifically supported the efforts of the Ag Container Recycling
Council (ACRC) and recommended a statement that refers to the ACRC and
provides the ACRC web site.
In response to the 2004 notice, four State regulatory agencies and
a registrant group urged the Agency to do more to encourage recycling
of pesticide containers and to remove label references to burning or
burying containers. A few State agencies noted efforts by ACRC, Earth
911 and the National Pesticide Stewardship Alliance to promote
recycling and reform label language. These respondents noted that the
Agency needs to go further than what was proposed in the rule in order
to improve labeling such that burning and burying of containers is no
longer allowed.
iv. EPA response - recycling. EPA agrees with intent of the
commenter who suggested codifying PR Notice 94-2. The third option
included in the final rule, a recycling statement approved by EPA and
published in an EPA document, is included to account for PR Notice 94-
2, other PR Notices, the label review manual, and other documents.
EPA agrees with the State regulatory agencies and Washington
container recycling group that it may be beneficial to provide more
specific information about pesticide container collection and recycling
programs in this statement, particularly for agricultural pesticide
products. Therefore, the final regulations allow the use of a new
recycling statement that provides details about how to obtain more
information on agricultural pesticide container collection and
recycling programs such as the ACRC. The ACRC is a non-profit
organization that promotes and supports the collection and recycling of
plastic pesticide containers in the U.S. The collection and recycling
programs conducted by the ACRC grew significantly during the 1990's, so
EPA is adding this statement to reflect currently available programs
(that were in the developmental stage when the proposed regulations
were being written). For example, in 1993 the ACRC collected about 2.5
million pounds of plastic containers. In 2001, ACRC collected over 7
million pounds of plastic containers, which represents about 25 percent
of the plastic containers distributed by the ACRC member companies.
(Ref. 1) EPA has been told by ACRC recyclers and member companies and
by ACRC's State partners that participation could be increased if the
label specifically referred to the ACRC program. EPA hopes to encourage
the recycling of pesticide containers by including this recycling
statement as an option. EPA also recognizes the need for flexibility in
the label instructions, as other, equally effective organizations may
come into existence in the future, and that the organization Earth 911
(http://www.earth911.org), a clearinghouse of information on
household hazardous waste disposal and recycling, may eventually include
information resources specifically for managing agricultural chemicals
and containers.
EPA agrees that the word ``possible'' may not be clear, and has
replaced it with the word ``available.'' ACRC programs are available
that is, accessible for agricultural pesticide users across much of the
U.S., but not all areas have local collection programs. EPA believes
that a reasonable interpretation of ``available'' is that pesticide
containers are collected at a location that is the same distance or
closer than the distance the user traveled to purchase the pesticides.
It is worth noting that the statement ``Offer for recycling if
available'' and the other statements in Sec. 156.140(a)(3) give
pesticide users an option for managing the containers. These statements
do not require the recycling or reconditioning of containers. EPA
believes that recycling or reconditioning pesticide containers is a
responsible, preferable way of managing pesticide containers. We
encourage these practices to save resources and minimize the amount of
material being disposed, although there are other legal ways of
managing the containers.
The final rule also includes the option for a registrant to offer
an alternative recycling statement. This is intended to allow for the
possibility of changes in the extent to which and the manner in which
pesticide containers are recycled over time. EPA must review and
approve an alternative recycling statement before it can be placed on a
pesticide label. One part of our review will involve considering
whether the alternative statement is consistent with the FTC guidelines
on environmental statements in 16 CFR part 260, ``Guides for the Use of
Environmental Marketing Claims.'' (Ref. 5)
(http://www.ftc.gov/bcp/conline/edcams/eande/index.html)
EPA agrees with commenters that label language regarding burning
and burying containers needs to be improved and is engaged in
discussions with stakeholders to address this issue. Container disposal
instructions were not addressed in the proposed container and
containment regulations and therefore are outside the scope of the
final regulations. In addition, EPA staff are actively working on
improving the label manual.
v. Comments - reconditioning. Many commenters on the proposed
regulations, including container manufacturer and registrant groups,
stated that the regulations do not account for the reconditioning of
containers and opposed many proposed provisions because they would be
problematic for reconditioning. These respondents also commented that
some containers are commonly reconditioned, particularly plastic and
steel drums holding non-agricultural pesticides.
vi. EPA response - reconditioning. EPA added a statement about
reconditioning to the final rule as an alternative for containers that
are commonly reconditioned. The statement says ``Offer for
reconditioning if appropriate'' because reconditioning is a logical,
reasonable option only for certain containers, specifically drums, and
not others, such as plastic jugs and aerosol cans. EPA believes this
flexibility should alleviate some of the commenters' concerns about the
apparent disregard for reconditioning.
4. Batch code--i. Final regulations. A lot number, or other code
used by the registrant or producer to identify the batch of the
pesticide product, is required for each nonrefillable container either
on the label or the container.
ii. Changes. The text specifying a lot number or other code in the
final rule is identical to the text in the proposal. In the final rule,
though, the introductory paragraph was modified to clarify that the lot
number/batch code could be placed anywhere on the label or durably (not
permanently) marked on the container.
D. Statements Required for Refillable Containers (Sec. 156.140(b))
1. Final regulations. For refillable containers, one of the
following statements is required on the label or the container:
(1) ``Refillable Container. Refill this container with pesticide
only. Do not reuse this container for any other purpose.''
(2) ``Refillable Container. Refill this container with [common
chemical name]
only. Do not reuse this container for any other purpose.''
If the statement is on the label, it must be placed under the
``Storage and Disposal'' heading. If the statement is
[[Page 47406]]
put on the container, the label must include an appropriate referral
statement under the ``Storage and Disposal'' heading.
2. Changes. The proposed rule specified only the first statement.
In response to comments, the second statement was added to the final
rule as an option to accommodate containers that may be filled with a
chemical that has both pesticidal and non-pesticidal uses. Also, the
phrase ``Refillable container'' was added to both statements to allow
pesticide users, registrants and government regulators to clearly
identify whether a container is nonrefillable or refillable. The final
rule specifies that if the statement is placed on the label (rather
than on the container), it must be placed under the ``Storage and
Disposal'' heading. EPA added this language to reinforce the
requirement in Sec. 156.10(i)(2)(ix) for the instructions in subpart H
to appear under the ``Storage and Disposal'' heading. Lastly, the final
rule was revised to require a referral statement on the label if the
statement is placed on the container. An example of an appropriate
referral statement is ``Refilling limitations are on the container.''
The referral statement will provide information to allow users who look
for refill prohibitions in the storage and disposal section of the
label to find the information.
E. Residue Removal Instructions - General (Sec. 156.144)
1. Final regulations. Unless exempt from these requirements, the
label of each pesticide product must have instructions on the removal
of pesticide residue prior to disposal, as specified in Sec. Sec.
156.146 and 156.156. The regulations in Sec. 156.144 include the
following specifications:
? Residue removal statements are required for both
nonrefillable and refillable containers.
? Residue removal statements must be placed under the
heading ``Storage and Disposal.''
? Residential/household use pesticide products are exempt
from the residue removal statement requirements.
? EPA may modify or waive the residue removal requirements
or permit or require alternative labeling statements.
2. Changes. The most significant change to this section is that the
final rule exempts residential/household use pesticide products from
the residue removal statement requirements. The proposed rule would
have applied to the labels of all products, regardless of the pesticide
market in which they are sold, distributed and used. EPA also made a
few minor changes in the final rule. The proposed rule specified a
subheading entitled ``Container Cleaning'' under the heading ``Storage
and Disposal.'' In the final rule, EPA deleted this subheading because
it is unnecessary. Section 156.144(b) regarding placement of the
residue removal statements was shortened by deleting the reference to
Directions for Use, which isn't necessary. EPA believes requiring the
statements to be placed under the heading ``Storage and Disposal'' is
sufficient because Sec. 156.10(i)(2)(ix) requires this heading to be
included in the directions for use. Finally, a few editorial changes
were made to shorten the phrase ``residue removal statements and
instructions'' to ``residue removal instructions'' to be more precise
and consistent. The rest of the requirements of Sec. 156.144 are
identical to those in the proposed rule.
FIFRA section 19(f) mandates ``regulations prescribing procedures
and standards for the removal of pesticides from containers prior to
disposal'' and says that EPA ``may, at the discretion of the
Administrator, exempt products intended solely for household use'' from
these requirements. In the proposed rule, EPA chose not to exercise
this discretion and proposed to require cleaning instructions on the
labels of household products because the preamble of the proposed rule
stated that, in many instances, the same pesticide product in the same
container is sold for agricultural or industrial use, as well as for
use in the home, yard, or garden.
The 1999 Supplemental Notice (Ref. 53) stated that the changes in
scope would only apply to the container standards and that:
EPA believes that it is appropriate to have container cleaning
and disposal instructions on the labels of all pesticides because of
safety and environmental protection considerations for recycling
operations. It is necessary for pesticide containers to be properly
emptied and cleaned prior to being recycled to protect workers who
handle the recyclable material and to prevent releases of pesticides
to the environment. Because pesticide containers from all segments
of the pesticide industry are currently being recycled, container
cleaning and disposal instructions are needed on the labels of all
pesticides. ...
During the development of the final PR Notice 2001-6, ``Disposal
Instructions on Non-Antimicrobial, Residential/Household Use Pesticide
Product Labels,'' however, EPA decided to change this position for non-
antimicrobial, residential/household use pesticide products. (Ref. 49).
As stated in PR Notice 2001-6:
Specific instructions to consumers to rinse their empty
containers have been left out of these revised instructions.
Experience has shown that many consumers are confused by rinsing
procedures and often incorrectly dispose of the rinse water down the
drain or down sewers. States have reported some detections of
pesticides in drinking water that appear, in some cases, to be
linked to disposal or rinsing in residential waste water systems. In
addition, storage of rinsate is highly discouraged because of the
absence of adequate labeling or packaging. There is also the
potential risk of adverse chemical reactions occurring when products
are poured down drains, singly, or in combination with other products.
One potential solution that EPA considered but rejected when
finalizing PR Notice 2001-6 was to require rinsing of non-
antimicrobial, residential/household use pesticide containers and to
include instructions on the label for how to manage the rinse water.
For example, the label statement in PR Notice 2001-6 could have
instructed the user to add the rinse water to the pesticide mixture
that will be applied, or if that isn't feasible, the rinse water could
be applied to a site on the label in accordance with the other label
provisions. EPA rejected this option because it could confuse
consumers, it could lead to the storage of rinse water in the absence
of adequate labeling or packaging, and it would require several
additional sentences on an already crowded label.
Therefore, EPA has decided to omit rinsing instructions from the
label directions specified for non-antimicrobial, residential/household
pesticide products in PR Notice 2001-6. In markets where empty
containers of these pesticides are recyclable, it is assumed that the
recycling programs will provide consumers with instructions to rinse
the containers if the recycling program believes it is necessary.
Additionally, if a manufacturer wants to include a rinsing statement on
the labels of these pesticides, EPA would consider such a request.
However, if a manufacturer chooses to include a rinsing statement, it
should also include instructions about how to manage the rinse water.
In the final rule, EPA is continuing the policy to omit rinsing
instructions from the label directions for non-antimicrobial,
residential/household pesticide products. In addition, EPA decided to
extend this policy to antimicrobial, residential/household pesticide
products in the final rule. Antimicrobial products were not included in
the scope of PR Notice 2001-6 because of differences of opinions on the
disposal statements in the PR Notice, not because of problems
[[Page 47407]]
with applying the no-rinsing policy to household/residential
antimicrobial products. EPA believes that some of the same concerns
about household/residential pesticide users, including users being
confused and trying to prevent the storage of rinsate, apply equally to
antimicrobial and non-antimicrobial products used by these household/
residential pesticide users.
F. Residue Removal Instructions for Nonrefillable Containers - General
(Sec. 156.146)
1. Final regulations. Section 156.146 sets out the residue removal
instructions for nonrefillable containers. The label of a product must
comply with these instructions if all of the following criteria are met:
? The product must comply with the residue removal
instructions based on Sec. 156.144 (i.e., it is not a residential/
household product, EPA has not waived the requirement, or EPA has not
established an alternative requirement);
? The product is dilutable (it could be a liquid or a solid); and
? The product is distributed or sold in a nonrefillable
container that is rigid.
The preamble to the proposed rule stated that EPA was holding
sections in reserve for residue removal instructions for other
formulation/container combinations, such as dilutable products in non-
rigid containers. While EPA may address other kinds of nonrefillable
containers in the future, the final rule establishes residue removal
instructions only for dilutable products in rigid nonrefillable containers.
The labels of dilutable products that are subject to this
requirement and that are sold or distributed in rigid, nonrefillable
containers must comply with the following standards:
? A statement instructing the user to clean the container
promptly after emptying is mandatory;
? Triple rinsing instructions are mandatory;
? Pressure rinsing instructions are optional; and
? A registrant must obtain EPA approval before including a
rinsing procedure that specifies a diluent other than water.
These requirements are discussed in more detail in Units IX.G.
through IX.K. below.
2. Changes. The final regulation includes several changes from the
proposal. The most significant changes are that the final rule requires
registrants to place the triple rinse instructions on all labels and
provides registrants the option to also include the pressure-rinse
instructions. The proposed rule gave registrants the option to include
either triple rinsing or pressure rinsing or both. Based on comments,
EPA changed the final rule because triple rinsing is always possible,
whereas pressure rinsing requires specific equipment. Other substantial
changes to the residue removal instructions include:
? Adding the phrase ``or equivalent'' as an option so labels
allow equivalent means of rinsing containers. This was added to account
for systems (such as closed system rinsing or home-made pressure
rinsing systems) that are designed to clean containers thoroughly but
do not technically triple rinse the containers. This change was made to
the statement identifying when containers must be rinsed and is
discussed in more detail in Unit IX.G.
? Both the triple rinse and pressure rinse procedures were
modified so they would take less time. For example, the intervals of
time for draining and shaking the containers were reduced. These
changes are intended to make the procedures more practical and
therefore more likely to be followed by end users. These changes are
discussed in more detail in Unit IX.H.
Numerous other minor modifications, which are described in Units
IX.G. - IX.K., were made to the residue removal instructions for
nonrefillable containers.
3. Comments - which procedure? The proposed rule would have
required the placement of either the triple rinse or the pressure rinse
procedure on the label, with the option of including both. The preamble
requested comments on this approach. The following comments addressed
this question.
i. Both procedures. Several State regulatory agencies and a
registrant group supported including both triple and pressure rinsing
instructions on labels. A few of these commenters pointed out that
pressure rinsing alone is not available to all applicators.
ii. Alternative approach. A few dealer groups recommended using the
statement ``Pressure rinse or triple rinse'' so users and dealers will
not have to worry about having both rinse systems available.
iii. Either or both procedures. A registrant group supported the
approach of allowing the registrant to put either or both of the
statements on the label, because pressure rinsing would not be appropriate
for institutional products and including both would crowd the label.
iv. Limit pressure rinsing. Some commenters, including registrants,
registrant groups, and a State regulatory agency, expressed concern
about household users pressure rinsing small containers. Many of these
respondents suggested excluding pressure rinsing from household product
labels. A registrant group also added institutional and industrial
products to this suggested exclusion. Similarly, another registrant
group commented that pressure rinsing is not common in the
institutional sector. Alternatively, a few registrant groups and a
registrant recommended that pressure rinsing instructions be permitted
only on containers with capacities larger than one gallon.
v. Decision making process. Some registrants and registrant groups
commented that EPA implies that some sort of decision making process
must be used to determine if triple rinsing, pressure rinsing, or both
should be included and requested EPA to clarify this. For example, does
a container have to meet a six 9's standard by a laboratory pressure
rinsing test for pressure rinsing instructions to be included on the
label? If so, EPA has to specify the pressure rinsing test procedure.
vi. Effectiveness of procedures. Several commenters addressed the
efficacy of pressure rinsing vs. triple rinsing. A registrant group and
two registrants commented that pressure rinsing should be recommended
on labels only if it has been shown to be as effective as triple
rinsing. Another registrant stated that their studies (in addition to
the work of other companies) shows that pressure rinsing is not as
effective as triple rinsing. A State regulatory agency commented that
pressure rinsing is a more effective method of cleaning containers.
vii. Advantages of pressure rinsing. A State regulatory agency and
a registrant commented that pressure rinsing is advantageous to the
pesticide users because it is a faster procedure.
4. EPA response - which procedure? EPA agrees with several of the
points made by commenters, in particular, that pressure rinsing alone
is not available to all applicators, that pressure rinsing isn't
appropriate for certain containers based on the pesticide market and/or
container size, and that pressure rinsing is attractive to pesticide
users because it is a faster procedure. Therefore, EPA changed the
approach so the final regulation requires labels to include the triple
rinse procedure and gives registrants the option to also include the
pressure rinse procedure. This approach provides a rinse procedure
(triple rinsing) that all pesticide users can follow. It also gives
registrants the option to include pressure rinsing if they believe it
is appropriate (with EPA concurrence during the review of
[[Page 47408]]
labels), which is preferable to establishing criteria for appropriate
(or inappropriate) pressure rinsing situations in the regulations.
EPA believes that both triple rinsing and pressure rinsing are
effective ways for users to clean most containers (with possible
exceptions for size and other situations) in the field. This conclusion
is based on the rinsing studies described in Reference 40 and on the
field experience of people who have inspected containers over the past
decade of pesticide container recycling programs. One registrant group
provided comprehensive comments during the 2004 reopening of the
comment period based on the ACRC's experience over the past 10 years.
This commenter described ACRC's efforts to assess and control the risk
from using the recycled plastic and noted that, since ACRC's inception
in 1992, there have been no reports of incidents where public health or
safety has been compromised as a result of exposure to the minimal
residues found in recycled plastic pesticide containers. This
registrant group also stated that ACRC's experience with recycling
clean, rinsed one-way pesticide containers for more than a decade leads
them to believe that residue removal is an issue of instructing
applicators to triple or pressure rinse containers immediately after use.
EPA's goal is to establish a situation where all containers are
adequately cleaned before they are recycled, disposed, or otherwise
managed. As stated in Unit V.H.1., one regulatory contribution to
achieving this goal is ensuring that pesticide users have access to
clear, detailed instructions for how to clean the containers. In the
final rule, pesticide labels must include triple rinse instructions and
may also include pressure rinse instructions.
Another regulatory contribution is to ensure the use of container
designs and formulations that facilitate effective residue removal,
which is the intent of the residue removal standard for nonrefillable
containers in Sec. 165.25(f). The residue removal test procedure
requires containers to be triple rinsed. In this case, triple rinsing
is used as an indication of how easily the pesticide can be removed
from the container. The residue removal test procedure does not require
containers to be pressure rinsed nor is it intended to evaluate whether
triple rinsing or pressure rinsing is more effective for a certain
container and pesticide formulation. Therefore, the decision of whether
or not to include pressure rinsing instructions on the pesticide label
is not tied to the results of laboratory residue removal testing.
Instead, registrants have the option to include pressure rinsing if
they believe it is appropriate (with EPA concurrence during the review
of labels).
There are other integral parts to achieving the goal of having
clean containers before they are disposed or recycled, including
educating pesticide users on the importance of rinsing and the proper
procedures, potential spot checks/inspections to ensure that the labels
and regulations are being complied with, and creating an incentive for
pesticide users to comply (or a disincentive for non-compliance). EPA
looks forward to working with all stakeholders, including State
regulatory agencies, pesticide registrants, distributors and dealers,
pesticide users, pesticide educators, and trade associations in
accomplishing this goal.
G. Timing of the Residue Removal Procedure (Sec. 156.146(a))
1. Final regulations. For products that are subject to the
requirements for residue removal instructions, the label of each
nonrefillable container must include one of the following statements:
(1) ``Clean container promptly after emptying.''
(2) ``Triple rinse or pressure rinse container (or equivalent)
promptly after emptying.''
(3) ``Triple rinse container (or equivalent) promptly after emptying.''
The statement about timing must immediately precede the rinsing
instructions and must be consistent with the rinsing instructions
(triple rinse or both triple and pressure rinse) that are include on
the label.
2. Changes. This section of the final rule includes three changes
from the proposed regulation. First, the proposed requirement to rinse
``immediately'' after emptying was replaced in the final rule by
requiring the container to be rinsed ``promptly'' after emptying it.
Second, the final rule adds the phrase ``(or equivalent)'' to the two
statements that identify a specific cleaning procedure, e.g., triple
rinsing. Third, the proposed rule included four options for statements
to include on the label. EPA is not finalizing one of these statements
in the final rule--``Pressure rinse container immediately after
emptying'' --because it is no longer needed. The final rule does not
allow pressure rinsing to be the only procedure listed on the label, so
this statement is irrelevant.
3. Comments - clean promptly. Some State regulatory agencies
supported the statement regarding the timing of rinsing, stating that
it should improve the management of the containers. Two other State
regulatory agencies stated that, based on results from their container
collection and recycling programs in the early 1990's, it is obvious
that not all containers are rinsed immediately. A registrant group
suggested using the phrase ``reasonably promptly'' rather than
``immediately'' to account for industrial situations where its not
practical to rinse immediately such as when multiple oil wells are
treated from the same drum of an industrial biocide and rinsing
equipment is not available. An agricultural pesticide registrant
supported immediate rinsing in a farm context so that the rinsate could
be added to the application mixture, but noted that clean water may not
be available at every loading site.
4. EPA response - clean promptly. EPA considers the timing of the
residue removal procedure to be a critical factor in effectiveness, and
is maintaining the approach in the proposed rule that requires users to
rinse containers within a certain (short) time period after emptying
them. When rinsing is not performed soon after emptying the container,
the residue can dry and adhere to the inside and outside of the
container, and is then more difficult to remove. Containers with dried
residue are likely to be rejected by pesticide container recycling and
collection programs as well as at solid waste landfills.
EPA believes that requiring pesticide users to rinse containers
promptly after emptying them is the best approach for the final rule.
Specifying that the containers are cleaned promptly accomplishes the
goal of rinsing them soon after they are emptied and before the residue
dries in the containers. Also, prompt rinsing provides a little more
flexibility than immediate rinsing. As an example, consider a pesticide
applicator who pours product from one container, sets it down to pour
out another container, and then rinses both containers. Technically,
this could be considered a violation if the label specified immediate
rinsing, because some time passed between the emptying and the rinsing
of the first container. However, this example fits within EPA's
understanding of prompt action.
Requiring that containers be rinsed promptly gives pesticide users,
regulatory agencies and inspectors some discretion in determining
appropriate time spans. It is beyond the scope of this preamble to
describe every situation that is or is not appropriate, so EPA is
relying on the good judgement of applicators, regulatory agencies and
inspectors to assess the specific conditions of the situation. However,
EPA believes that situations where the
[[Page 47409]]
time between emptying and rinsing is days or weeks and where the
residue has completely dried inside the container are definitely beyond
the boundaries of prompt rinsing. In addition, EPA strongly recommends
that pesticide users rinse containers when the application mixture is
being prepared so the rinsate can be added to the application mixture.
This provides many benefits, including getting all of the value out of
the product and avoiding the creation of a potential waste (which could
happen if the rinsate was collected separately).
5. Comments - equivalency. In commenting on the proposed approach
for residue removal instructions, a few commenters (a State regulatory
agency and a registrant) supported maintaining the current cleaning
statement of ``Triple rinse (or equivalent)'' because it is sufficient
if followed and it offers flexibility.
6. EPA response - equivalency. EPA agrees with the commenters that
including the phrase ``(or equivalent)'' that is on current labels is
beneficial and the final rule adds this phrase as an option to the
``rinse promptly'' statement. This phrase was added to account for
systems (such as closed system rinsing or home-made pressure rinsing
systems) that are designed to clean containers thoroughly but do not
technically triple rinse the containers. The alternative rinsing system
should be thorough and it is the responsibility of the pesticide user
to ensure that it is equivalent to triple rinsing.
H. Duration of Triple and Pressure Rinse Procedures (Sec. 156.146(b)
and 156.146(c))
1. Final regulations. As discussed in Unit IX.I. for triple rinsing
and Unit IX.J. for pressure rinsing, the rinsing procedures for
containers that are small enough to shake that are defined in the final
regulation take less time to conduct than the proposed procedures. The
key time intervals identified in the procedures are:
? How long to drain liquid product from containers (both
triple and pressure rinsing);
? How long to agitate/shake containers during triple rinsing;
? How long to drain rinsate from containers after each
shaking interval during triple rinsing; and
? How long to pressure rinse the container during pressure rinsing.
2. Changes. The procedures in the final rule specify the following
times for each of these intervals for containers that are small enough
to shake:
? 10 seconds to drain liquid product from containers for
both triple and pressure rinsing (changed from 30 seconds in the proposal);
? 10 seconds to agitate/shake containers during triple
rinsing (changed from 30 seconds in the proposal);
? 10 seconds to drain rinsate from containers after each
shaking interval during triple rinsing (changed from 30 seconds in the
proposal); and
? At least 30 seconds to pressure rinse the container during
pressure rinsing. (The proposed rule specified 30 seconds; the phrase
``at least'' was added to compensate for variations in pressure rinsing
equipment and in pressure.)
3. Comments. A registrant group, a registrant and two State
regulatory agencies commented that a shorter rinse time would be better
and would encourage user compliance, although the two State regulatory
agencies supported a shorter rinse time only if it was demonstrated
that the containers are cleaned adequately. Another State regulatory
agency stated that, in a 1991 survey, 43 percent of private applicators
and 11 percent of commercial applicators responded that they did not
rinse containers because it took too much time. A registrant group
opposed the initial drain time of 30 seconds as too long and
inappropriate for closed systems. This commenter also responded that
some states have requirements different than a 30-second drain and
urged EPA to consider these alternatives. A registrant commented that
the times of the proposed rinsing procedures seemed reasonable and
expressed doubts that the triple rinse procedure could be shortened
much. This commenter added that a 40-second pressure rinse is
inadequate to achieve 99.9999 percent removal.
4. EPA response. In the preamble of the proposed rule, EPA
estimated that the proposed triple rinsing instructions would take
approximately 5 minutes to perform and the pressure rinsing procedure
would take approximately 2 minutes. EPA also requested comments on the
time burden of the proposed rinsing procedures, and the voluntary
submission of data on residue removal, including in particular the
cleaning efficiency of any suggested shorter triple rinse and pressure
rinse procedures.
EPA agrees with the commenters that a shorter rinse time would be
better and would encourage user compliance with the requirement to
rinse pesticide containers. In particular, we believe it is relatively
unlikely that a pesticide user would spend about 5 minutes triple
rinsing each container. The 30-second intervals for the initial
container drain time, the shaking time and the rinsate-draining times
were based on the rinsing instructions of many States, which were
incorporated into the laboratory triple rinse test methodology for the
proposed nonrefillable container residue removal standard.
EPA contracted for two studies on the effectiveness of shorter
triple rinse procedures. In a study conducted by Formulogics (Refs. 7
and 38), a flowable concentrate product was tested in three containers:
1-gallon and 2.5-gallon plastic jugs and a 5-gallon steel flathead can.
Nine different rinsing procedures were conducted for each container
size by varying the initial drain, shake and rinsate drain times
between 5, 10 and 30 seconds. The shake and rinsate drain times were
always the same. For example, the three variations for the initial
drain time of 5 seconds were: 5 second shake and 5 second rinsate
drain; 10 second shake and 10 second rinsate drain; and 30 second shake
and 30 second rinsate drain. These same three shake and rinsate drain
times were conducted for the initial drain times of 10 second and of 30
seconds. The pesticide concentration in the second through fifth rinses
was measured. EPA concludes that all nine rinsing procedures tested
were effective in cleaning all three containers because the active
ingredient concentration in the fourth rinse showed at least 99.99%
removal in all rinse time iterations. Two of the rinse procedures for
the 5-gallon container (5 sec. initial drain/5 sec. shake & rinsate
drain and 30 sec. initial drain/5 sec. shake & rinsate drain) resulted
in 99.99 percent removal; all other rinse procedures for all containers
met at least five 9's percent removal and most resulted in six 9's
percent removal.
In a study conducted by the University of Florida (Refs. 14 and
41), two formulations were tested in three containers, 1-gallon, 2.5-
gallon and 5-gallon plastic jugs. The flowable concentrate was tested
in all three containers and the emulsifiable concentrate was tested in
the 2.5-gallon and 5-gallon containers. Four different rinsing
procedures were conducted for each container size by varying the
initial drain, shake and rinsate drain times between 10 and 30 seconds
where the shake and rinsate drain times were always the same. Again,
EPA concludes that all four rinsing procedures tested were effective in
cleaning both formulations from all of the containers because the
active ingredient concentration in the fourth rinse showed at least
99.99% removal in all rinse time iterations.
The triple rinse procedure for labels in the final rule includes 10
second initial drain, shake and rinsate drain
[[Page 47410]]
times. EPA believes the data described above shows that this shorter
triple rinsing procedure, which should encourage end user compliance
with the requirement to triple rinse, will adequately clean containers
prior to recycling or disposal.
In addition, EPA has lowered the residue removal requirement in the
final nonrefillable container regulations from six 9's (99.9999
percent) to four 9's (99.99 percent), as discussed in Unit V.H. The
shorter rinse procedures reached at least 99.99 percent removal in all
of the containers and formulations tested. As cited by one of the State
regulatory agencies in its comments, the field reality is that many
users who do not rinse claim the time factor as the reason. By reducing
the time frames in the cleaning instructions, EPA hopes to increase
compliance within the pesticide user community.
I. Triple Rinse Instructions (Sec. 156.146(b))
1. Final regulations. For products that are subject to the
requirements for residue removal instructions, the label of each
nonrefillable container must include triple rinse instructions. There
are three different sets of triple rinsing instructions:
? For containers that are small enough for users to shake
them, holding dilutable liquid pesticides;
? For containers that are small enough for users to shake
them, holding dilutable solid pesticides; and
? For containers that are too large for users to shake.
In general, EPA believes that the largest containers that users can
shake during a triple rinse are those with capacities of 5 gallons for
liquids and 50 pounds for solids.
The triple rinse instructions for liquid dilutable pesticide
products in containers small enough for users to shake are:
Triple rinse as follows: Empty the remaining contents into
application equipment or a mix tank, and drain for 10 seconds after
the flow begins to drip. Fill the container 1/4 full with water and
recap. Shake for 10 seconds. Pour rinsate into application equipment
or a mix tank or store rinsate for later use or disposal. Drain for
10 seconds after the flow begins to drip. Repeat this procedure two
more times.
The final rule specifies slightly different instructions for solid
dilutable pesticide products in ``shake-able'' containers, because
solid materials do not ``drip'' as liquids do. The only difference for
solid dilutable pesticide products is that the first line is ``Triple
rinse as follows: Empty the remaining contents into application
equipment or a mix tank. Fill the container 1/4 full...'' The rest of
the procedure is identical to the one for liquids.
For containers that are too large for users to shake (i.e.,
containers larger than 5 gallons for liquids or 50 pounds for solids),
the triple rinse instructions are:
Triple rinse as follows: Empty remaining contents into
application equipment or a mix tank. Fill the container 1/4 full
with water. Replace and tighten closures. Tip container on its side
and roll it back and forth, ensuring at least one complete
revolution, for 30 seconds. Stand the container on its end and tip
it back and forth several times. Turn the container over onto its
other end and tip it back and forth several times. Empty the rinsate
into application equipment or a mix tank or store rinsate for later
use or disposal. Repeat this procedure two more times.
2. Changes. One significant change from the proposed rule is that
the final regulation requires a triple rinse procedure to be on the
label, where the proposal gave registrants the option to include triple
rinsing or pressure rinsing or both. Another modification is that the
final regulations provide a defined procedure for containers that are
too large for users to shake. Also, the phrase ``or a mix tank'' was
added as an option for where the product or the rinsate can be placed.
In addition, the following clarifying changes were made to both sets of
instructions for triple rinsing smaller containers that can be shaken:
? The introductory text specifies that the instructions
apply to ``containers small enough to shake'';
? The instruction to ``agitate'' was changed to ``shake'';
and
? As discussed in Unit IX.H., the time intervals were
changed from 30 seconds to 10 seconds for the initial draining of the
container (for liquid products only), the time the container needs to
be shaken, and for the draining of the rinsate.
3. Comments - general. A State regulatory agency pointed out that
the directions prohibit preparing the use dilution in a mix tank, which
is a common practice. A registrant commented that the degree of
agitation needs to be specified, e.g., shake vigorously for 30 seconds.
4. EPA response - general. EPA did not intend to prohibit users
from pouring a product into a mix tank or diluting a product in a mix
tank, and we have amended the triple rinse procedures to address this
oversight. The phrase ``or a mix tank'' was added to the instructions
for emptying containers and to the rinsate management instructions to
allow the product and rinsate to be placed into application equipment
or a mix tank.
EPA agrees with the registrant and believes that ``shake'' is a
better description of the intended activity than ``agitate.'' We
decided not to include the qualifier ``vigorously'' to keep the
statement as succinct as possible. This kind of information could be
passed along to users during training and outreach.
5. Comments - large containers. Several commenters described
problems with cleaning drums according to the proposed triple rinse
statement. A registrant group stated that it is impractical to fill a
55-gallon drum one quarter full because more than 40 gallons of rinsate
would be produced. A different registrant group and a registrant
recommended directing the user to place the drum on its side and roll
it, because it is extremely difficult to shake a large container that
is one-quarter full. Another registrant commented that an additional
statement that describes rinsing by recirculation would be helpful, but
pointed out that many drum users don't use pumps to empty them.
6. EPA response - large containers. EPA agrees with the suggestion
by the commenters who recommended directing the user to place a drum on
its side and roll it. EPA is hesitant to recommend a cleaning procedure
for larger containers that requires equipment that a pesticide user may
not have, such as a pump, or an appropriately sized, heavy-duty
pressure rinse nozzle. Therefore, we decided to define a triple rinse
procedure in the final regulation for containers that are too large to
be shaken. This is consistent with the approach in the final rule to
require triple rinsing because all pesticide users can comply with
these instructions and to allow pressure rinsing as an optional,
additional statement.
J. Pressure Rinse Instructions (Sec. 156.146(c))
1. Final regulations. For products that are subject to the
requirements for residue removal instructions, the label of each
nonrefillable container may include pressure rinse instructions. The
decision regarding whether to include pressure rinsing instructions as
an option is at the discretion of the registrant, based on the
registrant's assessment of the procedure's effectiveness and
appropriateness for the formulation/container combination. However, if
the statement ``Triple rinse or pressure rinse container (or
equivalent) promptly after emptying'' is used on the label as the
statement about timing, pressure rinse instructions must be placed on
the label. If a registrant
[[Page 47411]]
chooses to include pressure rinsing instructions on the label as an
option for cleaning a liquid dilutable pesticide product, the statement
must immediately follow the triple rinse instructions.
The pressure rinse instructions for liquid dilutable pesticide
products are:
Pressure rinse as follows: Empty the remaining contents into
application equipment or a mix tank and continue to drain for 10
seconds after the flow begins to drip. Hold container upside down
over application equipment or mix tank or collect rinsate for later
use or disposal. Insert pressure rinsing nozzle in the side of the
container, and rinse at about 40 PSI for at least 30 seconds. Drain
for 10 seconds after the flow begins to drip.
Slightly different instructions are required for pressure rinsing
dilutable liquid and dilutable solid pesticide formulations, because
dry materials do not ``drip'' like liquids do. The pressure rinsing
procedure specified in the final regulations for dilutable solid
pesticides is identical to the one for liquids, except it does not
include the initial 10-second draining prior to rinsing.
2. Changes. One significant change is that pressure rinsing
instructions are optional in the final rule, which requires a triple
rinse procedure to be included on the labels of products that must
comply. The proposal gave registrants the option to include triple
rinsing or pressure rinsing or both. In addition, the following changes
were made to both sets of instructions for pressure rinsing:
? The phrase ``or a mix tank'' was added as an option for
where the product or the rinsate can be placed.
? As discussed in Unit IX.H., several of the time intervals
were changed from 30 seconds to 10 seconds for the initial draining of
the container (for liquid products only) and for the draining of the
rinsate after the pressure rinse. The length of the pressure rinse
interval was changed from ``30 seconds'' to ``at least 30 seconds.''
? Several details about the orientation of the container
were added, including that the user must hold the container upside down
and insert the rinsing nozzle in the side of the container.
? The pressure requirement was changed from exactly 40 PSI
to ``about 40 PSI'' to allow a range of pressures in response to
several comments expressing concern about requiring a pressure of
exactly 40 PSI in the field.
3. Comments - container orientation. A few commenters noted that
the instructions are not clear in stating that the container must be
inverted and that the rinse nozzle must be inserted on the side (or
bottom) of the container. A registrant group suggested inserting the
nozzle ``on the side of the container opposite the closure and in a
direction towards the bottom of the container.'' A registrant
recommended instructing the user to ``Force pressure rinsing nozzle
through what was the bottom of the container or through the side of the
container and...'' and also recommended that the instructions specify
holding the container upside-down during the rinse process.
4. EPA response - container orientation. EPA agrees with these
commenters that more details about how to hold the container and where
the nozzle should be inserted should be included. Therefore, the
procedure was modified to instruct the user to hold the container
upside down and to insert the rinsing nozzle in the side of the container.
K. Non-Water Diluents (Sec. 156.146(d))
1. Final regulations. A registrant who wishes to require users to
clean a container with a diluent other than water (e.g. solvents) must
submit a written request to EPA to modify the residue removal
instructions of this section. EPA may grant the request if certain
conditions are met. The registrant must indicate why a non-water
diluent is necessary and must propose appropriate residue removal
instructions and disposal instructions that identify the diluent. If
the non-water diluent is permitted by the label to be used in
application, the instructions may allow the rinsate to be added to
application equipment or mix tank. If use of the diluent in application
is not permitted, the rinsate must be collected and stored for eventual
disposal. EPA must approve, in writing, the modification of the residue
removal instructions before the pesticide product can be distributed or
sold.
2. Changes. The final regulations are almost identical to the
proposed regulations regarding non-water diluents. The final rule adds
the requirement for the registrant to propose disposal instructions to
ensure that end users have information about how to appropriately
dispose of rinsate from a diluent other than water. One minor
modification was to add ``or mix tank'' as an option for where rinsate
may be added if the label allows the non-water diluent to be part of
the application mixture. This change was made to be consistent with the
changes in the triple rinse and pressure rinse instructions. In
addition, several minor editorial changes were made to make this
section more clear.
L. Residue Removal Instructions for Refillable Containers (Sec.
156.156)
1. General (Introductory Text for Sec. 156.156)--i. Final
regulations. The label of each pesticide product packaged in a
refillable container must include the residue removal instructions
specified in Sec. 156.156. The residue removal instructions must be
given for all pesticide products that are distributed or sold in
refillable containers, including those that do not require dilution
prior to application.
ii. Changes. This requirement is substantively the same as it was
in the proposed regulation. Some minor editorial and format changes
were made to improve the clarity of the regulatory text. In addition,
the second sentence, which reinforces that the instructions apply to
all products that are distributed or sold in refillable containers,
including those that do not require dilution prior to disposal, was
moved from the subsection on instructions for residue removal to the
introductory text. EPA made this change because the explanatory
language applies to the whole section (including instructions on the
timing of the procedures).
2. Timing of residue removal procedures (Sec. 156.156(a))--i.
Final regulations. The label of a pesticide product packaged in a
refillable container (and that is subject to this requirement) must
have one of the following sets of instructions on the timing of
container cleaning:
? ``Cleaning the container before final disposal is the
responsibility of the person disposing of the container. Cleaning
before refilling is the responsibility of the refiller.''
? ``Pressure rinsing the container before final disposal is
the responsibility of the person disposing of the container. Cleaning
before refilling is the responsibility of the refiller.''
The statement must immediately precede the residue removal
instructions and must be consistent with those instructions.
ii. Changes. These statements were expanded in the final regulation
to distinguish between cleaning before disposal and cleaning before
refilling in response to comments. The proposed statements simply said
``Clean [or pressure rinse]
container before disposal.'' The changes in
the final rule include adding ``final'' to the description of disposal,
adding that the person disposing of the container is responsible for
cleaning it, and including the additional statement of ``Cleaning
before refilling is the responsibility of the refiller.''
3. Residue removal instructions prior to container disposal (Sec.
156.156(b))--i.
[[Page 47412]]
Final regulations. For pesticide products sold or distributed in
refillable containers, the label must include instructions for cleaning
the container prior to disposal. The instructions must be appropriate
for the characteristics of the product and adequate to protect human
health and the environment. The instructions could include any one of
the following, as long as the instructions meet the standards described
in the previous sentence:
? The refilling residue removal procedure developed by the
registrant for the pesticide product.
? Standard industry practices for cleaning refillable containers.
? For pesticides that require dilution prior to application,
the following statement:
``To clean container before final disposal, empty the remaining
contents from this container into application equipment or a mix tank.
Fill the container about 10% full with water. Agitate vigorously or
recirculate water with the pump for 2 minutes. Pour or pump rinsate
into application equipment or rinsate collection system. Repeat this
rinsing procedure two more times.''
? Any other statement the registrant considers appropriate.
ii. Changes. The final regulations are almost identical to those in
the proposed rule, except for a few editorial and format changes. The
phrase ``To clean container before final disposal'' was added to the
specified procedure to emphasize that users should only clean the
container before disposal and not before having the container refilled.
The phrase ``into application equipment or a mix tank'' was added to be
consistent with the emptying instructions for nonrefillable containers.
One sentence that helps clarify the scope of the requirement for
residue removal instructions on refillable containers was moved from
this section to the introductory text since it applies to the whole section.
M. Amendments to Existing Sec. 156.10
1. Final regulations. The final rule modifies the existing
regulations in 40 CFR 156.10 in the following three ways:
? A new Sec. 156.10(d)(7) is added that allows the labels
for refillable containers to have a blank space to allow the net weight
or contents to be marked in by a refiller according to 40 CFR 165.65(h)
or 165.70(i);
? The existing Sec. 156.10(f) was modified to allow labels
for refillable containers to have a blank space to allow the EPA
establishment number to be marked in by a refiller according to 40 CFR
165.65(h) or 165.70(i); and
? The existing Sec. 156.10(i)(2)(ix) regarding storage and
disposal instructions was modified to refer to the applicable
requirements in the rest of today's final rule.
2. Changes. The most significant change to the approach taken in
the proposed regulation is that ``shall'' was changed to ``may'' in the
two paragraphs establishing blank spaces, thus changing them from
requirements to options for pesticide registrants. This change was made
to provide flexibility to registrants in response to comments. EPA
decided to make several minor revisions to the paragraphs allowing
blank spaces to link the 40 CFR part 156 regulations to the 40 CFR part
165 repackaging regulations and to clarify that the blank space does
not change the requirement for having the net contents or EPA
establishment number on the label. First, the regulatory text allowing
blank spaces was modified to refer to the 40 CFR part 165 regulations
that require refillers to ensure that the net contents and EPA
establishment number appear on the label. Second, the new paragraph in
Sec. 156.10(d)(7) was amended to clarify that Sec. 156.10(a)(1)(iii)
requires the net contents to be shown clearly and prominently on the
label.
The paragraph on storage and disposal instructions was modified to
account for changes in the structure of the container-related labeling,
so it refers to subpart H of part 156 rather than specific sections.
Finally, a requirement about the type size of the storage and disposal
heading was added to Sec. 156.10(i)(2)(ix) after the container
regulations were proposed in 1994. Today's final rule maintains this
requirement and corrects the reference to the child hazard warnings,
which are located in Sec. 156.60(b).
N. Compliance Date (Sec. 156.159)
1. Final regulations. The final regulations provide a 3-year
compliance period. Specifically, within 3 years from today's date, all
pesticide products distributed or sold by a registrant must have labels
that comply with the 40 CFR part 156 requirements established in the
final rule. This gives registrants a phase in period of 3 years to
comply with the labeling requirements in Sec. Sec. 156.10(d)(7),
156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146, and 156.156.
2. Changes. The most significant change is that the phase-in period
was extended from 2 years to 3 years from the publication of the final
rule. In addition, the regulatory language was revised to make it more
clear. EPA agrees with some of the commenters that a longer compliance
period will make it easier and less burdensome to comply with the label
standards. To facilitate compliance while trying to minimize the impact
on companies, EPA lengthened the compliance period for the label
standards to 3 years. EPA believes that a 3-year period is sufficient
based on the results of the economic analysis. In addition, 3 years is
consistent with the phase-in period for the nonrefillable container
regulations.
X. Relationship to Other Programs and Agencies
Certain laws administered by EPA and other agencies may affect the
design of pesticide containers or procedures and standards for removal
of residue from pesticide containers. This section identifies the laws
that EPA considers to have the most significant impact on pesticide
containers and containment. The description of these laws is for
informational purposes only; no changes are being made in the laws
described below. Nothing in this final rule is intended to alter
obligations under other statutes.
A. Resource Conservation and Recovery Act (RCRA)
Requirements under RCRA may affect the handling of pesticide
containers under certain circumstances. RCRA Subtitles C and I are
described briefly below.
FIFRA sections 19(f)(3) and 19(h) specify that FIFRA section 19
does not affect the requirements or authorities of RCRA. Accordingly,
today's rule does not alter any existing RCRA requirements, and any
applicable RCRA provisions will apply in addition to the provisions of
any final rule issued under FIFRA section 19. In addition, FIFRA
section 19(f)(1)(B)(iv) specifies that the residue removal regulations
may be coordinated with requirements for container rinsing under RCRA.
As outlined below, this rule provides for coordination in this area.
1. Hazardous waste requirements. Subtitle C of RCRA creates a
cradle-to-grave system for managing hazardous wastes. RCRA Subtitle C
regulations include requirements for generators, transporters, and
others who handle hazardous wastes. The regulations cover any ``solid
waste'' (defined at 42 U.S.C. 1004 and 40 CFR 261.2) that is listed as
a hazardous waste or exhibits a characteristic of hazardous waste, as
set out in part 261. Pesticides (including pesticide residues in
containers that are not empty per the RCRA definition in Sec. 261.7)
that are discarded or intended to be discarded may qualify as hazardous
wastes, if the pesticide is a hazardous waste as defined in Sec. 261.33
[[Page 47413]]
(discarded commercial chemical products, off-specification products or
manufacturing intermediates, container residues, and spill residues),
or if they exhibit a characteristic of hazardous waste as described in
part 261 subpart C, and are not otherwise exempt from regulation. A
hazardous waste remaining in a container is not subject to Subtitle C
regulation if, among other things, the container is ``empty'' as
defined in Sec. 261.7. A container is ``empty'' if the wastes are
removed pursuant to Sec. 261.7(b)(1) or (b)(2), or, in the case of an
acute hazardous waste, the container has been triple rinsed or
otherwise cleaned pursuant to Sec. 261.7(b)(3). EPA believes that the
triple rinsing procedure provided in today's final rule meets the
requirements of Sec. 261.7(b)(3), thus meeting the directive in FIFRA
section 19(f)(1)(B)(iv).
2. Underground storage tanks. RCRA Subtitle I provides for the
development and implementation of a comprehensive regulatory program
for ``underground storage tanks'' (USTs), defined at 42 U.S.C. 6991 and
40 CFR 280.12 as tanks that are used to contain an accumulation of
``regulated substances'' and whose volume (including underground pipes
connected thereto) is 10 percent or more below ground. Regulated
substances include petroleum or substances defined as hazardous under
the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980 (CERCLA) (except hazardous wastes regulated under RCRA
Subtitle C). CERCLA hazardous substances, enumerated at 40 CFR part
302, include a number of pesticides. UST requirements at 40 CFR part
280 include standards for new tanks as well as requirements for leak
detection, closure, corrective action, and financial responsibility.
EPA is not aware of the extent of industry use of USTs to store
agricultural pesticides, and solicited comment on the use of
underground tanks to store agricultural pesticides and on the preferred
means of coordinating UST and FIFRA requirements. No comments were
received on the topic. Because today's final rule requires secondary
containment of any bulk container holding pesticide, underground
storage would be precluded unless the secondary containment structure
was also underground. EPA considers that the expense of such a
construction makes it unlikely that a facility would use underground
storage, and assumes that since no comments were received, underground
storage of agricultural pesticides is generally avoided in the
industry. Furthermore, EPA has noted, in its review of State
regulations, that underground storage of pesticides is forbidden by
States with bulk containment regulations.
B. Clean Water Act
EPA has issued several regulations under the Clean Water Act (CWA)
(33 U.S.C. 1251 et seq.) that are related to today's rule and that
affect some sectors of the pesticide industry. The goal of the CWA is
to achieve zero discharge of wastewater pollutants.
1. Pesticide chemicals category, formulating, packaging and
repackaging effluent limitations guidelines, pretreatment standards,
and new source performance standards: Final rule. On November 6, 1996,
EPA promulgated regulations governing effluents from pesticide
formulating, packaging and repackaging facilities (61 FR 57518, Ref.
57). Effluent guidelines establish limitations on the pollutants
discharged into waters of the United States from industrial point
sources. The Pesticide Formulating, Packaging and Repackaging (PFPR)
effluent guidelines apply to facilities engaged in formulating,
packaging or repackaging pesticides. The PFPR effluent guidelines
regulation set limitations for facilities in two different regulatory
subparts of 40 CFR part 455 (subparts C and E). Subpart C applies to
facilities that discharge (or have the potential to discharge)
wastewater from pesticide formulating, packaging, and/or repackaging
operations. All pesticides with the exception of a few specific
exemptions are included under subpart C. Subpart E applies only to
refilling establishments that repackage agricultural pesticides into
refillable containers. Subpart E does not apply to facilities that
repackage non-agricultural pesticides. The same formulators, packagers,
and repackagers (subpart E) and refilling establishments (subpart E)
are affected by today's final pesticide container and containment rule.
However, the PFPR effluent guidelines regulation does not include the
other types of facilities covered by today's containment rule, namely
commercial applicators and custom blenders.
Under the effluent guidelines rule, refilling establishments are
required to achieve zero discharge of wastewater pollutants. For these
facilities, the zero discharge regulation was based on reuse, recycle
and water conservation practices, as well as contract hauling of any
non-reusable wastewater for off-site disposal, if necessary. However,
effluent guidelines do not require specific practices or control
technologies. Many refilling establishments achieve the zero discharge
requirement through water conservation and good housekeeping, which
includes repairing leaking valves and fittings and collecting drips in
pans under appurtenances. Facilities that also provide application
services typically reuse rinsate as make-up water for application in
accordance with the label. Compliance with today's pesticide container
and containment rule regarding requirements for containment structures,
and adherence to the recommendations regarding rinsate collection will
assist refilling establishments in achieving the zero discharge of
pollutants required by the effluent guidelines.
Under the PFPR effluent guidelines, subpart C facilities
(formulators, packagers, and repackagers) are required to either
achieve zero discharge of wastewater pollutants or to implement
specific reuse, recycle, and water conservation practices (Pollution
Prevention Alternative). For example, under the pollution prevention
alternative, facilities must reuse their rinsates directly into the
formulation or store rinsates for use in future formulation of the same
or a compatible product.
When the PFPR effluent regulations were proposed in April 1994
(Ref. 64), the scope of subpart C included all pesticide active
ingredients (PAIs) (with the exception of sodium hypochlorite and the
partial exemption of specified sanitizers) and a wide variety of
associated wastewater sources. EPA published a supplemental notice on
June 8, 1995 (Ref. 61) which refined the scope of PAIs and wastewater
sources. In the final rule, most sanitizer products were excluded,
based on a number of factors, such as:
? Sanitizer products are formulated for the purposes of
their labeled end use to ``go down the drain;''
? Sanitizer active ingredients are more likely to be sent to
Publicly Owned Treatment Works (POTWs) in greater concentrations and
volumes from their labeled end use than from rinsing formulating
equipment at the PFPR facility;
? Biodegradation data received with comments on some of
these sanitizer active ingredients support the hypothesis that they do
not pass through POTWs;
? These sanitizer active ingredients represent a large
portion of the low toxicity PAIs considered for regulation at the time
of proposal; and
? Many sanitizer solutions containing these active
ingredients are cleared by the Food and Drug Administration
[[Page 47414]]
(FDA) as indirect food additives under 21 CFR 178.1010.
The final PFPR effluent guidelines rule (subpart C) combined the
pool chemicals exemption into the sanitizer exemption and exempted
other pool chemicals in addition to the only pool chemical in the
proposal, sodium hypochlorite. The additional chemicals that are
included in the definition of pool chemicals in 40 CFR 455.10 include
calcium hypochlorite, lithium hypochlorite, potassium hypochlorite,
chlorinated isocyanurate compounds and halogenated hydantoins.
The bulk containment requirements in today's rule are consistent
with the control technologies which are the basis for the PFPR effluent
guidelines for refilling establishments (subpart E). In addition, the
repackaging and refillable container requirements of today's rule,
particularly the adherence to the recommendations regarding rinsate
collection, will aid facilities in collecting and reusing rinsates to
meet the zero discharge/pollutant prevention alternative requirements
of subpart C of the PFPR effluent guidelines.
2. National Pollutant Discharge Elimination System (NPDES) - Storm
Water Phase II Final Rule. EPA issued final regulations on December 8,
1999 (64 FR 68722, Ref. 52) addressing storm water discharges. The
regulation established a ``no exposure'' exemption for storm water
discharges from facilities where industrial materials and activities
are not exposed to storm water. Upon review of earlier regulations that
excluded storm water discharges from certain categories of light
industry from NPDES permit requirements, a court invalidated the light
industry exemption. In 1992, the Ninth Circuit court concluded that the
exemption impermissibly relied on the unsubstantiated judgment of the
facility operator to determine applicability of the exemption. The new
rule established in 1999 now allows the exemption, but requires that
the facility meet certain conditions and provide a certification for
tracking and accountability. ``No exposure'' means that all industrial
materials or activities are protected by storm-resistant sheltering so
they are not exposed to rain, snow, snowmelt or runoff. (40 CFR 122.26(g))
Pesticide refilling operations and bulk storage operations required
to apply for and obtain NPDES permits for storm water discharges
associated with such operations may take advantage of this exemption if
they provide a certification of ``no exposure'' and maintain the
certified conditions at the facility. Even when an owner/operator
certifies to no exposure, the NPDES permitting authority may still
require a permit if it determines that there is a discharge interfering
with water quality standards. This will provide an added incentive to
place all tanks within secondary containment that is protected from the
elements. Facilities that are not exempt will have to get a discharge
permit.
3. Effluent guidelines and standards for the transportation
equipment cleaning (TEC) Industry. On August 14, 2000, EPA published a
final rule (65 CFR 49665, Ref. 51) establishing restrictions on the
discharge of wastewater from cleaning the interiors of tank trucks,
rail tank cars, inland tank barges, ocean/sea tankers, and other
similar tanks used to transport materials, including agricultural
chemicals and fertilizers. The TEC regulations do not apply to
wastewaters generated from cleaning the interiors of pesticide drums or
intermediate bulk containers (IBCs), defined as portable containers
with 450 liters (119 gallons) to 3,000 liters (793 gallons) capacity.
EPA subsequently studied the Industrial Container and Drum Cleaning
Industry. The Preliminary Data Summary - Industrial Container and Drum
Cleaning Industry (EPA-821-R-02-011 and Ref. 48) can be downloaded from
the following link:
http://www.epa.gov/waterscience/pollcontrol/drum/index.html.
4. Spill prevention control and countermeasures (SPCC). On July 17,
2002, (67 FR 47042, Ref. 47), EPA promulgated regulations under section
311(j)(1)(C) of the Clean Water Act (known as the SPCC regulations) for
the prevention of oil spills into navigable waters and adjoining
shorelines. The regulations apply to facilities that, because of their
location, could reasonably be expected to discharge oil into navigable
waters or adjoining shorelines. Part 112 of 40 CFR outlines
requirements for both the prevention and the response to oil spills.
Facilities that are subject to the SPCC regulations include any non-
transportation-related onshore or offshore facility engaged in
drilling, producing, gathering, storing, processing, refining,
transferring, distributing, using, or consuming oil and oil products,
which due to its location, could reasonably be expected to discharge
oil, in quantities that may be harmful, into navigable waters of the
United States or adjoining shorelines. Because the definition of
``oil'' under CWA section 311 is very broad (including oil ``of any
kind and in any form''), it could potentially include pesticides that
contain oil or are oil-based. EPA expects that comparatively few, if
any, of the facilities covered by today's pesticide container and
containment rule are also subject to SPCC requirements, but if any are,
both today's rule and SPCC requirements apply. On December 12, 2005,
EPA proposed two separate amendments to the SPCC Rule. One of them
(Ref. 24) streamlines the regulatory requirements for qualified
facilities and equipment regulated under 40 CFR part 112 and proposes a
separate extension of the compliance date for farms. The other
amendment (Ref. 23) extends the SPCC compliance dates for all facilities.
C. Occupational Safety and Health Administration Requirements
The Occupational Safety and Health Act (U.S.C. 2601 et seq.)
addresses occupational safety and health hazards by establishing
requirements for employers and employees and authorizing the
Occupational Safety and Health Administration (OSHA) to establish
mandatory occupational safety and health standards.
Tanks and containers that are used to store flammable and
combustible liquids in occupational settings are subject to OSHA
requirements under 29 CFR 1910.106. For storage tanks, Sec.
1910.106(b) contains design and construction requirements, including
standards for materials, spacing, venting, drainage and diking, fire
and flood resistance, and testing for strength and tightness. Section
1910.106(c) contains specifications for piping, valves, and fittings.
Section 1910.106(d) sets out design and construction requirements for
containers and portable tanks, and also contains specifications for
storage areas. Today's regulations do not contradict or supercede any
existing OSHA requirements, and any applicable OSHA provisions will
apply in addition to the provisions of today's rule.
D. Department of Transportation Hazardous Materials Regulations
The Hazardous Materials Transportation Act of 1974, (49 U.S.C. 1801
et seq) authorizes DOT to designate as hazardous materials those
materials that may pose unreasonable risk to health and safety or
property, and regulate the handling and transportation of such
materials. The DOT regulations and their relationship to today's final
pesticide container and containment regulations are discussed in detail
in Unit IV. and many other places throughout this preamble.
XI. FIFRA Mandated Reviews
In accordance with FIFRA sec. 25(a), the Agency submitted a draft
of this final rule to the FIFRA Scientific
[[Page 47415]]
Advisory Panel (SAP), the Secretary of Agriculture, and the Committee
on Agriculture in the House of Representatives, and the Committee on
Agriculture, Nutrition, and Forestry in the United States Senate.
The FIFRA SAP waived its review of this final rule because the
significant scientific issues involved have already been reviewed by
the SAP and additional review isn't necessary. The USDA did not submit
any official comments.
XII. References
The following is a listing of the documents that are specifically
referenced in this final rule. These documents, and other supporting
materials, are included in the docket established for this rulemaking
under docket ID No.EPA-HQ-OPP-2005-0327 at http://www.regulations.gov.
1. Ag Container Recycling Council. ``ACRC Celebrates 10 Years'', in
``News Bits from the Ag Container Recycling Council,'' Summer (2002).
2. Beaver, B.A. and W.D. Goetsch. ``Container Recycling in
Illinois,'' 1994 Illinois Agricultural Pesticides Conference, (1994).
3. Dwinell, S., 1992. Florida Department of Environmental
Regulation, ``Final Report: Jackson County Pesticide Container
Recycling Demonstration Project,'' (1992).
4. Dwinell, S., 1991. Florida Department of Environmental
Regulation, ``Final Report: South Florida Pesticide Container Recycling
Demonstration Project,'' (1991).
5. Federal Trade Commission. ``Guides for the Use of Environmental
Marketing Claims,'' 16 CFR 260, (2006).
6. Formulogics, 1991. ``Report to Mitchell System: Data Generation
- Rinsing Studies,'' September 24 (1991).
7. Formulogics, 1991. ``Triple Rinsing of Containers: Rinsing
Variables,'' results of a study conducted for U.S. EPA, December 2 (1991).
8. Formulogics, 1990. ``Container Rinsing: Methodology Support,''
testing conducted for the U.S. EPA, 1990.
9. Frieberg, D. Iowa Fertilizer and Chemical Association,
``Environmental Cleanup of Fertilizer and Agricultural Chemical Dealer
Sites,'' (1991).
10. Hudak, C.M., North Carolina Department of Agriculture and
Consumer Services. ``Pesticide Container Recycling in North Carolina''
presented at 2000 National Pesticide Stewardship Alliance Conference,
(2000).
11. Kammel, D., R. Noyes, G. Riskowski, and V. Hofman. ``Designing
Facilities for Pesticide and Fertilizer Containment,'' MidWest Plan
Service-37, Iowa State University, Ames, Iowa (1991).
12. Michigan Department of Agriculture. ``Environmental Stewardship
and the Michigan Department of Agriculture: A Report to Governor John
Engler'' (1993).
13. Minnesota Department of Agriculture. ``Empty Pesticide
Container Collection and Recycling Program: Annual Report,'' (1996).
14. Moye, Anson H., et al. ``Final Report: Work Assignment - Triple
Rinse,'' research conducted for U.S. EPA, January 31 (1995).
15. National Agricultural Chemicals Association, ``NACA Container
Management Task Force Empty Pesticide Container Rinsing Study: Product
Information and Analytical Results,'' October 16 (1990).
16. United Nations Economic Commission for Europe (UNECE).
``Globally Harmonized System of Classification and Labeling of
Chemicals (GHS)'' (2005).
17. Palmer, L. and R. Hansen. Minnesota Department of Agriculture
[Information on pesticide container collection programs], Personal
communication to members of the Minnesota Pesticide Container Advisory
Committee, September 30 (1991).
18. Poncin, S. Minnesota Department of Agriculture. ``Rinsing
Problems Associated with Pesticides that are Formulated as Flowable,''
September (1995).
19. U.S. EPA, 2006. ``Response to Comment Document: Standards for
Pesticide Containers and Containment,'' (2006).
20. U.S. EPA, 2006. ``Rinsing Procedures for Dilutable Pesticide
Products in Rigid Containers,'' (2006).
21. U.S. EPA, 2005. ``Economic Analysis of the Bulk Pesticide
Containment Structures Final Regulation,'' November 15 (2005).
22. U.S. EPA, 2005. ``Economic Analysis of the Pesticide Container
Design and Residue Removal Standards,'' November 21 (2005).
23. U.S. EPA, 2005. ``Oil Pollution Prevention; Non-Transportation
Related Onshore Facilities: Proposed Rule,'' 70 FR 73517, December 12
(2005).
24. U.S. EPA, 2005. ``Oil Pollution Prevention; Spill Prevention,
Control, and Countermeasure Plan Requirements - Amendments: Proposed
Rule,'' 70 FR 73523, December 12 (2005).
25. U.S. EPA, 2005. ``State Bulk Pesticide Containment Regulations
- Scope and Definition of Bulk,'' February 2 (2005).
26. U.S. EPA, 2005. ``Summary of Discussions re: Pesticide
Container Collection Program Observations,'' November 15 (2005).
27. U.S. EPA, 2005. ``Summary of Information on On-Farm Bulk
Storage and Repackaging from State Contacts from States with
Regulations that Include Farms,'' February 14 (2005).
28. U.S. EPA, 2005. ``Summary of State Responses to EPA Inquiries
About Bulk Storage on Farms,'' February 14 (2005).
29. U.S. EPA, 2005. ``Summary of Telephone Conversations with
Packaging Industry re: Dry Bulk Containers,'' February (2005).
30. U.S. EPA, 2006. ``Supporting Statement for an Information
Collection Request: Standards for Pesticide Containers and Containment
(Final Rule), June 21, (2006).
31. U.S. EPA, 2004. ``Meeting Summary,'' July 19 (2004).
32. U.S. EPA, 2004. ``Standards for Pesticide Containers and
Containment: Proposed Rule; Extension of Comment Period,'' 69 FR 50114,
August 13 (2004).
33. U.S. EPA, 2004. ``Standards for Pesticide Containers and
Containment: Proposed Rule; Partial Reopening of the Comment Period,''
69 FR 39392, June 30 (2004).
34. U.S. EPA, 2004. ``Summary Tables of State Bulk Pesticide
Containment Regulations,'' January 23 (2004).
35. U.S. EPA, 2003. ``Analysis and Summary of CSMA Data,'' March 5
(2003).
36. U.S. EPA, 2003. ``Analysis and Summary of Formulogics
Agricultural Formulation/Container Data,'' February 24 (2003).
37. U.S. EPA, 2003. ``Analysis and Summary of Formulogics
Household, Institutional and Industrial Data,'' March 5 (2003).
38. U.S. EPA, 2003. ``Analysis and Summary of Formulogics Quick
Rinse Data,'' February 26 (2003).
39. U.S. EPA, 2003. ``Analysis and Summary of NACA Triple Rinse
data,'' March 4 (2003).
40. U.S. EPA, 2003. ``Analysis and Summary of Pressure Rinse
Data,'' March 5 (2003).
41. U.S. EPA, 2003. ``Analysis and Summary of University of Florida
Quick Rinse Data,'' February 26 (2003).
42. U.S. EPA, 2003. ``Comparison of Triple Rinsing Data for
Proposed and Final Rule,'' July 7 (2003).
43. U.S. EPA, 2003. ``Information About Container Rejections from
Recycling Programs,'' July 15 (2003).
44. U.S. EPA, 2003. ``Label Review Manual: Third Edition,'' EPA
735-B-03-001, August (2003).
45. U.S. EPA, 2003. ``Revised Scope of the Container Regulations
(Non-Antimicrobial Products,'' January 6 (2003).
[[Page 47416]]
46. U.S. EPA, 2003. ``Summary of Conference Call with Wisconsin
Department of Agriculture Staff on Containment Regulations,'' July 29
(2003).
47. U.S. EPA, 2002. ``Oil Pollution Prevention and Response: Non-
Transportation-Related Onshore and Offshore Facilities: Final Rule,''
67 FR 47042, July 17 (2002).
48. U.S. EPA, 2002. ``Preliminary Data Summary for Industrial
Container and Drum Cleaning Industry,'' EPA-821-R-02-011, June (2002).
49. U.S. EPA, 2001. ``Disposal Instructions on Non-Antimicrobial
Residential/Household Use Pesticide Product Labels,'' Pesticide
Registration Notice 2001-6, September 7 (2001).
50. U.S. EPA, 2001. ``Regulations Under the Federal Insecticide,
Fungicide, and Rodenticide Act for Plant-Incorporated Protectants
(Formerly Plant-Pesticides): Final Rule,'' 66 FR 37771, July 19 (2001).
51. U.S. EPA, 2000. ``Effluent Limitations Guidelines, Pretreatment
Standards, and New Source Performance Standards for the Transportation
Equipment Cleaning Point Source Category: Final Rule,'' 65 FR 49665,
August 14 (2000).
52. U.S. EPA, 1999. ``National Pollutant Discharge Elimination
System-Regulations for Revision of the Water Pollution Control Program
Addressing Storm Water Discharges: Final Rule,'' 64 FR 68722, December
8 (1999).
53. U.S. EPA, 1999. ``Standards for Pesticide Containers and
Containment: Proposed Rule; Partial Reopening of the Comment Period,''
64 FR 56918, October 21 (1999).
54. U.S. EPA, 1998. ``Additional Guidance on Final FIFRA Section
6(a)(2) Regulations for Pesticide Product Registrants,'' Pesticide
Registration Notice 98-4, August 4 (1998).
55. U.S. EPA, 1998. ``Guidance on Final FIFRA Section 6(a)(2)
Regulations for Pesticide Product Registrants,'' Pesticide Registration
Notice 98-3, April 3 (1998).
56. U.S. EPA, 1998. ``Notifications, Non-notifications and Minor
Formulation Amendments,'' Pesticide Registration Notice 98-10, October
22 (1998).
57. U.S. EPA, 1996. ``Pesticide Chemicals Category, Formulating,
Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment
Standards, and New Source Performance Standards: Final Rule,'' 61 FR
57518, November 6 (1996).
58. U.S. EPA, 1996. ``Toxicologically Significant Levels of
Pesticide Active Ingredients,'' Pesticide Registration Notice 96-8,
October 31 (1996).
59. U.S. EPA, 1995. ``Bulk Pesticide Transfers,'' Memorandum from
Jesse Baskerville, U.S. EPA, to U.S. EPA Regional Pesticides and Toxics
Division Directors and Regional Counsels, March 22 (1995).
60. U.S. EPA, 1995. ``Notice of Interim Determination of Adequacy
of Certain State and Territorial Programs,'' 60 FR 24855, May 10 (1995).
61. U.S. EPA, 1995. ``Pesticide Chemicals Category, Formulating,
Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment
Standards, and New Source Performance Standards: Supplemental Notice,''
60 FR 30217, June 8 (1995).
62. U.S. EPA, 1995. ``Pesticides; Technical Amendments: Final
Rule,'' 60 FR 32094, June 19 (1995).
63. U.S. EPA, 1994. ``Bulk Policy Question & Answer Document,''
February 3 (1994).
64. U.S. EPA, 1994. ``Pesticide Chemicals Category, Formulating,
Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment
Standards, and New Source Performance Standards: Proposed Rule,'' April
14 (1994).
65. U.S. EPA, 1994. ``Recycling Empty Aerosol Pesticide
Containers,'' Pesticide Registration Notice 94-2, May 16 (1994).
66. U.S. EPA, 1994. ``Standards for Pesticide Containers and
Containment: Proposed Rule,'' 59 FR 6712, February 11 (1994).
67. U.S. EPA, 1994. ``State Pesticide Residue Removal Compliance
Programs; Notice of Interim Determination of Adequacy; Correction,'' 59
FR 9214, February 25 (1994).
68. U.S. EPA, 1993. ``Interim Determination of Adequacy of State
Pesticide Residue Removal Programs,'' 58 FR 43994, August 18 (1993).
69. U.S. EPA, 1993. ``Notice of Interim Determination of Adequacy
of Certain State Programs,'' 58 FR 65989, December 17 (1993).
70. U.S. EPA, 1992. ``State of the States: Pesticide Storage,
Disposal and Transportation,'' prepared for EPA by Mitchell Systems
Corporation, EPA publication number EPA 734-R-92-12 (1992).
71. U.S. EPA, 1991. ``Amendment to the July 11, 1977 Enforcement
Policy Applicable to Bulk Shipment of Pesticides,'' March 4 (1991).
72. U.S. EPA, 1984. ``Clarification of Label Improvement Program
for Farmworker Safety and Pesticide Storage and Disposal
Instructions,'' Pesticide Registration Notice 84-1, February 17 (1984).
73. U.S. EPA, 1983. Office of Pesticide Programs, ``Label
Improvement Program - Storage and Disposal Label Statements,''
Pesticide Registration Notice 83-3 (1983).
74. U.S. EPA, 1979. ``National Pollution Discharge Elimination
System (NPDES) Best Management Practices Guidance Document,'' EPA-600/
9-79-045, December (1979).
75. U.S. EPA, 1977. ``Enforcement Policy Applicable to Bulk
Shipment of Pesticides,'' July 11 (1977).
76. U.S. EPA, 1976. ``Pesticide Enforcement Policy Statement on
Structural Pest Control: Use and Labeling of Service Containers for the
Transportation or Temporary Storage of Pesticides,'' (1976).
77. Viera, K. Clorox [Data from container rinsing tests conducted
by Chemical Specialties Manufacturers Association], Personal
communication to U.S. EPA, July 13 (1993).
78. U.S., EPA, 2000. ``Analysis of Products that Meet the Scope
Criteria: Toxicity Category III Only,'' November 27 (2000).
XIII. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this final rule is a ``significant
regulatory action'' because these requirements may raise novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
Accordingly, EPA submitted a draft final rule to OMB for review under
Executive Order 12866 and any changes made in response to OMB
recommendations have been documented in the docket for this rulemaking
as required by sec. 6(a)(3)(E) of the Executive Order.
In addition, EPA has prepared two Economic Analyses (EAs) of the
potential costs and benefits associated with this rule, one for the
container requirements and another for the containment requirements.
The reason for having two EAs is because the regulated community
differs in each case. For example, the container requirements affect
pesticide formulators and refillers of all pesticides while the
containment requirements affect retailers, for-hire applicators and
custom blenders of agricultural pesticides. The EAs, entitled Economic
Analysis of the Pesticide Container Design and Residue Removal
Standards (Ref. 22) and Economic Analysis of the Bulk Pesticide
Containment Structure Regulations (Ref. 21), are available in
[[Page 47417]]
the docket for this rule and are briefly summarized here.
EPA estimates the total cost of the final rule to be $11.3 million
($8.37 million for containers + $2.93 million for containment) and the
total benefits from the final rule to be $17 - 23.4 million. When the
estimated cost of the final rule is compared to the estimated cost for
the proposed rule, there is an annual cost reduction of approximately
$27.4 - $38.6 million. This reduction in estimated cost is due to the
choices made in the final rule that lead to a narrowing in the scope of
regulated entities and products that are subject to the final rule.
During the first year, regulated facilities will experience an increase
in total paperwork cost burden of $1 million (containment) and $7.0
million (containers) due primarily to inspection and recordkeeping
costs. For containers, in the second year and continuing thereafter,
total paperwork cost burden per facility will decrease to 25 hours from
81 hours in the first year, reducing paperwork burden costs to $4.1
million annually.
Over 20 respondents submitted general comments on the Regulatory
Impact Analyses (RIAs) or EAs for the proposed rule. Nearly all of the
commenters wanted EPA to reevaluate the economic assessments. The most
common comments were: 1) The costs far outweigh the benefits; 2) costs
were underestimated; 3) benefits were overestimated; 4) this is a major
rule, contrary to EPA's assessment; 5) the rule will have a significant
impact on medium and large formulators as well as small formulators; 6)
the rule will have a general impact on various industry segments; and
7) the rule does not comply with the standards of the Executive Order.
Commenters who objected to the cost estimates mainly disagreed with
EPA's estimate of the cost of complying with the six 9's residue
removal standard. State regulatory agencies predicted that the rule
would increase their workload and expressed the hope that EPA would
increase State funding.
EPA reopened the comment period on the proposed rule on October 21,
1999 (64 FR 56918, Ref. 53) on three issues, proposing to reduce the
scope of the container standards, add an exemption for certain
antimicrobial pesticides, and adopt some of the Department of
Transportation (DOT) hazardous materials regulations. These potential
changes decreased the estimated economic impact by reducing the number
of pesticide products subject to the container requirements compared to
the original proposal.
Major changes resulted in cost reduction from the economic analysis
for the proposed rule. Among these is the elimination of the
requirement to demonstrate the hydraulic conductivity of containment
structures, lowering of the residue removal standard from six 9's to
four 9's, and limiting of rinse-testing requirement to those
formulations expected to be problematic.
B. Paperwork Reduction Act (PRA)
The information collection requirements in this final rule have
been submitted to the Office of Management and Budget (OMB) under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The Information
Collection Request (ICR) document prepared by EPA for this final rule
has been assigned EPA ICR No. 1631.02, and OMB control number 2070-
0133. Consistent with the procedures at 5 CFR 1320.11, EPA sought
comment on two Information Collection Request (ICR) documents that were
submitted to OMB in conjunction with issuing the proposed rule
(identified under EPA ICR No. 1631.01 and No. 1632.01). For the final
rule, the two ICR documents were combined into one ICR document, which
reflects the information collection provisions in this final rule. The
ICR document for this final rule (identified under EPA ICR No. 1631.02)
(Ref. 30) is included in the docket for the final rule.
Under the PRA, an agency may not conduct or sponsor, and a person
is not required to respond to a collection of information unless it
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations codified in Chapter 40 of the CFR, after
appearing in the preamble of the final rule, are listed in 40 CFR part
9, are displayed either by publication in the Federal Register or by
other appropriate means, such as on the related collection instrument
or form, if applicable. The display of OMB control numbers in certain
EPA regulations is consolidated in 40 CFR part 9. For the ICR activity
contained in this final rule, in addition to displaying the applicable
OMB control number in this Unit, the Agency is amending the table in 40
CFR 9.1 to list the OMB control number assigned to this ICR activity.
Due to the technical nature of the table, EPA finds that further notice
and comment about amending the table is unnecessary. As a result, EPA
finds that there is good cause under section 553(b)(B) of the
Administrative Procedures Act (APA), 5 U.S.C. 553(b)(B), to amend this
table without further notice and comment.
Under the PRA, burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, disclose
or provide information to or for a Federal agency. This includes the
time needed to review instructions; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
In this final rule, the information collection requirement burden
on the regulated community includes the administrative burden
associated with keeping monthly inspection and maintenance records for
bulk pesticide containment structures. The regulated community's
administrative burden is defined as the time spent to record and file
the inspection and maintenance of the bulk pesticide containment
structures per month. There is not a requirement to submit the records
or reports to the Agency, however, EPA or its representatives may, from
time to time, request information under these regulations to ensure
compliance with the regulation.
The two ICRs for the proposed rule were combined into a single ICR
for the final rule. This ICR document provides detailed presentations
of the estimated annual burden and costs for 3 years, which represents
the maximum OMB approval period for any collection activity, after
which the Agency must seek renewal of the ICR approval from OMB every 3
years for as long as the requirements exist.
1. Container burden. The public reporting burden for this
collection of information is estimated to be 66 hours in the first year
of compliance with this rule for approximately 1,804 pesticide
registrant respondents, and 10 hours in subsequent years. For an
estimated 16,795 agricultural pesticide refiller respondents, the
reporting burden is 7.5 hours per year. For an estimated 322 swimming
pool supply companies, the reporting burden is 7.5 hours per year. The
total annual paperwork burden across all pesticide registrant
respondents, assuming that 1,804 facilities will be affected by the
requirements, is 112,209 hours in first year, and 11,185 hours in all
other years. The total annual paperwork burden across all agricultural
pesticide refiller respondents, assuming 16,795 facilities will be
affected by the
[[Page 47418]]
requirements, is 125,963 hours. The total annual paperwork burden
across all swimming pool supply companies, assuming 322 facilities will
be affected by the requirements, is 2,415 hours.
2. Containment burden. The public recordkeeping burden for this
collection of information is estimated to be 7.5 hours for
approximately 4,665 respondents in the first year after promulgation of
this rule, which includes initial rule familiarization. The average
annual burden per respondent for subsequent years is estimated to be
7.5 hours. The total annual paperwork burden across all respondents,
assuming that 4,665 facilities will be affected by the requirement, is
34,988 hours per year.
In comments filed after reviewing the proposed ICRs in 1994, OMB
commented that EPA should consider less burdensome testing requirements
that meet the objective that disposal of containers poses no
unreasonable risk to health of the environment. As discussed
previously, EPA has modified the requirements to be less burdensome,
decreasing the total industry burden for the final rule. The decrease
in burden results mainly from the elimination of the hydraulic
conductivity standard for containment structures, lowering of the
residue removal standard to four 9's, and requiring residue removal
testing only for problematic formulations.
The Agency is seeking additional comments on the paperwork burden
estimates related to the provision in the final rule that allows States
with existing regulations (Sec. 165.97) to request the authority to
continue implementing its State containment regulations in lieu of
EPA's regulations. As discussed previously, EPA added this provision in
response to comments asking EPA to consider existing State regulations.
Since this provision and related burden estimates were not part of the
ICRs that were prepared and for which public comment was sought in
conjunction with the proposed rule, EPA is providing this opportunity
for public comment. Direct your comments on this to EPA using the
public docket that has been established for this final rule (docket ID
number EPA-HQ-OPP-2005-0327) at http://www.regulations.gov. In
addition, send a copy of your comments to OMB at: Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th St.,
NW., Washington, DC 20503, Attention: Desk Office for EPA ICR No.
1361.02. Since OMB is required to complete its review of the ICR
between 30 and 60 days after August 16, 2006, please submit your
comments no later than September 15, 2006.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this final
rule will not have a significant adverse economic impact on a
substantial number of small entities. This determination is based on
the Agency's two economic analyses performed for this rulemaking, which
are briefly summarized in Unit XIII.A., and copies of which are
available in the docket for this rulemaking (Refs. 21 and 22). The
following is a brief summary of the factual basis for this certification.
Under the RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of today's rule on small entities, small entity
is defined in accordance with the RFA as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district, or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field. Based on the industry profiles for
this rulemaking that EPA prepared as part of the Economic Analyses, EPA
has determined that this final rule is not expected to impact any small
not-for-profit organizations or small governmental jurisdictions. As
such, small entity for purposes of this final rule is synonymous with
small business.
In addition, for purposes of analyzing the potential impacts of
this final rule on small businesses, the Agency disaggregated the
universe of potentially impacted small business into subcategories of
large-small businesses, medium-small businesses, and small-small
businesses. The analysis disaggregated the impacts of small businesses
into these sub-categories because the SBA size standard for small
businesses, which are primarily intended to define whether a business
entity is eligible for Federal government programs and preferences
reserved for small businesses (13 CFR 121.101), may not be
representative of all small businesses in the industry sectors impacted
by this rulemaking. (See section 632(a)(1) of the Small Business Act.)
The SBA size standard is generally based on the number of employees an
entity in a particular industrial sector may have. For example, in the
Pesticide and Other Agricultural Chemical Manufacturing sector (i.e.,
NAICS code 325320) approximately 92% of the industries would be
classified as small businesses under the SBA definition (500 or fewer
employees). However, 60% of the SBA defined small companies have 1 to
19 employees, which are considered small-small businesses in the
Agency's analysis. By disaggregating the potential impacts of this
final rule on small businesses, the Agency was able to consider the
distribution of the estimated impacts among the universe of potentially
impacted small businesses, particularly potential impacts on the small-
small businesses.
Considering just the container requirements, the estimated costs of
compliance for the universe of potentially impacted small businesses in
each of the regulated industries as a proportion of their current
revenues are estimated to be less than 1 percent. Specifically, using
the SBA definition of small businesses, the costs of compliance for all
small businesses are estimated to be less than 0.02 percent of the
current average entity revenues. Looking at the estimated impacts using
the disaggregated small business sub-categories used in the Agency's
analysis (which further divides small businesses into large-small,
medium-small and small-small business within each of the regulated
industries), no small-small business is estimated to incur costs which
account for more than 0.04 percent of current average entity revenues.
Considering just the containment requirements, the estimated costs
of compliance for the universe of potentially impacted small businesses
as a proportion of their current revenues are estimated to be less than
1 percent, except for small commercial applicators. When only looking
at commercial applicators, and using the SBA definition of small
business, the costs of compliance for potentially impacted small
commercial applicators to install new secondary containment units are
estimated to be as high as 2.7 percent of the current average entity
revenues. Small-small commercial applicators, based on the
disaggregated small business sub-categories used in the Agency's
analysis, may face costs of compliance that are as much as 7.8 percent
of the current average entity revenues. However, only 6 of the 3,000
small commercial applicators were identified as small-small commercial
applicators that will need to install both a secondary containment unit
and a containment pad and thus are estimated to be impacted in this
way. The costs of compliance for potentially impacted
[[Page 47419]]
small commercial applicators to retrofit existing containment
structures are estimated to be less than 1 percent of the current
average entity revenues.
For agricultural pesticide refillers, the other industry estimated
to be impacted by the containment regulations, the costs of compliance
for small agricultural pesticide refillers are estimated to be less
than 0.18 percent of current average entity revenues using the SBA
definition of small businesses, and less than 0.34 percent of current
average entity revenues based on the disaggregated small-small business
sub-category used in the Agency's analysis.
Considering the overall impact of this final rule on the universe
of potentially impacted small businesses using the SBA definition for
small business, the Agency has determined that this final rule will not
have a significant adverse economic impact on a substantial number of
small entities.
In general, EPA strives to minimize potential adverse impacts on
small entities when developing regulations to achieve the environmental
and human health protection goals of the statute and the Agency. In
doing so for this particular rule, as discussed in more detail
previously, the major changes that EPA made to the proposed
requirements resulted in significant reductions in the potential costs
of compliance for this rulemaking.
D. Unfunded Mandates Reform Act (UMRA)
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(Public Law 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or for the private sector in any one year. As described in
Unit XIII.A., the annual costs associated with this action are
estimated to total $11.3 million ($8.37 millioin for containers + $2.93
million for containment). This cost represents the incremental cost to
registrants, pesticide dealers, commercial applicators and custom
blenders attributed to the requirements in this action. Accordingly,
this action is not subject to the requirements of sections 202 and 205
of UMRA.
E. Executive Order 13132
Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this final rule does
not have federalism implications, because it would not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in the Order. Under cooperative agreements with EPA, States will be
involved in compliance monitoring and enforcement activities, but are
not otherwise expected to engage in the activities regulated by this
rule. Thus, Executive Order 13132 does not apply to this rule.
F. Executive Order 13175
As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 22951, November 6,
2000), EPA has determined that this action does not have tribal
implications because it will not have substantial direct effects on
tribal governments, on the relationship between the Federal government
and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes, as
specified in the Order. EPA is not aware of any tribal governments
which are pesticide registrants, refillers or dealers storing large
quantities of pesticides. Thus, Executive Order 13175 does not apply to
this action.
G. Executive Order 13045
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997), does not apply to this action because it is not designated as an
economically significant regulatory action as defined by Executive
Order 12866 (see Unit XIII.A.). Further, this action does not establish
an environmental standard that is intended to have a negatively
disproportionate effect on children. To the contrary, this action will
provide added protection for children from pesticide risk by ensuring
the integrity of pesticide container design, as well as secure
pesticide storage and disposal.
H. Executive Order 13211
This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer Advancement Act (NTTAA)
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, business practices,
etc.) that are developed or adopted by voluntary consensus standards
bodies. NTTAA directs EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable voluntary consensus standards. This action requires
performance standards for containment structures and residue removal
testing for containers of certain pesticide formulations, but does not
require specific methods or standards. Therefore, this action does not
impose any technical standards that would require Agency consideration
of voluntary consensus standards.
J. Executive Order 12898
This action does not have an adverse impact on the environmental
and health conditions in low-income and minority communities.
Therefore, under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency has not
considered environmental justice-related issues. Although not directly
impacting environmental justice-related concerns, the Agency believes
that the requirements in this rule will assist EPA and others in
reducing potential exposures associated with the handling, storage,
management and disposal of pesticide containers covered by the rule.
XIV. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
major rule as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
List of Subjects in 40 CFR Part 156
Environmental protection, Labeling, Pesticides and pests.
[[Page 47420]]
List of Subjects in 40 CFR Part 165
Environmental protection, Packaging and containers, Containment
structures, Pesticides and pests.
Dated: August 3, 2006.
Stephen L. Johnson,
Administrator.
? Therefore, 40 CFR chapter I is amended as follows:
? 1. Part 9 is amended as follows:
PART 9--[AMENDED]
? a. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
? b. In Sec. 9.1 the table is amended by adding a new center heading
entitled ``Pesticide Management and Disposal'' and an entry for new
part 165 after the center heading and entries for ``State Registration
of Pesticide Products,'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
----------------------------------------------------------------------------------------------------------------
40 CFR citation OMB Control No.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Pesticide Management and Disposal
----------------------------------------------------------------------------------------------------------------
Part 165....................... 2070-0133
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
PART 156--[AMENDED]
? 2. Part 156 is amended as follows:
? a. The authority citation for part 156 continues to read as follows:
Authority: 7 U.S.C. 136 through 136y.
? b. In Sec. 156.10 by adding paragraph (d)(7), and by revising
paragraphs (f) and (i)(2)(ix) to read as follows:
Sec. 156.10 Labeling requirements.
* * * * *
(d)* * *
(7) For a pesticide product packaged in a refillable container, an
appropriately sized area on the label may be left blank to allow the
net weight or measure of content to be marked in by the refiller
according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or
sale of the pesticide. As required in paragraph (a)(1)(iii) of this
section, the net contents must be shown clearly and prominently on the
label.
* * * * *
(f) Producing establishment's registration number. The producing
establishment registration number preceded by the phrase ``EPA Est.'',
of the final establishment at which the product was produced may appear
in any suitable location on the label or immediate container. It must
appear on the wrapper or outside container of the package if the EPA
establishment registration number on the immediate container cannot be
clearly read through such wrapper or container. For a pesticide product
packaged in a refillable container, an appropriately sized area on the
label may be left blank after the phrase ``EPA Est.'' to allow the EPA
establishment registration number to be marked in by the refiller
according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or
sale of the pesticide.
* * * * *
(i) * * *
(2)* * *
(ix) Specific directions concerning the storage, residue removal
and disposal of the pesticide and its container, in accordance with
subpart H of this part and part 165 of this chapter. These instructions
must be grouped and appear under the heading, ``Storage and Disposal.''
This heading must be set in type of the same minimum sizes as required
for the child hazard warning. (See table in Sec. 156.60(b))
* * * * *
? c. By adding Subpart H entitled ``Container Labeling'' to read as
follows:
Subpart H--Container Labeling
Sec.
156.140 Identification of container types.
156.144 Residue removal instructions - general.
156.146 Residue removal instructions for nonrefillable containers -
rigid containers with dilutable pesticides.
156.156 Residue removal instructions for refillable containers.
156.159 Compliance date.
Subpart H--Container Labeling
Sec. 156.140 Identification of container types.
For products other than plant-incorporated protectants, the
following statements, as applicable, must be placed on the label or
container. The information may be located on any part of the container
except the closure. If the statements are placed on the container, they
must be durably marked on the container. Durable marking includes, but
is not limited to etching, embossing, ink jetting, stamping, heat
stamping, mechanically attaching a plate, molding, or marking with
durable ink.
(a) Nonrefillable container. For nonrefillable containers, the
statements in paragraphs (a)(1) through (a)(4) of this section are
required. If placed on the label, the statements in paragraphs (a)(1)
through (a)(3) of this section must be under an appropriate heading
under the heading ``Storage and Disposal.'' If any of the statements in
paragraphs (a)(1) through (a)(3) of this section are placed on the
container, an appropriate referral statement such as ``See container
for recycling [or other descriptive word]
information.'' must be placed
on the label under the heading ``Storage and Disposal.''
(1) Statement identifying a nonrefillable container. The following
phrase is required: ``Nonrefillable container.''
(2) Reuse statement. One of the following statements is required.
Products with labels that allow household/residential use must use the
statement in paragraph (a)(2)(i) or (a)(2)(iii) of this section. All
other products must use the statement in paragraph (a)(2)(i),
(a)(2)(ii), or (a)(2)(iii) of this section.
(i) ``Do not reuse or refill this container.''
(ii) ``Do not reuse this container to hold materials other than
pesticides or dilute pesticides (rinsate). After emptying and cleaning,
it may be allowable to temporarily hold rinsate or other pesticide-
related materials in the container. Contact your state regulatory
agency to determine allowable practices in your state.''
(iii) The following statement may be used if a product is ``ready-
to-use'' and
[[Page 47421]]
its directions for use allow a different product (that is a similar,
but concentrated formulation) to be poured into the container and
diluted by the end user: ``Do not reuse or refill this container unless
the directions for use allow a different (concentrated) product to be
diluted in the container.''
(3) Recycling or reconditioning statement. One of the following
statements is required:
(i) ``Offer for recycling if available.''
(ii) ``Once cleaned, some agricultural plastic pesticide containers
can be taken to a container collection site or picked up for recycling.
To find the nearest site, contact your chemical dealer or manufacturer
or contact [a pesticide container recycling organization]
at [phone
number]
or [web site]. For example, this statement could be ``Once
cleaned, some agricultural plastic pesticide containers can be taken to
a container collection site or picked up for recycling. To find the
nearest site, contact your chemical dealer or manufacturer or contact
the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free)
or http://www.acrecycle.org.''
(iii) A recycling statement approved by EPA and published in an EPA
document, such as a Pesticide Registration Notice.
(iv) An alternative recycling statement that has been reviewed and
approved by EPA.
(v) ``Offer for reconditioning if appropriate.''
(4) Batch code. A lot number, or other code used by the registrant
or producer to identify the batch of the pesticide product which is
distributed and sold is required.
(b) Refillable container. For refillable containers, one of the
following statements is required. If placed on the label, it must be
under the heading ``Storage and Disposal.'' If the statement is placed
on the container, an appropriate referral statement, such as
``Refilling limitations are on the container.'' must be placed under
the heading ``Storage and Disposal.''
(1) ``Refillable Container. Refill this container with pesticide
only. Do not reuse this container for any other purpose.''
(2) ``Refillable Container. Refill this container with [common
chemical name]
only. Do not reuse this container for any other purpose.''
Sec. 156.144 Residue removal instructions - general.
(a) General. Except as provided by paragraphs (c) and (d) of this
section, the label of each pesticide product must include the
applicable instructions for removing pesticide residues from the
container prior to container disposal that are specified in Sec. Sec.
156.146 and 156.156. The residue removal instructions are required for
both nonrefillable and refillable containers.
(b) Placement of residue removal statements. All residue removal
instructions must be placed under the heading ``Storage and Disposal.''
(c) Exemption for residential/household use products. Residential/
household use pesticide products are exempt from the residue removal
instruction requirements in this section through Sec. 156.156.
(d) Modification. EPA may, on its own initiative or based on data
submitted by any person, modify or waive the requirements of this
section through Sec. 156.156, or permit or require alternative
labeling statements.
Sec. 156.146 Residue removal instructions for nonrefillable
containers - rigid containers with dilutable pesticides.
The label of each dilutable (liquid or solid) pesticide product
packaged in a rigid nonrefillable container must include the following
residue removal instructions as appropriate.
(a) Timing of the residue removal procedure. One of the following
statements must immediately precede the instructions required in
paragraph (b) of this section and must be consistent with the
instructions in paragraphs (b) and (c) of this section:
(1) ``Clean container promptly after emptying.''
(2) ``Triple rinse or pressure rinse container (or equivalent)
promptly after emptying.''
(3) ``Triple rinse container (or equivalent) promptly after emptying.''
(b) Triple rinse instructions. The label of each dilutable
pesticide product packaged in rigid nonrefillable containers must
include one of the following sets of instructions.
(1) For liquid dilutable pesticide products in containers small
enough to shake, use the following instructions: ``Triple rinse as
follows: Empty the remaining contents into application equipment or a
mix tank and drain for 10 seconds after the flow begins to drip. Fill
the container 1/4 full with water and recap. Shake for 10 seconds. Pour
rinsate into application equipment or a mix tank or store rinsate for
later use or disposal. Drain for 10 seconds after the flow begins to
drip. Repeat this procedure two more times.''
(2) For solid dilutable pesticide products in containers small
enough to shake, use the following instructions: ``Triple rinse as
follows: Empty the remaining contents into application equipment or a
mix tank. Fill the container 1/4 full with water and recap. Shake for
10 seconds. Pour rinsate into application equipment or a mix tank or
store rinsate for later use or disposal. Drain for 10 seconds after the
flow begins to drip. Repeat this procedure two more times.''
(3) For containers that are too large to shake, use the following
instructions: ``Triple rinse as follows: Empty remaining contents into
application equipment or a mix tank. Fill the container 1/4 full with
water. Replace and tighten closures. Tip container on its side and roll
it back and forth, ensuring at least one complete revolution, for 30
seconds. Stand the container on its end and tip it back and forth
several times. Turn the container over onto its other end and tip it
back and forth several times. Empty the rinsate into application
equipment or a mix tank or store rinsate for later use or disposal.
Repeat this procedure two more times.''
(c) Pressure rinse instructions. The label of each dilutable
pesticide product packaged in rigid nonrefillable containers may
include one of the following sets of instructions, and one of them must
be used if the statement in paragraph (a)(2) of this section is used.
If one of these statements is included on the label, it must
immediately follow the triple rinse instructions specified in paragraph
(b) of this section.
(1) For liquid dilutable pesticide products, use the following
label instruction: ``Pressure rinse as follows: Empty the remaining
contents into application equipment or a mix tank and continue to drain
for 10 seconds after the flow begins to drip. Hold container upside
down over application equipment or mix tank or collect rinsate for
later use or disposal. Insert pressure rinsing nozzle in the side of
the container, and rinse at about 40 PSI for at least 30 seconds. Drain
for 10 seconds after the flow begins to drip.''
(2) For solid dilutable pesticide products, use the following label
instruction: ``Pressure rinse as follows: Empty the remaining contents
into application equipment or a mix tank. Hold container upside down
over application equipment or mix tank or collect rinsate for later use
or disposal. Insert pressure rinsing nozzle in the side of the
container, and rinse at about 40 PSI for at least 30 seconds. Drain for
10 seconds after the flow begins to drip.''
(d) Non-water diluent. (1) A registrant who wishes to require users
to clean a container with a diluent other than water (e.g., solvents)
must submit to EPA a written request to modify the
[[Page 47422]]
residue removal instructions of this section. The registrant may not
distribute or sell the pesticide with the modified residue removal
instructions until EPA approves the request in writing.
(2) The registrant must indicate why a non-water diluent is
necessary for efficient residue removal, and must propose residue
removal instructions and disposal instructions that are appropriate for
the characteristics and formulation of the pesticide product and non-
water diluent. The proposed residue removal instructions must identify
the diluent. If the Directions for Use permit the application of a
mixture of the pesticide and the non-water diluent, the instructions
may allow the rinsate to be added to the application equipment or mix
tank. If the Directions for Use do not identify the non-water diluent
as an allowable addition to the pesticide, the instructions must require
collection and storage of the rinsate in a rinsate collection system.
(3) EPA may approve the request if EPA finds that the proposed
instructions are necessary and appropriate.
Sec. 156.156 Residue removal instructions for refillable containers.
The label of each pesticide product packaged in a refillable
container must include the residue removal instructions in this
section. Instructions must be given for all pesticide products that are
distributed or sold in refillable containers, including those that do
not require dilution prior to application.
(a) Timing of the residue removal procedure. One of the following
statements must immediately precede the instructions required in
paragraph (b) of this section and must be consistent with the
instructions in paragraph (b) of this section:
(1) ``Cleaning the container before final disposal is the
responsibility of the person disposing of the container. Cleaning
before refilling is the responsibility of the refiller.''
(2) ``Pressure rinsing the container before final disposal is the
responsibility of the person disposing of the container. Cleaning
before refilling is the responsibility of the refiller.''
(b) Residue removal instructions prior to container disposal. (1)
Instructions for cleaning each refillable container prior to disposal
are required. The residue removal instructions must be appropriate for
the characteristics and formulation of the pesticide product and must
be adequate to protect human health and the environment.
(2) Subject to meeting the standard in paragraph (b)(1) of this
section, the statement on residue removal instructions could include
any one of the following:
(i) The refilling residue removal procedure developed by the
registrant for the pesticide product.
(ii) Standard industry practices for cleaning refillable containers.
(iii) For pesticides that require dilution prior to application,
the following statement: ``To clean the container before final
disposal, empty the remaining contents from this container into
application equipment or a mix tank. Fill the container about 10
percent full with water. Agitate vigorously or recirculate water with
the pump for 2 minutes. Pour or pump rinsate into application equipment
or rinsate collection system. Repeat this rinsing procedure two more
times.''
(iv) Any other statement the registrant considers appropriate.
Sec. 156.159 Compliance date.
As of August 17, 2009, all pesticide products distributed or sold
by a registrant must have labels that comply with Sec. Sec.
156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146,
and 156.156.
? 3. By adding a new part 165 to read as follows:
Part 165--Pesticide Management and Disposal
Sec.
Subpart A--General
165.1 Scope.
165.3 Definitions.
165.4-165.19 [Reserved]
Subpart B--Nonrefillable Container Standards: Container Design and
Residue Removal
165.20 General provisions.
165.23 Scope of pesticide products included.
165.25 Nonrefillable container standards.
165.27 Reporting and recordkeeping.
165.28-165.39 [Reserved]
Subpart C--Refillable Container Standards: Container Design
165.40 General provisions.
165.43 Scope of pesticide products included.
165.45 Refillable container standards.
165.47 What information must I report about my refillable containers?
165.48-165.59 [Reserved]
Subpart D--Standards for Repackaging Pesticide Products into Refillable
Containers
165.60 General provisions.
165.63 Scope of pesticide products included.
165.65 Registrants who distribute or sell pesticide products in
refillable containers.
165.67 Registrants who distribute or sell pesticide products to
refillers for repackaging.
165.70 Refillers who are not registrants.
165.71-165.79 [Reserved]
Subpart E--Standards for Pesticide Containment Structures
165.80 General provisions.
165.81 Scope of stationary pesticide containers included.
165.82 Scope of pesticide dispensing areas included.
165.83 Definition of new and existing structures.
165.85 Design and capacity requirements for new structures.
165.87 Design and capacity requirements for existing structures.
165.90 Operational, inspection and maintenance requirements for all
new and existing containment structures.
165.92 What if I need both a containment pad and a secondary
containment unit?
165.95 What recordkeeping do I have to do as a facility owner or operator?
165.97 States with existing containment programs.
Authority: 7 U.S.C. 136 through 136y.
Subpart A--General
Sec. 165.1 Scope.
The Part 165 regulations establish standards and requirements for
pesticide containers, repackaging pesticides, and pesticide containment
structures.
Sec. 165.3 Definitions.
Act means the Federal Insecticide, Fungicide, and Rodenticide Act.
Agricultural pesticide means any pesticide product labeled for use
in a nursery or greenhouse or for use in the production of any
agricultural commodity, including any plant, plant part, animal, or
animal product produced by persons (including farmers, ranchers,
vineyardists, plant propagators, Christmas tree growers,
aquaculturalists, horticulturists, orchardists, foresters, or other
comparable persons) primarily for sale, consumption, propagation or
other use by man or animals.
Appurtenance means any equipment or device which is used for the
purpose of transferring a pesticide from a stationary pesticide
container or to any refillable container, including but not limited to,
hoses, fittings, plumbing, valves, gauges, pumps and metering devices.
Container means any package, can, bottle, bag, barrel, drum, tank,
or other containing-device (excluding any application tanks) used to
enclose a pesticide. Containers that are used to sell or distribute a
pesticide product and that also function in applying the product (such
as spray bottles, aerosol
[[Page 47423]]
cans and containers that become part of a direct injection system) are
considered to be containers for the purposes of this part.
Containment pad means any structure that is designed and
constructed to intercept and contain pesticides, rinsates, and
equipment wash water at a pesticide dispensing area.
Containment structure means either a secondary containment unit or
a containment pad.
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.
Dry pesticide means any pesticide that is in solid form and that
has not been combined with liquids; this includes formulations such as
dusts, wettable powders, dry flowable powders, granules, and dry baits.
Establishment means any site where a pesticidal product, active
ingredient, or device is produced, regardless of whether such site is
independently owned or operated, and regardless of whether such site is
domestic and producing a pesticidal product for export only, or whether
the site is foreign and producing any pesticidal product for import
into the United States.
Facility means all buildings, equipment, structures, and other
stationary items which are located on a single site or on contiguous or
adjacent sites and which are owned or operated by the same person (or
by any person who controls, who is controlled by, or who is under
common control with such person).
Flowable concentrate means a stable suspension of active
ingredients in a liquid intended for dilution with water before use.
Nonrefillable container means a container that is not a refillable
container and that is designed and constructed for one time containment
of a pesticide for sale or distribution. Reconditioned containers are
considered to be nonrefillable containers.
One-way valve means a valve that is designed and constructed to
allow virtually unrestricted flow in one direction and no flow in the
opposite direction, thus allowing the withdrawal of material from, but
not the introduction of material into, a container.
Operator means any person in control of, or having responsibility
for, the daily operation of a facility at which a containment structure
is located.
Owner means any person who owns a facility at which a containment
structure is required.
Pesticide compatible means, as applied to containers, that the
container construction materials will not chemically react with the
formulation. A container is not compatible with the formulation if, for
example, the formulation:
(1) Is corrosive to the container;
(2) Causes softening, premature aging, or embrittlement of the
container;
(3) Otherwise causes the container to weaken or to create the risk
of discharge;
(4) Reacts in a significant chemical, electrolytic, or galvanic
manner with the container, or
(5) Interacts in a way, such as the active ingredient permeating
the container wall, that would cause the formulation to differ from its
composition as described in the statement required in connection with
its registration under FIFRA section 3.
Pesticide compatible means, as applied to secondary containment,
that the containment construction materials are able to withstand
anticipated exposure to stored or transferred materials without losing
the capacity to provide the required secondary containment of the same
or other materials within the containment area.
Pesticide dispensing area means an area in which pesticide is
transferred out of or into a container.
Portable pesticide container means a refillable container that is
not a stationary pesticide container.
Pressure rinse means the flushing of the container to remove
pesticide residue by using a pressure method with a pressure of at
least 40 PSI.
Produce means to manufacture, prepare, propagate, compound, or
process any pesticide, including any pesticide produced pursuant to
section 5 of the Act, and any active ingredient or device, or to
package, repackage, label, relabel, or otherwise change the container
of any pesticide or device.
Producer means any person, as defined by the Act, who produces any
pesticide, active ingredient, or device (including packaging,
repackaging, labeling and relabeling).
Refillable container means a container that is intended to be
filled with pesticide more than once for sale or distribution.
Refiller means a person who engages in the activity of repackaging
pesticide product into refillable containers. This could include a
registrant or a person operating under contract to a registrant.
Refilling establishment means an establishment where the activity
of repackaging pesticide product into refillable containers occurs.
Repackage means, for the purposes of this part, to transfer a
pesticide formulation from one container to another without a change in
the composition of the formulation, the labeling content, or the
product's EPA registration number, for sale or distribution.
Rinsate means the liquid produced from the rinsing of the interior
of any equipment or container that has come in direct contact with any
pesticide.
Runoff means surface water leaving the target site.
Secondary containment unit means any structure, including rigid
diking, that is designed and constructed to intercept and contain
pesticide spills and leaks and to prevent runoff and leaching from
stationary pesticide containers.
Stationary pesticide container means a refillable container that is
fixed at a single facility or establishment or, if not fixed, remains
at the facility or establishment for at least 30 consecutive days, and
that holds pesticide during the entire time.
Tamper-evident device means a device which can be visually
inspected to determine if a container has been opened.
Transport vehicle means a cargo-carrying vehicle such as an
automobile, van, tractor, truck, semitrailer, tank car or rail car used
for the transportation of cargo by any mode.
Triple rinse means the flushing of the container three times to
remove pesticide residue by using a non-pressurized method.
Washwater means the liquid produced from the rinsing of the
exterior of any equipment or containers that have or may have come in
direct contact with any pesticide or system maintenance compound.
[[Page 47424]]
Sec. Sec. 165.4-165.19 [Reserved]
Subpart B--Nonrefillable Container Standards: Container Design and
Residue Removal
Sec. 165.20 General provisions.
(a) What is the purpose of the regulations in this subpart? The
regulations in this subpart establish design and construction
requirements for nonrefillable containers used for the distribution or
sale of some pesticide products.
(b) Do I have to comply with the regulations in this subpart? You
must comply with the regulations in this subpart if you are a
registrant who distributes or sells a pesticide product in
nonrefillable containers. If your pesticide product is subject to the
regulations in this subpart as set out in Sec. 165.23, your pesticide
product must be distributed or sold in a nonrefillable container that
meets the standards of these regulations.
(c) When do I have to comply? As of August 17, 2009, all pesticide
products distributed or sold by you in nonrefillable containers must be
distributed or sold in compliance with these regulations.
Sec. 165.23 Scope of pesticide products included.
(a) Are manufacturing use products subject to the regulations in
this subpart? No, the regulations in this subpart do not apply to
manufacturing use products, as defined in Sec. 158.153(h) of this chapter.
(b) Are plant-incorporated protectants subject to the regulations
in this subpart? No, the regulations in this subpart do not apply to
plant-incorporated protectants, as defined in Sec. 174.3 of this chapter.
(c) Which antimicrobial pesticide products are not subject to the
regulations in this subpart? The regulations in this subpart do not
apply to a pesticide product if it satisfies all of the following
conditions:
(1) The pesticide product meets one of the following two criteria:
(i) The pesticide product is an antimicrobial pesticide as defined
in FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is intended to: disinfect,
sanitize, reduce or mitigate growth or development of microbiological
organisms; or protect inanimate objects, industrial processes or
systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria, viruses,
fungi, protozoa, algae, or slime; and
(B) In the intended use is subject to a tolerance under section 408
of the Federal Food, Drug, and Cosmetic Act or a food additive
regulation under section 409 of such Act.
(2) The labeling of the pesticide product includes directions for
use on a site in at least one of the following antimicrobial product
use categories: food handling/storage establishments premises and
equipment; commercial, institutional, and industrial premises and
equipment; residential and public access premises; medical premises and
equipment; human drinking water systems; materials preservatives;
industrial processes and water systems; antifouling coatings; wood
preservatives; or swimming pools.
(3) The pesticide product is not a hazardous waste as set out in
part 261 of this chapter when the pesticide product is intended to be
disposed.
(4) EPA has not specifically determined that the pesticide product
must be subject to the regulations in this subpart to prevent an
unreasonable adverse effect on the environment according to the
provisions of paragraph (d) of this section.
(d) How will EPA determine if an ``antimicrobial'' pesticide
product otherwise exempted must be subject to the regulations in this
subpart to prevent an unreasonable adverse effect on the environment?
(1) EPA may determine that an antimicrobial pesticide product otherwise
exempted by paragraph (c) of this section must be subject to the
nonrefillable container regulations in this subpart to prevent an
unreasonable adverse effect on the environment if all of the following
conditions exist:
(i) EPA obtains information, data or other evidence of a problem
with the containers of a certain pesticide product or related group of
products.
(ii) The information, data or other evidence is reliable and factual.
(iii) The problem causes or could reasonably be expected to cause
an unreasonable adverse effect on the environment.
(iv) Complying with the container regulations could reasonably be
expected to eliminate the problem.
(2) If EPA determines that an antimicrobial pesticide product
otherwise exempted by paragraph (c) of this section must be subject to
the nonrefillable container regulations in this subpart to prevent an
unreasonable adverse effect on the environment, EPA may require, by
rule, that the product be distributed or sold in nonrefillable
containers that comply with all or some of the requirements in this
subpart. Alternatively, EPA may notify the applicant or registrant of
its intent to make such a determination. After allowing the applicant
or registrant a reasonable amount of time to reply, EPA may require, by
notification and as a condition of registration, that the product be
distributed or sold in nonrefillable containers that comply with all or
some of the requirements in this subpart. For the purpose of the
previous sentence, 60 days would be a reasonable amount of time to
reply, although EPA may, in its discretion, provide more time. EPA may
deny registration or initiate cancellation proceedings if the
registrant fails to comply with the nonrefillable container regulations
within the time frames established by EPA in the rule or in its
notification.
(e) What other pesticide products are subject to the regulations in
this subpart? (1) Except for manufacturing use products, plant-
incorporated protectants, and antimicrobial products that are exempt
under paragraph (c) of this section, all of the regulations in this
subpart apply to a pesticide product if it satisfies at least one of
the following criteria:
(i) The pesticide product meets the criteria of Toxicity Category I
as set out in Sec. 156.62 of this chapter.
(ii) The pesticide product meets the criteria of Toxicity Category
II as set out in Sec. 156.62 of this chapter.
(iii) The pesticide product is classified for restricted use as set
out in Sec. Sec. 152.160 - 152.175 of this chapter.
(2) Except for manufacturing use products, plant-incorporated
protectants, antimicrobial products that are exempt under (c) of this
section, and other pesticide products that are regulated under
paragraph (e)(1) of this section, a pesticide product must be packaged
in compliance with 49 CFR 173.24. If the pesticide product meets the
definition of a hazardous material in 49 CFR 171.8, the Department of
Transportation requires it to be packaged according to 49 CFR parts
171-180.
(f) What does ``pesticide product'' or ``pesticide'' mean in the
rest of this subpart? In Sec. Sec. 165.25 through 165.27, the term
``pesticide product'' or ``pesticide'' refers only to a pesticide
product or a pesticide that is subject to the regulations in this
subpart as described in paragraphs (a) through (e) of this section.
Sec. 165.25 Nonrefillable container standards.
(a) What Department of Transportation (DOT) standards do my
nonrefillable containers have to meet under this part if my pesticide
product is not a DOT hazardous material? A pesticide product that does
not meet the definition of a hazardous material in 49
[[Page 47425]]
CFR 171.8 must be packaged in a nonrefillable container that is
designed, constructed, and marked to comply with the requirements of 49
CFR 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213,
173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and part 180
that are applicable to a Packing Group III material.
(b) What DOT standards do my nonrefillable containers have to meet
under this part if my pesticide product is a DOT hazardous material?
(1) If your pesticide product meets the definition of a hazardous
material in 49 CFR 171.8, the DOT requires your pesticide product to be
packaged according to 49 CFR parts 171-180.
(2) For the purposes of these regulations, a pesticide product that
meets the definition of a hazardous material in 49 CFR 171.8 must be
packaged in a nonrefillable container that is designed, constructed,
and marked to comply with the requirements of 49 CFR parts 171-180.
(c) What will EPA do if DOT proposes to change any of the cross-
referenced regulations? If the DOT proposes to change any of the
regulations that are incorporated in paragraphs (a) and (b) of this
section, EPA will provide notice of the proposed changes and an
opportunity to comment in the Federal Register. Following notice and
comment, EPA will take final action regarding whether or not to revise
its rules, and the extent to which any such revision will correspond
with revised DOT regulations.
(d) What standards for closures do my nonrefillable containers have
to meet? If your nonrefillable container is a rigid container with a
capacity equal to or greater than 3.0 liters (0.79 gallons), if the
container is not an aerosol container or a pressurized container, and
if the container is used to distribute or sell a liquid agricultural
pesticide, each nonrefillable container must have at least one of the
following standard closures:
(1) Bung, 2 inch pipe size (2.375 inches in diameter), external
threading, 11.5 threads per inch, National Pipe Straight (NPS) standard.
(2) Bung, 2 inch pipe size (2.375 inches in diameter), external
threading, 5 threads per inch, buttress threads.
(3) Screw cap, 63 millimeters, at least one thread revolution at 6
threads per inch.
(4) Screw cap, 38 millimeters, at least one thread revolution at 6
threads per inch. The cap may fit on a separate rigid spout or on a
flexible pull-out plastic spout.
(e) What standards for dispensing do my nonrefillable containers
have to meet? If your nonrefillable container has a capacity of 5
gallons (18.9 liters) or less, if the container is not an aerosol
container, a pressurized container, or a spray bottle, and if the
container holds a liquid pesticide, your nonrefillable container must
do both of the following:
(1) Allow the contents of the nonrefillable container to pour in a
continuous, coherent stream.
(2) Allow the contents of the nonrefillable container to be poured
with a minimum amount of dripping down the outside of the container.
(f) What standards for residue removal do my nonrefillable
containers have to meet? Each nonrefillable container and pesticide
formulation combination must meet the applicable residue removal
standard of this section.
(1) If the nonrefillable container is rigid and has a capacity less
than or equal to 5 gallons (18.9 liters) for liquid formulations or 50
pounds (22.7 kilograms) for solid formulations and if the pesticide
product's labeling allows or requires the pesticide product to be mixed
with a liquid diluent prior to application (that is, if the pesticide
is dilutable), each container/formulation combination must be capable
of attaining at least 99.99 percent removal of each active ingredient
when tested using the EPA test procedure ``Rinsing Procedures for
Dilutable Pesticide Products in Rigid Containers.''
(2) The test must be conducted only if the pesticide product is a
flowable concentrate or if EPA specifically requests the records on a
case by case basis.
(3) For the rigid container/dilutable product standard in paragraph
(f)(1) of this section, percent removal represents the percent of the
original concentration of the active ingredient in the pesticide
product when compared to the concentration of that active ingredient in
the fourth rinse. Percent removal is calculated by the formula:
percent removal = [1.0 - RR]
x 100.0, where
RR = rinsate ratio = Active ingredient concentration in fourth
rinsate/Original concentration of active ingredient in the product
(g) Can I obtain a waiver from or a modification to any of the
nonrefillable container standards? Yes, it is possible for you to
obtain a waiver from or a modification to the nonrefillable container
standards, as follows:
(1) EPA may waive or modify the requirements of paragraph (a) of
this section regarding the DOT standards for pesticide products that
are not DOT hazardous materials if EPA determines that an alternative
(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in
the requirements of paragraph (a) of this section.
(2) EPA may waive or modify the requirements of paragraph (b) of
this section regarding the DOT standards for pesticide products that
are DOT hazardous materials if EPA determines that an alternative
(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in
the requirements of paragraph (b) of this section. EPA will modify or
waive the requirements of paragraph (b) of this section only after
consulting with DOT to ensure consistency with DOT regulations and
exemptions.
(3) EPA may approve a non-standard closure (that is, a closure not
listed in paragraph (d) of this section) if EPA determines that both of
the following conditions are satisfied:
(i) The non-standard closure is necessary for the proper mixing,
loading, or application of the pesticide product.
(ii) The non-standard closure offers exposure protection to
handlers during mixing and loading that is the same or greater than
that provided by the standard closures.
(4) EPA may waive or modify the container dispensing capability
standards in paragraph (e) of this section if EPA determines that at
least one of the following conditions is satisfied:
(i) The product is typically removed from the container by a method
other than pouring.
(ii) Compliance with the container dispensing capability standards
would increase exposure to the pesticide container handler.
(5) EPA may waive or modify the requirements of paragraph (f) of
this section regarding the residue removal standard if EPA determines
that both of the following conditions are satisfied:
(i) The residue remaining in the container would not cause an
unreasonable adverse effect on the environment; and
(ii) The product offers significant benefits and cannot be
economically reformulated or repackaged.
(h) How do I obtain a waiver from or a modification to any of the
nonrefillable container standards? To obtain a waiver from or a
modification to any of the nonrefillable container standards, you must
submit a written request for a waiver or a modification to the EPA to
the following address: Office of Pesticide Programs (7504P); U.S.
Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania
[[Page 47426]]
Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the
pesticide product in a nonrefillable container that does not comply
with all of the nonrefillable container standards unless and until EPA
approves the request for the waiver or modification in writing. You
must include two copies of the following information (which may be part
of an application for registration or amended registration) with your
written request:
(1) The name and address of the registrant; the date; and the name,
title, signature, and phone number of the company official making the
request.
(2) The name and EPA registration number of the pesticide product
for which the waiver or modification is requested.
(3) A statement specifying the requirement or requirements from
which you are requesting a waiver or a modification.
(4) A description of the nonrefillable container or containers for
which the waiver or modification is requested.
(5) Documentation or justification to demonstrate that the
applicable waiver or modification criteria in paragraph (g) of this
section are satisfied.
Sec. 165.27 Reporting and recordkeeping.
(a) What information must I report about my nonrefillable
containers? You are not required to report to EPA with information
about your nonrefillable containers under the regulations in this
subpart. You should refer to the reporting standards in part 159 of
this chapter to determine if information on container failures or other
incidents involving pesticide containers must be reported to EPA under
FIFRA section 6(a)(2) (7 U.S.C. 136d(a)(2)).
(b) What recordkeeping do I have to do for my nonrefillable
containers? For each pesticide product that is subject to Sec. 165.25
- 165.27 and is distributed or sold in nonrefillable containers, you
must maintain the records listed in this section for as long as a
nonrefillable container is used to distribute or sell the pesticide
product and for 3 years after that. You must furnish these records for
inspection and copying upon request by an employee of EPA or any entity
designated by EPA, such as a State, another political subdivision or a
Tribe. You must keep the following records:
(1) The name and EPA registration number of the pesticide product.
(2) A description of the nonrefillable container(s) in which the
pesticide product is distributed or sold.
(3) At least one of the following records to document compliance
with the requirement for closures in Sec. 165.25(d) for each
nonrefillable container used to distribute or sell the pesticide
product that must comply with Sec. 165.25(d):
(i) A letter or document from the container supplier that describes
the closure.
(ii) A specification about the closure in the contract between the
registrant or applicant and the container supplier.
(iii) A copy of EPA's approval of any non-standard closure.
(4) At least one of the following records pertaining to the
container dispensing capability requirements in Sec. 165.25(e) for
each nonrefillable container used to distribute or sell the pesticide
product that must comply with Sec. 165.25(e):
(i) Test data or documentation demonstrating that the nonrefillable
container meets the standards in Sec. 165.25(e) when it contains the
pesticide product.
(ii) Test data or documentation demonstrating that a different
nonrefillable container meets the standards in Sec. 165.25(e) when it
contains the pesticide product or even a different pesticide product
and a written explanation of why such data or documentation
demonstrates that the container meets the standards in Sec. 165.25(e)
for the pesticide product.
(5) At least one of the following records pertaining to the
nonrefillable container residue removal requirement in Sec. 165.25(f)
if the pesticide product is a flowable concentrate or if EPA
specifically requests the records on a case by case basis:
(i) Test data showing that the nonrefillable container and
pesticide formulation meet the standard in Sec. 165.25(f) .
(ii) Test data showing that a different nonrefillable container
with the same or a different pesticide formulation meets the standard
in Sec. 165.25(f), together with a written explanation of why such
data demonstrate that the nonrefillable container and pesticide
formulation meet the standard in Sec. 165.25(f).
Sec. Sec. 165.28-165.39 [Reserved]
Subpart C--Refillable Container Standards: Container Design
Sec. 165.40 General provisions.
(a) What is the purpose of the regulations in this subpart? The
regulations in this subpart establish design and construction
requirements for refillable containers used for the distribution or
sale of some pesticide products.
(b) Do I have to comply with the regulations in this subpart? (1)
You must comply with all of the regulations in this subpart if you are
a registrant who distributes or sells a pesticide product in refillable
containers. If your pesticide product is subject to the regulations in
this subpart as set out in Sec. 165.43, your pesticide product must be
distributed or sold in a refillable container that meets the standards
of these regulations. This includes your pesticide products that are
repackaged according to subpart D of this part.
(2) You must comply with the regulations in Sec. 165.45(f) for
stationary pesticide containers if you are a refiller of a pesticide
product and you are not the registrant of the pesticide product. If the
pesticide product is subject to the regulations in this subpart as set
out in Sec. 165.43, the stationary pesticide containers used to
distribute or sell the product must meet the standards of Sec. 165.45(f).
(c) When do I have to comply? As of August 16, 2011, all pesticide
products distributed or sold by you in refillable containers must be
distributed or sold in compliance with these regulations.
Sec. 165.43 Scope of pesticide products included.
(a) Are manufacturing use products subject to the regulations in
this subpart? No, the regulations in this subpart do not apply to
manufacturing use products, as defined in Sec. 158.153(h) of this chapter.
(b) Are plant-incorporated protectants subject to the regulations
in this subpart? No, the regulations in this subpart do not apply to
plant-incorporated protectants, as defined in Sec. 174.3 of this chapter.
(c) Which ``antimicrobial'' pesticide products are not subject to
the regulations in this subpart? The regulations in this subpart do not
apply to a pesticide product if it satisfies all of the following
conditions:
(1) The pesticide product meets one of the following two criteria:
(i) The pesticide product is an antimicrobial pesticide as defined
in FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is intended to: disinfect,
sanitize, reduce or mitigate growth or development of microbiological
organisms; or protect inanimate objects, industrial processes or
systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria, viruses,
fungi, protozoa, algae, or slime; and
(B) In the intended use is subject to a tolerance under section 408
of the Federal Food, Drug, and Cosmetic Act or a food additive
regulation under section 409 of such Act.
[[Page 47427]]
(2) The labeling of the pesticide product includes directions for
use on a site in at least one of the following antimicrobial product
use categories: food handling/storage establishments premises and
equipment; commercial, institutional, and industrial premises and
equipment; residential and public access premises; medical premises and
equipment; human drinking water systems; materials preservatives;
industrial processes and water systems; antifouling coatings; wood
preservatives; or swimming pools.
(3) The pesticide product is not a hazardous waste as set out in
part 261 of this chapter when the pesticide product is intended to be
disposed.
(4) EPA has not specifically determined that the pesticide product
must be subject to the regulations in this subpart to prevent an
unreasonable adverse effect on the environment according to the
provisions of paragraph (e) of this section.
(d) Which requirements must an ``antimicrobial'' swimming pool
product comply with if it is not exempt from these regulations? An
antimicrobial swimming pool product that is not exempt by paragraph
(a), (b), or (c) of this section must comply with all of the
regulations in this subpart except Sec. 165.45(d) regarding marking
and Sec. 165.45(e) regarding openings. For the purposes of this
subpart, an antimicrobial swimming pool product is a pesticide product
that satisfies both of the following conditions:
(1) The pesticide product is intended to: disinfect, sanitize,
reduce or mitigate growth or development of microbiological organisms;
or protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from contamination,
fouling, or deterioration caused by bacteria, viruses, fungi, protozoa,
algae, or slime.
(2) The labeling of the pesticide product includes directions for
use on only a site or sites in the antimicrobial product use category
of swimming pools.
(e) How will EPA determine if an ``antimicrobial'' pesticide
product otherwise exempted must be subject to the regulations in this
subpart to prevent an unreasonable adverse effect on the environment?
(1) EPA may determine that an antimicrobial pesticide product otherwise
exempted by paragraph (c) of this section must be subject to the
refillable container regulations in this subpart to prevent an
unreasonable adverse effect on the environment if all of the following
conditions exist:
(i) EPA obtains information, data or other evidence of a problem
with the containers of a certain pesticide product or related group of
products.
(ii) The information, data or other evidence is reliable and
factual.
(iii) The problem causes or could reasonably be expected to cause
an unreasonable adverse effect on the environment.
(iv) Complying with the container regulations could reasonably be
expected to eliminate the problem.
(2) If EPA determines that an antimicrobial pesticide product
otherwise exempted by paragraph (c) of this section must be subject to
the refillable container regulations in this subpart to prevent an
unreasonable adverse effect on the environment, EPA may require, by
rule, that the product be distributed or sold in refillable containers
that comply with all or some of the requirements in this subpart.
Alternatively, EPA may notify the applicant or registrant of its intent
to make such a determination. After allowing the applicant or
registrant a reasonable amount of time to reply, EPA may require, by
notification and as a condition of registration, that the product be
distributed or sold in refillable containers that comply with all or
some of the requirements in this subpart. For the purpose of the
previous sentence, 60 days would be a reasonable amount of time to
reply, although EPA may, in its discretion, provide more time. EPA may
deny registration or initiate cancellation proceedings if the
registrant fails to comply with the refillable container regulations
within the time frames established by EPA in the rule or in its
notification.
(f) What other pesticide products are subject to the regulations in
this subpart? The regulations in this subpart apply to all pesticide
products other than manufacturing use products, plant-incorporated
protectants, and antimicrobial products that are exempt by paragraph
(c) of this section. Antimicrobial products covered under by paragraph
(d) of this section are subject to the regulations indicated in that
section.
(g) What does ``pesticide product'' or ``pesticide'' mean in the
rest of this subpart? In Sec. Sec. 165.43(h) through 165.47, the term
``pesticide product'' or ``pesticide'' refers only to a pesticide
product or a pesticide that is subject to the regulations in this
subpart as described in paragraphs (a) through(f) of this section.
(h) Are there any other exceptions? (1) The regulations in this
subpart do not apply to transport vehicles that contain pesticide in
pesticide-holding tanks that are an integral part of the transport
vehicle and that are the primary containment for the pesticide.
(2) The regulations in this subpart do not apply to containers that
hold pesticides that are gaseous at atmospheric temperature and pressure.
Sec. 165.45 Refillable container standards.
(a) What Department of Transportation (DOT) standards do my
refillable containers have to meet under this part if my pesticide
product is not a DOT hazardous material? (1) A pesticide product that
does not meet the definition of a hazardous material in 49 CFR 171.8
must be packaged in a refillable container that is designed,
constructed, and marked to comply with the requirements of 49 CFR
173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213,
173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and part 180
that are applicable to a Packing Group III material.
(2) A refiller is not required to comply with 49 CFR 173.28(b)(2)
for pesticide products that are not DOT hazardous materials if the
refillable container to be reused complies with the refillable
container regulations in this subpart and the refilling is done in
compliance with the repackaging regulations in subpart D of this part.
(b) What DOT standards do my refillable containers have to meet
under this part if my pesticide product is a DOT hazardous material?
(1) If your pesticide product meets the definition of a hazardous
material in 49 CFR 171.8, the DOT requires your pesticide product to be
packaged according to 49 CFR parts 171-180.
(2) For the purposes of these regulations, a pesticide product that
meets the definition of a hazardous material in 49 CFR 171.8 must be
packaged in a refillable container that is designed, constructed, and
marked to comply with the requirements of 49 CFR parts 171-180.
(c) What will EPA do if DOT proposes to change any of the cross-
referenced regulations? If the DOT proposes to change any of the
regulations that are incorporated in paragraphs (a) and (b) of this
section, EPA will provide notice of the proposed changes and an
opportunity to comment in the Federal Register. Following notice and
comment, EPA will take final action regarding whether or not to revise
its rules, and the extent to which any such revision will correspond
with revised DOT regulations.
(d) What standards for marking do my refillable containers have to
meet? Each refillable container must be marked in a durable and clearly
visible manner with
[[Page 47428]]
a serial number or other identifying code that will distinguish the
individual container from all other containers. Durable marking
includes, but is not limited to, etching, embossing, ink jetting,
stamping, heat stamping, mechanically attaching a plate, molding, and
marking with durable ink. The serial number or other identifying code
must be located on the outside part of the container except on a
closure. Placement on the label or labeling is not sufficient unless
the label is an integral, permanent part of or permanently stamped on
the container.
(e) What standards for openings do my refillable containers have to
meet? If your refillable container is a portable pesticide container
that is designed to hold liquid pesticide formulations and is not a
cylinder that complies with the DOT Hazardous Materials Regulations,
each opening of the container other than a vent must have a one-way
valve, a tamper-evident device or both. A one-way valve may be located
in a device or system separate from the container if the device or
system is the only reasonably foreseeable way to withdraw pesticide
from the container. A vent must be designed to minimize the amount of
material that could be introduced into the container through it.
(f) What standards do my stationary pesticide containers have to
meet? If a stationary pesticide container designed to hold undivided
quantities of pesticides equal to 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 is located at the refilling
establishment of a refiller operating under written contract to you,
the stationary pesticide container must meet the following standards:
(1) Except during a civil emergency or any unanticipated grave
natural disaster or other natural phenomenon of an exceptional,
inevitable and irresistible character, the effects of which could not
have been prevented or avoided by the exercise of due care or
foresight, each stationary pesticide container (for liquid and dry
pesticides) and its appurtenances must meet both of the following
standards:
(i) Each stationary pesticide container and its appurtenances must
be resistant to extreme changes in temperature and constructed of
materials that are adequately thick to not fail and that are resistant
to corrosion, puncture, or cracking.
(ii) Each stationary pesticide container must be capable of
withstanding all operating stresses, taking into account static heat,
pressure buildup from pumps and compressors, and any other foreseeable
mechanical stresses to which the container may be subjected in the
course of operations.
(2) Each stationary liquid pesticide container must meet all of the
following standards:
(i) Each stationary liquid pesticide container must be equipped
with a vent or other device designed to relieve excess pressure,
prevent losses by evaporation, and exclude precipitation.
(ii) External sight gauges, which are pesticide-containing hoses or
tubes that run vertically along the exterior of the container from the
top to the bottom, are prohibited on stationary liquid pesticide containers.
(iii) Each stationary liquid pesticide container connection below
the normal liquid level must be equipped with a shutoff valve which is
capable of being locked closed. A shutoff valve must be located within
a secondary containment unit if one is required by subpart E of this part.
(g) Can I obtain a waiver from or a modification to any of the
refillable container standards? Yes, it is possible for you to obtain a
waiver from or a modification to some of the refillable container
standards, as follows:
(1) EPA may waive or modify the requirements of paragraph (a) of
this section regarding the DOT standards for pesticide products that
are not DOT hazardous materials if EPA determines that an alternative
(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in
the requirements of paragraph (a) of this section.
(2) EPA may waive or modify the requirements of paragraph (b) of
this section regarding the DOT standards for pesticide products that
are DOT hazardous materials if EPA determines that an alternative
(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in
the requirements of paragraph (b) of this section. EPA will modify or
waive the requirements of paragraph (b) of this section only after
consulting with DOT to ensure consistency with DOT regulations and
exemptions.
(h) How do I obtain a waiver from or a modification to any of the
refillable container standards? To obtain a waiver from or a
modification to any of the refillable container standards, you must
submit a written request for a waiver or a modification to the EPA to
the following address: Office of Pesticide Programs (7504P); U.S.
Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania
Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the
pesticide product in a refillable container that does not comply with
all of the refillable container standards unless and until EPA approves
the request for the waiver or modification in writing. You must include
two copies of the following information (which may be part of an
application for registration or amended registration) with your written
request:
(1) The name and address of the registrant; the date; and the name,
title, signature, and phone number of the company official making the
request.
(2) The name and EPA registration number of the pesticide product
for which the waiver or modification is requested.
(3) A statement specifying the requirement or requirements from
which you are requesting a waiver or a modification.
(4) A description of the refillable container or containers for
which the waiver or modification is requested.
(5) Documentation or justification to demonstrate that the
applicable waiver or modification criteria in paragraph (g) of this
section are satisfied.
Sec. 165.47 What information must I report about my refillable containers?
You are not required to report to EPA with information about your
refillable containers under the regulations in this subpart. You should
refer to the reporting standards in part 159 of this chapter to
determine if information on container failures or other incidents
involving pesticide containers must be reported to EPA under FIFRA
section 6(a)(2) (7 U.S.C. 136d(a)(2)).
Sec. Sec. 165.48-165.59 [Reserved]
Subpart D--Standards for Repackaging Pesticide Products into
Refillable Containers
Sec. 165.60 General provisions.
(a) What is the purpose of the regulations in this subpart? The
regulations in this subpart establish requirements for repackaging some
pesticide products into refillable containers for distribution or sale.
(b) Do I have to comply with the regulations in this subpart? You
must comply with the regulations in this subpart if you are a
registrant who distributes or sells a pesticide product in refillable
containers, if you are a registrant who distributes or sells pesticide
products to a refiller (that is not part of your company) for
repackaging into refillable containers, or if you are a refiller of a
pesticide product and you are not the registrant of the pesticide
product. Each pesticide product that is subject to the regulations
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