provided by the standard closures.
     Sec.  165.25(e): Container dispensing capability. EPA may
waive or modify the standards in Sec.  165.25(e) if EPA determines that
at least one of the following conditions is satisfied:
    (1) The product is typically removed from the container by a method
other than pouring.
    (2) Compliance with the container dispensing capability standards
would increase exposure to the pesticide container handler.
     Sec.  165.25(f): Residue removal standard. EPA may waive
or modify the requirements of Sec.  165.25(f) if EPA determines that
both of the following conditions are satisfied:
    (1) The residue remaining in the container would not cause an
unreasonable adverse effect on the environment; and
    (2) The product offers significant benefits and cannot be
economically reformulated or repackaged.
    2. Changes. The final rule is significantly different than the
proposal. Additional waiver/modification provisions were added and all
of the criteria were consolidated into one section. The proposed rule
included waiver/modification provisions only for the standard closure
and residue removal requirements. The waiver/modification criteria for
the standard closure requirement in the final rule are similar to the
proposed regulations, although a few minor editorial changes were made.
Also, the final rule clarifies that both criteria must be met before
EPA will approve the use of an alternative closure, which was the
intent of the proposed rule. The waiver/modification provision for the
residue removal requirement was modified to add specific criteria that
must be met. This change was made partly because the proposed criterion
for waiving or modifying the residue removal standard was very broad
and partly because a more specific and limited waiver/modification
standard is appropriate with the less stringent residue removal
standard in the final rule. The final rule incorporates a DOT waiver
provision similar to the one set out in the potential alternative
regulatory text in the 1999 supplemental notice. EPA modified the DOT
waiver provision in several ways to address a few comments about the
problems that could be caused if EPA changed the adopted DOT
requirements for pesticides that are DOT hazardous materials. First, a
separate waiver/modification provision is included for pesticides that
are not DOT hazardous materials and for pesticides that are DOT
hazardous materials. Second, the waiver/modification provision for
pesticides that are DOT hazardous materials specifies that EPA will
modify or waive the requirements in Sec.  165.25(b) only after
consulting with DOT to ensure consistency with DOT regulations and
exemptions. The final rule also adds waiver/modification provisions for
the container dispensing standards.
    The waiver/modification provisions are included to address
situations where the nonrefillable container requirements might
compromise the success, safety and effectiveness of currently used
containers or those developed in the future. While EPA has attempted to
focus each nonrefillable container requirement on containers and
pesticides for which it is appropriate, we are not familiar with every
container used for every product. It is likely that there are some
problematic situations where existing containers that are specifically
designed for a certain use or adaptation may have difficulty complying
with the final regulations. We may not be aware of these situations and
they may not have been mentioned by commenters. In general, waivers or
modifications are intended to provide relief for a limited number of
situations, and we wanted to provide a mechanism to account for these
situations without having to amend the regulations. Waivers and
modifications are appropriate in a limited number of situations, such
as the use of non-standard closures, since the point of the requirement
is to limit the number of closures (and therefore adapters) to
encourage the use of closed transfer systems.

J. Procedure for Applying for a Waiver or Modification (Sec.
165.25(h))

    1. Final regulations. Section 165.25(h) describes the procedure for
registrants to follow if they want to obtain a waiver from or a
modification to any of the nonrefillable container standards. The
regulations specify that a registrant cannot distribute or sell a
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.
    To obtain a waiver or modification, a registrant must submit a
written request for a waiver or a modification to the EPA's Office of
Pesticide Programs at the address provided in the regulations. Two
copies of the following information (which may be part of an
application for registration or amended registration) must be included
with the request:
     The name and address of the registrant; the date; and the
name, title, signature, and phone number of the company official making
the request.
     The name and EPA registration number of the relevant
pesticide product.
     A statement specifying the requirement(s) from which the
waiver or a modification is requested.
     A description of the relevant nonrefillable container(s).
     Documentation or justification to demonstrate that the
applicable waiver or modification criteria in Sec.  165.25(g) are
satisfied.
    2. Changes. The procedure for obtaining all waivers and
modifications is essentially the same as the procedure proposed (in
Sec.  165.119) for obtaining a waiver of the standard closure
requirement. No specific procedure was identified for the residue
removal waiver in the proposed rule or for the waiver from DOT
requirements in the 1999 supplemental notice. Consolidating all of the
waiver criteria in Sec.  165.25(g) and using the same procedure for all
waivers requests should facilitate the process for registrants and EPA.
Therefore, the significant change to the waiver procedure requirements
in the final rule is that they clearly apply to all waiver requests.
Several additional minor modifications were made to the final rule,
including updating the address, clarifying the statement requiring EPA
approval before a pesticide product can be sold or distributed in
containers with waived or modified requirements, broadening several of
the information items to accommodate the additional waiver provisions,
and clarifying that a waiver request could apply to more than

one nonrefillable container design for the identified pesticide
product. Because the waiver and modification requests are part of an
application for registration or amended registration, each waiver
request must apply to only one product.

K. Reporting (Sec.  165.27(a))

    1. Final regulations. This section clarifies that the pesticide
container regulations do not require registrants to report to EPA with
information about their nonrefillable containers. It refers registrants
to the reporting standards in 40 CFR part 159 to determine if
information on container failures or other incidents involving
pesticide containers must be reported to EPA under FIFRA section
6(a)(2).
    2. Changes. The intent and substance of this standard is the same
as in the proposal. However, the wording was changed to clarify that
this is simply a reference to the existing 6(a)(2) standards and that
it does not add any new requirements.

L. Recordkeeping (Sec.  165.27(b))

    1. Final regulations. For each product that is subject to the full
set of nonrefillable container regulations and is distributed and sold
in nonrefillable containers, registrants must keep the following
records for as long as a nonrefillable container is used for the
product and for 3 years thereafter:
     The name and EPA registration number of the product.
     A description of the container(s) used to distribute or
sell the product.
     Documentation of compliance with the closure requirement,
if applicable.
     Documentation of compliance with the dispensing
requirement, if applicable.
     Documentation of compliance with the residue removal
requirement, if applicable.
    The registrant must make these records available for inspection or
copying upon request by an employee of EPA or any entity designated by
EPA, such as a State, another political subdivision or a Tribe.
    2. Changes. The requirements are substantially the same as
proposed. Several minor modifications were made in the final rule to
improve the clarity of the recordkeeping requirements, including:
     Deleting ``design type'' in several places to clarify that
the requirements apply to the containers used to distribute or sell the
product. However, the specific records for the dispensing and residue
removal recordkeeping allow information for different containers and
products to be used to document compliance, under the specified
conditions.
     The first sentence in the recordkeeping requirement in the
final rule was revised to clarify that the recordkeeping applies to
pesticide products distributed or sold in nonrefillable containers and
that are subject to the full set of nonrefillable container regulations
in Sec. Sec.  165.25 - 165.27. In other words, products that are
completely exempt and products that must comply only with the standards
in 49 CFR 173.24 do not have any recordkeeping requirements. This
change was necessary because of the changes in the scope of products
that are subject to the nonrefillable container standards.
     Because the requirement for registrants to submit a
certification is not being finalized, the need to keep a record of the
certification is no longer necessary.
     For the closure-related records, several minor changes
were made to further describe the kinds of documentation that would be
acceptable.

M. Proposed Standards That Are Not Being Finalized

    1. Final regulation/changes. The following requirements relating to
container design from the proposed regulation are not being finalized
in the final rule:
     Sec.  165.102(b): Container integrity and compatibility;
     Sec.  165.102(c)(1): Permanently marking the EPA
registration number;
     Sec.  165.102(c)(2): Permanently marking the container's
material of construction;
     Sec.  165.102(d)(3): Requiring the container to reclose
securely; and
     Sec.  165.106: Residue removal methodology for dilutable
products in rigid containers
     Sec.  165.111: Certification.
    Three of these proposed requirements for nonrefillable containers
are not being finalized because they were replaced by equivalent DOT
requirements. The following table lists the non-finalized requirements
from the proposed rule and the DOT equivalent regulations:

   Table 13.--Proposed Nonrefillable Container Standards That Were Not
                   Finalized and Their DOT Equivalents
------------------------------------------------------------------------
  Proposed Pesticide Container      Proposed 40 CFR    Equivalent 49 CFR
           Requirement                   Cite                Cite
------------------------------------------------------------------------
Container integrity and           Sec.   165.102(b)   Sec.  Sec.
 compatibility                                         173.24(b),
                                                       173.24(e)
------------------------------------------------------------------------
Permanently marking the material  Sec.                Sec.  Sec.
 of construction                   165.102(c)(2)       178.3(a),
                                                       178.503(a)
------------------------------------------------------------------------
Requiring the container to        Sec.                Sec.   173.24(f)
 reclose securely                  165.102(d)(3)
------------------------------------------------------------------------

    As discussed in Units V.H.1. and V.H.4., the residue removal
testing methodology that was proposed in Sec.  165.106 is not being
finalized in the regulatory language and will be incorporated into
EPA's testing guidelines. The test procedure is established as an OPP
test procedure titled ``Rinsing Procedures for Dilutable Pesticide
Products in Rigid Containers.'' (Ref. 20) The proposed regulatory
language provided some details of the test procedure, which EPA
intended to supplement with guidance. The final rule does not include
the specific testing requirements because we believe it is more
appropriate to provide these details in a test protocol than in the
regulations.
    EPA decided not to finalize the proposed requirement in Sec.
165.102(c)(1) that each nonrefillable container be permanently marked
with the EPA registration number of the pesticide in the final rule.
Also, EPA is not finalizing the proposed requirement in Sec.  165.111
for registrants to certify that their nonrefillable containers meet the
standards and to submit the certifications to EPA.
    2. Comments - EPA registration number. Several State regulatory
agencies supported requiring the EPA

registration number, saying it would help in the identification and
disposal of unwanted and/or abandoned pesticides. One acknowledged that
the container might not hold its original contents, but that the
benefits outweigh the disadvantages. One commenter suggested imbedding
identification stripes in bags to identify the contents and another
recommended requiring the year the pesticide was manufactured in
addition to the EPA registration number.
    Almost 30 commenters, including almost 20 registrants, some
registrant groups, a few container manufacturer groups, and a State
regulatory agency, opposed requiring the EPA registration number to be
permanently marked on the container because the container may not hold
its original contents, the number is already on the pesticide label, it
would be too expensive, and it would create inventory and container
ordering problems.
    3. EPA response - EPA Registration Number. This requirement was
intended to help the managers of State pesticide collection and
disposal programs (often called Clean Sweep programs) identify unknown
pesticides when they receive containers without labels. However, based
on the comments, we no longer believe that the benefits of this
standard would outweigh the costs. EPA believes that many commenters
misunderstood the intent of the proposed interpretation of permanent
marking because the comments implied that the EPA registration number
would have to be embossed in the container. This was not the intent of
the proposal, which would have allowed ink jetting, so the comments
regarding inventory problems and some of the costs are not relevant.
However, even the estimates for ink jet printing and the costs to alter
a filling line are substantial when extrapolated to all of the
formulators, particularly when the actual benefits are unclear. EPA
doesn't question the benefit of helping State pesticide disposal
programs identify pesticides to facilitate and minimize the cost of
disposing of unwanted pesticides. However, there are many legitimate
questions about how often this might happen and how much confidence a
pesticide disposal program manager would have that the container holds
its original contents. (See the discussion of good stewardship for
service containers in Unit VII.L. of this preamble.) Also, the EPA
registration number is required on the pesticide's label. Therefore,
EPA is not finalizing this requirement in today's final nonrefillable
container regulations. EPA continues to believe that durably marking a
product's EPA registration number on its nonrefillable containers is a
good practice and we encourage registrants to do this (or continue
doing it), although it is not required.
    4. Comments - certification. A registrant group commented that
registrants would be able to certify compliance if appropriate
standards are established. Another registrant group commented that
current registration guidelines make the certification redundant and
claimed that the requirement to certify was not in compliance with the
Paperwork Reduction Act. A registrant group and a registrant urged EPA
to develop guidance to define what registrants should certify, because
it is unclear what must be certified and when. A registrant group and a
registrant/distributor said that formulators and subregistrants should
be allowed to meet this requirement by a data certification process.
    5. EPA response - certification. EPA considered modifying the
certification requirement to clarify the intent. However, EPA decided
not to finalize the certification requirement because, in this case, we
believe that the benefits of having registrants certify compliance are
outweighed by the paperwork burden on industry and EPA. EPA believes
that having a high level official certify compliance with the
regulations generally facilitates compliance by having companies focus
on the regulations up-front and by creating an incentive for that
official to ensure compliance because of the responsibility of signing
such a statement. However, the registrants will already be sending in a
submission with an official's signature because of the changes to the
pesticide storage and disposal label statements. Therefore, we believe
that some of the benefits of the label submissions will carry over onto
the container standards. Also, this approach should eliminate potential
confusion about submitting label changes and certifications if a
product must comply with the label changes in this rule but not the
nonrefillable container standards (because of different scopes).
Lastly, the container regulations, promulgated under the authority of
FIFRA section 19, are directly enforceable by section 12(a)(2)(S) of
FIFRA, which states that it is unlawful to violate any regulation
issued under section 3(a) or 19. In other words, the certifications are
not necessary to enforce these regulations. For all of these reasons,
EPA decided not to finalize the certification requirement in today's
final rule.

VI. Refillable Containers

A. Key Terms

    1. Overview. The following terms, defined in Sec.  165.3 of subpart
A, are key to understanding the refillable container standards in
subpart C.
    (1) Dry pesticide
    (2) One-way valve
    (3) Portable pesticide container
    (4) Refillable container
    (5) Stationary pesticide container
    (6) Tamper-evident device
    (7) Transport vehicle.
    Three of these definitions--dry pesticide, tamper-evident device,
and transport vehicle--are identical to the proposed definitions. The
definition of refillable container was slightly modified to clarify
that refillable containers are used for sale or distribution. As
discussed below, a definition of portable pesticide container has been
added to the final rule and the other two definitions were changed
substantively.
    The following proposed definitions that were relevant to the
proposed refillable container standards are not being finalized: dry
bulk container; dry minibulk container; liquid bulk container; and
liquid minibulk container. These are discussed below in conjunction
with stationary pesticide container.
    2. One-way valve--i. Final regulation. One-way valve means a valve
that is designed and constructed to allow virtually unrestricted flow
in one direction and no flow in the opposition direction, thus allowing
the withdrawal of material from, but not the introduction of material
into a container.
    ii. Changes. EPA incorporated the following phrase, as suggested by
a registrant: ``to allow virtually unrestricted flow in one direction
and no flow in the opposition direction.'' EPA believes this improves
the definition by clarifying what we mean by one-way.
    3. Stationary pesticide container--i. Final regulation. 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.
    ii. Changes. The proposed definition for ``stationary bulk
container'' was revised in several ways, as discussed in detail in Unit
VIII.E. of this preamble, which describes the containers that are
subject to the containment requirements. The final rule changes the
term from ``stationary bulk container'' to ``stationary pesticide
container'' because

the changes to the final containment regulations eliminated the need
for the proposed definitions of minibulk and bulk containers.
    The proposed containment regulations would have required each
stationary bulk container to be protected by a secondary containment
unit. The proposed rule defined stationary bulk container to be ``a
liquid bulk container or a dry bulk container that is fixed at a single
facility or establishment...'' The proposed rule also defined liquid
bulk and dry bulk containers by size. For example, liquid bulk
container was defined as ``a refillable container designed and
constructed to hold liquid pesticide formulations with the capacity to
hold undivided quantities of greater than 3,000 liters (793 gallons).''
    The final containment regulations take a different approach of
delineating the containers that must be within secondary containment
units. Section 165.81(b) states that ``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 regulations in this subpart and must have
a secondary containment unit that complies with the provisions of this
subpart ...'' Because the container sizes are a regulatory criterion in
Sec.  165.81(b), the definitions of liquid bulk container and dry bulk
container are no longer necessary and are not being finalized. The
definition of dry minibulk container was not used in the proposed or
final regulations and is also not being finalized.
    4. Portable pesticide container--i. Final regulation. Portable
pesticide container means a refillable container that is not a
stationary pesticide container.
    ii. Changes. The proposed regulations did not define portable
pesticide container. However, this definition is necessary in the final
rule to replace the term liquid minibulk container in the refillable
container regulations. As described above, EPA is not finalizing the
definitions for liquid bulk, dry bulk and dry minibulk containers
because they are not necessary. Similarly, EPA believes that it is
logical to not finalize the definition for liquid minibulk container.
In the proposal, the only time the term liquid minibulk container was
used in the regulatory language was to define the kinds of refillable
containers that had to comply with the one-way valve/tamper-evident
device requirement. In the final rule, EPA partially describes the
containers that must comply with the one-way valve/tamper-evident
requirement in Sec.  165.45(e) as ``a refillable container that is a
portable pesticide container that is designed to hold liquid pesticide
formulations...''

B. Purpose (Sec.  165.40(a))

    1. Final regulations. The purpose of the refillable container
standards is to establish design and construction requirements for
refillable containers used for the distribution or sale of some
pesticide products.
    2. Changes. This is nearly the same as the proposed purpose (in
Sec.  165.120(a)). One minor change was to acknowledge the reduced
number of products that are subject to the final regulations by stating
that the rule applies only to the distribution or sale of some
pesticide products. The proposed regulations would have applied to all
products. Another insignificant modification was to delete the term
``standards'' from the phrase ``establish standards and requirements''
because it is redundant.

C. Who Must Comply (Sec.  165.40(b))?

    1. Final regulations. You must comply with all of the refillable
container regulations if you are a registrant who distributes or sells
a pesticide product in refillable containers. If your product is
subject to the refillable container regulations as described in Unit
VI.E., the product must be distributed or sold in refillable containers
that comply with these regulations. This is true regardless of whether
you repackage the product into the container yourself or whether you
sell or distribute the product to an independent refiller, who
repackages your product into refillable containers.
    In addition, 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.
    2. Changes. For registrants, this is the same approach that we
proposed in Sec. Sec.  165.122(a)(1)(i) and 165.122(a)(2)(i). However,
the wording is more straightforward because the regulations for
refillable containers were separated from the repackaging regulations
in the final rule. This subpart includes only the refillable container
standards, which apply to all registrants that use refillable
containers to distribute or sell their products. The standards for
repackaging were placed in a separate subpart, because those
regulations must distinguish between registrants who repackage product
directly into the containers and registrants who allow independent
refillers to repackage their product into refillable containers.
    The final rule clarifies that refillers must comply with the
requirements for stationary pesticide containers in Sec.  165.45(f).
EPA believes it is reasonable to hold both the registrants and
refillers responsible for meeting the stationary pesticide container
standards in Sec.  165.45(f) because they are both selling and
distributing the pesticide that is held in those containers.

D. Compliance Dates (Sec.  165.40(c))

    1. Final regulations. The final regulations provide a 5-year period
after the date of publication of the final rule in the Federal Register
before compliance with the refillable container standards is required.
Specifically, within 5 years from today's date, registrants must
distribute or sell all pesticide products in refillable containers in
compliance with these regulations.
    2. Changes. Based on the comments, EPA decided to extend the
compliance period from the 2-year time frame that was proposed in Sec.
165.139. Also, the compliance date for registrants to submit
certifications is not being finalized because the certification
requirement from the proposal is not being finalized, as described in
Unit VI.M.
    3. Comments. A few commenters (registrant groups, a registrant and
a State) on the proposed rule supported a 2-year compliance period if
EPA adopts a grandfather clause or references the DOT regulations
rather than the proposed regulations. However, many commenters (mostly
registrants, but also a dealer group and a few States) argued for a
longer compliance period to allow the continued use of sound containers
and to minimize the burden of retrofitting containers or replacing the
containers in inventory. Because refillable containers can be used for
many years (the average life span is 5 years for plastic minibulks and
15 years for steel minibulks), a 2-year phase-in period would require
companies to dispose of good containers or to retrofit them. Several of
the commenters mentioned that it would take longer than 2 years to come
into compliance.
    In addition, many commenters (registrants and registrant groups) on
the supplemental notice stressed the need for an adequate transition
period regarding the option of adopting the DOT Packing Group III
standards in the final rule. The main points made by the commenters
included:
     An adequate transition period is required to design and
obtain new packaging, finish using existing supplies of previously
authorized packaging, allow existing nonrefillable packaging to

work its way through the distribution system and let refillable
packaging complete its useful life.
     An inadequate transition period would significantly
increase the cost of compliance with this rule. Major costs would be
avoided as long as it is not necessary to dispose of packaging which
has not yet reached the end of its useful life or to recall packaging
which is still in the distribution channels and has not yet reached its
final destination. The suggested transition periods would minimize the
cost impact of the EPA container regulation.
     Pesticide products change hands several times as they move
down the distribution chain from the basic producer to the end user
(basic producers, formulators, distributors, retail dealers, brokers,
custom applicators and end users). In many cases, the movement of
materials is reversed when products are not consumed.
     The distribution process normally is completed in a given
sales year. However, when materials are not consumed, inventories build
at all levels of the distribution chain. Quite often materials may be
held in inventory for multiple years before re-entering the
distribution network. During periods when materials are being held in
inventory, the pesticide formulators and others are negatively impacted
when regulatory changes are imposed on products in the distribution
chain (rather than on products that will be sold or distributed at some
future date), which involves substantial expenses to producers with, in
most cases, no justifiable gain in safety.
    4. EPA response. As described above, EPA is extending the
compliance period for refillable containers to 5 years to provide for a
smoother and less burdensome transition for companies. Companies that
have already made significant investments in refillable containers will
be able to use their existing containers for 5 years, which covers the
average expected lifetime of a plastic minibulk container. Also, the
changes to the refillable container standards will allow existing
refillable containers that meet the DOT Packing Group III standards to
be retrofitted relatively easily (by durably marking each container
with a serial number and having a one-way valve and/or tamper-evident
device on each opening of liquid minibulk containers) so they can
continue being used. EPA believes that the longer compliance period in
the final regulations is reasonable and should apply equally to all
products and all refillable containers.

E. Pesticide Products Included (Sec.  165.43(a) - (g))

    1. Final regulations. As described in detail in Unit III., only
certain products have to comply with the refillable container
standards. MUPs, plant-incorporated protectants, and certain
antimicrobial products are completely exempt from the refillable
container requirements. All other pesticide products are subject to the
refillable container regulations.
    Some of the antimicrobial pesticides that are subject to the
refillable container regulations are subject to a reduced set of
regulations. In particular, antimicrobial pesticides that are used in
swimming pools and closely related sites (such as hot tubs, spas and
whirlpools) are exempt from the requirements for marking the serial
number and having a one-way valve and/or tamper-evident device on each
opening.
    2. Changes. In the proposed rule, only MUPs were exempt from the
refillable container regulations (in Sec.  165.122(b)(1)). All other
products would have been subject to the standards. The 1999
supplemental notice discussed regulatory options for exempting some
products (antimicrobials and non-antimicrobials) from the full set of
refillable container regulations and for exempting certain
antimicrobial products from specific requirements.
    The criteria in the final rule for exempting antimicrobials are
different than those discussed in the supplemental notice and the final
rule exempts plant-incorporated protectants. The final refillable
container regulations do not incorporate the toxicity category,
container size or environmental hazard criteria from the supplemental
notice. Also, the final rule changes some aspects of the supplemental
notice approach of subjecting antimicrobial swimming pool products to a
reduced set of requirements.
    Table 14 describes the provisions for determining which pesticide
products are subject to which refillable container regulations and a
brief explanation of how (or if) this provision changed from the
proposal and/or the supplemental notice.

 Table 14.--Changes to the Scope of the Refillable Container Regulations
------------------------------------------------------------------------
          Regulatory Provision                       Changes
------------------------------------------------------------------------
Manufacturing use products are exempt.   No change from proposed rule or
                                          supplemental notice.
------------------------------------------------------------------------
Plant-incorporated protectants are       Plant-incorporated protectants
 exempt.                                  would have been subject to the
                                          proposed rule. The regulations
                                          for plant-incorporated
                                          protectants were finalized in
                                          2001. We are exempting them
                                          from the final rule because of
                                          their unique nature.
------------------------------------------------------------------------
Certain antimicrobial products are       Antimicrobial products would
 exempt.                                  have been subject to the
                                          proposed rule. The final rule
                                          implements an approach similar
                                          to option 1 in the
                                          supplemental notice, although
                                          some of the details are
                                          different.
------------------------------------------------------------------------
All other products are subject to the    All products other than
 refillable container requirements,       manufacturing products would
 except for certain antimicrobial         have been subject to the
 swimming pool products.                  proposed rule. The final rule
                                          is different than the approach
                                          discussed in the supplemental
                                          notice, which would have
                                          exempted products in Toxicity
                                          Category III or IV in small
                                          containers and outdoor use
                                          products without the specified
                                          environmental hazard
                                          statements on their label.
------------------------------------------------------------------------
Antimicrobial products used in swimming  Antimicrobial products used in
 pools and closely related sites are      swimming pools would have been
 subject to a reduced set of refillable   subject to the proposed rule.
 container requirements.                  The final rule is the result
                                          that was intended in the
                                          supplemental notice, although
                                          the specifics of how it is
                                          implemented in the final rule
                                          are different than in the
                                          supplemental notice.
------------------------------------------------------------------------

F. Other Exemptions (Sec.  165.43(h))

    Final regulations and changes. The refillable container regulations
do not apply to transport vehicles that contain pesticide in pesticide-
holding tanks that are an integral part of the transport vehicle and
that are the primary containment for the pesticide. This is identical
to the exemption proposed in Sec.  165.122(b)(2). In addition, the
final rule includes a specific exemption for gaseous pesticides, which
is necessary to implement our intent from the proposal because the
final rule does not use the proposed terms liquid minibulk, dry
minibulk, liquid bulk and dry bulk containers, which would have
excluded gaseous pesticides.

G. DOT Standards (Sec.  165.45(a) - (c))

    1. Final regulations. As discussed in detail in Unit IV.,
refillable containers must comply with the DOT Hazardous Materials
Regulations that are referred to and adopted into EPA's regulations.
These incorporated regulations establish requirements for container
design, construction and marking.
    2. Changes. This is a change from the proposed regulation, although
the approach of referring to and adopting a subset of the DOT standards
was discussed in detail in the 1999 supplemental notice. See Unit IV.
for a detailed discussion. As discussed in Unit VI.M., some of the
proposed requirements for refillable containers are not being finalized
in the final rule because they were replaced by equivalent DOT
requirements.

H. Serial Number Marking (Sec.  165.45(d))

    1. Final regulations. Each refillable container must be marked in a
durable and clearly visible manner with 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. Antimicrobial products used in
swimming pools and closely related sites (that are subject to the
regulations) are exempt from this requirement.
    2. Changes. The marking requirement was changed significantly from
the proposal to the final rule. First, the proposed rule included seven
pieces of information that would have been marked on the containers and
the final rule only includes one piece of data, the serial number (or
other identifying code). Some of the proposed items--the container
manufacturer, date of manufacture, rated capacity, and material of
construction--were deleted because this information is required in the
DOT standards. The other pieces of information--the model number and
the phrase ``Meets EPA standards for refillable containers''--were
deleted from the regulations because they are no longer necessary for
implementing the refillable container and repackaging requirements due
to the change to refer to and adopt the DOT regulations and because
commenters raised some legitimate problems with them.
    Second, the regulatory text was changed to clarify that the serial
number (or identifying code) must be durably marked on the container,
rather than permanently marked as stated in the proposed regulations.
EPA's intent for permanent marking in the proposal was described in the
preamble as ``Permanent marking includes, but is not limited to,
etching, embossing, ink jetting, stamping, heat stamping, mechanically
attaching a plate, molding, or marking with durable ink.'' EPA believes
that durable marking is a more accurate term to describe our intent.
The text in the final regulation-- ``must be marked in a durable and
clearly visible manner''--is based on the DOT marking standards for
intermediate bulk containers in 49 CFR 178.703(a)(1).
    Third, the proposal included a provision that allowed compliance
with a similar DOT marking requirement to satisfy the corresponding EPA
pesticide container standard. This provision is no longer necessary
because the final regulation refers to and adopts some of the DOT
standards.
    3. Comments - permanent marking. The proposal for the container
marking drew a large number of comments. About 20 commenters,
consisting mainly of registrants, registrant groups, and container
manufacturer groups, addressed EPA's interpretation of permanent
marking. These comments focused on the proposed permanent marking
requirements for nonrefillable containers, but are applicable to the
refillable container and label regulations as well. These comments are
included in the refillable container section because the marking
requirements for nonrefillable containers are not being finalized.
    One registrant supported the list of different techniques that
would qualify for permanent marking. Some respondents (registrants and
registrant groups) specifically supported including ink jetting as a
means of permanent marking and one suggested adding rubber-stamping to
the list. A few registrants commented that many inks can be removed
with solvent-based products.
    Some commenters (registrants and registrant groups) urged EPA to
move the list of acceptable forms of permanent marking from the
preamble to the regulations if permanent marking is required.
Respondents said this would prevent confusion and misunderstanding
during enforcement.
    One container manufacturer group discussed the difference between
the UN/DOT terms ``permanent'' and ``durable'' and suggested that EPA's
purposes would be met by requiring durable marking. A registrant
provided similar comments and supported marks that are ``long-lasting
and persistent through the life of the pesticide.'' This registrant
also commented that permanent marking is best performed by container
manufacturers, although registrants can add durable marking, such as
ink jetting and stenciling with paint. A container manufacturer group
supported providing options because different types of markings are
suitable for different container types, but opposed mechanically
attaching a plate to plastic containers and expressed concern about
some of the other alternatives.
    Some respondents (registrants and registrant groups) urged EPA to
allow the use of pressure-sensitive labels and/or labels attached with
permanent adhesive as alternative ways to comply with the permanent
marking requirement. A container manufacturer group recommended
requiring the containers to be marked in a manner ``that at least some
of the material from which the container is made must be destroyed to
remove the marking.'' A pesticide user commented that the marking
should be legible after the third water rinse and dry cycles.
    4. EPA response - permanent marking. EPA modified the approach
toward permanent marking several ways in the final rule to eliminate
confusion about the intent and to facilitate compliance. First, EPA
changed the description of marking from ``permanent'' to ``durable''
marking. EPA believes that durable marking is a more accurate term to
describe our intent because the description of ``permanent'' marking in
the preamble of the proposal included marking methods, such as ink
jetting, stamping and marking with durable ink, that are durable but
not permanent. Second, the final rule clarifies that ink jetting and
stamping are allowable

methods of marking the required information on the containers. Third,
the allowable methods of marking are listed in the regulations, rather
than only in the preamble or guidance material, to enhance the
understanding of the intent.
    5. Comments - serial numbers. Serial numbers were uniformly opposed
by several registrants, several registrant groups, and a container
manufacturer because these commenters claimed requiring serial numbers
would greatly increase the cost of compliance. Several commenters
focused on the potential impact on plastic and steel drums and flexible
intermediate bulk containers, and said it would be very burdensome to
permanently mark a serial number on each container. Three respondents
specifically addressed swimming pool chemicals. These commenters stated
that the requirement for serial numbers and the associated
recordkeeping requirements would be completely unworkable for
refillable pool chemicals because millions of refillable containers
(from 1 to 55 gallons) are used each year and a single shipment can
contain 4,000 to 5,000 bottles. This increased cost would make
refillable containers uneconomical for swimming pool chemicals, which
would lead to the registrants switching to nonrefillable plastic jugs.
    6. EPA response - serial numbers. EPA disagrees with commenters
that the cost of complying with the serial number requirement (for
products other than swimming pool chemicals) would be overly
burdensome. First, the final regulation clarifies that the serial
number must only be durably marked, not permanently marked. Therefore,
it would not have to be done by an automatic marking device capable of
changing each time a new container is made. Second, this standard only
applies to containers that are refilled. It does not apply to
containers that are being reconditioned, remanufactured or repaired
according to the DOT standards in 49 CFR 173.28 or 180.352. In other
words, it does not apply to drums that are used once and reconditioned
according to DOT standards and then filled with pesticide or another
substance. See the discussion in Unit IV.B. that states that the
reference to 49 CFR 173.28 is included in the final regulations to
allow drums to be reconditioned and then reused under the pesticide
container regulations.
    EPA agrees with the commenters that applying serial numbers (and
some other requirements) to refillable containers used for swimming
pool pesticides would disrupt the current refillable container system
for swimming pool chemicals and would quite likely cause the
refillables to be replaced by millions of single-use, nonrefillable
containers. Therefore, the final rule exempts antimicrobial products
used in swimming pools and closely related sites (and that are subject
to the regulations) from the serial number requirement.

I. Openings - One-Way Valves or Tamper-Evident Devices (Sec.
165.45(e))

    1. Final regulations. Like the proposed rule, this standard applies
only to portable pesticide (refillable) containers designed to hold
liquids--not portable pesticide containers for dry pesticides or
stationary pesticide containers. Also, this standard does not apply to
cylinders that comply with the DOT HMR. Each opening of a portable
pesticide container for liquid materials (except for DOT cylinders)
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.
    2. Changes. EPA made several modifications to this requirement.
First, the description of the containers that must comply was changed
to portable pesticide containers that are designed to hold liquid
formulations because the definition of liquid minibulk container is not
being finalized. Second, we changed the word ``aperture'' in the
proposal to ``opening'' in the final rule because it is a more common
term that should facilitate understanding and therefore compliance with
the regulations. Third, the standard was changed so vents do not need
to have tamper-evident devices or one-way valves. Instead, a sentence
was added to ensure that vents are designed to minimize the amount of
material that could be introduced into containers through them. Fourth,
the requirement was amended to clarify that a one-way valve may be
located in a separate device or system, such as a coupler, if that
device or system is the only reasonably foreseeable way to withdraw
pesticide from the container. This was the intent of the proposed
standard, as described in the 1994 preamble, but we are adding it to
the regulations for clarity. Fifth, the final rule was amended to state
that this requirement does not apply to cylinders that comply with
DOT's Hazardous Materials Regulations. Sixth, antimicrobial products
used in swimming pools and closely related sites (that are subject to
the regulations) are exempt from this requirement.
    3. Comments - vents. A container manufacturer group pointed out
that vents are needed to provide air flow and that a person could
introduce a material through a vent if they tried hard enough. This
commenter recommended requiring vents to be designed to minimize the
introduction of material through them. Similarly, a State regulatory
agency urged EPA to modify the requirement to acknowledge that vents
are required on refillables and are not one-way.
    4. EPA response - vents. EPA agrees with the commenters that vents
are needed to provide air flow when unloading material from a container
and that vents do not meet the definitions of either one-way valves or
tamper-evident devices. Therefore, EPA modified the regulations to
clarify that vents do not need one-way valves or tamper-evident
devices, but that they must be designed to minimize the introduction of
material through them.
    5. Comments - chloropicrin. A group of chloropicrin manufacturers
and users cited several reasons why that product should be exempt from
the opening requirement. This commenter provided the following
information:
     Chloropicrin is a highly volatile liquid that is shipped
and handled essentially like a gas.
     End-use formulations containing chloropicrin are shipped
in refillable steel containers manufactured under the same DOT
specifications as propane cylinders.
     Chloropicrin containers typically have only one
specialized valve for filling and emptying the cylinder and specialized
connections are required to fill them.
     Chloropicrin cylinders contain screw-on valve protections
known as bonnets. The commenter stated that adding external one-way
valves is not possible due to space limitations and increasing the size
of the bonnets would reduce the ability of the bonnet to protect the
valve.
In addition, the commenter claimed that:
     The specialized valve and refilling connections minimize
the chance of contamination or unauthorized filling.
     No valves were available in 1994 that were compatible with
chloropicrin and that allow filling and emptying the container through
a one-way valve.
     Installing one-way valves on thousands of existing
cylinders could cause unnecessary worker exposure.
    6. EPA response - chloropicrin. EPA agrees that the one-way valve/
tamper-

evident device requirement could be problematic for cylinders, such as
those used to distribute chloropicrin end-use products and propane. The
one-way valve/tamper-evident device requirement applies to portable
pesticide containers for liquid materials, which we envisioned as DOT
portable tanks, IBCs and the non-bulk refillable containers designed to
hold liquids. As explained by the commenter, chloropicrin is unusual in
the sense that it is a liquid, but it is shipped and handled
essentially like a gas. DOT classifies chloropicrin as hazard division
6.1 (poisonous material). EPA believes that the DOT specifications for
cylinders are extremely detailed and extensive and we do not want to
add requirements to them that would compromise the safety and
protection provided by the DOT cylinder requirements. Note that
cylinders holding gases would not be subject to the one-way valve/
tamper-evident device requirement because they are exempt from the
refillable container regulations by Sec.  165.43(h)(2).
    EPA believes that the chloropicrin cylinders described by the
commenter should not have to comply with the one-way valve/tamper-
evident device requirement. However, rather than specifically exempt
containers holding chloropicrin, the final regulations take a more
general approach and exclude cylinders that comply with the DOT HMR.
The more general approach was taken because there may be other highly
volatile liquid pesticides that are distributed in DOT cylinders that
would face the same difficulties in complying with this requirement.
    7. Comments - sodium hypochlorite. In comments on the proposed
rule, a registrant group stated that the one-way valves identified in
their research cost several times more than the refillable containers
used to distribute sodium hypochlorite. According to this commenter,
the one-way valve costs (in 1994) ranged from $10 for a 1-gallon
container to $45 for a 55-gallon container. Another registrant group
identified one-way valves as one aspect of the proposed regulations
that would make refillable containers economically unfeasible for
sodium hypochlorite in the swimming pool industry. A trade group
representing all aspects of the swimming pool industry explained that
sodium hypochlorite is a relatively low value product that sold for as
little as $1.00 per gallon in 1994. At the time, purchasers would pay a
deposit of $0.50 to $1.00 per refillable container. This commenter
believes that the proposed regulations would make the refillable jugs
used to distribute sodium hypochlorite for swimming pool use
prohibitively expensive. All of these commenters favored exempting
sodium hypochlorite from the pesticide container rule.
    The comments on the supplemental notice were similar. The trade
group representing all aspects of the swimming pool industry stated
that the proposal to exempt eligible Toxicity Category I antimicrobial
products used in swimming pools from most of the refillable container
standards is laudable, but that it does not go far enough. A pool
supply company commented that using one-way valves and serial numbers
on its returnable bottles would increase the cost to the point where it
could no longer compete in the marketplace. A sodium hypochlorite
manufacturer stated that the relatively low value of the product makes
the use of one-way valves unaffordable. This commenter stated that one-
way valves for drums cost about $75 container, not including the
connectors/adaptors that the applicators would need. This manufacturer
identified a one-way valve device that could be added to the refillable
jugs for about $3 per container, which is more reasonable, but noted
that these devices could not be produced in large enough quantities to
account for all refillable jugs currently in use.
    8. EPA response - sodium hypochlorite. EPA modified the regulation
to exempt antimicrobial products (that are subject to the regulations)
used in swimming pools and closely related sites from this requirement
for one-way valves or tamper-evident devices. As stated in the
supplemental notice, EPA acknowledges that applying some of the
refillable container standards, including this one, to sodium
hypochlorite used in swimming pools would disrupt the current
refillable container system for these products. This disruption would
probably cause the refillables to be replaced by millions of single-
use, nonrefillable containers, which is inconsistent with the goals of
pollution prevention and of facilitating the safe refill and reuse of
containers (FIFRA section 19(e)). Therefore, the 1999 supplemental
notice described a regulatory option intended to exempt swimming pool
chemicals from some of the refillable container requirements. Based on
comments and further analysis, EPA realized that the products for which
relief was intended (sodium hypochlorite) may be hazardous wastes when
disposed and, therefore, would not be eligible for exemption as
described in the supplemental notice. Therefore, the final rule was
revised to clarify that swimming pool products are exempt from the
problematic requirements. Currently, EPA is aware of sodium
hypochlorite products that fit the exemption criteria and that are
distributed and sold in refillable containers, although the partial
exemption was drafted to be general so it would apply to any products
that fit the criteria. See Unit III.D. for a more detailed discussion.

J. Stationary Pesticide Container Standards (Sec.  165.45(f))

    1. Final regulation. Stationary pesticide containers that are
designed to hold undivided quantities of 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 and are
located at the refilling establishment of a refiller operating under
written contract to a registrant must meet certain standards. As
discussed in Unit VI.C., both registrants and refillers are responsible
for ensuring that these requirements for stationary pesticide
containers are met. First, all of these stationary pesticide containers
(for liquid and dry pesticides) must be:
     Resistant to extreme changes in temperature,
     Constructed of materials that are adequately thick and
that are resistant to corrosion, puncture, or cracking, and
     Capable of withstanding all operating stresses.
    As proposed, these requirements do not apply 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.
    Second, several other standards apply only to liquid bulk
containers. Specifically,
     They must be equipped with a vent or other device designed
to relieve excess pressure, prevent losses by evaporation, and exclude
precipitation.
     External sight gauges are prohibited.
     Each container connection below the normal liquid level
must be equipped with a shutoff valve, which is capable of being locked
closed.
     Shutoff valves must be located within a secondary
containment unit (if secondary containment is required).
    2. Changes. There were several changes in this section from the
proposed rule. First, the description of containers that must comply
with these requirements was changed to be consistent with the
quantities for secondary containment structures

because the definitions of liquid and dry bulk containers are not being
finalized. Second, the requirement for shutoff valves on liquid bulk
containers was amended to specify that a shutoff valve: (1) Is only
required for container connections that are below the normal liquid
level; and (2) must be located within a secondary containment unit, if
secondary containment is required by subpart E. Third, the text for the
shutoff valve requirement was adjusted to make it clear that the valves
must be capable of being locked closed. Fourth, the proposed phrase
``act of God'' is not included in the final rule. The language in Sec.
165.45(f)--``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''--sufficiently describes the kinds
of events that would be considered ``acts of God,'' so that phrase is
not necessary.
    3. Comments - shutoff valve. Some commenters addressed the need for
requiring shutoff valves and there were few common themes among the
respondents. A few registrants and a registrant group supported having
all connections on stationary liquid pesticide containers (except for
vents) equipped with a lockable valve. A container manufacturer group
asked to change the language to: ``Each liquid bulk container
connection below the normal liquid level...,'' stating that requiring
valves above that level serves no purpose on bulk tanks.
    4. EPA response - shutoff valve. EPA agrees with the container
manufacturer group and will amend the final rule so the shutoff valve
requirement applies to liquid pesticide container connections below the
normal liquid level. Vents and other openings on the top of the
container are above the normal liquid level, so the phrase ``except for
vents'' is no longer necessary and is not in the final regulation.
    5. Comments - location of shutoff valve. EPA requested comments on
whether it is necessary to regulate the location of shutoff valves, and
if so, what the location should be. Some commenters (registrants,
registrant groups, dealer groups, and a State regulatory agency)
supported a general guideline that would allow placement of the valve
anywhere within the secondary containment. These commenters believed
that fine-tuning the valve location wouldn't increase overall release
protection as long as the valve was in secondary containment. Only one
commenter, a State regulatory agency, stated a preference for locating
the valve close to the storage vessel, saying that field experience has
demonstrated that valves are subject to incidental spillage due to
factors such as ``pipe chatter.''
    6. EPA response - location of shutoff valve. EPA agrees with the
majority of the commenters that shutoff valves should be located within
a secondary containment unit. Therefore, this part of the standard will
be amended to specify that the shutoff valve be located within a
secondary containment unit, if secondary containment is required by
subpart E. EPA believes that nearly all, if not all, stationary
pesticide containers that are subject to Sec.  165.45(f) will be
required to be within a secondary containment unit by subpart E.
However, subpart E applies only to agricultural pesticides, so it is
possible that a container holding a nonagricultural pesticide could be
subject to the stationary pesticide container standards, but not the
containment standards.

K. Waivers and Modifications (Sec.  165.45(g) - (h))

    1. Final regulation. Section 165.45(g) of the final rule explains
that registrants may request waivers from or modifications to some of
the refillable container regulations and sets out the criteria that
must be met for EPA to approve a waiver/modification request. Section
165.45(g) regulations are identical to the corresponding portion of the
waiver/modification provisions regarding the DOT provisions for
nonrefillable containers in Sec.  165.25(g).
    Section 165.45(h) describes the procedure for registrants to follow
if they want to obtain a waiver from or modification to the specified
refillable container regulations. The procedure in Sec.  165.45(h) is
identical to the procedure for obtaining waivers from or modifications
to the nonrefillable container regulations in Sec.  165.25(h).
    2. Changes, comments and EPA responses. The proposed rule did not
include any waiver or modification provisions for the refillable
container regulations. The supplemental notice discussed an approach
for incorporating a waiver from or modification to the referenced and
adopted DOT requirements. EPA made several changes to the supplemental
approach before incorporating the waiver/modification provisions into
the final regulations. See Unit V.I. (on nonrefillable containers) for
changes, comments and EPA responses regarding the waivers from and
modifications to the pesticide container regulations that refer to and
adopt the DOT requirements, which apply to both nonrefillable and
refillable containers. Unit V.J. provides more details on the process
for applying for waivers and modifications, which is the same for
nonrefillable and refillable containers.

L. Reporting (Sec.  165.47)

    1. Final regulation. This section clarifies that the pesticide
container regulations do not require registrants to report to EPA with
information about their refillable containers. However, it refers
registrants to the reporting standards in 40 CFR part 159 to determine
if information on container failures or other incidents involving
pesticide containers must be reported to EPA under FIFRA section
6(a)(2).
    2. Changes. The intent and substance of this standard is the same
as in the proposal. However, the wording was changed to clarify that
this is simply a reference to the existing 6(a)(2) standards and that
it does not add any new requirements.

M. Proposed Standards That Are Not Being Finalized

    Final regulation/changes. The following requirements relating to
refillable container design from the proposed regulation are not being
finalized in today's final rule:
     Sec.  165.124(b)(1)(i) - (v) and (vii): Permanent marking
other than serial numbers
     Sec.  165.124(b)(2): Compliance with DOT's marking
satisfies the corresponding EPA permanent marking requirement
     Sec.  165.124(c): General minibulk integrity standard
     Sec.  165.124(d): Drop test for minibulk containers
(requirement)
     Sec.  165.125: Minibulk container drop test methodology
(test procedure)
     Sec.  165.128(a) & (b): Keep records of container
descriptions, minibulk drop test results and the GLP statement
specified for the drop test.
     Sec.  165.126: Certification
     Sec.  165.128(c): Keep records of the certification.
    The first six proposed standards are not being finalized in the
refillable container regulations because the approach of referring to
and adopting a subset of the DOT standards makes them unnecessary. In
particular:
     Some of the items for permanent marking in proposed Sec.
165.124(b)(1)--the container manufacturer, date of manufacture, rated
capacity, and material of construction--are not being finalized because
this information is required in the DOT standards that specify marking.
Two other proposed pieces of information--the model number and the
phrase ``Meets EPA

standards for refillable containers''--are not being finalized because
they are no longer necessary due to the change to refer to and adopt
the DOT regulations. See Unit VI.H. for more detail about the proposed
marking requirements.
     The statement proposed in Sec.  165.124(b)(2) is not being
finalized because the final rule specifically refers to the DOT
marking, so it is no longer necessary to include a provision stating
that compliance with DOT's marking satisfies the corresponding EPA
marking requirement.
     The proposed general minibulk integrity standard in Sec.
165.124(c) is not being finalized because the DOT regulations address
container integrity in 49 CFR 173.24.
     The proposed drop test requirement for minibulks in Sec.
165.124(d) and the proposed minibulk container drop test in Sec.
165.125 are not being finalized because the DOT regulations include a
drop test requirement. The drop test procedure for nonbulk packagings
is defined in 49 CFR 178.603 and the drop test procedure for
intermediate bulk containers is defined in 49 CFR 178.810.
     The proposed recordkeeping requirements in Sec.
165.128(a) and (b) for container descriptions, drop test results and a
GLP statement for the drop test are not being finalized because they
are no longer necessary because compliance with the DOT requirements
can be ensured by the structure and certification standards in the DOT
HMR. Because we can rely on the DOT or UN marking to ensure compliance
with the applicable DOT requirements, EPA no longer needs to see
records of the testing to confirm compliance with the drop test (and in
the final rule) and other test requirements.
    The final two proposed items listed above--having registrants
certify compliance with the regulations and the associated
recordkeeping--are not being finalized for the same reasons that the
nonrefillable container certification and recordkeeping are not being
finalized, as described in Unit V.M.

N. Options for Implementing the Rule

    1. Final regulations. In the preamble to the proposed rule, EPA
discussed three options for implementing the refillable container and
repackaging standards, which were all in one subpart in the proposed
rule. These options covered different approaches for determining who
would be held responsible for ensuring that the refillable containers
meet the refillable container standards. EPA considered several options
because the pesticide products distributed or sold in refillable
containers and the containers themselves often enter the pesticide
distribution chain separately, so identifying responsibility for
compliance is not as straightforward as it is for nonrefillables, which
the registrants fill at their establishments.
    In evaluating the options for container design responsibility, EPA
considered the differences among the options in terms of seeking the
least burdensome approach that is also effective, practicable, and
easily enforceable. In the proposal, we identified Option 1 as our
preferred option (as indicated in the proposed regulatory text) because
we thought it was more effective, more practicable, and significantly
more easily enforceable than the other two options. The three options
are described below.
     Option 1. Registrants would be responsible for containers
meeting the design standards. The containers would be marked ``Meets
EPA standards for refillable pesticide containers'' and registrants
would maintain records for their containers. The registrants would
develop a list of acceptable containers for each product, identified by
manufacturer and model number, and provide the list to refillers.
Refillers could repackage pesticide only in containers identified on
the registrants list.
     Option 2. Anyone could produce containers, certify to EPA
that the containers meet EPA design standards, and receive permission
to mark containers with EPA certification seal. This could be container
manufacturers, but it could also be registrants, refillers, or even end
users. EPA would compile a list of certified container models.
Registrants and refillers could repackage products only into certified
containers. Registrants would develop a list of acceptable container
construction materials for each product and provide the list to
refillers, who could refill only into certified containers made from
materials identified as acceptable by the registrant.
     Option 3. Container manufacturers would be responsible for
containers meeting EPA's design standards and would mark containers
with a certification seal. Container manufacturers would keep records
for containers. Registrants would develop a list of acceptable
container materials for each product and provide the list to refillers.
Registrants and refillers would repackage only into containers marked
with the seal and made of materials identified as acceptable by the
registrant.
    As discussed in the 1999 supplemental notice, EPA is implementing a
combination of Option 1 and Option 3 in the final rule.
    2. Changes. The key change from the proposed rule is that the final
regulations adopt and refer to the DOT standards for container design,
construction and marking, as discussed in Unit IV. Therefore,
registrants only have to ensure that they use containers that meet the
cross-referenced DOT standards for container integrity, construction
and testing, rather than being responsible for the testing themselves.
Registrants must also ensure compliance with the permanent marking
(serial number) and opening (one-way valve/tamper-evident device)
requirements. Because containers will be identifiable by the UN/DOT
marking, some of the repackaging standards can be adjusted to be more
flexible. Specifically, rather than requiring the registrants to
identify acceptable containers by the model numbers and container
manufacturers, they will be able to identify acceptable containers by
the appropriate level of DOT testing (Packing Group I, II or III) and
the container materials that are compatible with the product. The
general structure of the repackaging standards, though, remains as
proposed: (1) Registrants are responsible for developing certain
information and providing it to the refillers; (2) refillers have
certain responsibilities for inspecting, cleaning, and labeling the
container since they are the ones actually handling the containers; and
(3) both registrants and independent refillers have certain
responsibilities if an independent refiller repackages a registrant's
product. The changes to the repackaging regulations are discussed in
more detail in Unit VII.

VII. Repackaging Standards

A. Format Changes

    Final regulation and changes. In the proposed regulation, the
refillable container design standards and the repackaging requirements
were included in the same subpart of the regulations. In the final
rule, EPA moved the repackaging requirements into a separate subpart
because we think separating the two kinds of requirements will make the
regulations easier to understand. The container design requirements are
mostly technical and apply mostly to registrants. The repackaging
requirements are mostly procedural and apply to registrants and to
anyone who repackages pesticide products into refillable containers,
which could be registrants, distributors, retailers, or other kinds of
companies.

    In addition, the repackaging requirements were reorganized so all
of the requirements that apply to a certain kind of business are listed
together. Specifically, the requirements are listed for: (1)
Registrants who distribute or sell pesticide products directly in
refillable containers; (2) registrants who distribute or sell pesticide
products to independent refillers for repackaging; and (3) independent
refillers. The term ``independent refiller'' is used to identify a
refiller that is not part of the registrant's company. The differences
between these categories are described in more detail below in Unit
VII.C. This format requires some standards to be repeated. For example,
the container inspection requirement applies to registrants who
distribute or sell pesticide products directly in refillable containers
and to independent refillers, so the inspection requirement is
repeated. Despite the repetition, EPA believes this regulatory
structure is more clear and easier to understand.

B. Purpose (Sec.  165.60(a))

    1. Final regulations. The purpose of the repackaging standards is
to establish requirements for repackaging some pesticide products into
refillable containers for distribution or sale.
    2. Changes. This is nearly the same as the proposed purpose (in
Sec.  165.120(b)). One minor change was to acknowledge the reduced
number of products that are subject to the final regulations by stating
that the rule applies only to repackaging some pesticide products. The
proposed regulations would have applied to all products. Another
insignificant modification was to delete the term ``standards'' from
the phrase ``establish standards and requirements'' because it is
redundant.

C. Who Must Comply (Sec. Sec.  165.60(b), 165.65(a), 165.67(a), and
165.70(a))

    1. Final regulation. You must comply with the repackaging
regulations if you are a:
     Registrant who distributes or sells a pesticide product in
refillable containers. This means that you conduct all of the
repackaging for a pesticide product and that you do not distribute or
sell your pesticide product to a refiller that is not part of your
company for repackaging into refillable containers.
     Registrant who distributes or sells a pesticide product to
a refiller that is not part of your company for repackaging into
refillable containers.
     Refiller of a pesticide product and you are not the
registrant of the pesticide product.
    As explained in Units VII.J. and VII.K., 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.
    2. Changes. The same kinds of businesses that were included in the
proposed rule (in Sec.  165.122(a)(1), (2) and (3)) are subject to the
final rule. One minor modification was to clarify that refillers in the
last two categories are refillers that are not part of the registrant's
company. Registrants can also be refillers, which is the situation
described in the first category; the registrant conducts all of the
packaging and repackaging. Therefore, the changes are intended to
clarify that the second and third category refer to independent
refillers, i.e., refillers that are not part of the registrant's
company.

D. Compliance Dates (Sec.  165.60(c))

    1. Final regulations. The final regulations provide a 5-year period
after the date of publication of the final rule in the Federal Register
before compliance with the repackaging standards is required.
Specifically, within 5 years from today's date, all products sold in
refillable containers must be distributed or sold in compliance with
these regulations.
    2. Changes. Based on the comments relating to refillable container
design as described in Unit VI.D., EPA decided to extend the compliance
period for the refillable container regulations from the 2-year time
frame that was proposed in Sec.  165.139. The longer time frame is to
provide for a smoother and less burdensome transition for companies.
Because the repackaging regulations require pesticide product to be
repackaged only into containers that meet the refillable container
standards, the compliance date for these regulations needed to be
changed for consistency.

E. Pesticide Products Included (Sec.  165.63(a) - (g))

    1. Final regulations. As described in detail in Unit III., only
certain products have to comply with the repackaging standards. MUPs,
plant-incorporated protectants, and certain antimicrobial products are
completely exempt from the repackaging requirements. All other
pesticide products are subject to the repackaging regulations. This is
identical to the scope of the refillable container regulations.
    Some of the antimicrobial pesticides that are subject to the
repackaging regulations are subject to a reduced set of regulations. In
particular, antimicrobial pesticides that are used in swimming pools
and closely related sites (such as hot tubs, spas and whirlpools) are
exempt from certain recordkeeping requirements, as well as the parts of
the standards for inspecting and cleaning containers that relate to
serial numbers, one-way valves, and tamper-evident devices.
    2. Changes. In the proposed rule, only MUPs were exempt from the
repackaging requirements, which were included in the refillable
container regulations (see Sec.  165.122(b)(1)). All other products
would have been subject to the standards. The 1999 supplemental notice
discussed regulatory options for exempting some products
(antimicrobials and non-antimicrobials) from the full set of refillable
container regulations including the repackaging requirements and for
exempting certain antimicrobial products from specific requirements.
    The criteria in the final rule for exempting antimicrobials are
different than those discussed in the supplemental notice and the final
rule exempts plant-incorporated protectants. The final repackaging
regulations do not incorporate the toxicity category, container size or
environmental hazard criteria from the supplemental notice. Also, the
final rule changes some aspects of the supplemental notice approach of
subjecting antimicrobial swimming pool products to a reduced set of
requirements.
    The following table describes the provisions for determining which
pesticide products are subject to the repackaging regulations and a
brief explanation of how (or if) this provision changed from the
proposal and/or the supplemental notice.

     Table 15.--Changes to the Scope of the Repackaging Regulations
------------------------------------------------------------------------
          Regulatory Provision                       Changes
------------------------------------------------------------------------
Manufacturing use products are exempt.   No change from proposed rule or
                                          supplemental notice.
------------------------------------------------------------------------

Plant-incorporated protectants are       Plant-incorporated protectants
 exempt.                                  would have been subject to the
                                          proposed rule. The regulations
                                          for plant-incorporated
                                          protectants were finalized in
                                          2001. We are exempting them
                                          from the final rule because of
                                          their unique nature.
------------------------------------------------------------------------
Certain antimicrobial products are       Antimicrobial products would
 exempt.                                  have been subject to the
                                          proposed rule. The final rule
                                          implements an approach similar
                                          to option 1 in the
                                          supplemental notice, although
                                          some of the details are
                                          different.
------------------------------------------------------------------------
All other products are subject to all    All products other than
 of the repackaging requirements,         manufacturing use products
 except for certain antimicrobial         would have been subject to the
 swimming pool products.                  proposed rule. The final rule
                                          is different than the approach
                                          discussed in the supplemental
                                          notice, which would have
                                          exempted products in Toxicity
                                          Category III or IV in small
                                          containers and outdoor use
                                          products without the specified
                                          environmental hazard
                                          statements on their label.
------------------------------------------------------------------------
Antimicrobial products used in swimming  Antimicrobial products used in
 pools and closely related sites are      swimming pools would have been
 subject to a reduced set of              subject to the proposed rule.
 repackaging requirements.                The final rule is the result
                                          that was intended in the
                                          supplemental notice, although
                                          the specifics of how it is
                                          implemented in the final rule
                                          are different than in the
                                          supplemental notice.
------------------------------------------------------------------------

F. Other Exemptions (Sec.  165.63(h))

    1. Final regulations. The repackaging regulations do not apply to
transport vehicles that contain pesticide in pesticide-holding tanks
that are an integral part of the transport vehicle and that are the
primary containment for the pesticide or to containers that hold
gaseous pesticides. In addition, the final rule includes a statement
that clearly exempts custom blending from the repackaging requirements.
    2. Changes. The exemption for transport vehicles is identical to
the exemption proposed in Sec.  165.122(b)(2) and the exemption
included in the final refillable container regulations. The exemption
for custom blending was not included in the proposed regulatory text.
It is discussed in Unit VII.L. In addition, the final rule includes a
specific exemption for gaseous pesticides, which is necessary to
implement our intent from the proposal because the final rule does not
use the proposed terms liquid minibulk, dry minibulk, liquid bulk and
dry bulk containers, which would have excluded gaseous pesticides.

G. Legal Basis for Repackaging Pesticide Products for Distribution or
Sale

    Before continuing with a section-by-section analysis of the
regulations, EPA believes it is necessary to address three broad issues
regarding repackaging pesticide products into refillable containers:
(1) The legal basis for repackaging pesticide products (and the related
Bulk Pesticides Enforcement Policy); (2) the integrity and purity of
products sold or distributed in refillable containers; and (3) whether
pesticides can be repackaged at locations other than registered
establishments.
    1. Background. FIFRA section 3(a) provides in pertinent part that
``no person in any State may distribute or sell to any person any
pesticide which is not registered under this Act.'' Registration is the
principal means of ensuring that a product is brought under the FIFRA
regulatory scheme. The registrant must demonstrate to EPA's
satisfaction that the product meets the statutory criteria for
registration with respect to composition, labeling, and the lack of
unreasonable adverse effects. The registrant must take responsibility
for quality control of the product's composition and for adequate
labeling describing the product, its hazards, and its uses. Repackaging
a pesticide produces a new pesticide product that must be registered
before it can be distributed or sold.
    Before a pesticide product that is not included within the terms of
an existing registration enters the channels of trade, a separate
registration must be obtained. Changes in the formulation of a
registered product, changes in accepted labeling, as well as any
repackaging of a pesticide into another container activate the
registration requirement, unless the purposes of product registration
would be fully met by carrying forward the Federal registration of the
constituent product.
    In 1977, EPA issued an enforcement policy for bulk shipments of
pesticides. (Ref. 75) The policy describes certain conditions in which
EPA allows the transfer and repackaging of bulk pesticides to occur
without requiring registration of the repackaged pesticides. The 1977
Bulk Pesticides Enforcement Policy (the Policy) defined ``bulk'' for
the purposes of the Policy as ``any volume of pesticide greater than 55
gallons or 100 pounds held in an individual container.'' EPA developed
the Policy to accommodate business practices of manufacturers and
distributors who handle pesticides in large undivided quantities rather
than in small individual containers because of the environmental and
logistical benefits associated with refillable containers.
    In the Policy, EPA determined that repackaging of bulk pesticides
could occur without a separate registration if certain conditions were
met that would assure that the purposes of registration would be
satisfied. The conditions are that repackaging of the registered bulk
pesticides could involve nothing more than changing the product
container; i.e., no change in: (1) The pesticide formulation, (2) the
pesticide's labeling except to add an appropriate statement of net
contents and a registered establishment number, and (3) the identity of
the party accountable for the product's integrity.
    The Policy elaborated on the accountability requirement and set out
that the pesticide had to be: (1) transferred at an establishment owned
by the registrant; or (2) transferred at a registered establishment
operated by a person under contract with the registrant; or (3)
transferred at a registered establishment owned by a party not under
contract to the product registrant, but who had been furnished written
authorization for use of the product label by the registrant. The
requirement for written authorization assures that the registrant
remains responsible for quality control of the product's composition
and adequate labeling describing the product, its hazards, and its
uses.
    The 1977 Policy only addressed the transfer of a volume of
pesticide greater

than 55 gallons or 100 pounds held in an individual container. In March
1991, the Policy was amended (Ref. 71) to allow repackaging of any
quantity of pesticides into refillable containers, provided that all
three conditions below are met:
    (1) The container is designed and constructed to accommodate the
return and refill of greater than 55 gallons of liquid or 100 pounds of
dry material.
    (2) Either: (a) The containers are dedicated to and refilled with
one specific active ingredient in a compatible formulation; or (b) the
container is thoroughly cleaned according to written instructions
provided by the registrant to the dealer prior to introducing another
chemical into the container, in order to avoid cross-contamination.
    (3) All other conditions of the July 11, 1977 Policy are met.
    As discussed in the preamble of the proposed rule, EPA is replacing
the Bulk Pesticides Enforcement Policy with these regulations,
specifically Sec. Sec.  165.67(b) - (c) and 165.70(b) - (c). These
regulations provide that a registrant may allow an independent refiller
to repackage the registrant's pesticide product into any size
refillable container and to distribute or sell such repackaged product
under the registrant's registration (i.e., the product's EPA
registration number stays the same), provided all conditions set out in
the rule are met.
    These regulations do not change the existing law; the Bulk
Pesticides Enforcement Policy would be replaced by a regulation. The
registrant remains responsible for the integrity, labeling, and
packaging of the repackaged product. Both the registrant and
independent refiller may be held liable for violations pertaining to
the repackaged product. The repackaging regulations set out the
requirements for both registrants and independent refillers, because
they have different roles and responsibilities in distributing
pesticide products in refillable containers.
    The conditions set out in Sec. Sec.  165.67(b) - (c) and 165.70(b)
- (c) do not apply to registrants repackaging their own pesticide
products solely at their own establishments. As described in Pesticide
Registration (PR) Notice 98-10 ``Notifications, Non-notifications and
Minor Formulation Amendments,'' the registrant generally can modify the
package size and label net contents statement without notifying EPA.
(Ref. 56) This would be an amendment to the registration not requiring
EPA notification or approval.
    2. Final regulations. The regulations implementing the legal basis
for repackaging are similar to the provisions in the proposed rule with
two significant changes, described in the next section, and some minor
formatting modifications. Specifically, Sec. Sec.  165.67(b) and
165.70(b) specify that a registrant may allow a refiller to repackage a
pesticide product into refillable containers and to distribute or sell
such repackaged product under the existing registration if all of the
following conditions are satisfied:
     The repackaging results in no change to the pesticide
formulation.
     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 of this
chapter.
    (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.
     The registrant has entered into a written contract with
the refiller to repackage the pesticide product and to use the label of
the pesticide product.
     The pesticide product is repackaged only into refillable
containers that meet the standards of subpart C.
     The pesticide product is labeled with the product's label
with no changes except the addition of an appropriate net contents
statement and the refiller's EPA establishment number.
    In addition, the regulations (Sec. Sec.  165.67(c) and 165.70(c))
state that repackaging a pesticide product for distribution or sale
without either obtaining a registration or meeting all of the
conditions listed above is a violation of section 12 of FIFRA. Both the
registrant of the product and the refiller that is repackaging the
pesticide product under contract to the registrant may be liable for
violations pertaining to the repackaged product.
    3. Changes. One significant change to these conditions for
repackaging pesticide products for distribution or sale is to add the
specification that the pesticide product can be repackaged by a
registered refilling establishment at the site of a user who intends to
use or apply the product as an acceptable alternative to the condition
that the product must be repackaged at a registered refilling
establishment. This change is discussed in detail in Unit VII.I. below.
Another change is that the final rule specifies that the registrant
must enter into a written contract with the refiller. The proposed
option for the registrant to enter into a ``written authorization''
with the refiller is not being finalized for several reasons. First,
EPA believes it is not necessary to have two different mechanisms. It
is more straightforward to specify one method, which should facilitate
compliance and minimize confusion. Second, EPA believes that a
``written contract'' is more familiar to the regulated community and
more defined in law than a ``written authorization,'' which is why we
chose to specify contracts as the mechanism for establishing a
repackaging relationship between the registrant and refiller in the
final rule. Third, in the years since the Bulk Pesticides Enforcement
Policy was issued, the ``written authorizations'' have become virtually
indistinguishable from ``written contracts'' in format, length and
level of detail. Therefore, EPA anticipates that specifying a contract
(and not an authorization) in the final rule should not cause a
substantial impact to the way repackaging is currently being conducted,
particularly considering the 5-year implementation period for the
refillable container and repackaging regulations. The other
modifications were minor formatting changes that were needed to
accommodate: (1) the revision to plain language; (2) needing to include
the conditions in the requirements for registrants who distribute or
sell to independent refillers and in the requirements for independent
refillers; and (3) clarifying that the EPA establishment number added
to the label is the refiller's EPA establishment number.
    4. Comments - implementation. One registrant urged EPA not to
eliminate the ability of manufacturers and distributors that are not
registrants of an MUP to repackage that product for distribution and
sale.
    5. EPA response - implementation. In the preamble to the proposed
regulations, EPA stated that the Bulk Pesticides Enforcement Policy
would remain in effect until the date specified for compliance with the
refillable container and repackaging regulations, at which point it
would be rescinded. EPA will implement this as discussed in the
preamble to the proposal. The refillable container and repackaging
regulations will supersede the Bulk Policy for products that are
subject to these regulations. Pesticide products that are exempt from
the refillable container and repackaging regulations--MUPs, plant-
incorporated protectants, and some antimicrobials--can only be
repackaged under the limitations established by FIFRA, the registration
requirements in 40 CFR part 152, and the applicable OPP policies. A key

[[Continued on page 47379]]

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[[pp. 47379-47428]] Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment

[[Continued from page 47378]]

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

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

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.

    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

producing establishments, who are required to register their
establishments. Condition 6 does not prevent a facility from