specifically exempt to comply with the refillable container and
repackaging regulations.
    First, one of the goals of the refillable container and repackaging
regulations is to minimize cross-contamination in refillable
containers. The regulatory standards in the final rule - including one-
way valves, tamper-evident devices, having registrants develop cleaning
procedures, and requiring refillers to clean containers if necessary -
are necessary for preventing cross-contamination in all products. All
products that are distributed or sold must have the composition as
stated in their confidential statements of formula and not be
adulterated. This standard does not differ based on the toxicity of the
product, the container size or any other factor. Therefore, minimizing
the chance of cross-contamination is one reason that the final
regulations were changed so that the refillable container and
repackaging regulations apply to all products that are not specifically
exempt. Note that certain antimicrobial products are subject to a
reduced number of requirements, as described in Unit III.D.
    Second, the repackaging regulations assign responsibility for
certain requirements to registrants and to refillers, in addition to
setting out the procedures that both parties must follow for pesticide
products to be repackaged into refillable containers. EPA believes that
it is important for all products that are not specifically exempt to be
handled consistently under the repackaging regulations. We think that
this consistency will facilitate compliance by both the registrants and
refillers.
    Third, as stated earlier, the final rule takes the approach that
all containers should meet standards for integrity and compatibility.
EPA believes that the DOT Packing Group III standards, including the
performance-oriented packaging tests, are an appropriate minimum
standard for refillable containers. Refillable containers need to be
sturdier, stronger and able to withstand more stress than
nonrefillables because they spend more time in use (i.e., full of
pesticide) and in the lanes of transportation. Because refillable
containers are returned to the refiller and/or registrant repeatedly
over the useful life of the containers, they are subject to more wear
and tear than containers that are used once. Therefore, EPA believes
that it is appropriate to require refillable containers to be capable
of meeting DOT's packaging standards at the Packing Group III level, if
the pesticide product is not a DOT hazardous material. If the pesticide
product is a DOT hazardous material, it must comply with the relevant
DOT standards.
    7. Changes to the container vs. label regulations--i. Final
regulations. In general, all products must comply with the container
labeling requirements -- the labeling regulations do not exempt MUPs or
certain antimicrobial products. One exception is that plant-
incorporated protectant container-related labeling instructions will be
determined by EPA on a case-by-case basis until specific labeling
guidance for plant-incorporated protectants are promulgated under 40
CFR part 174. This approach is discussed in more detail in Unit IX.
    ii. Changes. This is the same approach described in the 1999
supplemental notice except for the case-by-case handling of plant-
incorporated protectants.

I. Flow Chart/Summary

    The full scope of the final pesticide container and containment
rule is summarized in this section. Different sections of the final
rule apply to different subsets of products:
     The label requirements apply to all products.
     The containment structure requirements apply to
agricultural products (stored in stationary pesticide containers by
retailers, custom applicators and custom blenders).
     The nonrefillable container, refillable container and
repackaging requirements apply to products other than MUPs, plant-
incorporated protectants and certain antimicrobial products, as shown
in Figure 1.
    Within Figure 1, there is a box with the question ``Is it an
antimicrobial product that meets all four criteria?'' This box
represents a placeholder for the flow chart in Figure 2.
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BILLING CODE 6560-50-C

IV. Container Regulations--Relationship with the Department of
Transportation Regulations

A. Background

    1. Department of Transportation Hazardous Materials Regulations.
The U.S. Department of Transportation (DOT) Hazardous Materials
Regulations (HMR) are based on the authority in the Federal hazardous
materials transportation law, the Hazardous Materials Transportation
Act, and are found in 49 CFR parts 171 through 180. The HMR establish
standards governing a wide range of the safety aspects of
transportation, including requirements for the classification of
materials, packaging (including manufacture, continuing qualification
and maintenance), hazard communication (i.e., package marking,
labeling, placarding, and shipping documentation), transportation,
handling and incident reporting.
    Some, but not all, pesticide products are defined as DOT hazardous
materials by 49 CFR 171.8. A pesticide product may be classified as a
DOT hazardous material for displaying any of the hazards identified in
the DOT regulations, which are defined in nine different classes. Some
DOT hazard classes include several different divisions. The most common
hazard classes and divisions for pesticide products include:
     Class 3: flammable or combustible liquids;
     Division 6.1: poisonous materials;
     Class 8: corrosive materials; and
     Class 9: miscellaneous hazardous materials, such as marine
pollutants.
    Pesticide products that are DOT hazardous materials are required
under existing DOT regulations to comply with all applicable
regulations in all of the safety areas mentioned above -
classification, packaging, hazard communication, transportation and
handling. For pesticide products that are not DOT hazardous materials,
EPA has focused on the DOT requirements for package design (and
manufacture, continuing qualification, and maintenance) and package
marking, because these are the areas that overlap with the proposed
pesticide container regulations. In other words, EPA is not adopting
the HMR standards for DOT labeling, placarding, shipping documentation,
transportation and handling, and incident reporting because these areas
are generally outside the scope of the pesticide container regulations.
    The DOT HMR include general packaging requirements that address
areas such as compatibility, closures, venting, and filling limits. The
HMR also set out performance standards and related tests that packaging
must meet, including drop, leakproofness, hydrostatic pressure,
stacking, and vibration tests. The stringency of these tests varies
according to the packing group (PG) of the material being transported.
The packing group represents a measure of the relative hazards, where
PG I includes materials that pose a relatively great hazard and PG III
includes materials that pose a relatively minor hazard. Within a given
hazard class or division, the DOT HMR assign packing groups based on
the materials characteristics, or the regulations refer to the
hazardous materials table in 49 CFR 172.101 for substance-specific
assignments of packing groups. Most pesticide products that are
classified as DOT hazardous materials are in Packing Group III,
although some are in PG II and a few are in PG I.
    The HMR include exceptions from some portions of the overall
regulatory scheme in certain situations, e.g., for damaged packages
placed in salvage drums (49 CFR 173.3), for small quantities of
hazardous materials (49 CFR 173.4) and for the shipment of waste
materials (49 CFR 173.12). Also, the regulations in 49 CFR 173.150
through 173.156 set out limited quantity and consumer commodity
exceptions for different hazard classes. The limited quantity
exceptions provide relief from some of the HMR requirements,
specifically the labeling requirements (unless the package is
transported by aircraft), the placarding provisions, and the testing
standards in 49 CFR part 178. Also, if a limited quantity meets the
definition of consumer commodity, relief from the shipping paper
requirements is provided in many cases.
    Pesticide products that are classified as DOT hazardous materials
must continue to be packaged in accordance with the DOT HMR. Nothing in
the pesticide container regulations changes the specific requirements
in the HMR that apply to pesticide products based on the criteria in
the DOT regulations. Additionally, the pesticide container regulations
do not change the stringency of the DOT HMR. If a pesticide product is
categorized as a PG II material, it would continue to have to meet the
PG II standards and likewise for products in PG I or PG III.
    2. Final regulations (Sec. Sec.  165.25(a), (b) and (c), and
165.45(a), (b) and (c)). The final regulations adopt and refer to some
of the HMR for pesticides that are subject to this final rule. The
approach in the final rule is closely tied to the changes in scope
described in Unit III. Some products, including MUPs, plant-
incorporated protectants, and some antimicrobial products are
completely exempt from the container regulations and are not included
in the following discussion because they are exempt. All other products
are subject to the final regulations.
    For pesticide products that are lower risk (in Toxicity Category
III or IV and not restricted use products) in nonrefillable containers,
the nonrefillable containers must comply only with the general
requirements for packagings and packages in 49 CFR 173.24. No other
requirements in EPA's pesticide container regulations apply to these
lower risk products. Of course, if any of these products are DOT
hazardous materials, they must comply with all applicable DOT
regulations. For the purpose of enforcing the pesticide container
regulations, however, EPA is only referring to and adopting 49 CFR
173.24 for any lower risk products that are subject to the regulations,
regardless of whether or not they are classified as DOT hazardous
materials.
    Pesticide products that are higher risk (in Toxicity Category I or
II or a restricted use product) in nonrefillable containers and all
products in refillable containers must be packaged in a container that
is designed, constructed, and marked to comply with the requirements of
49 CFR 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213,
173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178 and part 180
that apply to a Packing Group III material. These portions of the DOT
regulations, which are described in more detail in later sections of
this preamble unit, include:
     General requirements for packagings and packages
(Sec. Sec.  173.24, 173.24a, 173.24b);
     Reuse, reconditioning and remanufacture of packagings
(Sec.  173.28), except for the leakproofness test specified in Sec.
173.28(b)(2);
     Exceptions for Class 9 materials, miscellaneous hazardous
materials (Sec.  173.155);
     Non-bulk packagings for hazardous materials in Packing
Group III (Sec.  173.203 for liquids and Sec.  173.213 for solids);
     Portable tanks, closed bulk bins and intermediate bulk
containers for certain low hazard materials (Sec. Sec.  173.240(c) and
173.240(d) for low hazard solid materials and Sec. Sec.  173.241(c) and
173.241(d) for low hazard liquid and solid materials);
     Specifications for Packagings (part 178), including non-
bulk performance-oriented packaging standards (subpart

L), testing of non-bulk packagings and packages (subpart M),
intermediate bulk container (IBC) performance-oriented standards
(subpart N), and testing of IBCs (subpart O); and
     Continuing qualification and maintenance of packagings
(part 180)
    Again, products that are DOT hazardous materials must comply with
all applicable DOT regulations. For the purposes of enforcing the
pesticide container regulations, the final rule states that a pesticide
product that meets the definition of a hazardous material in 49 CFR
171.8 must be packaged in a container that is ``designed, constructed
and marked'' to comply with the requirements of 49 CFR parts 171-180.
Including the phrase ``designed, constructed and marked'' allows EPA to
focus on the DOT requirements for package design (and manufacture,
continuing qualification, and maintenance) and package marking, as
described above, rather than the HMR standards for DOT labeling,
placarding, shipping documentation, transportation and handling, and
incident reporting.
    Because the pesticide container regulations refer to and adopt
certain DOT requirements, these requirements also are EPA standards
that can be enforced by EPA and the State agencies that implement EPA's
pesticide programs. However, EPA and the State pesticide programs will
enforce only the 49 CFR requirements that are referred to and adopted
in the pesticide container regulations; not the full DOT HMR. Clearly,
DOT maintains authority to enforce all of its regulations against
parties that are subject to the HMR.
    The final rule includes two other provisions related to the DOT
standards. These provisions are discussed in more detail in Units IV.E.
and IV.F. First, if DOT proposes to change any of the regulations that
are incorporated into the pesticide container regulations, EPA will
provide notice of the proposed changes and an opportunity to comment in
the Federal Register. Following notice and comment, EPA will take final
action regarding whether or not to revise its rules and the extent to
which any such revision will correspond with revised DOT regulation.
Second, the regulations include a provision for modifying or waiving
the adopted standards if EPA determines that an alternative (partial or
modified) set of standards or pre-existing requirements achieves a
level of safety that is at least equal to that specified in the adopted
requirements.
    3. Changes. The same general approach that was described in the
1999 supplemental notice is included in the final regulations. The
final rule refers to and adopts some DOT standards for pesticide
products that are not DOT hazardous materials and requires that these
products be packaged in containers that are designed, constructed, and
marked to comply with the adopted requirements for Packing Group III
materials. However, a number of changes are made in the final rule
approach:
     The biggest change is related to the changes in the scope
of the nonrefillable container standards. Rather than completely exempt
the lower risk pesticide products (e.g., lower toxicity in small
containers without an environmental hazard statement on the label), the
final rule mandates that the lower risk products must comply with the
general packaging requirements in 49 CFR 173.24.
     Some of the specific 49 CFR standards that are adopted for
the higher risk products in nonrefillable containers and for all
products in refillable containers are different in the final rule than
in the supplemental notice approach. In particular, the final
regulations include an exception from 49 CFR 173.28(b)(2), which
requires leakproofness testing every time a non-bulk packaging is
refilled. The final regulations specify that this leakproofness testing
is not required for products that are not DOT hazardous materials if
containers comply with the 40 CFR part 165, subpart C regulations and
the repackaging is done in compliance with the 40 CFR part 165, subpart
D regulations. Also, the final rule refers to and adopts only portions
of 49 CFR 173.240 and 173.241 (bulk packaging for certain low hazard
materials) to clarify that the pesticide container regulations do not
regulate transport vehicles. By referring to and adopting only
paragraphs (c) and (d) in both sections, the final rule incorporates
the standards for portable tanks, bulk bins and intermediate bulk
containers, but not for rail cars, motor vehicles or cargo tanks.
     The final regulations specifically refer to and adopt the
terms of the exceptions for Class 9 miscellaneous materials in 49 CFR
173.155 instead of incorporating the relevant text from that section
into the pesticide container regulations, as discussed in the
supplemental notice.
    4. Comments on the overall approach. More than 20 respondents
commented on the approach of adopting some DOT requirements at the
Packing Group III level in the supplemental notice. The comments can be
split into two categories according to the type of commenter. State
regulatory agencies and agricultural pesticide registrants and
registrant groups generally supported the overall approach, while
registrants and registrant groups from the non-agricultural pesticide
sector generally opposed the overall approach.
    i. Support. Several State regulatory agencies and an agricultural
registrant group supported EPA's approach of adopting some DOT
requirements for pesticide products that are not DOT hazardous
materials. These commenters stated that consistency with DOT should
facilitate compliance and minimize confusion in the regulated community
and will avoid conflicting regulations.
    In addition, a few agricultural registrant groups and some
agricultural registrants supported EPA's overall approach, if EPA
incorporates the changes included in their comments on the supplemental
notice. These comments recommended changing several sections of the DOT
regulations that are adopted and extending the compliance period for
refillable containers. One of the registrants commented that all
pesticides in nonrefillable containers should meet the DOT PG III
standards at a minimum to provide an updated level of protection for
the environment and for all who use, store, display, buy or distribute
pesticide products.
    ii. Oppose. About 10 respondents clearly opposed the supplemental
notice approach of adopting some DOT Packing Group III standards for
products that are not DOT hazardous materials, including several
nonagricultural registrant groups, a group representing agricultural
formulators and distributors, an institutional formulator/distributor
group and some non-agricultural registrants. These respondents opposed
EPA's approach because they claim that:
     There is no need to regulate pesticides that are not DOT
hazardous materials. Several commenters stated that DOT requirements
take into consideration the seriousness of transporting the substances
and that DOT chose not to regulate these substances. Several others
questioned whether there is evidence of a problem with shipping non-DOT
hazardous pesticides.
     Costs of packaging would increase, which respondents state
would be burdensome for small businesses. Costs mentioned were $2,500
for design plate changes and about the same amount per package type to
maintain the required certification files.
     This approach would be burdensome for EPA to monitor DOT
regulatory changes and to render exemption decisions. A commenter also

questioned whether EPA had the expertise to make exemption decisions.
     EPA's approach would be confusing because it incorporates
some, but not all, of DOT's standards.
     EPA's regulations could be different than DOT's. Several
commenters cited the waiver provision and the lack of a consumer
commodity exemption in EPA's approach as examples.
    iii. EPA response. EPA continues to believe that the general
approach of referring to and adopting the DOT Packing Group III
packaging design, construction and marking requirements is the best
approach for regulating pesticide containers.
    Commenters who opposed this approach in the supplemental notice
must recognize that the alternative to the supplemental notice approach
of referring to and adopting some of DOT's standards is not an option
of declining to establish regulations for container integrity and
construction. Instead, as described in the supplemental notice, the
alternative is to finalize the standards from the 1994 proposed rule
that address container integrity and construction. These standards
include container integrity and compatibility, marking, and reclosing
securely for nonrefillable containers and container integrity, marking
and a drop test for refillable containers. EPA is separately required
under FIFRA to promulgate such regulations for all pesticides. If
Congress had believed that existing Federal requirements promulgated by
DOT were sufficient, or that EPA should restrict its regulation to
pesticides covered as DOT hazardous materials, Congress could have
restricted FIFRA section 19 to that extent. Instead, it appears that,
with limited exceptions, Congress intended all pesticides to be
regulated under section 19.
    In fact, the approach to refer to and adopt the DOT Packing Group
III packaging design, construction and marking requirements was based
on suggestions from commenters on the proposed rule, who urged EPA to
be consistent with the DOT regulations. More than 20 respondents,
including individual companies and trade groups from the pesticide
registrant and container manufacturing industries, provided commentary
on the DOT HMR and the United Nations (UN) Recommendations on the
Transport of Dangerous Goods. All of the commenters agreed that EPA
should be consistent with the DOT HMR and the UN standards in terms of
definitions, requirements, and testing. Respondents argued that such
consistency would: (1) Facilitate compliance because the industry is
already familiar with the DOT and UN standards; (2) eliminate the
potential burden of complying with two different, overlapping
regulatory schemes; and (3) not establish additional trade barriers.
Most of the commenters on the DOT issue in the proposed rule
specifically favored the use of DOT's Packing Group III criteria as the
minimum standard for pesticide products not regulated by DOT as
hazardous materials.

B. Leakproofness Testing Before Reuse (49 CFR 173.28(b)(2))

    1. Final regulations. The final regulations retain the reference to
49 CFR 173.28, which establishes standards for the reuse,
reconditioning and remanufacture of packagings. Also, the final rule
adds a provision that exempts refillers from the leakproofness test
requirement in 49 CFR 173.28(b)(2) for products that are not DOT
hazardous materials if the refillable container complies with the
refillable container regulations and the refilling is done in
compliance with the repackaging regulations.
    2. Changes. The major change to this part of the approach is that
the final regulations add a provision that exempts refillers (which
includes registrants and independent refillers) from the leakproofness
test requirement in 49 CFR 173.28(b)(2) for products that are not DOT
hazardous materials if the refillable container is in compliance with
the subpart C refillable container regulations and the refilling is
done in compliance with the subpart D repackaging regulations. This
exception was added in response to comments on the supplemental notice.
    3. Comments. Some commenters - including several registrant groups
and several registrants - opposed the requirement in 49 CFR
173.28(b)(2) for non-bulk packaging to pass a leakproofness test before
every time it is refilled. The test involves applying a raised internal
air pressure to the container and ensuring that no air leaks from it.
The test method for the leakproofness test described in 49 CFR 178.604
specifies restraining the container under water to determine if air
leaks from the container, although alternatives are provided in an
appendix to part 178. The commenters generally requested EPA to delete
the reference to 49 CFR 173.28, although they did not point out
problems with any other provisions of 49 CFR 173.28. One of the
registrants provided the most precise and detailed description of the
potential problems that could result from requiring leakproofness
testing before every refill, including:
     It would pose practical problems and increased costs
because refillers and possibly farmers would have to obtain the
training and equipment required to do the leakproofness test.
     Due to the logistical and cost problems, the registrant
believes that many non-bulk refillable containers would be replaced by
nonrefillable containers, contrary to EPA's stated goals of pollution
prevention.
     This commenter believes that the general packaging
requirements in 49 CFR 173.24 and the container inspection provisions
in subpart D of EPA's regulations are sufficient to ensure the
integrity of non-bulk refillable containers.
     In addition to a leakproofness test, 49 CFR 173.28(b)(2)
specifies a marking requirement, which could be interpreted to impose a
testing requirement because of other DOT provisions (such as 49 CFR
171.2(c)), even if the packaging is used to transport only non-
hazardous materials. The commenter stated that DOT provided a verbal
interpretation that 49 CFR 171.2(c) does not require such testing of
non-bulk containers used to transport only non-hazardous materials. The
registrant recommended that EPA consult with DOT to confirm the
approach on this topic. This commenter and a few registrant groups
recommended deleting the reference to 49 CFR 173.28 to avoid confusion
about whether a container must be leakproofness tested before it is
refilled.
    4. EPA response. EPA agrees with the commenter's concerns about the
problems that might be caused by requiring a leakproofness test each
time a non-bulk refillable container is refilled with a pesticide
product that is not a DOT hazardous material. However, EPA disagrees
with the commenters that the solution is to delete the reference to 49
CFR 173.28. EPA believes that Sec.  173.28 includes useful provisions
that will help ensure the safe reuse of pesticide containers. In
addition, Sec.  173.28 includes provisions for reconditioning and
remanufacturing containers, which will clarify and allow the
reconditioning of certain kinds of packaging, such as drums. Many
commenters on the proposed rule and supplemental notice identified the
lack of a regulatory option for reconditionable containers as an issue.
Including the reference to Sec.  173.28 solves this problem and allows
drums to be reconditioned and then reused under the pesticide container
regulations.
    Rather than deleting the reference to 49 CFR 173.28, EPA is
modifying the final regulations to exempt refillers from the
leakproofness test requirement in 49 CFR 173.28(b)(2) for products that
are

not DOT hazardous materials if the refillable container complies with
the refillable container regulations and the refilling is done in
compliance with the repackaging regulations. This provision is similar
to one in DOT's regulations, specifically 49 CFR 173.28(b)(7), which
allows a package to be reused without being leakproofness tested with
air if four criteria are met, including being refilled and offered for
transportation by the original filler. EPA believes that the refillable
container requirements in subpart C, including the adopted DOT
standards, and the repackaging requirements in subpart D, including the
container inspection standards, provide for the safe refill and reuse
of refillable pesticide containers without requiring leakproofness
testing before each refill.

C. Regulating DOT Intermediate Bulk and Bulk Containers (49 CFR 173.240
and 173.241)

    1. Final regulations. The final regulations refer to and adopt only
certain paragraphs of the DOT regulations that authorize bulk
packagings for certain low hazard materials. In particular, the final
container rule refers to and adopts 49 CFR 173.240(c), 173.240(d),
173.241(c), and 173.241(d), so it incorporates standards for portable
tanks, bulk bins and intermediate bulk containers, but not for rail
cars, motor vehicles or cargo tanks. DOT defines bulk packagings to be
larger than 119 gallons for liquids and 882 pounds for solids.
    2. Changes. The approach described in the supplemental notice would
have incorporated all of 49 CFR 173.240 and 173.241. The final
regulations were changed to refer to and adopt only the portions of
those sections that authorize portable tanks, closed bulk bins and
intermediate bulk containers (IBCs). The portions of 49 CFR 173.240 and
173.241 that are not included in the final regulations authorize rail
cars, motor vehicles and cargo tanks, which are not regulated by the
container regulations.
    3. Comments - supplemental notice. The comments from eight
respondents (registrants and registrant groups) were split fairly
evenly on this topic, even though these commenters tended to provide
similar comments on other parts of the approach to incorporate some DOT
regulations.
    A few registrant groups and a registrant (all from the agricultural
pesticide sector) supported the reference to 49 CFR 173.240 and
173.241. These respondents supported authorizing bulk packagings by
adopting these sections for the following reasons:
     DOT provides greater latitude on the construction and less
frequent testing requirements for bulk packages because of their size
and sturdier construction. EPA should follow the same approach and
authorize the same standards for bulk containers used to distribute
pesticides that are not DOT hazardous materials.
     These sections of the DOT regulations authorize the use of
certain non-DOT specification bulk packaging, including portable tanks
and bulk bins. A few of these commenters stated that non-DOT
specification packagings that are authorized for DOT Class 9 materials
should also be acceptable for pesticides that are not DOT hazardous
materials. The non-specification packagings must comply with the
general packaging requirements in 49 CFR part 173, but not all of the
testing and marking standards in other portions of the HMR.
    In addition, the registrant explained that the HMR do not require
non-DOT specification packagings (which are authorized by 49 CFR
173.240 and 173.241) to have the UN symbol marked on them. This
commenter requested EPA to confirm that the pesticide container
regulations authorize the use of these non-DOT specification
packagings.
    On the other hand, a non-agricultural registrant group and several
agricultural registrants opposed the reference to 49 CFR 173.240 and
173.241. Several of the registrants stated that the intent of their
comments on the proposed rule was for EPA to adopt the DOT Packing
Group III standards for non-bulk packagings, not for bulk containers
(which includes intermediate bulk containers by definition). The
registrant group stated that the requirements in Sec. Sec.  173.240 and
Sec. Sec.  173.241 would be burdensome and are not necessary from a
safety standpoint. This commenter also believes that adopting these
requirements would lead to a decrease in the use of refillable
containers.
    A registrant requested that EPA re-evaluate the reference to these
sections because they authorize bulk and intermediate bulk containers
and the definitions of these kinds of containers are very different
than the ones customarily used within the agricultural pesticide
industry. A few other commenters also addressed the definition issue by
pointing out that the term minibulk (used in the agricultural pesticide
industry and in the proposed regulations) has no DOT regulatory
definition.
    4. EPA response - supplemental notice. EPA is aware that the DOT
regulations do not include a definition of minibulk container. However,
the proposed definitions for dry and liquid minibulks were developed to
intentionally include container sizes in both DOT's non-bulk and
intermediate bulk container categories. As mentioned above, under the
DOT regulations, intermediate bulk containers are a subset of bulk
containers. EPA is not finalizing the definitions of dry and liquid
minibulk (and bulk) containers in the final rule, as described in Unit
V.
    EPA intended to refer to and adopt DOT Packing Group III packaging
standards for DOT non-bulk containers and intermediate bulk containers.
EPA disagrees with the commenters who support the DOT standards for
non-bulk containers (less than 119 gallons for liquids or 882 pounds
for solids) but not for the next largest size, intermediate bulk
containers. Minibulk containers used for pesticides include ones with
capacities in the non-bulk classification, e.g., 60 to 110 gallons, and
containers in the intermediate bulk container sizes, e.g., 150 to 250
gallons. EPA believes that it is not logical to require smaller
minibulks to comply with the DOT Packing Group III testing standards,
and to not specify any testing standards for larger minibulks, which
could lead to a bigger spill. EPA believes strongly that both non-bulk
and intermediate bulk containers holding pesticides that are not DOT
hazardous materials should comply with the applicable Packing Group III
packaging construction, testing and marking requirements.
    Upon re-evaluation of the reference to 40 CFR 173.240 and 173.241,
however, EPA realized that there may be some confusion caused by the
paragraphs that authorize rail cars, motor vehicles and cargo tanks.
EPA has never intended to regulate transport vehicles. The proposed
rule (in Sec.  165.122(b)(2)) and the final rule (in Sec.  165.43(h))
state that the pesticide 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. To eliminate potential
confusion, EPA changed the final rule to only include the portions of
49 CFR 173.240 and 173.241 that authorize portable tanks, bulk bins and
intermediate bulk containers.
    5. Comments - UN marking. In response to the 2004 reopening of the
comment period, some commenters provided new information and comments
regarding the approach of referring to and adopting a subset of DOT's
hazardous materials packaging regulations. A registrant group and two
registrants commented that, since the supplemental notice was published
in

1999, several manufacturers have voluntarily changed their packaging
specifications for all products, hazardous materials and nonhazardous
materials, to meet DOT Packing Group III standards.
    These three respondents and two other commenters (a registrant
group and a registrant) supported the marking that would be required by
adopting the DOT standards. One registrant group stated that ``It is
important to have the UN marks to provide a minimum performance
standard to those in the channels of distribution that purchase, fill,
and sell crop protection products in refillable containers.'' The other
commenters also supported adopting the DOT marking, but asked for
clarification about which containers would need the UN mark. The DOT
regulations do not require UN markings on certain kinds of containers,
such as non-DOT specification portable tanks and containers holding
limited quantities or consumer commodities. One of the registrants
stated that their understanding of the DOT reference is that EPA is
proposing UN markings only for those kinds of containers that require
UN markings for DOT Packing Group III hazardous materials. In other
words, when DOT regulations require UN marking for a container holding
a DOT hazardous material, that same marking would also be required for
the same kind of containers that hold pesticides that are not DOT
hazardous materials. Most of the respondents recommended adding a
statement to the regulatory text referring to the DOT regulations such
as ``This includes certain containers which require UN markings (e.g.,
2 x 2.5 gallon cartons, 50 pound multiwall paper bags, 5, 30 and 55
gallon drums) and certain other containers which do not require UN
markings (e.g., limited quantities, consumer commodities and non-DOT
specification portable tanks).''
    On the other hand, a registrant group and two registrants stated
that the marking size and location requirements of 49 CFR 178.3 should
not apply to non-hazardous materials, claiming that placing the UN mark
on the containers of these materials could create confusion among
carriers and emergency responders. They expressed concern that non-
certified transporters may refuse entire loads of non-hazardous
materials marked with the circle UN mark since this is an indication of
a DOT regulated material. These commenters also said that emergency
responders may assume the cargo is a hazardous material and handle the
situation accordingly if there was an accident involving such
materials. These respondents suggested a certification process similar
to Child Resistant Packaging approval or placing the specification
packaging designation for non-hazardous materials on the product label
(like the EPA Registration Number) rather than the large and prominent
marking required by 49 CFR part 178.
    6. Response - UN marking. EPA wants to clarify that the approach of
referring to and adopting a subset of the DOT requirements would
require the marking that is specified in the DOT regulations. UN
markings would be required only for those containers that require UN
markings for DOT Packing Group III hazardous materials. If DOT does not
require the UN marking but allows the use of the packaging for Packing
Group III materials (e.g., limited quantities, consumer commodities and
non-DOT specification portable tanks), the EPA regulations would allow
the use of these packagings and would not require the UN marking.
However, EPA is not modifying the final regulations to add the
suggested additional sentence because we do not believe it provides
additional clarification. In addition, EPA believes that the preamble
and guidance documents are the proper vehicles for providing this kind
of clarification. EPA disagrees with the commenters who opposed using
containers with the UN mark for non-DOT hazardous materials. As other
commenters stated, several companies have voluntarily switched to use
DOT Packing Group III (presumably with the UN mark) since 1999 and have
not reported any of the potential problems described by the respondents
who oppose using the UN mark. Further, EPA clarifies that the UN mark
would only be required if required by the DOT regulations.

D. Limited Quantity/Consumer Commodity Exception (49 CFR 173.155)

    1. Final regulations. The final regulations refer to and adopt 49
CFR 173.155, which establish limited quantity and consumer commodity
exceptions for Class 9 materials (miscellaneous hazardous materials).
    2. Changes. The potential alternative regulatory text in the
supplemental notice would have incorporated the relevant portions of
the limited quantity exception in 49 CFR 173.155 into the text of the
pesticide container regulations. After reviewing the comments and re-
evaluating the regulations, EPA believes it is more straightforward to
simply refer to and adopt the entire section of the DOT regulatory
exceptions for Class 9 materials in 49 CFR 173.155.
    3. Comments. About 11 commenters addressed the idea of including a
provision such as a limited quantity exception in the pesticide
container regulations and all but one strongly supported this kind of
provision. The opposing commenter, a registrant, stated that it did not
believe that incorporating the Class 9 limited quantity exception was
appropriate. The other commenters, mainly registrant groups and
registrants, varied a bit in the specific approach they recommended,
but all supported the idea of including this kind of exception in the
pesticide container regulations.
    Several commenters specifically requested that EPA add a reference
to 49 CFR 173.155, the limited quantity and consumer commodity
exceptions for Class 9 materials, to the pesticide container
regulations to be more consistent with the DOT regulations. Several
respondents supported the limited quantity exception as described in
the supplemental notice. Several other commenters recommended that EPA
incorporate both the limited quantity exception and the consumer
commodity exception in 49 CFR 173.155. As defined in the HMR, consumer
commodity means a material that is packaged and distributed in a form
intended or suitable for sale through retail sales agencies or
instrumentalities for consumption by individuals for purposes of
personal care or household use. This term also includes drugs and
medicines. Two registrant groups who urged EPA to also adopt the
consumer commodity exception said that the consumer commodity exception
is necessary to prevent increased costs and unnecessary complications
caused by complying with EPA and DOT regulations that would be
different.
    4. EPA response. As stated in the supplemental notice, EPA
continues to believe that it is necessary to incorporate a DOT limited
quantity exception to maintain consistency with the HMR and to provide
regulatory relief for relatively small quantities of pesticides.
However, after reviewing the comments and re-evaluating the
regulations, EPA believes it is better to simply refer to and adopt 49
CFR 173.155 in its entirety because it is more straightforward. In
addition, the final rule approach adds the benefit of including the
consumer commodity exception for Class 9 materials, which will provide
clarity and consistency for registrants of products that are not DOT
hazardous materials and that meet DOT's definition of consumer
commodity.

E. Waiving or Modifying the Requirement to Comply with Some DOT
Regulations (Sec. Sec.  165.25(g) and 165.45(g))

    1. Final regulations. The final regulations include provisions that
would allow EPA to modify or waive the requirements of the regulatory
sections that refer to and adopt the DOT requirements if EPA determines
that the alternative (partial or modified) set of standards or pre-
existing conditions achieves a level of safety that is at least equal
to that specified in the requirements of this section. Section
165.25(g) establishes the waiver/modification standard for
nonrefillable containers and Sec.  165.45(g) provides it for refillable
containers.
    2. Changes. This is the same basic approach that was described in
the supplemental notice. EPA made a few adjustments in the final
regulations, such as clarifying that EPA must determine that the
alternative set of standards achieves an acceptable level of safety
before a waiver is granted (rather than being based on the registrant
submitting information.) In addition, EPA reorganized the final
regulations so all of the waiver requests are grouped together to
simplify the process of applying for a waiver from any of the container
standards. Finally, EPA changed the wording of the regulations to
clarify that, for pesticide products that are DOT hazardous materials,
we will modify or waive the requirements regarding the DOT standards
only after consulting with DOT to ensure consistency with DOT
regulations and exemptions.
    3. Comments - DOT regulations. Some commenters (registrant groups
and registrants) supported the DOT waiver provision set out in the
potential alternative regulatory text in the 1999 supplemental notice,
stating they believed it was sufficient. A few registrant groups
opposed the suggested DOT waiver provision in the supplemental notice.
In particular, these commenters opposed EPA modifying DOT's standards
for pesticides subject to DOT standards, because these pesticides could
be rendered out of compliance with DOT standards and could not be
transported legally. One of these commenters also expressed concern
about EPA's ability to make waiver decisions, questioning EPA's
resources, lack of expertise similar to DOT's, and the absence of the
kinds of relationships that DOT has with transportation-related
standard setting organizations.
    4. EPA response - DOT regulations. EPA understands some of the
concerns expressed by commenters regarding pesticides that are DOT
hazardous materials. It is possible that EPA modifications to the
adopted DOT requirements for a pesticide that is a DOT hazardous
material could create a set of requirements that conflict with DOT's
regulations. In this case, it would not be possible to package a
pesticide such that it could meet both EPA's and DOT's standards. To
prevent this kind of situation, EPA modified the final regulation in
several ways. First, a separate waiver provision is included for
pesticides that are DOT hazardous materials and for pesticides that are
not DOT hazardous materials. Second, the waiver provision for
pesticides that are DOT hazardous materials specifies that EPA will
modify or waive the requirements only after consulting with DOT to
ensure consistency with DOT regulations and exemptions. A similar
provision is not necessary for pesticides that are not DOT hazardous
materials, because these pesticides aren't subject to DOT's
requirements, so there won't be a conflict.
    EPA plans to coordinate with DOT as much as possible and hopes to
benefit from their great experience in regulating packaging and their
relationships with other organizations. EPA is very familiar with
regulating pesticides. Through our authority in FIFRA to regulate
pesticide products (which includes the pesticides, the labeling and the
containers), we have directly or indirectly set packaging standards for
a number of pesticide products. We also have established relationships
with pesticide manufacturers and have developed expertise with
pesticide handling and use practices. It is possible that at some
point, compliance with one of the adopted DOT standards may conflict
with safe use and handling practices for pesticides. For pesticides
that are not DOT hazardous materials, EPA believes we should have the
ability to modify or waive the adopted DOT standards if we determine
(based on information provided) that an alternative set of standards
achieves a level of safety that is at least equal to that specified in
the adopted DOT standards.

F. Providing Public Notice of Changes in the Adopted DOT Regulations
(Sec. Sec.  165.25(c) and 165.45(c))

    1. Final regulations. The final regulations include a provision
that says EPA will provide notice to the public in the Federal
Register, and an opportunity to comment, if DOT proposes to change any
of the regulations that are referred to and adopted in EPA's pesticide
container regulations. Following notice and comment, EPA will take
final action regarding whether or not to revise its rules, and the
extent to which any such revision will correspond with revised DOT
regulations.
    2. Changes. This is similar to the approach described in the
supplemental notice.
    3. Comments. A registrant group questioned whether OPP has the
resources for the on-going effort of monitoring DOT's regulatory
changes and constantly proposing and promulgating its own revisions to
mirror the DOT actions. This respondent also expressed concern that
there would be lag times between DOT's and EPA's regulatory changes,
creating confusion and putting registrants in the position of being
subject to conflicting Federal standards.
    4. EPA response. EPA does not believe that the notification process
in the pesticide container regulations will be overly burdensome. An
OPP staff member currently monitors the DOT regulatory changes.
Increased communication with DOT resulting from these final regulations
should provide advanced notice of any changes, which would make any
monitoring efforts even easier. In addition, EPA believes the commenter
misunderstood the point of this notification provision. EPA does not
anticipate changing its regulations based on proposed changes by DOT in
most situations. Instead, the purpose of EPA's notifications will be to
let EPA's regulated community know that DOT has proposed to modify the
DOT regulations adopted by the pesticide container regulations.
Therefore, pesticide registrants and related parties will be able to
monitor the DOT rule process themselves and can provide comments to DOT
if they believe it is warranted. If a DOT rule change creates a
significant obstacle to compliance or another substantial problem for
pesticide containers, EPA would consider changing the pesticide
container regulations that refer to and adopt the DOT requirements.
However, EPA believes the chances of this happening are very small
because it defeats the purpose of referring to and adopting the DOT
requirements to provide a consistent set of packaging requirements.

V. Nonrefillable Container Standards

A. Purpose (Sec.  165.20(a))

    1. Final regulations. The purpose of the nonrefillable container
standards is to establish design and construction requirements for
nonrefillable containers used for the distribution or sale of some
pesticide products.

    2. Changes. This is nearly the same as the proposed purpose (in
Sec.  165.100). 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 modification was to delete the term ``standards'' from the
phrase ``establish standards and requirements'' because it is
redundant.

B. Who Must Comply (Sec.  165.20(b))

    1. Final regulations. You must comply with the nonrefillable
container regulations if you are a registrant who distributes or sells
a pesticide product in nonrefillable containers. If your product is
subject to the nonrefillable container regulations as described in Unit
V.D., the product must be distributed or sold in nonrefillable
containers that comply with these regulations. This statement applies
to each and every nonrefillable container used to sell or distribute
the product.
    2. Changes. This is the same approach that we proposed in Sec.
165.100. As described in Unit V.D., the final rule exempts some
products from the final rule and subjects some products to only the
basic DOT general packaging standards. However, the approach of
registrants being responsible for complying with the nonrefillable
container standards is unchanged.

C. Compliance Date (Sec.  165.20(c))

    1. Final regulations. The final regulations provide a 3-year period
after the date of publication of the final rule in the Federal Register
before compliance with the nonrefillable container standards is
required. Specifically, within 3 years from today's date, registrants
must distribute or sell all subject pesticide products in nonrefillable
containers in compliance with these regulations.
    2. Changes. EPA made several significant changes to the compliance
date for nonrefillable containers in the final rule. First, the final
regulations provide a 3-year period after today's date before
compliance is required, compared to the 2-year period in the proposed
rule. Second, the proposed rule specified (in Sec.  165.117(b)) that 5
years after the date of publication of the final rule, all products
distributed or sold in nonrefillable containers by persons other than
the registrant would have had to comply with these standards. This
``channels of trade'' date affecting persons other than the registrant
is not being finalized in today's final regulations. Third, 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 V.M.
    3. Comments - length of compliance period. About 15 commenters,
including registrants, registrant groups, a dealer group, and a State
regulatory agency, stated that 2 years would not be enough time to
comply with the proposed standards, especially the nonrefillable
container residue removal standard. Many of the respondents commented
that 2 years is not long enough to test containers initially and, for
containers that fail the residue removal standard, to redesign
containers, reformulate the product, or obtain EPA approval for a
waiver. Also, many commenters expressed concerns about delays caused by
EPA in providing necessary implementation information, processing
waiver requests, and reviewing reformulated products.
    4. EPA response - length of compliance period. EPA agrees with some
of the commenters that a longer compliance period will make it easier
for registrants to comply with the nonrefillable container standards.
To facilitate compliance while trying to minimize the impact on
companies, EPA lengthened the compliance period for the nonrefillable
container requirements to 3 years. EPA believes a 3-year period is
sufficient based on the results of the economic analysis and because
some of the changes made to the regulations facilitate compliance.
These changes include: (1) Some products are completely exempt from the
nonrefillable container requirements; (2) many products must comply
only with basic DOT requirements, not the full set of nonrefillable
container requirements; and (3) changes in the residue removal
requirement, discussed in Unit V.H., which reduce the burden of that
requirement.
    5. Comments - channels of trade. Some commenters -- registrant
groups and registrants -- urged EPA to delete the channels of trade
provision, generally stating that current products/containers don't
pose a large enough hazard to justify the costs of a recall. A few
State regulatory agencies and a container manufacturer requested
clarification of this requirement, i.e., who would be included and who
would be responsible for compliance and/or disposition of ``expired''
products.
    6. EPA response - channels of trade. EPA is not finalizing the 5-
year channels of trade provision in the final rule to minimize the
disruption and burden of implementing the rule. EPA does not believe
that current products and containers pose a large enough hazard
(compared to the containers that would be used to comply with the
requirements) to justify the costs of recalling them from retailers and
distributors to either repackage or dispose of them. EPA believes that
setting a date for when products distributed or sold by registrants
must comply is sufficient. Products that are distributed and sold
before this date can adequately work their way through the distribution
system.

D. Pesticide Products Included (Sec.  165.23)

    1. Final regulations. As described in detail in Unit III., only
certain products have to comply with the nonrefillable container
standards. MUPs, plant-incorporated protectants, and certain
antimicrobial products are completely exempt from the nonrefillable
container requirements. All other pesticide products are subject to the
nonrefillable container regulations.
    There are different tiers of regulation for products that are
subject to the nonrefillable container regulations. A product is
subject to all of the nonrefillable container requirements if it
satisfies at least one of the following criteria:
     It meets the criteria of Toxicity Category I.
     It meets the criteria of Toxicity Category II.
     It is classified for restricted use as set out in 40 CFR
152.160 - 152.175.
    If a product does not satisfy any of these criteria (and it is not
an MUP, plant-incorporated protectant or an exempt antimicrobial), it
must be packaged in accordance with 49 CFR 173.24. These products do
not have to comply with any other nonrefillable container requirements.
However, if any of these products are DOT hazardous materials, they are
separately obligated under DOT regulations to comply with all
applicable DOT requirements. In other words, nothing in EPA's
regulations changes the requirements in the DOT HMR for products that
meet DOT's criteria for hazardous materials.
    2. Changes. In the proposal, only MUPs would have been exempt from
the nonrefillable container regulations (in Sec.  165.100). 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
somewhat different from those we indicated as our preferred approach in
the supplemental notice. The final rule exempts plant-incorporated
protectants. Also, the final rule uses toxicity category and restricted
use product status to determine the level of regulation subject to all
nonrefillable container requirements compared to the basic DOT
packaging requirements rather than to determine whether the product is
subject to or exempt from the nonrefillable container regulations.
    Table 6 describes the provisions for determining which pesticide
products are subject to which nonrefillable container regulations and a
brief explanation of how (or if) this provision changed from the
proposal and/or the supplemental notice.

      Table 6.--Changes to the Scope of the Nonrefillable Container
                               Regulations
------------------------------------------------------------------------
 Regulatory Provision in the Final Rule               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 regulations as follows:\1\
------------------------------------------------------------------------
Products in Toxicity Category I or II     No change from the
 are subject to all of the nonrefillable   supplemental notice approach.
 container requirements.
------------------------------------------------------------------------
Restricted use products are subject to    This is different from the
 all of the nonrefillable container        other two criteria discussed
 requirements.                             most thoroughly in the
                                           supplemental notice, which
                                           were: (1) container capacity
                                           equal to or larger than 5
                                           liters or 5 kilograms and (2)
                                           having a specified
                                           environmental hazard
                                           statement on the label of an
                                           outdoor use product.
------------------------------------------------------------------------
All other products (those in Toxicity     This category of lowest
 Category III or IV and that are not       regulation is different from
 restricted use products) must comply      the supplemental notice in
 only with the basic DOT packaging         two ways. First, these
 requirements in 49 CFR 173.24.            products are subject to the
                                           basic DOT requirements rather
                                           than being completely exempt
                                           from the nonrefillable
                                           container regulations.
                                           Second, more products are in
                                           this category of lowest
                                           regulation because there are
                                           fewer Toxicity Category III
                                           or IV products subject to all
                                           of the nonrefillable
                                           container requirements in the
                                           final rule (restricted use
                                           products) than under the
                                           supplemental notice (products
                                           in small containers and
                                           outdoor use products with a
                                           specified environmental
                                           hazard statement on the
                                           label).
------------------------------------------------------------------------
\1\The rest of the changes focus on changes from the supplemental
  notice. All of these products would have been subject to the proposed
  rule because the proposed rule would have applied to all products
  except for manufacturing use products.

E. DOT Standards (Sec.  165.25(a) - (c))

    1. Final regulations. As discussed in detail in Unit IV.,
nonrefillable 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 significant 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
V.M., three of the proposed requirements for nonrefillable containers
(container integrity, marking the material of construction and ensuring
that the container recloses securely) are not being finalized in the
final rule because they were replaced by equivalent DOT requirements.

F. Closures (Sec.  165.25(d))

    1. Final regulations. A nonrefillable container must have at least
one of the four closures listed below if it meets all of the following
criteria:
     The container is used to distribute or sell a liquid,
agricultural pesticide;
     The container is rigid;
     The capacity of the container is equal to or greater than
3.0 liters (0.79 gal); and
     The container is not an aerosol container or a pressurized
container.
    The four closures specified in the regulations are:
     Bung, 2 inch pipe size (2.375 inches in diameter),
external threading, 11.5 threads per inch, National Pipe Straight (NPS)
standard.
     Bung, 2 inch pipe size (2.375 inches in diameter),
external threading, 5 threads per inch, buttress threads.
     Screw cap, 63 millimeters, at least one thread revolution
at 6 threads per inch.
     Screw cap, 38 millimeters, at least one thread revolution
at 6 threads per inch. The cap may fit on a separate rigid spout or on
a flexible pull-out plastic spout.
    2. Changes. The scope of the requirement for standardized closures
is unchanged from the proposal; it applies to liquid agricultural
pesticides in rigid containers with capacities equal to or greater than
3.0 liters. The closure standard does not apply to aerosol or
pressurized containers. The final regulation made several changes in
the dimensions and other specifications of the closures based on
comments and additional research to accurately reflect

the closures that are most commonly used in the agricultural pesticide
industry. Also, the proposed provision that would allow the use of non-
standard closures was moved to a separate section of the final rule
(Sec.  165.25(g)) along with the other waiver and modification
provisions, as described in Unit V.I.

G. Dispensing Capability - Glugging and Dripping (Sec.  165.25(e))

    1. Final regulations. A nonrefillable container with a capacity of
5 gallons (18.9 liters) or less, that is not an aerosol or pressurized
container or a spray bottle, and that holds a liquid pesticide must do
both of the following:
     Allow the contents of the nonrefillable container to pour
in a continuous, coherent stream.
     Allow the contents of the nonrefillable container to be
poured with a minimum amount of dripping down the outside of the
container.
    2. Changes. The final rule includes several substantial changes
from the proposal. First, the dispensing requirements in the proposed
rule would have applied to all nonrefillable containers for liquid
pesticides, regardless of the size of the container. The final rule
only applies the dispensing requirements to containers that are less
than 5 gallons (18.9 liters) in size. This change was made in response
to the comments that said large containers should not be subject to the
dispensing standards. Because these standards are intended to minimize
exposure to pesticides when they are poured from containers, EPA agrees
that the requirements should not apply to containers that are too large
to allow their contents to be poured from them. The dispensing
requirements in the final rule apply only to containers with capacities
of 5 gallons (18.93 liters) or less, which we believe are the
containers that can be picked up and the contents poured out.
    Second, the final rule clarifies that, like the nonrefillable
container closure requirement, the glugging and dripping standards do
not apply to aerosol containers or pressurized containers. The proposed
dispensing requirements would have applied only to liquid pesticides,
and the final rule maintains this approach. EPA did not intend that
these requirements would apply to aerosol or pressurized containers.
The proposed closure regulation specifically excluded aerosols and
pressurized containers, so the lack of similar language in the
dispensing requirements led some commenters to believe that aerosol and
pressurized containers are subject to the dripping and glugging
standards. To clarify our intent, EPA modified the final rule to
clearly state that the dispensing standards do not apply to aerosol
containers and pressurized containers. As mentioned above, the
dispensing standard is intended to minimize exposure to pesticides when
they are poured from containers, which is not how pesticides are
dispensed from aerosol or pressurized containers.
    Third, the requirement in the final rule was modified to also
exclude spray bottles. During a review of products that would be
subject to the final regulation, EPA realized that spray bottles should
also be exempt from the dispensing requirements because the container
contents are sprayed out by a trigger mechanism, rather than poured.
    Fourth, the requirement regarding dripping in the final rule
specifies that the contents of a container must be poured with a
minimum amount of dripping, rather than no dripping as proposed. Fifth,
the dripping standard was clarified to specify ``dripping down the
outside of the container'' to distinguish this from when the pesticide
drips out of the container into its target when the material is poured
from the container. Many commenters (registrants, registrant groups, a
grower group, a container manufacturer, and a State regulatory agency)
supported modifying this standard from ``eliminating'' dripping to
``minimizing'' dripping. Most of these respondents commented that
completely eliminating dripping is impractical or impossible and that
the amount of pesticide on the outside of the container is largely a
function of user care. EPA agrees with the commenters that the proposed
standard of eliminating dripping is not practical, particularly without
a specific testing procedure and considering the significant role of
user handling practices in whether the containers drip. Therefore, EPA
is modifying the dripping standard to minimize rather than eliminate
dripping. The structure of the standard was revised to be similar to
the glugging standard so it would be clear that the dripping standard
applies when the contents are poured from the container. Finally, the
requirement refers to minimizing the amount of ``dripping down the
outside of the container.'' EPA believes this phrase clarifies that the
dripping that should be minimized is the trickle or drops of liquid on
the container exterior; not the last few drops of material or rinsate
that leave the container when the contents are poured.
    Lastly, the proposed standard for reclosing securely is not being
finalized in the final rule, because there is an equivalent DOT
standard that is being adopted, as explained in Unit V.M.

H. Residue Removal (Sec.  165.25(f))

    1. Overview--i. Final rule. Rigid containers with capacities less
than or equal to 5 gallons for liquid formulations or 50 pounds for
solid formulations holding dilutable formulations must be capable of
attaining at least 99.99 percent removal for each active ingredient
when tested using the EPA testing methodology. Percent removal
represents the percent of the original concentration of an active
ingredient in the pesticide product formulation when compared to the
concentration of that active ingredient in an extra rinse following
administration of the triple rinse procedure specified in the testing
methodology, i.e., in the fourth rinse. All dilutable products in these
smaller rigid containers must be capable of meeting the 99.99 percent
removal standard, although the testing must be done only if products
are flowable concentrate formulations or if EPA requests the test data
on a case-by-case basis.
    ii. Changes. EPA made many substantive changes to the nonrefillable
container residue removal standard in the final rule based on public
comments and a re-evaluation of currently available data. The
significant changes are listed briefly in this subsection and are
described in more detail below in the response to comment summaries.
The major changes in the residue removal standard are:
     The performance standard was changed from 99.9999 percent
removal (``six 9's'') in the proposal to 99.99 percent removal (``four
9's'') in the final rule.
     The wording was changed from ``The registrant shall
demonstrate for each container/formulation combination that the
standard is achieved'' in the proposal to ``Each container/formulation
combination must be capable of attaining the standard.'' The language
in the final rule provides more flexibility in showing compliance with
the standard, while still placing the responsibility of meeting the
standard on the registrant.
     Testing (and the corresponding recordkeeping in Sec.
165.27(b)(5)) is only required for flowable concentrate formulations or
if EPA specifically requests the records on a case by case basis.
     The test procedure will be established as an OPP test
procedure titled ``Rinsing Procedures for Dilutable Pesticide Products
in Rigid Containers,'' which is incorporated into the

regulations. (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
detailed procedures in a test protocol rather than in the regulations.
     The residue removal standard only applies to containers
that are small enough to be shaken because the final test procedure and
the supporting data involved shaking the containers during triple
rinsing. As stated in Unit IX.I., EPA generally believes that the
largest containers that users can shake during a triple rinse are those
with capacities of 5 gallons for liquids and 50 pounds for solids.
    In addition, the final residue removal test procedures,
incorporated in ``Rinsing Procedures for Dilutable Pesticide Products
in Rigid Containers,'' (Ref. 20) contain several key changes.
     In the final test procedure, the test must be conducted on
three containers, rather than the proposed approach of a minimum of 19
containers.
     Rather than the proposed statistical standard (at least 95
percent confidence that at least 85 percent of containers tested will
meet the standard), the final test procedure specifies that all three
containers tested must meet the four 9's standard in the final rule.
The final rule approach is similar to the standards for complying with
DOT's drop tests and other performance tests.
     The final rule does not specify that the testing must be
conducted in compliance with the full set of Good Laboratory Practice
Standards in 40 CFR part 160. While registrants may comply with the GLP
standards, it is not required. However, some key GLP requirements are
specified in the final test procedure to accomplish the goals of
ensuring adequate quality of the testing and the resulting data.
    iii. Comments. Several State regulatory agencies and a container
manufacturer group supported EPA's proposal to require a laboratory
standard for removing residue from nonrefillable containers. These
commenters stated that such a standard would enhance safe use and
recycling, facilitate management of empty containers and provide
flexibility to registrants.
    A registrant and a registrant group supported consideration of a
residue removal performance standard but opposed the stringency of
EPA's proposal. Additionally, a few registrants commented that
encouraging the use of containers and formulations that facilitate
residue removal is reasonable, but did not support the proposed
standard.
    Many respondents (from nearly all commenter categories, but mostly
the pesticide registrant industry) opposed the establishment of any
numeric standard for residue removal for the following reasons (which
are described in more depth in the Response to Comment document (Ref.
19)):
     EPA doesn't demonstrate a problem;
     Much of the information cited by EPA isn't relevant/
applicable;
     The problem is that users don't rinse containers; not the
container designs; and
     The solution is educating users and enforcing rinsing
standards.
    Many commenters specifically opposed the six 9's standard as too
stringent. These comments claimed that the six 9's standard is overly
ambitious and that the standard would be too costly for the benefit
obtained. In many cases, commenters said the standard would be
impossible to achieve. While some respondents acknowledged that the six
9's standard is technologically feasible, they said it would not be
practical in application.
    iv. EPA response. EPA believes that ensuring adequate residue
removal at the user level to achieve the goal of containers that can be
safely managed for disposal or recycling involves the following steps:
    (1) The use of container designs and formulations that facilitate
effective residue removal;
    (2) Defining proper cleaning procedures;
    (3) Educating users about proper cleaning procedures;
    (4) Motivating users to properly clean containers; and
    (5) Enforcing proper cleaning in the field.
    Problems and breakdowns can occur with any of these steps. If
problems do occur, containers will not be adequately clean when they
are offered for disposal or recycling. EPA acknowledges the commenters'
point that much of the problem with inadequately cleaned containers
lies with the fact that the users don't rinse them properly, implying a
breakdown in items 2, 3, and/or 4. EPA believes that the label
standards associated with these regulations establish proper and clear
cleaning procedures, as described in Units IX.F. - IX.K. EPA agrees
that it is important and appropriate to dedicate adequate resources to
user education and motivation and to enforcing the rinsing standards.
Additional efforts on these points will be discussed in Unit V.H.5.
    However, EPA still believes that the first step in adequate
container cleaning - and a responsibility of the registrant - is making
sure that the containers can come clean. Therefore, EPA is retaining a
residue removal performance standard in the final regulations for rigid
nonrefillable containers with dilutable formulations. Additional
information about the many variables observed in more than 20 rinsing
studies and about the FIFRA Section 19 mandates is in the Response to
Comment document. (Ref. 19)
    2. Numeric residue removal standard. EPA decided to change the
performance standard from 99.9999 percent removal (``six 9's'') in the
proposal to 99.99 percent removal (``four 9's'') in the final rule.
    i. Comments. Several State regulatory agencies and an environmental
group specifically expressed support for the ``six 9's'' standard. One
State regulatory agency said their data show that 99.9999 percent
removal is achievable under field conditions. Another said that the
standard is achievable for most containers, but not for flat-topped
metal cans -- a container type it feels is not suited for use with
pesticides.
    On the other hand, many commenters opposed the proposed six 9's
standard, stating that it was overly ambitious and too burdensome.
Specific comments include:
     Almost 20 commenters, mostly registrants and registrant
groups, objected to EPA's interpretation of the residue removal data
and particularly opposed EPA's assessment that a level of six 9's was
technologically practicable.
     About 20 commenters (mostly registrants and registrant
groups) urged EPA to base the standard on the risks involved. Many of
these respondents commented that there is no risk analysis showing that
residues in existing containers pose a theoretical or real threat or
that reaching a six 9's standard would substantially reduce this risk.
     Many commenters, including registrants, registrant groups,
State regulatory agencies, a dealer and a dealer group, questioned the
cost-effectiveness of the six 9's standard.
     Some registrants who opposed the six 9's standard favored
adopting a less stringent four 9's requirement. They termed it more
practical, in line with industry expectations, and the only achievable
level of removal.
    One registrant group provided comprehensive comments during the
2004 reopening of the comment period based on the Ag Container
Recycling

Council's (ACRC's) experience over the past 10 years. This commenter
described ACRC's efforts to assess and control the risk from using the
recycled plastic and noted that, since ACRC's inception in 1992, there
have been no reports of incidents where public health or safety has
been compromised as a result of exposure to the minimal residues found
in recycled plastic pesticide containers. Further, ACRC's study
indicated that the risk to human health and the environment from
recycling emptied pesticide containers that remove 99.99 percent of
residue from containers is within acceptable levels for recycling.
    This registrant group also stated that ACRC's experience with
recycling clean, rinsed one way pesticide containers for more than a
decade leads them to believe that residue removal is an issue of
instructing applicators to triple or pressure rinse containers
immediately after use. A registrant expanded on this idea by stating
that recent experience with pesticide container collection programs has
shown substantial improvement in the cleanliness of incoming containers
and that it has become obvious that problems with dirty containers are
not caused by product that is not able to be rinsed, but by users who
do not rinse, or do not rinse in a timely manner. The registrant
contrasted this experience with EPA's focus in the proposed rule on
ensuring that products will rinse easily from their containers, which
seems to have been based the reports of poorly rinsed containers from
early container collection programs. The registrant said that great
strides have been made in the growth of State container return/recycle
programs and in grower, applicator, and user education since that
period.
    ii. EPA response. After considering the comments, re-evaluating the
residue removal data and factoring in the experiences of pesticide
container collection and recycling programs over the past decade, EPA
believes the residue removal standard should be revised from 99.9999
percent to 99.99 percent removal.
    Of the many rinsing studies, four sets of data were developed using
a standard testing procedure (similar to the final test procedure) to
test currently used formulations and container designs. Two sets of
data focused on containers and formulations typical of the agricultural
pesticide market and the other two were intended to represent
containers and formulations in the household, institutional and
industrial market. Table 7 summarizes the results of these studies in
terms of the standard that the container/formulation would meet based
on the concentration of active ingredient in the rinsate from the
fourth rinse.

                                                       Table 7.--Analysis of Residue Removal Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of Container/Formulations That Meet*
                     Study Name                           Total Cntr/Form     --------------------------------------------------------------------------
                                                        Combinations Tested            Four 9's                 Five 9's                 Six 9's
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formulogics (agricultural) (Refs. 8 and 36)                                19                       19                       17                       13
--------------------------------------------------------------------------------------------------------------------------------------------------------
NACA (triple rinse) (Refs. 15 and 39)                                      24                       24                       19                       12
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Subtotal: agricultural market                                  43                43 (100%)                 36 (84%)                 25 (58%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Formulogics (nonagricultural) (Refs. 6 and 37)                            29                       29                       26                       16
--------------------------------------------------------------------------------------------------------------------------------------------------------
CSMA (Refs. 35 and 77)                                                      7                        6                        4                        1
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Subtotal: nonagricultural market                                36                 35 (97%)                 30 (83%)                 17 (47%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                      79                 78 (99%)                 66 (84%)                 42 (53%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Note: Some container/formulation combinations were tested on one container; others on two or three (identical) containers for that formulation.
  Formulations tested on more than one container were classified in the highest standard that all of the containers met. For example, a container/
  formulation would be classified as four 9's if the results for the formulation in three containers were 99.9988, 99.9996 and 99.9995. For reference,
  the structure of the studies were: (1) Formulogics (ag): all 19 tests on 1 container; (2) NACA (triple rinse): 9 tests on 1 container, 15 tests on 3
  containers; (3) Formulogics (nonag): 3 tests on 2 containers, 6 tests on 3 containers but the rinsates had to be composited to provide adequate
  volume, and 21 tests on 3 containers; and (4) CSMA: all 7 tests on 1 container.

    While a more thorough discussion of these data and the comments
regarding them is included in the next section, EPA believes that the
data show that a standard of four 9's adequately represents the results
from a careful laboratory triple rinse. Of the 79 container/
formulations tested, only one did not meet a 99.99 percent removal
standard. The Consumer Specialties Manufacturers Association (CSMA, now
the Consumer Products Manufacturers Association) provided information
indicating that the container/formulation that failed was an
agricultural pesticide product in a household pesticide container.
Therefore, EPA does not believe that this data point represents a
formulation/container that is actually distributed in the marketplace.
After reconsidering the available data, EPA believes that the proposed
standard of six 9's would be a ``technology-forcing standard,'' whereas
the final standard of four 9's accomplishes the goal stated in the
preamble of the proposed rule and mandated in FIFRA section 19(f)(1)(B)
to establish a standard that is equivalent to triple rinsing.
    EPA also considered the experiences and results of pesticide
container and recycling programs over the past decade. When the
regulations were proposed, the experiences and observations of some of
the earliest container collection and recycling programs were
available. This information led to the statement in the preamble of the
proposed rule that ``Pesticide container recycling programs and
municipal waste facilities report the frequent rejection of certain
pesticide formulation and container combinations because of
unacceptable pesticide residues.'' The data from some of the earliest
container collections are shown in Table 8.

                 Table 8.--Results from Early Pesticide Container Collection Programs (Ref. 43)
----------------------------------------------------------------------------------------------------------------
                                                     Number of Containers
                                              --------------------------------- Rejection
               State                   Year                           Brought      Rate          Reference
                                                Accepted   Rejected      In     (percent)
----------------------------------------------------------------------------------------------------------------
Florida (South Florida)                  1991      1,594        231      1,825       12.7  (Ref. 4)
----------------------------------------------------------------------------------------------------------------
Florida (Jackson County)                 1991        991        113      1,104       10.2  (Ref. 3)
----------------------------------------------------------------------------------------------------------------
Illinois                                 1993     57,086      3,451     60,537        5.7  (Ref. 2)
----------------------------------------------------------------------------------------------------------------
Iowa                                     1990     64,000         ND         ND         50  (Ref. 9)
----------------------------------------------------------------------------------------------------------------
Michigan                                 1992     18,959      2,990     21,949       13.6  (Ref. 12)
----------------------------------------------------------------------------------------------------------------
Minnesota                                1990      9,192      2,136     11,328       18.9  (Ref. 17)
----------------------------------------------------------------------------------------------------------------
Minnesota                                1991     56,928      4,646     61,574        7.5  (Ref. 17)
----------------------------------------------------------------------------------------------------------------

    However, more recent information provided by several States shows
that the container rejection rate decreases over time. This is
generally attributed to pesticide users becoming more aware of proper
rinsing procedures and the container cleanliness standards because of
outreach, training and education efforts. One example is the decrease
in the rejection rate experienced in Minnesota from 1990 (18.9 percent)
to 1991 (7.5 percent) despite a large increase in the number of
containers collected, as shown in Table 8. Out of the five Minnesota
counties that had programs both years and for which data are available
(Ref. 17), the rejection rate in four of them decreased substantially
in 1991 while one stayed constant:
     Isanti County: The rejection rate decreased from 20.9
percent in 1990 to 12.9 percent in 1991;
     Polk, Pennington and Red Lake Counties: 9.5 percent in
1990 to 2.3 percent in 1991;
     Pope County: 13.8 percent in 1990 to 14.1 percent in 1991;
     Stevens County: 25.0 percent in 1990 to 0.2 percent in
1991; and
     Swift County: 14.6 percent in 1990 to 2.7 percent in 1991.
(Ref. 17)
    A 1996 report from the Minnesota Department of Agriculture confirms
that this trend continued over time. (Ref. 13) From 1990 through 1995,
the container rejection rate in Minnesota ranged from 10 percent to 20
percent, with a high of 35 percent. The report stated that ``Pesticide
users had a difficult time rinsing containers to acceptable standards.
Timing of the rinse, poor equipment for rinsing and inadequate rinsing
techniques resulted in many containers not being accepted.'' The
rejection rate for 1996 ranged from 0 percent to 2 percent.
    Before 1995, a county in North Carolina collected about 2,500
containers per year and had a container rejection rate around 28
percent. After receiving a grant in 1995 which allowed the county to
expand the program to 12 convenient sites and to provide additional
training on proper rinsing, the county collected about 21,000
containers and the rejection rate dropped to 3 percent. (Ref. 10)
Nebraska and South Carolina report current rejection rates of 2 percent
on their web sites. Virginia reported a rejection rate of 0.5 percent
in 2002, which was higher than the 2000 rate but still deemed to be
acceptable. (Ref. 43)
    EPA believes this information shows that the main reason containers
are rejected from pesticide container collection programs is because
they were not rinsed properly. EPA agrees with the States that the
container rejection rates decreased substantially over time as
pesticide users improved their rinsing techniques, rinsed the
containers before residue dried, and gained understanding of the
cleanliness criteria used by the Ag Container Recycling Council (ACRC)
recycling contractors. The ACRC contractors have a strong incentive to
carefully inspect containers to ensure they are clean because
contamination increases the risk to the contractor's workers and
reduces the value of the collected plastic. Therefore, we think it is
accurate to conclude that the lower rejection rates in recent years are
not a reflection of relaxed or reduced inspection standards.
    EPA also believes that the container rejection rates from the
container collection and recycling programs show that containers do not
have to meet a standard of six 9's to be adequately cleaned. Table 7
shows that almost 60 percent of the agricultural formulations and
containers tested met a standard of six 9's. Assuming that the tested
formulations/containers are representative of the agricultural market,
we would expect to find a rejection rate of over 40 percent if a six
9's standard was necessary for adequate cleaning. Data from several
States show that currently a maximum of 2 percent of containers are
rejected, which is much lower than 40 percent. EPA interprets this to
indicate that meeting a standard of six 9's is not necessary to ensure
that a container is clean enough to be recycled safely.
    EPA disagrees with commenters who stated that the residue removal
standard should be based solely on toxicological significance, because
establishing and proving compliance with such a standard would be very
complex. In addition, any amount of residue in a container could cause
a disruption to its proper disposal or recycling because of the
perception of risk the concentration of active ingredient may not be
relevant in such a situation. However, toxicity and relative risk are
indirectly taken into account for the nonrefillable residue removal
standard in the final rule because of the changes in the scope of the
container regulations. The less toxic/risky pesticide products (those
in Toxicity Categories III and IV and that are not restricted use
pesticides) are subject only to the basic DOT standards, and are exempt
from some of the container requirements, including this one. Only
products that are in Toxicity Category I and II and others that are
restricted use products are subject to the residue removal standard in
the final rule.
    Setting the residue removal standard at four 9's in the final rule
will reduce the costs of implementing the regulations because a higher
percentage of existing container/formulations will comply with the
standard. Therefore, fewer container design changes, re-formulations,
and modification or

waiver requests will be needed. Reducing the stringency of the residue
removal standard does not reduce the testing costs. However, the
testing costs attributed to the final rule are reduced from those in
the proposal because fewer containers/formulations are subject to the
standard (due to the changes in the scope). In addition, changes in the
final test procedure (see Unit V.H.4.) and the final implementation
approach (discussed in Unit V.H.5.) of only requiring testing for
flowable concentrate formulations and if requested on a case-by-case
basis will greatly reduce testing costs.
    EPA believes that a 99.99 percent removal standard is consistent
with the results from triple rinsing current containers/formulations,
which we generally believe can be adequately cleaned if they are
properly rinsed.
    In summary, EPA believes that most containers/formulations can meet
a four 9's standard. However, we do believe that a standard is
necessary and appropriate for several reasons. First, the initial step
in ensuring clean containers is to use container designs and
formulations that facilitate residue removal. This is a responsibility
of the registrant and a standard ensures that the registrants
appropriately facilitate safe and proper residue removal. Second, the
rinsing data show that there is a difference in how easily residues can
be removed from containers, based on the formulation and container
characteristics, meaning that there is the potential for problems in
removing residues. Third, observations from State pesticide container
collection programs have noted a problem over time (i.e., not just when
collections were initiated) with certain pesticide formulations as
discussed in more detail in Unit V.H.5. Lastly, a four 9's standard
maintains the current level of rinsability and prevents the use of
formulations or containers that retain more residue or are harder to
rinse than currently used containers and formulations.
    3. Rinsing data--i. Comments. Some commenters specifically
addressed the triple rinsing data discussed in the preamble of the
proposed rule. A registrant group and a registrant questioned the
relevancy of some of the container cleaning data cited by EPA. These
respondents pointed out that some of the data were 6 to 10 years old,
and cited a widespread move to plastic jugs, making data on metal pails
obsolete.
    Several commenters expressed the following specific concerns about
the residue removal data that EPA cited to support the proposed six 9's
standard:
     A registrant group and a registrant commented that several
transcription errors were made in constructing Table 1 (triple rinsing
data for agricultural containers/formulations) in the preamble of the
proposed rule. One of the respondents added that these errors undermine
the credibility of the data and the arguments developed that use the
data as their basis.
     A registrant questioned whether the research data were
generated under GLPs.
     Two registrants questioned whether the data are truly
representative of containers/formulations that are subject to the
regulations.
     A registrant commented that data other than EPA's
(Formulogics), NACA's and CSMA's are not relevant because they are not
generated from the same test procedures.
    A registrant group and a few registrants expressed concerns that
the EPA data for non-agricultural pesticide markets (in Table 2 of the
preamble of the proposal) are not representative of the household,
industrial and institutional markets. All of these commenters pointed
out that the EPA data do not include tests on dilutable antimicrobial
products or similar formulations. In addition, the registrant group
stated that EPA (Formulogics) did not test formulations containing
active ingredient concentrations lower than 38 percent by weight. This
respondent also added that the data provided by CSMA cover a small but
representative number of nonagricultural container/formulation
combinations and that most of them (10 out of 12) would not meet the
six 9's standard.
    ii. EPA response. EPA agrees that residue removal data produced
using a rinsing procedure other than the one identified in the EPA
standard methodology are not relevant to supporting or changing a
regulatory standard. As stated in Unit V.H.2., four sets of data were
developed using a standard testing procedure (that is very similar to
the final test procedure) to test currently used formulations and
container designs. Two sets of data focused on containers and
formulations typical in the agricultural pesticide market and the other
two were intended to represent containers and formulations in the
household, institutional and industrial market. Even though the testing
to develop these four sets of data was done in the early 1990's, EPA
believes that the formulations and containers tested are still commonly
used.
    Table 7 presents the results of these studies in terms of the
standard that the container/formulation would meet based on the
concentration of active ingredient in the rinsate from the fourth
rinse. The following table presents the information in a somewhat
different format. In Table 9, each container/formulation combination is
included only once per row in the column for the most stringent
standard it would meet. For example, if the percent removal for a
container/formulation combination was 99.9992 percent, it would be
listed only in the five 9's column (even though it also meets a
standard of four 9's).

                                                       Table 9.--Analysis of Residue Removal Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Total Cntr/             Number of Container/Formulation Combinations That:\1\
                                                                    Form     ---------------------------------------------------------------------------
                          Study Name                            Combinations   Don't meet Four
                                                                   Tested            9's           Meet Four 9's      Meet Five 9's       Meet Six 9's
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formulogics (agricultural)                                               19              0 (0%)            2 (11%)            4 (21%)           13 (68%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NACA (triple rinse)                                                      24              0 (0%)            5 (21%)            7 (29%)           12 (50%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formulogics (nonagricultural)                                            29              0 (0%)            3 (10%)           10 (34%)           16 (55%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CSMA                                                                      7             1 (14%)            2 (29%)            3 (43%)            1 (14%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                             Total                                       79              1 (1%)           12 (15%)           24 (30%)           42 (53%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Same note as Table 7.

    Looking at the presentation of the results of the four studies in
Tables 7 and 9, it can be seen that a higher percentage of the
container/formulations tested by Formulogics for EPA meet a standard of
six 9's than the containers/formulations tested by the industry
associations. This is especially true for the tests of nonagricultural
products. However, there is no difference or minimal difference in the
results between EPA's data and industry's data in terms of whether the
containers/formulations meet a standard of four 9's. As described
earlier, only one container-formulation combination (which isn't
actually distributed in the marketplace) did not meet a four 9's
standard.
    EPA acknowledges that there were discrepancies between the data in
the Report to Congress and the data in Table 1 in the proposed rule's
preamble. These discrepancies were due to corrections made to the NACA
data reported to EPA; the earlier (and incorrect) data were presented
in the Report to Congress and the more recent, correct data (which
should have been cited) were included in the preamble for the proposal.
Reference 42 explains these discrepancies in more detail. Tables 7 and
9 present the correct data.
    EPA acknowledges that the sample size of 79 container/formulation
combinations is relatively small, but we believe that the formulation
types and container designs tested to produce the data in Tables 7 and
9 are representative of the formulations and containers that are
currently used. Some formulations (such as dilutable sanitizers and
disinfectants) may be under-represented numerically, since only the
CSMA testing included these kinds of formulations. However, the CSMA
tests done on the dilutable sanitizers and disinfectants show that
these kinds of products can attain a standard of four 9's. Also, only a
limited number of antimicrobial products will be subject to the
container regulations (and therefore the residue removal standard)
based on the revised scope of the final rule. Therefore, the proportion
of antimicrobial product formulation types that were tested may be
similar to the proportion that are subject to the residue removal
standard in the final regulation.
    The supporting data were not generated according to GLPs.
Additionally, the supporting studies were conducted on one, two or
three containers per formulation; not 19 containers. As described in
Unit V.H.4., the methodology in the final rule was changed to be
consistent with the supporting data.
    4. Final test protocol. Many respondents commented on the proposed
testing methodology and particularly its relationship to the protocol
developed for EPA by Formulogics prior to proposing the rule. Most of
these comments are addressed in the Response to Comment document,
although the comments regarding GLP standards and the number of
containers tested are summarized below.
    i. Comments - GLP standards. Many commenters (registrants,
registrant groups, and a consultant) objected to the GLP testing
requirement as unnecessarily burdensome, substantially increasing the
cost of testing without increasing the validity of the data. However,
one respondent (a consultant) commented that all studies should be done
under GLPs in some form to ensure data quality. A registrant group and
a registrant suggested that it would be sufficient to require a company
official to certify the data. Several registrants commented that GLP
testing would force them to have outside labs conduct the testing and
claimed that this would dramatically increase the costs. One registrant
said that many container testing labs are not familiar with EPA's GLP
regulations. Another stated that because labs cannot dispose of rinsate
properly, they will send it back to the registrants, increasing costs
and waste generation. A registrant group and a registrant pointed out
that the data used to develop EPA's proposal were not generated under
GLP and asked that the GLP requirement be dropped from the final rule.
    ii. EPA response - GLP standards. EPA changed the test protocol for
the final rule in several ways to address some of the problems
described by commenters. First, the final rule does not specify that
the testing must be conducted in compliance with the full set of GLP
standards in 40 CFR part 160. While registrants may comply with the GLP
standards, it is not required. EPA believes that the container residue
removal testing can adequately be accomplished by registrants at their
facilities; the intent was not to have this testing contracted to
outside labs, although a registrant may choose that option.
    While EPA does not believe that compliance with the full GLP
standards in 40 CFR part 160 is necessary, we think that it is
necessary to incorporate some of the key GLP requirements to ensure
that the data are of sufficient quality. EPA reviewed the part 160
regulations and particularly the subset of requirements specified in 40
CFR 160.135 for certain studies to determine physical and chemical
characteristics of pesticides. Of the subset of requirements identified
in 160.135, we identified some requirements that residue removal
testing must meet. These GLP requirements are identified in the final
test protocol. (Ref. 20)
    iii. Comments - number of containers. All of the many (nearly 20)
commenters (registrants, registrant groups and a container manufacturer
group) who addressed this issue were opposed to testing 19 containers
per formulation/container combination. Many registrants and a
registrant group urged EPA to require testing of only three replicates
of each container/formulation combination, rather than the proposed 19.
A registrant group and a few registrants suggested starting with three
and testing more if necessary to achieve a predetermined level of
statistical significance. Commenters said testing of 19 containers is
not statistically justified, not cost effective, and not necessary for
achieving the data requirements. Some of these commenters pointed out
that EPA used only three containers to generate the preamble data and
asked why the same standard is not sufficient for registrants.
    iv. EPA response - number of containers. EPA changed the test
protocol for the final rule to specify that the test must be conducted
on a minimum of three containers, rather than the proposed approach of
a minimum of 19 containers. The main reason for changing the number of
containers that must be tested is that the testing conducted to produce
the data supporting the residue removal standard was conducted on three
containers. The supporting data was not conducted on 19 containers, so
it is unclear whether the available data could support a standard based
on testing 19 containers. Upon re-evaluation, EPA agrees that the test
procedure used to produce the supporting data and the test procedure
for the regulatory standard should be very similar if not identical. In
addition, EPA believes that testing three containers offers cost
reduction benefits including less time to actually conduct the testing
with one-sixth the number of containers to be rinsed, one-sixth the
number of analyses that need to be conducted, and one-sixth the amount
of rinsate that needs to be managed or disposed. The final rule
approach of testing three containers is similar to the standards for
complying with DOT's drop tests and other performance tests.
    5. Implementation--i. Comments. In the preamble of the proposed
rule, EPA requested comments on the circumstances under which
submission of residue removal data from pesticide products with
substantially similar

container/formulation characteristics would be sufficient in lieu of
data generation for every pesticide product. EPA also requested
comments on the factors to be considered in determining when container
and formulation characteristics should be considered ``substantially
similar'' for the purposes of this requirement. The following comments
address these issues:
     Too many tests required: Some respondents, including
registrants, registrant groups, and a container manufacturer group,
expressed concern that the proposed residue removal standard and the
interpretation of design type as expressed in the proposed rule would
necessitate testing for virtually every container/formulation
combination in every size and variation. They said the costs to
registrants would be crippling and asked EPA to consider alternatives.
     Design type clarification: Several commenters asked for
clarification of EPA's criteria for determining whether containers are
the same or different. They urged a broad definition of design type to
reduce the testing burden.
     Formulation similarities: Several commenters suggested
ways to eliminate duplicative testing on the basis of formulation, such
as granting waivers to products that meet certain physical property
criteria or to formulations similar to ones that have already passed.
     Industry task force: Some agricultural registrants and a
registrant group voiced support for a plan to establish an industry
task force that would conduct studies to determine the physical
properties of formulations and containers that meet the four 9's
standard. Combinations matching those criteria would be exempted from
testing; necessary testing would be limited to broad categories of
product/container combinations developed by the studies.
    ii. EPA response. Many of the changes in the residue removal
standard discussed in the previous sections reduce the cost of
complying with this standard, including:
     Changing the scope of the nonrefillable container
regulations so only dilutable products in Toxicity Category I or II or
that are restricted use products have to comply with the residue
removal standard;
     Reducing the standard from 99.9999 percent to 99.99
percent removal; and
     Changing the testing protocol.
    Despite these changes, the estimated costs of complying with the
residue removal standard were still a fairly large percentage of the
overall annual costs and costs per facility. Rather than trying to
minimize the burden to registrants by trying to identify and define
substantially similar containers and formulations, EPA believes it is
better to require testing only for formulations and containers that
have shown to be difficult to clean. As stated earlier, EPA believes
the data show that most containers/formulations can meet a four 9's
standard although practical experience with container recycling
programs shows that there are problems with certain formulations.
Because a universal approach (testing all products subject to the
regulations) to identify the exceptions (the problematic formulations)
is inefficient, EPA believes there is a more efficient yet effective
way to implement the residue removal standard in the final regulations.
    In particular, the final rule takes the following approach:
     All dilutable liquid products in rigid containers must be
capable of meeting the 99.99 percent removal standard. This sets a
minimum standard for all products.
     On the basis of the Formulogics and NACA data, EPA is
making the assumption that nearly all products meet a standard of 99.99
percent removal, and therefore is requiring testing only in limited
circumstances. In particular, registrants only have to conduct the
residue removal testing if the products are flowable concentrate
formulations or if EPA requests the test data on a case-by-case basis.
     Accordingly, the recordkeeping standards in Sec.
165.27(b)(5) were changed so recordkeeping of test results is only
required for flowable concentrate formulations or if EPA specifically
requests the records on a case-by-case basis.
    EPA chose to require testing of flowable concentrate formulations
for several reasons. First, the results of the four studies in Table 7
show that there is a difference in rinsing efficiency between the
formulation types that were tested, specifically flowable concentrates,
emulsifiable concentrates, aqueous solutions, and encapsulated
formulations. Tables 10, 11, and 12 show the data from the studies in
Table 7 with the residue removal performance broken down by formulation
type. The results - particularly for the studies with the most testing
- show that flowable concentrate formulations had the biggest
difference between meeting four 9's and five 9's, which suggests that
these kinds of products may generally be a little more difficult to
remove from containers due to characteristics of the formulation type
in general. The emulsifiable concentrates tested generally reached a
five 9's level of residue removal but showed a similar difficulty as
flowable concentrates in reaching the six 9's level of residue removal
in the Formulogics study of agricultural formulations and containers.
While not completely conclusive, EPA believes these data support the
observation that flowable concentrates may generally be more difficult
to remove from containers than other kinds of formulations.

   Table 10.--Analysis of Residue Removal Data by Formulation Type - Agricultural Formulations and Containers
                                              (Formulogics & NACA)
----------------------------------------------------------------------------------------------------------------
                                       Total Cntr/Form         Number of Containers/Formulations That Meet:
             Formulation                 Combinations   --------------------------------------------------------
                                            Tested            Four 9's           Five 9's           Six 9's
----------------------------------------------------------------------------------------------------------------
Flowable concentrate                                 15                 15                 11                 10
----------------------------------------------------------------------------------------------------------------
Emulsifiable concentrate                             20                 20                 18                 12
----------------------------------------------------------------------------------------------------------------
Encapsulated                                          4                  4                  3                  1
----------------------------------------------------------------------------------------------------------------
Aqueous Solution                                      3                  3                  3                  1
----------------------------------------------------------------------------------------------------------------
Dry Flowable                                          1                  1                  1                  1
----------------------------------------------------------------------------------------------------------------
                Total                                43                 43                 36                 25
----------------------------------------------------------------------------------------------------------------

    Table 11.--Analysis of Residue Removal Data by Formulation Type--Household, Industrial and Institutional
                                            Containers (Formulogics)
----------------------------------------------------------------------------------------------------------------
                                       Total Cntr/Form         Number of Containers/Formulations That Meet:
             Formulation                 Combinations   --------------------------------------------------------
                                            Tested            Four 9's           Five 9's           Six 9's
----------------------------------------------------------------------------------------------------------------
Flowable concentrate                                 10                 10                  7                  1
----------------------------------------------------------------------------------------------------------------
Emulsifiable concentrate                              9                  9                  9                  8
----------------------------------------------------------------------------------------------------------------
Encapsulated                                         10                 10                 10                  7
----------------------------------------------------------------------------------------------------------------
                Total                                29                 29                 26                 16
----------------------------------------------------------------------------------------------------------------

          Table 12.--Analysis of Residue Removal Data by Formulation Type--Household Containers (CSMA)
----------------------------------------------------------------------------------------------------------------
                                       Total Cntr/Form         Number of Containers/Formulations That Meet:
             Formulation                 Combinations   --------------------------------------------------------
                                            Tested            Four 9's           Five 9's           Six 9's
----------------------------------------------------------------------------------------------------------------
Flowable concentrate\1\                               1                  1                  1                  0
----------------------------------------------------------------------------------------------------------------
Emulsifiable concentrate\1 2\                         2                  1                  0                  0
----------------------------------------------------------------------------------------------------------------
Aqueous solution\1\                                   4                  4                  3                  1
----------------------------------------------------------------------------------------------------------------
                Total                                 7                  6                  4                  1
----------------------------------------------------------------------------------------------------------------
\1\ Based on the description of the formulations, we assumed that the CSMA data included one flowable
  concentrate, two emulsifiable concentrates and four aqueous solutions.
\2\ The container/formulation that did not meet four 9's was an agricultural emulsifiable concentrate in a small
  (16 ounce) container.

    Second, the Minnesota Department of Agriculture (DOA) developed a
report that summarized the observations of inspectors and the
experiences of pesticide users regarding rinsing containers that held
pesticide products formulated as flowable concentrates. (Ref. 18) These
containers tended to be rejected at a higher rate than other types of
formulations. The Minnesota DOA observed that about 60 percent of the
containers of one specific flowable concentrate formulation contained
pesticide residue, even when the overall container rejection rate at
the collection site was less than 1 percent. To make the containers
holding the studied formulation come clean, users had to take extra
measures beyond triple rinsing, such as power rinsing for a long time,
using hot water, cutting the containers open to allow access to hard-
to-reach areas, soaking the containers, using soap or another material
and conducting extra rinses. While we do not have laboratory triple
rinsing data on this product to confirm whether or not it meets a 99.99
percent standard, the description in Minnesota's report clearly
documents a problem with cleaning the containers used for this product,
which was a flowable concentrate. The Minnesota DOA report mentioned
several other products that it also categorizes as more difficult to
rinse.
    Third, recent conversations with people active in pesticide
container recycling confirmed commenters' assertions that the main
reasons for unclean containers at recycling programs are lack of effort
by the end users when rinsing containers and because of pesticide
product drying along the inside of the container if the material in the
container is not used all at once. (Ref. 26) Neither of these problems
would be addressed by the residue removal standard. Based on their
observations, these people believe that any container with any
formulation type can be adequately cleaned if the container is emptied
completely at one time (all contents are used initially), if the end
user rinses the container promptly after emptying it and if the end
user rinses it properly (either pressure or triple rinsing). On the
other hand, these people also commented that specific products may need
a little extra effort into rinsing (more time in a pressure rinse or an
extra rinse after the triple rinse procedure) to completely clean the
container.
    Based on this information, EPA believes the final regulations
should be implemented in a way that minimizes the required testing
because the laboratory data and field observations do not support a
widespread problem with residue removal that could be solved by the
residue removal standard. Therefore, EPA decided to only require
residue removal testing for flowable concentrates, which showed the
most difficulty in being removed in the laboratory testing. EPA
believes that the field observations indicated that specific products -
in any formulation type - may be more difficult to remove by rinsing
than other products. Therefore, the final regulations also provide EPA
the option to require residue removal testing (and keeping records of
it) on a case-by-case basis. EPA anticipates using this option if we
receive credible information about a wide-spread problem with a
specific container/formulation combination being difficult to clean.

I. Waiver and Modification Criteria (Sec.  165.25(g))

    1. Final regulations. Section 165.25(g) of the final rule explains
that registrants may request waivers from or modifications to the
nonrefillable container standards. This section sets out the criteria
that must be met for EPA to approve a waiver/modification request. The
criteria are different for each of the nonrefillable container
requirements, as described below.
     Sec.  165.25(a): DOT standards for pesticide products that
are not DOT hazardous materials. EPA may waive or modify the
requirements of Sec.  165.25(a) if EPA determines that an alternative
(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in
the requirements of Sec.  165.25(a).
     Sec.  165.25(b): DOT standards for pesticide products that
are DOT

hazardous materials. EPA may waive or modify the requirements of Sec.
165.25(b) if EPA determines that an alternative (partial or modified)
set of standards or pre-existing requirements achieves a level of
safety that is at least equal to that specified in the requirements of
Sec.  165.25(b). EPA will modify or waive the requirements of Sec.
165.25(b) only after consulting with DOT to ensure consistency with DOT
regulations and exemptions.
     Sec.  165.25(d): Container closures. EPA may approve a
non-standard closure (that is, a closure not listed in Sec.  165.25(d))
if EPA determines that both of the following conditions are satisfied:
    (1) The non-standard closure is necessary for the proper mixing,
loading, or application of the pesticide product.
    (2) The non-standard closure offers exposure protection to handlers
during mixing and loading that is the same or greater than that