[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Rules and Regulations]
[Page 47329-47437]
[DOCID:fr16au06-25]

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Part II

Environmental Protection Agency

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40 CFR Parts 9, 156 and 165

Pesticide Management and Disposal; Standards for Pesticide Containers
and Containment; Final Rule

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 156 and 165

[EPA-HQ-OPP-2005-0327; FRL-8076-2]
RIN 2070-AB95

Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: With this final rule, EPA is establishing regulations for the
safe storage and disposal of pesticides as a means of protecting human
health and the environment pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act. This final rule establishes
requirements for pesticide container design, and procedures, standards
and label language to facilitate removal of pesticides from containers
prior to disposal or recycling. This final rule also establishes
requirements for containment of stationary pesticide containers and
procedures for container refilling operations. In addition, in order to
display the OMB control number for the information collection
requirements contained in this final rule, EPA is amending the table of
OMB approval numbers for EPA regulations that appears in 40 CFR part 9.

DATES: This final rule is effective on October 16, 2006. For purposes
of judicial review, this rule shall be promulgated at 1pm eastern
daylight/standard time on August 30, 2006 (See 40 CFR 23.6).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0327. Please note that the
docket material for the proposed rule and supplemental notice,
identified previously by docket ID number OPP-190001, is included as
part of the official docket for this action, although the material in
the legacy docket is available only in hard copy. All documents in the
docket are listed on the regulations.gov web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov
, or if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.
The hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nancy Fitz, Field and External Affairs
Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a
pesticide formulator, agrichemical dealer, or an independent commercial
applicator. Potentially affected categories and entities may include,
but are not limited to:
     Pesticide formulators (NAICS 35232, former SIC code 2879),
e.g., establishments that formulate and prepare insecticides,
fungicides, herbicides or other pesticides from technical chemicals or
concentrates produced by pesticide manufacturing establishments. Some
formulating establishments are owned by the large basic pesticide
producers and others are independent.
     Agrichemical dealers (NAICS 44422, former SIC code 5191),
e.g., retail dealers that distribute or sell pesticides to agricultural
users.
     Independent commercial applicators (NAICS 115112, former
SIC code 0721), e.g., businesses that apply pesticides for compensation
(by aerial and/or ground application) and that are not affiliated with
agrichemical dealers.
     Custom blenders (NAICS 44422, former SIC code 5191), e.g.,
most custom blenders are also dealers.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Units II.D., III.,
V.B., VI.C., VII.B., VIII.C. and IX.A. of this document. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov,

you may access this Federal Register document electronically through
the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr/.
 You may also access a frequently updated

electronic version of the Code of Federal Regulations (CFR) through the
Government Printing Offices pilot e-CFR site at http://www.gpoaccess.gov/ecfr/
.

II. Background

A. Statutory Authority

    These final regulations are issued pursuant to the authority given
the Administrator of EPA in sections 3, 8, 19 and 25 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a,
136f, 136q and 136w.
    Sections 19(e) and (f) of FIFRA grant EPA broad authority to
establish standards and procedures to assure the safe use, reuse,
storage, and disposal of pesticide containers. FIFRA section 19(e)
requires EPA to promulgate regulations for the design of pesticide
containers that will promote the safe storage and disposal of
pesticides. The regulations must ensure, to the fullest extent
practicable, that the containers:
    (1) Accommodate procedures used for removal of pesticides from the
containers and rinsing of the containers.
    (2) Facilitate safe use of the containers, including elimination of
splash and leakage.
    (3) Facilitate safe disposal of the containers.
    (4) Facilitate safe refill and reuse of the containers.
    FIFRA section 19(f) requires EPA to promulgate regulations
prescribing procedures and standards for the removal of pesticides from
containers prior to disposal. The statute states that the regulations
may:
    (1) Specify, for each major type of pesticide container, procedures
and standards for, at a minimum, triple rinsing or the equivalent
degree of pesticide removal.
    (2) Specify procedures that can be implemented promptly and easily
in various circumstances and conditions.

    (3) Provide for reuse, whenever practicable, or disposal of rinse
water and residue.
    (4) Be coordinated with requirements imposed under the Resource
Conservation and Recovery Act (RCRA) for rinsing containers.
    Section 19(f) provides that the EPA, at the discretion of the
Administrator, may exempt products intended solely for household use.
    Section 19(f)(2) states that after December 24, 1993, a State may
not exercise primary enforcement responsibility under section 26, or
certify an applicator under section 11, unless the Administrator
determines that the State is carrying out an adequate program to ensure
compliance with regulations promulgated under the authority of section
19(f)(1).
    Section 19(h), titled Relationship to Solid Waste Disposal Act,
specifies that nothing in section 19 shall diminish the authorities or
requirements of RCRA. Also, the Food Quality Protection Act (FQPA) of
1996 amended section 19(h) of FIFRA to add an exemption for certain
antimicrobial pesticides.

B. Regulatory Background

    Prior to 1995, recommendations regarding procedures for storage and
disposal of pesticides and pesticide containers were listed under 40
CFR part 165. On June 19, 1995, as part of the Federal government's
initiative to streamline regulations, part 165 was deleted as
unnecessary (60 FR 32094) because it contained recommendations rather
than requirements. (Ref. 62) Subpart A of part 165 covered the scope
and definitions in the recommendations. Subpart B dealt with EPA's
disposal of suspended and canceled pesticides, and EPA has completed
disposal of all pesticides for which it was responsible under those
regulations. Subparts C and D contained recommended procedures for
storage and disposal of pesticide containers. Subparts A, B, C, and D
were superseded by the passage of the Resource Conservation and
Recovery Act in 1976. FIFRA section 19, as revised in 1988 and 1996,
contains authority for EPA in the area of pesticide storage and
disposal, and the container and containment regulations promulgated
today are being inserted into a newly established part 165.
    In a Notice of Proposed Rulemaking (NPRM) issued on February 11,
1994 (59 FR 6712), EPA proposed standards for pesticide containers and
containment structures. (Ref. 66) This proposal included requirements
for nonrefillable and refillable containers that would ensure the safe
use and disposal of the containers. The proposal also included
standards for containment structures, which would promote safe storage
by facilitating the safe use, refill, and reuse of refillable
containers. Additionally, the proposed rule contained amendments to the
labeling regulations in 40 CFR part 156 to ensure adequate levels of
residue removal from containers.
    The public comment period for the NPRM closed on July 11, 1994. EPA
received about 1,900 pages of comments from more than 200 commenters,
including many trade associations and individual companies from the
pesticide manufacturing, pesticide retail, and container manufacturing
industries as well as many State regulatory agencies.
    EPA received numerous comments on a few particular issues;
specifically the scope of the container standards and the relationship
between the 1994 proposed rule and the U.S. Department of
Transportation (DOT) standards for hazardous materials packaging. A
third issue arose from the 1996 passage of the FQPA, which amended
section 19(h) of FIFRA to add an exemption for certain antimicrobial
pesticides. To solicit comment on EPA's interpretation of the new
statutory language on exempting antimicrobial pesticides and to reopen
comment on the scope of the container regulations and an approach for
incorporating DOT's standards, EPA published a supplemental notice in
the Federal Register on October 21, 1999 (64 FR 56918). (Ref. 53) The
supplemental notice also provided an alternative definition of small
business for certain sectors of the pesticide industry for use in
analyzing the potential impacts to small businesses that were presented
as part of the economic analysis.
    The public comment period for the supplemental notice closed on
March 20, 2000. EPA received comments from about 70 respondents,
including many trade associations and individual companies from the
pesticide manufacturing, pesticide retail, and container manufacturing
industries as well as many State regulatory agencies.
    On June 30, 2004 (69 FR 39392), EPA reopened the public comment
period for this rulemaking for 45 days because significant time had
passed since the proposed rule in 1994 and supplemental notice in 1999.
(Ref. 33) The purpose of the reopening was to solicit public input on
any policies, market practices, technology or other issues relating to
this rule's requirements which would not have been available or could
not have been addressed at the time of either the proposal or
supplemental notice. On August 13, 2004 (69 FR 50114), the comment
period was extended for 30 days. (Ref. 32) The public comment period
closed on September 15, 2004. EPA received about 50 comments, mainly
from individual entities or trade associations representing pesticide
manufacturers, agricultural pesticide retailers and State regulatory
agencies.
    On December 17, 1993 (58 FR 65989), EPA published an interim
determination of adequacy for States with primary enforcement
responsibility and/or certification programs because EPA had not
promulgated regulations under section 19(f)(1) by December 24, 1993.
(Ref. 69) To avoid having the provisions of section 19(f)(2) adversely
impact the States and EPA, the Agency published a policy in the Federal
Register on August 18, 1993 (58 FR 43994), which set forth a process
for EPA to make such an interim determination. (Ref. 68) EPA's interim
determination of adequacy was based on an initial commitment by a State
to conduct a number of activities which will position the State to have
an adequate program in place by the time compliance with the
regulations promulgated under section 19(f)(1) is required. The
December 17 notice stated that the determination of adequacy is
temporary and will expire 2 years after promulgation of a final rule
issued under section 19(f)(1). Thereafter, States must have a program
to ensure compliance with the section 19(f) regulations. Related
Federal Register notices were published on February 25, 1994 (59 FR
9214) regarding New Mexico and May 10, 1995 (60 FR 24855) regarding the
Virgin Islands. (Refs. 60 and 67) The criteria and process for
evaluating State programs to ensure that they have adequate compliance
programs for regulations promulgated under section 19(f) will be
published in a separate Federal Register notice.

C. Additional Container Issues Under Consideration for Potential
Regulation

    Since the 2004 public comment period closed, EPA has gathered
information from a variety of sources about the status and robustness
of existing pesticide container recycling programs. Over the past
decade, the Ag Container Recycling Council (ACRC) has demonstrated that
pesticide containers can be safely and efficiently recycled, and their
success in recycling more than 80 million pounds of plastic since 1992
is commendable. However, the current voluntary container recycling
system is showing signs of instability and non-sustainability, largely
because it is financially

supported by only a portion of the pesticide industry.
    EPA has an interest in promoting recycling to minimize the use of
less environmentally-sound methods of disposing of these containers,
such as by landfill or burning, and to reduce the amount of solid waste
produced annually. After considering and evaluating a number of
alternatives to sustain and increase the current level of container
recycling, EPA has initiated development of proposed regulations for
the recycling of plastic pesticide containers to ensure equitable,
safe, effective and robust implementation of recycling programs. We are
exploring a range of regulatory options for requiring participation in
pesticide recycling programs and we will work with stakeholders to
evaluate and pursue the most efficacious of these approaches.

D. Summary of the Final Rule

    The Container and Containment Rule is composed of the following
five specific sets of requirements or standards:
     Nonrefillable containers (container design and residue
removal);
     Refillable containers (container design and residue
removal);
     Repackaging pesticide products;
     Containment structures; and
     Container labeling.
    Table 1 provides a brief overview of each portion of today's final
rule. For each section of the regulations, the table identifies the
types of businesses that must comply, the major requirements and the
compliance date. The regulations, along with a summary of comments on
major issues and comments that led to changes to the final regulations
and EPA's responses, are discussed in later units of this preamble. EPA
has also prepared a Response to Comment document that provides
additional details with regard to the comments and EPA's responses
(Ref. 19).
    Each portion of the regulations applies to a different subset of
pesticide products. The criteria that define which pesticide products
are subject to which regulations (and which ones are exempt from them)
are relatively complex, but some key points are:
     The new label standards apply to all pesticide products.
     The containment regulations apply to agricultural
pesticides only.
     The nonrefillable container, refillable container and
repackaging regulations apply to the same subset of pesticide products.
These products are described in Table 2 below.
     For the refillable container and repackaging regulations,
antimicrobial products that are used only in swimming pools (and
closely related sites like hot tubs, spas and/or whirl pools) are
subject to a reduced set of the requirements.
     For the nonrefillable container regulations, some products
are subject to all of the regulations, while others must comply only
with the basic Department of Transportation packaging requirements in
49 CFR 173.24.

                                   Table 1.--Overview of the Pesticide Container and Containment Structure Regulations
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                                          Nonrefillable                              Repackaging Pesticide                              Containment
              Category                     Containers         Refillable Containers         Products          Container Labeling         Structures
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Who must comply                       Registrants             Registrants             Registrants           Registrants            Ag retailers
                                                             Refillers (retailers,   Refillers (retailers,  Pesticide users (must  Ag commercial
                                                              distributors).          distributors).         follow new             applicators
                                                                                directions).          Ag custom blenders
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Major Requirements                   DOT container design,   DOT container design,    Registrants develop    Identify container    Secondary containment
                                      construction and        construction and        information            as nonrefillable or    structures (dikes)
                                      marking standards       marking standards      Registrants and         refillable (all)       around stationary
                                     Container dispensing    Serial number marking.   others comply with    Statements to           tanks
                                      capability.            One-way valves or        specified conditions.  prohibit reuse and    Containment pads for
                                     Standardized closures.   tamper-evident         Refillers               offer for recycling;   pesticide dispensing
                                     Residue removal.......   devices.                (registrants and       batch code (all        areas
                                     Recordkeeping.........  Stationary container     others) obtain and     nonrefillables).      Good operating
                                                              requirements.           follow registrant     Cleaning instructions   procedures
                                                                                information, and       (some                 Monthly inspections
                                                                                clean, inspect and     nonrefillables).       of tanks and
                                                                                label containers      Cleaning instructions   structures
                                                                                before refilling       before final          Recordkeeping
                                                                                them.                  disposal (all         Provisions for States
                                                                                refillables).          with existing
                                                                                programs
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Compliance Date                      August 17, 2009         August 16, 2011         August 16, 2011        August 17, 2009        August 17, 2009
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    Table 2.--Products that are Subject to the Nonrefillable Container, Refillable Container and Repackaging
                                                   Regulations
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                                            Nonrefillable                                 Repackaging Pesticide
               Category                       Containers         Refillable Containers           Products
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Products that are not subject to the   (1) Manufacturing use    (1) Manufacturing use    (1) Manufacturing use
 regulations.                           products,                products,                products,
                                       (2) Plant-incorporated   (2) Plant-incorporated   (2) Plant-incorporated
                                        protectants, and.        protectants, and.        protectants, and
                                       (3) Antimicrobial        (3) Antimicrobial        (3) Antimicrobial
                                        pesticide products       pesticide products       pesticide products
                                        that satisfy all four    that satisfy all four    that satisfy all four
                                        of these criteria:.      of the criteria listed   of the criteria listed
                                       The product is an         in the nonrefillable     in the nonrefillable
                                        antimicrobial            container column..       container column.
                                        pesticide (as defined
                                        in FIFRA section
                                        2(mm)) or it has
                                        antimicrobial
                                        properties (as defined
                                        in FIFRA section
                                        2(mm)(1)(A)) and is
                                        subject to a tolerance
                                        or a food additive
                                        regulation..
                                       Its label includes
                                        directions for use on
                                        a site in at least one
                                        of the 10
                                        antimicrobial product
                                        use categories
                                        identified as
                                        household, industrial
                                        or institutional..
                                       It is not a hazardous
                                        waste when it is
                                        intended to be
                                        disposed, as defined
                                        in 40 CFR part 261..
                                       EPA has not
                                        specifically found
                                        that the product must
                                        be subject to these
                                        provisions to prevent
                                        an unreasonable
                                        adverse effect on the
                                        environment..
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Products that are subject to the       A product is subject to  All products not listed  All products not listed
 regulations                            ALL nonrefillable        above.                   above.
                                        container requirements
                                        if it satisfies at
                                        least one of the
                                        following criteria:
                                       It meets the criteria
                                        of Toxicity Category I
                                        in 40 CFR 156.62..
                                       It meets the criteria
                                        of Toxicity Category
                                        II in 40 CFR 156.62..
                                       It is a restricted use
                                        product..
                                      -------------------------
                                       If a product does not                             .......................
                                        meet any of these
                                        criteria, the product
                                        is subject to only the
                                        basic Department of
                                        Transportation
                                        requirements in the
                                        nonrefillable
                                        container regulations.
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E. Summary of the Major Changes Since Proposal

    1. Plain language format. Many of the comments on the proposed rule
and the supplemental notice made clear that the scope of parties and
products subject to the rule was complex and potentially confusing. We
have rewritten the Container and Containment rule in a plain language
format to make it clearer and easier to use. A plain language format
includes maximum use of the active voice; short, clear sentences;
questions and answers; use of ``you'' to identify the person who must
comply; use of ``we'' to identify EPA; and ``must'' rather than
``shall.'' This new format, which minimizes the layers of
subparagraphs, should also allow the reader to easily locate specific
provisions of the regulation. While we have made substantive changes in
some provisions, the plain language changes are only editorial. The
legal implications of plain English regulations are the same as
traditional regulatory text. The word ``must'' indicates a requirement.
Words like ``should,'' ``could,'' or ``encourage'' indicate a
recommendation or guidance.
    In this preamble, as in the rule text, we often use the pronoun
``he'' as a generic term. ``He'' does not necessarily mean a man; it
may be a woman, or in some cases, a business organization when
referring to an owner or operator.
    The plain language approach also leads to more separate sections
than traditional regulatory language.

 Therefore, we had to reorganize and renumber the regulations to
accommodate the increased number of separate sections. The changes are
shown in Table 3.
    Some sections of today's regulation are presented in the
traditional language or format because these sections are amending or
changing existing regulations. The plain language format was not used
in these existing provisions in an attempt to avoid any possible
confusion or disruption in the flow of the regulations.

                      Table 3.--Comparison of Proposed Rule and Final Rule Section Numbers
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                    Format in Proposed Rule                                   Format in Final Rule
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               Subpart                     Section Numbers              Subpart              Section Numbers
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                                                    Part 156
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Subpart H: Container Labeling          Sec.  Sec.   156.140 -   Subpart H: Container     Sec.  Sec.   156.140 -
                                        156.144                  Labeling                 156.159
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                                                    Part 165
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Subpart A: General                     Sec.  Sec.   165.1 -     Subpart A: General       Sec.  Sec.   165.1 -
                                        165.16                                            165.3
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Subpart B                              Reserved                 Subpart B:               Sec.  Sec.   165.20 -
                                                                 Nonrefillable            165.27
                                                                 Containers
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Subpart C                              Reserved                 Subpart C: Refillable    Sec.  Sec.   165.40 -
                                                                 Containers.              165.47
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Subpart D                              Reserved                 Subpart D: Repackaging.  Sec.  Sec.   165.60 -
                                                                                165.70
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Subpart E                              Reserved                 Subpart E: Containment   Sec.  Sec.   165.80 -
                                                                 Structures.              165.97
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Subpart F: Nonrefillable Containers    Sec.  Sec.   165.100 -   Subpart F                Reserved
                                        165.119
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Subpart G: Refillable Containers       Sec.  Sec.   165.120 -   Subpart G..............  Reserved
                                        165.139
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Subpart H: Containment Structures      Sec.  Sec.   165.140 -   Subpart H..............  Reserved
                                        165.157
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    2. Reorganization of the rule. In the final rule, we split the
refillable container standards and the repackaging standards into two
separate subparts to reinforce and clarify the differences between
these requirements. The refillable container regulations are mostly
technical and apply mostly to pesticide registrants. On the other hand,
the repackaging requirements are mostly procedural and apply to
registrants and refillers (who could be registrants, distributors or
retailers). EPA believes that separating these regulations into
different subparts will better illustrate the differences and make it
easier for the regulated parties to understand.
    3. Scope of products subject to container-related regulations. In
the February 1994 NPRM, EPA proposed that the container standards would
generally apply to all pesticides and all containers except for
manufacturing use products (MUPs). The 1999 supplemental notice
proposed several options for exempting specific subsets of products
from the container standards. Today's final rule exempts MUPs, plant-
incorporated protectants and certain antimicrobial products from the
nonrefillable container, refillable container and repackaging
regulations. All other products are subject to the container-related
regulations, although the number of applicable standards is greatly
reduced for some products. These changes apply only to the container-
related sections of the rule. As we proposed, all pesticide products
are subject to the container labeling requirements in today's final
rule and only agricultural pesticide products are subject to the
containment requirements.
    4. Exemption from container-related regulations for certain
antimicrobial products. The FQPA amended section 19 of FIFRA to exempt
certain types of antimicrobial pesticides from the pesticide container
provisions. The amendment exempted household, industrial, or
institutional antimicrobial products which are not subject to the Solid
Waste Disposal Act (SWDA) from the container regulations unless the EPA
Administrator determines that the product causes an unreasonable
adverse effect on the environment. Because the definition of an
antimicrobial product is complex, the phrase ``subject to the SWDA'' is
unclear and ``unreasonable adverse effects on the environment'' from
pesticide containers need to be clarified, EPA conducted many analyses
based on the comments received. According to today's final rule, an
antimicrobial product is exempt from the container standards if meets
all four of the following criteria:
     The product is an antimicrobial pesticide as defined in
FIFRA section 2(mm) or it has antimicrobial properties (as defined in
FIFRA section 2(mm)(1)(A)) and is subject to a tolerance or a food
additive regulation.
     The product includes directions for use on a site in one
of the antimicrobial product use categories identified as household,
industrial or institutional.
     The product is not a hazardous waste when it is intended
to be disposed.
     EPA has not specifically determined that the product must
be subject to the container regulations to prevent an unreasonable
adverse effect on the environment.
In addition, antimicrobial products that would not otherwise be exempt
from the regulations and that are used only in swimming pools (and
closely related sites like hot tubs, spas and/or whirl pools) are
subject to a reduced set of the refillable container and repackaging
requirements.
    5. Scope of container-related regulations for products other than
antimicrobial products. As proposed in 1994, MUPs are exempt from the

container regulations. Plant-incorporated protectants, which were not
discussed in the proposed rule, are also exempt from the container
regulations. According to today's final rule, all other pesticide
products, except antimicrobial pesticides that are exempt, are subject
to the nonrefillable container, refillable container and repackaging
regulations. For the nonrefillable container regulations, a product is
subject to all of the requirements if it classified in at least one of
the following categories:
     Toxicity Category I;
     Toxicity Category II;
     Restricted use pesticide.
Products that do not meet at least one of these criteria (i.e.,
products that are classified in Toxicity Category III or IV and that
are not restricted use pesticides) are excluded from all of the
nonrefillable container standards except the basic DOT requirements.
    In general, products other than MUPs, plant-incorporated
protectants and exempt antimicrobial products are subject to all of the
refillable container and repackaging regulations. One exception is that
antimicrobial products that are used only in swimming pools and closely
related sites are subject to a reduced set of the refillable container
and repackaging requirements.
    6. Referring to and adopting some Department of Transportation
regulations. In the 1994 proposed rule, EPA clarified that compliance
with EPA's container regulations would not exempt registrants from
complying with applicable DOT Hazardous Materials Regulations, and that
compliance with DOT's marking and drop test requirements would satisfy
the corresponding EPA requirement for refillable containers. Also, the
preamble of the proposed rule requested comment on several options for
determining who would be responsible for ensuring that containers meet
the standards. In the 1999 supplemental notice, we discussed the
comments on the proposal and discussed a new approach, namely to adopt
and refer to the DOT Packing Group III criteria for both nonrefillable
and refillable containers. Today's final rule includes the same basic
approach as described in the supplemental notice. Specifically:
     Pesticide products that are DOT hazardous materials must
be packaged as required by DOT.
     Pesticide products that are not DOT hazardous materials
must be packaged in containers that are designed, constructed, and
marked to comply with the cross-referenced and adopted requirements of
DOT regulations, as applicable to a Packing Group III material or the
limited quantity/consumer commodity exception.
     All pesticide products must comply with the pesticide-
specific requirements in the nonrefillable and refillable container
regulations.
     EPA may modify or waive these requirements under certain,
limited conditions.
     If DOT proposes to change any of the regulations that are
incorporated by these regulations, EPA will provide notice to the
public in the Federal Register.
    7. Residue removal standard for nonrefillable containers. The 1994
NPRM required that registrants demonstrate at least 99.9999 (six 9's)
percent residue removal using a prescribed testing methodology for
dilutable products in rigid containers. Testing would have been
required on 19 representative samples in accordance with Good
Laboratory Practice (GLP) standards in 40 CFR part 160. We received
many comments opposing virtually every aspect of this proposed
requirement. Today's final rule requires rigid containers of dilutable
liquid formulations to be capable of achieving at least 99.99 percent
(four 9's) residue removal using a defined laboratory triple rinse
method conducted on three representative containers. In addition,
testing and recordkeeping is only required for flowable concentrate
formulations or if EPA requests the tests on a case-by-case basis.
    8. Consistency with existing State containment regulations. At
least 19 States have already promulgated and implemented State bulk
containment regulations. EPA's proposed rule included basic standards
generally similar to State standards, although some were more rigorous
and others less stringent than certain State standards. Today's
containment standards are intended to introduce substantial safeguards
in States that currently lack containment regulations and to harmonize
with containment requirements in States where adequate containment
safety programs already exist. While EPA believes a national standard
must provide substantial environmental protection, a mechanism is being
provided to accommodate States that have successfully implemented bulk
containment programs.
    9. Hydraulic conductivity standard for containment structures. The
proposed rule would have required that existing and new structures
demonstrate compliance with a hydraulic conductivity standard of 1 x
10-6 cm/sec and 1 x 10-7 cm/sec, respectively.
EPA received many comments opposed to the hydraulic conductivity
standard which was perceived to be too restrictive, not achievable and
too costly. The requirement for a numeric hydraulic conductivity
standard was dropped from the final rule, but all existing and new
structures are required to be liquid-tight, with cracks and seams
sealed.
    10. Scope of products subject to label regulations. The final
labeling regulations in today's rule cover the same statements and
topics that were included in the proposed rule. Unlike the container-
related regulations, 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.
    While today's label requirements generally apply to all pesticide
products, the specific label requirements apply to different groups of
products and containers. In particular:
     A statement identifying a container as nonrefillable or
refillable is required on the labels of all products and all
containers.
     Statements to prohibit reuse and offer for recycling and a
batch code are required on the labels or container of all products
distributed or sold in nonrefillable containers.
     Rinsing instructions are required on the labels of some
products distributed or sold in nonrefillable containers. Specifically,
the requirement for rinsing instructions applies to dilutable products
in rigid nonrefillable containers. Residential/household use pesticide
products are exempt from this requirement.
     Instructions for cleaning before final disposal (not
before refilling) are required on the labels of all products
distributed or sold in refillable containers.

III. Container Regulations--Scope

    The purpose of Unit III. is to describe the scope of the container-
related regulations, including the standards for nonrefillable
containers in 40 CFR part 165, subpart B, refillable containers in
subpart C and repackaging pesticide products in subpart D. The
regulations themselves are discussed in more detail in Units V., VI.
and VII. for nonrefillable containers, refillable containers and
repackaging, respectively. Unit IV. discusses the relationship between

EPA's container-related regulations and the Department of
Transportation's Hazardous Materials Regulations.
    EPA is exempting some pesticides and containers from today's rule
based on the statutory language and the relative risk posed by the
pesticides and containers. The 1994 NPRM proposed that the container
regulations would generally apply to all end use pesticides and all
containers, regardless of the pesticide market sector. The NPRM
proposed to exempt MUPs from the container requirements. Many
commenters opposed the broad scope of the regulations and requested EPA
to exempt one or more subsets of pesticides from the container
requirements.
    The 1996 FQPA amended section 19 of FIFRA to exempt certain types
of antimicrobial pesticides from the container provisions under certain
circumstances. In the October 1999 Supplemental Notice, EPA proposed a
regulatory option for exempting certain pesticides, and requested
comment on the applicability and interpretation of the antimicrobial
exemption to FIFRA.
    As described in this unit, the container-related provisions in the
final rule apply only to a subset of end use pesticide products. All
MUPs and plant-incorporated protectants are exempt from the container-
related requirements. The container regulations define criteria for
antimicrobial products that are subject to the container-related
standards. Other than MUPs, plant-incorporated protectants and exempt
antimicrobial products, all products are subject to the nonrefillable
container, refillable container and repackaging regulations. However,
some products are subject to a reduced number of requirements. The
discussion in Unit III. applies only to the nonrefillable container,
refillable container and repackaging regulations. The containment and
labeling regulations have different scopes, as described in Units VIII.
and IX.

A. Exempt Manufacturing Use Products (Sec. Sec.  165.23(a), 165.43(a)
and 165.63(a))

    1. Final regulations. MUPs, as defined in 40 CFR 158.153(h), are
exempt from the container regulations. As described in the preamble to
the proposed rule, this exemption applies to technical grade products
and formulation intermediates intended only for formulation into other
pesticide products and labeled for formulation use only.
    2. Changes. This exemption is identical to the exemption in the
1994 proposed rule and the 1999 Supplemental Notice.

B. Exempt Plant-Incorporated Protectants (Sec. Sec.  165.23(b),
165.43(b) and 165.63(b))

    1. Final regulations. Plant-incorporated protectants, as defined in
40 CFR 174.3, are exempt from the container regulations.
    2. Changes. EPA did not specifically mention plant-incorporated
protectants in either the proposed rule or the supplemental notice
because there were either no registrations for these products or they
were uncommon at that time; these types of products are relatively new
to the marketplace. In the June 30, 2004 Federal Register notice (69 FR
39393), EPA cited plant-incorporated protectants as an example of a
topic that would be appropriate to comment on during the 2004 reopening
of the comment period. (Ref. 33) As explained below, EPA believes it is
appropriate to exempt plant-incorporated protectants from the container
requirements in the final rule.
    In comments on the 2004 Federal Register notice, two registrant
groups and five registrants urged EPA to exempt plant-incorporated
protectants from the container and containment regulations. These
commenters stated that plant-incorporated protectants fit the three
conditions of EPA's treated article policy and therefore should be
exempt from all provisions of FIFRA when used in the manner described.
They also concurred with EPA's assessment in the 2004 Federal Register
notice that plant-incorporated protectants are not sold and distributed
in containers like other pesticides; they are distributed as parts of
seeds or plants.
    The regulations for plant-incorporated protectants in 40 CFR parts
152 and 174 were finalized in the Federal Register on July 19, 2001 (66
FR 37771). (Ref. 50) A plant-incorporated protectant is a pesticidal
substance that is intended to be produced and used in a living plant,
or in the produce thereof, and the genetic material necessary for
production of such a pesticidal substance. As explained in the preamble
to the final rule for plant-incorporated protectants (66 FR 37774),
``[p]lant-incorporated protectants are primarily distinguished from
other types of pesticides because they are intended to be produced and
used in a living plant. This difference in use pattern dictates in some
instances differences in approach.'' (Ref. 50) Plant-incorporated
protectants are not sold and distributed in containers as distinct
substances (e.g., liquids, solids or gels) like other pesticides; they
are distributed as part of the seeds or plants. In other words, plant-
incorporated protectants do not have containers like most pesticides.
Therefore, EPA believes it is appropriate to exempt plant-incorporated
protectants from the requirements of the container-related regulations.

C. Exempt Certain Antimicrobial Products (Sec. Sec.  165.23(c),
165.43(c) and 165.63(c))

    The 1996 FQPA amended section 19 of FIFRA to exempt certain types
of antimicrobial pesticide products from the pesticide container
provisions under certain circumstances. Specifically, FQPA added the
following to FIFRA section 19(h):

    A household, industrial, or institutional antimicrobial product
that is not subject to regulation under the Solid Waste Disposal Act
(42 U.S.C. 6901 et seq.) shall not be subject to the provisions of
subsections (a), (e), and (f), unless the Administrator determines
that such product must be subject to such provisions to prevent an
unreasonable adverse effect on the environment.

    Because this language was added after the pesticide container and
containment rule was proposed in 1994, EPA solicited public comment on
the applicability of this provision to the proposed container
regulations in the 1999 supplemental Federal Register notice. In
addition, the supplemental notice described EPA's interpretation and
response to the following two broad questions relating to the
antimicrobial exemption provision:
     What is the scope of household, industrial, or
institutional antimicrobial products that are not subject to regulation
under the Solid Waste Disposal Act?
     Which products must be subject to the container provisions
to prevent an unreasonable adverse effect on the environment?
    Based on comments on the proposed rule and supplemental notice and
on several additional analyses, EPA is making a number of changes in
the approach for regulating antimicrobial products in the final
regulations. The approach in the final rule is briefly described here
and the details are provided in the issue-by-issue sections below.
     All four of the following criteria must be met for a
product to be exempt from the container regulations:
    (1) The product is an antimicrobial pesticide as defined in FIFRA
section 2(mm) or it has antimicrobial properties (as defined in FIFRA
section 2(mm)(1)(A)) and is subject to a tolerance or a food additive
regulation.
    (2) The product includes directions for use on a site in one of the

antimicrobial product use categories identified as household,
industrial or institutional.
    (3) The product is not a hazardous waste when it is intended to be
disposed.
    (4) EPA has not specifically determined that the product must be
subject to the container regulations to prevent an unreasonable adverse
effect on the environment.
     EPA will determine which products must be subject to the
container provisions to prevent an unreasonable adverse effect on the
environment on a case-by-case basis as described in the regulations.
     The final rule exempts refillable containers used to
distribute antimicrobials used in swimming pools (and that are subject
to the regulations because they do not meet all of the exemption
criteria) from some of the refillable container and repackaging
standards (including, but not limited to, serial number markings, one-
way valves or tamper-evident devices, and some recordkeeping).
    The four criteria that identify which antimicrobial products are
exempt from the container regulations are discussed in greater detail
in Units III.C.1. - III.C.4. The other aspects of the approach toward
regulating antimicrobials are discussed in Units III.D. - III.F.
    Throughout the preamble, the term ``antimicrobial'' is intended to
be interpreted broadly with the property of destroying or inhibiting
the growth of microorganisms (and as identified in FIFRA section
2(mm)(1)(A)) unless specified otherwise. In other words, we specify
``FIFRA 2(mm) antimicrobial pesticides'' if we are referring to the
more limited definition of antimicrobial pesticides in FIFRA section
2(mm).
    1. Exemption criteria: definition of an antimicrobial pesticide--i.
Final regulations. The first of the four criteria that must be met for
an antimicrobial product to be exempt from the container regulations
is:
    The pesticide product meets one of the following two criteria:
    (1) The pesticide product is an antimicrobial pesticide as defined
in FIFRA section 2(mm); or
    (2) The pesticide product:
    (i) Is intended to: disinfect, sanitize, reduce or mitigate growth
or development of microbiological organisms; or protect inanimate
objects, industrial processes or systems, surfaces, water, or other
chemical substances from contamination, fouling, or deterioration
caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
    (ii) In the intended use is subject to a tolerance under section
408 of the Federal Food, Drug, and Cosmetic Act or a food additive
regulation under section 409 of such Act.
    ii. Changes. In the supplemental notice, this criterion was limited
to ``The product meets the definition of an antimicrobial pesticide in
FIFRA section 2(mm).'' EPA continues to believe that the most
straightforward approach for defining antimicrobial products is to use
the FIFRA definition of antimicrobial pesticide. The second criterion
was added because, after thorough analysis of the definition of
antimicrobial pesticide, EPA believes that some pesticides that are
excluded from the definition should be eligible for exemption from the
container regulations. Specifically, FIFRA section 2(mm)(1)(B)
explicitly excludes pesticides with antimicrobial properties as
identified in section 2(mm)(1)(A) from being FIFRA section 2(mm)
antimicrobial pesticides if they are subject to a tolerance or a food
additive regulation in their intended use. EPA believes that these
pesticides should be eligible for exemption from the container
regulations along with pesticides that are FIFRA section 2(mm)-defined
antimicrobial pesticides.
    Although there is no official legislative history documenting the
intent of the definition of antimicrobial pesticide in FQPA, EPA
acknowledges that FQPA also established time periods in FIFRA section 3
for registration review and action for various kinds of antimicrobial
pesticides. EPA believes it is reasonable to conclude that pesticides
subject to a tolerance or food additive regulation were excluded from
the FIFRA section 2(mm) definition of antimicrobial pesticide at least
partly because these pesticides require more data and analysis than
other antimicrobial pesticides and, therefore, should not be subject to
the registration time periods established in FIFRA section 3.
    More importantly, EPA believes that the containers of pesticides
with antimicrobial properties that are subject to a tolerance or food
additive regulation generally pose a limited risk to human health and
the environment. If either EPA or the Food and Drug Administration
(FDA) determine that a pesticide with antimicrobial properties can be
safely used on food or on food contact surfaces, the containers holding
these pesticides are unlikely to pose a significant risk or even a risk
greater than the pesticides that are FIFRA 2(mm) antimicrobial
pesticides. EPA believes that these pesticides should also be eligible
for exemption from the pesticide container regulations and that
exempting these pesticides should not significantly increase the risk
posed by containers of these pesticides. Therefore, it is very unlikely
that such an exemption would pose an unreasonable adverse effect on the
environment. We believe the provisions of FIFRA sections 19 and 25
authorize such an exemption.
    While EPA is identifying pesticides with antimicrobial properties
that are subject to a tolerance or food additive regulation as being
eligible for exemption from the container regulations, they are not
automatically exempt. Pesticides with antimicrobial properties that are
subject to a tolerance or food additive regulation must also meet the
other criteria identified by Congress in the FIFRA section 19(h)
language: (1) It is a household, industrial or institutional product;
(2) it is not a hazardous waste when disposed; and (3) EPA has not
determined it must be subject to the regulations to prevent an
unreasonable adverse effect. While EPA believes it is reasonable to
make pesticides with antimicrobial properties that are subject to a
tolerance or food additive regulation eligible for exemption from the
pesticide container regulations, we see no reason that these pesticides
shouldn't be subject to the other criteria that Congress established
for antimicrobial pesticides.
    EPA is not implementing similar exemption provisions for the other
pesticide types excluded from the definition of antimicrobial pesticide
in FIFRA section 2(mm), which include:
     Wood preservatives with claims for pests other than micro-
organisms;
     Antifouling paint products with claims for pesticides
other than micro-organisms;
     Agricultural fungicide products; and
     Aquatic herbicide products.
    EPA does not believe that the pesticides in this list generally
pose a limited risk to human health and the environment, as is the case
with pesticides with antimicrobial properties that are subject to a
tolerance or food additive regulation. EPA analyzed one of its
pesticide data bases (Reference File System or REFS) and identified the
wood preservative and antifouling paint products that claim to control
pests other than micro-organisms. Many of the wood preservative
products that claim to control pests other than micro-organisms also
would be hazardous wastes when they are disposed and many of these are
also restricted use products, such as those containing arsenic acid,
arsenic pentoxide, chromic

acid, coal tar, creosote and pentachlorophenol. Many of the antifouling
paint products that claim to control pests other than micro-organisms
are also restricted use pesticides, such as products containing copper
(I) oxide, bis(tributyltin oxide) and tributyltin methacrylate. EPA
does not believe that products containing these active ingredients meet
the criterion of generally posing a limited risk to human health and
the environment, as is the case with pesticides with antimicrobial
properties that are subject to a tolerance or food additive regulation.
    2. Exemption criteria: household, institutional or industrial
products--i. Final regulations. The second of four criteria that must
be met for an antimicrobial product to be exempt from the container
regulations is:
    The product includes directions for use on a site in one of the
following 10 antimicrobial product use categories identified as
``household, industrial or institutional:''
    (1) Food handling/storage establishments premises and equipment.
    (2) Commercial, institutional, and industrial premises and
equipment.
    (3) Residential and public access premises.
    (4) Medical premises and equipment.
    (5) Human drinking water systems.
    (6) Materials preservatives.
    (7) Industrial processes and water systems.
    (8) Antifouling coatings.
    (9) Wood preservatives.
    (10) Swimming pools.
    ii. Changes. Prompted by comments and after re-evaluating the
antimicrobial product use categories, EPA is modifying the approach in
the supplemental notice by adding a tenth category, human drinking
water systems, to the list of ``household, industrial or
institutional'' uses. EPA agrees with commenters that the category of
human drinking water systems includes use in individual water systems,
which could be used in homes. Additionally, human drinking water
systems include use in public water systems and the drinking water
treatment facilities that use the pesticides for this purpose fit into
a reasonable understanding of industrial use. Therefore, 10 of the 12
antimicrobial product use categories will be ``household, industrial or
institutional'' uses, compared to the nine categories identified in the
supplemental notice. The two antimicrobial product use categories that
are not identified as ``household, industrial or institutional'' are
``agricultural premises and equipment'' and ``aquatic areas.''
Multiple-use products with labels that include directions for use on a
site in one of the excluded categories (``agricultural premises and
equipment'' and ``aquatic areas'') and in at least one of the ten
antimicrobial use product categories identified as ``household,
industrial and institutional'' would be eligible for exemption.
    3. Exemption criteria: not subject to RCRA--i. Final regulations.
The third of four criteria that must be met for an antimicrobial
product to be exempt from the container regulations is:
    The pesticide product is not a hazardous waste as set out in 40 CFR
part 261 when the pesticide product is intended to be disposed.
    ii. Changes. This criterion is nearly the same as in the
supplemental notice, but EPA modified the language slightly in response
to a few comments to clarify that antimicrobials that are household
waste are eligible for exemption. Rather than specifying that ``the
pesticide product does not meet the criteria for hazardous waste as set
out in part 261...'' as discussed in the supplemental notice, the final
rule uses broader language (``the pesticide product is not a hazardous
waste as set out in part 261...'') that clearly includes all of the
criteria, exclusions and other provisions in 40 CFR part 261.
    4. Exemption criteria: EPA has not specifically determined the
product must be subject to the regulations--i. Final regulations. The
fourth of four criteria that must be met for an antimicrobial product
to be exempt from the container regulations is that EPA has not
specifically determined that the pesticide product must be subject to
the regulations to prevent an unreasonable adverse effect on the
environment according to the provisions discussed in Unit III.F.
    ii. Changes. This criterion is necessary to implement Option 1 in
the supplemental notice. The sample regulatory text in the supplemental
notice did not specifically have a provision for subjecting
antimicrobial products to the container regulations on a case-by-case
basis because the sample regulatory text reflected Option 3. As
discussed in Unit III.F, the final rule must define conditions and
procedures for EPA to determine that an antimicrobial product or group
of products must be subject to the container regulations to prevent an
unreasonable adverse effect on the environment. Because EPA may subject
certain antimicrobial products to the container regulations in the
future, a fourth criterion is necessary for the list of criteria for
the antimicrobial products that are exempt from the container
regulations. Respondents provided extensive comments (described in Unit
III.E.) about how EPA should make these determinations.

D. Antimicrobial Swimming Pool Products That Are Not Exempt (Sec. Sec.
165.43(d), 165.63(d))

    1. Final regulations. An antimicrobial swimming pool product that
is not otherwise exempt (because it is a manufacturing use product,
plant-incorporated product or an exempt antimicrobial product) is
subject to a reduced set of the refillable container and repackaging
regulations. Comments on the supplemental notice and an analysis of
antimicrobial products indicated that some antimicrobial swimming pool
products are hazardous wastes when they are disposed and, therefore,
would be subject to the pesticide container regulations because they do
not meet all four criteria for exemption.
    For the purposes of subparts C and D, an antimicrobial swimming
pool product is a pesticide product that satisfies both of the
following conditions:
     The pesticide product is intended to: disinfect, sanitize,
reduce or mitigate growth or development of microbiological organisms;
or protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from contamination,
fouling, or deterioration caused by bacteria, viruses, fungi, protozoa,
algae, or slime.
     The labeling of the pesticide product includes directions
for use only on a site or sites in the antimicrobial product use
category of swimming pools.
    Antimicrobial swimming pool products that are not exempt must
comply with all of the refillable container regulations in subpart C
except for:
     Sec.  165.45(d) regarding marking; and
     Sec.  165.45(e) regarding openings.
    Antimicrobial swimming pool products that are not exempt must
comply with all of the repackaging regulations in subpart D except for
the following requirements:

------------------------------------------------------------------------
                                    Requirement for
                                    registrants who
                                  distribute or sell    Requirement for
           Requirement                directly in      refillers who are
                                      refillable        not registrants
                                      containers
------------------------------------------------------------------------
Recordkeeping specific to each    Sec.                Sec.
 instance of repackaging           165.65(i)(2)        165.70(j)(2)
------------------------------------------------------------------------
Container inspection: criteria    Sec.                Sec.
 regarding a serial number or      165.65(e)(3)        165.70(f)(3)
 other identifying code
------------------------------------------------------------------------
Container inspection: criteria    Sec.                Sec.
 regarding one-way valve or        165.65(e)(4)        165.70(f)(4)
 tamper-evident device
------------------------------------------------------------------------
Cleaning requirement: criteria    Sec.                Sec.
 regarding one-way valve or        165.65(f)(1)        165.70(g)(1)
 tamper-evident device
------------------------------------------------------------------------
Cleaning if the one-way valve or  Sec.   165.65(g)    Sec.   165.70(h)
 tamper-evident device is not
 intact
------------------------------------------------------------------------

    2. Changes. The supplemental notice included a similar provision,
but it would have applied only to products eligible for exemption.
Based on the comments and further analysis, EPA realized that the
products for which relief was intended (those with sodium hypochlorite)
may be hazardous wastes when disposed and, therefore, would not be
eligible for either full or partial exemption according to the approach
in the supplemental notice. Today's final rule subjects antimicrobial
swimming pool products to a reduced set of the refillable container and
repackaging requirements if they are sold and distributed in refillable
containers. Specifically, antimicrobial swimming pool products would
not have to comply with some of the standards, including, but not
limited to, serial number markings, one-way valves or tamper-evident
devices, and some recordkeeping. Currently, EPA is aware of sodium
hypochlorite products that fit these criteria and that are sold and
distributed in refillable containers. However, the partial exemption
was drafted to be general so it would apply to any products that fit
the criteria.
    A description of an antimicrobial swimming pool product was added
to subparts C and D for clarity. The regulatory text was modified to
clarify that the reduced set of requirements applies to products
labeled for use on a site or sites only in the antimicrobial product
use category of swimming pools (which includes swimming pools, spas,
hot tubs, and whirlpools). In other words, a product that is labeled
for use in swimming pools (and/or spas, hot tubs and whirlpools) and
another site, such as human drinking water systems, would have to
comply with the full set of refillable container and repackaging
requirements. Alternatively, the registrant of such a product could
remove the use site(s) other than those in the antimicrobial product
use category of swimming pools from the label, in which case the
product would be subject to the reduced set of refillable container and
repackaging requirements.
    Many antimicrobial swimming pool products are completely exempt
from the nonrefillable container, refillable container and repackaging
regulations by Sec. Sec.  165.23(c), 165.43(c) and 165.63(c). However,
some antimicrobial swimming pool products are subject to the container-
related regulations because they do not meet all of the criteria in
these sections, for example, because they are hazardous wastes when
they are disposed. The partial exemption in Sec. Sec.  165.43(d) and
165.63(d) provides some regulatory relief from the refillable container
and repackaging requirements for such antimicrobial swimming pool
products. Antimicrobial swimming pool products that are not completely
exempt must comply with all of the nonrefillable container
requirements.

E. EPA Determinations that Products Must be Subject to the Container
Regulations to Prevent an Unreasonable Adverse Effect on the
Environment

    1. Final regulations. The final regulations exempt all
antimicrobial products that are eligible for exemption according to the
criteria described in Unit III.C. from needing to comply with the
nonrefillable container, refillable container and repackaging
regulations. The final regulations also include a provision that allows
EPA to determine, on a case-by-case basis, that a specific product or
group of products must be subject to the regulations to prevent an
unreasonable adverse effect on the environment if a problem becomes
evident. The specifics of this provision are discussed in Unit III.F.
    2. Changes. The approach in the final rule is a change from the
approach that was identified as our preferred approach (Option 3) in
the supplemental notice, which would have subjected all antimicrobials
eligible for exemption that were classified in Toxicity Category I to a
subset of the container regulations. In the supplemental notice, EPA
described four options for determining which antimicrobial products
that are eligible for exemption would be subject to the container
provisions to prevent an unreasonable adverse effect on the
environment. Today's final rule establishes Option 1 as the procedure
to be implemented, which exempts all eligible antimicrobials, but
includes a provision to require a specific product or group of products
to comply with the container regulations if a problem becomes evident.
The four options in the supplemental notice were:
     Option 1: Exempt all eligible antimicrobials, but include
a provision to require a specific product or group of products to
comply with the container regulations if a problem becomes evident.
     Option 2: Subject eligible antimicrobials classified in
Toxicity Category I to all of the container regulations.
     Option 3: Subject eligible antimicrobials classified in
Toxicity

Category I to a subset of the container regulations.
     Option 4: Apply the scope criteria being considered for
other pesticides to eligible antimicrobials.
    3. Comments. Two state agencies supported EPA's approach in the
supplemental notice (Option 3). Eighteen commenters, representing the
antimicrobial and/or the swimming pool/spa industries, strongly opposed
EPA's approach, and most supported Option 1. An agricultural registrant
stated that the language in section 19(h) is not a blanket exemption,
and that focusing on only Toxicity Category I (as opposed to Toxicity
Categories I and II in the applicability for all other products) is
unfair and inconsistent.
    Many commenters opposed EPA's approach and supported Option 1,
either by specifically identifying it as the option EPA should adopt or
by describing and supporting an approach that is consistent with Option
1. These commenters supported their positions with the following
claims:
    i. Statutory intent. Some commenters stated that only Option 1 is
consistent with the statutory language. Several respondents
specifically disagreed with EPA's general criteria approach, saying it
was unnecessary, inappropriate and inconsistent with the statutory
language.
    ii. Congress's intent. Similarly, many commenters stated that only
Option 1 is consistent with Congress's intent. The commenters generally
argued that Congress's clear intent was to exempt nearly all eligible
antimicrobials. One commenter referred to testimony received and
comments made at various committee hearings to support its
interpretation of the congressional intent. Several commenters stated
that EPA's approach is contrary to the position of EPA negotiators
during pre-FQPA discussions, which was that the provision constituted
essentially a complete exemption.
    iii. No information about unreasonable adverse effects. Many
respondents pointed out that EPA does not have concrete information,
such as documented incidents, of unreasonable adverse effects (UAEs)
caused by antimicrobial pesticides. In addition, several pool supply
companies said that there are no reports of accidents with refillable
containers used for pool chemicals and mentioned that they have used
these containers safely for many years and for large volumes of sodium
hypochlorite.
    iv. Standard of unreasonable adverse effect on the environment.
Several commenters stated that the process of registration is intended
to ensure that the pesticide will not cause an UAE, and therefore all
registered products, including those in Toxicity Category I, have been
determined to meet a standard of no UAE. These commenters further
argued that information on specific exposures, leakage or other
problems is needed to overturn the registration decision of no UAE and
to determine that an UAE must be prevented. Another respondent
commented that Congress didn't provide additional insight into what
constitutes an UAE in the context of section 19, so it must have the
same meaning as in the FIFRA registration standard in section 3(c)(5)
and the obligation to report information on UAE in section 6(a)(2).
    v. FIFRA section 6(a)(2) reporting. Several commenters stated that
the section 6(a)(2) obligation for registrants to submit factual
information regarding UAE to EPA provides an adequate mechanism for EPA
to identify UAEs caused by antimicrobials eligible for exemption. A few
of these respondents pointed out that the UAE standard in section
6(a)(2) is exactly the same as the standard in section 19(h)(2).
    vi. Minimal threat to the environment. Several commenters
specifically addressed sodium hypochlorite and commented that it is not
a threat to the environment because: it has a short half life; it's
final fate is sodium chloride (table salt); it is used widely without
evidence that it is problematic; it's only in Toxicity Category I for
eye effects, unlike the toxic and persistent agricultural pesticides;
it's an inorganic chemical; the institutional/industrial formulation is
only slightly more concentrated than common household bleach; it's less
toxic than many automotive and household chemicals; and the resultant
liquid from hosing down a spill is indistinguishable from drinking
water. An industry association argued that many of these claims apply
to institutional and industrial sanitizers and disinfectants in
general.
    vii. No need for additional regulations. Several commenters stated
that there is no need for EPA to regulate institutional and industrial
disinfectants because these products are already adequately regulated
by EPA waste regulations, DOT's packaging requirements, and OSHA's
health and safety standards. One commenter stated that most
manufacturers and formulators of antimicrobial products use containers
that meet at least the DOT Packing Group III standards for all
materials, because it's not feasible to use certain containers for DOT
hazardous materials and other containers for products that aren't DOT
hazardous materials.
    4. EPA response. EPA has decided to change its approach for
determining which antimicrobial products that are eligible for
exemption must be subject to the container regulations to prevent an
unreasonable adverse effect. The final rule will implement Option 1
rather than Option 3.
    EPA believes that Option 1 is acceptable because it is a
legitimate, reasonable interpretation of the statutory language. In
addition, making determinations for subjecting products to the
container regulations based on specific information, data or other
evidence of a problem to prevent unreasonable adverse effects on the
environment is more straightforward than making such a determination
based on arguments supporting the fact that there could be unreasonable
effects.
    In changing the approach to Option 1, EPA was partly convinced by
the comments and observations relating to the standard of unreasonable
adverse effect. The process of registration (including the submission
and review of data plus establishing label restrictions) is intended to
ensure that the pesticide will not cause UAEs on the environment. In
other words, all registered products have been determined to meet a
standard of not causing UAEs on the environment. This determination can
be re-visited and changed by EPA if UAEs are identified during the
process of reregistration or other review, under the ongoing mechanisms
of FIFRA section 6(a)(2) (as implemented by 40 CFR part 159) or when
other relevant information is received by EPA.
    If all eligible Toxicity Category I antimicrobial products needed
to be subject to the container regulations to prevent UAEs on the
environment (according to options 2 and 3 in the supplemental notice),
then currently we should be seeing UAEs from the containers of these
products. This is especially true given the relatively large quantities
of antimicrobial pesticides used annually. As described in the
supplemental notice, in 1995 approximately 3,290 million pounds of
antimicrobial active ingredients were used in the United States,
compared to 1,222 million pounds of non-antimicrobial active
ingredients.
    However, EPA is unaware of a substantial number of UAEs resulting
from the containers of antimicrobial pesticides. Data from the
California Pesticide Illness Surveillance Program indicate only a
limited number of cases where exposure to antimicrobial pesticides was
very likely to be prevented if the container regulations had been in
place. (Ref.22) Given the

limited number of incidents, we do not believe it is appropriate to
require all eligible Toxicity Category 1 antimicrobial products to be
subject to the container regulations, and we believe that a case-by-
case approach is better suited to the issue.
    Because Congress didn't provide additional insight into what
constitutes an unreasonable adverse effect in the context of section
19, EPA agrees with the comment that it should have the same meaning as
in the FIFRA registration standard in section 3(c)(5) and the
obligation for registrants to report information about UAEs on the
environment in FIFRA section 6(a)(2).
    While some of the public comments were persuasive, EPA does not
agree with all of the comments submitted in support of Option 1. For
example, EPA stands by the statements in the supplemental notice that
the statutory language ``unless the Administrator determines that [an
eligible antimicrobial] product must be subject to [the container]
provisions to prevent an unreasonable adverse effect on the
environment'' provides considerable flexibility for EPA to implement it
by establishing general criteria or by product-specific decisions. In
addition, the lack of significant documented legislative or statutory
history on the FQPA amendment to FIFRA section 19(h) makes it
impossible to identify Congress's intent one way or another on this
issue. Moreover, the fact that this language was added toward the end
of the legislation's adoption indicates that commenters' statements
regarding the intent of section 19(h) may not be an altogether accurate
depiction of how Congress intended this portion of section 19(h) to be
interpreted. EPA believes that some antimicrobial products may need to
be subject to the container regulations to protect human health and the
environment. These products will be identified and regulated by the
process described in Unit III.F. below. Finally, EPA believes that the
other regulations cited by commenters including EPA waste regulations,
DOT's packaging requirements, and the OSHA health and safety standards
overlap to some degree with the pesticide container regulations but
generally address different stages of a container's life cycle. Also,
these regulations apply to other pesticides and therefore do not
uniquely affect antimicrobials.

F. Process for EPA to Make These Determinations (Sec. Sec.
165.23(d),165.43(e) and 165.63(e))

    1. Final regulations. The final regulations describe the process
and standards by which EPA may determine that an antimicrobial
pesticide product that would otherwise be exempt must be subject to the
container regulations to prevent an unreasonable adverse effect on the
environment. EPA may make this determination if all of the following
conditions exist:
     EPA obtains information, data or other evidence of a
problem with the containers of a certain pesticide product or related
group of products.
     The information, data or other evidence is reliable and
factual.
     The problem causes or could reasonably be expected to
cause an unreasonable adverse effect on the environment.
     Complying with the container regulations could reasonably
be expected to eliminate the problem.
    The process in the final rule for making these determinations is
based on the regulations in 40 CFR 152.164 for classifying products as
restricted use pesticides. If EPA determines that an antimicrobial
pesticide product that would otherwise be exempt must be subject to the
container regulations to prevent an unreasonable adverse effect on the
environment, EPA may:
     Require, by rule, that the product be repackaged (if
applicable) and distributed or sold in containers that comply with all
or some of the requirements in these regulations; or
     Notify the applicant or registrant of EPA's intent to make
such a determination. After allowing the applicant or registrant a
reasonable amount of time to reply, EPA may require, by notification
and as a condition of registration, that the product be repackaged (if
applicable) and distributed or sold in containers that comply with all
or some of the requirements in these regulations.
For the purposes of notification, 60 days would be a reasonable amount
of time to reply, although EPA may, in its discretion, provide more
time. This process allows EPA to apply all of the requirements in the
nonrefillable container, refillable container and repackaging subparts
to the product. Alternatively, EPA could apply a subset of the
container-related requirements to the product if compliance with some
but not necessarily all of the requirements would eliminate the
problem.
    EPA may deny registration or initiate cancellation proceedings if
the registrant fails to comply with the container and, if appropriate,
the repackaging regulations within the time frames established by EPA
in the rule or in its notification.
    2. Changes. Because we are finalizing Option 1 rather than Option 3
in the supplemental notice, the final rule provides more specific
criteria and a better-defined process for EPA to make determinations to
prevent an unreasonable adverse effect on the environment. The criteria
and process are outgrowths of comments on the supplemental notice and
the following potential regulatory provision from the supplemental
notice:

    EPA may determine that an antimicrobial product or products must
comply with the container standards. EPA may consider evidence such
as field studies, use history, accident data, monitoring data, or
other pertinent evidence in deciding whether the product must comply
with the container standards to prevent an unreasonable adverse
effect on the environment.

    3. Comments. Many commenters provided suggestions and information
about how they believe the case-by-case determinations should be made.
While the actual language varied among commenters, the respondents
agreed that EPA needs specific evidence of a problem related to
containers before EPA can determine a product must be subject to the
container regulations to prevent an unreasonable adverse effect.
    4. EPA response. EPA believes that the criteria and process in the
final regulations for making determinations to prevent an UAE represent
a legitimate, reasonable, straightforward interpretation of the
statutory language. In addition, we think these criteria and the
process for making determinations are similar to EPA's current systems.
EPA has the ability to re-visit a product's registration standard of
not causing UAEs and change it if UAEs are identified during the
process of reregistration or other review, under the ongoing mechanisms
of FIFRA section 6(a)(2) (as implemented by 40 CFR part 159, PR Notice
98-3 (Ref. 55), PR Notice 98-4 (Ref. 54) and other guidance documents)
or when other relevant information is received by EPA. The criteria and
process included in the final rule are consistent with most comments
received on the supplemental notice.
    It is difficult to precisely identify the kind of information that
EPA would consider sufficient and to characterize in great detail the
problems that could trigger this regulatory provision, because we
cannot anticipate every situation that might arise in the future.
However, the following items are intended to provide some guidance on
the different factors that EPA will consider in making determinations
about whether an antimicrobial product

or products must be subject to the container regulations:
     What kind of information, data or other evidence of a
problem with containers has EPA obtained? This could be descriptions of
cases, incidents or examples of problems or it could be some other kind
of information.
     How severe are the problems identified in the information,
data or other evidence obtained by EPA? The 6(a)(2) regulations in 40
CFR part 159 define severity categories assigned to incidents and PR
Notice 98-3 (Ref. 55) expands the definitions for incidents involving
humans and domestic animals.
     How prevalent are the problems identified in the
information, data or other evidence obtained by EPA? Are the problems
isolated or are they widespread? EPA will evaluate the prevalence of
the problems and the severity of the problems before taking any action
to subject the product or products to the container regulations.
     Where do the problems occur in the distribution chain? In
other words, whether the incidents occur predominantly at the
facilities of manufacturers, retailers or end users may affect our
decision. Also, this information may allow EPA to trace a problem back
to a certain facility or a limited number of facilities.
     What is the company's history in terms of reacting to
problems of concern?
     Do the problems cause an unreasonable adverse effect on
the environment?
     Could the problems reasonably be expected to cause an
unreasonable adverse effect on the environment if they continue to
occur? For example, about a decade ago, EPA received a significant
number of reports of a household pesticide that exploded over time.
While these initial incidents may not have directly led to a severe
human injury or illness, it is reasonable to expect that someone could
have been injured or become ill if they were in a garage or storage
area when a container exploded.
     Would complying with the container regulations reasonably
be expected to eliminate the problem? If the container regulations
don't address the problem or would not mitigate the problem, then EPA
could consider other approaches (such as establishing conditions
specific to that registration) to mitigate the problem. As an example,
it is possible that a problem could be caused by a problem with a
specific kind of container material. In this case, the solution may be
to require the product to be distributed in a certain container
material or a container material that has been treated, e.g.,
fluorinated high density polyethylene. It is possible that some of
these alternative approaches may have other impacts with respect to the
container regulations. For example, requiring a product to be
distributed in a nonrefillable container that is rigid rather than non-
rigid would increase the number of nonrefillable container standards
the product must comply with.

G. Summary Table of the Scope for Antimicrobial Products

    The following tables compare the approach for regulating
antimicrobial products in the final regulations and the supplemental
notice. Table 4 compares the exemption criteria in the final rule with
the criteria discussed in the supplemental notice. Table 5 compares
whether certain kinds of products (assuming they would otherwise be
exempt) are exempt from or subject to the container standards in the
final regulations and the supplemental notice approach.

  Table 4.--Exemption Criteria for Antimicrobial Products in the Final
                Rule Compared to the Supplemental Notice
------------------------------------------------------------------------
                                                        Approach in the
     Criterion for Exemption        Approach in the      Supplemental
                                      Final Rule            Notice
------------------------------------------------------------------------
FIFRA section 2(mm)               As defined in       As defined in
 antimicrobial pesticide           FIFRA section       FIFRA section
                                   2(mm)               2(mm)
------------------------------------------------------------------------
Antimicrobial products that are   Criterion is        Criterion wasn't
 not FIFRA 2(mm) antimicrobial     included as an      included; these
 pesticides because they are       additional          would have been
 subject to a tolerance or food    criterion           subject to the
 additive regulation               allowing            container
                                   exemption           regulations
------------------------------------------------------------------------
Antimicrobial product use         10 antimicrobial    9 antimicrobial
 categories that are considered    product use         product use
 household, industrial, or         categories are      categories were
 institutional                     household,          identified as
                                   institutional or    household,
                                   industrial. The     institutional or
                                   additional          industrial. The
                                   antimicrobial       additional
                                   product use         antimicrobial
                                   categories are:     product use
                                   aquatic     categories were:
                                   areas; and.         aquatic
                                               areas;
                                   agricultural
                                   premises and        agricultural
                                   equipment.          premises and
                                                       equipment; and
                                                       human
                                                       drinking water
                                                       systems
------------------------------------------------------------------------
Is not a hazardous waste when it  Is not a hazardous  Does not meet the
 is intended to be disposed        waste as set out    criteria for
                                   in 40 CFR part      hazardous waste
                                   261 when intended   in 40 CFR part
                                   to be disposed      261 when intended
                                                       to be disposed
------------------------------------------------------------------------
EPA has not specifically          Criteria and a      Making case-by-
 determined product must be        process for         case
 subject to container              making the          determinations
 regulations to prevent an         determination are   was discussed as
 unreasonable adverse effect       included in the     an option, but
                                   final rule          was not
                                                       specifically
                                                       included in the
                                                       potential
                                                       regulatory
                                                       language
------------------------------------------------------------------------

Table 5.--Analysis of Whether Certain Types of Antimicrobial Products\1\
Would Be Subject to or Exempt from the Container Regulations - Comparing
              the Final Rule to the Supplemental Notice\2\
------------------------------------------------------------------------
      Antimicrobial Product                              Supplemental
           Description                Final Rule       Notice(Option 3)
------------------------------------------------------------------------
Products that are subject to a    Exempt from the     Subject to the
 tolerance or food additive        regulations\3\      regulations
 regulation                                            according to
                                                       2(mm) definition
------------------------------------------------------------------------
Products that are exempt from,    Exempt from the     Exempt from the
 or otherwise not subject to a     regulations         regulations
 tolerance or food additive        according to        according to
 regulation                        2(mm)               2(mm)
                                   definition\3\       definition\3\
------------------------------------------------------------------------
Wood preservative or antifouling  Exempt from the     Exempt from the
 paint intended to control only    regulations         regulations
 micro-organisms                   according to        according to
                                   2(mm)               2(mm)
                                   definition\3\       definition\3\
------------------------------------------------------------------------
Wood preservative or antifouling  Subject to the      Subject to the
 paint intended to control macro-  regulations         regulations
 organisms as well as micro-       according to        according to
 organisms                         2(mm) definition    2(mm) definition
------------------------------------------------------------------------
Agricultural fungicide or         Subject to the      Subject to the
 aquatic herbicide                 regulations         regulations
                                   according to        according to
                                   2(mm) definition    2(mm) definition
------------------------------------------------------------------------
Product in Toxicity Category I    Exempt from the     Subject to all
                                   regulations\3\      nonrefillable
                                                       container
                                                       requirements
                                                       except the
                                                       residue removal
                                                       standard; subject
                                                       to all refillable
                                                       container
                                                       requirements
                                                       unless used in
                                                       swimming pools
                                                       according to
                                                       determination to
                                                       prevent UAE
------------------------------------------------------------------------
Product in Toxicity Category II,  Exempt from the     Exempt from the
 III or IV                         regulations\3\      regulations\3\
------------------------------------------------------------------------
Product used only in swimming     Exempt from some    Exempt from some
 pools and closely related sites   refillable          refillable
                                   container and       container and
                                   repackaging         repackaging
                                   requirements if     requirements if
                                   subject to the      it met all of the
                                   regulations for     exemption
                                   any reason          criteria and is
                                                       in Toxicity
                                                       Category I
------------------------------------------------------------------------
\1\ In this table, the term antimicrobial has a broad interpretation,
  i.e., as described in FIFRA section 2(mm)(1)(A).
\2\ All antimicrobial products must comply with the new labeling
  requirements. (See Unit IX. for more details about the label
  regulations.) This table refers only to complying with the container-
  related regulations, i.e., standards for nonrefillable containers,
  refillable containers and repackaging.
\3\ The product is exempt from the regulations unless it would be
  subject because of other triggers, such as it is a hazardous waste
  when intended to be disposed.

H. Other Pesticide Products Subject to These Regulations (Sec. Sec.
165.23 (e), 165.43(f) and 165.63(f))

    1. Overview--i. Final regulations. For nonrefillable containers,
all pesticide products other than MUPs, plant-incorporated protectants
and exempt antimicrobial products are subject to the nonrefillable
container standards. However, only the ``higher risk'' products are
subject to all of the nonrefillable container requirements. The
``lower-risk'' products are subject only to the basic DOT requirements.
In particular:
     A product must comply with all of the nonrefillable
container requirements if it is classified in at least one of the
following categories: (1) Toxicity Category I; (2) Toxicity Category
II; or (3) Restricted use product.
     All other products (those in Toxicity Category III or IV
that are not restricted use products) must comply only with the basic
DOT requirements in 49 CFR 173.24. If the pesticide product meets the
definition of a hazardous material in 49 CFR 171.8, the DOT requires it
to be packaged according to 49 CFR parts 171-180.
    The final rule does not distinguish between higher risk and lower
risk products for the refillable container and repackaging regulations.
In other words, pesticide products other than MUPs, plant-incorporated
protectants and exempt antimicrobial products must comply with all of
the refillable container and repackaging standards. The only exception
is that antimicrobial products that are used in swimming pools and
closely related sites are subject to a reduced number of the
requirements, as described in Unit III.D.
    ii. Changes. The 1994 NPRM proposed that the container regulations
would generally apply to all end use pesticide products and all
containers, regardless of the pesticide market sector. The proposed
container regulations included requirements that are equivalent to some
DOT requirements, such as marking, container integrity, reclosing
securely and a drop test, and some requirements that are pesticide-
specific, such as standard closures, one-way valves, and the residue
removal standard. Many commenters opposed the broad scope of the
regulations and requested EPA to exempt one or more subsets of
pesticides from the container requirements.
    In the 1999 supplemental notice, EPA described a potential
regulatory option for products other than antimicrobials that would
exempt some pesticides and containers from the final rule. Rather than
exempt products based on the pesticide market sector or the type of
pesticide (as specified by the commenters on the proposal), EPA's
approach was to exempt pesticides based on the relative risk they
posed.
    The regulatory approach in the supplemental notice would have
exempted manufacturing use products, as we proposed in 1994, and
included a previously described set of standards for antimicrobial
products that would be eligible for exemption. For all other

products, a product would be subject to the regulations if it met any
one of the following criteria:
     The product is classified in Toxicity Category I or II;
     The capacity of the container is equal to or larger than 5
liters (1.3 gal) for liquids or 5 kilograms (11.0 lbs) for solids;
     The product's labeling permits outdoor use and includes at
least one of the specified environmental hazard statements.
The container size and environmental hazard label statement criteria
would have captured many products in Toxicity Category III and IV so
they would have been subject to the regulations.
    About 18 respondents provided comments on these general (non-
antimicrobial) scope criteria in the supplemental notice, consisting
largely of individual registrants and registrant groups. The commenters
generally agreed that it was appropriate to differentiate the
stringency of the regulations based on the relative risk posed by the
products and containers. None of the commenters wholly supported the
approach in the supplemental notice and there was no general agreement
in an approach among the suggestions provided by the respondents. Some
commenters stated that certain standards (either the DOT Packing Group
III standards or the standards in a DOT limited quantity exception)
should apply to all products. Many commenters suggested changes to the
Toxicity Category and container size criteria. None of the commenters
supported the environmental hazard statement criteria. A few commenters
suggested other exemptions that should be included, such as exempting
all residential use products.
    After carefully reviewing these comments and conducting an analysis
of the products that would be regulated using the supplemental notice
criteria, EPA decided to revise the approach in the final rule for
regulating pesticide products other than MUPs, plant-incorporated
protectants and antimicrobials that are exempt. As described above, the
approach for the nonrefillable container standards, which
differentiates between ``higher risk'' and ``lower risk'' products, is
different from the approach for the refillable container and
repackaging requirements, which do not make that distinction.
    iii.Refillable container and repackaging regulations. Pesticide
products other than MUPs, plant-incorporated protectants and exempt
antimicrobial products must comply with all of the refillable container
and repackaging standards. One exception is that antimicrobial products
that are used in swimming pools and closely related sites are subject
to a reduced number of the requirements.
    2. Alternative approach and rationale for changes. The final rule
approach for regulating pesticide products that are not otherwise
exempt was developed based on the comments on the supplemental notice
and on an analysis conducted by EPA. The broad comments related to
substantial changes in the approach are described in this subunit,
while comments on the specific criteria in the supplemental notice are
discussed individually in subunits below.
    i. Comments - overall approach. EPA posed six questions in the
supplemental notice related to the scope of products subject to the
container regulations. The first question was ``Is it appropriate to
apply the container standards only to the higher-risk pesticides?''
Eight respondents specifically addressed this question and seven of
them generally agreed with EPA that it is reasonable to apply different
levels of regulation to higher-risk and lower-risk pesticides. However,
the commenters differed in their recommendations for regulating the
lower-risk pesticides. Only one of the eight commenters, a non-
agricultural registrant group, specifically supported a complete
exemption for the lower-risk pesticides. Some commenters took a middle
ground. In particular, the comments from a registrant group and three
registrants were a bit vague, stating that it is appropriate to apply
the container standards only to the higher risk pesticides and that
lower-risk pesticides should not be subject to the same requirements.
Several commenters opposed the approach of completely exempting some
products. Two registrant groups explicitly supported an option where
lower risk pesticides would be subject to some regulations, although
different standards would be appropriate. Also, the commenter who
didn't support distinguishing between risk levels was a registrant who
stated that the requirements for DOT Class 9 materials should apply to
all pesticides that are not DOT hazardous materials.
    The second question was ``Are the criteria being considered by EPA
to distinguish between higher-risk and lower-risk pesticides
appropriate?'' The same eight commenters addressed this question and
none of them believed that the criteria in the supplemental notice were
appropriate for distinguishing between higher-risk and lower-risk
pesticides. An agricultural registrant group commented that toxicity
and container size are generally appropriate criteria, but questioned
the viability of using these criteria because of the wide range of
combinations of toxicity (human health and environmental), container
sizes and distribution and handling practices. This commenter supports
establishing the DOT Packing Group III standards as a minimum for
agricultural pesticides in nonrefillable containers. A registrant group
and a registrant stated that DOT limited quantity provisions should be
authorized for pesticides that are not DOT hazardous materials. The
regulatory language recommended by one of these commenters would
require pesticide products to comply with all nonrefillable container
standards unless they were specifically exempt or subject to a limited
quantity exception. Four commenters--a registrant group and three
registrants--strongly opposed the environmental hazard statement
criterion because they don't believe the environmental hazard
statements on the label are appropriate indicators of risk. One of them
said that toxicity category alone should be used to distinguish between
higher-risk and lower-risk pesticides. A non-agricultural registrant
group questioned the appropriateness of human toxicity characteristics
for packaging regulations that, it claims, deal primarily with storage
and disposal. This commenter urged EPA to develop alternate criteria,
such as the potential for the product to leak from containers and/or to
persist in the environment.
    In addition, a registrant group and a registrant who addressed the
above question provided more detailed comments on an alternate
approach. These commenters stated that all agricultural pesticides
distributed in nonrefillable containers should comply with the DOT
packaging standards. Under this option, pesticides that are not DOT
hazardous materials would comply with the Packing Group III standards
or, if appropriate, one of the limited quantity exceptions. The
registrant group stated that having minimum requirements on pesticide
integrity is in the best interest of agriculture, the public and our
industry.
    Another registrant provided a detailed description of an alternate
approach. This commenter split the regulations into two primary issues
- (1) container design and integrity testing and (2) container residue
removal standards and others - based on the goals of the rule and their
financial impact. This agricultural registrant strongly believes that
all pesticides in nonrefillable containers should be required to use
DOT Packing Group III containers as a minimum safety standard. On the
other

hand, this respondent believes that it may be reasonable and
appropriate to consider exempting lower-risk pesticides from some
standards, such as the residue removal requirement.
    ii. EPA response - overall approach. These comments prompted EPA to
reconsider the approach discussed in the supplemental notice where
lower-risk pesticides would be completely exempt from the nonrefillable
container standards. EPA agrees with the point made by some commenters
that all containers should meet standards for integrity and
compatibility and is modifying the final rule accordingly. However, EPA
believes that the minimum standards for integrity are different between
nonrefillable and refillable containers.
    In general, DOT has two different sets of package integrity
standards. The most thorough set of requirements are the performance-
oriented packaging standards, which include drop, leakproofness,
hydrostatic pressure, stacking and vibration tests. These tests may
vary in stringency depending on the packing group of the material. For
example, a Packing Group I test involves a drop from 1.8 meters (5.9
feet) while a Packing Group III test has a drop from 0.8 meters (2.6
feet). The other set of requirements are the packaging standards in 49
CFR part 173 subpart B, which are referenced in DOT limited quantity
exceptions. In other words, packages that are subject to a limited
quantity exception must comply with the standards in subpart B of part
173, even though they are exempt from the full array of performance-
oriented packaging tests and other standards.
    The requirements in 49 CFR part 173 subpart B include many
different standards related to ``Preparation of Hazardous Materials for
Transportation.'' Some of these requirements address aspects of
transportation other than packaging, such as the loading and unloading
of transport vehicles, or establish requirements for specific modes of
transportation, such as general requirements for transportation by
aircraft. Therefore, it would not be appropriate for EPA to reference
all of part 173 subpart B, because we are only interested in
incorporating the DOT standards that address packaging design,
construction and marking. After analyzing the subpart B regulations,
EPA believes that the general requirements for packagings and packages
in 49 CFR 173.24 are appropriate basic standards that all nonrefillable
containers must meet. The standards in 49 CFR 173.24 address container
integrity, compatibility, closures and outage/filling limits. These DOT
standards cover the same areas as the proposed requirements for
nonrefillable container integrity/compatibility in Sec.  165.102(b) and
reclosing containers securely in Sec.  165.102(d)(3). EPA believes that
all nonrefillable containers should easily be able to comply with these
requirements, yet they provide a standard that we could enforce in
situations where container problems may arise. Therefore, the final
rule references the general requirements for packagings and packages in
49 CFR 173.24 as the basic standards for all nonrefillable containers,
unless the pesticide product is exempt from the regulations.
    On the other hand, 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.
    3. Nonrefillable containers: human toxicity criterion--i. Final
regulations. For pesticide products other than MUPs, plant-incorporated
protectants, and exempt antimicrobial products, a pesticide product
must comply with all the nonrefillable container requirements if it is
classified in Toxicity Category I or II, as set out in 40 CFR 156.62.
    ii. Changes. For pesticide products in nonrefillable containers,
this criterion is identical to the one set forth in the potential
alternative regulatory text in the 1999 supplemental notice. EPA
continues to believe that the most hazardous groups of pesticides in
terms of human toxicity - those in Toxicity Category I and Toxicity
Category II - should be subject to the nonrefillable container
standards. Most problems with handling containers will lead to human
exposure, as a result of dripping, glugging, leaking, or container
failures, so EPA believes that human toxicity is an appropriate
criterion. Furthermore, EPA believes that products in Toxicity Category
I and II pose a significant enough risk in these situations that these
products should be subject to the nonrefillable container requirements.
    EPA is participating in a global effort to harmonize the
classification and labeling of chemicals for human and environmental
hazards, which is being led by international agencies such as the
Organization for Economic Co-operation and Development (OECD), the
International Labor Organization and the UN Committee of Experts on the
Transportation of Dangerous Goods. The global harmonization effort
resulted in new definitions for toxicity characteristics and a new
Category V. The categories and rationale were described in OECD Series
on Testing and Assessment Number 33, Harmonized Integrated
Classification System for Human Health and Environmental Hazards of
Chemical Substances and Mixtures. That document has since been
superceded by a consolidated document published by the United Nations
Economic Commission for Europe (UNECE) entitled Globally Harmonized
System of Classification and Labeling of Chemicals (GHS) and is
available at the following Web site: http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/01files_e.html.
 (Ref. 16) Each country will

select elements of the system deemed appropriate for regulating
transport, worker and environmental protection. When EPA modifies its
definitions of toxicity categories in 40 CFR part 156 to harmonize with
the OECD guidelines, EPA plans to revise the toxicity category criteria
in Sec.  165.23(e) to incorporate the new toxicity categories. The
criteria and signal words associated with the GHS toxicity categories
are different than EPA's existing criteria and signal words. Therefore,
the universe of products subject to the full set of nonrefillable
container standards and the universe of products subject only to the
basic DOT packaging requirements will likely change.
    4. Nonrefillable containers: other toxicity criterion--i. Final
regulations. For pesticide products other than MUPs, plant-incorporated
protectants, and exempt antimicrobial products, a pesticide product
must comply with all the nonrefillable container requirements if it is
classified by EPA as a restricted use product.
    ii. Changes. This criterion is different than the criterion
described in the supplemental notice that would have required a product
to comply with the nonrefillable container regulations if its labeling
allowed outdoor use and included at least one of the specified

environmental hazard statements. Rather than relying on the
environmental hazard statements on pesticide labels, such as ``This
pesticide is toxic to birds,'' EPA decided to change this criterion to
products that are classified as restricted use products, which was
discussed as an option in the supplemental notice. According to an EPA
analysis, fewer than 250 restricted use products are in Toxicity
Category III or IV (i.e., that are not already captured by the human
toxicity criteria). (Ref. 45)
    iii. Comments. Many commenters--all registrant groups and
registrants--commented on the environmental toxicity criterion in the
supplemental notice. One non-agricultural registrant group stated that
some of the criteria covered by the hazard statements, such as whether
a pesticide leaches through the soil to groundwater, are appropriate
and should be substituted for the human toxicity criteria. A registrant
group and a registrant opposed any environmental criteria. A registrant
group and two registrants opposed the environmental hazard criterion
because they did not agree that the actual use (indoor or outdoor) of a
pesticide is a realistic basis for determining exemptions from the
container regulations. These commenters said that a spill or release
could happen at any point during transportation, storage or handling
and that all pesticide products share the same lanes of transportation.
Therefore, these commenters believe the distinction between whether the
pesticide is used indoors or outdoors is irrelevant. Several commenters
opposed the environmental hazard criterion because they don't believe
the environmental hazard statements on the label are appropriate
indicators of risk.
    Several commenters addressed the option discussed in the
supplemental notice for including a criterion for pesticides that are
classified as restricted use for environmental or ecological reasons.
In particular, a registrant group and several registrants commented
that ``while it is true that compounds that are restricted in their use
for ecological reasons would have some of the specified environmental
hazard statements ..., it is also true that many compounds with little
or no potential for risk could easily contain such language.'' This
statement implies that these respondents distinguish between the risks
posed by pesticides that are restricted in their use for ecological
reasons - which are higher - and the risks posed by other pesticides.
    iv. EPA response. As stated in the supplemental notice, EPA
continues to believe that it is important and necessary to account for
environmental factors when evaluating the risks posed by pesticide
containers. After considering the comments and re-evaluating the
environmental hazard statement approach described in the supplemental
notice, EPA is changing the approach in the final regulations. EPA
believes that the environmental hazard statement option, as described
in the supplemental notice, would be difficult to implement because
each label would have to be evaluated and because the ``catch-all''
standard included in the supplemental notice (``Any environmental
hazard statement pertaining to wildlife, fish, birds or groundwater'')
raises some ambiguity about which products would be included by this
criterion. Also, while EPA doesn't necessarily agree with all of the
comments, an EPA analysis (Ref. 78) raised questions about whether
using the environmental hazard statements on the label would capture
the highest-risk pesticides. Finally, the final rule uses the criterion
of restricted use classification to distinguish between levels of
regulation (subject to all of the nonrefillable container standards
versus subject to the basic DOT standards) rather than to distinguish
between whether the product is regulated or exempt. Therefore, we can
afford to set the criterion at a level that would focus on the most
environmentally risky products, because the other products will be
subject to basic container integrity and compatibility standards,
rather than being completely exempt.
    The criteria that EPA utilizes to restrict an end use product to
use by certified applicators (or persons under their direct
supervision) are described in 40 CFR 152.170. The general criteria for
restricting the use of a product are that EPA determines that:
     The product's toxicity exceeds one or more of the specific
hazard criteria in 152.170, or evidence substantiates that the product
or use poses a serious hazard that may be mitigated by restricting its
use;
     The product's labeling is not adequate to mitigate these
hazards;
     Restriction of the product would decrease the risk of
adverse effects; and
     The decrease in risks of the pesticide as a result of
restriction would exceed the decrease in benefits.
    Section 152.170 lists specific human and ecological toxicity
endpoints that cause a product to be considered for restricted use
classification. In addition, the regulations state that EPA may
consider evidence such as field studies, use history, accident data,
monitoring data or other pertinent evidence in deciding whether the
product or use may pose a serious hazard that could be mitigated by
restricted use classification.
    An analysis of products in EPA's REFS data base shows that many
restricted use products are also classified in Toxicity Category I or
II. However, there are about 225 restricted use products in Toxicity
Category III or IV and all of these products were restricted at least
partly for environmental/ecological reasons. (Ref. 45) In particular,
the criteria for restricting the Toxicity Category III/IV products
include ground water contamination; toxicity to fish, birds, or aquatic
organisms; and hazard to wildlife or non-target organisms.
    5. Nonrefillable containers: container size criterion--i. Final
regulations. Container size is not a criterion in the final regulations
for determining whether a pesticide product is subject to the
nonrefillable container regulations.
    ii. Changes. The approach in the supplemental notice included a
container size limit as one of the criteria for being subject to the
nonrefillable container regulations. Specifically, a product would have
been subject to the nonrefillable container regulations if the
container's capacity was equal to or larger than 5.0 liters (1.3
gallons) for liquid formulations or 5.0 kilograms (11.0 pounds) for
solid formulations. EPA decided not to incorporate the container size
criterion into the final rule for nonrefillable containers because of
other changes in the structure of the final regulations. In particular,
the final rule uses the scope criteria to distinguish between levels of
regulation (subject to all of the nonrefillable container standards
versus subject to the basic DOT standards) rather than to distinguish
between whether the product is regulated or exempt. The criteria in the
final rule subject the most toxic and most risky pesticides -- those in
Toxicity Categories I and II and any others that are restricted use
products -- to the full set of nonrefillable container requirements.
All other products that are not specifically exempt are subject to
basic container integrity and compatibility standards, rather than
being completely exempt. EPA believes the basic DOT packaging standards
offer an acceptable level of protection for the products that are in
Toxicity Categories III and IV and that are not restricted use
products. Therefore, a container size criterion is not necessary for
nonrefillable containers.
    6. Refillable containers and repackaging--i. Final regulations.
Pesticide products other than MUPs, plant-incorporated protectants and
exempt antimicrobial products must comply with all of the refillable

container and repackaging standards. One exception is that
antimicrobial products that are used in swimming pools and closely
related sites are subject to a reduced number of the requirements.
    ii. Changes. The regulatory language is different than the approach
described in the supplemental notice, which described the criteria of
Toxicity Category I or II, container size and environmental hazard
statements for subjecting a pesticide product to the refillable
container and repackaging regulations. However, the net effect of the
scope language in the supplemental notice is very similar to the scope
of the final rule. Because nearly all, if not all, refillable
containers are larger than the container size identified in the
supplemental notice of 5 liters (1.3 gallons) or 5 kilograms (11
pounds), the supplemental notice criteria would have subjected nearly
all, if not all, products in refillable containers to the regulations.
    iii. Comments. Respondents did not specifically address how the
general scope criteria should apply to refillable containers. A few
commenters specifically limited some points to nonrefillable
containers, although most did not. Therefore, EPA believes that the
comments described in Units III.H.1. though III.H.5. generally also
apply to refillable containers.
    iv. EPA response. Under the supplemental notice approach, nearly
all refillable containers would have been subject to the refillable
container and repackaging regulations because of the container size
criterion of 5 liters for liquids and 5 kilograms for solids. Although
the container size criterion is not being incorporated into the final
regulations, EPA believes it is necessary for products that are not