[Federal Register Volume 71, Number 158 (Wednesday, August 16, 2006)]
[Rules and Regulations]
[Pages 47330-47437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6856]



[[Page 47329]]

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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

Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / 
Rules and Regulations

[[Page 47330]]


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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 (703) 305-5805.

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: (703) 305-7385; fax number: (703) 308-2962; e-
mail address: <a href="/cdn-cgi/l/email-protection#a9cfc0ddd387c7c8c7cad0e9ccd9c887cec6df"><span class="__cf_email__" data-cfemail="1f79766b6531717e717c665f7a6f7e31787069">[email protected]</span></a>.

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:
    <bullet> 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.
    <bullet> Agrichemical dealers (NAICS 44422, former SIC code 5191), 
e.g., retail dealers that distribute or sell pesticides to agricultural 
users.
    <bullet> 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.
    <bullet> 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 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.

[[Page 47331]]

    (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

[[Page 47332]]

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:
    <bullet> Nonrefillable containers (container design and residue 
removal);
    <bullet> Refillable containers (container design and residue 
removal);
    <bullet> Repackaging pesticide products;
    <bullet> Containment structures; and
    <bullet> 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:
    <bullet> The new label standards apply to all pesticide products.
    <bullet> The containment regulations apply to agricultural 
pesticides only.
    <bullet> The nonrefillable container, refillable container and 
repackaging regulations apply to the same subset of pesticide products. 
These products are described in Table 2 below.
    <bullet> 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.
    <bullet> 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.

[[Page 47334]]

 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
----------------------------------------------------------------------------------------------------------------
               Subpart                     Section Numbers              Subpart              Section Numbers
----------------------------------------------------------------------------------------------------------------
                                                    Part 156
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Subpart E                              Reserved                 Subpart E: Containment   Sec.  Sec.   165.80 -
                                                                 Structures.              165.97
----------------------------------------------------------------------------------------------------------------
Subpart F: Nonrefillable Containers    Sec.  Sec.   165.100 -   Subpart F                Reserved
                                        165.119
----------------------------------------------------------------------------------------------------------------
Subpart G: Refillable Containers       Sec.  Sec.   165.120 -   Subpart G..............  Reserved
                                        165.139
----------------------------------------------------------------------------------------------------------------
Subpart H: Containment Structures      Sec.  Sec.   165.140 -   Subpart H..............  Reserved
                                        165.157
----------------------------------------------------------------------------------------------------------------

    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:
    <bullet> 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.
    <bullet> The product includes directions for use on a site in one 
of the antimicrobial product use categories identified as household, 
industrial or institutional.
    <bullet> The product is not a hazardous waste when it is intended 
to be disposed.
    <bullet> 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

[[Page 47335]]

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:
    <bullet> Toxicity Category I;
    <bullet> Toxicity Category II;
    <bullet> 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:
    <bullet> Pesticide products that are DOT hazardous materials must 
be packaged as required by DOT.
    <bullet> 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.
    <bullet> All pesticide products must comply with the pesticide-
specific requirements in the nonrefillable and refillable container 
regulations.
    <bullet> EPA may modify or waive these requirements under certain, 
limited conditions.
    <bullet> 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<SUP>-6</SUP> cm/sec and 1 x 10<SUP>-7</SUP> 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:
    <bullet> A statement identifying a container as nonrefillable or 
refillable is required on the labels of all products and all 
containers.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 47336]]

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:
    <bullet> What is the scope of household, industrial, or 
institutional antimicrobial products that are not subject to regulation 
under the Solid Waste Disposal Act?
    <bullet> 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.
    <bullet> 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

[[Page 47337]]

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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Wood preservatives with claims for pests other than micro-
organisms;
    <bullet> Antifouling paint products with claims for pesticides 
other than micro-organisms;
    <bullet> Agricultural fungicide products; and
    <bullet> 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

[[Page 47338]]

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:
    <bullet> 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.
    <bullet> 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:
    <bullet> Sec.  165.45(d) regarding marking; and
    <bullet> 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:

[[Page 47339]]



------------------------------------------------------------------------
                                    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:
    <bullet> 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.
    <bullet> Option 2: Subject eligible antimicrobials classified in 
Toxicity Category I to all of the container regulations.
    <bullet> Option 3: Subject eligible antimicrobials classified in 
Toxicity

[[Page 47340]]

Category I to a subset of the container regulations.
    <bullet> 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

[[Page 47341]]

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:
    <bullet> EPA obtains information, data or other evidence of a 
problem with the containers of a certain pesticide product or related 
group of products.
    <bullet> The information, data or other evidence is reliable and 
factual.
    <bullet> The problem causes or could reasonably be expected to 
cause an unreasonable adverse effect on the environment.
    <bullet> 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:
    <bullet> 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
    <bullet> 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

[[Page 47342]]

or products must be subject to the container regulations:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> What is the company's history in terms of reacting to 
problems of concern?
    <bullet> Do the problems cause an unreasonable adverse effect on 
the environment?
    <bullet> 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.
    <bullet> 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
                                  <bullet> aquatic     categories were:
                                   areas; and.        <bullet> aquatic
                                  <bullet>             areas;
                                   agricultural       <bullet>
                                   premises and        agricultural
                                   equipment.          premises and
                                                       equipment; and
                                                      <bullet> 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
------------------------------------------------------------------------


[[Page 47343]]


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:
    <bullet> 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.
    <bullet> 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

[[Page 47344]]

products, a product would be subject to the regulations if it met any 
one of the following criteria:
    <bullet> The product is classified in Toxicity Category I or II;
    <bullet> 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;
    <bullet> 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

[[Page 47345]]

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

[[Page 47346]]

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:
    <bullet> 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;
    <bullet> The product's labeling is not adequate to mitigate these 
hazards;
    <bullet> Restriction of the product would decrease the risk of 
adverse effects; and
    <bullet> 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

[[Page 47347]]

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

I. Flow Chart/Summary

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

A. Background

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

[[Page 47351]]

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

[[Page 47352]]

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

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

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

[[Page 47353]]

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

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

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

[[Page 47354]]

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

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

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

[[Page 47355]]

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

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

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

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

V. Nonrefillable Container Standards

A. Purpose (Sec.  165.20(a))

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

[[Page 47356]]

    2. Changes. This is nearly the same as the proposed purpose (in 
Sec.  165.100). One minor change was to acknowledge the reduced number 
of products that are subject to the final regulations by stating that 
the rule applies only to the distribution or sale of some pesticide 
products. The proposed regulations would have applied to all products. 
Another modification was to delete the term ``standards'' from the 
phrase ``establish standards and requirements'' because it is 
redundant.

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

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

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

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

D. Pesticide Products Included (Sec.  165.23)

    1. Final regulations. As described in detail in Unit III., only 
certain products have to comply with the nonrefillable container 
standards. MUPs, plant-incorporated protectants, and certain 
antimicrobial products are completely exempt from the nonrefillable 
container requirements. All other pesticide products are subject to the 
nonrefillable container regulations.
    There are different tiers of regulation for products that are 
subject to the nonrefillable container regulations. A product is 
subject to all of the nonrefillable container requirements if it 
satisfies at least one of the following criteria:
    <bullet> It meets the criteria of Toxicity Category I.
    <bullet> It meets the criteria of Toxicity Category II.
    <bullet> It is classified for restricted use as set out in 40 CFR 
152.160 - 152.175.
    If a product does not satisfy any of these criteria (and it is not 
an MUP, plant-incorporated protectant or an exempt antimicrobial), it 
must be packaged in accordance with 49 CFR 173.24. These products do 
not have to comply with any other nonrefillable container requirements. 
However, if any of these products are DOT hazardous materials, they are 
separately obligated under DOT regulations to comply with all 
applicable DOT requirements. In other words, nothing in EPA's 
regulations changes the requirements in the DOT HMR for products that 
meet DOT's criteria for hazardous materials.
    2. Changes. In the proposal, only MUPs would have been exempt from 
the nonrefillable container regulations (in Sec.  165.100). All other 
products would have been subject to the standards. The 1999 
supplemental notice discussed regulatory options for exempting some 
products (antimicrobials and non-antimicrobials) from the full set of 
refillable container regulations and for exempting certain 
antimicrobial products from specific requirements.

[[Page 47357]]

    The criteria in the final rule for exempting antimicrobials are 
somewhat different from those we indicated as our preferred approach in 
the supplemental notice. The final rule exempts plant-incorporated 
protectants. Also, the final rule uses toxicity category and restricted 
use product status to determine the level of regulation subject to all 
nonrefillable container requirements compared to the basic DOT 
packaging requirements rather than to determine whether the product is 
subject to or exempt from the nonrefillable container regulations.
    Table 6 describes the provisions for determining which pesticide 
products are subject to which nonrefillable container regulations and a 
brief explanation of how (or if) this provision changed from the 
proposal and/or the supplemental notice.

      Table 6.--Changes to the Scope of the Nonrefillable Container
                               Regulations
------------------------------------------------------------------------
 Regulatory Provision in the Final Rule               Changes
------------------------------------------------------------------------
Manufacturing use products are exempt.    No change from proposed rule
                                           or supplemental notice.
------------------------------------------------------------------------
Plant-incorporated protectants are        Plant-incorporated protectants
 exempt.                                   would have been subject to
                                           the proposed rule. The
                                           regulations for plant-
                                           incorporated protectants were
                                           finalized in 2001. We are
                                           exempting them from the final
                                           rule because of their unique
                                           nature.
------------------------------------------------------------------------
Certain antimicrobial products are        Antimicrobial products would
 exempt.                                   have been subject to the
                                           proposed rule. The final rule
                                           implements an approach
                                           similar to option 1 in the
                                           supplemental notice, although
                                           some of the details are
                                           different.
------------------------------------------------------------------------
    All other products are subject to the regulations as follows:\1\
------------------------------------------------------------------------
Products in Toxicity Category I or II     No change from the
 are subject to all of the nonrefillable   supplemental notice approach.
 container requirements.
------------------------------------------------------------------------
Restricted use products are subject to    This is different from the
 all of the nonrefillable container        other two criteria discussed
 requirements.                             most thoroughly in the
                                           supplemental notice, which
                                           were: (1) container capacity
                                           equal to or larger than 5
                                           liters or 5 kilograms and (2)
                                           having a specified
                                           environmental hazard
                                           statement on the label of an
                                           outdoor use product.
------------------------------------------------------------------------
All other products (those in Toxicity     This category of lowest
 Category III or IV and that are not       regulation is different from
 restricted use products) must comply      the supplemental notice in
 only with the basic DOT packaging         two ways. First, these
 requirements in 49 CFR 173.24.            products are subject to the
                                           basic DOT requirements rather
                                           than being completely exempt
                                           from the nonrefillable
                                           container regulations.
                                           Second, more products are in
                                           this category of lowest
                                           regulation because there are
                                           fewer Toxicity Category III
                                           or IV products subject to all
                                           of the nonrefillable
                                           container requirements in the
                                           final rule (restricted use
                                           products) than under the
                                           supplemental notice (products
                                           in small containers and
                                           outdoor use products with a
                                           specified environmental
                                           hazard statement on the
                                           label).
------------------------------------------------------------------------
\1\The rest of the changes focus on changes from the supplemental
  notice. All of these products would have been subject to the proposed
  rule because the proposed rule would have applied to all products
  except for manufacturing use products.

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

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

F. Closures (Sec.  165.25(d))

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

[[Page 47358]]

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

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

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

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

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

[[Page 47359]]

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

[[Page 47360]]

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

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

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

[[Page 47361]]



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

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

[[Page 47362]]

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

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


[[Page 47363]]

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

[[Page 47364]]

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

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


[[Page 47365]]


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


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

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

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

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

[[Page 47366]]

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

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

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

[[Page 47367]]

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

K. Reporting (Sec.  165.27(a))

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

L. Recordkeeping (Sec.  165.27(b))

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

M. Proposed Standards That Are Not Being Finalized

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

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

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

[[Page 47368]]

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

VI. Refillable Containers

A. Key Terms

    1. Overview. The following terms, defined in Sec.  165.3 of subpart 
A, are key to understanding the refillable container standards in 
subpart C.
    (1) Dry pesticide
    (2) One-way valve
    (3) Portable pesticide container
    (4) Refillable container
    (5) Stationary pesticide container
    (6) Tamper-evident device
    (7) Transport vehicle.
    Three of these definitions--dry pesticide, tamper-evident device, 
and transport vehicle--are identical to the proposed definitions. The 
definition of refillable container was slightly modified to clarify 
that refillable containers are used for sale or distribution. As 
discussed below, a definition of portable pesticide container has been 
added to the final rule and the other two definitions were changed 
substantively.
    The following proposed definitions that were relevant to the 
proposed refillable container standards are not being finalized: dry 
bulk container; dry minibulk container; liquid bulk container; and 
liquid minibulk container. These are discussed below in conjunction 
with stationary pesticide container.
    2. One-way valve--i. Final regulation. One-way valve means a valve 
that is designed and constructed to allow virtually unrestricted flow 
in one direction and no flow in the opposition direction, thus allowing 
the withdrawal of material from, but not the introduction of material 
into a container.
    ii. Changes. EPA incorporated the following phrase, as suggested by 
a registrant: ``to allow virtually unrestricted flow in one direction 
and no flow in the opposition direction.'' EPA believes this improves 
the definition by clarifying what we mean by one-way.
    3. Stationary pesticide container--i. Final regulation. Stationary 
pesticide container means a refillable container that is fixed at a 
single facility or establishment or, if not fixed, remains at the 
facility or establishment for at least 30 consecutive days, and that 
holds pesticide during the entire time.
    ii. Changes. The proposed definition for ``stationary bulk 
container'' was revised in several ways, as discussed in detail in Unit 
VIII.E. of this preamble, which describes the containers that are 
subject to the containment requirements. The final rule changes the 
term from ``stationary bulk container'' to ``stationary pesticide 
container'' because

[[Page 47369]]

the changes to the final containment regulations eliminated the need 
for the proposed definitions of minibulk and bulk containers.
    The proposed containment regulations would have required each 
stationary bulk container to be protected by a secondary containment 
unit. The proposed rule defined stationary bulk container to be ``a 
liquid bulk container or a dry bulk container that is fixed at a single 
facility or establishment...'' The proposed rule also defined liquid 
bulk and dry bulk containers by size. For example, liquid bulk 
container was defined as ``a refillable container designed and 
constructed to hold liquid pesticide formulations with the capacity to 
hold undivided quantities of greater than 3,000 liters (793 gallons).''
    The final containment regulations take a different approach of 
delineating the containers that must be within secondary containment 
units. Section 165.81(b) states that ``Stationary pesticide containers 
designed to hold undivided quantities of agricultural pesticides equal 
to or greater than 500 gallons (1,890 liters) of liquid pesticide or 
equal to or greater than 4,000 pounds (1,818 kilograms) of dry 
pesticide are subject to the regulations in this subpart and must have 
a secondary containment unit that complies with the provisions of this 
subpart ...'' Because the container sizes are a regulatory criterion in 
Sec.  165.81(b), the definitions of liquid bulk container and dry bulk 
container are no longer necessary and are not being finalized. The 
definition of dry minibulk container was not used in the proposed or 
final regulations and is also not being finalized.
    4. Portable pesticide container--i. Final regulation. Portable 
pesticide container means a refillable container that is not a 
stationary pesticide container.
    ii. Changes. The proposed regulations did not define portable 
pesticide container. However, this definition is necessary in the final 
rule to replace the term liquid minibulk container in the refillable 
container regulations. As described above, EPA is not finalizing the 
definitions for liquid bulk, dry bulk and dry minibulk containers 
because they are not necessary. Similarly, EPA believes that it is 
logical to not finalize the definition for liquid minibulk container. 
In the proposal, the only time the term liquid minibulk container was 
used in the regulatory language was to define the kinds of refillable 
containers that had to comply with the one-way valve/tamper-evident 
device requirement. In the final rule, EPA partially describes the 
containers that must comply with the one-way valve/tamper-evident 
requirement in Sec.  165.45(e) as ``a refillable container that is a 
portable pesticide container that is designed to hold liquid pesticide 
formulations...''

B. Purpose (Sec.  165.40(a))

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

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

    1. Final regulations. You must comply with all of the refillable 
container regulations if you are a registrant who distributes or sells 
a pesticide product in refillable containers. If your product is 
subject to the refillable container regulations as described in Unit 
VI.E., the product must be distributed or sold in refillable containers 
that comply with these regulations. This is true regardless of whether 
you repackage the product into the container yourself or whether you 
sell or distribute the product to an independent refiller, who 
repackages your product into refillable containers.
    In addition, you must comply with the regulations in Sec.  
165.45(f) for stationary pesticide containers if you are a refiller of 
a pesticide product and you are not the registrant of the pesticide 
product.
    2. Changes. For registrants, this is the same approach that we 
proposed in Sec. Sec.  165.122(a)(1)(i) and 165.122(a)(2)(i). However, 
the wording is more straightforward because the regulations for 
refillable containers were separated from the repackaging regulations 
in the final rule. This subpart includes only the refillable container 
standards, which apply to all registrants that use refillable 
containers to distribute or sell their products. The standards for 
repackaging were placed in a separate subpart, because those 
regulations must distinguish between registrants who repackage product 
directly into the containers and registrants who allow independent 
refillers to repackage their product into refillable containers.
    The final rule clarifies that refillers must comply with the 
requirements for stationary pesticide containers in Sec.  165.45(f). 
EPA believes it is reasonable to hold both the registrants and 
refillers responsible for meeting the stationary pesticide container 
standards in Sec.  165.45(f) because they are both selling and 
distributing the pesticide that is held in those containers.

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

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

[[Page 47370]]

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

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

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

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


[[Page 47371]]

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

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

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

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

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

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

[[Page 47372]]

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

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

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

[[Page 47373]]

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

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

    1. Final regulation. Stationary pesticide containers that are 
designed to hold undivided quantities of pesticides equal to or greater 
than 500 gallons (1,890 liters) of liquid pesticide or equal to or 
greater than 4,000 pounds (1,818 kilograms) of dry pesticide and are 
located at the refilling establishment of a refiller operating under 
written contract to a registrant must meet certain standards. As 
discussed in Unit VI.C., both registrants and refillers are responsible 
for ensuring that these requirements for stationary pesticide 
containers are met. First, all of these stationary pesticide containers 
(for liquid and dry pesticides) must be:
    <bullet> Resistant to extreme changes in temperature,
    <bullet> Constructed of materials that are adequately thick and 
that are resistant to corrosion, puncture, or cracking, and
    <bullet> Capable of withstanding all operating stresses.
    As proposed, these requirements do not apply during a civil 
emergency or any unanticipated grave natural disaster or other natural 
phenomenon of an exceptional, inevitable and irresistible character, 
the effects of which could not have been prevented or avoided by the 
exercise of due care or foresight.
    Second, several other standards apply only to liquid bulk 
containers. Specifically,
    <bullet> They must be equipped with a vent or other device designed 
to relieve excess pressure, prevent losses by evaporation, and exclude 
precipitation.
    <bullet> External sight gauges are prohibited.
    <bullet> Each container connection below the normal liquid level 
must be equipped with a shutoff valve, which is capable of being locked 
closed.
    <bullet> Shutoff valves must be located within a secondary 
containment unit (if secondary containment is required).
    2. Changes. There were several changes in this section from the 
proposed rule. First, the description of containers that must comply 
with these requirements was changed to be consistent with the 
quantities for secondary containment structures

[[Page 47374]]

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

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

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

L. Reporting (Sec.  165.47)

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

M. Proposed Standards That Are Not Being Finalized

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

[[Page 47375]]

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

N. Options for Implementing the Rule

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

VII. Repackaging Standards

A. Format Changes

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

[[Page 47376]]

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

B. Purpose (Sec.  165.60(a))

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

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

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

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

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

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

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

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

[[Page 47377]]

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

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

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

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

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

[[Page 47378]]

than 55 gallons or 100 pounds held in an individual container. In March 
1991, the Policy was amended (Ref. 71) to allow repackaging of any 
quantity of pesticides into refillable containers, provided that all 
three conditions below are met:
    (1) The container is designed and constructed to accommodate the 
return and refill of greater than 55 gallons of liquid or 100 pounds of 
dry material.
    (2) Either: (a) The containers are dedicated to and refilled with 
one specific active ingredient in a compatible formulation; or (b) the 
container is thoroughly cleaned according to written instructions 
provided by the registrant to the dealer prior to introducing another 
chemical into the container, in order to avoid cross-contamination.
    (3) All other conditions of the July 11, 1977 Policy are met.
    As discussed in the preamble of the proposed rule, EPA is replacing 
the Bulk Pesticides Enforcement Policy with these regulations, 
specifically Sec. Sec.  165.67(b) - (c) and 165.70(b) - (c). These 
regulations provide that a registrant may allow an independent refiller 
to repackage the registrant's pesticide product into any size 
refillable container and to distribute or sell such repackaged product 
under the registrant's registration (i.e., the product's EPA 
registration number stays the same), provided all conditions set out in 
the rule are met.
    These regulations do not change the existing law; the Bulk 
Pesticides Enforcement Policy would be replaced by a regulation. The 
registrant remains responsible for the integrity, labeling, and 
packaging of the repackaged product. Both the registrant and 
independent refiller may be held liable for violations pertaining to 
the repackaged product. The repackaging regulations set out the 
requirements for both registrants and independent refillers, because 
they have different roles and responsibilities in distributing 
pesticide products in refillable containers.
    The conditions set out in Sec. Sec.  165.67(b) - (c) and 165.70(b) 
- (c) do not apply to registrants repackaging their own pesticide 
products solely at their own establishments. As described in Pesticide 
Registration (PR) Notice 98-10 ``Notifications, Non-notifications and 
Minor Formulation Amendments,'' the registrant generally can modify the 
package size and label net contents statement without notifying EPA. 
(Ref. 56) This would be an amendment to the registration not requiring 
EPA notification or approval.
    2. Final regulations. The regulations implementing the legal basis 
for repackaging are similar to the provisions in the proposed rule with 
two significant changes, described in the next section, and some minor 
formatting modifications. Specifically, Sec. Sec.  165.67(b) and 
165.70(b) specify that a registrant may allow a refiller to repackage a 
pesticide product into refillable containers and to distribute or sell 
such repackaged product under the existing registration if all of the 
following conditions are satisfied:
    <bullet> The repackaging results in no change to the pesticide 
formulation.
    <bullet> One of the following conditions regarding a registered 
refilling establishment is satisfied:
    (1) The pesticide product is repackaged at a refilling 
establishment registered with EPA as required by Sec.  167.20 of this 
chapter.
    (2) The pesticide product is repackaged at the site of a user who 
intends to use or apply the product by a refilling establishment 
registered with EPA as required by Sec.  167.20.
    <bullet> The registrant has entered into a written contract with 
the refiller to repackage the pesticide product and to use the label of 
the pesticide product.
    <bullet> The pesticide product is repackaged only into refillable 
containers that meet the standards of subpart C.
    <bullet> The pesticide product is labeled with the product's label 
with no changes except the addition of an appropriate net contents 
statement and the refiller's EPA establishment number.
    In addition, the regulations (Sec. Sec.  165.67(c) and 165.70(c)) 
state that repackaging a pesticide product for distribution or sale 
without either obtaining a registration or meeting all of the 
conditions listed above is a violation of section 12 of FIFRA. Both the 
registrant of the product and the refiller that is repackaging the 
pesticide product under contract to the registrant may be liable for 
violations pertaining to the repackaged product.
    3. Changes. One significant change to these conditions for 
repackaging pesticide products for distribution or sale is to add the 
specification that the pesticide product can be repackaged by a 
registered refilling establishment at the site of a user who intends to 
use or apply the product as an acceptable alternative to the condition 
that the product must be repackaged at a registered refilling 
establishment. This change is discussed in detail in Unit VII.I. below. 
Another change is that the final rule specifies that the registrant 
must enter into a written contract with the refiller. The proposed 
option for the registrant to enter into a ``written authorization'' 
with the refiller is not being finalized for several reasons. First, 
EPA believes it is not necessary to have two different mechanisms. It 
is more straightforward to specify one method, which should facilitate 
compliance and minimize confusion. Second, EPA believes that a 
``written contract'' is more familiar to the regulated community and 
more defined in law than a ``written authorization,'' which is why we 
chose to specify contracts as the mechanism for establishing a 
repackaging relationship between the registrant and refiller in the 
final rule. Third, in the years since the Bulk Pesticides Enforcement 
Policy was issued, the ``written authorizations'' have become virtually 
indistinguishable from ``written contracts'' in format, length and 
level of detail. Therefore, EPA anticipates that specifying a contract 
(and not an authorization) in the final rule should not cause a 
substantial impact to the way repackaging is currently being conducted, 
particularly considering the 5-year implementation period for the 
refillable container and repackaging regulations. The other 
modifications were minor formatting changes that were needed to 
accommodate: (1) the revision to plain language; (2) needing to include 
the conditions in the requirements for registrants who distribute or 
sell to independent refillers and in the requirements for independent 
refillers; and (3) clarifying that the EPA establishment number added 
to the label is the refiller's EPA establishment number.
    4. Comments - implementation. One registrant urged EPA not to 
eliminate the ability of manufacturers and distributors that are not 
registrants of an MUP to repackage that product for distribution and 
sale.
    5. EPA response - implementation. In the preamble to the proposed 
regulations, EPA stated that the Bulk Pesticides Enforcement Policy 
would remain in effect until the date specified for compliance with the 
refillable container and repackaging regulations, at which point it 
would be rescinded. EPA will implement this as discussed in the 
preamble to the proposal. The refillable container and repackaging 
regulations will supersede the Bulk Policy for products that are 
subject to these regulations. Pesticide products that are exempt from 
the refillable container and repackaging regulations--MUPs, plant-
incorporated protectants, and some antimicrobials--can only be 
repackaged under the limitations established by FIFRA, the registration 
requirements in 40 CFR part 152, and the applicable OPP policies. A key

[[Page 47379]]

limitation is that the products that are exempt from the refillable 
container and repackaging regulations must be repackaged by the 
registrant or a person under written contract to the registrant. EPA 
believes this constraint will not be a problem for MUPs and exempt 
antimicrobials because we have received information that these products 
are repackaged by the registrants if they are sold or distributed in 
refillable containers. In addition, refillable containers are not 
appropriate for distributing plant-incorporated protectants, so these 
products will also not be adversely affected.
    One issue that has been raised is whether registrants and 
independent refillers can comply with the regulations (and specifically 
the conditions for repackaging pesticide products for distribution or 
sale) before the compliance date. This is appealing to registrants and 
independent refillers because the regulations allow pesticides to be 
repackaged under written contracts into refillable containers of any 
size (compared to the 55 gallon container size limit established in the 
Bulk Policy and maintained in the 1991 amendment). EPA believes that it 
is acceptable for registrants and independent refillers to repackage 
pesticide products under the regulations before the 5 year compliance 
date as long as they are in full compliance with the refillable 
container and repackaging regulations. In other words, registrants can 
enter into contracts with independent refillers to refill containers 
only if: (1) The containers comply with the refillable container 
regulations, i.e., they meet the specified DOT standards, have a 
durable serial number or other identifying code, and have one-way 
valves and/or tamper-evident devices; (2) the registrant meets the 
repackaging conditions and develops and provides the necessary 
information, including a description of acceptable containers and a 
cleaning procedure; (3) the refillers meet the repackaging conditions 
and comply with the operational procedures, including inspecting, 
cleaning (if necessary), and labeling the containers; and (4) all other 
requirements specified in the refillable container and repackaging 
regulations are followed.

H. Product Integrity

    1. Background. The Bulk Pesticides Enforcement Policy and both the 
proposed and final rules hold the registrant and the refiller (if 
different than the registrant) responsible for product integrity of the 
pesticide product repackaged by the refiller. ``Product integrity'' 
means that the pesticide product is not adulterated or different from 
the composition described in its confidential statement of formula that 
is required under FIFRA section 3. This requirement reflects current 
law. Under FIFRA section 12(a)(1), it is unlawful for any person to 
distribute or sell to any person a pesticide which is adulterated or 
whose composition differs from the composition described in its 
confidential statement of formula.
    FIFRA Section 12(a)(1) applies to pesticide distributed or sold in 
nonrefillable containers and in refillable containers. For pesticides 
distributed or sold in nonrefillable containers, it is clear that the 
registrants are responsible for product integrity because there are no 
other parties involved (except for supplemental registrants, as 
regulated by 40 CFR 152.132, and parties acting as agents under 
contract to the registrant). Similarly, when a registrant repackages a 
product directly into a refillable container for distribution or sale, 
it is also clear that the registrant is responsible for product 
integrity.
    The situation is less clear when a registrant distributes or sells 
a product to an independent refiller for repackaging into refillable 
containers. Both the registrants and the independent refillers are 
selling or distributing the product, so both parties are responsible 
for product integrity. The registrant is responsible because the 
registrant has authorized the independent refiller to repackage the 
registrant's pesticide product and to use the registrant's label 
according to the terms of the written contract (or authorization under 
the Bulk Policy). The registrant remains accountable for its repackaged 
product which is distributed or sold in the refillable container. EPA 
believes it is appropriate for registrants to be held responsible for 
acts by independent refillers because the repackaging is being done 
under the registrant's registration and the independent refillers are 
agents of the registrants for purposes of carrying out the written 
contract. The independent refiller is responsible for product integrity 
because the refiller is the person who physically places the product 
into the container for sale or distribution.
    In 1996, EPA established a policy on ``Toxicologically Significant 
Levels of Pesticide Active Ingredients'' in PR Notice 96-8. (Ref. 58) 
This document describes EPA's interpretation of the term 
``toxicologically significant'' as it applies to contaminants in 
pesticide products that are also active ingredients. The policy 
provides risk-based concentration levels of such contaminants that are 
generally considered to be toxicologically significant (and therefore 
must be reported and accepted as part of product registration according 
to 40 CFR 158.167). The concentrations are defined according to the 
type of pesticide that is contaminated (insecticide, herbicide, low 
dose herbicide, etc.) and the pesticide category of the contaminant. 
While PR Notice 96-8 applies to all pesticide products in nonrefillable 
and refillable containers, a driving force in developing the policy was 
the cross-contamination found in refillable containers in the early 
1990's.
    2. Final regulations. The repackaging regulations clearly hold all 
parties subject to the repackaging standards to be responsible for 
product integrity. This includes:
    (1) Registrants who distribute or sell a pesticide product in 
refillable containers (in Sec.  165.65(b));
    (2) Registrants who distribute or sell pesticide products to 
independent refillers for repackaging into refillable containers (in 
Sec.  165.67(e)); and
    (3) Refillers of a pesticide product that are not the registrants 
of the pesticide product (in Sec.  165.70(d)).
    Specifically, all of these businesses are responsible for the 
pesticide product that they distribute or sell not being adulterated or 
different from the composition described in the product's confidential 
statement of formula that is required under FIFRA section 3.
    3. Changes. The language in the final regulation is nearly 
identical to the text in the proposed regulation. One slight 
modification is that the phrase ``described in its confidential 
statement of formula that is required under FIFRA section 3'' is used 
in the final regulations because it is more straightforward than the 
proposed phrase ``described in the statement required in connection 
with registration under section 3 of the Act.'' EPA considers these two 
phrases to mean exactly the same thing.
    However, one thing that has changed since the proposed rule is 
EPA's policy on toxicologically significant levels of pesticide active 
ingredients. PR Notice 96-8 defines risk-based concentration levels of 
contaminants that are generally considered to be toxicologically 
significant. Active ingredient contaminants that are present at lower 
concentrations do not have to be reported by registrants and accepted 
by EPA as part of product registration. For example, if an herbicide 
active ingredient is detected at less than 1,000 ppm in any pesticide 
where the contaminant is accepted for use on all

[[Page 47380]]

sites for which the product is labeled, the herbicide active ingredient 
is not considered to be toxicologically significant. As described in PR 
Notice 96-8, the purpose of this policy is to: (1) Recognize that 
cross-contamination is a reality, and that not all cross-contamination 
is problematic; (2) set a clear standard that can be readily applied by 
EPA, States and the regulated industry; (3) ensure that allowable 
cross-contamination does not pose unreasonable adverse effects; (4) 
minimize the paperwork burden for EPA and registrants; (5) maintain 
accountability for the product from the registrant to the end user; and 
(6) not preclude marketplace or private solutions to correct problems 
that do arise.

I. Delivery and Repackaging at End User Locations

    1. Background. The 1977 Bulk Policy (Ref. 75) provided the 
following two examples of acceptable practices for shipping ``bulk'' 
pesticides to end users:
    <bullet> A registrant ships a bulk pesticide directly to an end 
user (custom applicator, farmer, etc.). The label accompanies the 
shipment and is placed on the user's tank. No new establishment or 
product registration is needed for the bulk container since the labeled 
product is fully registered and has been sold intact to the user.
    <bullet> A tank car of pesticide from which commercial applicators 
meter off into their own tanks, without being put into a dealer's 
holding tank, would be exempt from new producer establishment 
registration. It is considered that the original container has not been 
changed in delivery to the applicator and the tank car label (placard) 
will bear the producer's establishment number.
    In the preamble to the 1994 proposed rule, EPA stated that 
repackaging by the registrant must be done at a registered 
establishment, as required by 40 CFR part 167. In addition, EPA stated 
that we saw no reason to continue the exemption from the registered 
establishment requirement described in the second bullet in Unit I.1., 
above. We requested comments on the effect of discontinuing this 
exception.
    On February 3, 1994, EPA released the ``Bulk Pesticide Repackaging 
Question & Answer Document'' (Ref. 63) which included the following 
question and answer that address the issue of making a bulk delivery 
directly to an end user.
    18. May a registrant deliver pesticides in bulk directly to a 
farm, even if the farm is not registered as a producing 
establishment? May someone other than the registrant do this?
    Under the bulk pesticide repackaging policy, a registrant may 
deliver pesticides directly to a farm, even if the farm is not 
registered as a pesticide producing establishment. Someone other 
than the registrant could not deliver pesticides in bulk to a farm 
unless the farm was registered as a pesticide producing 
establishment and that person has received written authorization 
from the registrant to deliver the pesticide to the specific farm. 
The registrant of the establishment (i.e., the farmer) would also be 
required to submit annual production reports. Please note that some 
States and most registrants require containment structures for the 
storage of bulk pesticides. Most farmers do not have these 
containment structures and delivery to these farms may not be 
allowed under State law.

    After discussion and debate on this question among the regulated 
community and regulatory agencies, EPA reconsidered and revised our 
position in a memo titled ``Bulk Pesticide Transfers'' dated March 22, 
1995. (Ref. 59) The new question 18 supersedes the question in the 1994 
Bulk Policy Question & Answer document and is:
    18(a). May a registrant deliver pesticides in bulk directly to a 
farm, even if the farm is not registered as a producing 
establishment? May someone other than the registrant do this?
    A registrant, dealer, or other authorized person pursuant to the 
``Enforcement Policy Applicable to Bulk Shipments of Pesticides'' 
(July 11, 1977) may transfer pesticides in bulk at a farm, even if 
the farm is not registered as a pesticide producing establishment.
    18(b). May a registrant deliver pesticides in bulk directly to 
end use sites other than a farm, even if such site is not registered 
as a producing establishment? May someone other than the registrant 
do this?
    Yes. See answer to question 18(a) above. However, the Agency 
will continue to pursue enforcement actions against all end users 
that use any registered pesticide in a manner inconsistent with its 
labeling pursuant to FIFRA 12(a)(2)(G).

    The March 22, 1995 memo explained that this revision was made 
because end users are not the persons repackaging shipments of bulk 
pesticides at the farm and other end use sites. The memo further stated 
that the terms and conditions of the 1977 Bulk Policy and 1991 
amendment are unchanged. Since the pesticide that is transferred at the 
farm or other end use site is not being transferred and held for 
further sale, final accountability for meeting the terms of the Bulk 
Policy remains with the registrant and the last establishment making a 
transfer associated with a pesticide sale, the dealer. Registrant and 
dealer establishments are responsible for reporting repackaging as 
production pursuant to 40 CFR 167.85. In the memo, EPA recommended (but 
did not require) that pesticides be transferred into stationary bulk 
containers protected by a secondary containment structure at end user 
sites.
    2. Final Regulation. One of the requirements specified in 
Sec. Sec.  165.67(b) and 165.70(b) for when a registrant may allow a 
refiller to repackage its pesticide product into refillable containers 
and to distribute or sell such repackaged product under the existing 
registration is:
    One of the following conditions regarding a registered refilling 
establishment is satisfied:
    (1) The pesticide product is repackaged at a refilling 
establishment registered with EPA as required by Sec.  167.20.
    (2) The pesticide product is repackaged at the site of a user who 
intends to use or apply the product by a refilling establishment 
registered with EPA as required by Sec.  167.20.
    3. Changes. The first condition listed above (Unit I.2.(1)) (the 
product is repackaged at a registered refilling establishment) is the 
same as the proposed regulation. The second condition--the product is 
repackaged at the site of a user who intends to use or apply the 
product by a registered refilling establishment--was added to the final 
rule to be consistent with EPA's revised policy as described in the 
March 22, 1995 ``Bulk Pesticide Transfers'' memo. The final regulation 
is consistent with EPA's 1995 position that final accountability for 
meeting the terms of the Bulk Policy remains with the registrant and 
the last establishment making a transfer associated with a pesticide 
sale (an independent refiller in this case), because the pesticide that 
is transferred at the farm or other end use site is not being 
transferred and held for further sale.
    EPA has received anecdotal evidence that the practice of refilling 
containers (bulk containers, minibulks, application tanks, nurse tanks, 
etc.) at end user sites has increased over the past few years and may 
continue to increase in the future. Therefore, EPA is concerned about 
the potential for spills, leaks and other releases during transfers at 
end user sites to cause soil and water contamination. As described in 
the preamble to the proposed rule, EPA decided to require containment 
structures at dealers, commercial applicators and custom blenders with 
bulk storage tanks, largely because these were the kinds of sites where 
contamination had been documented. EPA did not and still does not have 
documentation of end user site contamination due to repackaging 
pesticide product. Therefore, the final pesticide container and 
containment

[[Page 47381]]

regulations do not require repackaging at end user sites to be done 
within a containment structure. However, EPA strongly recommends that 
repackaging at end user sites be conducted over some kind of 
containment--whether it is a permanent concrete containment pad or a 
portable containment structure. In the future, EPA may revise the 
repackaging regulations to require all repackaging (including at end 
user sites) to occur over a containment structure if we become aware of 
a pattern of end user site contamination being caused by repackaging.

J. Registrants Who Distribute or Sell Pesticide Products in Refillable 
Containers - Overview (Sec.  165.65)

    1. Final Regulation. The regulations in Sec.  165.65 apply to 
registrants who distribute or sell pesticide products in refillable 
containers. This means that the registrant conducts all of the 
repackaging for the product and does not distribute or sell the product 
to a refiller that is not part of its company for refilling.
    Of course, a registrant may repackage a product directly into 
refillable containers for sale or distribution and distribute or sell 
that same product to an independent refiller for repackaging. In this 
case, the registrant must comply with both sets of requirements: the 
standards in Sec.  165.65 for those quantities the registrant 
distributes or sells directly in refillable containers and the 
requirements in Sec.  165.67 for those quantities that the registrant 
distributes or sells to independent refillers for repackaging.
    A registrant who distributes or sells a pesticide product directly 
in refillable containers:
    <bullet> Is responsible for the integrity of the product, as 
discussed in Unit VII.H.;
    <bullet> Must develop a refilling residue removal procedure, as 
discussed in Unit VII.M.;
    <bullet> Must develop a description of acceptable containers, as 
discussed in Unit VII.N.;
    <bullet> Must comply with the requirements for refillers (including 
having certain information and inspecting, cleaning, and labeling the 
refillable containers), as discussed in Unit VII.O. through VII.R.;
    <bullet> Must keep records, including copies of the refilling 
residue removal procedure and the description of acceptable containers 
and certain information about each instance of repackaging. The 
recordkeeping requirements are discussed in Unit VII.S.
    2. Changes. All of these requirements for registrants who 
distribute or sell pesticide products directly in refillable containers 
were included in the proposed regulation. Some of the requirements were 
modified based on comments and the change to refer to and adopt some of 
the DOT standards. The specific changes to these requirements are 
discussed in other sections of Unit VII.

K. Registrants Who Distribute or Sell Pesticide Products to Refillers 
for Repackaging - Overview (Sec.  165.67)

    1. Final Regulation. The regulations in Sec.  165.67 apply to 
registrants who distribute or sell pesticide products to refillers that 
are not part of their companies for repackaging into refillable 
containers. This is the more common form of repackaging, where the 
registrant ships in bulk to a refiller (normally a retailer) who 
repackages the product into portable pesticide containers.
    As mentioned above, a registrant may repackage a product directly 
into refillable containers for sale or distribution and distribute or 
sell that same product to an independent refiller for repackaging. In 
this case, the registrant must comply with both sets of requirements: 
the standards in Sec.  165.65 for those quantities the registrant 
distributes or sells directly in refillable containers and the 
requirements in Sec.  165.67 for those quantities that the registrant 
distributes or sells to independent refillers for repackaging.
    A registrant who distributes or sells a pesticide product to an 
independent refiller for repackaging:
    <bullet> Must comply with the conditions for allowing a refiller to 
repackage his product, as discussed in Unit VII.G.;
    <bullet> Must provide the refiller with the written contract to 
repackage before distributing or selling the product to the refiller;
    <bullet> Is responsible for the integrity of the product, as 
discussed in Unit VII.H.;
    <bullet> Must develop a refilling residue removal procedure, as 
discussed in Unit VII.M.;
    <bullet> Must develop a description of acceptable containers, as 
discussed in Unit VII.N.;
    <bullet> Must provide the refilling residue removal procedure, 
description of acceptable containers, and the product's label and 
labeling to the refiller before or at the time of distribution or sale 
to the refiller;
    <bullet> Must keep records of the contracts, the refilling residue 
removal procedure, and the description of acceptable containers. The 
recordkeeping requirements are discussed in Unit VII.S.
    The requirements that are specific to registrants who distribute or 
sell pesticide products to independent refillers for repackaging are 
the two that establish standards for the timing of when the registrant 
provides documents to the refiller. Under Sec.  165.67(d), the 
registrant must provide the written contract to repackage the product 
before selling or distributing the product to the refiller. Section 
165.67(g) specifies that the other information (cleaning procedure, 
description of acceptable containers, and label/labeling) can be 
provided earlier but must be provided to the refiller at the time of 
sale or distribution at the latest. These two provisions are identical 
to the proposed regulations.
    2. Changes. All of these requirements for registrants who 
distribute or sell pesticide products to refillers for repackaging were 
included in the proposed regulation. Some of the requirements were 
modified based on comments, modifications to some EPA policies, and the 
change to refer to and adopt some of the DOT standards. The specific 
changes to these requirements are discussed in other sections of Unit 
VII.

L. Refillers Who Are Not Registrants - Overview (Sec.  165.70)

    1. Final Regulation. The regulations in Sec.  165.70 apply to 
refillers who are not registrants of the products that they repackage 
for sale or distribution.
    A refiller who repackages a product for distribution or sale and is 
not the registrant of the product:
    <bullet> Must comply with the conditions for allowing him to 
repackage the registrant's product, as discussed in Unit VII.G.;
    <bullet> Is responsible for the integrity of the product, as 
discussed in Unit VII.H.;
    <bullet> Must comply with the requirements for refillers (including 
having certain information and inspecting, cleaning, and labeling the 
refillable containers), as discussed in Unit VII.O. through VII.R.;
    <bullet> Must keep records, including copies of the contract from 
the registrant, refilling residue removal procedure, and description of 
acceptable containers, and certain information about each instance of 
repackaging. The recordkeeping requirements are discussed in Unit 
VII.S.
    2. Changes. All of these requirements for independent refillers 
were included in the proposed regulation. Some of the requirements were 
modified based on comments, modifications to some EPA policies, and the 
change to refer to and adopt some of the DOT standards. The specific 
changes to these requirements are discussed in other sections of Unit 
VII.

[[Page 47382]]

    3. Comments - whether or not to include custom blending in this 
rule. In the preamble to the proposed rule, EPA discussed whether or 
not the requirements for independent refillers should apply to custom 
blenders, who provide the service of mixing pesticides with fertilizer, 
feed, or another pesticide to a customer's specification. The preamble 
provided two options for the final rule: (1) Issue a regulation on 
refilling practices that is tailored specifically to custom blenders 
that distribute pesticide mixtures, or (2) exempt custom blenders from 
the repackaging requirements. EPA requested comments on these options.
    A few commenters showed lukewarm support for applying the 
repackaging regulations to custom blenders. A registrant was unaware of 
pressing reasons to exclude custom blenders and pointed out that custom 
blenders are usually custom applicators. A State regulatory agency 
stated that custom blenders should be required to meet the refilling 
requirements if the criteria apply to them. This commenter also pointed 
out that custom blends are generally placed into a spreader, not a 
container.
    A registrant group stated that custom blenders provide valuable 
service in reducing pesticide container use and applicator exposure. 
This respondent recommended developing standards that are specific to 
custom blenders and that address items such as container integrity and 
cleaning procedures.
    A registrant distinguished between custom blending and selling a 
pesticide product in a refillable container with a registrant's label 
on it as two different activities. A few dealer groups strongly urged 
EPA to exclude custom applicators from the refiller requirements. The 
retailer-related commenters believe it is inappropriate to address 
custom blenders in a section that focuses on maintaining the original 
integrity of repackaged pesticides. They also described current custom 
blending practices in the Midwest, including the following points:
    <bullet> Midwest dealers with bulk pesticides are mostly all custom 
blenders and custom applicators and have become repackagers recently.
    <bullet> It is common for the volume of bulk pesticides that goes 
into custom blends to exceed the volume that is repackaged into 
refillable containers.
    <bullet> Custom blends may be loaded into custom application and 
nurse vehicles of that dealer, another for-hire custom applicator, or a 
customer.
    <bullet> On the other hand, registered bulk pesticides are: (1) 
Repackaged into minibulk containers; (2) moved in portable service 
containers from the bulk container to supply the dealer's custom 
application operation in the field; and (3) loaded into tanks that are 
an integral part of application or nurse vehicles for field nursing or 
to supply injection systems.
    4. EPA response - whether or not to include custom blending in this 
rule. In the final rule, EPA decided to exempt custom blending from 
having to comply with the repackaging requirements. As stated by 
several of the commenters, EPA determined that there is an inherent 
difference between custom blending and repackaging pesticide products 
for sale or distribution. When a product is repackaged for sale or 
distribution, it must maintain the characteristics of the product and 
meet the ingredient contents identified on the label and in the 
product's registration. On the other hand, a custom blend intentionally 
mixes a pesticide with another substance. While the product's labeling 
must be consistent with the custom blend (i.e., the labeling directions 
do not prohibit the use of the product in such a blend) and the 
product's label must be delivered to the end-user, the material in the 
custom blend is no longer just the pesticide product identified on the 
label. In fact, the custom blender must deliver a statement specifying 
the composition of the mixture.
    The exemption for custom blending was added to Sec.  165.63(h) of 
the final regulation, which asks ``Are there any other exceptions?'' 
Paragraph (h) in Sec.  165.63 was added to state that custom blending 
is exempt from the regulations in this subpart. In addition, Sec.  
165.3 of the regulations define custom blending as ``Custom blending 
means the service of mixing pesticides to a customer's specifications, 
usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a 
pesticide-animal feed mixture, when:
    (1) The blend is prepared to the order of the customer and is not 
held in inventory by the blender;
    (2) The blend is to be used on the customer's property (including 
leased or rented property);
    (3) The pesticide(s) used in the blend bears end-use labeling 
directions which do not prohibit use of the product in such a blend;
    (4) The blend is prepared from registered pesticides; and
    (5) The blend is delivered to the end-user along with a copy of the 
end-use labeling of each pesticide used in the blend and a statement 
specifying the composition of the mixture.''
    This description is based on the definition of ``custom blender'' 
in 40 CFR 167.3, but was modified to reflect the practice of custom 
blending rather than the establishment at which it takes place. The 
Sec.  167.3 definition focuses on the establishment, because the part 
167 regulations then exempt custom blenders from the requirements to 
register their establishments (in Sec.  167.20(a)(1)) and to report 
production (in Sec.  167.85(a)). The Sec.  167.3 definition of custom 
blender includes a sixth condition--that no other pesticide production 
activity is performed at the establishment--because these other 
activities would subject a custom blender to the establishment 
registration and production reporting requirements. However, this sixth 
condition is not relevant to the pesticide product repackaging 
requirements in 40 CFR part 165 subpart D because the subpart D 
regulations are tied to the process or action of repackaging. As 
reported by several commenters, a facility may conduct several 
different activities, including repackaging pesticide products into 
refillable containers and custom blending. In this case, the 
repackaging must be conducted in accordance with the regulations in 
this subpart, while the custom blending is exempt from the regulations 
in this subpart.
    It is worth noting that the containment regulations in subpart E 
apply to some custom blenders, specifically ``custom blenders of 
agricultural pesticides.''
    5. Comments - mixing diluent with pesticides. Several commenters 
(dealer groups and a dealer) urged EPA to allow water as a blend 
component. One retailer described the awkwardness of the situation when 
such mixing is not permitted -- a dealer can put pesticide in a 
farmer's application equipment at its facility (with a containment 
pad), but the farmer has to return to his own location to add water and 
finish preparing the application mixture. The two dealer groups 
suggested or stated that using water as a custom blend component is 
currently practiced in the Midwest. The two dealer groups also 
recommended deleting condition <greek-i>6 in the Sec.  167.3 definition 
of custom blender which specifies that ``no other pesticide production 
activity is performed at the establishment.''
    6. EPA response - mixing diluent with pesticides. EPA disagrees 
with the comment to delete condition <greek-i>6 in the Sec.  167.3 
definition of custom blender that specifies ``no other pesticide 
production activity is performed at the establishment.'' As described 
above, this condition is intended to distinguish between custom 
blenders - who are exempt from the part 167 establishment registration 
requirements - and

[[Page 47383]]

producing establishments, who are required to register their 
establishments. Condition <greek-i>6 does not prevent a facility from 
conducting custom blending and repackaging (producing). These 
facilities must register as establishments because they are producing 
establishments. Instead, condition <greek-i>6 is intended to describe 
the facilities that are exempt from the establishment registration 
requirements, i.e., facilities that custom blend and do not repackage 
or otherwise produce pesticides.
    However, EPA considered the request from commenters to allow custom 
blends to be diluted with water. Various offices and Regions within 
EPA, as well as the States, have not had a consistent policy about 
whether custom blends can be diluted with water or another diluent. 
After reviewing this issue, it is appropriate to clarify our position 
on diluting custom blends. EPA believes that the definition of custom 
blender in Sec.  167.3 provides flexibility. Custom blenders are 
defined as ``any establishment which provides the service of mixing 
pesticides to a customer's specifications, usually a pesticide(s)-
fertilizer(s), pesticide-pesticide, or a pesticide-animal feed mixture, 
when'' the six conditions described above are met. In particular, the 
word ``usually'' in this definition provides flexibility and allows 
water (or other diluents when specified by the labeling of the 
pesticide[s] in the blend) to be added to custom blends.
    EPA believes that the language of Sec.  167.3 allows custom blends 
to be diluted with water or a diluent specified on the labels of all 
pesticides in the blend. In many ways, it is more efficient and 
possibly more accurate for the facility that is measuring and blending 
pesticides, fertilizers and/or animal feed to also measure and blend 
the diluent into the custom blend. In addition, custom blends (with 
diluents) that are delivered to an end user as a use-dilution (usually 
in refillable containers) offer worker exposure and environmental 
protection benefits including eliminating the need for end users to 
mix, handle and potentially spill the pesticide in the field; 
eliminating the need for the end user to rinse containers in the field; 
allowing the use of closed systems; and reducing the number of 
nonrefillable containers that must be disposed or recycled. However, 
EPA wants to clarify that custom blends with a diluent added still must 
comply with all five conditions in the definition of custom blend in 
Sec.  165.3: ``Custom blending means the service of mixing pesticides 
to a customer's specifications, usually a pesticide(s)-fertilizer(s), 
pesticide-pesticide, or a pesticide-animal feed mixture, when:
    (1) The blend is prepared to the order of the customer and is not 
held in inventory by the blender;
    (2) The blend is to be used on the customer's property (including 
leased or rented property);
    (3) The pesticide(s) used in the blend bears end-use labeling 
directions which do not prohibit use of the product in such a blend;
    (4) The blend is prepared from registered pesticides; and
    (5) The blend is delivered to the end-user along with a copy of the 
end-use labeling of each pesticide used in the blend and a statement 
specifying the composition of the mixture.''
    EPA will monitor the practices and procedures that develop and 
proliferate in the field with this interpretation. If problems develop, 
EPA will consider options, including revising its interpretation, 
adding protective conditions if diluents are added to custom blends, 
and subjecting custom blending to the repackaging requirements in part 
165.
    In addition, EPA does not view a difference between custom blending 
and custom mixing from a regulatory point of view. A custom mixer is a 
facility that stores materials previously purchased by end-users and 
that custom mixes the products just prior to application. A custom 
mixer does not own, sell or apply the product, although the conditions 
in the Sec.  165.3 definition of custom blending are met. Over the 
years, there have been different interpretations of whether or not 
there is a difference between custom blending and custom mixing. At 
least a few businesses have been established as custom mixers under the 
determination that they are not custom blenders. This final rule does 
not distinguish between custom blenders and custom mixers. Similarly, 
the policy of allowing diluents to be added to custom blends applies to 
both custom blenders and custom mixers. As discussed above, custom 
blending is excluded from the subpart D repackaging requirements. 
However, custom blenders (including custom mixers) would be subject to 
the subpart E containment standards if they blend (mix) agricultural 
pesticides.
    7. Comments - service containers. A few dealer groups noted that 
the proposed rule does not address service containers, which are used 
to move pesticides from bulk storage to end-use applications in the 
field, e.g., the tanks that are an integral part of application or 
nurse vehicles. These commenters pointed out some advantages of service 
containers including: reducing the number of nonrefillable containers 
used, keeping pesticides separate from water or fertilizers during 
transportation, accommodating on-board injection systems and allowing 
the applicator to adjust pesticides in the field. These commenters 
urged EPA and industry to consider providing for the expanded use of 
service containers, with some exclusions from the refillable container 
requirements, to increase the use of bulk pesticides. A State 
regulatory agency supported keeping the Bulk Policy because they don't 
want to register each facility where bulk pesticides are metered, such 
as where pest control operators place pesticides into service 
containers.start here
    8. EPA response - service containers. The pesticide container and 
repackaging regulations do not regulate service containers, because the 
container and repackaging regulations only apply to containers that are 
used to sell or distribute pesticide products and to the repackaging of 
products for sale or distribution. For the purposes of this discussion, 
a service container is defined as ``any container used to hold, store, 
or transport a pesticide concentrate or a pesticide use-dilution 
mixture, other than the original labeled container in which the product 
was distributed or sold, the measuring device, or the application 
device.''
    EPA does not currently regulate service containers. In 1976, EPA 
issued a Pesticide Enforcement Policy Statement (PEPS) on ``Structural 
Pest Control: Use and Labeling of Service Containers for the 
Transportation or Temporary Storage of Pesticides,'' which defined 
minimal labeling requirements and several other limitations for the 
acceptable use of service containers by structural pest control 
operators. (Ref. 76) However, this PEPS was later rescinded. EPA 
continues to believe that it is a good management practice to ensure 
that the contents of service containers are identified and that the 
label of a pesticide product that is in a service container is 
available to the person handling and/or applying the pesticide. EPA may 
consider developing a separate policy on service containers while the 
pesticide container and containment regulations are being phased in.

M. Registrant Refilling Residue Removal Procedure (Sec.  165.65(c)(1) 
and 165.67(f)(1))

    1. Final Regulation. Registrants who sell or distribute pesticide 
products directly in refillable containers and registrants who sell or 
distribute products to independent refillers for repackaging must 
develop a refilling

[[Page 47384]]

residue removal procedure that describes how to remove pesticide 
residue from a refillable container (portable or stationary pesticide 
container) before it is refilled. Registrants must specify a cleaning 
procedure for each product sold or distributed in refillable 
containers, although the same procedure can be used for multiple 
products. The refilling residue removal procedure must provide 
instructions for removing residues from all refillable containers. The 
same procedure can apply to portable and stationary pesticide 
containers, or the registrant can describe different procedures if it 
is appropriate and necessary. Finally, the refilling residue removal 
procedure describes how to remove residue from a refillable container. 
While this generally involves rinsing the container with water, the 
regulations do not specifically require rinsing with water. If a 
different procedure is appropriate for a given formulation, it can be 
used as long as it meets the following performance standard.
    The refilling residue removal procedure must meet the performance 
standard of being adequate to ensure that the composition of the 
pesticide product does not differ at the time of its distribution or 
sale from the composition described in its confidential statement of 
formula. This standard ensures that the products distributed and sold 
in refillable containers meet the existing product integrity 
requirements, as described in Unit VII.H.
    The refilling residue removal procedure must describe how to manage 
any rinsate resulting from the procedure in accordance with applicable 
Federal and State regulations if: (1) The procedure requires the use of 
a solvent other than the diluent used for applying the pesticide, or 
(2) there is no diluent used for application. This information is 
necessary to help refillers manage rinsate that cannot easily be used 
as make-up water in future applications.
    2. Changes. This requirement is the same as it was in the proposed 
rule. Several minor editing change have been made to improve the 
clarity and the different refillable containers are described as 
portable and stationary pesticide containers because the definitions of 
minibulk and bulk are not being finalized. These modifications have not 
changed the requirement or intent of the requirement.

N. Registrant Description of Acceptable Containers (Sec. Sec.  
165.65(c)(2) and 165.67(f)(2))

    1. Final regulation. Registrants who sell or distribute pesticide 
products directly in refillable containers and registrants who sell or 
distribute products to independent refillers for repackaging must 
develop a description of acceptable refillable containers (portable and 
stationary pesticide containers) that can be used for distributing or 
selling that pesticide product. An acceptable container is one which 
the registrant has determined meets the refillable container standards 
in subpart C and is compatible with the pesticide formulation intended 
to be distributed and sold using the refillable container. The 
registrant must identify the containers by specifying: (1) The 
container materials of construction that are compatible with the 
pesticide formulation; and (2) information necessary to confirm 
compliance with the refillable container requirements in subpart C. The 
refillable container requirements include the adopted DOT standards, 
being marked with a serial number or other identifying code, having a 
one-way valve or tamper-evident device on each opening (other than a 
vent) of a portable pesticide container designed for liquids, and the 
stationary pesticide container requirements.
    Similar to the refilling residue removal procedure, registrants 
must specify a description of acceptable containers for each product 
sold or distributed in refillable containers, although the same 
description can be used for multiple products if it meets the 
standards.
    2. Changes. This requirement was changed significantly from the 
proposed rule. The proposal would have required registrants to develop 
lists (not descriptions) of acceptable containers, which would have 
been identified by specifying the container manufacturer and model 
number of the container. This was proposed because registrants are 
responsible for ensuring that the refillable containers used to sell 
and distribute their products meet the requirements in the container 
regulations. When EPA proposed the rule, specifying the container 
manufacturer and model number seemed like a relatively easy way for 
registrants to identify acceptable containers for their refillers.
    However, the final rule's approach of referring to and adopting 
some DOT requirements provides an even easier way for registrants to 
identify acceptable containers to the refillers. Rather than citing 
specific model numbers, the registrants can provide refillers with a 
much less prescriptive approach by identifying characteristics, such as 
the material of construction, how to determine if the container meets 
the applicable DOT standards, how to comply with the serial number 
requirement, how to obtain and apply one-way valves and/or tamper-
evident devices to the openings of portable pesticide containers for 
liquids and information for complying with the stationary pesticide 
container standards.
    3. Comments. Several commenters (registrants and a registrant 
group) recommended that instead of a list of acceptable containers, the 
registrants should identify acceptable containers by providing the 
compatible materials of construction and the necessary information to 
apply the DOT standards. The registrant group and a distributor 
commented that this requirement will be helpful to ensure that 
formulators and subregistrants know and obtain information about the 
proper packaging.
    4. EPA response. In the final rule, EPA changed the requirement for 
identifying acceptable containers so registrants can describe 
acceptable containers by specifying compatible materials of 
construction and the information necessary to comply with the 
refillable container requirements. This includes information for 
complying with the adopted DOT standards, but also the other 
requirements in subpart C.

O. Requirements for All Refillers (Sec. Sec.  165.65(d) and 165.70(e))

    1. Final regulation. All refillers, including those at registrant's 
facilities and those who are not part of a registrant's company must 
comply with the following provisions regarding repackaging a pesticide 
product into refillable containers:
    *(1) The establishment must be registered with EPA as a producing 
establishment as required by Sec.  167.20 of this chapter.
    *(2) The refiller must not change the pesticide formulation unless 
he has a registration for the new formulation.
    (3) The refiller must repackage a pesticide product only into a 
refillable container that is identified on the description of 
acceptable containers for that pesticide product.
    (4) The refiller may repackage any quantity of a pesticide product 
into a refillable container up to the rated capacity of the container. 
In addition, there are no general limits on the size of the refillable 
containers that can be used.
    (5) The refiller must have all of the following items at the 
establishment

[[Page 47385]]

before repackaging a pesticide product into any refillable container 
for distribution or sale:
    *(A) The written contract from the pesticide product's registrant. 
[Subparagraph A applies only to independent refillers.]
    *(B) The pesticide product's label and labeling.
    (C) The written refilling residue removal procedure for the 
pesticide product.
    (D) The written description of acceptable containers for the 
pesticide product.
    (6) Before repackaging a pesticide product into any refillable 
container for distribution or sale, the refiller must identify the 
pesticide product previously contained in the refillable container to 
determine whether a residue removal procedure must be conducted in 
accordance with the cleaning requirements described in Unit VII.Q. The 
refiller may identify the previous pesticide product by referring to 
the label or labeling.
    (7) The refiller must inspect each refillable container as 
discussed in Unit VII.P.
    (8) The refiller must clean each refillable container, if required, 
as discussed in Unit VII.Q.
    *(9) The refiller must ensure that each refillable container is 
properly labeled as discussed in Unit VII.R.
    (10) The refiller's establishment must maintain records, as 
discussed in Unit VII.S.
    *(11) The refiller's establishment must maintain records as 
required by 40 CFR part 169.
    *(12) The refiller's establishment must report as required by 40 
CFR part 167.
    (13) Stationary pesticide containers (that meet the specified size 
criteria) at the establishments of independent refillers must meet the 
standards in Sec.  165.45(f). [Paragraph 13 is only included in the 
regulations in Sec.  165.70(e) for independent refillers. The 
refillable container regulations state that both the registrant and 
independent refillers are responsible for complying with the stationary 
pesticide container requirements.]
    (14) Refillers may be required to comply with the containment 
standards in subpart E. [Paragraph 14 applies only to independent 
refillers.]
    These requirements, except for items 5(A), 13 and 14 which apply 
only to independent refillers, apply to any refiller that repackages a 
product subject to the regulations regardless of the main business of 
the refiller (registrant, retailer, etc.). Some of these conditions 
(indicated by an asterisk) simply refer to or reinforce key 
requirements in existing regulations, including 40 CFR parts 156, 167 
and 169 or incorporate existing standards of the Bulk Policy (having a 
copy of the registrant's contract). These provisions are included here 
for the sake of completeness and as a reference for refillers.
    In other words, the new provisions for refillers are that each 
refiller:
    <bullet> Must repackage a product only into a container identified 
on the registrant's description of acceptable containers;
    <bullet> May repackage any quantity of a product into a refillable 
container (up to its rated capacity) and there are no general limits on 
the size of the refillable containers;
    <bullet> Must have certain documents before repackaging;
    <bullet> Must identify the product previously in the container by 
its label;
    <bullet> Must inspect and, if necessary, clean the container; and
    <bullet> Must maintain certain records.
    EPA believes that these provisions are good management practices 
that are intended to ensure product and container integrity. The second 
provision actually removes a condition on container size from the bulk 
policy. In other words, it provides more flexibility to registrants and 
refillers than currently exists.
    2. Changes. Regarding the list of requirements for refillers, the 
final regulations are very similar to the proposed rule. However, the 
structure and order of the final rule was revised to list these 
requirements in one section. EPA believes this makes the regulations 
more clear, which should facilitate compliance. The items that refer to 
existing requirements in 40 CFR parts 167 and 169 were added to the 
list to provide a more complete reference for refillers. However, these 
statements simply refer to existing requirements; they don't add new 
ones.
    Adjustments were made to a few of the provisions. Specifically, the 
requirements in the proposed rule that referred to the registrant's 
list of acceptable containers were changed to refer to the registrant's 
description of acceptable containers (see items 3 and 5 above), to 
accommodate the changes described in Unit VII.N. Also, the proposed 
regulatory text did not explicitly allow any size refillable container 
to be used, although the preamble discussed removing the size limit in 
the Bulk Policy in some detail. Therefore, a sentence clarifying that 
there are no general limits for the size of refillable containers was 
added to the statement allowing any quantity of pesticide (up to the 
container's rated capacity) to be repackaged. (See item 4.)
    Specific modifications made to the inspecting, cleaning, labeling 
and recordkeeping requirements and comments on these standards are 
discussed in detail in Units VII.P. - VII.S.
    The refillable container regulations were modified to clarify that 
both registrants and refillers are responsible for complying with the 
stationary pesticide container requirements in Sec.  165.45(f). The 
final repackaging rule includes this provision in the list of 
requirements as a reminder for independent refillers.

P. Inspecting Refillable Containers (Sec. Sec.  165.65(e)and 165.70(f))

    1. Final regulation. Before repackaging pesticide products into 
refillable containers, refillers must visually inspect the exterior and 
(if possible) the interior of the container and the exterior of 
appurtenances. The purpose of the inspection is to determine whether 
the container meets the necessary criteria with respect to continued 
container integrity, required markings and openings (tamper-evident 
devices or one-way valves). As with the proposed regulations, 
inspecting the containers is the responsibility of the refillers, since 
they are the ones who are actually handling and refilling the 
containers. If any of the failure conditions in this section are 
observed during the inspection, the container cannot be refilled unless 
the problems are rectified and the associated acceptability criterion 
(either reconditioning according to DOT's requirements or coming into 
compliance with the refillable container standards in subpart C) is 
satisfied.
    The container fails the inspection and must not be refilled (unless 
the applicable DOT standards for reconditioning are met) if the 
integrity of the container is compromised in any of the following ways:
    <bullet> The container shows signs of rupture or other damage which 
reduces its structural integrity. [Based on the criterion in 49 CFR 
173.28(a)]
    <bullet> The container has visible pitting, significant reduction 
in material thickness, metal fatigue, damaged threads or closures, or 
other significant defects. [Based on the criterion in 49 CFR 
173.28(c)(1)(iii)]
    <bullet> The container has cracks, warpage, corrosion or any other 
damage which might render it unsafe for transportation. [Based on the 
criterion in 49 CFR 180.352(b)(2)(iii)]
    <bullet> There is damage to the fittings, valves, tamper-evident 
devices or other appurtenances that may cause failure of the container. 
[Similar to the criterion in

[[Page 47386]]

49 CFR 180.352(b)(2)(ii) for service equipment.]
    If either of the following conditions exists (or both), the 
container fails the inspection and must not be refilled until the 
container meets the refillable standards specified in subpart C. The 
conditions are:
    <bullet> The container does not bear the markings required by 
subpart C or such markings are not legible.
    <bullet> The container does not have an intact and functioning one-
way valve or tamper-evident device on each opening other than a vent, 
if required.
Note that these two conditions are written so refillers of 
antimicrobial products used in swimming pools and related sites would 
not have to inspect for a serial number (because it's not a marking 
required by subpart C for these products) or for an intact and 
functioning one-way valve or tamper-evident device on each opening, 
because neither is required for these products.
    2. Changes. The general obligation to inspect refillable containers 
before repackaging pesticide products into them is the same as the 
proposed rule. However, EPA made several changes to the details of the 
inspection. First, we based the conditions for failing the inspection 
on conditions specified in the DOT regulations in 49 CFR 173.28 and 
180.352(b)(2). A commenter suggested this change and EPA believes it is 
an appropriate modification and is consistent with other changes in the 
regulation to refer to and adopt the DOT standards for container 
design, construction and marking. While we don't think the criteria in 
the final rule are necessarily more stringent than those in the 
proposed rule, we believe that consistency with DOT is beneficial. 
Second, the inspection requirement was modified to clarify that if 
problems found during the inspection are fixed and certain criteria are 
met, the container can be refilled. Under the proposed standard, it was 
not clear that a container could be reconditioned or brought into 
compliance with the refillable container standards and then refilled. 
Several other minor modifications were made to account for changes in 
the regulations, including: (1) removing the reference to a standard 
for the age of the container and (2) clarifying that vents do not need 
to have one-way valves or tamper-evident devices. Because the 
refillable container regulations in subpart C exempt antimicrobial 
products used in swimming pools and related sites from the serial 
number requirement and the standard requiring a one-way valve or 
tamper-evident device, the final rule was written so that refillers of 
these products are not subject to the failure criteria that address 
serial numbers, one-way valves, or tamper-evident devices.

Q. Cleaning Refillable Containers (Sec. Sec.  165.65(f) - (g) and 
165.70(g) - (h))

    1. Final regulation. Refillers must clean refillable containers by 
conducting the pesticide product's refilling residue removal procedure 
before repackaging the product into the refillable container, unless 
condition <greek-i>1 and either condition <greek-i>2 or <greek-i>3 are 
satisfied:
    (1) Each tamper-evident device and one-way valve is intact (if 
required).
    (2) The refillable container is being refilled with the same 
pesticide product.
    (3) Both of the following conditions are satisfied.
    (A) The container previously held a pesticide product with a single 
active ingredient and is being used to repackage a pesticide product 
with the same single active ingredient.
    (B) There is no change that would cause the composition of the 
product being repackaged to differ from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3. Examples of unallowable changes include the active 
ingredient concentration increasing or decreasing beyond the limits 
established by the confidential statement of formula or a reaction or 
interaction between the pesticide product being repackaged and the 
residue remaining in the container.
If a tamper-evident device or one-way valve is not intact, the refiller 
must clean the container according to the product's refilling residue 
removal procedure. In addition, the final regulations state in Sec.  
165.65(g) for registrants who refill and in Sec.  165.70(h) for 
independent refillers that other procedures may be necessary in this 
case to assure that product integrity is maintained.
The first condition is written so it would not apply to refillers of 
antimicrobial products used in swimming pools because neither a one-way 
valve or tamper-evident device is required.
    2. Changes. The biggest change from the proposed regulations is 
adding the condition where the container is being refilled with the 
same pesticide product as a case for not needing to clean the 
container. Some commenters pointed out that the conditions in the 
proposed regulation and the 1991 amendment to the Bulk Pesticides 
Enforcement Policy (Ref. 71) would require a refillable container 
holding a product with multiple active ingredients to be cleaned even 
when it was refilled with that product. This is true because the 
proposed rule, based on the 1991 amendment to the Bulk Policy, 
specified a product with a single active ingredient in a compatible 
formulation as an acceptable condition for refilling without cleaning. 
EPA corrected this oversight in the final rule, because refilling with 
the same product (regardless of how many active ingredients there are) 
is certainly the most clear way to ensure product integrity and should 
be allowed (assuming any tamper-evident devices and one-way valves are 
intact).
    Several other minor changes include:
    (1) Changing the first condition so it includes one-way valves and 
not just tamper-evident devices like in the proposal;
    (2) Adding ``if required'' to the first condition, since one-way 
valves or tamper-evident devices are only required on portable 
pesticide containers for liquids and are not required on the containers 
of antimicrobial products used in swimming pools;
    (3) Using the phrase ``described in its confidential statement of 
formula that is required under FIFRA section 3'' because it is more 
straightforward than the proposed phrase as described in Unit VII.H.;
    (4) The condition in criterion 3(B) was modified to be more general 
to account for situations other than reactions or interactions between 
the two products such as very different active ingredient 
concentrations that could cause the repackaged product to differ from 
the confidential statement of formula; and
    (5) Splitting the situation of a broken tamper-evident device or 
one-way valve into a separate paragraph for clarity.

R. Labeling Refillable Containers (Sec. Sec.  165.65(h) and 165.70(i))

    1. Final regulation. Before distributing or selling a pesticide 
product in refillable containers, refillers must ensure that the label 
of the product is securely attached to the refillable containers such 
that the label can reasonably be expected to remain affixed during the 
foreseeable conditions and period of use. The label and labeling must 
comply in all respects with the requirements of 40 CFR part 156. In 
particular, refillers must ensure that the net contents statement and 
EPA establishment number appear on the label. This part of the 
regulations simply re-states requirements from 40 CFR part 156 and 
FIFRA for clarity.
    2. Changes. The major change to the labeling requirement was to 
change it

[[Page 47387]]

from an ``active'' standard (i.e., the refiller must securely attach 
the label) to a ``passive'' standard (i.e., the refiller must ensure 
that the label is securely attached). Also, the regulatory text was 
modified to state that the net contents and EPA establishment number 
appear on the label (rather than the new label as proposed). Both of 
these changes account for situations where the label is embossed on the 
container or the container already has an intact label that meets all 
the requirements. For example, a commenter said that 1-gallon 
refillable containers for the swimming pool market are embossed with 
label information because they are refilled automatically at a rate of 
100-120 bottles per minute.

S. Recordkeeping (Sec. Sec.  165.65(i), 165.67(h), 165.70(j))

    1. Final regulation. All of the companies subject to the 
repackaging standards must keep certain records, although the specific 
records vary according to who the company is and what it does. These 
records must be furnished and made available for inspection and copying 
upon request of EPA or our designee, such as a State or Tribe. 
Informational records (listed in the first few rows of Table 16) must 
be maintained for the current operating year and for 3 years after 
that. The repackaging records (listed in the last three rows of Table 
16) must be generated each time a product is repackaged into a 
refillable container for distribution or sale and must be maintained 
for at least 3 years after the date of repackaging. All of the records 
are product-specific. In other words, this information must be kept for 
each product distributed or sold in refillable containers. The same 
cleaning procedure or description of containers can be used for 
different products, but there must be a record documenting a procedure 
and a description for each product distributed or sold in refillables.

                                          Table 16.--Recordkeeping Requirements in the Repackaging Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Registrants who d/s directly in refillables\1\   Registrants who d/s         Refillers who aren't registrants
                                    ------------------------------------------------    to refillers for   ---------------------------------------------
                                                                                        repackaging into
      Product-Specific Record                                                           refillables \1\
                                      Swim pool products\2\    All other products   ----------------------- Swim pool products\2\    All other products
                                                                                          All products
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Informational Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contract to repackage                No                      No                      Yes                    Yes                    Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refilling residue removal procedure  Yes                     Yes                     Yes                    Yes                    Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Description of acceptable            Yes                     Yes                     Yes                    Yes                    Yes
 containers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Repackaging Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPA registration number of the       No                      Yes                     No                     No                     Yes
 product distributed or sold in the
 container
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of the repackaging              No                      Yes                     No                     No                     Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Serial number of the container       No                      Yes                     No                     No                     Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ ``d/s''= distributed or sold.
\2\ Swim pool products = antimicrobial products used in swimming pools and closely related sites, that are subject to the pesticide container-related
  regulations.

    EPA reminds registrants and refillers that the records identified 
in Sec. Sec.  165.65(i), 165.6(h) and 165.70(j) of the repackaging 
regulations do not change other recordkeeping requirements that 
currently apply to them, such as restricted use product records or 
applicable records required in 40 CFR parts 167 and 169.
    2. Changes. EPA made the following significant changes in the 
recordkeeping requirements in the final regulations:
    <bullet> The informational records must be kept for the current 
operating year and for 3 years after that rather than the proposed time 
period of as long as the pesticide product is distributed or sold in 
refillable containers and for 3 years thereafter. The specific 
informational records kept by each of the three categories of 
businesses is the same in the final rule as in the proposal, although 
the list of acceptable containers was changed to the description of 
acceptable containers.
    <bullet> The repackaging records in the final rule are a subset of 
what was included in the proposed rule. The final regulations do not 
include the name or quantity of the product, the name and address of 
the consignee, a record that the refiller has inspected the container 
(and the results), and a record of whether a refilling residue removal 
procedure was conducted (and, if not, why not). Additionally, the date 
of the distribution or sale (in the proposal) was changed to the date 
of the repackaging in the final rule.
    <bullet> Refillers that repackage antimicrobial products used only 
in swimming pools or closely related sites would not have to comply 
with the repackaging recordkeeping. However, these refillers would have 
to comply with the informational recordkeeping.
    <bullet> The proposed regulations would have required refillers to 
maintain certain records of containers that were received by them to be 
refilled, including the name and address of the person providing the 
container, its serial number, the date it was received and the name and 
EPA registration number of the product that was last distributed or 
sold in the refillable container. These records are not being finalized 
in today's final regulations.

[[Page 47388]]

    3. Comments - refiller records. Many commenters (registrants, 
registrant groups, State regulatory agencies, a dealer, a dealer group, 
and an equipment manufacturer) opposed the recordkeeping requirements 
for refillers. Most of these respondents commented that the proposed 
recordkeeping requirements were too burdensome and several stated that 
these standards will discourage the use of refillable containers. A 
registrant group recommended requiring refillers to maintain records of 
the serial number, the amount of product placed in the container and 
the date the refilling took place.
    4. EPA response - refiller records. EPA modified the refiller 
recordkeeping requirements to minimize the paperwork burden of 
maintaining these records. However, EPA believes that some records are 
necessary to ensure safe repackaging and compliance with these 
requirements. First, the refiller must have the informational records, 
including the registrant's contract (if applicable), the refilling 
residue removal procedure and the description of acceptable containers. 
These records are necessary so the refiller has the information needed 
to properly repackage a product into refillable containers and to 
ensure that an independent refiller has the proper approval from a 
registrant to repackage the product.
    Second, certain information about when a product is repackaged into 
a refillable container is needed in case there is a problem with a 
product sold in refillable containers, i.e., it is adulterated or 
contaminated or it causes damage to the site after application. 
However, EPA pared the repackaging records down to the minimum amount 
of information that would allow the refiller and investigators to 
identify the product, the container, and the date of the repackaging. 
All of this information is readily available at the time the pesticide 
product is repackaged into the refillable container, unlike in the 
proposed rule where the information also included the name and address 
of the person receiving the container. EPA deleted the requirement to 
record the results of the inspection and whether the container was 
cleaned because these records would probably not be useful in 
enforcement cases. We will be able to determine that a container was 
not inspected if a container in poor condition (that did not just 
sustain recent damage) is found and, similarly, we'll be able to tell 
if a container was not properly cleaned if we find high levels of 
contamination in the product in that refillable container.
    5. Comments - sodium hypochlorite. Several respondents from the 
sodium hypochlorite industry commented on the proposed rule and stated 
that the refiller recordkeeping requirements would be especially 
burdensome for this market. One registrant group described a typical 
sodium hypochlorite delivery, where a truck holding up to 4,000, 1-
gallon refillable containers stops at several locations, delivers 
various volumes of product, and picks up empty containers. This 
commenter estimated all the recordkeeping standards could triple the 
time for deliveries and increase the cost of the product by 100 
percent. An association representing many businesses involved with 
swimming pools commented that the requirement for individual serial 
numbers and the recordkeeping requirements attendant to the serial 
number marking would be completely unworkable for refillable pool 
chemical containers. These respondents and a swimming pool supply 
company stated that the recordkeeping would discourage the use of 
refillables in the pool chemical industry.
    When commenting on the supplemental notice, the registrant group 
representing the sodium hypochlorite industry reiterated its estimate 
of the increase in time and costs that could be attributed to the 
proposed recordkeeping. In addition, a sodium hypochlorite manufacturer 
requested EPA to exempt all refillable plastic containers of sodium 
hypochlorite from the requirements for serial numbers, one-way valves, 
tamper-evident devices and burdensome recordkeeping that would 
negatively impact the currently used refillable container system.
    6. EPA response - sodium hypochlorite. EPA was persuaded by the 
arguments from the companies who repackage sodium hypochlorite into 
refillable containers for use in swimming pools. Because of the huge 
number of small (1- and 2.5-gallon) refillable containers used in this 
market segment, EPA acknowledges that compliance with this 
recordkeeping would be burdensome. Therefore, the final rule exempts 
refillers of antimicrobials used in swimming pools and similar sites 
from the repackaging recordkeeping, although they must comply with the 
informational recordkeeping.

T. Proposed Standards That Are Not Being Finalized

    Final regulation/changes. The following proposed requirements 
relating to repackaging are not being finalized in today's final rule:
    <bullet> Sec.  165.134(f): Age of plastic liquid minibulk 
containers; and
    <bullet> Sec.  165.136(b): Records on the return of refillable 
containers to refillers.
    The proposed rule would have prohibited a refiller from repackaging 
a product into a plastic liquid minibulk container more than 6 years 
after the container's date of manufacture. EPA decided not to finalize 
this provision to be consistent with the DOT regulations, which do not 
establish a life limit for plastic nonbulk containers (which may be 
portable pesticide containers under our regulations) or for plastic 
intermediate bulk containers (which also may be portable pesticide 
containers under our regulations).
    As discussed in Unit VII.S., EPA is not finalizing the requirement 
for refillers to keep records on the return of refillable containers to 
minimize the burden on refillers. Also, this information would have 
been of limited use because it would not have been sufficient to 
conclusively identify where a container had been and who had had 
possession of it.

VIII. Containment

A. Introduction

    1. Regulatory background. In 1994, EPA proposed standards in 
subpart H of 40 CFR part 165 for containment of large pesticide 
containers and procedures for container refilling operations. Standards 
for pesticide containers, including large storage containers, are 
covered in Units III. through VII. of this notice, and apply to all 
pesticides unless specifically exempted. The requirements for a 
secondary containment unit (either a containment structure around a 
stationary container, or a containment pad under a container refilling 
operation) only apply to agricultural pesticides. The requirements are 
intended to protect human health and the environment from contamination 
by spills and leaks which may occur during container filling or when a 
stationary container fails. Affected facilities are required to have 
structures which intercept and contain spills and leaks of agricultural 
pesticides in areas where stationary containers are stored and 
agricultural containers are refilled or cleaned.
    Secondary containment means a structure, such as rigid diking, 
berms or walls, designed to intercept and contain leaks and spills from 
the enclosed containers. Some States define bulk quantities as a 
pesticide container with a volume exceeding 55 gallons; others use 210, 
300, or 500 gallon criteria. EPA's proposed definition of bulk 
quantities was 3,000 liters (793 gallons)

[[Page 47389]]

for liquid pesticides and 2,000 kilograms (4,409 pounds) for dry 
pesticides. The final rule establishes quantities of 500 gallons (1,890 
liters) for liquids and 4,000 pounds (1,818 kilograms) as the threshold 
for requiring secondary containment. Thus, EPA's regulations cover only 
relatively large containers which pose the greatest risk of 
catastrophic contamination in case of failure.
    EPA believes the Federal containment standards, together with 
requirements for container design and residue removal, are essential 
for ensuring the safe use, reuse and refill of containers as required 
by FIFRA section 19. The regulations promulgated today will be located 
in 40 CFR part 165 in Sec.  Sec. 165.80 - 165.97.
    2. Summary of proposed and final containment standards. The 
proposed and final standards include criteria for design, maintenance 
and operation of containment structures (units and pads) at certain 
facilities. The design criteria include standards for material of 
construction, capacity, and protection from stormwater and 
precipitation. The facilities subject to the requirements are 
agricultural pesticide refilling establishments and custom blenders (as 
defined in Sec.  167.3), and facilities of businesses that apply 
agricultural pesticides for compensation (also referred to as for-hire 
applicators in this preamble). In the preamble to the proposal, the 
Agency explained its rationale for choosing these facilities. Although 
spills can occur throughout the chain of pesticide commerce (from 
manufacturer to user), the accumulated evidence points to agrichemical 
dealerships, custom blenders, and for-hire applicators as facilities 
where pesticide contamination of soil and water is most frequently 
documented. (See 59 FR 6750 (Ref. 66) and Unit VIII.C. for a detailed 
discussion.) The agricultural chemical distribution system has the most 
potential for spills and a requirement for reporting spills, and is 
uniquely characterized by the use of large tanks and container 
refilling operations, often outdoors, while other sectors generally use 
smaller containers, pre-packaged indoors by a manufacturer.
    Standards which are considered critical are required for all 
existing and new containment units and pads, and some additional 
criteria are imposed for new containment structures. For this final 
rule, the criteria identified as critical reflect the comments received 
and new information, and are not necessarily the same criteria used in 
the proposed rule. For example, hydraulic conductivity criteria were 
considered critical in the proposed rule, but, as a result of comments 
we received on hydraulic conductivity, are not being finalized in the 
final rule (see discussion in VIII.H).
    Many respondents provided comments on specific provisions of the 
containment regulations. EPA has made certain revisions to the proposed 
regulations based on these comments. The following units of the 
preamble discuss the comments received on each of the major issues 
raised in the proposed rule, any differences between the proposal and 
the final rule, and the Agency's reasons for making the changes.
    Costs and benefits of the rule have been revised from those 
projected at the time of the proposed rule. Total costs are predicted 
to be less than estimated in the proposal, due to the changes made as a 
result of comments and new information.
    3. State secondary containment regulations. At least 19 States have 
already promulgated and begun implementing their own secondary 
containment regulations for bulk storage of pesticides. The 1992 State 
of the States Report (Pesticide Storage, Disposal and Transportation, 
Ref. 70) cited in the proposed rule showed the wide variety of 
containment regulations among States. There are variations in the 
facilities affected, the container volume triggering the requirement 
for secondary containment, etc. The economic assessment for the 
proposed rule estimated the number of facilities with bulk pesticide 
storage in each State based on commercial, State and government 
business census data. EPA estimated that a total of 5,214 agrichemical 
dealers in all States and the District of Columbia have containers of a 
size defined in the proposed rule as bulk (greater than 3,000 liters 
liquid or 2,000 kilograms dry). (Ref. 21) EPA has reviewed the 
secondary containment regulations in all 19 States and has found that 
they are generally comparable to or more stringent than the 
requirements in today's final rule. These 19 States contain 81 percent 
(4,220) of the agrichemical facilities regulated by this final rule.
    EPA received many comments on the negative impact of the proposed 
regulations on facilities in States with preexisting regulations. 
Today's containment standards are intended to introduce basic 
safeguards in States that currently lack containment regulations and to 
harmonize with containment requirements in States where adequate 
containment safety programs already exist. While EPA believes a 
national standard must provide baseline environmental protection, a 
mechanism is being provided to accommodate States that are already 
successfully implementing pesticide containment programs.
    4. Key terms for understanding the requirements of subpart E. The 
following terms, defined in Sec.  165.3 of subpart A, are key to 
understanding the containment standards in subpart E:
    (1) Agricultural pesticide.
    (2) Appurtenances.
    (3) Container.
    (4) Containment pad.
    (5) Containment structure.
    (6) Dry pesticide.
    (7) Establishment.
    (8) Facility.
    (9) Owner.
    (10) Operator.
    (11) Pesticide compatible.
    (12) Pesticide dispensing area.
    (13) Refillable container.
    (14) Refilling establishment.
    (15) Rinsate.
    (16) Secondary containment unit.
    (17) Stationary pesticide container.
    (18) Transport vehicle.
    (19) Washwater.
    i. Changes. Based on commenters' suggestions and additional 
research, the definitions of the following terms were added to the 
final rule to clarify the requirements: facility, pesticide compatible, 
and rinsate.
    ii. Comments. A regulatory agency in a State with many bulk 
containment facilities commented that the definition of a stationary 
bulk container uses the words ``facility'' and ``establishment,'' but 
only defines the latter. The State agency advised that those trying to 
avoid the costly container and containment requirements might choose to 
view this as a legal loophole, and that the term facility should also 
be defined.
    Several State agencies requested that EPA clarify the phrase 
``resistant to pesticide,'' because its meaning could be either 
compatible or unreactive and could be difficult or burdensome to 
enforce. Alternatives were proposed, including ``chemically 
compatible,'' defined as the ability of the containment structure 
materials to withstand anticipated exposure to stored or transferred 
materials without losing the ability to provide the required secondary 
containment of the same or other materials within the containment area.
    Several State regulatory agencies commented that their regulations 
require containment of rinsate, and recommend containment for wash 
waters, because hazardous waste violations at pesticide facilities are 
often linked to problems with rinsate/wash waters. One State agency 
asked if a 300-

[[Page 47390]]

gallon spill mixed with 600 gallons of cleanup water can be considered 
rinsate. Another State agency has an expanded definition of rinsate to 
include recovered sedimentation, washwater, contaminated precipitation, 
or other contaminated debris.
    iii. EPA response. The word facility has been added to the list of 
definitions. The Agency agrees that the phrase pesticide compatible is 
clearer than pesticide resistant and has changed the regulation 
accordingly. For the purpose of this regulation, rinsate is being 
defined as the liquid (usually water) used to rinse the interior of any 
equipment or container that has come in direct contact with any 
pesticide. The Agency agrees that it is a good management practice to 
place rinsate tanks within containment and is recommending that 
practice, but does not have information on the risks of storage of such 
dilute pesticides.

B. Purpose (Sec.  165.80(a))

    1. Final regulations. The purpose of the containment standards is 
to protect people and the environment from exposure to agricultural 
pesticides from spills and leaks, and to reduce wastes produced during 
pesticide storage, handling or refilling of pesticide containers.
    2. Changes. This is the same as the proposed purpose in Sec.  
165.140.

C. Who Must Comply (Sec.  165.80(b))

    1. Final regulations. You must comply with these regulations if you 
are the owner or operator of a facility that stores pesticides in a 
stationary pesticide container or conducts any of the regulated 
pesticide transferring activities and if you are a retailer, for-hire 
applicator, or custom blender (as defined in 40 CFR 167.3) of 
agricultural pesticides.
    2. Changes. This is the same approach and scope that we proposed in 
Sec.  165.141. The proposed regulations included only retailers, for-
hire applicators, and custom blenders because they are the three 
categories for which EPA has accumulated the most substantial evidence 
of soil and groundwater contamination by pesticides. The final rule 
maintains the same scope. These facilities represent only a subset of 
the realm of operations where containment requirements might be 
appropriate. The Agency may consider further containment rulemaking for 
other elements of the pesticide industry if further information 
indicates that such requirements are needed. In addition, the final 
rule revises the regulatory language to clarify that the containment 
regulations only apply to agricultural pesticides. (See Unit VII.L. for 
a discussion of custom blending and custom mixing.) Also, a description 
of ``principal business is retail sale'' -- more than 50% of total 
annual revenue comes from retail operations -- was added to the final 
regulation for clarity.
    3. Comments. Many commenters (dealer groups, dealers, State 
regulatory agencies, and a distributor/registrant) responding to both 
the 1994 proposal and the 2004 reopening of the comment period argued 
for a level playing field and urged EPA to expand the scope of the 
containment standards to include manufacturing plants, distributors, 
farms, and non-agricultural facilities. Commenters argued that there 
are similar potential risks of environmental contamination at any 
facility that meets the volume, time or activity criteria, regardless 
of the location of the facility or the type of pesticide, Many 
commenters (State regulatory agencies, a dealer, a dealer group, an 
aerial applicator and an aerial applicator group) stated that there are 
some farms which store and handle more pesticides than some small 
retailers, and that the regulations should focus on the activity and/or 
the quantity stored, not the individual storing it.
    Commenters to the 2004 Federal Register Notice reopening the 
comment period stated that there have been changes in pesticide use 
patterns in the 11 years since the regulations were proposed. They 
stated that equipment technology developments in the handling and 
application of bulk agricultural chemicals have advanced dramatically, 
and that these new technologies coupled with the increase in the number 
of farms with large acreage have led to end users becoming a dramatic 
growth sector of purchasers of commercial application equipment. A 
dealer association stated it had surveyed chemical equipment dealers in 
Kansas and that 20 to 25 percent of all new large commercial 
application rigs and 80 percent of all used application equipment is 
currently purchased by end users, most of whom are farmers. The 
commenter said that using such equipment requires large quantities of 
chemicals on site and concluded that on-farm bulk storage is growing.
    Another dealer association commented in 2004 that by the end of 
2006, 70 percent of all crop protection products, mainly herbicides, 
will be off-patent, creating a marketing opportunity for non-
traditional suppliers and chemical brokers. They noted that end users 
could become direct crop protection customers without appropriate 
facilities, resulting in increased environmental incidents. The 
association also stated that at least 58 percent of U.S. farmland is 
not farmed by the landowner, countering the belief that farmers are 
better stewards because they have a vested interest in protecting their 
farmland from contamination. They commented that retailers are 
professionals trained in handling hazardous materials compared to end 
users, who tend to have less knowledge and training in safety, 
containment, and cleanup procedures. A dealer stated that some farmers 
have become tool shed dealers who store bulk without containment and 
repackage for neighboring farmers. This point was reinforced by 
retailers during a meeting in 2004 following the reopening of the 
comment period (Ref. 31), where the dealer associations and individual 
dealers reiterated their submitted written comments and cited a growing 
problem of cash and carry dealers who repackage product on farms 
illegally without a license.
    Several commenters opposed expanding the scope to include farmers. 
In 2004, the Farm Bureau and associated grower groups opposed any 
change in the proposed scope. A registrant group recommended that EPA 
work jointly with State pesticide regulatory officials and industry to 
devise a method for obtaining reliable data on the number of farmers 
storing bulk nationwide. The Association of American Pest Control 
Officials recommended that EPA not expand the scope to farmers without 
first researching the number, volumes and other pertinent data 
regarding on-farm bulk practices, an assessment of the risks of on-farm 
operations, and an analysis of the costs and benefits of on-farm bulk 
containment.
    Several commenters specifically supported requiring non-
agricultural pesticides stored in bulk to be subject to the rule. They 
state that bulk pesticide storage presents potential hazards regardless 
of use or activity, and that risk may be even higher due to greater 
population density compared to rural agricultural settings.
    EPA response. Due to the large number of commenters in 1994 and 
2004 from all sectors who supported requiring farms to have containment 
for stationary container pesticide storage, the Agency considered the 
option of expanding the scope of the rule to include farms and other 
entities. Although the Agency had solicited data on bulk pesticide 
storage on farms and at non-agricultural facilities in both the 1994 
proposed rule and the 1999 supplemental notice, only anecdotal 
information was received alleging an

[[Page 47391]]

increase of stationary container pesticide storage on farms. (Ref. 27)
    The Agency therefore researched the issue of whether pesticide 
storage on farms is a significant problem. The Agency contacted several 
commenters to the rule for clarification and was unable to confirm that 
the use of larger spray equipment relates to increased bulk pesticide 
storage or only to fertilizer storage and application. In cases where 
bulk storage of pesticide most likely occurs on large farms, such as 
with metam-sodium, it is not clear that pesticide remains in the tank 
for 30 days or more. The Agency asked the USDA to contact its sources 
in the extension network, and Agency staff contacted regulatory 
representatives and dealers in several States, particularly those with 
large areas under field crops. In general, the persons contacted knew 
of few, if any, farms with bulk pesticide storage, with the definition 
of bulk as 500 gallon containers or greater.
    USDA contacted Colorado, where less than 1 percent of farmers 
potentially store pesticides in bulk, and where minibulks up to 660 
gallons are exempt from the requirement for containment if they are 
approved by DOT or MACA. USDA also contacted Illinois, Kansas and 
Nebraska. Illinois has implemented new regulations which require 
farmers to have secondary containment if they meet the volume criteria, 
so any farmers with large tanks are taking them out of service. They 
learned that Kansas has three to six farms with bulk pesticides, and 
most farmers are using 250 gallon minibulks. Nebraska representatives 
could not estimate how many farms have bulk pesticide, but the most 
commonly used containers are 85 to 250 gallon minibulks. The only State 
with hard data was Indiana, which has 65 farmers with bulk storage 
(defined as larger than 55 gallons), of which 31 reportedly had tanks 
larger than 500 gallons.
    EPA has no data on the existence of bulk storage in non-
agricultural facilities. EPA assumes that at such facilities, 
pesticides are often stored indoors, where the building itself affords 
some measure of containment. EPA is aware of some isolated mosquito-
control facilities which may store pesticides in large stationary tanks 
during the treatment period, but does not have any way to estimate the 
existence of such facilities nationwide.
    In short, EPA has not received sufficient evidence of contamination 
at manufacturing plants, distributors, farms and non-agricultural sites 
to justify regulating them. In the proposed rule, we outlined the data 
available to the Agency documenting contamination at agricultural 
retailers, refilling establishments and commercial applicator sites. At 
least 30 of the references to the proposed rule were State monitoring 
studies showing contamination at such sites. Data documenting 
widespread contamination at other facilities were not submitted, and 
have not been identified.
    The consensus, even from commenters who support expansion of the 
scope to include farmers, is that on-farm bulk storage is still rare. 
The Agency does not wish to regulate in anticipation of a potential 
problem, particularly since it is questionable that such a regulation 
could be enforced on an equitable basis. We recognize the staff and 
resource restrictions of State agencies, and do not wish to add to 
their burden in anticipation of a problem which may or may not occur in 
the future.
    The Agency recognizes that all large, stationary tanks have the 
potential to leak or burst, and considered requiring all stationary 
tanks, regardless of location, to conform to the containment standards. 
However, the Agency also believes that the volume through-put of tanks 
used for retail sale or commercial application of pesticides is higher 
than that expected for individual farms, resulting in a higher 
potential risk associated with their usage. The Agency further believes 
that an end-user who is not significantly involved in resale of product 
has less opportunity and motivation to finance the purchase of large 
tanks and the construction of secondary containment.
    EPA added a description of the phrase ``principal business is 
retail sale'' to the final rule so Sec.  165.180(b)(1) states that 
refilling establishments who repackage agricultural pesticides and 
whose principal business is retail sale (i.e., more than 50% of total 
annual revenue comes from retail operations) must comply with the 
containment regulations. EPA's intent of including the phrase principal 
business in the 1994 proposed rule was to distinguish between refilling 
establishments whose principal business is retail sale and refilling 
establishments whose primary function is formulation or manufacturing 
of pesticides. The description of principal business was added to the 
final rule to provide clarification on how to make this distinction. In 
addition, the information we received during the 2004 comment period 
about some farmers reportedly repackaging pesticides for sale further 
supported the need to clarify the meaning of principal business is 
retail sale. For the reasons discussed in this section, EPA decided not 
to apply the final containment regulations to farmers. We believe that 
adding the clarification of principal business to the final rule will 
help identify the retail facilities that we intend to regulate with 
Sec.  165.180(b)(1). However, EPA wants to clarify that anyone 
including a farmer - who is repackaging pesticides for sale or 
distribution must comply with the existing requirements in 40 CFR part 
167 to register their establishments and report their production 
(repackaging) to EPA and must also keep records of pesticide production 
according to 40 CFR part 169. In addition, such facilities would be 
regulated as refillers under this final rule and would have to comply 
with the refiller requirements in subpart D, Standards for Repackaging 
Pesticide Products into Refillable Containers. These facilities would 
have to comply with the containment requirements in subpart E if they 
repackage agricultural pesticides and if more than 50% of their total 
annual revenue comes from retail operations.
    The Agency is willing to amend the regulation to include such sites 
if a pervasive pattern of contamination or other handling problems 
appear at other sites in the future. It is recommended that State and 
local agencies regulate such facilities at the local level as needed.

D. Compliance Dates (Sec.  165.80(c))

    1. Final regulations. All containment structures subject to today's 
rule must comply with all applicable containment regulations for new 
and existing structures within 3 years of today's date.
    2. Changes. The proposed rule required new structures to comply 
with the containment standards beginning 2 years after publication of 
the final rule. Existing structures would have been required to comply 
with interim standards for a period of 8 years, beginning 2 years after 
publication of the final rule, and then existing structures would have 
to comply with the same standards as new structures. The interim 
standards were defined as critical to safe containment, and considered 
readily implemented within 2 years. The interim period was intended to 
allow existing structures which have design or structural features not 
amenable to upgrading without major modification to phase in those 
modifications over time. The final rule has no provision for an interim 
period; the final rule applies only one set of requirements to existing 
structures over their life spans. Both new and existing structures must 
comply with applicable standards beginning 3 years after publication of 
the final rule.

[[Page 47392]]

    3. Comments. Many commenters had objections or changes to propose 
on the interim period. Several respondents commented specifically on 
the length of the interim period. A registrant thought it should be 
longer and a State regulatory agency said it should be shortened to 5 
years and be based on the structure's age and performance. A State 
regulatory agency said that the nine critical standards were sufficient 
and that the only distinction between new and existing facilities 
should be the compliance date. A dealer opposed the interim period 
because States already have containment standards and would have to 
learn two new sets of standards above and beyond existing State rule. 
Several respondents commented on the different possibilities for an 
interim period discussed in the preamble. A State regulatory agency 
supported an age-based approach of setting the compliance date on a 
formula using 20 years minus the existing containment facility's age. 
Many commenters (dealers, a dealer group and a State regulatory agency 
group) opposed setting any standards that are more stringent than 
existing State standards. A principal reason for opposition was that 
interim requirements would comprise an extra, unnecessary set of 
requirements to be learned by regulators and regulated parties, 
particularly in States with containment programs in place. It would 
also be costly for existing structures to have to retrofit, 
particularly in States where facilities had already been constructed to 
conform with State requirements. Several commenters (State regulatory 
agencies, a dealer, and a grower group) recommended that EPA 
grandfather existing containment facilities that are already in 
compliance with State standards. A State regulatory agency group 
requested EPA to seriously consider accepting small discrepancies in 
some standards due to differences in existing State rules and 
legislation. This commenter said that national uniformity in regulation 
is desirable, although progress toward this goal should not be at the 
expense of States that have already enacted rules and statutes that 
vary slightly from the proposed Federal regulations. A dealer group 
suggested that EPA set the Federal standards as a baseline, which would 
allow the proactive work of some States to stand. Many dealers 
recommended that EPA adopt the Iowa standards in lieu of those in the 
proposal. A dealer said that making States enforce standards different 
from their own would cause difficulties for enforcing agencies, 
distributors, retailers and end users, and a State regulatory agency 
elaborated, stating that States with containment requirements would 
have to reinitiate their compliance efforts and would lose credibility 
and trust of the regulated community. A few State regulatory agencies 
suggested adding a provision that would use the time during the interim 
period to collect data about the adequacy of State regulations. If the 
collected information indicated a State's requirements weren't 
adequate, EPA could justify compliance with the Federal standards.
    4. EPA response. The interim period was intended to allow 
substandard facilities sufficient time to retrofit and come into full 
compliance with the regulations and for owners to recoup the benefits 
from the depreciation of their capital investment and financially 
prepare to upgrade their structure. EPA has maintained a dialogue and 
information exchange with States and the regulated community 
(facilities and their associations) since the rule was published in 
1994. EPA has decided not to finalize the most onerous and contentious 
standards from the requirements for existing facilities, such as a 
hydraulic conductivity standard, thereby significantly reducing the 
effort and expense needed to comply. EPA believes that 33 months 
between the reference date for new structures (3 months after 
publication) and the compliance date (36 months after publication) 
would provide a reasonable period of time for new structures to be 
planned and built in compliance with the full requirements of subpart 
E. If an existing structure does not already comply with the standards 
for existing structures, EPA believes that the remaining modifications 
can be readily implemented at existing structures within 3 years. The 
proposed period of 2 years before compliance may not have provided 
ample time for facilities to meet the requirements, particularly 
facilities in locales with significant seasonal constraints on 
construction. In addition, allowing 3 years as a compliance date for 
both new and existing structures will allow one year for States with 
their own containment regulations to apply for an equivalency 
determination, and still avoid confusion by retaining the same 
compliance date for all facilities. EPA believes that allowing one more 
year before implementation will not have a significant adverse impact 
on the environment, particularly given the many State regulations that 
are already in effect. This is a shorter time frame than the 5-year 
phase-in period allowed for the refillable container and repackaging 
regulations, but given that most States with dealerships have already 
implemented containment regulations, the Agency considers 3 years 
sufficient time for facilities to comply. The Agency is allowing 5 
years for compliance with the refillable container standards because 
registrants need to phase out existing containers without recalling 
them prior to the completion of their normal usable life. The 
transition period helps distribute costs over time and improve 
regulatory compliance.
    The critical standards cited in the preamble of the proposed rule 
(59 FR 6765, February 11, 1994) for implementation during the interim 
period have been modified based on comments, additional research, and 
evaluation of existing State regulations. The modified standards for 
existing structures are considered crucial to safe containment and 
comprise the basic standards demonstrated to be effective for existing 
structures in States with containment regulations. The following table 
compares standards in the proposed rule to today's final standards for 
existing structures. New structures are subject to these standards plus 
additional standards representing further protectiveness.

     Table 17.--Comparison of Standards for Proposed and Final Rule
------------------------------------------------------------------------
                                                           Additional
  Standard in Proposed Rule for    Standard in Final   Standard in Final
       Existing Structures         Rule for Existing     Rule for New
                                      Structures          Structures
------------------------------------------------------------------------
Construction with rigid           Same.               NA
 materials.
------------------------------------------------------------------------
Use of pesticide-resistant        Use of pesticide-   NA
 materials.                        compatible
                                   materials.
------------------------------------------------------------------------

[[Page 47393]]

 
Hydraulic conductivity no         None. Liquid-       NA
 greater than 1 x 10-6 cm/sec      tight.
 during interim, 1 x 10-7 cm/sec
 after 10 years.
------------------------------------------------------------------------
Withstand full hydrostatic head.  Same.               NA
------------------------------------------------------------------------
Stormwater run-on protection for  Sufficient          NA
 a 25-year, 24-hour storm.         freeboard to
                                   contain
                                   precipitation and
                                   prevent water and
                                   other liquids
                                   from seeping into
                                   or flowing onto
                                   it.
------------------------------------------------------------------------
Protection of appurtenances and   Same.                Appurtenances
 containers.                                           configured so
                                                       leaks can be
                                                       observed.
------------------------------------------------------------------------
Seal joints and cracks and        Same.               NA
 repair any visible damage.
------------------------------------------------------------------------
Inventory reconciliation of       None.               NA
 liquid remaining in tank during
 interim only.
------------------------------------------------------------------------
Pad capacity 1,000 gallons.       Pad capacity 750    Sloped to liquid-
                                   gallons.            tight sump.
------------------------------------------------------------------------
Liquid stationary containers -    Liquid stationary   Liquid stationary
 unit capacity 100 percent/110     containers - unit    outdoor capacity
 percent indoor/outdoor minimum    capacity 100        110 percent
 during interim, 110 percent/125   percent indoor/     minimum.
 percent indoor/outdoor after 10   outdoor minimum.
 years.
------------------------------------------------------------------------
Anchoring liquid stationary       Anchoring or        NA
 containers.                       elevating liquid
                                   stationary
                                   containers.
------------------------------------------------------------------------
Prevent pesticide-containing      Seal                Appurtenances must
 material from escaping from       appurtenances,      be configured in
 containment.                      discharge outlets   such a way that
                                   and gravity         spills or leaks
                                   drains through      are easy to see.
                                   base or wall of
                                   containment unit,
                                   including sump.
                                   Containment pads
                                   may drain to a
                                   watertight sump
                                   with method of
                                   removing
                                   accumulated
                                   liquids, such as
                                   a pump, which
                                   transfers
                                   contents to
                                   aboveground
                                   container.
------------------------------------------------------------------------
Dry product stationary container  Dry product         NA
 - no capacity requirement         stationary
 during interim, 100% after 10     container
 years.                            protected from
                                   wind/rain with 6-
                                   inch berm at
                                   least 2 feet from
                                   container.
------------------------------------------------------------------------
Attended transfers; locked        Same.               NA
 valves; cleanup by the end of
 day of spill; monthly
 inspection.
------------------------------------------------------------------------

E. Stationary Containers Included (Sec.  165.81)

    1. Final regulations. Stationary pesticide containers designed to 
hold undivided quantities of agricultural pesticides equal to or 
greater than 500 gallons (1,890 liters) of liquid pesticide or equal to 
or greater than 4,000 pounds (1,818 kilograms) of dry pesticide are 
subject to the containment regulations. Containers of less than these 
volume/weight capacities are not required to be protected with a 
secondary containment unit. The definition of stationary pesticide 
container includes transport vehicles that are fixed or remain at a 
facility for at least 30 consecutive days.
    A stationary pesticide container is subject to the containment 
regulations and must have a secondary containment unit unless it 
satisfies any one of the following conditions:
    <bullet> The container is empty, which means that it has been 
cleared of all pesticide that can be removed by customary methods such 
as draining, pumping, or aspirating (whether or not residues have been 
removed by washing or rinsing).
    <bullet> The container holds pesticide rinsates or wash waters and 
is so labeled.
    <bullet> The container holds only pesticides which would be gaseous 
when released at atmospheric temperature and pressure.
    <bullet> The container is dedicated and labeled for non-pesticide 
use.
    2. Changes. This is not the same subset of stationary containers 
proposed in Sec.  165.142(a) as subject to, or exempt from, the 
standards. The three differences are that the: (1) Liquid container 
size subject to the rule is 500 gallons rather than 793 gallons; (2) 
dry container size subject to the rule is 4,000 pounds rather than 
4,409 pounds; and (3) period of time that a container can remain fixed 
or at a single facility in order to be considered stationary is 30 
days, rather than the 14-day period in the proposed rule.
    3. Comments - holding capacity. Many commenters (State regulatory 
agencies, dealer groups, and another government agency) urged EPA to 
reduce the capacity threshold for containers for which secondary 
containment is required. Specific alternative suggestions included: (1) 
300 gallons for liquids or 100 pounds for dry products; (2) 300 gallons 
for liquids or 500 pounds for dry products; (3) 500 gallons for liquids 
or 2,000 pounds for dry products. A registrant group commented in 2004 
that packaging experts believe plastic containers larger than 330 
gallons would not meet DOT

[[Page 47394]]

Packing Group III standards, which they cite as further evidence that 
containers that size and larger need secondary containment. A State 
agency stated that they are already seeing a shift in container size 
(below the regulatory cut-off) in order to be exempt from the State's 
containment regulations. Another State agency suggested that States 
have geographical differences and that perhaps EPA should allow 
individual States to mandate storage limits based on their individual 
situation. A dealer group and a registrant group jointly commented that 
containers with a liquid capacity of greater than 330 gallons should be 
protected by containment. There were no commenters who thought the 
container size of 793 gallons was appropriate or that it should be 
larger.
    4. EPA response - holding capacity - liquids. The Agency recognized 
that the liquid capacity proposed was substantially greater than volume 
criteria adopted by many States with containment regulations. These 
States use lower limit ``bulk'' criteria ranging from 55 to 500 gallons 
to trigger secondary containment requirements for liquid pesticides. 
The reasoning for the proposed definition (793 gallons) of liquid bulk 
container was to be consistent with the DOT definitions in 
distinguishing between intermediate bulk containers and bulk 
containers. Since the final containment regulations do not use 
definitions of bulk or intermediate bulk, the DOT definitions are 
irrelevant here. As discussed in Unit VI.A., EPA is not finalizing the 
definitions of minibulk and bulk containers in the final rule. The 
Agency's intent for the secondary containment requirement is to prevent 
the most catastrophic spills, and the larger the container, the greater 
the risk of contamination. The Agency believes contamination from 
failure of a 500-gallon container would be significant, and agrees with 
commenters that a 330-gallon container is generally considered the 
largest size container that can be moved by a fork lift and can be 
considered mobile. The next most common size used in the field is 500 
gallons. The Agency agrees with States that those 500 gallon tanks 
should be required to have secondary containment, and is lowering the 
size cut off to capture those tanks and harmonize with existing 
regulations. The Agency has confirmed by personal communication with 
some State regulators and extension staff (Ref. 28) that there are few, 
if any, containers between the sizes of 500 and 793 gallons, (the next 
most common size after 500 gallons is 1,000 gallons) and expects that 
today's rule will discourage demand for container sizes in that range 
in an attempt to be exempt from the containment regulations. The Agency 
confirmed that 500-gallon tanks are common in the field, and recognizes 
that the regulations may prompt some demand for tanks slightly smaller 
(e.g., 450 gallons) in order to be exempt from the Federal requirement. 
There may always be facilities which try to skirt the law in such ways, 
but the Agency intended the containment regulations to prevent the 
environmental consequences from the most catastrophic spills. The 
smaller the tank size, the less contamination will result from leaks or 
spills. The Agency also reviewed containment regulations in the 19 
States which have them, and determined that the size cut-off which 
triggers the requirement for secondary containment varies from 55 to 
550 gallons, with many states selecting 300- or 330-gallon tanks as the 
cut-off size. The Agency believes that selecting a volume cut off 
between 55 and 500 gallons would conflict with some State regulations 
at a cost to both States and facilities, with no measurable benefit to 
the environment (Ref. 25) and has therefore selected 500 gallons as a 
realistic, practical and protective size which triggers the need for 
secondary containment.
    5. EPA response - holding capacity - dry pesticides. As with liquid 
pesticides, the Agency's goal in proposing larger weight criteria for 
dry pesticides, was to target containers that pose the greatest risk of 
catastrophic consequences in the event of failure. The proposed size 
criterion for dry pesticide containers was 4,409 pounds (2,000 
kilograms). There were many comments on the size criterion for dry 
pesticide containers in 1994. Those comments objected specifically to 
the proposed standard for 100 percent containment capacity for such 
containers based on the physical nature of a dry spill. The Agency has 
confirmed with the packaging industry (Ref. 29) that dry pesticides are 
not packaged in containers between the sizes of 4,000 and 4,409 pounds. 
Therefore, EPA is lowering the size of the container for which 
containment is required to 4,000 pounds (1,818 kilograms) for 
simplicity and clarity, since 4,000 is an easier number to remember for 
compliance and enforcement purposes, and there is no functional 
difference between 4,000 and 4,409 pounds for refillable dry bulk 
containers, since neither size exists. In addition, EPA has replaced 
the requirement for 100 percent containment capacity for dry pesticides 
with a requirement for a 6-inch berm in the final rule.
    6. Comments - 14-day residence. Several commenters suggested 
increasing the time criterion to 30 days to account for factors beyond 
the control of the facility. One commenter questioned the associated 
recordkeeping as burdensome and unclear as to what was required. A 
registrant requested that EPA exempt packaged product in nonrefillable 
containers from the 14-day time trigger because it would burden small 
facilities.
    7. EPA response - 14-day residence. Although most large containers 
used at commercial agrichemical facilities are stationary, some 
containers are actually vehicles (such as tank trucks) used for 
prolonged storage or repeated on-site dispensing of pesticide at one 
location. In this case, the primary function of the vessels shifts from 
pesticide transport to pesticide storage or handling, and therefore 
containment is required. Since monthly inspection is required at such 
facilities, EPA believes that it would be reasonable to allow a 30-day 
maximum residence time without containment requirements, since any 
transport vehicles temporarily stored would have to be inspected by the 
owner or operator within that period. The recordkeeping required for 
stationary containers which do not have secondary containment could 
simply be a signature of the driver and/or facility owner/operator on a 
paper listing the driver's arrival date. The regulation is not intended 
to impose burdensome recordkeeping. The regulations will not affect 
packaged pesticide in small quantities used by small entities, since 
the quantities required that would trigger containment requirements are 
500 gallons liquid or 4,000 pounds dry pesticide.

F. Pesticide Dispensing Areas Included (Sec.  165.82)

    1. Final regulations. Dispensing areas are subject to the 
requirements for a containment pad if one of the following activities 
is conducted in the dispensing area:
    <bullet> Emptying, cleaning, and rinsing of refillable containers 
that hold agricultural pesticides.
    <bullet> Dispensing of an agricultural pesticide from a stationary 
pesticide container of a size holding 500 gallons or more of liquid or 
4,000 pounds or more of dry pesticide for any purpose.
    <bullet> Dispensing of an agricultural pesticide from a transport 
vehicle to fill a refillable container.
    <bullet> Dispensing of an agricultural pesticide from any other 
container for

[[Page 47395]]

the purpose of refilling a refillable container for sale or 
distribution.
    A dispensing area is exempt from subpart E requirements for a 
containment pad if it satisfies any of the following conditions:
    (1) The only pesticides handled in the pesticide dispensing area 
are pesticides which would be gaseous if released at atmospheric 
temperature and pressure.
    (2) The only pesticide containers refilled within the pesticide 
dispensing area are stationary pesticide containers protected by a 
secondary containment unit that complies with the requirements of this 
subpart.
    (3) The pesticide dispensing area is used solely for dispensing 
pesticide from a rail car that is not a stationary pesticide container. 
However, if a rail car is used as a stationary pesticide container, 
secondary containment is required.
    2. Changes. This is the same approach and scope that was proposed 
in Sec.  165.142(b) for including and exempting pesticide dispensing 
areas from the requirement for a containment pad. The language in Sec.  
165.82(a)(2) has been slightly revised to reflect the lower container 
sizes, and all of the conditions have been slightly revised to be 
clearer.
    3. Comments. As with the scope of facilities subject to the 
containment requirements above, many commenters responding to both the 
1994 proposal and the 2004 Notice (State regulatory agencies, a few 
dealer groups and a registrant) urged EPA to expand the scope to all 
permanent areas where the transfer of pesticides from any container 
occurs, regardless of container size or pesticide type. In particular, 
they argued for requiring containment pads for mixer/loader activities 
by farmers or for-hire applicators, citing significant soil and 
groundwater contamination in agricultural States, and equivalent risk 
whenever large quantities of pesticides are handled. They noted the 
possibility that farmers are less well-trained in pesticide management 
than commercial dealers. State agencies supported including farmer 
mixer/loader pads in order to strengthen their own regulations.
    Arguments by State regulatory agencies, user groups, a registrant, 
and a registrant group against including farmers in the scope cited the 
difficulty of monitoring numerous individual farms and lower quantities 
of pesticides used. Two user groups opposed including farmers because 
the costs would be significant to farmers and could not be passed on; 
the costs of monitoring the large number of farm sites would be 
burdensome; and farm sites generally handle less material, which should 
result in fewer spills.
    4. EPA response. As discussed above in Unit VIII.C., Who Must 
Comply, EPA focused on commercial agrichemical facilities because these 
have the clearest pattern of soil and ground water contamination by 
pesticides. EPA did not include farms because farms conduct operations 
on an occasional basis and would not have the same environmental 
impacts as refilling establishments. Containment on a farm would also 
be expensive and require year-round maintenance but only be needed on a 
seasonal basis. EPA does not have a good estimate of the number of 
farms with stationary bulk storage, nor evidence that significant 
contamination is occurring at farm sites. Although it follows logically 
that any area where pesticides are transferred between containers and 
application equipment may become contaminated, the quantities 
transferred at dealer and commercial sites for sale to multiple 
customers are expected to far exceed quantities transferred at 
individual farms.
    EPA noted that the language in Sec.  165.82(a)(4) did not fit the 
plain-English standard for simplicity and revised it to clarify that 
the activity of refilling refillable containers for sale or 
distribution, even if the source container is smaller than the size 
requiring secondary containment, requires a secondary containment pad. 
For example, refilling a 15-gallon minibulk from a 400-gallon 
stationary tank would still require a containment pad if the product 
was intended to be sold or distributed.

G. Definition of New and Existing Structures (Sec.  165.83)

    1. Final regulations. A new containment structure is one whose 
installation begins more than 3 months after the final rule is 
published. Installation is considered to have begun if:
    (1) You, as the owner or operator, have obtained all Federal, 
State, and local approvals or permits necessary to begin physical 
construction of the containment structure; AND
    (2) You have either begun a continuous on-site physical 
construction or installation program OR you have entered into 
contractual obligations for physical construction of the containment 
structure. The contract must be such that it cannot be canceled or 
modified without substantial loss, and must be for the physical 
construction or installation of the containment structure within a 
specific and reasonable time frame.
    An existing containment structure is one whose installation began 
on or before the date 3 months after the final rule is published.
    2. Changes. This is identical to the definitions of new and 
existing containment structures proposed in Sec.  165.144. However, the 
general structure of the final rule is different from the proposal, as 
explained in more detail in Unit VIII.K. The proposed rule would have 
required existing structures to comply with interim standards for a 
period of 8 years, beginning 2 years after publication of the final 
rule, and then existing structures would have had to comply with the 
same standards as new structures. Instead, the final rule establishes 
critical design standards for both new and existing structures, and 
several additional standards for new structures. In other words, 
certain standards in the final rule apply to all existing structures 
for their lifetimes. Similar but slightly different standards apply to 
all new containment structures. As noted earlier, these standards would 
not apply in States that show that their regulations afford 
environmental protection at least equivalent to that provided by EPA's 
regulations.
    Also, EPA reorganized the regulatory text so all the design and 
capacity standards for new structures are grouped together in Sec.  
165.85. (See Unit VIII.H.) All the design and capacity standards for 
existing structures are grouped together in Sec.  165.87. (See Unit 
VIII.I.) The regulations that follow these two groupings of standards, 
including but not limited to operational, inspection, maintenance and 
recordkeeping requirements, apply to both new and existing structures. 
EPA believes this format is clearer and should facilitate compliance 
compared to the structure of the proposed rule, which intermingled 
requirements for the interim period and for new structures.

H. Design and Capacity Requirements for All New Structures (Sec.  
165.85)

    1. Construction materials for new containment structures (Sec.  
165.85(a))--i. Final regulations. New containment structures must be 
made of steel, reinforced concrete or other rigid material which will 
withstand the full hydrostatic head, load and impact of any pesticides, 
precipitation, other substances, equipment and appurtenances placed 
within the structure. The construction material must not be natural 
earthen material, unfired clay, or asphalt, and must be compatible with 
the stored pesticide.
    ii. Changes. The proposed rule stated that the construction 
material had to be

[[Page 47396]]

resistant to pesticide. The final rule states that the material must be 
compatible with the pesticide. The proposed rule also had the following 
additional requirement for new structures, which is not being finalized 
in the final rule:
    Each new containment structure must have a hydraulic conductivity 
less than or equal to 1 x 10<SUP>-7</SUP> centimeters per second. 
During the interim period, each existing structure must have a 
hydraulic conductivity standard less than or equal to 1 x 
10<SUP>-6</SUP> centimeters per second.
    iii. Comments - rigid structures. A few State regulatory agencies 
supported requiring rigid structures. One recommended allowing flexible 
synthetic liners in the base. A university and a registrant supported 
the use of steel structures. A few State regulatory agencies and a 
containment materials supplier supported portable rigid or non-rigid 
structures.
    iv. EPA response - rigid structures. EPA does not believe that 
flexible, portable, or non-rigid structures can adequately ensure the 
permanent and continuous liquid-tight containment of large quantities 
of agricultural pesticides or of areas where pesticides are transferred 
and handled regularly. Years of State experience with secondary 
containment has shown that structures of concrete, steel or other rigid 
material are effective in containing spills and leaks. Furthermore, as 
stated in the proposed rule, key technical guidance documents recommend 
that rigid materials, especially reinforced concrete, be used for 
structural support in pesticide containment facilities. Industry 
guidance (Ref. 11) indicates that water-tight concrete can be achieved 
with nonporous aggregate, high-quality cement paste, proper curing, 
etc., and that maintenance plays an important role in keeping the 
structure impermeable to liquids. Although flexible, portable 
containment structures may be appropriate in certain other situations, 
EPA believes that durable, rigid materials should be required for 
stationary pesticide containment at facilities covered in today's final 
rule.
    v. Comments - hydraulic conductivity. Several State regulatory 
agencies supported the hydraulic conductivity standard as proposed. 
Many commenters (including State regulatory agencies, another agency, 
registrants, a registrant group, dealer groups, and a dealer) commented 
that a hydraulic conductivity standard would be difficult to implement, 
generally citing a lack of methods to verify compliance with such a 
standard. Some respondents (dealers, State regulatory agencies, 
registrants and a registrant group) commented that there are no on-
site, non-destructive tests to verify hydraulic conductivity. 
Respondents from a variety of commenter categories opposed the standard 
as too restrictive, unnecessary, unachievable, and too costly. Some 
commenters (registrants, a registrant group, and State regulatory 
agencies) pointed out that RCRA-mandated wood preservative drip pads 
serve as primary containment, whereas the proposed regulations apply to 
secondary containment, arguing that the same standard should not apply 
in both cases. A few State regulatory agencies expressed concern that 
construction modifications of existing structures to comply with the 
capacity and hydraulic conductivity standards may not be technically 
feasible and could penalize proactive States. A few State regulatory 
agencies and a dealer group commented that there is no evidence of 
pesticide moving through concrete slabs or unsatisfactory performance 
by existing concrete structures, and one commenter observed that most 
releases from secondary containment are through unsealed cracks and 
installed drains.
    Respondents commented on the methods needed to achieve a hydraulic 
conductivity standard, such as use of coatings, sealants, and liners. A 
State regulatory agency supported the use of sealants and coatings and 
a few dealer groups acknowledged that coatings on concrete would extend 
the useful life of the structure and make it less permeable. Many 
commenters expressed concerns about the use of coatings and sealants on 
containment structures, for reasons such as: coatings can cover cracks 
and problems that would not be visible (dealer, dealer association and 
a State regulatory agency); abrasion from traffic (State regulatory 
agency) and deterioration of sealants due to ultraviolet light 
(registrant group and several registrants) could prevent a structure 
from maintaining compliance; and high cost of maintenance and 
replacement. Some commenters (dealer groups, State regulatory agencies) 
suggested qualitative alternative ways to implement an impermeability 
standard: liquid-tight with cracks, seams and joints sealed; spill 
retention; leakproof, coupled with permit and other requirements; 
leakproof and constructed with materials resistant to pesticides. A 
State regulatory agency observed that most releases from secondary 
containment are through unsealed cracks or installed drains.
    vi. Comments - hydrostatic head. A few State regulatory agencies 
argued that a requirement for construction to withstand full 
hydrostatic head would require dike walls to be unreasonably thick in 
order to withstand a very rare but not impossible tidal wave impact of 
a large tank rupture. A dealer group urged EPA to replace the standard 
with the following language from the Association of American Pest 
Control Officials (AAPCO) model rule: ``Secondary containment shall be 
constructed of sufficient thickness, density, and composition so as to 
contain any discharged material...''
    vii. EPA response - hydraulic conductivity and hydrostatic head. 
Based on the comments and additional research, EPA agrees that the 
proposed hydraulic conductivity requirements would be unnecessarily 
burdensome, and that rigid walls of chemically compatible material have 
been proven effective in controlling accidental spills. The 1 x 
10<SUP>-7</SUP> cm/sec standard was based on the hydraulic conductivity 
requirement found in current RCRA requirements for wood preservative 
drip pads in subpart W of 40 CFR parts 264 and 265. EPA agrees that 
secondary containment structures are intended to catch and briefly 
retain spills and releases, not store them indefinitely, and recognizes 
the difficulty in verifying hydraulic conductivity. The Agency has 
therefore decided not to finalize the standards for hydraulic 
conductivity. The Agency disagrees that the requirement to withstand 
full hydrostatic head is unreasonable. It is a requirement in many 
State containment regulations. The final rule was modified slightly to 
delete the phrase (dynamic or static) because that phrase adds more 
confusion than clarity. However, EPA believes that the standard of 
being ``capable of withstanding the full hydrostatic head, load and 
impact of any pesticides, precipitation...'' requires the secondary 
containment unit to be able to contain a catastrophic spill. EPA 
believes that using industry construction guidance on concrete quality 
and reinforcement bars will ensure that containment structure's 
integrity in the case of a catastrophic spill of a large tank.
    2. General design requirements for all new containment structures 
(Sec.  165.85(b))--i. Final regulations. These are the general design 
requirements for new containment structures:
    (1) You must protect appurtenances and pesticide containers against 
damage from operating personnel and moving equipment. Means of 
protection include, but are not limited to, supports to prevent 
sagging, flexible connections, the use of guard rails, barriers, and 
protective cages.
    (2) Appurtenances, discharge outlets, or gravity drains must not be 
configured

[[Page 47397]]

through the base or wall of the containment structure, except for 
direct interconnections between adjacent containment structures which 
meet the requirements of this subpart. Appurtenances must be configured 
in such a way that spills or leaks are easy to see.
    (3) The containment structure must be constructed with sufficient 
freeboard to contain precipitation and prevent water and other liquids 
from seeping into or flowing onto it from adjacent land or structures.
    (4) Multiple stationary pesticide containers may be protected 
within a single secondary containment unit. The volume of the largest 
container determines the capacity requirement of the unit.
    ii. Changes. Requirements in Sec.  165.85(b)(1) and (2) are 
identical to those proposed in Sec.  165.146(b). Paragraph (4) is added 
to clarify a statement in the proposed rule under Sec.  165.152. The 
requirement in Sec.  165.85(b)(3) has been changed. In the proposed 
rule, the requirement was to prevent storm water run-on from seeping 
into or flowing onto it from adjacent land or structures during a 25-
year, 24-hour rainfall event.
    iii. Comments - storm protection. Several respondents (a registrant 
and two State regulatory agencies) supported the stormwater control 
provision. Several others (a dealer group and two State regulatory 
agencies) suggested alternative language, such as diverts water, no 
discharge, or constructed to prevent any surface water from moving onto 
or across the structure. Several commenters (a dealer group, a 
registrant group and two State regulatory agencies) noted that it would 
be difficult to comply because (1) a watershed runoff study would be 
needed; (2) the 25-year, 24-hour criterion would be difficult to 
determine at different sites; (3) rainfall varies substantially from 
year to year. A few State regulatory agencies commented that the 
stormwater control standard doesn't adequately address precipitation 
and stated that the containment capacity requirements must be based on 
rainfall volume, such as a 25-year, 24-hour rainfall event. A few 
dealers recommended the example of the Illinois pesticide containment 
rule, which requires that stormwater be diverted from containment 
structures.
    iv. EPA response - storm protection. A 25-year, 24-hour storm is 
commonly used as a benchmark for the capacity of secondary containment 
structures, and is recommended in the National Pollution Discharge 
Elimination System (NPDES) Best Management Practices Guidance 
Document.(Ref. 74) EPA believes that, just as a 25-year, 24-hour storm 
is a reasonable criterion for stormwater retention (prevention of run-
off), it would also serve as sufficient freeboard and a reasonable 
standard for prevention of stormwater seepage and run-on from adjacent 
lands or structures. Such a standard allows flexibility for varying 
climatic conditions. It is also the standard required for certain tank 
systems storing or treating hazardous waste. See, for example, 40 CFR 
265.1(e)(1)(ii) and (e)(2)(ii). However, the Agency has decided not to 
require a 25-year, 24-hour storm criterion here in order to be 
consistent with the final EPA rule on Oil Pollution Prevention and 
Response: Non-Transportation-Related Onshore and Offshore Facilities 
(67 FR 47042, Ref. 47). The Oil Prevention Rule states that while a 25-
year, 24-hour storm event standard is appropriate for most facilities 
and protective of the environment, it may be difficult and expensive 
for some facilities to secure recent information concerning such storm 
events at this time. Recent data do not exist for all areas of the 
United States, or may be costly for small operators to secure. Should 
recent and inexpensive information concerning a 25-year, 24-hour storm 
event become easily accessible for every part of the United States, we 
will reconsider proposing such a standard. Instead, at this time, we 
are requiring, as a few commenters suggested, that the containment 
structure have sufficient freeboard to contain precipitation and 
prevent water and other liquids from seeping into or flowing onto it 
from adjacent land or structures. Most States with containment 
regulations do not use a 25-year, 24-hour storm criterion, and have 
indicated that, in their experience, requiring a numerical capacity 
(110 percent) or sufficient freeboard to accommodate local 
precipitation conditions provides adequate protection.
    3. Capacity requirements for new stationary liquid pesticide 
containment units and new containment pads in pesticide dispensing 
areas (Sec.  165.85(c))--i. Capacity for new stationary liquid 
pesticide containment units--Final regulations. These are the capacity 
requirements:
    <bullet> New secondary containment units for stationary liquid 
containers, if protected from precipitation, must have a capacity of at 
least 100 percent of the volume of the largest stationary container 
plus the volume displaced by other containers and appurtenances within 
the unit.
    <bullet> New secondary containment units for stationary liquid 
containers, if exposed to or unprotected from precipitation, must have 
a capacity of at least 110 percent of the volume of the largest 
stationary container plus the volume displaced by other containers and 
appurtenances within the unit.
    a. Changes. The proposed rule required higher capacity of 110 
percent for units protected from precipitation and 125 percent for 
units exposed to precipitation.
    b. Comments. Several State regulatory agencies supported the 
proposed standards, stating that adjusting the standard to reflect 
variable rainfall would add confusion. Many commenters (dealers, dealer 
groups and a State regulatory agency) supported instead the standard 
that EPA had proposed for the interim period for existing structures, 
namely 100 percent/110 percent capacity (indoor/outdoor). Reasons cited 
included: (1) Many dikes that meet this standard have been in place for 
years with no overflows; (2) EPA provides little or no justification 
that capacity in excess of 100 percent of the volume of the largest 
container is necessary; (3) modifying a dike to add additional capacity 
would be expensive; and (4) many Midwestern States have adopted the 100 
percent/110 percent standard from the AAPCO model rule.
    c. EPA response. EPA agrees with comments based on practical field 
experience and has reduced the volumes needed to 100 percent and 110 
percent, respectively for indoor and outdoor units. The 110 percent 
criterion for storage areas without roofing adds an extra margin of 
safety for retention of precipitation. An extra 10% is not needed 
indoors as long as the displaced volume or other containers is added. 
However, the Agency recognizes that, for enforcement purposes, it may 
be difficult to reconcile capacity with climatic conditions. For 
example, in the case of a 2-inch rain, capacity at a new outdoor liquid 
pesticide facility could be temporarily reduced to less than 110 
percent of the largest tank if that tank were full, and the facility 
would no longer be in compliance. To avoid disputed calculations of 
capacity, the Agency recommends that facilities make allowances for 
additional capacity beyond the 110 percent required, such as 125 
percent, to build in a margin of error.
    ii. Capacity for new containment pads in pesticide dispensing 
areas--i. Final regulations. These are the capacity requirements:
    <bullet> New containment pads in pesticide dispensing areas subject 
to the regulations in this subpart which have a pesticide container or 
pesticide-holding equipment with a volume of

[[Page 47398]]

750 gallons or greater must have a holding capacity of at least 750 
gallons.
    <bullet> New containment pads in pesticide dispensing areas subject 
to the regulations in this subpart which do NOT have a pesticide 
container or pesticide-holding equipment with a volume of at least 750 
gallons must have a holding capacity of at least 100 percent of the 
volume of the largest pesticide container or pesticide-holding 
equipment used on the pad.
    ii. Changes. The proposal required that pads have a minimum holding 
capacity of 1,000 gallons, or, if no equipment used on the pad exceeded 
1,000 gallons, at least 100% of the capacity of the largest container 
or equipment used on the pad. Today's rule reduces the minimum pad 
holding capacity to 750 gallons in the most likely scenario where large 
(greater than 750 gallon) containers or pesticide-holding equipment 
will be on the pad. Additionally, the capacity requirement refers to 
gravity capacity, as defined in oral comments by Wisconsin state 
regulatory officials (Ref. 46) in 2003. The gravity capacity of a sump 
or containment structure is the capacity before any method of removing 
or transferring the contained liquid by pump or other means is 
employed. For example, a facility is prohibited from claiming a 
capacity of 750 gallons if the sump or containment structure has an 
actual capacity of less than 750 gallons but is serviced by a pump 
which transfers accumulated liquid into holding tanks such that the 
effective capacity would be 750 gallons. Since achieving 750-gallon 
storage capacity under those circumstances relies on the proper and 
dependable functioning of a pump as well as a continual supply of fuel 
or electrical current to run the pump, this is not an acceptable way of 
achieving the required capacity because if these conditions are not 
met, a spill is more likely.
    iii. Comments. Indiana state regulators argued that the state had 
spent three difficult years and had invested considerable resources in 
implementing its regulations, which require a pad capacity of 750 
gallons. They stated that to get the cooperation and voluntary 
compliance of the impacted industries, they had to suggest to those 
making the investment that there would be no significant changes in 
requirements. To reverse themselves now, they stated, would jeopardize 
their credibility. Illinois, a state with over 1,000 bulk facilities, 
suggested that the pad capacity requirement should take into account 
the additional volume of a 6-inch rainfall (the volume expected from a 
24-year, 25-hour storm). A few State regulatory agencies did not object 
to EPA's proposed pad capacity requirements, although their State 
regulations are slightly more stringent. A State regulatory agency 
noted that the difference between 750 gallon and 1,000 gallon capacity 
would do little to accommodate a spill from a 3,000 gallon delivery 
truck.
    iv. EPA response. The Agency did not have a technical basis for 
choosing the 1,000 gallon capacity in the proposed rule, but based it 
on a review of proposed and actual State containment regulations. Based 
on comments and subsequent research, we determined that the criteria of 
750 gallons used in some States has proven adequate. We believe that in 
most actual situations of spillage on a pad, 750 gallons would be 
adequate, especially since product transfers must be attended under the 
requirements of this subpart. In a catastrophic event, neither 750 
gallons nor 1,000 gallons would be sufficient to contain a large spill, 
and the added cost of increasing capacity to 1,000 from 750 would 
exceed any marginal environmental benefit. The Agency also agrees with 
Wisconsin State regulators that a 750-gallon pad may be as small as 12 
feet square, and that a top-loaded tank may risk splashing during the 
refilling process. Consequently, while we are lowering the gallon 
capacity to 750 gallons of gravity capacity, we are recommending that 
the pad have a minimum size of 15 feet by 15 feet (or 225 square feet). 
Additionally, for new operational pads unprotected from precipitation, 
we recommend constructing a pad with a gravity capacity of 1,000 
gallons.
    4. Specific requirements for new stationary liquid pesticide 
containment units (Sec.  165.85(d))--i. Final regulations. In addition 
to meeting the requirements of Sec.  165.85(a), (b) and (c), each new 
stationary liquid container protected by a secondary containment unit 
must either be anchored or elevated to prevent flotation in the event 
that the secondary containment unit fills with liquid.
    ii. Changes. The proposed rule required that the containment unit 
had to allow for observation of leakage from the base of any enclosed 
stationary pesticide container. Thus, a flat-bottomed container would 
have had to be elevated so that leakage would be visible. In addition, 
the proposed rule required that flotation of the container, in the 
event the containment filled with liquid, be prevented by either 
elevating or anchoring the container. The final rule requires either 
elevation or anchoring in response to comments that argued that 
elevating containers is not necessary to detect leaks and may engender 
risks from inadequate support devices.
    5. Specific requirements for new containment pads in pesticide 
dispensing areas (Sec.  165.85(e))--i. Final regulations. In addition 
to meeting the requirements for Sec.  165.85(a), (b) and (c), each new 
containment pad in a pesticide dispensing area must:
    <bullet> Be designed and constructed to intercept leaks and spills 
of pesticides which may occur in the pesticide dispensing area.
    <bullet> Have enough surface area to extend completely beneath any 
container on it, with the exception of transport vehicles dispensing 
pesticide for sale or distribution to a stationary container. For such 
vehicles, the surface area of the containment pad must accommodate at 
least the portion of the vehicle where the delivery hose or device 
couples to the vehicle. This exception does not apply to transport 
vehicles that are used for prolonged storage or repeated on-site 
dispensing of pesticides.
    <bullet> Allow, in conjunction with its sump, for removal and 
recovery of spilled, leaked, or discharged material and rainfall, such 
as by a manually activated pump. Automatically activated pumps which 
lack automatic overflow cutoff switches for the receiving container are 
prohibited.
    <bullet> Have its surface sloped toward a liquid-tight sump where 
liquids can be collected for removal.
    ii. Changes. These requirements are identical to those in Sec.  
165.152(b) of the proposed rule. The proposed rule noted that tanker 
trucks are considerably larger than containers or equipment normally 
used on the containment pad, but that such deliveries are not expected 
to be frequent, and did not propose that the pad had to be large enough 
to accommodate the entire vehicle. This exception does not apply to 
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides, since the primary function of such a 
vehicle would be pesticide storage rather than transport. EPA reasons 
that the full containment requirements imposed on fixed containers 
would also apply to non-fixed containers that remain at an applicable 
facility for at least 30 days.
    6. Specific Requirements for new stationary dry pesticide 
containment units (Sec.  165.85(f))--i. Final regulations. In addition 
to the requirements in Sec.  165.85(a) and (b), each new stationary dry 
pesticide containment must meet the following requirements:
    <bullet> The stationary dry pesticide containers within the 
containment unit

[[Page 47399]]

must be protected from wind and precipitation.
    <bullet> Stationary dry pesticide containers must be placed on 
pallets or a raised concrete platform to prevent the accumulation of 
water in or under the pesticide.
    <bullet> The stationary dry pesticide container storage area must 
be enclosed by a curb that is a minimum of a 6 inches high and that 
extends at least 2 feet beyond the perimeter of the container.
    ii. Changes. The proposal required that dry bulk secondary 
containment units have a capacity of 100 percent of the largest 
container plus the volume displaced by other containers and 
appurtenances within the containment. The Agency was concerned that dry 
pesticide could still mix with rainwater, fire suppression water, etc., 
to reach and contaminate groundwater and soil. The proposed rule did 
not have any provisions for protection from wind and precipitation, nor 
for elevated storage to prevent water accumulation under the pesticide, 
but did request comment on such options. The final rule does not have a 
numerical capacity requirement.
    iii. Comments. Several commenters (State regulatory agencies and a 
dealer group) opposed the 100 percent proposed capacity as excessive, 
since dry materials do not spread and disperse like liquid materials. 
Several State regulatory agencies suggested that dry bulk secondary 
containment should be protected by roofing or similar cover from wind 
and precipitation, which would make 100 percent capacity unnecessary. 
One State noted that it already has dry bulk containment regulations 
which require that the containers be raised off the floor, and several 
States require at least a 6-inch curb around an area extending at least 
2 feet beyond the perimeter of the bulk tank. A registrant stated that 
the typical practice is to store dry pesticides under a roof. Some 
commenters offered alternative strategies, generally based on existing 
State regulations, including a curb 6 inches high at least 2 to 3 feet 
beyond the perimeter.
    iv. EPA response. EPA has reviewed State bulk storage regulations 
and best management practices for storing dry bulk pesticides and has 
noted that States require storage under a roof and, if outdoors, on 
pallets or raised concrete platforms, and that the most common 
requirement for dry bulk is a 6-inch berm at least 2 to 3 feet from the 
container. (Ref. 34) Given that the States with the most experience 
with dry bulk storage have the most practical experience with dry spill 
containment, EPA agrees with the common sense arguments of commenters 
regarding protection from precipitation, elevation, and the flow 
properties of dry material, and has changed the dry containment 
requirement accordingly. In regard to roofing, EPA believes that the 
advantages of keeping rainwater out of containment will outweigh the 
cost of installing a roof. However, in arid regions, a roof may not be 
cost-effective, and if EPA provided roofing specifications, it is 
possible that they would conflict with local construction requirements 
and building codes. Therefore, the final rule requires protection from 
wind and precipitation rather than specifically requiring a roof to 
allow some flexibility. The Agency agrees that 100 percent capacity, 
given that dry materials spread differently that liquids, would be 
excessive. We also recognize that significant quantities of dust may be 
generated during the refilling process, where the dry product is a 
dust, granules or flowable formulation. While today's rule makes no 
requirement for dust minimization or collection, we recommend that 
every effort be made to contain the dust generated, both for the 
respiratory protection of the persons attending the transfer and for 
the preservation of air and soil quality in the vicinity of the 
facility.

I. Design and Capacity Requirements for Existing Structures (Sec.  
165.87)

    1. Construction Materials for all existing containment structures 
(Sec.  165.87(a))--i. Final regulations. Existing containment 
structures must be made of steel, reinforced concrete or other rigid 
material which will withstand the full hydrostatic head, load and 
impact of any pesticides, precipitation, other substances, equipment 
and appurtenances placed within the structure. The construction 
material must not be natural earthen material, unfired clay, or 
asphalt, and must be compatible with the stored pesticide.
    ii. Changes. The requirements in Sec.  165.87(a) for existing 
structures are identical to the requirements for construction materials 
for new containment structures in Sec.  165.85(a). The proposed rule 
stated that the construction material had to be resistant to pesticide, 
while the final rule requires the material to be compatible with the 
stored pesticides. In addition, the following proposed standard for 
existing structures is not being finalized:
    During the interim period, each existing structure must have a 
hydraulic conductivity standard less than or equal to 1 x 
10<SUP>-6</SUP> centimeters per second. After the interim period, each 
new containment structure must meet the hydraulic conductivity standard 
for new structures of less than or equal to 1 x 10<SUP>-7</SUP> 
centimeters per second.
    iii. Comments. General comments and EPA's response on construction 
material are discussed in Unit VIII.H.1. EPA believes that existing 
structures should easily meet these requirements based on the 
information we have gathered. We are not aware of secondary containment 
units being constructed of any of the prohibited materials. We are 
aware of the existence of some asphalt containment pads, but we believe 
these are mostly used by aerial applicators that probably are not 
subject to these regulations because they do not have large stationary 
pesticide containers.
    2. General design requirements for all existing containment 
structures (Sec.  165.87(b))--i. Final regulations. These are the 
general design requirements for existing containment structures:
    (1) Protect appurtenances and pesticide containers against damage 
from operating personnel and moving equipment. Means of protection 
include, but are not limited to, supports to prevent sagging, flexible 
connections, the use of guard rails, barriers, and protective cages.
    (2) Seal (permanently close) all appurtenances, discharge outlets 
and gravity drains through the base or wall of the containment 
structure, except for direct interconnections between adjacent 
containment structures which meet the requirements of this subpart.
    (3) Construct the containment structure with sufficient freeboard 
to contain precipitation and prevent water and other liquids from 
seeping into or flowing onto it from adjacent land or structures.
    (4) Multiple stationary pesticide containers may be protected 
within a single secondary containment unit.
    ii. Changes. Requirements are similar to those proposed in proposed 
Sec.  165.146, except that (4) is added to clarify a statement in the 
proposed rule under Sec.  165.152. The requirement in paragraph (2) was 
proposed for existing structures 10 years after the publication date of 
the rule (at the expiration of an interim period that was proposed for 
existing units. See discussion on compliance dates in Unit VIII.D. 
above.) In addition, at the end of the interim period, existing 
structures had to meet the requirements for new structures, including 
configuring appurtenances in such a way that leaks and spills could be 
readily observed. The final rule requires facilities with existing 
structures to seal appurtenances, discharge outlets and gravity drains 
at the base and walls. EPA believes it is

[[Page 47400]]

necessary for existing structures to comply with this requirement 
because some studies cited in the proposed rule estimated that 30 
percent of the reported pesticide spill incidents resulted from 
appurtenance failure, and many releases were reported from discharge 
outlets and gravity drains. Requirements in paragraph (3) have also 
been changed. In the proposed rule, the requirement was to prevent 
storm water run-on from seeping into or flowing onto it from adjacent 
land or structures during a 25-year, 24-hour rainfall event. The 
requirement has been changed to ensuring sufficient freeboard to 
prevent run-on. The comments on general design requirements and EPA's 
responses are discussed in Unit VIII.H.2.
    3. Capacity requirements for existing stationary liquid pesticide 
containment units and existing containment pads in pesticide dispensing 
areas (Sec.  165.87(c))--i. Capacity for existing stationary liquid 
pesticide containment units--a. Final regulations. Each existing 
stationary liquid pesticide containment unit must have a capacity of at 
least 100 percent of the volume of the largest stationary pesticide 
container plus the volume displaced by other containers and 
appurtenances within the unit.
    b. Changes. The proposed rule required a capacity of 100 percent 
for existing liquid bulk containment units protected from precipitation 
and 110 percent for units exposed to precipitation for the 8-year 
interim compliance period. At the expiration of the interim period, the 
capacity requirements would be the same as those proposed for new 
structures, that is, 110 percent for units protected from precipitation 
and 125 percent for outdoor, unprotected units. The approach of having 
an interim period is not being finalized. The final rule requires 
existing liquid pesticide containment units to have capacities of 100 
percent whether protected from precipitation or not.
    c. Comments. The comments on capacity requirements for new and 
existing stationary liquid pesticide containment units are discussed in 
the comment section under Unit VIII.H.3.a. In addition, many commenters 
noted that changes in capacity requirements for existing structures 
would require major modification, re-certification by an engineer and 
significant costs. A few State regulatory agencies noted that little if 
any additional benefit will be afforded by requiring extra capacity, 
and that they had never experienced a breach of containment structure 
based on existing laws.
    d. EPA response. As discussed in Unit VIII.H.3., EPA agrees, based 
on field experience, that the proposed capacity requirements were 
excessive and has reduced the capacity requirements in the final rule. 
In addition, the Agency is not requiring a numerical standard of 110 
percent for existing unprotected units (in contrast to the requirements 
for new unprotected units) in order to harmonize with existing State 
containment regulations which have chosen to require unprotected units 
to have 100 percent capacity plus either a 6-inch freeboard or capacity 
to withstand a 25-year/24-hour storm. The Agency understands that some 
existing units would need to retrofit to meet a 110 percent capacity 
requirement, and that the burden of adding the extra capacity appears 
to outweigh any benefit of the extra capacity. The Agency recognizes 
that States may have existing structures in low-precipitation areas, 
and is allowing them the flexibility to define capacity requirements 
above 100 percent according to local conditions.
    ii. Capacity for Existing containment pads in pesticide dispensing 
areas-- a. Final regulations. Existing containment pads with pesticide-
holding equipment with a volume of 750 gallons or greater must have a 
holding capacity of at least 750 gallons. Pads which do not have a 
pesticide container or pesticide-holding equipment with a volume of at 
least 750 gallons must have a holding capacity of at least 100 percent 
of the volume of the largest pesticide container or pesticide-holding 
equipment used on the pad.
    b. Changes. The proposal required that existing pads have a minimum 
holding capacity of 1,000 gallons or 100 percent of the capacity of the 
largest container or equipment used on the pad. The final rule reduces 
the minimum pad holding capacity to 750 gallons in the most likely 
scenario where large (greater than 750 gallon) containers or pesticide-
holding equipment will be on the pad. Comments and EPA responses apply 
as discussed in Unit VIII.H.3. for new containment pads.
    4. Specific design requirements for existing stationary liquid 
pesticide containment units (Sec.  165.87(d))--i. Final regulations. In 
addition to the requirements in Sec.  165.87(a), (b) and (c), each 
existing stationary liquid pesticide container protected by a secondary 
containment unit must be adequately elevated or anchored to prevent 
flotation in the event that the secondary containment unit fills with 
liquid.
    ii. Changes. This requirement is identical to that proposed in 
Sec.  165.148(b)(2). In the proposed rule, existing secondary 
containment units would have had to allow for the observation of 
leakage from the base of all stationary bulk containers after the 
interim period expired. As explained in Unit VIII.H.4., the standard 
for observing leakage from the base of stationary bulk containers is 
not being finalized.
    5. Specific design requirements for existing containment pads in 
pesticide dispensing areas (Sec.  165.87(e))--i. Final regulations. In 
addition to meeting the requirements for Sec.  165.87(a), (b) and (c), 
each existing containment pad in a pesticide dispensing area must:
    <bullet> Be designed and constructed to intercept leaks and spills 
of pesticides which may occur in the pesticide dispensing area.
    <bullet> Have enough surface area to extend completely beneath any 
container on it, with the exception of transport vehicles dispensing 
pesticide for sale or distribution to a stationary container. For such 
vehicles, the surface area of the containment pad must accommodate at 
least the portion of the vehicle where the delivery hose or device 
couples to the vehicle. This exception does not apply to transport 
vehicles that are used for prolonged storage or repeated on-site 
dispensing of pesticides.
    <bullet> Allow, in conjunction with its sump, for removal and 
recovery of spilled, leaked, or discharged material and rainfall, such 
as by a manually activated pump. Automatically-activated pumps which 
lack automatic overflow cutoff switches for the receiving container are 
prohibited.
    ii. Changes. The requirements in the final rule are identical to 
those in the proposal. The proposed rule noted that tanker trucks are 
considerably larger than containers or equipment normally used on the 
containment pad, but that such deliveries are not expected to be 
frequent, and did not propose that the pad had to be large enough to 
accommodate the entire vehicle. This exception does not apply to 
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides, since the primary function of such a 
vehicle would be pesticide storage rather than transport. In addition, 
the proposed rule required that, at the expiration of the interim 
period, each existing containment pad would be sloped to a liquid-tight 
sump where liquids can be collected for removal. The interim period has 
been deleted, and the requirement for sloped pads is not being 
finalized for existing containment pads. The requirement for sloped 
pads applies only to new containment pads in the final rule.
    6. Specific design requirements for existing stationary dry 
pesticide

[[Page 47401]]

containment units (Sec.  165.87(f))--i. Final regulations. In addition 
to the requirements in Sec.  165.87(a) and (b), each existing dry 
stationary pesticide containment must meet the following requirements:
    <bullet> The containment must protect stationary dry pesticide 
containers within it from wind and precipitation.
    <bullet> Dry stationary pesticide containers must be stored on 
pallets or a raised concrete platform to prevent the accumulation of 
water in or under the pesticide.
    <bullet> The container storage area must be enclosed by a minimum 
of a 6-inch high curb that extends at least 2 feet beyond the perimeter 
of the container.
    ii. Changes. The proposal required that dry bulk secondary 
containment units have a capacity of 100 percent of the largest 
container plus the volume displaced by other containers and 
appurtenances within the containment. The proposed rule did not have 
any provisions for protection from wind and precipitation, nor for 
elevated storage to prevent water accumulation under the pesticide. The 
final rule does not have a numerical capacity requirement. All 
modifications must now be made within 3 years instead of the 10 years 
in the proposed rule, but the requirements are modified and simplified 
such that the Agency believes they are feasible within the 3-year 
period. See Unit VIII.H.6. for a summary of the significant comments 
and EPA's responses.

J. Operational, Inspection and Maintenance Requirements (Sec.  165.90)

    1. Operating procedures for all new and existing pesticide 
containment structures (Sec.  165.90(a))--i. Final regulations. An 
owner or operator of a new or existing pesticide containment structure 
must:
    <bullet> Manage the structure in a manner that prevents pesticides 
or materials containing pesticides from escaping from the containment 
structure (including, but not limited to, pesticide residues washed off 
the containment structure by rainfall or cleaning liquids used within 
the structure.)
    <bullet> Ensure that pesticide spills and leaks on or in any 
containment structure are collected and recovered in a manner that 
ensures protection of human health and the environment (including 
surface water and ground water) and maximum practicable recovery of the 
pesticide spilled or leaked. Cleanup must occur no later than the end 
of each day on which pesticides have been spilled or leaked.
    <bullet> Ensure that all materials resulting from spills and leaks 
and any materials containing pesticide residue are managed according to 
label instructions and applicable Federal, State and local laws and 
regulations.
    <bullet> Ensure that transfers of pesticides between containers, or 
between containers and transport vehicles are attended at all times.
    <bullet> Ensure that each lockable valve on a stationary pesticide 
container, if it is required by Sec.  165.45(f), is closed and locked 
whenever the facility is unattended.
    ii. Changes. These requirements are substantially the same as those 
proposed in Sec.  165.146(c). The order of the standards and several 
minor wording modifications were made to improve the clarity of the 
requirements.
    2. Inspection and maintenance of all new and existing pesticide 
containment structures (Sec.  165.90(b))--i. Final regulations. The 
owner or operator of each pesticide containment structure must:
    <bullet> Inspect each stationary pesticide container and its 
appurtenances at least monthly during periods when pesticides are being 
stored or dispensed on the containment structure. Your inspection must 
look for visible signs of wetting, discoloration, blistering, bulging, 
corrosion, cracks or other signs of damage or leakage.
    <bullet> Immediately repair any areas showing visible signs of 
damage and seal any cracks and gaps in the containment structure or 
appurtenances with material compatible with the pesticide being stored 
or dispensed.
    <bullet> Not store any pesticide on a containment structure if the 
structure fails to meet the requirements of this subpart until suitable 
repairs have been made. Prompt removal of pesticides, including 
emptying of stationary containers, in order to effect repairs or 
recovery of spilled material is acceptable.
    ii. Changes. These inspection and maintenance requirements are 
substantially the same as those proposed in Sec.  165.146(d). A few 
minor modifications were made to improve the clarity of the language. 
In addition, several changes were made to be consistent with other 
changes in the regulations. In particular, EPA decided not to finalize 
the hydraulic conductivity standard, so the corresponding inspection 
and maintenance requirement is also not being finalized. Also, the 
final rule specifies that the containment structure be compatible with 
the pesticides, rather than resistant as proposed. The corresponding 
inspection and maintenance standard was changed accordingly.

K. Combined Pads and Units (Sec.  165.92)

    1. Final Regulation. Facility owners and operators may combine 
containment pads and secondary containment units as an integrated 
system provided the requirements set out in this subpart for pads and 
units in Sec. Sec.  165.85(a) and (b), 165.87(a) and (b) and 165.190, 
and as applicable, Sec. Sec.  165.85(c)-(f) and 165.87(c)-(f) are 
satisfied separately.
    2. Changes. This provision for allowing integrated containment 
systems is substantially the same as that proposed in Sec.  165.153.

L. Recordkeeping (Sec.  165.95)

    1. Final regulations. Facility owners and operators subject to the 
requirements of this rule must maintain the following records, and must 
furnish these records for inspection and copying upon request by any 
employee of EPA or any entity designated by EPA, such as a State, 
another political subdivision or a Tribe:
    <bullet> Records of inspection and maintenance for each containment 
structure and for each stationary pesticide container and its 
appurtenances must be kept for 3 years and must include the following 
information:
    <bullet> name of the person conducting the inspection or 
maintenance;
    <bullet> date the inspection or maintenance was conducted;
    <bullet> conditions noted;
    <bullet> specific maintenance performed.
    <bullet> Records for any non-stationary container designed to hold 
undivided quantities of agricultural pesticides equal to or greater 
than 500 gallons (1,890 liters) of liquid pesticide or equal to or 
greater than 4,000 pounds (1,818 kilograms) of dry pesticide that holds 
pesticide but is not protected by a secondary containment unit meeting 
today's regulations must be kept for 3 years. Records on these non-
stationary pesticide containers must include the time period that the 
container remains at the same location.
    <bullet> Records of the construction date of the containment 
structure must be kept for as long as the pesticide containment 
structure is in use, and for 3 years afterwards.
    2. Changes. The proposed rule required additional recordkeeping of 
inventory reconciliation for existing bulk liquid containers that were 
not elevated during the interim period. The proposed rule also required 
owners and operators to maintain records of written confirmation of 
hydraulic conductivity and statements of resistance to pesticide for as 
long as the structure was in use,

[[Page 47402]]

and for 3 years thereafter. These requirements are not being finalized, 
so the corresponding recordkeeping requirements are also not being 
finalized. Since the standards differ depending on whether the facility 
was considered existing or new at the time of this final rule, a new 
recordkeeping requirement has been added: each facility must maintain 
records of the construction date of the containment structure for as 
long as the pesticide containment structure is in use, and for 3 years 
afterwards.

M. States With Existing Containment Programs (Sec.  165.97)

    1. Final regulations. States that have promulgated containment 
regulations effective prior to August 16, 2006, and which also have 
primary enforcement responsibility and/or certification programs, have 
the option of continuing to implement their own programs in lieu of 
today's Federal regulations under certain conditions.
    A State that wishes to continue implementing the State's 
containment regulations must request the authority to do so by August 
16, 2007 in the following manner:
    <bullet> The State must submit a letter and any supporting 
documentation to EPA. Supporting documentation must demonstrate that 
the State's program is providing environmental protection equivalent to 
that expected to be provided by the Federal regulations in 40 CFR 
subpart E.
    <bullet> The State must identify any significant changes to State 
regulations which would be necessary in order to provide environmental 
protection equivalent to the EPA regulations, and develop an estimated 
timetable to effect these changes. The letter must be signed by the 
designated State Lead Agency (SLA).
    EPA's Office of Pesticide Programs (OPP), in collaboration with the 
EPA Regions and other EPA offices, will review the State's 
correspondence and determine whether the State's program is adequate to 
provide environmental protection equivalent to or more protective than 
these Federal regulations for new and existing containment structures. 
OPP will inform the State of its determination through a letter 
authorizing or declining to authorize the State to continue 
implementing its containment regulations and will detail any reasons 
for declining authorization.
    Any State that has received authorization to continue implementing 
its State containment regulations must inform EPA by letter signed by 
the designated State Lead Agency within 6 months of any revision to the 
State containment regulations. EPA will inform the State by letter if 
it determines that the State's containment regulations are no longer 
adequate based on the revisions. The State containment regulations will 
remain in effect, unless and until EPA sends the State a letter making 
this determination.
    2. Changes. The proposed rule made no provision for States to 
implement their own containment regulations in lieu of EPA's rule.
    3. Comments. Many commenters to the 1994 proposed rule (dealers, a 
dealer group, a State regulatory agency group and individual State 
regulatory agencies) opposed setting any Federal standards that are 
more stringent than existing State requirements. They requested that 
EPA accept current State rules and statutes where the discrepancies are 
not significant from Federal standards. The State regulatory agency 
group requested EPA to seriously consider accepting small discrepancies 
in some standards due to differences in existing State legislation, and 
said that while national uniformity in regulation is desirable, it 
should not be at the expense of States that have already enacted rules 
that vary slightly from the Federal rule. A dealer group suggested that 
EPA set the Federal standards as a baseline, which would allow the 
proactive work of some States to stand and would preclude dealers from 
incurring the same economic burdens twice (i.e., to build and then 
rebuild containment structures).
    Several commenters (State regulatory agencies, a dealer, and a 
grower group) recommended that EPA grandfather existing containment 
facilities that are in compliance with State standards or that are 
comparable in function, design, and construction. Similarly, a grower 
group said that State rules for bulk containment should take precedence 
over this proposal. A State regulatory agency elaborated on these 
difficulties, stating that States with containment requirements would 
have to reinitiate their compliance efforts and would lose credibility 
and the trust of the regulated industry, with whom they worked closely 
to develop and implement the State rules.
    A dealer commented that forcing States to enforce different rules 
from their own would cause difficulties for the enforcing agency, 
distributors, retailers and end users who will have to learn an extra 
set of requirements. A few State regulatory agencies commented that 
millions of dollars have been spent by industry on compliance with 
State regulations, some of which have been in place since 1985, and 
that containment structures have not had failures when built to State 
standards. They recommended that the final rule be crafted to harmonize 
with State or other environmental statutes, and that it should not 
penalize States which have spent years building effective relationships 
with the regulated community for safe pesticide handling.
    Similarly, many commenters to the 2004 Notice reiterated these 
arguments and said States have taken a pro-active role and have enacted 
pesticide containment regulations which have proven to be protective of 
the environment and which EPA should accept by a grandfather clause. A 
few commenters in 2004 pointed out that in some States it is not the 
State lead pesticide regulatory agency (usually, department of 
agriculture) that has authority for regulating the storage of hazardous 
materials/pesticides, but instead the State environmental protection or 
pollution control agency. They argued that situations where one State 
agency does the comprehensive pesticide regulatory work but another is 
charged with the containment regulations begs questions about 
responsibilities for and resources necessary to accomplish expected 
compliance monitoring and enforcement response.
    4. EPA response. The Agency agrees that Federal regulations should 
reinforce, rather than undermine or conflict with the efforts of 
proactive States. While the Agency believes in the need for national 
standards, EPA does not want to burden proactive States and facilities 
in those States with additional expenditures to revise their regulatory 
implementation system if the differences between their containment 
regulations and today's rule are minimal, and especially where State 
standards are more stringent than Federal standards. EPA has evaluated 
the pesticide containment regulations in those States that have 
promulgated them, and believes that the regulations in those States 
have generally brought facilities into compliance with today's 
regulations, with some potential deficiencies in certain States. EPA 
recognizes that simply reading regulations without awareness of the 
field reality, State enforcement discretion, and policy and guidance 
directives provided to inspectors may provide a less accurate reading 
of the equivalency of regulations. Consequently, EPA expects that 
States will be able to readily document their equivalency by providing 
existing information or pre-existing documents. EPA does not anticipate 
a significant paperwork burden for States, and is

[[Page 47403]]

offering this opportunity in response to States' requests in comments 
to be allowed to continue to implement their own regulations. EPA 
believes that in States where the lead pesticide agency is not 
responsible for enforcing containment regulations, collaboration 
between the State's agencies will be feasible. State regulators are 
encouraged to consult with EPA prior to preparing their submission.

IX. Labeling Requirements for Pesticides and Devices

A. Overview

    1. Final regulations. Today's final rule changes the requirements 
for labeling pesticides in 40 CFR part 156 in several ways. First, 
these regulations add a new subpart H, entitled Container Labeling to 
part 156. The new container labeling regulations include the following 
requirements:
    <bullet> A statement identifying the container as nonrefillable or 
refillable is required on all pesticide labels. In addition, 
nonrefillable container labels must include several statements 
providing basic instructions for managing the container and a batch 
code for the product. (See Units IX.B. - IX.D. for more details.)
    <bullet> Cleaning instructions for some nonrefillable containers, 
specifically for dilutable products that are sold or distributed in 
rigid containers and that are not household/residential. (See Units 
IX.E. - IX.K. for more details.)
    <bullet> Instructions for cleaning all refillable containers before 
disposal. (See Units IX.E. and IX.L. for more details.)
    In addition, today's final rule modifies several existing 
requirements in 40 CFR 156.10 to allow for blank spaces on the labels 
of some refillable containers for the net contents and EPA 
establishment number. In addition, the paragraph in 40 CFR 156.10 that 
requires storage and disposal statements is being changed to be 
consistent with the label requirements added to 40 CFR part 156 in 
subpart H and the container regulations being added to 40 CFR part 165 
in today's rule. (See Unit IX.M.)
    Container-related labeling instructions for plant-incorporated 
protectants will be determined on a case-by-case basis until specific 
labeling guidance for plant-incorporated protectants are promulgated 
under 40 CFR part 174.
    Existing EPA guidance on label statements for cleaning, recycling 
and disposing of pesticide containers, includes:
    <bullet> The Label Review Manual (Ref. 44);
    <bullet> PR Notice 83-3, Label Improvement Program -- Storage and 
Disposal Label Statements (Ref. 73);
    <bullet> PR Notice 84-1, Clarification of Label Improvement Program 
(Ref. 72);
    <bullet> PR Notice 94-2, Recycling Empty Aerosol Pesticide 
Containers (Ref. 65);
    <bullet> PR Notice 98-10, Notifications, Non-Notifications and 
Minor Formulation Amendments (Ref. 56); and
    <bullet> PR Notice 2001-6, Disposal Instructions on Non-
Antimicrobial Residential/Household Use Pesticide Product Labels (Ref. 
49).
    This guidance will be revised, if necessary, to be consistent with 
the requirements in today's final regulation.
    2. Changes. The final labeling regulations in today's rule cover 
the same statements and topics that were included in the proposed rule. 
However, a number of changes have been made to the regulations, 
including but not limited to modifying specific statements, adding 
alternative statements, restructuring the regulations based on the 
plain language format, and exempting household/residential pesticide 
products from the requirements for cleaning instructions on 
nonrefillable container labels. The specific changes are described in 
the section-by-section discussion below.

B. Identification of Container Types (Sec.  156.140)

    1. Final regulations. This section applies to all pesticide 
products and requires statements that, among other things, identify the 
container as nonrefillable or refillable. These statements must be 
placed on the label or container. The regulations in 40 CFR 
156.10(a)(4)(i) require the label to ``appear on or be securely 
attached to the immediate container of the pesticide product.'' 
Therefore, the statements required by Sec.  156.140 cannot be placed 
only on labeling that is not attached to the container, because it may 
become separated. The information may be located on any part of the 
container except the closure. If the statements are placed on the 
container, they must be durably marked on the container. Durable 
marking includes, but is not limited to etching, embossing, ink 
jetting, stamping, heat stamping, mechanically attaching a plate, 
molding, or marking with durable ink.
    2. Changes. In the final rule, EPA has changed the word 
``permanent'' to ``durable'' to describe the required container 
marking. In addition, the language from the preamble of the proposed 
rule that lists acceptable formats of the marking was added to the 
regulations to clearly establish our intent. Finally, the phrase ``as 
applicable'' was added to the first sentence to accommodate the fact 
that the statements in paragraph (a) apply only to labels on 
nonrefillable containers and the statements in paragraph (b) apply only 
to the labels on refillable containers.

C. Statements Required for Nonrefillable Containers (Sec.  156.140(a))

    1. Final regulations. The final rule requires all nonrefillable 
containers to have the following four items on the label or the 
container:
    <bullet> The phrase ``Nonrefillable container;''
    <bullet> A statement regarding reuse;
    <bullet> A statement about recycling or reconditioning; and
    <bullet> A batch code.
    If the first three items are placed on the label, they must be put 
under an appropriate heading under the heading ``Storage and 
Disposal.'' If any of the first three items are placed on the 
container, an appropriate referral statement, such as the statement in 
Sec.  156.140(a), must be placed on the label under the heading 
``Storage and Disposal.''
    2. Changes. These statements were reorganized by separating each 
phrase or statement into a different regulatory paragraph to 
accommodate the addition of alternative statements. The proposed rule 
included all four items, but included the first three as one statement: 
``Nonrefillable container. Do not reuse or refill this container. Offer 
for recycling if possible.'' Also, the final rule specifies that if the 
first three statements are placed on the label (rather than on the 
container), they must be placed under the ``Storage and Disposal'' 
heading on the label. EPA added this language to reinforce the 
requirement in Sec.  156.10(i)(2)(ix) for the instructions in subpart H 
to appear under the ``Storage and Disposal'' heading. These three 
statements must be under an appropriate heading under the storage and 
disposal heading, although they may be in any order. EPA believes it is 
better to provide registrants flexibility in where to place these 
statements. Some registrants may choose to place them all together, 
while others may choose to place the recycling statement after the 
cleaning (residue removal) instructions.
    The final rule was revised to require a referral statement on the 
label if any of the statements except the batch code are placed on the 
container. Examples of appropriate referral statements are ``See 
container for handling and recycling statements.''; ``Recycling 
information is located on the container.''; and ``See the container for 
refill limitations.'' The

[[Page 47404]]

referral statement will provide information to allow users who look for 
refill prohibitions or recycling statements in the storage and disposal 
section of the label to find the information.
    i. Statement identifying a nonrefillable container--Final 
regulations and changes. The identifying phrase ``Nonrefillable 
container'' is identical to the identifying phrase in the proposed 
regulations.
    ii. Reuse Statement--Final regulations. Registrants must choose to 
use one of the following reuse statements, as appropriate. Products 
with labels that allow household/residential use must use the statement 
in item (1) or (3). All other products must use one of the three 
statements.
    (1) ``Do not reuse or refill this container.''
    (2) ``Do not reuse this container to hold materials other than 
pesticides or dilute pesticides (rinsates). After emptying and 
cleaning, it may be allowable to temporarily hold rinsate or other 
pesticide-related materials in the container. Contact your state 
regulatory agency to determine allowable practices in your state.''
    (3) The following statement may be used if a product is ``ready-to-
use'' and its directions for use allow a different product (that is a 
similar, but concentrated formulation) to be poured into the container 
and diluted by the end user: ``Do not reuse or refill this container 
unless the directions for use allow a different (concentrated) product 
to be diluted in the container.''
    iii. Changes. The proposed rule required the first statement, ``Do 
not reuse or refill this container.'' The second statement was added to 
address a common practice where pesticide applicators use plastic jugs 
to hold rinsate that contains the pesticide on the label, which could 
be interpreted as a violation of a ``Do not reuse'' statement. While 
EPA has some concerns about the widespread storage of rinsate or other 
pesticide-containing materials in pesticide containers (without proper 
management practices such as marking the contents and date on the 
container), we acknowledge the day-to-day reality of pesticide 
operations that sometimes there are materials such as rinsates or 
leftover tank mix that must be dealt with. While temporarily storing 
these materials in pesticide containers can create disposal problems if 
the material is not managed properly and promptly, temporary storage is 
better than most of the other low-cost, practical alternatives such as 
dumping the rinsate or leftover material. Therefore, the second 
statement was added to provide some flexibility while still prohibiting 
the reuse of nonrefillable containers for materials other than 
pesticides, including but not limited to water, food, feed and oil. 
However, EPA does not believe that household/residential pesticide 
users are likely to be able to properly manage rinsate and other 
pesticide-containing materials in this way, so this statement cannot be 
used on household/residential use products.
    The third statement was added in response to comments describing 
ready-to-use products in containers that are intended to be sold or 
distributed only once, but that can be refilled by the end user with a 
concentrate (a different product) and then diluted. The third statement 
gives registrants the option to continue distributing products in this 
way, but still provides end users with the message that these 
containers should generally not be reused or refilled.
    iv. Comments - refill with concentrate. Several commenters noted 
that a prohibition on reuse or refill would make a common practice 
illegal. Specifically, some ready-to-use products are distributed or 
sold in containers that are intended to be sold or distributed only 
once (and therefore meet the definition of nonrefillable containers). 
However, these containers can be refilled by the end user (generally a 
household user) with a concentrate and then diluted. A few respondents 
suggested not requiring the reuse statement on ready-to-use product 
containers and several others offered an alternative statement for 
these products.
    v. EPA response - refill with concentrate. EPA agrees that the use 
of containers of ready-to-use products to be refilled with a different 
product (that is a similar, but concentrated formulation) and diluted 
by the end user should be allowed to continue. In a relatively quick 
search of product labels, EPA found a number of household/residential 
use herbicides with label directions that allowed this practice. This 
environmentally beneficial practice reduces the amount of packaging 
used and packaging waste produced, since a smaller container can be 
used to distribute the concentrate. Therefore, the final regulation 
includes an alternative statement that allows this practice to 
continue. Currently, we believe this situation is most commonly used 
for household products, although the final regulations were written to 
allow any products (not just household/residential use products) to be 
able to use the appropriate refill/reuse statement on their labels.
    3. Recycling or reconditioning statement--i. Final regulations. 
Registrants must use at least one of the following statements:
    (1) ``Offer for recycling if available.''
    (2) ``Once cleaned, some agricultural plastic pesticide containers 
can be taken to a container collection site or picked up for recycling. 
To find the nearest site, contact your chemical dealer or manufacturer 
or contact [a pesticide container recycling organization] at [phone 
number] or [web site]. For example, this statement could be ``Once 
cleaned, some agricultural plastic pesticide containers can be taken to 
a container collection site or picked up for recycling. To find the 
nearest site, contact your chemical dealer or manufacturer or contact 
the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) 
or www.acrecycle.org.''
    (3) A recycling statement approved by EPA and published in an EPA 
document, such as a Pesticide Registration Notice.
    (4) An alternative recycling statement that has been reviewed and 
approved by EPA.
    (5) ``Offer for reconditioning if appropriate.''
    ii. Changes. The final rule includes options for container 
recycling statements to account for differences in the process for 
recycling different kinds of containers (e.g., aerosol cans or plastic 
jugs) and differences in recycling among markets (agricultural or 
household). In addition, the proposed rule specified the statement 
``Offer for recycling if possible.'' In the final rule, EPA changed the 
word possible to available. Finally, EPA added a statement ``Offer for 
reconditioning if appropriate'' as an alternative.
    iii. Comments - recycling. Several commenters addressed the issue 
of recycling. A user group supported the continued development of 
container collection and recycling programs. A registrant endorsed 
recycling but commented that the language must comply with Federal 
Trade Commission (FTC) guidance. A registrant group requested that the 
terms of PR Notice 94-2 ``Recycling Empty Aerosol Pesticide 
Containers'' as amended by letter on June 9, 1994, be codified into 
regulation. A State regulatory agency urged EPA to specifically direct 
users to agricultural pesticide container collection programs to 
prevent agricultural pesticide containers being offered for household 
recycling collection. Another State regulatory agency suggested a label 
statement requiring small rinsed containers to be delivered to State-
authorized container collection programs. This commenter stated that 
use of the word ``possible''

[[Page 47405]]

would be problematic because while it is possible for farmers to travel 
more than 100 miles to a recycling center, it would be unreasonable to 
expect that. A group of people involved with pesticide container 
recycling in Washington State submitted suggestions for changing the 
storage and disposal statements on pesticide containers. These comments 
specifically supported the efforts of the Ag Container Recycling 
Council (ACRC) and recommended a statement that refers to the ACRC and 
provides the ACRC web site.
    In response to the 2004 notice, four State regulatory agencies and 
a registrant group urged the Agency to do more to encourage recycling 
of pesticide containers and to remove label references to burning or 
burying containers. A few State agencies noted efforts by ACRC, Earth 
911 and the National Pesticide Stewardship Alliance to promote 
recycling and reform label language. These respondents noted that the 
Agency needs to go further than what was proposed in the rule in order 
to improve labeling such that burning and burying of containers is no 
longer allowed.
    iv. EPA response - recycling. EPA agrees with intent of the 
commenter who suggested codifying PR Notice 94-2. The third option 
included in the final rule, a recycling statement approved by EPA and 
published in an EPA document, is included to account for PR Notice 94-
2, other PR Notices, the label review manual, and other documents.
    EPA agrees with the State regulatory agencies and Washington 
container recycling group that it may be beneficial to provide more 
specific information about pesticide container collection and recycling 
programs in this statement, particularly for agricultural pesticide 
products. Therefore, the final regulations allow the use of a new 
recycling statement that provides details about how to obtain more 
information on agricultural pesticide container collection and 
recycling programs such as the ACRC. The ACRC is a non-profit 
organization that promotes and supports the collection and recycling of 
plastic pesticide containers in the U.S. The collection and recycling 
programs conducted by the ACRC grew significantly during the 1990's, so 
EPA is adding this statement to reflect currently available programs 
(that were in the developmental stage when the proposed regulations 
were being written). For example, in 1993 the ACRC collected about 2.5 
million pounds of plastic containers. In 2001, ACRC collected over 7 
million pounds of plastic containers, which represents about 25 percent 
of the plastic containers distributed by the ACRC member companies. 
(Ref. 1) EPA has been told by ACRC recyclers and member companies and 
by ACRC's State partners that participation could be increased if the 
label specifically referred to the ACRC program. EPA hopes to encourage 
the recycling of pesticide containers by including this recycling 
statement as an option. EPA also recognizes the need for flexibility in 
the label instructions, as other, equally effective organizations may 
come into existence in the future, and that the organization Earth 911 
(www.earth911.org), a clearinghouse of information on household 
hazardous waste disposal and recycling, may eventually include 
information resources specifically for managing agricultural chemicals 
and containers.
    EPA agrees that the word ``possible'' may not be clear, and has 
replaced it with the word ``available.'' ACRC programs are available 
that is, accessible for agricultural pesticide users across much of the 
U.S., but not all areas have local collection programs. EPA believes 
that a reasonable interpretation of ``available'' is that pesticide 
containers are collected at a location that is the same distance or 
closer than the distance the user traveled to purchase the pesticides. 
It is worth noting that the statement ``Offer for recycling if 
available'' and the other statements in Sec.  156.140(a)(3) give 
pesticide users an option for managing the containers. These statements 
do not require the recycling or reconditioning of containers. EPA 
believes that recycling or reconditioning pesticide containers is a 
responsible, preferable way of managing pesticide containers. We 
encourage these practices to save resources and minimize the amount of 
material being disposed, although there are other legal ways of 
managing the containers.
    The final rule also includes the option for a registrant to offer 
an alternative recycling statement. This is intended to allow for the 
possibility of changes in the extent to which and the manner in which 
pesticide containers are recycled over time. EPA must review and 
approve an alternative recycling statement before it can be placed on a 
pesticide label. One part of our review will involve considering 
whether the alternative statement is consistent with the FTC guidelines 
on environmental statements in 16 CFR part 260, ``Guides for the Use of 
Environmental Marketing Claims.'' (Ref. 5) (http://www.ftc.gov/bcp/conline/edcams/eande/index.html)
    EPA agrees with commenters that label language regarding burning 
and burying containers needs to be improved and is engaged in 
discussions with stakeholders to address this issue. Container disposal 
instructions were not addressed in the proposed container and 
containment regulations and therefore are outside the scope of the 
final regulations. In addition, EPA staff are actively working on 
improving the label manual.
    v. Comments - reconditioning. Many commenters on the proposed 
regulations, including container manufacturer and registrant groups, 
stated that the regulations do not account for the reconditioning of 
containers and opposed many proposed provisions because they would be 
problematic for reconditioning. These respondents also commented that 
some containers are commonly reconditioned, particularly plastic and 
steel drums holding non-agricultural pesticides.
    vi. EPA response - reconditioning. EPA added a statement about 
reconditioning to the final rule as an alternative for containers that 
are commonly reconditioned. The statement says ``Offer for 
reconditioning if appropriate'' because reconditioning is a logical, 
reasonable option only for certain containers, specifically drums, and 
not others, such as plastic jugs and aerosol cans. EPA believes this 
flexibility should alleviate some of the commenters' concerns about the 
apparent disregard for reconditioning.
    4. Batch code--i. Final regulations. A lot number, or other code 
used by the registrant or producer to identify the batch of the 
pesticide product, is required for each nonrefillable container either 
on the label or the container.
    ii. Changes. The text specifying a lot number or other code in the 
final rule is identical to the text in the proposal. In the final rule, 
though, the introductory paragraph was modified to clarify that the lot 
number/batch code could be placed anywhere on the label or durably (not 
permanently) marked on the container.

D. Statements Required for Refillable Containers (Sec.  156.140(b))

    1. Final regulations. For refillable containers, one of the 
following statements is required on the label or the container:
    (1) ``Refillable Container. Refill this container with pesticide 
only. Do not reuse this container for any other purpose.''
    (2) ``Refillable Container. Refill this container with [common 
chemical name] only. Do not reuse this container for any other 
purpose.''
    If the statement is on the label, it must be placed under the 
``Storage and Disposal'' heading. If the statement is

[[Page 47406]]

put on the container, the label must include an appropriate referral 
statement under the ``Storage and Disposal'' heading.
    2. Changes. The proposed rule specified only the first statement. 
In response to comments, the second statement was added to the final 
rule as an option to accommodate containers that may be filled with a 
chemical that has both pesticidal and non-pesticidal uses. Also, the 
phrase ``Refillable container'' was added to both statements to allow 
pesticide users, registrants and government regulators to clearly 
identify whether a container is nonrefillable or refillable. The final 
rule specifies that if the statement is placed on the label (rather 
than on the container), it must be placed under the ``Storage and 
Disposal'' heading. EPA added this language to reinforce the 
requirement in Sec.  156.10(i)(2)(ix) for the instructions in subpart H 
to appear under the ``Storage and Disposal'' heading. Lastly, the final 
rule was revised to require a referral statement on the label if the 
statement is placed on the container. An example of an appropriate 
referral statement is ``Refilling limitations are on the container.'' 
The referral statement will provide information to allow users who look 
for refill prohibitions in the storage and disposal section of the 
label to find the information.

E. Residue Removal Instructions - General (Sec.  156.144)

    1. Final regulations. Unless exempt from these requirements, the 
label of each pesticide product must have instructions on the removal 
of pesticide residue prior to disposal, as specified in Sec. Sec.  
156.146 and 156.156. The regulations in Sec.  156.144 include the 
following specifications:
    <bullet> Residue removal statements are required for both 
nonrefillable and refillable containers.
    <bullet> Residue removal statements must be placed under the 
heading ``Storage and Disposal.''
    <bullet> Residential/household use pesticide products are exempt 
from the residue removal statement requirements.
    <bullet> EPA may modify or waive the residue removal requirements 
or permit or require alternative labeling statements.
    2. Changes. The most significant change to this section is that the 
final rule exempts residential/household use pesticide products from 
the residue removal statement requirements. The proposed rule would 
have applied to the labels of all products, regardless of the pesticide 
market in which they are sold, distributed and used. EPA also made a 
few minor changes in the final rule. The proposed rule specified a 
subheading entitled ``Container Cleaning'' under the heading ``Storage 
and Disposal.'' In the final rule, EPA deleted this subheading because 
it is unnecessary. Section 156.144(b) regarding placement of the 
residue removal statements was shortened by deleting the reference to 
Directions for Use, which isn't necessary. EPA believes requiring the 
statements to be placed under the heading ``Storage and Disposal'' is 
sufficient because Sec.  156.10(i)(2)(ix) requires this heading to be 
included in the directions for use. Finally, a few editorial changes 
were made to shorten the phrase ``residue removal statements and 
instructions'' to ``residue removal instructions'' to be more precise 
and consistent. The rest of the requirements of Sec.  156.144 are 
identical to those in the proposed rule.
    FIFRA section 19(f) mandates ``regulations prescribing procedures 
and standards for the removal of pesticides from containers prior to 
disposal'' and says that EPA ``may, at the discretion of the 
Administrator, exempt products intended solely for household use'' from 
these requirements. In the proposed rule, EPA chose not to exercise 
this discretion and proposed to require cleaning instructions on the 
labels of household products because the preamble of the proposed rule 
stated that, in many instances, the same pesticide product in the same 
container is sold for agricultural or industrial use, as well as for 
use in the home, yard, or garden.
    The 1999 Supplemental Notice (Ref. 53) stated that the changes in 
scope would only apply to the container standards and that:
    EPA believes that it is appropriate to have container cleaning 
and disposal instructions on the labels of all pesticides because of 
safety and environmental protection considerations for recycling 
operations. It is necessary for pesticide containers to be properly 
emptied and cleaned prior to being recycled to protect workers who 
handle the recyclable material and to prevent releases of pesticides 
to the environment. Because pesticide containers from all segments 
of the pesticide industry are currently being recycled, container 
cleaning and disposal instructions are needed on the labels of all 
pesticides. ...

    During the development of the final PR Notice 2001-6, ``Disposal 
Instructions on Non-Antimicrobial, Residential/Household Use Pesticide 
Product Labels,'' however, EPA decided to change this position for non-
antimicrobial, residential/household use pesticide products. (Ref. 49). 
As stated in PR Notice 2001-6:
    Specific instructions to consumers to rinse their empty 
containers have been left out of these revised instructions. 
Experience has shown that many consumers are confused by rinsing 
procedures and often incorrectly dispose of the rinse water down the 
drain or down sewers. States have reported some detections of 
pesticides in drinking water that appear, in some cases, to be 
linked to disposal or rinsing in residential waste water systems. In 
addition, storage of rinsate is highly discouraged because of the 
absence of adequate labeling or packaging. There is also the 
potential risk of adverse chemical reactions occurring when products 
are poured down drains, singly, or in combination with other 
products.

    One potential solution that EPA considered but rejected when 
finalizing PR Notice 2001-6 was to require rinsing of non-
antimicrobial, residential/household use pesticide containers and to 
include instructions on the label for how to manage the rinse water. 
For example, the label statement in PR Notice 2001-6 could have 
instructed the user to add the rinse water to the pesticide mixture 
that will be applied, or if that isn't feasible, the rinse water could 
be applied to a site on the label in accordance with the other label 
provisions. EPA rejected this option because it could confuse 
consumers, it could lead to the storage of rinse water in the absence 
of adequate labeling or packaging, and it would require several 
additional sentences on an already crowded label.
    Therefore, EPA has decided to omit rinsing instructions from the 
label directions specified for non-antimicrobial, residential/household 
pesticide products in PR Notice 2001-6. In markets where empty 
containers of these pesticides are recyclable, it is assumed that the 
recycling programs will provide consumers with instructions to rinse 
the containers if the recycling program believes it is necessary. 
Additionally, if a manufacturer wants to include a rinsing statement on 
the labels of these pesticides, EPA would consider such a request. 
However, if a manufacturer chooses to include a rinsing statement, it 
should also include instructions about how to manage the rinse water.
    In the final rule, EPA is continuing the policy to omit rinsing 
instructions from the label directions for non-antimicrobial, 
residential/household pesticide products. In addition, EPA decided to 
extend this policy to antimicrobial, residential/household pesticide 
products in the final rule. Antimicrobial products were not included in 
the scope of PR Notice 2001-6 because of differences of opinions on the 
disposal statements in the PR Notice, not because of problems

[[Page 47407]]

with applying the no-rinsing policy to household/residential 
antimicrobial products. EPA believes that some of the same concerns 
about household/residential pesticide users, including users being 
confused and trying to prevent the storage of rinsate, apply equally to 
antimicrobial and non-antimicrobial products used by these household/
residential pesticide users.

F. Residue Removal Instructions for Nonrefillable Containers - General 
(Sec.  156.146)

    1. Final regulations. Section 156.146 sets out the residue removal 
instructions for nonrefillable containers. The label of a product must 
comply with these instructions if all of the following criteria are 
met:
    <bullet> The product must comply with the residue removal 
instructions based on Sec.  156.144 (i.e., it is not a residential/
household product, EPA has not waived the requirement, or EPA has not 
established an alternative requirement);
    <bullet> The product is dilutable (it could be a liquid or a 
solid); and
    <bullet> The product is distributed or sold in a nonrefillable 
container that is rigid.
    The preamble to the proposed rule stated that EPA was holding 
sections in reserve for residue removal instructions for other 
formulation/container combinations, such as dilutable products in non-
rigid containers. While EPA may address other kinds of nonrefillable 
containers in the future, the final rule establishes residue removal 
instructions only for dilutable products in rigid nonrefillable 
containers.
    The labels of dilutable products that are subject to this 
requirement and that are sold or distributed in rigid, nonrefillable 
containers must comply with the following standards:
    <bullet> A statement instructing the user to clean the container 
promptly after emptying is mandatory;
    <bullet> Triple rinsing instructions are mandatory;
    <bullet> Pressure rinsing instructions are optional; and
    <bullet> A registrant must obtain EPA approval before including a 
rinsing procedure that specifies a diluent other than water.
    These requirements are discussed in more detail in Units IX.G. 
through IX.K. below.
    2. Changes. The final regulation includes several changes from the 
proposal. The most significant changes are that the final rule requires 
registrants to place the triple rinse instructions on all labels and 
provides registrants the option to also include the pressure-rinse 
instructions. The proposed rule gave registrants the option to include 
either triple rinsing or pressure rinsing or both. Based on comments, 
EPA changed the final rule because triple rinsing is always possible, 
whereas pressure rinsing requires specific equipment. Other substantial 
changes to the residue removal instructions include:
    <bullet> Adding the phrase ``or equivalent'' as an option so labels 
allow equivalent means of rinsing containers. This was added to account 
for systems (such as closed system rinsing or home-made pressure 
rinsing systems) that are designed to clean containers thoroughly but 
do not technically triple rinse the containers. This change was made to 
the statement identifying when containers must be rinsed and is 
discussed in more detail in Unit IX.G.
    <bullet> Both the triple rinse and pressure rinse procedures were 
modified so they would take less time. For example, the intervals of 
time for draining and shaking the containers were reduced. These 
changes are intended to make the procedures more practical and 
therefore more likely to be followed by end users. These changes are 
discussed in more detail in Unit IX.H.
    Numerous other minor modifications, which are described in Units 
IX.G. - IX.K., were made to the residue removal instructions for 
nonrefillable containers.
    3. Comments - which procedure? The proposed rule would have 
required the placement of either the triple rinse or the pressure rinse 
procedure on the label, with the option of including both. The preamble 
requested comments on this approach. The following comments addressed 
this question.
    i. Both procedures. Several State regulatory agencies and a 
registrant group supported including both triple and pressure rinsing 
instructions on labels. A few of these commenters pointed out that 
pressure rinsing alone is not available to all applicators.
    ii. Alternative approach. A few dealer groups recommended using the 
statement ``Pressure rinse or triple rinse'' so users and dealers will 
not have to worry about having both rinse systems available.
    iii. Either or both procedures. A registrant group supported the 
approach of allowing the registrant to put either or both of the 
statements on the label, because pressure rinsing would not be 
appropriate for institutional products and including both would crowd 
the label.
    iv. Limit pressure rinsing. Some commenters, including registrants, 
registrant groups, and a State regulatory agency, expressed concern 
about household users pressure rinsing small containers. Many of these 
respondents suggested excluding pressure rinsing from household product 
labels. A registrant group also added institutional and industrial 
products to this suggested exclusion. Similarly, another registrant 
group commented that pressure rinsing is not common in the 
institutional sector. Alternatively, a few registrant groups and a 
registrant recommended that pressure rinsing instructions be permitted 
only on containers with capacities larger than one gallon.
    v. Decision making process. Some registrants and registrant groups 
commented that EPA implies that some sort of decision making process 
must be used to determine if triple rinsing, pressure rinsing, or both 
should be included and requested EPA to clarify this. For example, does 
a container have to meet a six 9's standard by a laboratory pressure 
rinsing test for pressure rinsing instructions to be included on the 
label? If so, EPA has to specify the pressure rinsing test procedure.
    vi. Effectiveness of procedures. Several commenters addressed the 
efficacy of pressure rinsing vs. triple rinsing. A registrant group and 
two registrants commented that pressure rinsing should be recommended 
on labels only if it has been shown to be as effective as triple 
rinsing. Another registrant stated that their studies (in addition to 
the work of other companies) shows that pressure rinsing is not as 
effective as triple rinsing. A State regulatory agency commented that 
pressure rinsing is a more effective method of cleaning containers.
    vii. Advantages of pressure rinsing. A State regulatory agency and 
a registrant commented that pressure rinsing is advantageous to the 
pesticide users because it is a faster procedure.
    4. EPA response - which procedure? EPA agrees with several of the 
points made by commenters, in particular, that pressure rinsing alone 
is not available to all applicators, that pressure rinsing isn't 
appropriate for certain containers based on the pesticide market and/or 
container size, and that pressure rinsing is attractive to pesticide 
users because it is a faster procedure. Therefore, EPA changed the 
approach so the final regulation requires labels to include the triple 
rinse procedure and gives registrants the option to also include the 
pressure rinse procedure. This approach provides a rinse procedure 
(triple rinsing) that all pesticide users can follow. It also gives 
registrants the option to include pressure rinsing if they believe it 
is appropriate (with EPA concurrence during the review of

[[Page 47408]]

labels), which is preferable to establishing criteria for appropriate 
(or inappropriate) pressure rinsing situations in the regulations.
    EPA believes that both triple rinsing and pressure rinsing are 
effective ways for users to clean most containers (with possible 
exceptions for size and other situations) in the field. This conclusion 
is based on the rinsing studies described in Reference 40 and on the 
field experience of people who have inspected containers over the past 
decade of pesticide container recycling programs. One registrant group 
provided comprehensive comments during the 2004 reopening of the 
comment period based on the ACRC's experience over the past 10 years. 
This commenter described ACRC's efforts to assess and control the risk 
from using the recycled plastic and noted that, since ACRC's inception 
in 1992, there have been no reports of incidents where public health or 
safety has been compromised as a result of exposure to the minimal 
residues found in recycled plastic pesticide containers. This 
registrant group also stated that ACRC's experience with recycling 
clean, rinsed one-way pesticide containers for more than a decade leads 
them to believe that residue removal is an issue of instructing 
applicators to triple or pressure rinse containers immediately after 
use.
    EPA's goal is to establish a situation where all containers are 
adequately cleaned before they are recycled, disposed, or otherwise 
managed. As stated in Unit V.H.1., one regulatory contribution to 
achieving this goal is ensuring that pesticide users have access to 
clear, detailed instructions for how to clean the containers. In the 
final rule, pesticide labels must include triple rinse instructions and 
may also include pressure rinse instructions.
    Another regulatory contribution is to ensure the use of container 
designs and formulations that facilitate effective residue removal, 
which is the intent of the residue removal standard for nonrefillable 
containers in Sec.  165.25(f). The residue removal test procedure 
requires containers to be triple rinsed. In this case, triple rinsing 
is used as an indication of how easily the pesticide can be removed 
from the container. The residue removal test procedure does not require 
containers to be pressure rinsed nor is it intended to evaluate whether 
triple rinsing or pressure rinsing is more effective for a certain 
container and pesticide formulation. Therefore, the decision of whether 
or not to include pressure rinsing instructions on the pesticide label 
is not tied to the results of laboratory residue removal testing. 
Instead, registrants have the option to include pressure rinsing if 
they believe it is appropriate (with EPA concurrence during the review 
of labels).
    There are other integral parts to achieving the goal of having 
clean containers before they are disposed or recycled, including 
educating pesticide users on the importance of rinsing and the proper 
procedures, potential spot checks/inspections to ensure that the labels 
and regulations are being complied with, and creating an incentive for 
pesticide users to comply (or a disincentive for non-compliance). EPA 
looks forward to working with all stakeholders, including State 
regulatory agencies, pesticide registrants, distributors and dealers, 
pesticide users, pesticide educators, and trade associations in 
accomplishing this goal.

G. Timing of the Residue Removal Procedure (Sec.  156.146(a))

    1. Final regulations. For products that are subject to the 
requirements for residue removal instructions, the label of each 
nonrefillable container must include one of the following statements:
    (1) ``Clean container promptly after emptying.''
    (2) ``Triple rinse or pressure rinse container (or equivalent) 
promptly after emptying.''
    (3) ``Triple rinse container (or equivalent) promptly after 
emptying.''
    The statement about timing must immediately precede the rinsing 
instructions and must be consistent with the rinsing instructions 
(triple rinse or both triple and pressure rinse) that are include on 
the label.
    2. Changes. This section of the final rule includes three changes 
from the proposed regulation. First, the proposed requirement to rinse 
``immediately'' after emptying was replaced in the final rule by 
requiring the container to be rinsed ``promptly'' after emptying it. 
Second, the final rule adds the phrase ``(or equivalent)'' to the two 
statements that identify a specific cleaning procedure, e.g., triple 
rinsing. Third, the proposed rule included four options for statements 
to include on the label. EPA is not finalizing one of these statements 
in the final rule--``Pressure rinse container immediately after 
emptying'' --because it is no longer needed. The final rule does not 
allow pressure rinsing to be the only procedure listed on the label, so 
this statement is irrelevant.
    3. Comments - clean promptly. Some State regulatory agencies 
supported the statement regarding the timing of rinsing, stating that 
it should improve the management of the containers. Two other State 
regulatory agencies stated that, based on results from their container 
collection and recycling programs in the early 1990's, it is obvious 
that not all containers are rinsed immediately. A registrant group 
suggested using the phrase ``reasonably promptly'' rather than 
``immediately'' to account for industrial situations where its not 
practical to rinse immediately such as when multiple oil wells are 
treated from the same drum of an industrial biocide and rinsing 
equipment is not available. An agricultural pesticide registrant 
supported immediate rinsing in a farm context so that the rinsate could 
be added to the application mixture, but noted that clean water may not 
be available at every loading site.
    4. EPA response - clean promptly. EPA considers the timing of the 
residue removal procedure to be a critical factor in effectiveness, and 
is maintaining the approach in the proposed rule that requires users to 
rinse containers within a certain (short) time period after emptying 
them. When rinsing is not performed soon after emptying the container, 
the residue can dry and adhere to the inside and outside of the 
container, and is then more difficult to remove. Containers with dried 
residue are likely to be rejected by pesticide container recycling and 
collection programs as well as at solid waste landfills.
    EPA believes that requiring pesticide users to rinse containers 
promptly after emptying them is the best approach for the final rule. 
Specifying that the containers are cleaned promptly accomplishes the 
goal of rinsing them soon after they are emptied and before the residue 
dries in the containers. Also, prompt rinsing provides a little more 
flexibility than immediate rinsing. As an example, consider a pesticide 
applicator who pours product from one container, sets it down to pour 
out another container, and then rinses both containers. Technically, 
this could be considered a violation if the label specified immediate 
rinsing, because some time passed between the emptying and the rinsing 
of the first container. However, this example fits within EPA's 
understanding of prompt action.
    Requiring that containers be rinsed promptly gives pesticide users, 
regulatory agencies and inspectors some discretion in determining 
appropriate time spans. It is beyond the scope of this preamble to 
describe every situation that is or is not appropriate, so EPA is 
relying on the good judgement of applicators, regulatory agencies and 
inspectors to assess the specific conditions of the situation. However, 
EPA believes that situations where the

[[Page 47409]]

time between emptying and rinsing is days or weeks and where the 
residue has completely dried inside the container are definitely beyond 
the boundaries of prompt rinsing. In addition, EPA strongly recommends 
that pesticide users rinse containers when the application mixture is 
being prepared so the rinsate can be added to the application mixture. 
This provides many benefits, including getting all of the value out of 
the product and avoiding the creation of a potential waste (which could 
happen if the rinsate was collected separately).
    5. Comments - equivalency. In commenting on the proposed approach 
for residue removal instructions, a few commenters (a State regulatory 
agency and a registrant) supported maintaining the current cleaning 
statement of ``Triple rinse (or equivalent)'' because it is sufficient 
if followed and it offers flexibility.
    6. EPA response - equivalency. EPA agrees with the commenters that 
including the phrase ``(or equivalent)'' that is on current labels is 
beneficial and the final rule adds this phrase as an option to the 
``rinse promptly'' statement. This phrase was added to account for 
systems (such as closed system rinsing or home-made pressure rinsing 
systems) that are designed to clean containers thoroughly but do not 
technically triple rinse the containers. The alternative rinsing system 
should be thorough and it is the responsibility of the pesticide user 
to ensure that it is equivalent to triple rinsing.

H. Duration of Triple and Pressure Rinse Procedures (Sec.  156.146(b) 
and 156.146(c))

    1. Final regulations. As discussed in Unit IX.I. for triple rinsing 
and Unit IX.J. for pressure rinsing, the rinsing procedures for 
containers that are small enough to shake that are defined in the final 
regulation take less time to conduct than the proposed procedures. The 
key time intervals identified in the procedures are:
    <bullet> How long to drain liquid product from containers (both 
triple and pressure rinsing);
    <bullet> How long to agitate/shake containers during triple 
rinsing;
    <bullet> How long to drain rinsate from containers after each 
shaking interval during triple rinsing; and
    <bullet> How long to pressure rinse the container during pressure 
rinsing.
    2. Changes. The procedures in the final rule specify the following 
times for each of these intervals for containers that are small enough 
to shake:
    <bullet> 10 seconds to drain liquid product from containers for 
both triple and pressure rinsing (changed from 30 seconds in the 
proposal);
    <bullet> 10 seconds to agitate/shake containers during triple 
rinsing (changed from 30 seconds in the proposal);
    <bullet> 10 seconds to drain rinsate from containers after each 
shaking interval during triple rinsing (changed from 30 seconds in the 
proposal); and
    <bullet> At least 30 seconds to pressure rinse the container during 
pressure rinsing. (The proposed rule specified 30 seconds; the phrase 
``at least'' was added to compensate for variations in pressure rinsing 
equipment and in pressure.)
    3. Comments. A registrant group, a registrant and two State 
regulatory agencies commented that a shorter rinse time would be better 
and would encourage user compliance, although the two State regulatory 
agencies supported a shorter rinse time only if it was demonstrated 
that the containers are cleaned adequately. Another State regulatory 
agency stated that, in a 1991 survey, 43 percent of private applicators 
and 11 percent of commercial applicators responded that they did not 
rinse containers because it took too much time. A registrant group 
opposed the initial drain time of 30 seconds as too long and 
inappropriate for closed systems. This commenter also responded that 
some states have requirements different than a 30-second drain and 
urged EPA to consider these alternatives. A registrant commented that 
the times of the proposed rinsing procedures seemed reasonable and 
expressed doubts that the triple rinse procedure could be shortened 
much. This commenter added that a 40-second pressure rinse is 
inadequate to achieve 99.9999 percent removal.
    4. EPA response. In the preamble of the proposed rule, EPA 
estimated that the proposed triple rinsing instructions would take 
approximately 5 minutes to perform and the pressure rinsing procedure 
would take approximately 2 minutes. EPA also requested comments on the 
time burden of the proposed rinsing procedures, and the voluntary 
submission of data on residue removal, including in particular the 
cleaning efficiency of any suggested shorter triple rinse and pressure 
rinse procedures.
    EPA agrees with the commenters that a shorter rinse time would be 
better and would encourage user compliance with the requirement to 
rinse pesticide containers. In particular, we believe it is relatively 
unlikely that a pesticide user would spend about 5 minutes triple 
rinsing each container. The 30-second intervals for the initial 
container drain time, the shaking time and the rinsate-draining times 
were based on the rinsing instructions of many States, which were 
incorporated into the laboratory triple rinse test methodology for the 
proposed nonrefillable container residue removal standard.
    EPA contracted for two studies on the effectiveness of shorter 
triple rinse procedures. In a study conducted by Formulogics (Refs. 7 
and 38), a flowable concentrate product was tested in three containers: 
1-gallon and 2.5-gallon plastic jugs and a 5-gallon steel flathead can. 
Nine different rinsing procedures were conducted for each container 
size by varying the initial drain, shake and rinsate drain times 
between 5, 10 and 30 seconds. The shake and rinsate drain times were 
always the same. For example, the three variations for the initial 
drain time of 5 seconds were: 5 second shake and 5 second rinsate 
drain; 10 second shake and 10 second rinsate drain; and 30 second shake 
and 30 second rinsate drain. These same three shake and rinsate drain 
times were conducted for the initial drain times of 10 second and of 30 
seconds. The pesticide concentration in the second through fifth rinses 
was measured. EPA concludes that all nine rinsing procedures tested 
were effective in cleaning all three containers because the active 
ingredient concentration in the fourth rinse showed at least 99.99% 
removal in all rinse time iterations. Two of the rinse procedures for 
the 5-gallon container (5 sec. initial drain/5 sec. shake & rinsate 
drain and 30 sec. initial drain/5 sec. shake & rinsate drain) resulted 
in 99.99 percent removal; all other rinse procedures for all containers 
met at least five 9's percent removal and most resulted in six 9's 
percent removal.
    In a study conducted by the University of Florida (Refs. 14 and 
41), two formulations were tested in three containers, 1-gallon, 2.5-
gallon and 5-gallon plastic jugs. The flowable concentrate was tested 
in all three containers and the emulsifiable concentrate was tested in 
the 2.5-gallon and 5-gallon containers. Four different rinsing 
procedures were conducted for each container size by varying the 
initial drain, shake and rinsate drain times between 10 and 30 seconds 
where the shake and rinsate drain times were always the same. Again, 
EPA concludes that all four rinsing procedures tested were effective in 
cleaning both formulations from all of the containers because the 
active ingredient concentration in the fourth rinse showed at least 
99.99% removal in all rinse time iterations.
    The triple rinse procedure for labels in the final rule includes 10 
second initial drain, shake and rinsate drain

[[Page 47410]]

times. EPA believes the data described above shows that this shorter 
triple rinsing procedure, which should encourage end user compliance 
with the requirement to triple rinse, will adequately clean containers 
prior to recycling or disposal.
    In addition, EPA has lowered the residue removal requirement in the 
final nonrefillable container regulations from six 9's (99.9999 
percent) to four 9's (99.99 percent), as discussed in Unit V.H. The 
shorter rinse procedures reached at least 99.99 percent removal in all 
of the containers and formulations tested. As cited by one of the State 
regulatory agencies in its comments, the field reality is that many 
users who do not rinse claim the time factor as the reason. By reducing 
the time frames in the cleaning instructions, EPA hopes to increase 
compliance within the pesticide user community.

I. Triple Rinse Instructions (Sec.  156.146(b))

    1. Final regulations. For products that are subject to the 
requirements for residue removal instructions, the label of each 
nonrefillable container must include triple rinse instructions. There 
are three different sets of triple rinsing instructions:
    <bullet> For containers that are small enough for users to shake 
them, holding dilutable liquid pesticides;
    <bullet> For containers that are small enough for users to shake 
them, holding dilutable solid pesticides; and
    <bullet> For containers that are too large for users to shake.
In general, EPA believes that the largest containers that users can 
shake during a triple rinse are those with capacities of 5 gallons for 
liquids and 50 pounds for solids.
    The triple rinse instructions for liquid dilutable pesticide 
products in containers small enough for users to shake are:
    Triple rinse as follows: Empty the remaining contents into 
application equipment or a mix tank, and drain for 10 seconds after 
the flow begins to drip. Fill the container 1/4 full with water and 
recap. Shake for 10 seconds. Pour rinsate into application equipment 
or a mix tank or store rinsate for later use or disposal. Drain for 
10 seconds after the flow begins to drip. Repeat this procedure two 
more times.

    The final rule specifies slightly different instructions for solid 
dilutable pesticide products in ``shake-able'' containers, because 
solid materials do not ``drip'' as liquids do. The only difference for 
solid dilutable pesticide products is that the first line is ``Triple 
rinse as follows: Empty the remaining contents into application 
equipment or a mix tank. Fill the container 1/4 full...'' The rest of 
the procedure is identical to the one for liquids.
    For containers that are too large for users to shake (i.e., 
containers larger than 5 gallons for liquids or 50 pounds for solids), 
the triple rinse instructions are:
    Triple rinse as follows: Empty remaining contents into 
application equipment or a mix tank. Fill the container 1/4 full 
with water. Replace and tighten closures. Tip container on its side 
and roll it back and forth, ensuring at least one complete 
revolution, for 30 seconds. Stand the container on its end and tip 
it back and forth several times. Turn the container over onto its 
other end and tip it back and forth several times. Empty the rinsate 
into application equipment or a mix tank or store rinsate for later 
use or disposal. Repeat this procedure two more times.

    2. Changes. One significant change from the proposed rule is that 
the final regulation requires a triple rinse procedure to be on the 
label, where the proposal gave registrants the option to include triple 
rinsing or pressure rinsing or both. Another modification is that the 
final regulations provide a defined procedure for containers that are 
too large for users to shake. Also, the phrase ``or a mix tank'' was 
added as an option for where the product or the rinsate can be placed. 
In addition, the following clarifying changes were made to both sets of 
instructions for triple rinsing smaller containers that can be shaken:
    <bullet> The introductory text specifies that the instructions 
apply to ``containers small enough to shake'';
    <bullet> The instruction to ``agitate'' was changed to ``shake''; 
and
    <bullet> As discussed in Unit IX.H., the time intervals were 
changed from 30 seconds to 10 seconds for the initial draining of the 
container (for liquid products only), the time the container needs to 
be shaken, and for the draining of the rinsate.
    3. Comments - general. A State regulatory agency pointed out that 
the directions prohibit preparing the use dilution in a mix tank, which 
is a common practice. A registrant commented that the degree of 
agitation needs to be specified, e.g., shake vigorously for 30 seconds.
    4. EPA response - general. EPA did not intend to prohibit users 
from pouring a product into a mix tank or diluting a product in a mix 
tank, and we have amended the triple rinse procedures to address this 
oversight. The phrase ``or a mix tank'' was added to the instructions 
for emptying containers and to the rinsate management instructions to 
allow the product and rinsate to be placed into application equipment 
or a mix tank.
    EPA agrees with the registrant and believes that ``shake'' is a 
better description of the intended activity than ``agitate.'' We 
decided not to include the qualifier ``vigorously'' to keep the 
statement as succinct as possible. This kind of information could be 
passed along to users during training and outreach.
    5. Comments - large containers. Several commenters described 
problems with cleaning drums according to the proposed triple rinse 
statement. A registrant group stated that it is impractical to fill a 
55-gallon drum one quarter full because more than 40 gallons of rinsate 
would be produced. A different registrant group and a registrant 
recommended directing the user to place the drum on its side and roll 
it, because it is extremely difficult to shake a large container that 
is one-quarter full. Another registrant commented that an additional 
statement that describes rinsing by recirculation would be helpful, but 
pointed out that many drum users don't use pumps to empty them.
    6. EPA response - large containers. EPA agrees with the suggestion 
by the commenters who recommended directing the user to place a drum on 
its side and roll it. EPA is hesitant to recommend a cleaning procedure 
for larger containers that requires equipment that a pesticide user may 
not have, such as a pump, or an appropriately sized, heavy-duty 
pressure rinse nozzle. Therefore, we decided to define a triple rinse 
procedure in the final regulation for containers that are too large to 
be shaken. This is consistent with the approach in the final rule to 
require triple rinsing because all pesticide users can comply with 
these instructions and to allow pressure rinsing as an optional, 
additional statement.

J. Pressure Rinse Instructions (Sec.  156.146(c))

    1. Final regulations. For products that are subject to the 
requirements for residue removal instructions, the label of each 
nonrefillable container may include pressure rinse instructions. The 
decision regarding whether to include pressure rinsing instructions as 
an option is at the discretion of the registrant, based on the 
registrant's assessment of the procedure's effectiveness and 
appropriateness for the formulation/container combination. However, if 
the statement ``Triple rinse or pressure rinse container (or 
equivalent) promptly after emptying'' is used on the label as the 
statement about timing, pressure rinse instructions must be placed on 
the label. If a registrant

[[Page 47411]]

chooses to include pressure rinsing instructions on the label as an 
option for cleaning a liquid dilutable pesticide product, the statement 
must immediately follow the triple rinse instructions.
    The pressure rinse instructions for liquid dilutable pesticide 
products are:
    Pressure rinse as follows: Empty the remaining contents into 
application equipment or a mix tank and continue to drain for 10 
seconds after the flow begins to drip. Hold container upside down 
over application equipment or mix tank or collect rinsate for later 
use or disposal. Insert pressure rinsing nozzle in the side of the 
container, and rinse at about 40 PSI for at least 30 seconds. Drain 
for 10 seconds after the flow begins to drip.

    Slightly different instructions are required for pressure rinsing 
dilutable liquid and dilutable solid pesticide formulations, because 
dry materials do not ``drip'' like liquids do. The pressure rinsing 
procedure specified in the final regulations for dilutable solid 
pesticides is identical to the one for liquids, except it does not 
include the initial 10-second draining prior to rinsing.
    2. Changes. One significant change is that pressure rinsing 
instructions are optional in the final rule, which requires a triple 
rinse procedure to be included on the labels of products that must 
comply. The proposal gave registrants the option to include triple 
rinsing or pressure rinsing or both. In addition, the following changes 
were made to both sets of instructions for pressure rinsing:
    <bullet> The phrase ``or a mix tank'' was added as an option for 
where the product or the rinsate can be placed.
    <bullet> As discussed in Unit IX.H., several of the time intervals 
were changed from 30 seconds to 10 seconds for the initial draining of 
the container (for liquid products only) and for the draining of the 
rinsate after the pressure rinse. The length of the pressure rinse 
interval was changed from ``30 seconds'' to ``at least 30 seconds.''
    <bullet> Several details about the orientation of the container 
were added, including that the user must hold the container upside down 
and insert the rinsing nozzle in the side of the container.
    <bullet> The pressure requirement was changed from exactly 40 PSI 
to ``about 40 PSI'' to allow a range of pressures in response to 
several comments expressing concern about requiring a pressure of 
exactly 40 PSI in the field.
    3. Comments - container orientation. A few commenters noted that 
the instructions are not clear in stating that the container must be 
inverted and that the rinse nozzle must be inserted on the side (or 
bottom) of the container. A registrant group suggested inserting the 
nozzle ``on the side of the container opposite the closure and in a 
direction towards the bottom of the container.'' A registrant 
recommended instructing the user to ``Force pressure rinsing nozzle 
through what was the bottom of the container or through the side of the 
container and...'' and also recommended that the instructions specify 
holding the container upside-down during the rinse process.
    4. EPA response - container orientation. EPA agrees with these 
commenters that more details about how to hold the container and where 
the nozzle should be inserted should be included. Therefore, the 
procedure was modified to instruct the user to hold the container 
upside down and to insert the rinsing nozzle in the side of the 
container.

K. Non-Water Diluents (Sec.  156.146(d))

    1. Final regulations. A registrant who wishes to require users to 
clean a container with a diluent other than water (e.g. solvents) must 
submit a written request to EPA to modify the residue removal 
instructions of this section. EPA may grant the request if certain 
conditions are met. The registrant must indicate why a non-water 
diluent is necessary and must propose appropriate residue removal 
instructions and disposal instructions that identify the diluent. If 
the non-water diluent is permitted by the label to be used in 
application, the instructions may allow the rinsate to be added to 
application equipment or mix tank. If use of the diluent in application 
is not permitted, the rinsate must be collected and stored for eventual 
disposal. EPA must approve, in writing, the modification of the residue 
removal instructions before the pesticide product can be distributed or 
sold.
    2. Changes. The final regulations are almost identical to the 
proposed regulations regarding non-water diluents. The final rule adds 
the requirement for the registrant to propose disposal instructions to 
ensure that end users have information about how to appropriately 
dispose of rinsate from a diluent other than water. One minor 
modification was to add ``or mix tank'' as an option for where rinsate 
may be added if the label allows the non-water diluent to be part of 
the application mixture. This change was made to be consistent with the 
changes in the triple rinse and pressure rinse instructions. In 
addition, several minor editorial changes were made to make this 
section more clear.

L. Residue Removal Instructions for Refillable Containers (Sec.  
156.156)

    1. General (Introductory Text for Sec.  156.156)--i. Final 
regulations. The label of each pesticide product packaged in a 
refillable container must include the residue removal instructions 
specified in Sec.  156.156. The residue removal instructions must be 
given for all pesticide products that are distributed or sold in 
refillable containers, including those that do not require dilution 
prior to application.
    ii. Changes. This requirement is substantively the same as it was 
in the proposed regulation. Some minor editorial and format changes 
were made to improve the clarity of the regulatory text. In addition, 
the second sentence, which reinforces that the instructions apply to 
all products that are distributed or sold in refillable containers, 
including those that do not require dilution prior to disposal, was 
moved from the subsection on instructions for residue removal to the 
introductory text. EPA made this change because the explanatory 
language applies to the whole section (including instructions on the 
timing of the procedures).
    2. Timing of residue removal procedures (Sec.  156.156(a))--i. 
Final regulations. The label of a pesticide product packaged in a 
refillable container (and that is subject to this requirement) must 
have one of the following sets of instructions on the timing of 
container cleaning:
    <bullet> ``Cleaning the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning 
before refilling is the responsibility of the refiller.''
    <bullet> ``Pressure rinsing the container before final disposal is 
the responsibility of the person disposing of the container. Cleaning 
before refilling is the responsibility of the refiller.''
    The statement must immediately precede the residue removal 
instructions and must be consistent with those instructions.
    ii. Changes. These statements were expanded in the final regulation 
to distinguish between cleaning before disposal and cleaning before 
refilling in response to comments. The proposed statements simply said 
``Clean [or pressure rinse] container before disposal.'' The changes in 
the final rule include adding ``final'' to the description of disposal, 
adding that the person disposing of the container is responsible for 
cleaning it, and including the additional statement of ``Cleaning 
before refilling is the responsibility of the refiller.''
    3. Residue removal instructions prior to container disposal (Sec.  
156.156(b))--i.

[[Page 47412]]

Final regulations. For pesticide products sold or distributed in 
refillable containers, the label must include instructions for cleaning 
the container prior to disposal. The instructions must be appropriate 
for the characteristics of the product and adequate to protect human 
health and the environment. The instructions could include any one of 
the following, as long as the instructions meet the standards described 
in the previous sentence:
    <bullet> The refilling residue removal procedure developed by the 
registrant for the pesticide product.
    <bullet> Standard industry practices for cleaning refillable 
containers.
    <bullet> For pesticides that require dilution prior to application, 
the following statement:
    ``To clean container before final disposal, empty the remaining 
contents from this container into application equipment or a mix tank. 
Fill the container about 10% full with water. Agitate vigorously or 
recirculate water with the pump for 2 minutes. Pour or pump rinsate 
into application equipment or rinsate collection system. Repeat this 
rinsing procedure two more times.''
    <bullet> Any other statement the registrant considers appropriate.
    ii. Changes. The final regulations are almost identical to those in 
the proposed rule, except for a few editorial and format changes. The 
phrase ``To clean container before final disposal'' was added to the 
specified procedure to emphasize that users should only clean the 
container before disposal and not before having the container refilled. 
The phrase ``into application equipment or a mix tank'' was added to be 
consistent with the emptying instructions for nonrefillable containers. 
One sentence that helps clarify the scope of the requirement for 
residue removal instructions on refillable containers was moved from 
this section to the introductory text since it applies to the whole 
section.

M. Amendments to Existing Sec.  156.10

    1. Final regulations. The final rule modifies the existing 
regulations in 40 CFR 156.10 in the following three ways:
    <bullet> A new Sec.  156.10(d)(7) is added that allows the labels 
for refillable containers to have a blank space to allow the net weight 
or contents to be marked in by a refiller according to 40 CFR 165.65(h) 
or 165.70(i);
    <bullet> The existing Sec.  156.10(f) was modified to allow labels 
for refillable containers to have a blank space to allow the EPA 
establishment number to be marked in by a refiller according to 40 CFR 
165.65(h) or 165.70(i); and
    <bullet> The existing Sec.  156.10(i)(2)(ix) regarding storage and 
disposal instructions was modified to refer to the applicable 
requirements in the rest of today's final rule.
    2. Changes. The most significant change to the approach taken in 
the proposed regulation is that ``shall'' was changed to ``may'' in the 
two paragraphs establishing blank spaces, thus changing them from 
requirements to options for pesticide registrants. This change was made 
to provide flexibility to registrants in response to comments. EPA 
decided to make several minor revisions to the paragraphs allowing 
blank spaces to link the 40 CFR part 156 regulations to the 40 CFR part 
165 repackaging regulations and to clarify that the blank space does 
not change the requirement for having the net contents or EPA 
establishment number on the label. First, the regulatory text allowing 
blank spaces was modified to refer to the 40 CFR part 165 regulations 
that require refillers to ensure that the net contents and EPA 
establishment number appear on the label. Second, the new paragraph in 
Sec.  156.10(d)(7) was amended to clarify that Sec.  156.10(a)(1)(iii) 
requires the net contents to be shown clearly and prominently on the 
label.
    The paragraph on storage and disposal instructions was modified to 
account for changes in the structure of the container-related labeling, 
so it refers to subpart H of part 156 rather than specific sections. 
Finally, a requirement about the type size of the storage and disposal 
heading was added to Sec.  156.10(i)(2)(ix) after the container 
regulations were proposed in 1994. Today's final rule maintains this 
requirement and corrects the reference to the child hazard warnings, 
which are located in Sec.  156.60(b).

N. Compliance Date (Sec.  156.159)

    1. Final regulations. The final regulations provide a 3-year 
compliance period. Specifically, within 3 years from today's date, all 
pesticide products distributed or sold by a registrant must have labels 
that comply with the 40 CFR part 156 requirements established in the 
final rule. This gives registrants a phase in period of 3 years to 
comply with the labeling requirements in Sec. Sec.  156.10(d)(7), 
156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146, and 156.156.
    2. Changes. The most significant change is that the phase-in period 
was extended from 2 years to 3 years from the publication of the final 
rule. In addition, the regulatory language was revised to make it more 
clear. EPA agrees with some of the commenters that a longer compliance 
period will make it easier and less burdensome to comply with the label 
standards. To facilitate compliance while trying to minimize the impact 
on companies, EPA lengthened the compliance period for the label 
standards to 3 years. EPA believes that a 3-year period is sufficient 
based on the results of the economic analysis. In addition, 3 years is 
consistent with the phase-in period for the nonrefillable container 
regulations.

X. Relationship to Other Programs and Agencies

    Certain laws administered by EPA and other agencies may affect the 
design of pesticide containers or procedures and standards for removal 
of residue from pesticide containers. This section identifies the laws 
that EPA considers to have the most significant impact on pesticide 
containers and containment. The description of these laws is for 
informational purposes only; no changes are being made in the laws 
described below. Nothing in this final rule is intended to alter 
obligations under other statutes.

A. Resource Conservation and Recovery Act (RCRA)

    Requirements under RCRA may affect the handling of pesticide 
containers under certain circumstances. RCRA Subtitles C and I are 
described briefly below.
    FIFRA sections 19(f)(3) and 19(h) specify that FIFRA section 19 
does not affect the requirements or authorities of RCRA. Accordingly, 
today's rule does not alter any existing RCRA requirements, and any 
applicable RCRA provisions will apply in addition to the provisions of 
any final rule issued under FIFRA section 19. In addition, FIFRA 
section 19(f)(1)(B)(iv) specifies that the residue removal regulations 
may be coordinated with requirements for container rinsing under RCRA. 
As outlined below, this rule provides for coordination in this area.
    1. Hazardous waste requirements. Subtitle C of RCRA creates a 
cradle-to-grave system for managing hazardous wastes. RCRA Subtitle C 
regulations include requirements for generators, transporters, and 
others who handle hazardous wastes. The regulations cover any ``solid 
waste'' (defined at 42 U.S.C. 1004 and 40 CFR 261.2) that is listed as 
a hazardous waste or exhibits a characteristic of hazardous waste, as 
set out in part 261. Pesticides (including pesticide residues in 
containers that are not empty per the RCRA definition in Sec.  261.7) 
that are discarded or intended to be discarded may qualify as hazardous 
wastes, if the pesticide is a hazardous waste as defined in Sec.  
261.33

[[Page 47413]]

(discarded commercial chemical products, off-specification products or 
manufacturing intermediates, container residues, and spill residues), 
or if they exhibit a characteristic of hazardous waste as described in 
part 261 subpart C, and are not otherwise exempt from regulation. A 
hazardous waste remaining in a container is not subject to Subtitle C 
regulation if, among other things, the container is ``empty'' as 
defined in Sec.  261.7. A container is ``empty'' if the wastes are 
removed pursuant to Sec.  261.7(b)(1) or (b)(2), or, in the case of an 
acute hazardous waste, the container has been triple rinsed or 
otherwise cleaned pursuant to Sec.  261.7(b)(3). EPA believes that the 
triple rinsing procedure provided in today's final rule meets the 
requirements of Sec.  261.7(b)(3), thus meeting the directive in FIFRA 
section 19(f)(1)(B)(iv).
    2. Underground storage tanks. RCRA Subtitle I provides for the 
development and implementation of a comprehensive regulatory program 
for ``underground storage tanks'' (USTs), defined at 42 U.S.C. 6991 and 
40 CFR 280.12 as tanks that are used to contain an accumulation of 
``regulated substances'' and whose volume (including underground pipes 
connected thereto) is 10 percent or more below ground. Regulated 
substances include petroleum or substances defined as hazardous under 
the Comprehensive Environmental Response, Compensation, and Liability 
Act of 1980 (CERCLA) (except hazardous wastes regulated under RCRA 
Subtitle C). CERCLA hazardous substances, enumerated at 40 CFR part 
302, include a number of pesticides. UST requirements at 40 CFR part 
280 include standards for new tanks as well as requirements for leak 
detection, closure, corrective action, and financial responsibility.
    EPA is not aware of the extent of industry use of USTs to store 
agricultural pesticides, and solicited comment on the use of 
underground tanks to store agricultural pesticides and on the preferred 
means of coordinating UST and FIFRA requirements. No comments were 
received on the topic. Because today's final rule requires secondary 
containment of any bulk container holding pesticide, underground 
storage would be precluded unless the secondary containment structure 
was also underground. EPA considers that the expense of such a 
construction makes it unlikely that a facility would use underground 
storage, and assumes that since no comments were received, underground 
storage of agricultural pesticides is generally avoided in the 
industry. Furthermore, EPA has noted, in its review of State 
regulations, that underground storage of pesticides is forbidden by 
States with bulk containment regulations.

B. Clean Water Act

    EPA has issued several regulations under the Clean Water Act (CWA) 
(33 U.S.C. 1251 et seq.) that are related to today's rule and that 
affect some sectors of the pesticide industry. The goal of the CWA is 
to achieve zero discharge of wastewater pollutants.
    1. Pesticide chemicals category, formulating, packaging and 
repackaging effluent limitations guidelines, pretreatment standards, 
and new source performance standards: Final rule. On November 6, 1996, 
EPA promulgated regulations governing effluents from pesticide 
formulating, packaging and repackaging facilities (61 FR 57518, Ref. 
57). Effluent guidelines establish limitations on the pollutants 
discharged into waters of the United States from industrial point 
sources. The Pesticide Formulating, Packaging and Repackaging (PFPR) 
effluent guidelines apply to facilities engaged in formulating, 
packaging or repackaging pesticides. The PFPR effluent guidelines 
regulation set limitations for facilities in two different regulatory 
subparts of 40 CFR part 455 (subparts C and E). Subpart C applies to 
facilities that discharge (or have the potential to discharge) 
wastewater from pesticide formulating, packaging, and/or repackaging 
operations. All pesticides with the exception of a few specific 
exemptions are included under subpart C. Subpart E applies only to 
refilling establishments that repackage agricultural pesticides into 
refillable containers. Subpart E does not apply to facilities that 
repackage non-agricultural pesticides. The same formulators, packagers, 
and repackagers (subpart E) and refilling establishments (subpart E) 
are affected by today's final pesticide container and containment rule. 
However, the PFPR effluent guidelines regulation does not include the 
other types of facilities covered by today's containment rule, namely 
commercial applicators and custom blenders.
    Under the effluent guidelines rule, refilling establishments are 
required to achieve zero discharge of wastewater pollutants. For these 
facilities, the zero discharge regulation was based on reuse, recycle 
and water conservation practices, as well as contract hauling of any 
non-reusable wastewater for off-site disposal, if necessary. However, 
effluent guidelines do not require specific practices or control 
technologies. Many refilling establishments achieve the zero discharge 
requirement through water conservation and good housekeeping, which 
includes repairing leaking valves and fittings and collecting drips in 
pans under appurtenances. Facilities that also provide application 
services typically reuse rinsate as make-up water for application in 
accordance with the label. Compliance with today's pesticide container 
and containment rule regarding requirements for containment structures, 
and adherence to the recommendations regarding rinsate collection will 
assist refilling establishments in achieving the zero discharge of 
pollutants required by the effluent guidelines.
    Under the PFPR effluent guidelines, subpart C facilities 
(formulators, packagers, and repackagers) are required to either 
achieve zero discharge of wastewater pollutants or to implement 
specific reuse, recycle, and water conservation practices (Pollution 
Prevention Alternative). For example, under the pollution prevention 
alternative, facilities must reuse their rinsates directly into the 
formulation or store rinsates for use in future formulation of the same 
or a compatible product.
    When the PFPR effluent regulations were proposed in April 1994 
(Ref. 64), the scope of subpart C included all pesticide active 
ingredients (PAIs) (with the exception of sodium hypochlorite and the 
partial exemption of specified sanitizers) and a wide variety of 
associated wastewater sources. EPA published a supplemental notice on 
June 8, 1995 (Ref. 61) which refined the scope of PAIs and wastewater 
sources. In the final rule, most sanitizer products were excluded, 
based on a number of factors, such as:
    <bullet> Sanitizer products are formulated for the purposes of 
their labeled end use to ``go down the drain;''
    <bullet> Sanitizer active ingredients are more likely to be sent to 
Publicly Owned Treatment Works (POTWs) in greater concentrations and 
volumes from their labeled end use than from rinsing formulating 
equipment at the PFPR facility;
    <bullet> Biodegradation data received with comments on some of 
these sanitizer active ingredients support the hypothesis that they do 
not pass through POTWs;
    <bullet> These sanitizer active ingredients represent a large 
portion of the low toxicity PAIs considered for regulation at the time 
of proposal; and
    <bullet> Many sanitizer solutions containing these active 
ingredients are cleared by the Food and Drug Administration

[[Page 47414]]

(FDA) as indirect food additives under 21 CFR 178.1010.
    The final PFPR effluent guidelines rule (subpart C) combined the 
pool chemicals exemption into the sanitizer exemption and exempted 
other pool chemicals in addition to the only pool chemical in the 
proposal, sodium hypochlorite. The additional chemicals that are 
included in the definition of pool chemicals in 40 CFR 455.10 include 
calcium hypochlorite, lithium hypochlorite, potassium hypochlorite, 
chlorinated isocyanurate compounds and halogenated hydantoins.
    The bulk containment requirements in today's rule are consistent 
with the control technologies which are the basis for the PFPR effluent 
guidelines for refilling establishments (subpart E). In addition, the 
repackaging and refillable container requirements of today's rule, 
particularly the adherence to the recommendations regarding rinsate 
collection, will aid facilities in collecting and reusing rinsates to 
meet the zero discharge/pollutant prevention alternative requirements 
of subpart C of the PFPR effluent guidelines.
    2. National Pollutant Discharge Elimination System (NPDES) - Storm 
Water Phase II Final Rule. EPA issued final regulations on December 8, 
1999 (64 FR 68722, Ref. 52) addressing storm water discharges. The 
regulation established a ``no exposure'' exemption for storm water 
discharges from facilities where industrial materials and activities 
are not exposed to storm water. Upon review of earlier regulations that 
excluded storm water discharges from certain categories of light 
industry from NPDES permit requirements, a court invalidated the light 
industry exemption. In 1992, the Ninth Circuit court concluded that the 
exemption impermissibly relied on the unsubstantiated judgment of the 
facility operator to determine applicability of the exemption. The new 
rule established in 1999 now allows the exemption, but requires that 
the facility meet certain conditions and provide a certification for 
tracking and accountability. ``No exposure'' means that all industrial 
materials or activities are protected by storm-resistant sheltering so 
they are not exposed to rain, snow, snowmelt or runoff. (40 CFR 
122.26(g))
    Pesticide refilling operations and bulk storage operations required 
to apply for and obtain NPDES permits for storm water discharges 
associated with such operations may take advantage of this exemption if 
they provide a certification of ``no exposure'' and maintain the 
certified conditions at the facility. Even when an owner/operator 
certifies to no exposure, the NPDES permitting authority may still 
require a permit if it determines that there is a discharge interfering 
with water quality standards. This will provide an added incentive to 
place all tanks within secondary containment that is protected from the 
elements. Facilities that are not exempt will have to get a discharge 
permit.
    3. Effluent guidelines and standards for the transportation 
equipment cleaning (TEC) Industry. On August 14, 2000, EPA published a 
final rule (65 CFR 49665, Ref. 51) establishing restrictions on the 
discharge of wastewater from cleaning the interiors of tank trucks, 
rail tank cars, inland tank barges, ocean/sea tankers, and other 
similar tanks used to transport materials, including agricultural 
chemicals and fertilizers. The TEC regulations do not apply to 
wastewaters generated from cleaning the interiors of pesticide drums or 
intermediate bulk containers (IBCs), defined as portable containers 
with 450 liters (119 gallons) to 3,000 liters (793 gallons) capacity. 
EPA subsequently studied the Industrial Container and Drum Cleaning 
Industry. The Preliminary Data Summary - Industrial Container and Drum 
Cleaning Industry (EPA-821-R-02-011 and Ref. 48) can be downloaded from 
the following link: http://www.epa.gov/waterscience/pollcontrol/drum/index.html.
    4. Spill prevention control and countermeasures (SPCC). On July 17, 
2002, (67 FR 47042, Ref. 47), EPA promulgated regulations under section 
311(j)(1)(C) of the Clean Water Act (known as the SPCC regulations) for 
the prevention of oil spills into navigable waters and adjoining 
shorelines. The regulations apply to facilities that, because of their 
location, could reasonably be expected to discharge oil into navigable 
waters or adjoining shorelines. Part 112 of 40 CFR outlines 
requirements for both the prevention and the response to oil spills. 
Facilities that are subject to the SPCC regulations include any non-
transportation-related onshore or offshore facility engaged in 
drilling, producing, gathering, storing, processing, refining, 
transferring, distributing, using, or consuming oil and oil products, 
which due to its location, could reasonably be expected to discharge 
oil, in quantities that may be harmful, into navigable waters of the 
United States or adjoining shorelines. Because the definition of 
``oil'' under CWA section 311 is very broad (including oil ``of any 
kind and in any form''), it could potentially include pesticides that 
contain oil or are oil-based. EPA expects that comparatively few, if 
any, of the facilities covered by today's pesticide container and 
containment rule are also subject to SPCC requirements, but if any are, 
both today's rule and SPCC requirements apply. On December 12, 2005, 
EPA proposed two separate amendments to the SPCC Rule. One of them 
(Ref. 24) streamlines the regulatory requirements for qualified 
facilities and equipment regulated under 40 CFR part 112 and proposes a 
separate extension of the compliance date for farms. The other 
amendment (Ref. 23) extends the SPCC compliance dates for all 
facilities.

C. Occupational Safety and Health Administration Requirements

    The Occupational Safety and Health Act (U.S.C. 2601 et seq.) 
addresses occupational safety and health hazards by establishing 
requirements for employers and employees and authorizing the 
Occupational Safety and Health Administration (OSHA) to establish 
mandatory occupational safety and health standards.
    Tanks and containers that are used to store flammable and 
combustible liquids in occupational settings are subject to OSHA 
requirements under 29 CFR 1910.106. For storage tanks, Sec.  
1910.106(b) contains design and construction requirements, including 
standards for materials, spacing, venting, drainage and diking, fire 
and flood resistance, and testing for strength and tightness. Section 
1910.106(c) contains specifications for piping, valves, and fittings. 
Section 1910.106(d) sets out design and construction requirements for 
containers and portable tanks, and also contains specifications for 
storage areas. Today's regulations do not contradict or supercede any 
existing OSHA requirements, and any applicable OSHA provisions will 
apply in addition to the provisions of today's rule.

D. Department of Transportation Hazardous Materials Regulations

    The Hazardous Materials Transportation Act of 1974, (49 U.S.C. 1801 
et seq) authorizes DOT to designate as hazardous materials those 
materials that may pose unreasonable risk to health and safety or 
property, and regulate the handling and transportation of such 
materials. The DOT regulations and their relationship to today's final 
pesticide container and containment regulations are discussed in detail 
in Unit IV. and many other places throughout this preamble.

XI. FIFRA Mandated Reviews

    In accordance with FIFRA sec. 25(a), the Agency submitted a draft 
of this final rule to the FIFRA Scientific

[[Page 47415]]

Advisory Panel (SAP), the Secretary of Agriculture, and the Committee 
on Agriculture in the House of Representatives, and the Committee on 
Agriculture, Nutrition, and Forestry in the United States Senate.
    The FIFRA SAP waived its review of this final rule because the 
significant scientific issues involved have already been reviewed by 
the SAP and additional review isn't necessary. The USDA did not submit 
any official comments.

XII. References

    The following is a listing of the documents that are specifically 
referenced in this final rule. These documents, and other supporting 
materials, are included in the docket established for this rulemaking 
under docket ID No.EPA-HQ-OPP-2005-0327 at http://www.regulations.gov.
    1. Ag Container Recycling Council. ``ACRC Celebrates 10 Years'', in 
``News Bits from the Ag Container Recycling Council,'' Summer (2002).
    2. Beaver, B.A. and W.D. Goetsch. ``Container Recycling in 
Illinois,'' 1994 Illinois Agricultural Pesticides Conference, (1994).
    3. Dwinell, S., 1992. Florida Department of Environmental 
Regulation, ``Final Report: Jackson County Pesticide Container 
Recycling Demonstration Project,'' (1992).
    4. Dwinell, S., 1991. Florida Department of Environmental 
Regulation, ``Final Report: South Florida Pesticide Container Recycling 
Demonstration Project,'' (1991).
    5. Federal Trade Commission. ``Guides for the Use of Environmental 
Marketing Claims,'' 16 CFR 260, (2006).
    6. Formulogics, 1991. ``Report to Mitchell System: Data Generation 
- Rinsing Studies,'' September 24 (1991).
    7. Formulogics, 1991. ``Triple Rinsing of Containers: Rinsing 
Variables,'' results of a study conducted for U.S. EPA, December 2 
(1991).
    8. Formulogics, 1990. ``Container Rinsing: Methodology Support,'' 
testing conducted for the U.S. EPA, 1990.
    9. Frieberg, D. Iowa Fertilizer and Chemical Association, 
``Environmental Cleanup of Fertilizer and Agricultural Chemical Dealer 
Sites,'' (1991).
    10. Hudak, C.M., North Carolina Department of Agriculture and 
Consumer Services. ``Pesticide Container Recycling in North Carolina'' 
presented at 2000 National Pesticide Stewardship Alliance Conference, 
(2000).
    11. Kammel, D., R. Noyes, G. Riskowski, and V. Hofman. ``Designing 
Facilities for Pesticide and Fertilizer Containment,'' MidWest Plan 
Service-37, Iowa State University, Ames, Iowa (1991).
    12. Michigan Department of Agriculture. ``Environmental Stewardship 
and the Michigan Department of Agriculture: A Report to Governor John 
Engler'' (1993).
    13. Minnesota Department of Agriculture. ``Empty Pesticide 
Container Collection and Recycling Program: Annual Report,'' (1996).
    14. Moye, Anson H., et al. ``Final Report: Work Assignment - Triple 
Rinse,'' research conducted for U.S. EPA, January 31 (1995).
    15. National Agricultural Chemicals Association, ``NACA Container 
Management Task Force Empty Pesticide Container Rinsing Study: Product 
Information and Analytical Results,'' October 16 (1990).
    16. United Nations Economic Commission for Europe (UNECE). 
``Globally Harmonized System of Classification and Labeling of 
Chemicals (GHS)'' (2005).
    17. Palmer, L. and R. Hansen. Minnesota Department of Agriculture 
[Information on pesticide container collection programs], Personal 
communication to members of the Minnesota Pesticide Container Advisory 
Committee, September 30 (1991).
    18. Poncin, S. Minnesota Department of Agriculture. ``Rinsing 
Problems Associated with Pesticides that are Formulated as Flowable,'' 
September (1995).
    19. U.S. EPA, 2006. ``Response to Comment Document: Standards for 
Pesticide Containers and Containment,'' (2006).
    20. U.S. EPA, 2006. ``Rinsing Procedures for Dilutable Pesticide 
Products in Rigid Containers,'' (2006).
    21. U.S. EPA, 2005. ``Economic Analysis of the Bulk Pesticide 
Containment Structures Final Regulation,'' November 15 (2005).
    22. U.S. EPA, 2005. ``Economic Analysis of the Pesticide Container 
Design and Residue Removal Standards,'' November 21 (2005).
    23. U.S. EPA, 2005. ``Oil Pollution Prevention; Non-Transportation 
Related Onshore Facilities: Proposed Rule,'' 70 FR 73517, December 12 
(2005).
    24. U.S. EPA, 2005. ``Oil Pollution Prevention; Spill Prevention, 
Control, and Countermeasure Plan Requirements - Amendments: Proposed 
Rule,'' 70 FR 73523, December 12 (2005).
    25. U.S. EPA, 2005. ``State Bulk Pesticide Containment Regulations 
- Scope and Definition of Bulk,'' February 2 (2005).
    26. U.S. EPA, 2005. ``Summary of Discussions re: Pesticide 
Container Collection Program Observations,'' November 15 (2005).
    27. U.S. EPA, 2005. ``Summary of Information on On-Farm Bulk 
Storage and Repackaging from State Contacts from States with 
Regulations that Include Farms,'' February 14 (2005).
    28. U.S. EPA, 2005. ``Summary of State Responses to EPA Inquiries 
About Bulk Storage on Farms,'' February 14 (2005).
    29. U.S. EPA, 2005. ``Summary of Telephone Conversations with 
Packaging Industry re: Dry Bulk Containers,'' February (2005).
    30. U.S. EPA, 2006. ``Supporting Statement for an Information 
Collection Request: Standards for Pesticide Containers and Containment 
(Final Rule), June 21, (2006).
    31. U.S. EPA, 2004. ``Meeting Summary,'' July 19 (2004).
    32. U.S. EPA, 2004. ``Standards for Pesticide Containers and 
Containment: Proposed Rule; Extension of Comment Period,'' 69 FR 50114, 
August 13 (2004).
    33. U.S. EPA, 2004. ``Standards for Pesticide Containers and 
Containment: Proposed Rule; Partial Reopening of the Comment Period,'' 
69 FR 39392, June 30 (2004).
    34. U.S. EPA, 2004. ``Summary Tables of State Bulk Pesticide 
Containment Regulations,'' January 23 (2004).
    35. U.S. EPA, 2003. ``Analysis and Summary of CSMA Data,'' March 5 
(2003).
    36. U.S. EPA, 2003. ``Analysis and Summary of Formulogics 
Agricultural Formulation/Container Data,'' February 24 (2003).
    37. U.S. EPA, 2003. ``Analysis and Summary of Formulogics 
Household, Institutional and Industrial Data,'' March 5 (2003).
    38. U.S. EPA, 2003. ``Analysis and Summary of Formulogics Quick 
Rinse Data,'' February 26 (2003).
    39. U.S. EPA, 2003. ``Analysis and Summary of NACA Triple Rinse 
data,'' March 4 (2003).
    40. U.S. EPA, 2003. ``Analysis and Summary of Pressure Rinse 
Data,'' March 5 (2003).
    41. U.S. EPA, 2003. ``Analysis and Summary of University of Florida 
Quick Rinse Data,'' February 26 (2003).
    42. U.S. EPA, 2003. ``Comparison of Triple Rinsing Data for 
Proposed and Final Rule,'' July 7 (2003).
    43. U.S. EPA, 2003. ``Information About Container Rejections from 
Recycling Programs,'' July 15 (2003).
    44. U.S. EPA, 2003. ``Label Review Manual: Third Edition,'' EPA 
735-B-03-001, August (2003).
    45. U.S. EPA, 2003. ``Revised Scope of the Container Regulations 
(Non-Antimicrobial Products,'' January 6 (2003).

[[Page 47416]]

    46. U.S. EPA, 2003. ``Summary of Conference Call with Wisconsin 
Department of Agriculture Staff on Containment Regulations,'' July 29 
(2003).
    47. U.S. EPA, 2002. ``Oil Pollution Prevention and Response: Non-
Transportation-Related Onshore and Offshore Facilities: Final Rule,'' 
67 FR 47042, July 17 (2002).
    48. U.S. EPA, 2002. ``Preliminary Data Summary for Industrial 
Container and Drum Cleaning Industry,'' EPA-821-R-02-011, June (2002).
    49. U.S. EPA, 2001. ``Disposal Instructions on Non-Antimicrobial 
Residential/Household Use Pesticide Product Labels,'' Pesticide 
Registration Notice 2001-6, September 7 (2001).
    50. U.S. EPA, 2001. ``Regulations Under the Federal Insecticide, 
Fungicide, and Rodenticide Act for Plant-Incorporated Protectants 
(Formerly Plant-Pesticides): Final Rule,'' 66 FR 37771, July 19 (2001).
    51. U.S. EPA, 2000. ``Effluent Limitations Guidelines, Pretreatment 
Standards, and New Source Performance Standards for the Transportation 
Equipment Cleaning Point Source Category: Final Rule,'' 65 FR 49665, 
August 14 (2000).
    52. U.S. EPA, 1999. ``National Pollutant Discharge Elimination 
System-Regulations for Revision of the Water Pollution Control Program 
Addressing Storm Water Discharges: Final Rule,'' 64 FR 68722, December 
8 (1999).
    53. U.S. EPA, 1999. ``Standards for Pesticide Containers and 
Containment: Proposed Rule; Partial Reopening of the Comment Period,'' 
64 FR 56918, October 21 (1999).
    54. U.S. EPA, 1998. ``Additional Guidance on Final FIFRA Section 
6(a)(2) Regulations for Pesticide Product Registrants,'' Pesticide 
Registration Notice 98-4, August 4 (1998).
    55. U.S. EPA, 1998. ``Guidance on Final FIFRA Section 6(a)(2) 
Regulations for Pesticide Product Registrants,'' Pesticide Registration 
Notice 98-3, April 3 (1998).
    56. U.S. EPA, 1998. ``Notifications, Non-notifications and Minor 
Formulation Amendments,'' Pesticide Registration Notice 98-10, October 
22 (1998).
    57. U.S. EPA, 1996. ``Pesticide Chemicals Category, Formulating, 
Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment 
Standards, and New Source Performance Standards: Final Rule,'' 61 FR 
57518, November 6 (1996).
    58. U.S. EPA, 1996. ``Toxicologically Significant Levels of 
Pesticide Active Ingredients,'' Pesticide Registration Notice 96-8, 
October 31 (1996).
    59. U.S. EPA, 1995. ``Bulk Pesticide Transfers,'' Memorandum from 
Jesse Baskerville, U.S. EPA, to U.S. EPA Regional Pesticides and Toxics 
Division Directors and Regional Counsels, March 22 (1995).
    60. U.S. EPA, 1995. ``Notice of Interim Determination of Adequacy 
of Certain State and Territorial Programs,'' 60 FR 24855, May 10 
(1995).
    61. U.S. EPA, 1995. ``Pesticide Chemicals Category, Formulating, 
Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment 
Standards, and New Source Performance Standards: Supplemental Notice,'' 
60 FR 30217, June 8 (1995).
    62. U.S. EPA, 1995. ``Pesticides; Technical Amendments: Final 
Rule,'' 60 FR 32094, June 19 (1995).
    63. U.S. EPA, 1994. ``Bulk Policy Question & Answer Document,'' 
February 3 (1994).
    64. U.S. EPA, 1994. ``Pesticide Chemicals Category, Formulating, 
Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment 
Standards, and New Source Performance Standards: Proposed Rule,'' April 
14 (1994).
    65. U.S. EPA, 1994. ``Recycling Empty Aerosol Pesticide 
Containers,'' Pesticide Registration Notice 94-2, May 16 (1994).
    66. U.S. EPA, 1994. ``Standards for Pesticide Containers and 
Containment: Proposed Rule,'' 59 FR 6712, February 11 (1994).
    67. U.S. EPA, 1994. ``State Pesticide Residue Removal Compliance 
Programs; Notice of Interim Determination of Adequacy; Correction,'' 59 
FR 9214, February 25 (1994).
    68. U.S. EPA, 1993. ``Interim Determination of Adequacy of State 
Pesticide Residue Removal Programs,'' 58 FR 43994, August 18 (1993).
    69. U.S. EPA, 1993. ``Notice of Interim Determination of Adequacy 
of Certain State Programs,'' 58 FR 65989, December 17 (1993).
    70. U.S. EPA, 1992. ``State of the States: Pesticide Storage, 
Disposal and Transportation,'' prepared for EPA by Mitchell Systems 
Corporation, EPA publication number EPA 734-R-92-12 (1992).
    71. U.S. EPA, 1991. ``Amendment to the July 11, 1977 Enforcement 
Policy Applicable to Bulk Shipment of Pesticides,'' March 4 (1991).
    72. U.S. EPA, 1984. ``Clarification of Label Improvement Program 
for Farmworker Safety and Pesticide Storage and Disposal 
Instructions,'' Pesticide Registration Notice 84-1, February 17 (1984).
    73. U.S. EPA, 1983. Office of Pesticide Programs, ``Label 
Improvement Program - Storage and Disposal Label Statements,'' 
Pesticide Registration Notice 83-3 (1983).
    74. U.S. EPA, 1979. ``National Pollution Discharge Elimination 
System (NPDES) Best Management Practices Guidance Document,'' EPA-600/
9-79-045, December (1979).
    75. U.S. EPA, 1977. ``Enforcement Policy Applicable to Bulk 
Shipment of Pesticides,'' July 11 (1977).
    76. U.S. EPA, 1976. ``Pesticide Enforcement Policy Statement on 
Structural Pest Control: Use and Labeling of Service Containers for the 
Transportation or Temporary Storage of Pesticides,'' (1976).
    77. Viera, K. Clorox [Data from container rinsing tests conducted 
by Chemical Specialties Manufacturers Association], Personal 
communication to U.S. EPA, July 13 (1993).
    78. U.S., EPA, 2000. ``Analysis of Products that Meet the Scope 
Criteria: Toxicity Category III Only,'' November 27 (2000).

XIII. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this final rule is a ``significant 
regulatory action'' because these requirements may raise novel legal or 
policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order. 
Accordingly, EPA submitted a draft final rule to OMB for review under 
Executive Order 12866 and any changes made in response to OMB 
recommendations have been documented in the docket for this rulemaking 
as required by sec. 6(a)(3)(E) of the Executive Order.
    In addition, EPA has prepared two Economic Analyses (EAs) of the 
potential costs and benefits associated with this rule, one for the 
container requirements and another for the containment requirements. 
The reason for having two EAs is because the regulated community 
differs in each case. For example, the container requirements affect 
pesticide formulators and refillers of all pesticides while the 
containment requirements affect retailers, for-hire applicators and 
custom blenders of agricultural pesticides. The EAs, entitled Economic 
Analysis of the Pesticide Container Design and Residue Removal 
Standards (Ref. 22) and Economic Analysis of the Bulk Pesticide 
Containment Structure Regulations (Ref. 21), are available in

[[Page 47417]]

the docket for this rule and are briefly summarized here.
    EPA estimates the total cost of the final rule to be $11.3 million 
($8.37 million for containers + $2.93 million for containment) and the 
total benefits from the final rule to be $17 - 23.4 million. When the 
estimated cost of the final rule is compared to the estimated cost for 
the proposed rule, there is an annual cost reduction of approximately 
$27.4 - $38.6 million. This reduction in estimated cost is due to the 
choices made in the final rule that lead to a narrowing in the scope of 
regulated entities and products that are subject to the final rule. 
During the first year, regulated facilities will experience an increase 
in total paperwork cost burden of $1 million (containment) and $7.0 
million (containers) due primarily to inspection and recordkeeping 
costs. For containers, in the second year and continuing thereafter, 
total paperwork cost burden per facility will decrease to 25 hours from 
81 hours in the first year, reducing paperwork burden costs to $4.1 
million annually.
    Over 20 respondents submitted general comments on the Regulatory 
Impact Analyses (RIAs) or EAs for the proposed rule. Nearly all of the 
commenters wanted EPA to reevaluate the economic assessments. The most 
common comments were: 1) The costs far outweigh the benefits; 2) costs 
were underestimated; 3) benefits were overestimated; 4) this is a major 
rule, contrary to EPA's assessment; 5) the rule will have a significant 
impact on medium and large formulators as well as small formulators; 6) 
the rule will have a general impact on various industry segments; and 
7) the rule does not comply with the standards of the Executive Order. 
Commenters who objected to the cost estimates mainly disagreed with 
EPA's estimate of the cost of complying with the six 9's residue 
removal standard. State regulatory agencies predicted that the rule 
would increase their workload and expressed the hope that EPA would 
increase State funding.
    EPA reopened the comment period on the proposed rule on October 21, 
1999 (64 FR 56918, Ref. 53) on three issues, proposing to reduce the 
scope of the container standards, add an exemption for certain 
antimicrobial pesticides, and adopt some of the Department of 
Transportation (DOT) hazardous materials regulations. These potential 
changes decreased the estimated economic impact by reducing the number 
of pesticide products subject to the container requirements compared to 
the original proposal.
    Major changes resulted in cost reduction from the economic analysis 
for the proposed rule. Among these is the elimination of the 
requirement to demonstrate the hydraulic conductivity of containment 
structures, lowering of the residue removal standard from six 9's to 
four 9's, and limiting of rinse-testing requirement to those 
formulations expected to be problematic.

B. Paperwork Reduction Act (PRA)

    The information collection requirements in this final rule have 
been submitted to the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The Information 
Collection Request (ICR) document prepared by EPA for this final rule 
has been assigned EPA ICR No. 1631.02, and OMB control number 2070-
0133. Consistent with the procedures at 5 CFR 1320.11, EPA sought 
comment on two Information Collection Request (ICR) documents that were 
submitted to OMB in conjunction with issuing the proposed rule 
(identified under EPA ICR No. 1631.01 and No. 1632.01). For the final 
rule, the two ICR documents were combined into one ICR document, which 
reflects the information collection provisions in this final rule. The 
ICR document for this final rule (identified under EPA ICR No. 1631.02) 
(Ref. 30) is included in the docket for the final rule.
    Under the PRA, an agency may not conduct or sponsor, and a person 
is not required to respond to a collection of information unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations codified in Chapter 40 of the CFR, after 
appearing in the preamble of the final rule, are listed in 40 CFR part 
9, are displayed either by publication in the Federal Register or by 
other appropriate means, such as on the related collection instrument 
or form, if applicable. The display of OMB control numbers in certain 
EPA regulations is consolidated in 40 CFR part 9. For the ICR activity 
contained in this final rule, in addition to displaying the applicable 
OMB control number in this Unit, the Agency is amending the table in 40 
CFR 9.1 to list the OMB control number assigned to this ICR activity. 
Due to the technical nature of the table, EPA finds that further notice 
and comment about amending the table is unnecessary. As a result, EPA 
finds that there is good cause under section 553(b)(B) of the 
Administrative Procedures Act (APA), 5 U.S.C. 553(b)(B), to amend this 
table without further notice and comment.
    Under the PRA, burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; develop, acquire, install, and 
utilize technology and systems for the purposes of collecting, 
validating, and verifying information, processing and maintaining 
information, and disclosing and providing information; adjust the 
existing ways to comply with any previously applicable instructions and 
requirements; train personnel to be able to respond to a collection of 
information; search data sources; complete and review the collection of 
information; and transmit or otherwise disclose the information.
    In this final rule, the information collection requirement burden 
on the regulated community includes the administrative burden 
associated with keeping monthly inspection and maintenance records for 
bulk pesticide containment structures. The regulated community's 
administrative burden is defined as the time spent to record and file 
the inspection and maintenance of the bulk pesticide containment 
structures per month. There is not a requirement to submit the records 
or reports to the Agency, however, EPA or its representatives may, from 
time to time, request information under these regulations to ensure 
compliance with the regulation.
    The two ICRs for the proposed rule were combined into a single ICR 
for the final rule. This ICR document provides detailed presentations 
of the estimated annual burden and costs for 3 years, which represents 
the maximum OMB approval period for any collection activity, after 
which the Agency must seek renewal of the ICR approval from OMB every 3 
years for as long as the requirements exist.
    1. Container burden. The public reporting burden for this 
collection of information is estimated to be 66 hours in the first year 
of compliance with this rule for approximately 1,804 pesticide 
registrant respondents, and 10 hours in subsequent years. For an 
estimated 16,795 agricultural pesticide refiller respondents, the 
reporting burden is 7.5 hours per year. For an estimated 322 swimming 
pool supply companies, the reporting burden is 7.5 hours per year. The 
total annual paperwork burden across all pesticide registrant 
respondents, assuming that 1,804 facilities will be affected by the 
requirements, is 112,209 hours in first year, and 11,185 hours in all 
other years. The total annual paperwork burden across all agricultural 
pesticide refiller respondents, assuming 16,795 facilities will be 
affected by the

[[Page 47418]]

requirements, is 125,963 hours. The total annual paperwork burden 
across all swimming pool supply companies, assuming 322 facilities will 
be affected by the requirements, is 2,415 hours.
    2. Containment burden. The public recordkeeping burden for this 
collection of information is estimated to be 7.5 hours for 
approximately 4,665 respondents in the first year after promulgation of 
this rule, which includes initial rule familiarization. The average 
annual burden per respondent for subsequent years is estimated to be 
7.5 hours. The total annual paperwork burden across all respondents, 
assuming that 4,665 facilities will be affected by the requirement, is 
34,988 hours per year.
    In comments filed after reviewing the proposed ICRs in 1994, OMB 
commented that EPA should consider less burdensome testing requirements 
that meet the objective that disposal of containers poses no 
unreasonable risk to health of the environment. As discussed 
previously, EPA has modified the requirements to be less burdensome, 
decreasing the total industry burden for the final rule. The decrease 
in burden results mainly from the elimination of the hydraulic 
conductivity standard for containment structures, lowering of the 
residue removal standard to four 9's, and requiring residue removal 
testing only for problematic formulations.
    The Agency is seeking additional comments on the paperwork burden 
estimates related to the provision in the final rule that allows States 
with existing regulations (Sec.  165.97) to request the authority to 
continue implementing its State containment regulations in lieu of 
EPA's regulations. As discussed previously, EPA added this provision in 
response to comments asking EPA to consider existing State regulations. 
Since this provision and related burden estimates were not part of the 
ICRs that were prepared and for which public comment was sought in 
conjunction with the proposed rule, EPA is providing this opportunity 
for public comment. Direct your comments on this to EPA using the 
public docket that has been established for this final rule (docket ID 
number EPA-HQ-OPP-2005-0327) at http://www.regulations.gov. In 
addition, send a copy of your comments to OMB at: Office of Information 
and Regulatory Affairs, Office of Management and Budget, 725 17th St., 
NW., Washington, DC 20503, Attention: Desk Office for EPA ICR No. 
1361.02. Since OMB is required to complete its review of the ICR 
between 30 and 60 days after August 16, 2006, please submit your 
comments no later than September 15, 2006.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this final 
rule will not have a significant adverse economic impact on a 
substantial number of small entities. This determination is based on 
the Agency's two economic analyses performed for this rulemaking, which 
are briefly summarized in Unit XIII.A., and copies of which are 
available in the docket for this rulemaking (Refs. 21 and 22). The 
following is a brief summary of the factual basis for this 
certification.
    Under the RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of today's rule on small entities, small entity 
is defined in accordance with the RFA as: (1) A small business as 
defined by the Small Business Administration's (SBA) regulations at 13 
CFR 121.201; (2) a small governmental jurisdiction that is a government 
of a city, county, town, school district, or special district with a 
population of less than 50,000; and (3) a small organization that is 
any not-for-profit enterprise which is independently owned and operated 
and is not dominant in its field. Based on the industry profiles for 
this rulemaking that EPA prepared as part of the Economic Analyses, EPA 
has determined that this final rule is not expected to impact any small 
not-for-profit organizations or small governmental jurisdictions. As 
such, small entity for purposes of this final rule is synonymous with 
small business.
    In addition, for purposes of analyzing the potential impacts of 
this final rule on small businesses, the Agency disaggregated the 
universe of potentially impacted small business into subcategories of 
large-small businesses, medium-small businesses, and small-small 
businesses. The analysis disaggregated the impacts of small businesses 
into these sub-categories because the SBA size standard for small 
businesses, which are primarily intended to define whether a business 
entity is eligible for Federal government programs and preferences 
reserved for small businesses (13 CFR 121.101), may not be 
representative of all small businesses in the industry sectors impacted 
by this rulemaking. (See section 632(a)(1) of the Small Business Act.) 
The SBA size standard is generally based on the number of employees an 
entity in a particular industrial sector may have. For example, in the 
Pesticide and Other Agricultural Chemical Manufacturing sector (i.e., 
NAICS code 325320) approximately 92% of the industries would be 
classified as small businesses under the SBA definition (500 or fewer 
employees). However, 60% of the SBA defined small companies have 1 to 
19 employees, which are considered small-small businesses in the 
Agency's analysis. By disaggregating the potential impacts of this 
final rule on small businesses, the Agency was able to consider the 
distribution of the estimated impacts among the universe of potentially 
impacted small businesses, particularly potential impacts on the small-
small businesses.
    Considering just the container requirements, the estimated costs of 
compliance for the universe of potentially impacted small businesses in 
each of the regulated industries as a proportion of their current 
revenues are estimated to be less than 1 percent. Specifically, using 
the SBA definition of small businesses, the costs of compliance for all 
small businesses are estimated to be less than 0.02 percent of the 
current average entity revenues. Looking at the estimated impacts using 
the disaggregated small business sub-categories used in the Agency's 
analysis (which further divides small businesses into large-small, 
medium-small and small-small business within each of the regulated 
industries), no small-small business is estimated to incur costs which 
account for more than 0.04 percent of current average entity revenues.
    Considering just the containment requirements, the estimated costs 
of compliance for the universe of potentially impacted small businesses 
as a proportion of their current revenues are estimated to be less than 
1 percent, except for small commercial applicators. When only looking 
at commercial applicators, and using the SBA definition of small 
business, the costs of compliance for potentially impacted small 
commercial applicators to install new secondary containment units are 
estimated to be as high as 2.7 percent of the current average entity 
revenues. Small-small commercial applicators, based on the 
disaggregated small business sub-categories used in the Agency's 
analysis, may face costs of compliance that are as much as 7.8 percent 
of the current average entity revenues. However, only 6 of the 3,000 
small commercial applicators were identified as small-small commercial 
applicators that will need to install both a secondary containment unit 
and a containment pad and thus are estimated to be impacted in this 
way. The costs of compliance for potentially impacted

[[Page 47419]]

small commercial applicators to retrofit existing containment 
structures are estimated to be less than 1 percent of the current 
average entity revenues.
    For agricultural pesticide refillers, the other industry estimated 
to be impacted by the containment regulations, the costs of compliance 
for small agricultural pesticide refillers are estimated to be less 
than 0.18 percent of current average entity revenues using the SBA 
definition of small businesses, and less than 0.34 percent of current 
average entity revenues based on the disaggregated small-small business 
sub-category used in the Agency's analysis.
    Considering the overall impact of this final rule on the universe 
of potentially impacted small businesses using the SBA definition for 
small business, the Agency has determined that this final rule will not 
have a significant adverse economic impact on a substantial number of 
small entities.
    In general, EPA strives to minimize potential adverse impacts on 
small entities when developing regulations to achieve the environmental 
and human health protection goals of the statute and the Agency. In 
doing so for this particular rule, as discussed in more detail 
previously, the major changes that EPA made to the proposed 
requirements resulted in significant reductions in the potential costs 
of compliance for this rulemaking.

D. Unfunded Mandates Reform Act (UMRA)

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4), EPA has determined that this action does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or for the private sector in any one year. As described in 
Unit XIII.A., the annual costs associated with this action are 
estimated to total $11.3 million ($8.37 millioin for containers + $2.93 
million for containment). This cost represents the incremental cost to 
registrants, pesticide dealers, commercial applicators and custom 
blenders attributed to the requirements in this action. Accordingly, 
this action is not subject to the requirements of sections 202 and 205 
of UMRA.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999), EPA has determined that this final rule does 
not have federalism implications, because it would not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the Order. Under cooperative agreements with EPA, States will be 
involved in compliance monitoring and enforcement activities, but are 
not otherwise expected to engage in the activities regulated by this 
rule. Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175

    As required by Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 22951, November 6, 
2000), EPA has determined that this action does not have tribal 
implications because it will not have substantial direct effects on 
tribal governments, on the relationship between the Federal government 
and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes, as 
specified in the Order. EPA is not aware of any tribal governments 
which are pesticide registrants, refillers or dealers storing large 
quantities of pesticides. Thus, Executive Order 13175 does not apply to 
this action.

G. Executive Order 13045

    Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997), does not apply to this action because it is not designated as an 
economically significant regulatory action as defined by Executive 
Order 12866 (see Unit XIII.A.). Further, this action does not establish 
an environmental standard that is intended to have a negatively 
disproportionate effect on children. To the contrary, this action will 
provide added protection for children from pesticide risk by ensuring 
the integrity of pesticide container design, as well as secure 
pesticide storage and disposal.

H. Executive Order 13211

    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

I. National Technology Transfer Advancement Act (NTTAA)

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. NTTAA directs EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards. This action requires 
performance standards for containment structures and residue removal 
testing for containers of certain pesticide formulations, but does not 
require specific methods or standards. Therefore, this action does not 
impose any technical standards that would require Agency consideration 
of voluntary consensus standards.

J. Executive Order 12898

    This action does not have an adverse impact on the environmental 
and health conditions in low-income and minority communities. 
Therefore, under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency has not 
considered environmental justice-related issues. Although not directly 
impacting environmental justice-related concerns, the Agency believes 
that the requirements in this rule will assist EPA and others in 
reducing potential exposures associated with the handling, storage, 
management and disposal of pesticide containers covered by the rule.

XIV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
major rule as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 156

    Environmental protection, Labeling, Pesticides and pests.


[[Page 47420]]



List of Subjects in 40 CFR Part 165

    Environmental protection, Packaging and containers, Containment 
structures, Pesticides and pests.

    Dated: August 3, 2006.
Stephen L. Johnson,
Administrator.


0
Therefore, 40 CFR chapter I is amended as follows:
0
1. Part 9 is amended as follows:

PART 9--[AMENDED]

0
a. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.


0
b. In Sec.  9.1 the table is amended by adding a new center heading 
entitled ``Pesticide Management and Disposal'' and an entry for new 
part 165 after the center heading and entries for ``State Registration 
of Pesticide Products,'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

----------------------------------------------------------------------------------------------------------------
        40 CFR citation                                          OMB Control No.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                                        Pesticide Management and Disposal
----------------------------------------------------------------------------------------------------------------
Part 165.......................                                                                        2070-0133
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

PART 156--[AMENDED]

0
2. Part 156 is amended as follows:
0
a. The authority citation for part 156 continues to read as follows:

    Authority: 7 U.S.C. 136 through 136y.


0
b. In Sec.  156.10 by adding paragraph (d)(7), and by revising 
paragraphs (f) and (i)(2)(ix) to read as follows:


Sec.  156.10  Labeling requirements.

* * * * *
    (d)* * *
    (7) For a pesticide product packaged in a refillable container, an 
appropriately sized area on the label may be left blank to allow the 
net weight or measure of content to be marked in by the refiller 
according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or 
sale of the pesticide. As required in paragraph (a)(1)(iii) of this 
section, the net contents must be shown clearly and prominently on the 
label.
* * * * *
    (f) Producing establishment's registration number. The producing 
establishment registration number preceded by the phrase ``EPA Est.'', 
of the final establishment at which the product was produced may appear 
in any suitable location on the label or immediate container. It must 
appear on the wrapper or outside container of the package if the EPA 
establishment registration number on the immediate container cannot be 
clearly read through such wrapper or container. For a pesticide product 
packaged in a refillable container, an appropriately sized area on the 
label may be left blank after the phrase ``EPA Est.'' to allow the EPA 
establishment registration number to be marked in by the refiller 
according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or 
sale of the pesticide.
* * * * *
    (i) * * *
    (2)* * *
    (ix) Specific directions concerning the storage, residue removal 
and disposal of the pesticide and its container, in accordance with 
subpart H of this part and part 165 of this chapter. These instructions 
must be grouped and appear under the heading, ``Storage and Disposal.'' 
This heading must be set in type of the same minimum sizes as required 
for the child hazard warning. (See table in Sec.  156.60(b))
* * * * *

0
c. By adding Subpart H entitled ``Container Labeling'' to read as 
follows:
Subpart H--Container Labeling
Sec.
156.140 Identification of container types.
156.144 Residue removal instructions - general.
156.146 Residue removal instructions for nonrefillable containers - 
rigid containers with dilutable pesticides.
156.156 Residue removal instructions for refillable containers.
156.159 Compliance date.

Subpart H--Container Labeling


Sec.  156.140  Identification of container types.

    For products other than plant-incorporated protectants, the 
following statements, as applicable, must be placed on the label or 
container. The information may be located on any part of the container 
except the closure. If the statements are placed on the container, they 
must be durably marked on the container. Durable marking includes, but 
is not limited to etching, embossing, ink jetting, stamping, heat 
stamping, mechanically attaching a plate, molding, or marking with 
durable ink.
    (a) Nonrefillable container. For nonrefillable containers, the 
statements in paragraphs (a)(1) through (a)(4) of this section are 
required. If placed on the label, the statements in paragraphs (a)(1) 
through (a)(3) of this section must be under an appropriate heading 
under the heading ``Storage and Disposal.'' If any of the statements in 
paragraphs (a)(1) through (a)(3) of this section are placed on the 
container, an appropriate referral statement such as ``See container 
for recycling [or other descriptive word] information.'' must be placed 
on the label under the heading ``Storage and Disposal.''
    (1) Statement identifying a nonrefillable container. The following 
phrase is required: ``Nonrefillable container.''
    (2) Reuse statement. One of the following statements is required. 
Products with labels that allow household/residential use must use the 
statement in paragraph (a)(2)(i) or (a)(2)(iii) of this section. All 
other products must use the statement in paragraph (a)(2)(i), 
(a)(2)(ii), or (a)(2)(iii) of this section.
    (i) ``Do not reuse or refill this container.''
    (ii) ``Do not reuse this container to hold materials other than 
pesticides or dilute pesticides (rinsate). After emptying and cleaning, 
it may be allowable to temporarily hold rinsate or other pesticide-
related materials in the container. Contact your state regulatory 
agency to determine allowable practices in your state.''
    (iii) The following statement may be used if a product is ``ready-
to-use'' and

[[Page 47421]]

its directions for use allow a different product (that is a similar, 
but concentrated formulation) to be poured into the container and 
diluted by the end user: ``Do not reuse or refill this container unless 
the directions for use allow a different (concentrated) product to be 
diluted in the container.''
    (3) Recycling or reconditioning statement. One of the following 
statements is required:
    (i) ``Offer for recycling if available.''
    (ii) ``Once cleaned, some agricultural plastic pesticide containers 
can be taken to a container collection site or picked up for recycling. 
To find the nearest site, contact your chemical dealer or manufacturer 
or contact [a pesticide container recycling organization] at [phone 
number] or [web site]. For example, this statement could be ``Once 
cleaned, some agricultural plastic pesticide containers can be taken to 
a container collection site or picked up for recycling. To find the 
nearest site, contact your chemical dealer or manufacturer or contact 
the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) 
or www.acrecycle.org.''
    (iii) A recycling statement approved by EPA and published in an EPA 
document, such as a Pesticide Registration Notice.
    (iv) An alternative recycling statement that has been reviewed and 
approved by EPA.
    (v) ``Offer for reconditioning if appropriate.''
    (4) Batch code. A lot number, or other code used by the registrant 
or producer to identify the batch of the pesticide product which is 
distributed and sold is required.
    (b) Refillable container. For refillable containers, one of the 
following statements is required. If placed on the label, it must be 
under the heading ``Storage and Disposal.'' If the statement is placed 
on the container, an appropriate referral statement, such as 
``Refilling limitations are on the container.'' must be placed under 
the heading ``Storage and Disposal.''
    (1) ``Refillable Container. Refill this container with pesticide 
only. Do not reuse this container for any other purpose.''
    (2) ``Refillable Container. Refill this container with [common 
chemical name] only. Do not reuse this container for any other 
purpose.''


Sec.  156.144  Residue removal instructions - general.

    (a) General. Except as provided by paragraphs (c) and (d) of this 
section, the label of each pesticide product must include the 
applicable instructions for removing pesticide residues from the 
container prior to container disposal that are specified in Sec. Sec.  
156.146 and 156.156. The residue removal instructions are required for 
both nonrefillable and refillable containers.
    (b) Placement of residue removal statements. All residue removal 
instructions must be placed under the heading ``Storage and Disposal.''
    (c) Exemption for residential/household use products. Residential/
household use pesticide products are exempt from the residue removal 
instruction requirements in this section through Sec.  156.156.
    (d) Modification. EPA may, on its own initiative or based on data 
submitted by any person, modify or waive the requirements of this 
section through Sec.  156.156, or permit or require alternative 
labeling statements.


Sec.  156.146  Residue removal instructions for nonrefillable 
containers - rigid containers with dilutable pesticides.

    The label of each dilutable (liquid or solid) pesticide product 
packaged in a rigid nonrefillable container must include the following 
residue removal instructions as appropriate.
    (a) Timing of the residue removal procedure. One of the following 
statements must immediately precede the instructions required in 
paragraph (b) of this section and must be consistent with the 
instructions in paragraphs (b) and (c) of this section:
    (1) ``Clean container promptly after emptying.''
    (2) ``Triple rinse or pressure rinse container (or equivalent) 
promptly after emptying.''
    (3) ``Triple rinse container (or equivalent) promptly after 
emptying.''
    (b) Triple rinse instructions. The label of each dilutable 
pesticide product packaged in rigid nonrefillable containers must 
include one of the following sets of instructions.
    (1) For liquid dilutable pesticide products in containers small 
enough to shake, use the following instructions: ``Triple rinse as 
follows: Empty the remaining contents into application equipment or a 
mix tank and drain for 10 seconds after the flow begins to drip. Fill 
the container 1/4 full with water and recap. Shake for 10 seconds. Pour 
rinsate into application equipment or a mix tank or store rinsate for 
later use or disposal. Drain for 10 seconds after the flow begins to 
drip. Repeat this procedure two more times.''
    (2) For solid dilutable pesticide products in containers small 
enough to shake, use the following instructions: ``Triple rinse as 
follows: Empty the remaining contents into application equipment or a 
mix tank. Fill the container 1/4 full with water and recap. Shake for 
10 seconds. Pour rinsate into application equipment or a mix tank or 
store rinsate for later use or disposal. Drain for 10 seconds after the 
flow begins to drip. Repeat this procedure two more times.''
    (3) For containers that are too large to shake, use the following 
instructions: ``Triple rinse as follows: Empty remaining contents into 
application equipment or a mix tank. Fill the container 1/4 full with 
water. Replace and tighten closures. Tip container on its side and roll 
it back and forth, ensuring at least one complete revolution, for 30 
seconds. Stand the container on its end and tip it back and forth 
several times. Turn the container over onto its other end and tip it 
back and forth several times. Empty the rinsate into application 
equipment or a mix tank or store rinsate for later use or disposal. 
Repeat this procedure two more times.''
    (c) Pressure rinse instructions. The label of each dilutable 
pesticide product packaged in rigid nonrefillable containers may 
include one of the following sets of instructions, and one of them must 
be used if the statement in paragraph (a)(2) of this section is used. 
If one of these statements is included on the label, it must 
immediately follow the triple rinse instructions specified in paragraph 
(b) of this section.
    (1) For liquid dilutable pesticide products, use the following 
label instruction: ``Pressure rinse as follows: Empty the remaining 
contents into application equipment or a mix tank and continue to drain 
for 10 seconds after the flow begins to drip. Hold container upside 
down over application equipment or mix tank or collect rinsate for 
later use or disposal. Insert pressure rinsing nozzle in the side of 
the container, and rinse at about 40 PSI for at least 30 seconds. Drain 
for 10 seconds after the flow begins to drip.''
    (2) For solid dilutable pesticide products, use the following label 
instruction: ``Pressure rinse as follows: Empty the remaining contents 
into application equipment or a mix tank. Hold container upside down 
over application equipment or mix tank or collect rinsate for later use 
or disposal. Insert pressure rinsing nozzle in the side of the 
container, and rinse at about 40 PSI for at least 30 seconds. Drain for 
10 seconds after the flow begins to drip.''
    (d) Non-water diluent. (1) A registrant who wishes to require users 
to clean a container with a diluent other than water (e.g., solvents) 
must submit to EPA a written request to modify the

[[Page 47422]]

residue removal instructions of this section. The registrant may not 
distribute or sell the pesticide with the modified residue removal 
instructions until EPA approves the request in writing.
    (2) The registrant must indicate why a non-water diluent is 
necessary for efficient residue removal, and must propose residue 
removal instructions and disposal instructions that are appropriate for 
the characteristics and formulation of the pesticide product and non-
water diluent. The proposed residue removal instructions must identify 
the diluent. If the Directions for Use permit the application of a 
mixture of the pesticide and the non-water diluent, the instructions 
may allow the rinsate to be added to the application equipment or mix 
tank. If the Directions for Use do not identify the non-water diluent 
as an allowable addition to the pesticide, the instructions must 
require collection and storage of the rinsate in a rinsate collection 
system.
    (3) EPA may approve the request if EPA finds that the proposed 
instructions are necessary and appropriate.


Sec.  156.156  Residue removal instructions for refillable containers.

    The label of each pesticide product packaged in a refillable 
container must include the residue removal instructions in this 
section. Instructions must be given for all pesticide products that are 
distributed or sold in refillable containers, including those that do 
not require dilution prior to application.
    (a) Timing of the residue removal procedure. One of the following 
statements must immediately precede the instructions required in 
paragraph (b) of this section and must be consistent with the 
instructions in paragraph (b) of this section:
    (1) ``Cleaning the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning 
before refilling is the responsibility of the refiller.''
    (2) ``Pressure rinsing the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning 
before refilling is the responsibility of the refiller.''
    (b) Residue removal instructions prior to container disposal. (1) 
Instructions for cleaning each refillable container prior to disposal 
are required. The residue removal instructions must be appropriate for 
the characteristics and formulation of the pesticide product and must 
be adequate to protect human health and the environment.
    (2) Subject to meeting the standard in paragraph (b)(1) of this 
section, the statement on residue removal instructions could include 
any one of the following:
    (i) The refilling residue removal procedure developed by the 
registrant for the pesticide product.
    (ii) Standard industry practices for cleaning refillable 
containers.
    (iii) For pesticides that require dilution prior to application, 
the following statement: ``To clean the container before final 
disposal, empty the remaining contents from this container into 
application equipment or a mix tank. Fill the container about 10 
percent full with water. Agitate vigorously or recirculate water with 
the pump for 2 minutes. Pour or pump rinsate into application equipment 
or rinsate collection system. Repeat this rinsing procedure two more 
times.''
    (iv) Any other statement the registrant considers appropriate.


Sec.  156.159  Compliance date.

    As of August 17, 2009, all pesticide products distributed or sold 
by a registrant must have labels that comply with Sec. Sec.  
156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146, 
and 156.156.

0
3. By adding a new part 165 to read as follows:

Part 165--Pesticide Management and Disposal

Sec.
Subpart A--General
165.1 Scope.
165.3 Definitions.
165.4-165.19 [Reserved]
Subpart B--Nonrefillable Container Standards: Container Design and 
Residue Removal
165.20 General provisions.
165.23 Scope of pesticide products included.
165.25 Nonrefillable container standards.
165.27 Reporting and recordkeeping.
165.28-165.39 [Reserved]
Subpart C--Refillable Container Standards: Container Design
165.40 General provisions.
165.43 Scope of pesticide products included.
165.45 Refillable container standards.
165.47 What information must I report about my refillable 
containers?
165.48-165.59 [Reserved]
Subpart D--Standards for Repackaging Pesticide Products into Refillable 
Containers
165.60 General provisions.
165.63 Scope of pesticide products included.
165.65 Registrants who distribute or sell pesticide products in 
refillable containers.
165.67 Registrants who distribute or sell pesticide products to 
refillers for repackaging.
165.70 Refillers who are not registrants.
165.71-165.79 [Reserved]
Subpart E--Standards for Pesticide Containment Structures
165.80 General provisions.
165.81 Scope of stationary pesticide containers included.
165.82 Scope of pesticide dispensing areas included.
165.83 Definition of new and existing structures.
165.85 Design and capacity requirements for new structures.
165.87 Design and capacity requirements for existing structures.
165.90 Operational, inspection and maintenance requirements for all 
new and existing containment structures.
165.92 What if I need both a containment pad and a secondary 
containment unit?
165.95 What recordkeeping do I have to do as a facility owner or 
operator?
165.97 States with existing containment programs.

    Authority: 7 U.S.C. 136 through 136y.

Subpart A--General


Sec.  165.1  Scope.

    The Part 165 regulations establish standards and requirements for 
pesticide containers, repackaging pesticides, and pesticide containment 
structures.


Sec.  165.3  Definitions.

    Act means the Federal Insecticide, Fungicide, and Rodenticide Act.
    Agricultural pesticide means any pesticide product labeled for use 
in a nursery or greenhouse or for use in the production of any 
agricultural commodity, including any plant, plant part, animal, or 
animal product produced by persons (including farmers, ranchers, 
vineyardists, plant propagators, Christmas tree growers, 
aquaculturalists, horticulturists, orchardists, foresters, or other 
comparable persons) primarily for sale, consumption, propagation or 
other use by man or animals.
    Appurtenance means any equipment or device which is used for the 
purpose of transferring a pesticide from a stationary pesticide 
container or to any refillable container, including but not limited to, 
hoses, fittings, plumbing, valves, gauges, pumps and metering devices.
    Container means any package, can, bottle, bag, barrel, drum, tank, 
or other containing-device (excluding any application tanks) used to 
enclose a pesticide. Containers that are used to sell or distribute a 
pesticide product and that also function in applying the product (such 
as spray bottles, aerosol

[[Page 47423]]

cans and containers that become part of a direct injection system) are 
considered to be containers for the purposes of this part.
    Containment pad means any structure that is designed and 
constructed to intercept and contain pesticides, rinsates, and 
equipment wash water at a pesticide dispensing area.
    Containment structure means either a secondary containment unit or 
a containment pad.
    Custom blending means the service of mixing pesticides to a 
customer's specifications, usually a pesticide(s)-fertilizer(s), 
pesticide-pesticide, or a pesticide-animal feed mixture, when:
    (1) The blend is prepared to the order of the customer and is not 
held in inventory by the blender;
    (2) The blend is to be used on the customer's property (including 
leased or rented property);
    (3) The pesticide(s) used in the blend bears end-use labeling 
directions which do not prohibit use of the product in such a blend;
    (4) The blend is prepared from registered pesticides; and
    (5) The blend is delivered to the end-user along with a copy of the 
end-use labeling of each pesticide used in the blend and a statement 
specifying the composition of the mixture.
    Dry pesticide means any pesticide that is in solid form and that 
has not been combined with liquids; this includes formulations such as 
dusts, wettable powders, dry flowable powders, granules, and dry baits.
    Establishment means any site where a pesticidal product, active 
ingredient, or device is produced, regardless of whether such site is 
independently owned or operated, and regardless of whether such site is 
domestic and producing a pesticidal product for export only, or whether 
the site is foreign and producing any pesticidal product for import 
into the United States.
    Facility means all buildings, equipment, structures, and other 
stationary items which are located on a single site or on contiguous or 
adjacent sites and which are owned or operated by the same person (or 
by any person who controls, who is controlled by, or who is under 
common control with such person).
    Flowable concentrate means a stable suspension of active 
ingredients in a liquid intended for dilution with water before use.
    Nonrefillable container means a container that is not a refillable 
container and that is designed and constructed for one time containment 
of a pesticide for sale or distribution. Reconditioned containers are 
considered to be nonrefillable containers.
    One-way valve means a valve that is designed and constructed to 
allow virtually unrestricted flow in one direction and no flow in the 
opposite direction, thus allowing the withdrawal of material from, but 
not the introduction of material into, a container.
    Operator means any person in control of, or having responsibility 
for, the daily operation of a facility at which a containment structure 
is located.
    Owner means any person who owns a facility at which a containment 
structure is required.
    Pesticide compatible means, as applied to containers, that the 
container construction materials will not chemically react with the 
formulation. A container is not compatible with the formulation if, for 
example, the formulation:
    (1) Is corrosive to the container;
    (2) Causes softening, premature aging, or embrittlement of the 
container;
    (3) Otherwise causes the container to weaken or to create the risk 
of discharge;
    (4) Reacts in a significant chemical, electrolytic, or galvanic 
manner with the container, or
    (5) Interacts in a way, such as the active ingredient permeating 
the container wall, that would cause the formulation to differ from its 
composition as described in the statement required in connection with 
its registration under FIFRA section 3.
    Pesticide compatible means, as applied to secondary containment, 
that the containment construction materials are able to withstand 
anticipated exposure to stored or transferred materials without losing 
the capacity to provide the required secondary containment of the same 
or other materials within the containment area.
    Pesticide dispensing area means an area in which pesticide is 
transferred out of or into a container.
    Portable pesticide container means a refillable container that is 
not a stationary pesticide container.
    Pressure rinse means the flushing of the container to remove 
pesticide residue by using a pressure method with a pressure of at 
least 40 PSI.
    Produce means to manufacture, prepare, propagate, compound, or 
process any pesticide, including any pesticide produced pursuant to 
section 5 of the Act, and any active ingredient or device, or to 
package, repackage, label, relabel, or otherwise change the container 
of any pesticide or device.
    Producer means any person, as defined by the Act, who produces any 
pesticide, active ingredient, or device (including packaging, 
repackaging, labeling and relabeling).
    Refillable container means a container that is intended to be 
filled with pesticide more than once for sale or distribution.
    Refiller means a person who engages in the activity of repackaging 
pesticide product into refillable containers. This could include a 
registrant or a person operating under contract to a registrant.
    Refilling establishment means an establishment where the activity 
of repackaging pesticide product into refillable containers occurs.
    Repackage means, for the purposes of this part, to transfer a 
pesticide formulation from one container to another without a change in 
the composition of the formulation, the labeling content, or the 
product's EPA registration number, for sale or distribution.
    Rinsate means the liquid produced from the rinsing of the interior 
of any equipment or container that has come in direct contact with any 
pesticide.
    Runoff means surface water leaving the target site.
    Secondary containment unit means any structure, including rigid 
diking, that is designed and constructed to intercept and contain 
pesticide spills and leaks and to prevent runoff and leaching from 
stationary pesticide containers.
    Stationary pesticide container means a refillable container that is 
fixed at a single facility or establishment or, if not fixed, remains 
at the facility or establishment for at least 30 consecutive days, and 
that holds pesticide during the entire time.
    Tamper-evident device means a device which can be visually 
inspected to determine if a container has been opened.
    Transport vehicle means a cargo-carrying vehicle such as an 
automobile, van, tractor, truck, semitrailer, tank car or rail car used 
for the transportation of cargo by any mode.
    Triple rinse means the flushing of the container three times to 
remove pesticide residue by using a non-pressurized method.
    Washwater means the liquid produced from the rinsing of the 
exterior of any equipment or containers that have or may have come in 
direct contact with any pesticide or system maintenance compound.

[[Page 47424]]

Sec. Sec.  165.4-165.19  [Reserved]

Subpart B--Nonrefillable Container Standards: Container Design and 
Residue Removal


Sec.  165.20  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
regulations in this subpart establish design and construction 
requirements for nonrefillable containers used for the distribution or 
sale of some pesticide products.
    (b) Do I have to comply with the regulations in this subpart? You 
must comply with the regulations in this subpart if you are a 
registrant who distributes or sells a pesticide product in 
nonrefillable containers. If your pesticide product is subject to the 
regulations in this subpart as set out in Sec.  165.23, your pesticide 
product must be distributed or sold in a nonrefillable container that 
meets the standards of these regulations.
    (c) When do I have to comply? As of August 17, 2009, all pesticide 
products distributed or sold by you in nonrefillable containers must be 
distributed or sold in compliance with these regulations.


Sec.  165.23  Scope of pesticide products included.

    (a) Are manufacturing use products subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to 
manufacturing use products, as defined in Sec.  158.153(h) of this 
chapter.
    (b) Are plant-incorporated protectants subject to the regulations 
in this subpart? No, the regulations in this subpart do not apply to 
plant-incorporated protectants, as defined in Sec.  174.3 of this 
chapter.
    (c) Which antimicrobial pesticide products are not subject to the 
regulations in this subpart? The regulations in this subpart do not 
apply to a pesticide product if it satisfies all of the following 
conditions:
    (1) The pesticide product meets one of the following two criteria:
    (i) The pesticide product is an antimicrobial pesticide as defined 
in FIFRA section 2(mm); or
    (ii) The pesticide product: (A) Is intended to: disinfect, 
sanitize, reduce or mitigate growth or development of microbiological 
organisms; or protect inanimate objects, industrial processes or 
systems, surfaces, water, or other chemical substances from 
contamination, fouling, or deterioration caused by bacteria, viruses, 
fungi, protozoa, algae, or slime; and
    (B) In the intended use is subject to a tolerance under section 408 
of the Federal Food, Drug, and Cosmetic Act or a food additive 
regulation under section 409 of such Act.
    (2) The labeling of the pesticide product includes directions for 
use on a site in at least one of the following antimicrobial product 
use categories: food handling/storage establishments premises and 
equipment; commercial, institutional, and industrial premises and 
equipment; residential and public access premises; medical premises and 
equipment; human drinking water systems; materials preservatives; 
industrial processes and water systems; antifouling coatings; wood 
preservatives; or swimming pools.
    (3) The pesticide product is not a hazardous waste as set out in 
part 261 of this chapter when the pesticide product is intended to be 
disposed.
    (4) EPA has not specifically determined that the pesticide product 
must be subject to the regulations in this subpart to prevent an 
unreasonable adverse effect on the environment according to the 
provisions of paragraph (d) of this section.
    (d) How will EPA determine if an ``antimicrobial'' pesticide 
product otherwise exempted must be subject to the regulations in this 
subpart to prevent an unreasonable adverse effect on the environment? 
(1) EPA may determine that an antimicrobial pesticide product otherwise 
exempted by paragraph (c) of this section must be subject to the 
nonrefillable container regulations in this subpart to prevent an 
unreasonable adverse effect on the environment if all of the following 
conditions exist:
    (i) EPA obtains information, data or other evidence of a problem 
with the containers of a certain pesticide product or related group of 
products.
    (ii) The information, data or other evidence is reliable and 
factual.
    (iii) The problem causes or could reasonably be expected to cause 
an unreasonable adverse effect on the environment.
    (iv) Complying with the container regulations could reasonably be 
expected to eliminate the problem.
    (2) If EPA determines that an antimicrobial pesticide product 
otherwise exempted by paragraph (c) of this section must be subject to 
the nonrefillable container regulations in this subpart to prevent an 
unreasonable adverse effect on the environment, EPA may require, by 
rule, that the product be distributed or sold in nonrefillable 
containers that comply with all or some of the requirements in this 
subpart. Alternatively, EPA may notify the applicant or registrant of 
its intent to make such a determination. After allowing the applicant 
or registrant a reasonable amount of time to reply, EPA may require, by 
notification and as a condition of registration, that the product be 
distributed or sold in nonrefillable containers that comply with all or 
some of the requirements in this subpart. For the purpose of the 
previous sentence, 60 days would be a reasonable amount of time to 
reply, although EPA may, in its discretion, provide more time. EPA may 
deny registration or initiate cancellation proceedings if the 
registrant fails to comply with the nonrefillable container regulations 
within the time frames established by EPA in the rule or in its 
notification.
    (e) What other pesticide products are subject to the regulations in 
this subpart? (1) Except for manufacturing use products, plant-
incorporated protectants, and antimicrobial products that are exempt 
under paragraph (c) of this section, all of the regulations in this 
subpart apply to a pesticide product if it satisfies at least one of 
the following criteria:
    (i) The pesticide product meets the criteria of Toxicity Category I 
as set out in Sec.  156.62 of this chapter.
    (ii) The pesticide product meets the criteria of Toxicity Category 
II as set out in Sec.  156.62 of this chapter.
    (iii) The pesticide product is classified for restricted use as set 
out in Sec. Sec.  152.160 - 152.175 of this chapter.
    (2) Except for manufacturing use products, plant-incorporated 
protectants, antimicrobial products that are exempt under (c) of this 
section, and other pesticide products that are regulated under 
paragraph (e)(1) of this section, a pesticide product must be packaged 
in compliance with 49 CFR 173.24. If the pesticide product meets the 
definition of a hazardous material in 49 CFR 171.8, the Department of 
Transportation requires it to be packaged according to 49 CFR parts 
171-180.
    (f) What does ``pesticide product'' or ``pesticide'' mean in the 
rest of this subpart? In Sec. Sec.  165.25 through 165.27, the term 
``pesticide product'' or ``pesticide'' refers only to a pesticide 
product or a pesticide that is subject to the regulations in this 
subpart as described in paragraphs (a) through (e) of this section.


Sec.  165.25  Nonrefillable container standards.

    (a) What Department of Transportation (DOT) standards do my 
nonrefillable containers have to meet under this part if my pesticide 
product is not a DOT hazardous material? A pesticide product that does 
not meet the definition of a hazardous material in 49

[[Page 47425]]

CFR 171.8 must be packaged in a nonrefillable container that is 
designed, constructed, and marked to comply with the requirements of 49 
CFR 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213, 
173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and part 180 
that are applicable to a Packing Group III material.
    (b) What DOT standards do my nonrefillable containers have to meet 
under this part if my pesticide product is a DOT hazardous material? 
(1) If your pesticide product meets the definition of a hazardous 
material in 49 CFR 171.8, the DOT requires your pesticide product to be 
packaged according to 49 CFR parts 171-180.
    (2) For the purposes of these regulations, a pesticide product that 
meets the definition of a hazardous material in 49 CFR 171.8 must be 
packaged in a nonrefillable container that is designed, constructed, 
and marked to comply with the requirements of 49 CFR parts 171-180.
    (c) What will EPA do if DOT proposes to change any of the cross-
referenced regulations? If the DOT proposes to change any of the 
regulations that are incorporated in paragraphs (a) and (b) of this 
section, EPA will provide notice of the proposed changes and an 
opportunity to comment in the Federal Register. Following notice and 
comment, EPA will take final action regarding whether or not to revise 
its rules, and the extent to which any such revision will correspond 
with revised DOT regulations.
    (d) What standards for closures do my nonrefillable containers have 
to meet? If your nonrefillable container is a rigid container with a 
capacity equal to or greater than 3.0 liters (0.79 gallons), if the 
container is not an aerosol container or a pressurized container, and 
if the container is used to distribute or sell a liquid agricultural 
pesticide, each nonrefillable container must have at least one of the 
following standard closures:
    (1) Bung, 2 inch pipe size (2.375 inches in diameter), external 
threading, 11.5 threads per inch, National Pipe Straight (NPS) 
standard.
    (2) Bung, 2 inch pipe size (2.375 inches in diameter), external 
threading, 5 threads per inch, buttress threads.
    (3) Screw cap, 63 millimeters, at least one thread revolution at 6 
threads per inch.
    (4) Screw cap, 38 millimeters, at least one thread revolution at 6 
threads per inch. The cap may fit on a separate rigid spout or on a 
flexible pull-out plastic spout.
    (e) What standards for dispensing do my nonrefillable containers 
have to meet? If your nonrefillable container has a capacity of 5 
gallons (18.9 liters) or less, if the container is not an aerosol 
container, a pressurized container, or a spray bottle, and if the 
container holds a liquid pesticide, your nonrefillable container must 
do both of the following:
    (1) Allow the contents of the nonrefillable container to pour in a 
continuous, coherent stream.
    (2) Allow the contents of the nonrefillable container to be poured 
with a minimum amount of dripping down the outside of the container.
    (f) What standards for residue removal do my nonrefillable 
containers have to meet? Each nonrefillable container and pesticide 
formulation combination must meet the applicable residue removal 
standard of this section.
    (1) If the nonrefillable container is rigid and has a capacity less 
than or equal to 5 gallons (18.9 liters) for liquid formulations or 50 
pounds (22.7 kilograms) for solid formulations and if the pesticide 
product's labeling allows or requires the pesticide product to be mixed 
with a liquid diluent prior to application (that is, if the pesticide 
is dilutable), each container/formulation combination must be capable 
of attaining at least 99.99 percent removal of each active ingredient 
when tested using the EPA test procedure ``Rinsing Procedures for 
Dilutable Pesticide Products in Rigid Containers.''
    (2) The test must be conducted only if the pesticide product is a 
flowable concentrate or if EPA specifically requests the records on a 
case by case basis.
    (3) For the rigid container/dilutable product standard in paragraph 
(f)(1) of this section, percent removal represents the percent of the 
original concentration of the active ingredient in the pesticide 
product when compared to the concentration of that active ingredient in 
the fourth rinse. Percent removal is calculated by the formula:

    percent removal = [1.0 - RR] x 100.0, where

    RR = rinsate ratio = Active ingredient concentration in fourth 
rinsate/Original concentration of active ingredient in the product

    (g) Can I obtain a waiver from or a modification to any of the 
nonrefillable container standards? Yes, it is possible for you to 
obtain a waiver from or a modification to the nonrefillable container 
standards, as follows:
    (1) EPA may waive or modify the requirements of paragraph (a) of 
this section regarding the DOT standards for pesticide products that 
are not DOT hazardous materials if EPA determines that an alternative 
(partial or modified) set of standards or pre-existing requirements 
achieves a level of safety that is at least equal to that specified in 
the requirements of paragraph (a) of this section.
    (2) EPA may waive or modify the requirements of paragraph (b) of 
this section regarding the DOT standards for pesticide products that 
are DOT hazardous materials if EPA determines that an alternative 
(partial or modified) set of standards or pre-existing requirements 
achieves a level of safety that is at least equal to that specified in 
the requirements of paragraph (b) of this section. EPA will modify or 
waive the requirements of paragraph (b) of this section only after 
consulting with DOT to ensure consistency with DOT regulations and 
exemptions.
    (3) EPA may approve a non-standard closure (that is, a closure not 
listed in paragraph (d) of this section) if EPA determines that both of 
the following conditions are satisfied:
    (i) The non-standard closure is necessary for the proper mixing, 
loading, or application of the pesticide product.
    (ii) The non-standard closure offers exposure protection to 
handlers during mixing and loading that is the same or greater than 
that provided by the standard closures.
    (4) EPA may waive or modify the container dispensing capability 
standards in paragraph (e) of this section if EPA determines that at 
least one of the following conditions is satisfied:
    (i) The product is typically removed from the container by a method 
other than pouring.
    (ii) Compliance with the container dispensing capability standards 
would increase exposure to the pesticide container handler.
    (5) EPA may waive or modify the requirements of paragraph (f) of 
this section regarding the residue removal standard if EPA determines 
that both of the following conditions are satisfied:
    (i) The residue remaining in the container would not cause an 
unreasonable adverse effect on the environment; and
    (ii) The product offers significant benefits and cannot be 
economically reformulated or repackaged.
    (h) How do I obtain a waiver from or a modification to any of the 
nonrefillable container standards? To obtain a waiver from or a 
modification to any of the nonrefillable container standards, you must 
submit a written request for a waiver or a modification to the EPA to 
the following address: Office of Pesticide Programs (7504P); U.S. 
Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania

[[Page 47426]]

Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the 
pesticide product in a nonrefillable container that does not comply 
with all of the nonrefillable container standards unless and until EPA 
approves the request for the waiver or modification in writing. You 
must include two copies of the following information (which may be part 
of an application for registration or amended registration) with your 
written request:
    (1) The name and address of the registrant; the date; and the name, 
title, signature, and phone number of the company official making the 
request.
    (2) The name and EPA registration number of the pesticide product 
for which the waiver or modification is requested.
    (3) A statement specifying the requirement or requirements from 
which you are requesting a waiver or a modification.
    (4) A description of the nonrefillable container or containers for 
which the waiver or modification is requested.
    (5) Documentation or justification to demonstrate that the 
applicable waiver or modification criteria in paragraph (g) of this 
section are satisfied.


Sec.  165.27  Reporting and recordkeeping.

    (a) What information must I report about my nonrefillable 
containers? You are not required to report to EPA with information 
about your nonrefillable containers under the regulations in this 
subpart. You should refer to the reporting standards in part 159 of 
this chapter to determine if information on container failures or other 
incidents involving pesticide containers must be reported to EPA under 
FIFRA section 6(a)(2) (7 U.S.C. 136d(a)(2)).
    (b) What recordkeeping do I have to do for my nonrefillable 
containers? For each pesticide product that is subject to Sec.  165.25 
- 165.27 and is distributed or sold in nonrefillable containers, you 
must maintain the records listed in this section for as long as a 
nonrefillable container is used to distribute or sell the pesticide 
product and for 3 years after that. You must furnish these records for 
inspection and copying upon request by an employee of EPA or any entity 
designated by EPA, such as a State, another political subdivision or a 
Tribe. You must keep the following records:
    (1) The name and EPA registration number of the pesticide product.
    (2) A description of the nonrefillable container(s) in which the 
pesticide product is distributed or sold.
    (3) At least one of the following records to document compliance 
with the requirement for closures in Sec.  165.25(d) for each 
nonrefillable container used to distribute or sell the pesticide 
product that must comply with Sec.  165.25(d):
    (i) A letter or document from the container supplier that describes 
the closure.
    (ii) A specification about the closure in the contract between the 
registrant or applicant and the container supplier.
    (iii) A copy of EPA's approval of any non-standard closure.
    (4) At least one of the following records pertaining to the 
container dispensing capability requirements in Sec.  165.25(e) for 
each nonrefillable container used to distribute or sell the pesticide 
product that must comply with Sec.  165.25(e):
    (i) Test data or documentation demonstrating that the nonrefillable 
container meets the standards in Sec.  165.25(e) when it contains the 
pesticide product.
    (ii) Test data or documentation demonstrating that a different 
nonrefillable container meets the standards in Sec.  165.25(e) when it 
contains the pesticide product or even a different pesticide product 
and a written explanation of why such data or documentation 
demonstrates that the container meets the standards in Sec.  165.25(e) 
for the pesticide product.
    (5) At least one of the following records pertaining to the 
nonrefillable container residue removal requirement in Sec.  165.25(f) 
if the pesticide product is a flowable concentrate or if EPA 
specifically requests the records on a case by case basis:
    (i) Test data showing that the nonrefillable container and 
pesticide formulation meet the standard in Sec.  165.25(f) .
    (ii) Test data showing that a different nonrefillable container 
with the same or a different pesticide formulation meets the standard 
in Sec.  165.25(f), together with a written explanation of why such 
data demonstrate that the nonrefillable container and pesticide 
formulation meet the standard in Sec.  165.25(f).


Sec. Sec.  165.28-165.39  [Reserved]

Subpart C--Refillable Container Standards: Container Design


Sec.  165.40  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
regulations in this subpart establish design and construction 
requirements for refillable containers used for the distribution or 
sale of some pesticide products.
    (b) Do I have to comply with the regulations in this subpart? (1) 
You must comply with all of the regulations in this subpart if you are 
a registrant who distributes or sells a pesticide product in refillable 
containers. If your pesticide product is subject to the regulations in 
this subpart as set out in Sec.  165.43, your pesticide product must be 
distributed or sold in a refillable container that meets the standards 
of these regulations. This includes your pesticide products that are 
repackaged according to subpart D of this part.
    (2) You must comply with the regulations in Sec.  165.45(f) for 
stationary pesticide containers if you are a refiller of a pesticide 
product and you are not the registrant of the pesticide product. If the 
pesticide product is subject to the regulations in this subpart as set 
out in Sec.  165.43, the stationary pesticide containers used to 
distribute or sell the product must meet the standards of Sec.  
165.45(f).
    (c) When do I have to comply? As of August 16, 2011, all pesticide 
products distributed or sold by you in refillable containers must be 
distributed or sold in compliance with these regulations.


Sec.  165.43  Scope of pesticide products included.

    (a) Are manufacturing use products subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to 
manufacturing use products, as defined in Sec.  158.153(h) of this 
chapter.
    (b) Are plant-incorporated protectants subject to the regulations 
in this subpart? No, the regulations in this subpart do not apply to 
plant-incorporated protectants, as defined in Sec.  174.3 of this 
chapter.
    (c) Which ``antimicrobial'' pesticide products are not subject to 
the regulations in this subpart? The regulations in this subpart do not 
apply to a pesticide product if it satisfies all of the following 
conditions:
    (1) The pesticide product meets one of the following two criteria:
    (i) The pesticide product is an antimicrobial pesticide as defined 
in FIFRA section 2(mm); or
    (ii) The pesticide product: (A) Is intended to: disinfect, 
sanitize, reduce or mitigate growth or development of microbiological 
organisms; or protect inanimate objects, industrial processes or 
systems, surfaces, water, or other chemical substances from 
contamination, fouling, or deterioration caused by bacteria, viruses, 
fungi, protozoa, algae, or slime; and
    (B) In the intended use is subject to a tolerance under section 408 
of the Federal Food, Drug, and Cosmetic Act or a food additive 
regulation under section 409 of such Act.

[[Page 47427]]

    (2) The labeling of the pesticide product includes directions for 
use on a site in at least one of the following antimicrobial product 
use categories: food handling/storage establishments premises and 
equipment; commercial, institutional, and industrial premises and 
equipment; residential and public access premises; medical premises and 
equipment; human drinking water systems; materials preservatives; 
industrial processes and water systems; antifouling coatings; wood 
preservatives; or swimming pools.
    (3) The pesticide product is not a hazardous waste as set out in 
part 261 of this chapter when the pesticide product is intended to be 
disposed.
    (4) EPA has not specifically determined that the pesticide product 
must be subject to the regulations in this subpart to prevent an 
unreasonable adverse effect on the environment according to the 
provisions of paragraph (e) of this section.
    (d) Which requirements must an ``antimicrobial'' swimming pool 
product comply with if it is not exempt from these regulations? An 
antimicrobial swimming pool product that is not exempt by paragraph 
(a), (b), or (c) of this section must comply with all of the 
regulations in this subpart except Sec.  165.45(d) regarding marking 
and Sec.  165.45(e) regarding openings. For the purposes of this 
subpart, an antimicrobial swimming pool product is a pesticide product 
that satisfies both of the following conditions:
    (1) The pesticide product is intended to: disinfect, sanitize, 
reduce or mitigate growth or development of microbiological organisms; 
or protect inanimate objects, industrial processes or systems, 
surfaces, water, or other chemical substances from contamination, 
fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, 
algae, or slime.
    (2) The labeling of the pesticide product includes directions for 
use on only a site or sites in the antimicrobial product use category 
of swimming pools.
    (e) How will EPA determine if an ``antimicrobial'' pesticide 
product otherwise exempted must be subject to the regulations in this 
subpart to prevent an unreasonable adverse effect on the environment? 
(1) EPA may determine that an antimicrobial pesticide product otherwise 
exempted by paragraph (c) of this section must be subject to the 
refillable container regulations in this subpart to prevent an 
unreasonable adverse effect on the environment if all of the following 
conditions exist:
    (i) EPA obtains information, data or other evidence of a problem 
with the containers of a certain pesticide product or related group of 
products.
    (ii) The information, data or other evidence is reliable and 
factual.
    (iii) The problem causes or could reasonably be expected to cause 
an unreasonable adverse effect on the environment.
    (iv) Complying with the container regulations could reasonably be 
expected to eliminate the problem.
    (2) If EPA determines that an antimicrobial pesticide product 
otherwise exempted by paragraph (c) of this section must be subject to 
the refillable container regulations in this subpart to prevent an 
unreasonable adverse effect on the environment, EPA may require, by 
rule, that the product be distributed or sold in refillable containers 
that comply with all or some of the requirements in this subpart. 
Alternatively, EPA may notify the applicant or registrant of its intent 
to make such a determination. After allowing the applicant or 
registrant a reasonable amount of time to reply, EPA may require, by 
notification and as a condition of registration, that the product be 
distributed or sold in refillable containers that comply with all or 
some of the requirements in this subpart. For the purpose of the 
previous sentence, 60 days would be a reasonable amount of time to 
reply, although EPA may, in its discretion, provide more time. EPA may 
deny registration or initiate cancellation proceedings if the 
registrant fails to comply with the refillable container regulations 
within the time frames established by EPA in the rule or in its 
notification.
    (f) What other pesticide products are subject to the regulations in 
this subpart? The regulations in this subpart apply to all pesticide 
products other than manufacturing use products, plant-incorporated 
protectants, and antimicrobial products that are exempt by paragraph 
(c) of this section. Antimicrobial products covered under by paragraph 
(d) of this section are subject to the regulations indicated in that 
section.
    (g) What does ``pesticide product'' or ``pesticide'' mean in the 
rest of this subpart? In Sec. Sec.  165.43(h) through 165.47, the term 
``pesticide product'' or ``pesticide'' refers only to a pesticide 
product or a pesticide that is subject to the regulations in this 
subpart as described in paragraphs (a) through(f) of this section.
    (h) Are there any other exceptions? (1) The regulations in this 
subpart do not apply to transport vehicles that contain pesticide in 
pesticide-holding tanks that are an integral part of the transport 
vehicle and that are the primary containment for the pesticide.
    (2) The regulations in this subpart do not apply to containers that 
hold pesticides that are gaseous at atmospheric temperature and 
pressure.


Sec.  165.45  Refillable container standards.

    (a) What Department of Transportation (DOT) standards do my 
refillable containers have to meet under this part if my pesticide 
product is not a DOT hazardous material? (1) A pesticide product that 
does not meet the definition of a hazardous material in 49 CFR 171.8 
must be packaged in a refillable container that is designed, 
constructed, and marked to comply with the requirements of 49 CFR 
173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213, 
173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and part 180 
that are applicable to a Packing Group III material.
    (2) A refiller is not required to comply with 49 CFR 173.28(b)(2) 
for pesticide products that are not DOT hazardous materials if the 
refillable container to be reused complies with the refillable 
container regulations in this subpart and the refilling is done in 
compliance with the repackaging regulations in subpart D of this part.
    (b) What DOT standards do my refillable containers have to meet 
under this part if my pesticide product is a DOT hazardous material? 
(1) If your pesticide product meets the definition of a hazardous 
material in 49 CFR 171.8, the DOT requires your pesticide product to be 
packaged according to 49 CFR parts 171-180.
    (2) For the purposes of these regulations, a pesticide product that 
meets the definition of a hazardous material in 49 CFR 171.8 must be 
packaged in a refillable container that is designed, constructed, and 
marked to comply with the requirements of 49 CFR parts 171-180.
    (c) What will EPA do if DOT proposes to change any of the cross-
referenced regulations? If the DOT proposes to change any of the 
regulations that are incorporated in paragraphs (a) and (b) of this 
section, EPA will provide notice of the proposed changes and an 
opportunity to comment in the Federal Register. Following notice and 
comment, EPA will take final action regarding whether or not to revise 
its rules, and the extent to which any such revision will correspond 
with revised DOT regulations.
    (d) What standards for marking do my refillable containers have to 
meet? Each refillable container must be marked in a durable and clearly 
visible manner with

[[Page 47428]]

a serial number or other identifying code that will distinguish the 
individual container from all other containers. Durable marking 
includes, but is not limited to, etching, embossing, ink jetting, 
stamping, heat stamping, mechanically attaching a plate, molding, and 
marking with durable ink. The serial number or other identifying code 
must be located on the outside part of the container except on a 
closure. Placement on the label or labeling is not sufficient unless 
the label is an integral, permanent part of or permanently stamped on 
the container.
    (e) What standards for openings do my refillable containers have to 
meet? If your refillable container is a portable pesticide container 
that is designed to hold liquid pesticide formulations and is not a 
cylinder that complies with the DOT Hazardous Materials Regulations, 
each opening of the container other than a vent must have a one-way 
valve, a tamper-evident device or both. A one-way valve may be located 
in a device or system separate from the container if the device or 
system is the only reasonably foreseeable way to withdraw pesticide 
from the container. A vent must be designed to minimize the amount of 
material that could be introduced into the container through it.
    (f) What standards do my stationary pesticide containers have to 
meet? If a stationary pesticide container designed to hold undivided 
quantities of pesticides equal to greater than 500 gallons (1,890 
liters) of liquid pesticide or equal to or greater than 4,000 pounds 
(1,818 kilograms) of dry pesticide is located at the refilling 
establishment of a refiller operating under written contract to you, 
the stationary pesticide container must meet the following standards:
    (1) Except during a civil emergency or any unanticipated grave 
natural disaster or other natural phenomenon of an exceptional, 
inevitable and irresistible character, the effects of which could not 
have been prevented or avoided by the exercise of due care or 
foresight, each stationary pesticide container (for liquid and dry 
pesticides) and its appurtenances must meet both of the following 
standards:
    (i) Each stationary pesticide container and its appurtenances must 
be resistant to extreme changes in temperature and constructed of 
materials that are adequately thick to not fail and that are resistant 
to corrosion, puncture, or cracking.
    (ii) Each stationary pesticide container must be capable of 
withstanding all operating stresses, taking into account static heat, 
pressure buildup from pumps and compressors, and any other foreseeable 
mechanical stresses to which the container may be subjected in the 
course of operations.
    (2) Each stationary liquid pesticide container must meet all of the 
following standards:
    (i) Each stationary liquid pesticide container must be equipped 
with a vent or other device designed to relieve excess pressure, 
prevent losses by evaporation, and exclude precipitation.
    (ii) External sight gauges, which are pesticide-containing hoses or 
tubes that run vertically along the exterior of the container from the 
top to the bottom, are prohibited on stationary liquid pesticide 
containers.
    (iii) Each stationary liquid pesticide container connection below 
the normal liquid level must be equipped with a shutoff valve which is 
capable of being locked closed. A shutoff valve must be located within 
a secondary containment unit if one is required by subpart E of this 
part.
    (g) Can I obtain a waiver from or a modification to any of the 
refillable container standards? Yes, it is possible for you to obtain a 
waiver from or a modification to some of the refillable container 
standards, as follows:
    (1) EPA may waive or modify the requirements of paragraph (a) of 
this section regarding the DOT standards for pesticide products that 
are not DOT hazardous materials if EPA determines that an alternative 
(partial or modified) set of standards or pre-existing requirements 
achieves a level of safety that is at least equal to that specified in 
the requirements of paragraph (a) of this section.
    (2) EPA may waive or modify the requirements of paragraph (b) of 
this section regarding the DOT standards for pesticide products that 
are DOT hazardous materials if EPA determines that an alternative 
(partial or modified) set of standards or pre-existing requirements 
achieves a level of safety that is at least equal to that specified in 
the requirements of paragraph (b) of this section. EPA will modify or 
waive the requirements of paragraph (b) of this section only after 
consulting with DOT to ensure consistency with DOT regulations and 
exemptions.
    (h) How do I obtain a waiver from or a modification to any of the 
refillable container standards? To obtain a waiver from or a 
modification to any of the refillable container standards, you must 
submit a written request for a waiver or a modification to the EPA to 
the following address: Office of Pesticide Programs (7504P); U.S. 
Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania 
Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the 
pesticide product in a refillable container that does not comply with 
all of the refillable container standards unless and until EPA approves 
the request for the waiver or modification in writing. You must include 
two copies of the following information (which may be part of an 
application for registration or amended registration) with your written 
request:
    (1) The name and address of the registrant; the date; and the name, 
title, signature, and phone number of the company official making the 
request.
    (2) The name and EPA registration number of the pesticide product 
for which the waiver or modification is requested.
    (3) A statement specifying the requirement or requirements from 
which you are requesting a waiver or a modification.
    (4) A description of the refillable container or containers for 
which the waiver or modification is requested.
    (5) Documentation or justification to demonstrate that the 
applicable waiver or modification criteria in paragraph (g) of this 
section are satisfied.


Sec.  165.47  What information must I report about my refillable 
containers?

    You are not required to report to EPA with information about your 
refillable containers under the regulations in this subpart. You should 
refer to the reporting standards in part 159 of this chapter to 
determine if information on container failures or other incidents 
involving pesticide containers must be reported to EPA under FIFRA 
section 6(a)(2) (7 U.S.C. 136d(a)(2)).


Sec. Sec.  165.48-165.59  [Reserved]

Subpart D--Standards for Repackaging Pesticide Products into 
Refillable Containers


Sec.  165.60  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
regulations in this subpart establish requirements for repackaging some 
pesticide products into refillable containers for distribution or sale.
    (b) Do I have to comply with the regulations in this subpart? You 
must comply with the regulations in this subpart if you are a 
registrant who distributes or sells a pesticide product in refillable 
containers, if you are a registrant who distributes or sells pesticide 
products to a refiller (that is not part of your company) for 
repackaging into refillable containers, or if you are a refiller of a 
pesticide product and you are not the registrant of the pesticide 
product. Each pesticide product that is subject to the regulations

[[Page 47429]]

in this subpart as set out in Sec.  165.63 and that is distributed or 
sold in a refillable container must be distributed or sold in 
compliance with the standards of these regulations.
    (c) When do I have to comply? As of August 16, 2011, all pesticide 
products distributed or sold by you in refillable containers must be 
distributed or sold in compliance with these regulations.


Sec.  165.63  Scope of pesticide products included.

    (a) Are manufacturing use products subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to 
manufacturing use products, as defined in Sec.  158.153(h) of this 
chapter.
    (b) Are plant-incorporated protectants subject to the regulations 
in this subpart? No, the regulations in this subpart do not apply to 
plant-incorporated protectants, as defined in Sec.  174.3 of this 
chapter.
    (c) Which antimicrobial pesticide products are not subject to the 
regulations in this subpart? The regulations in this subpart do not 
apply to a pesticide product if it satisfies all of the following 
conditions:
    (1) The pesticide product meets one of the following two criteria:
    (i) The pesticide product is an antimicrobial pesticide as defined 
in FIFRA section 2(mm); or
    (ii) The pesticide product: (A) Is intended to: disinfect, 
sanitize, reduce or mitigate growth or development of microbiological 
organisms; or protect inanimate objects, industrial processes or 
systems, surfaces, water, or other chemical substances from 
contamination, fouling, or deterioration caused by bacteria, viruses, 
fungi, protozoa, algae, or slime; and
    (B) In the intended use is subject to a tolerance under section 408 
of the Federal Food, Drug, and Cosmetic Act or a food additive 
regulation under section 409 of such Act.
    (2) The labeling of the pesticide product includes directions for 
use on a site in at least one of the following antimicrobial product 
use categories: food handling/storage establishments premises and 
equipment; commercial, institutional, and industrial premises and 
equipment; residential and public access premises; medical premises and 
equipment; human drinking water systems; materials preservatives; 
industrial processes and water systems; antifouling coatings; wood 
preservatives; or swimming pools.
    (3) The pesticide product is not a hazardous waste as set out in 
part 261 of this chapter when the pesticide product is intended to be 
disposed.
    (4) EPA has not specifically determined that the pesticide product 
must be subject to the regulations in this subpart to prevent an 
unreasonable adverse effect on the environment according to the 
provisions of paragraph (e) of this section.
    (d) Which requirements must an antimicrobial swimming pool product 
comply with if it is not exempt from these regulations? (1) An 
antimicrobial swimming pool product that is not exempt by paragraph 
(a), (b), or (c) of this section must comply with all of the 
regulations in this subpart except for the following requirements:

------------------------------------------------------------------------
                                     Requirement for
                                     registrants who
                                      distribute or     Requirement for
            Requirement              sell 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 tamper-      165.65(e)(4)       165.70(f)(4)
 evident device
------------------------------------------------------------------------
Cleaning requirement: criteria                   Sec.               Sec.
 regarding one-way valve or tamper-      165.65(f)(1)       165.70(g)(1)
 evident device
------------------------------------------------------------------------
Cleaning if the one-way valve or     Sec.   165.65(g)   Sec.   165.70(h)
 tamper-evident device is not
 intact
------------------------------------------------------------------------

    (2) For the purposes of this subpart, an antimicrobial swimming 
pool product is a pesticide product that satisfies both of the 
following conditions:
    (i) 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.
    (ii) The labeling of the pesticide product includes directions for 
use on only a site or sites in the antimicrobial product use category 
of swimming pools.
    (e) How will EPA determine if an antimicrobial pesticide product 
otherwise exempted must be subject to the regulations in this subpart 
to prevent an unreasonable adverse effect on the environment? (1) EPA 
may determine that an antimicrobial pesticide product otherwise 
exempted by paragraph (c) of this section must be subject to the 
repackaging regulations in this subpart to prevent an unreasonable 
adverse effect on the environment if all of the following conditions 
exist:
    (i) EPA obtains information, data or other evidence of a problem 
with the containers of a certain pesticide product or related group of 
products.
    (ii) The information, data or other evidence is reliable and 
factual.
    (iii) The problem causes or could reasonably be expected to cause 
an unreasonable adverse effect on the environment.
    (iv) Complying with the container regulations could reasonably be 
expected to eliminate the problem.
    (2) If EPA determines that an antimicrobial pesticide product 
otherwise exempted by paragraph (c) of this section must be subject to 
the repackaging regulations in this subpart to prevent an unreasonable 
adverse effect on the environment, EPA may require, by rule, that the 
product be repackaged in compliance with all or some of the 
requirements in this subpart. Alternatively, EPA may notify the 
applicant or registrant of its intent to make such a determination. 
After allowing the applicant or registrant a reasonable amount of time 
to reply, EPA may require, by notification and as a condition of 
registration, that the product be repackaged in compliance with all or 
some of the requirements in this subpart. For the purpose of the 
previous sentence, 60 days would be a reasonable amount of time to 
reply, although EPA may, in its discretion, provide more time. EPA may 
deny registration or initiate cancellation proceedings if the 
registrant fails to

[[Page 47430]]

comply with the repackaging regulations within the time frames 
established by EPA in the rule or in its notification.
    (f) What other pesticide products are subject to the regulations in 
this subpart? The regulations in this subpart apply to all pesticide 
products other than manufacturing use products, plant-incorporated 
protectants, and antimicrobial products that are exempt paragraph (c) 
of this section. Antimicrobial products covered under paragraph (d) of 
this section are subject to the regulations indicated in that section.
    (g) What does ``pesticide product'' or ``pesticide'' mean in the 
rest of this subpart? In Sec. Sec.  165.63(h) through 165.70, the term 
``pesticide product'' or ``pesticide'' refers only to a pesticide 
product or a pesticide that is subject to the regulations in this 
subpart as described in paragraphs (a) through (f) of this section.
    (h) Are there any other exceptions? (1) The regulations in this 
subpart do not apply to transport vehicles that contain pesticide in 
pesticide-holding tanks that are an integral part of the transport 
vehicle and that are the primary containment for the pesticide.
    (2) Custom blending is not subject to the regulations in this 
subpart.
    (3) The regulations in this subpart do not apply to containers that 
hold pesticides that are gaseous at atmospheric temperature and 
pressure.


Sec.  165.65  Registrants who distribute or sell pesticide products in 
refillable containers.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a registrant who 
distributes or sells pesticide products in refillable containers. This 
means that you conduct all of the repackaging for a pesticide product 
and that you do not distribute or sell the pesticide product to a 
refiller that is not part of your company for repackaging into 
refillable containers. If you are a registrant that repackages a 
product directly into refillable containers for sale or distribution 
and you also sell or distribute other quantities of that product to an 
independent refiller for repackaging, then you must meet the 
requirements in this section for those quantities you distribute or 
sell directly and the requirements in Sec.  165.67 for those quantities 
that you distribute or sell to an independent refiller.
    (b) Am I responsible for product integrity? Yes, you are 
responsible for the pesticide product that you distribute or sell in 
refillable containers not being adulterated or different from the 
composition described in its confidential statement of formula that is 
required under FIFRA section 3.
    (c) What information must I develop? For each pesticide product 
distributed or sold in refillable containers, you must develop both of 
the following documents in writing.
    (1) You must develop a refilling residue removal procedure that 
describes how to remove pesticide residue from a refillable container 
(portable or stationary pesticide container) before it is refilled.
    (i) The refilling residue removal procedure must be adequate to 
ensure that the composition of the pesticide product does not differ at 
the time of its distribution or sale from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3.
    (ii) If the refilling residue removal procedure requires the use of 
a solvent other than the diluent used for applying the pesticide as 
specified on the labeling under ``Directions for Use,'' or if there is 
no diluent used for application, the refilling residue removal 
procedure must describe how to manage any rinsate resulting from the 
procedure in accordance with applicable Federal and State regulations.
    (2) You must develop a description of acceptable refillable 
containers (portable or stationary pesticide containers) that can be 
used for distributing or selling that pesticide product.
    (i) An acceptable container is one that you have determined meets 
the standards in subpart C of this part and is compatible with the 
pesticide formulation intended to be distributed and sold using the 
refillable container.
    (ii) You must identify the containers by specifying the container 
materials of construction that are compatible with the pesticide 
formulation and specifying information necessary to confirm compliance 
with the refillable container requirements in subpart C of this part.
    (d) What requirements must my individual establishments follow 
regarding repackaging a pesticide product into refillable containers? A 
refiller at your individual establishment that repackages a pesticide 
product into refillable containers for distribution or sale must comply 
with all of the following provisions.
    (1) The establishment must be registered with EPA as a producing 
establishment as required by Sec.  167.20 of this chapter.
    (2) The refiller must not change the pesticide formulation unless 
the refiller has a registration for the new formulation.
    (3) The refiller must repackage a pesticide product only into a 
refillable container that is identified on your description of 
acceptable containers for that pesticide product.
    (4) The refiller may repackage any quantity of a pesticide product 
into a refillable container up to the rated capacity of the container. 
In addition, there are no general limits on the size of the refillable 
containers that the refiller can use.
    (5) The refiller must have all of the following items at the 
establishment before repackaging a pesticide product into any 
refillable container for distribution or sale:
    (i) The pesticide product's label and labeling.
    (ii) The written refilling residue removal procedure for the 
pesticide product.
    (iii) The written description of acceptable containers for the 
pesticide product.
    (6) Before repackaging a pesticide product into any refillable 
container for distribution or sale, the refiller must identify the 
pesticide product previously contained in the refillable container to 
determine whether a residue removal procedure must be conducted in 
accordance with paragraph (f) of this section. The refiller may 
identify the previous pesticide product by referring to the label or 
labeling.
    (7) The refiller must inspect each refillable container according 
to paragraph (e) of this section.
    (8) The refiller must clean each refillable container according to 
paragraph (f) or (g) of this section, if required by either paragraph.
    (9) The refiller must ensure that each refillable container is 
properly labeled according to paragraph (h) of this section.
    (10) The establishment must maintain records in accordance with 
paragraph (i) of this section.
    (11) The establishment must maintain records as required by part 
169 of this chapter.
    (12) The establishment must report as required by part 167 of this 
chapter.
    (e) How must my individual establishments inspect refillable 
containers? Before repackaging a pesticide product into any refillable 
container, a refiller at your establishment must visually inspect the 
exterior and (if possible) the interior of the container and the 
exterior of appurtenances. The purpose of the inspection is to 
determine whether the container meets the necessary criteria with 
respect to continued container integrity, required markings, and

[[Page 47431]]

openings. If the condition in paragraph (e)(1) of this section exists, 
the container fails the inspection and must not be refilled unless the 
container is repaired, reconditioned, or remanufactured in compliance 
with the relevant DOT requirement. If the condition in paragraph (e)(2) 
or (e)(3) of this section exists (or both), the container fails the 
inspection and must not be refilled until the container meets the 
standards specified in subpart C of this part. The conditions are:
    (1) The integrity of the container is compromised in at least one 
of the following ways:
    (i) The container shows signs of rupture or other damage which 
reduces its structural integrity.
    (ii) The container has visible pitting, significant reduction in 
material thickness, metal fatigue, damaged threads or closures, or 
other significant defects.
    (iii) The container has cracks, warpage, corrosion or any other 
damage which might render it unsafe for transportation.
    (iv) There is damage to the fittings, valves, tamper-evident 
devices or other appurtenances that may cause failure of the container.
    (2) The container does not bear the markings required by Sec.  
165.45(a), (b) and (d), or such markings are not legible.
    (3) The container does not have an intact and functioning one-way 
valve or tamper-evident device on each opening other than a vent, if 
required.
    (f) How must my individual establishments clean refillable 
containers? A refiller at your establishment must clean each refillable 
container by conducting the pesticide product's refilling residue 
removal procedure before repackaging the pesticide product into the 
refillable container, unless the conditions in paragraph (f)(1) of this 
section and either paragraph (f)(2) or (f)(3) of this section are 
satisfied:
    (1) If required, each tamper-evident device and one-way valve is 
intact.
    (2) The refillable container is being refilled with the same 
pesticide product.
    (3) Both of the following conditions are satisfied:
    (i) The container previously held a pesticide product with a single 
active ingredient and is being used to repackage a pesticide product 
with the same single active ingredient.
    (ii) There is no change that would cause the composition of the 
product being repackaged to differ from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3. Examples of unallowable changes include the active 
ingredient concentration increasing or decreasing beyond the limits 
established by the confidential statement of formula or a reaction or 
interaction between the pesticide product being repackaged and the 
residue remaining in the container.
    (g) How must my individual establishments clean a refillable 
container that has a broken (non-intact) tamper-evident device or one-
way valve? As required in paragraph (f) of this section, a refiller at 
your establishment must clean each refillable container that has a 
tamper-evident device or one-way valve that is not intact by conducting 
the pesticide product's refilling residue removal procedure before 
repackaging the pesticide product into the refillable container. In 
addition, other procedures may be necessary to assure that product 
integrity is maintained in such cases.
    (h) How must my individual establishments label refillable 
containers? Before distributing or selling a pesticide product in a 
refillable container, a refiller at your establishment must ensure that 
the label of the pesticide product is securely attached to the 
refillable container such that the label can reasonably be expected to 
remain affixed during the foreseeable conditions and period of use. The 
label and labeling must comply in all respects with the requirements of 
part 156 of this chapter. In particular, the refiller at your 
establishment must ensure that the net contents statement and EPA 
establishment number appear on the label.
    (i) What recordkeeping must my individual establishments do? Each 
of your individual establishments that repackages a pesticide product 
into refillable containers for distribution or sale must maintain all 
of the records listed in this section in addition to the applicable 
records identified in parts 167 and 169 of this chapter. The 
establishment must furnish these records for inspection and copying 
upon request by an employee of EPA or any entity designated by EPA, 
such as a State, another political subdivision or a Tribe.
    (1) For each pesticide product distributed or sold in refillable 
containers, both of the following records must be maintained for the 
current operating year and for 3 years after that:
    (i) The written refilling residue removal procedure for the 
pesticide product.
    (ii) The written description of acceptable containers for the 
pesticide product.
    (2) Each time a refiller at your establishment repackages a 
pesticide product into a refillable container and distributes or sells 
the product, the following records must be generated and maintained for 
at least 3 years after the date of repackaging:
    (i) The EPA registration number of the pesticide product 
distributed or sold in the refillable container.
    (ii) The date of the repackaging.
    (iii) The serial number of the refillable container.


Sec.  165.67  Registrants who distribute or sell pesticide products to 
refillers for repackaging.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a registrant who 
distributes or sells pesticide products to a refiller that is not part 
of your company for repackaging into refillable containers.
    (b) Under what conditions can I allow a refiller to repackage my 
pesticide product into refillable containers? You may allow a refiller 
to repackage your pesticide product into refillable containers and to 
distribute or sell such repackaged product under your existing 
registration if all of the following conditions are satisfied:
    (1) The repackaging results in no change to the pesticide 
formulation.
    (2) One of the following conditions regarding a registered 
refilling establishment is satisfied:
    (i) The pesticide product is repackaged at a refilling 
establishment registered with EPA as required by Sec.  167.20 of this 
chapter.
    (ii) The pesticide product is repackaged at the site of a user who 
intends to use or apply the product by a refilling establishment 
registered with EPA as required by Sec.  167.20 of this chapter.
    (3) You have entered into a written contract with the refiller to 
repackage the pesticide product and to use the label of your pesticide 
product.
    (4) The pesticide product is repackaged only into refillable 
containers that meet the standards of subpart C of this part.
    (5) The pesticide product is labeled with the product's label with 
no changes except the addition of an appropriate net contents statement 
and the refiller's EPA establishment number.
    (c) What violations are applicable to illegal repackaging? 
Repackaging a pesticide product for distribution or sale without either 
obtaining a registration or meeting all of the conditions in paragraph 
(b) of this section is a violation of section 12 of the Act. Both you 
and the refiller that is repackaging your pesticide product under 
written contract with you may be liable for

[[Page 47432]]

violations pertaining to the repackaged product.
    (d) When must I provide the written contract to the refiller? If 
you allow a refiller to repackage your product as specified in 
paragraph (b) of this section you must provide the written contract to 
the refiller before you distribute or sell the pesticide product to the 
refiller.
    (e) Am I responsible for product integrity? Yes, for a product that 
you distribute or sell to a refiller that is not part of your company 
for repackaging into refillable containers, you are responsible for the 
pesticide product not being adulterated or different from the 
composition described in its confidential statement of formula that is 
required under FIFRA section 3.
    (f) What information must I develop? For each pesticide product 
distributed or sold in refillable containers, you must develop both of 
the following documents in writing.
    (1) You must develop a refilling residue removal procedure that 
describes how to remove pesticide residue from a refillable container 
(portable or stationary pesticide container) before it is refilled.
    (i) The refilling residue removal procedure must be adequate to 
ensure that the composition of the pesticide product does not differ at 
the time of its distribution or sale from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3.
    (ii) If the refilling residue removal procedure requires the use of 
a solvent other than the diluent used for applying the pesticide as 
specified on the labeling under ``Directions for Use,'' or if there is 
no diluent used for application, the refilling residue removal 
procedure must describe how to manage any rinsate resulting from the 
procedure in accordance with applicable Federal and State regulations.
    (2) You must develop a description of acceptable refillable 
containers (portable or stationary pesticide containers) that can be 
used for distributing or selling that pesticide product.
    (i) An acceptable container is one that you have determined meets 
the standards in subpart C of this part and is compatible with the 
pesticide formulation intended to be distributed and sold using the 
refillable container.
    (ii) You must identify the containers by specifying the container 
materials of construction that are compatible with the pesticide 
formulation and specifying information necessary to confirm compliance 
with the refillable container requirements in subpart C of this part.
    (g) When must I provide the information to the refiller? You must 
provide the refiller with all of the following information and 
documentation before or at the time of distribution or sale of your 
pesticide product to the refiller:
    (1) Your written refilling residue removal procedure for the 
pesticide product.
    (2) Your written description of acceptable containers for the 
pesticide product.
    (3) The pesticide product's label and labeling.
    (h) What recordkeeping must I do? You must maintain all of the 
records listed in this section for the current operating year and for 3 
years after that. You must furnish these records for inspection and 
copying upon request by an employee of EPA or any entity designated by 
EPA, such as a State, another political subdivision or a Tribe:
    (1) Each written contract entered into with a refiller for 
repackaging your pesticide product into refillable containers.
    (2) Your written refilling residue removal procedure for the 
pesticide product.
    (3) Your written description of acceptable containers for the 
pesticide product.


Sec.  165.70  Refillers who are not registrants.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a refiller of a 
pesticide product and you are not the registrant of the pesticide 
product.
    (b) Under what conditions can I repackage a registrant's pesticide 
product into refillable containers? A registrant may allow you to 
repackage the registrant's pesticide product into refillable containers 
and to distribute or sell such repackaged product under the 
registrant's existing registration if all of the following conditions 
are satisfied:
    (1) The repackaging results in no change to the pesticide 
formulation.
    (2) One of the following conditions regarding a registered 
refilling establishment is satisfied:
    (i) The pesticide product is repackaged at a refilling 
establishment registered with EPA as required by Sec.  167.20 of this 
chapter.
    (ii) The pesticide product is repackaged at the site of a user who 
intends to use or apply the product by a refilling establishment 
registered with EPA as required by Sec.  167.20 of this chapter.
    (3) The registrant has entered into a written contract with you to 
repackage the pesticide product and to use the label of the 
registrant's pesticide product.
    (4) The pesticide product is repackaged only into refillable 
containers that meet the standards of subpart C of this part.
    (5) The pesticide product is labeled with the product's label with 
no changes except the addition of an appropriate net contents statement 
and the refillers EPA establishment number.
    (c) What violations are applicable to illegal repackaging? 
Repackaging a pesticide product for distribution or sale without either 
obtaining a registration or meeting all of the conditions in paragraph 
(b) of this section is a violation of section 12 of the Act. Both you 
and the pesticide product's registrant may be liable for violations 
pertaining to the repackaged product.
    (d) Am I responsible for product integrity? Yes, you are 
responsible for the pesticide product that you distribute or sell in 
refillable containers not being adulterated or different from the 
composition described in its confidential statement of formula that is 
required under FIFRA section 3.
    (e) What requirements must I follow regarding repackaging a 
pesticide product into refillable containers? You must comply with all 
of the following provisions.
    (1) Your establishment must be registered with EPA as a producing 
establishment as required by Sec.  167.20 of this chapter.
    (2) You must not change the pesticide formulation unless you have a 
registration for the new formulation.
    (3) You must repackage a pesticide product only into a refillable 
container that is identified on the description of acceptable 
containers for that pesticide product provided by the registrant.
    (4) You may repackage any quantity of a pesticide product into a 
refillable container up to the rated capacity of the container. In 
addition, there are no general limits on the size of the refillable 
containers that you can use.
    (5) You must have all of the following items at your establishment 
before repackaging a pesticide product into any refillable container 
for distribution or sale:
    (i) The written contract from the pesticide product's registrant.
    (ii) The pesticide product's label and labeling.
    (iii) The registrant's written refilling residue removal procedure 
for the pesticide product.
    (iv) The registrant's written description of acceptable containers 
for the pesticide product.
    (6) Before repackaging a pesticide product into any refillable 
container for distribution or sale, you must identify the pesticide 
product previously

[[Page 47433]]

contained in the refillable container to determine whether a residue 
removal procedure must be conducted in accordance with paragraph (g) of 
this section. You may identify the previous pesticide product by 
referring to the label or labeling.
    (7) You must inspect each refillable container according to 
paragraph (f) of this section.
    (8) You must clean each refillable container according to paragraph 
(g) or (h) of this section, if required by either paragraph.
    (9) You must ensure that each refillable container is properly 
labeled according to paragraph (i) of this section.
    (10) You must maintain records in accordance with paragraph (j) of 
this section.
    (11) You must maintain records as required by part 169 of this 
chapter.
    (12) You must report as required by part 167 of this chapter.
    (13) The stationary pesticide containers at your establishment must 
meet the standards in Sec.  165.45(f).
    (14) You may be required to comply with the containment standards 
in subpart E of this part.
    (f) How must I inspect refillable containers? Before repackaging a 
pesticide product into any refillable container, you must visually 
inspect the exterior and (if possible) the interior of the container 
and the exterior of appurtenances. The purpose of the inspection is to 
determine whether the container meets the necessary criteria with 
respect to continued container integrity, required markings, and 
openings. If the condition in paragraph (f)(1) of this section exists, 
the container fails the inspection and must not be refilled unless the 
container is repaired, reconditioned, or remanufactured in compliance 
with the relevant DOT requirement. If the condition in paragraph (f)(2) 
or (f)(3) of this section exists (or both), the container fails the 
inspection and must not be refilled until the container meets the 
standards specified in subpart C of this part. The conditions are:
    (1) The integrity of the container is compromised in at least one 
of the following ways:
    (i) The container shows signs of rupture or other damage which 
reduces its structural integrity.
    (ii) The container has visible pitting, significant reduction in 
material thickness, metal fatigue, damaged threads or closures, or 
other significant defects.
    (iii) The container has cracks, warpage, corrosion or any other 
damage which might render it unsafe for transportation.
    (iv) There is damage to the fittings, valves, tamper-evident 
devices or other appurtenances that may cause failure of the container.
    (2) The container does not bear the markings required by Sec.  
165.45(a), (b) and (d), or such markings are not legible.
    (3) The container does not have an intact and functioning one-way 
valve or tamper-evident device on each opening other than a vent, if 
required.
    (g) How must I clean refillable containers? You must clean each 
refillable container by conducting the pesticide product's refilling 
residue removal procedure before repackaging the pesticide product into 
the refillable container, unless the conditions in paragraph (g)(1) of 
this section and either paragraph (g)(2) or (g)(3) of this section are 
satisfied:
    (1) If required, each tamper-evident device and one-way valve is 
intact.
    (2) The refillable container is being refilled with the same 
pesticide product.
    (3) Both of the following conditions are satisfied.
    (i) The container previously held a pesticide product with a single 
active ingredient and is being used to repackage a pesticide product 
with the same single active ingredient.
    (ii) There is no change that would cause the composition of the 
product being repackaged to differ from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3. Examples of unallowable changes include the active 
ingredient concentration increasing or decreasing beyond the limits 
established by the confidential statement of formula or a reaction or 
interaction between the pesticide product being repackaged and the 
residue remaining in the container.
    (h) How must I clean a refillable container that has a broken (non-
intact) tamper-evident device or one-way valve? As required in 
paragraph (g) of this section, you must clean each refillable container 
that has a tamper-evident device or one-way valve that is not intact by 
conducting the pesticide product's refilling residue removal procedure 
before repackaging the pesticide product into the refillable container. 
In addition, other procedures may be necessary to assure that product 
integrity is maintained in such cases.
    (i) How must I label refillable containers? Before distributing or 
selling a pesticide product in a refillable container, you must ensure 
that the label of the pesticide product is securely attached to the 
refillable container such that the label can reasonably be expected to 
remain affixed during the foreseeable conditions and period of use. The 
label and labeling must comply in all respects with the requirements of 
part 156 of this chapter. In particular, you must ensure that the net 
contents statement and EPA establishment number appear on the label.
    (j) What recordkeeping must I do? You must maintain all of the 
records listed in this section in addition to the applicable records 
identified in parts 167 and 169 of this chapter. You must furnish these 
records for inspection and copying upon request by an employee of EPA 
or any entity designated by EPA, such as a State, another political 
subdivision or a Tribe.
    (1) For each pesticide product distributed or sold in refillable 
containers, all of the following records must be maintained for the 
current operating year and for 3 years after that:
    (i) The written contract from the pesticide product's registrant 
for the pesticide product.
    (ii) The written refilling residue removal procedure for the 
pesticide product.
    (iii) The written description of acceptable containers for the 
pesticide product.
    (2) Each time you repackage a pesticide product into a refillable 
container and distribute or sell the product, the following records 
must be generated and maintained for at least 3 years after the date of 
repackaging:
    (i) The EPA registration number of the pesticide product 
distributed or sold in the refillable container.
    (ii) The date of the repackaging.
    (iii) The serial number of the refillable container.


Sec. Sec.  165.71-165.79  [Reserved]

Subpart E--Standards for Pesticide Containment Structures


Sec.  165.80  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
purpose of the containment regulations in this subpart is to protect 
human health and the environment from exposure to agricultural 
pesticides which may spill or leak from stationary pesticide 
containers. This protection is achieved by the construction of 
secondary containment units or pads at certain facilities handling 
agricultural pesticides. These regulations will also reduce waste 
generation associated with:
    (1) Storage and handling of large quantities of pesticide products.
    (2) Pesticide dispensing and container-refilling operations.

[[Page 47434]]

    (b) Do I have to comply with the regulations in this subpart? You 
must comply with the regulations in this subpart if you are an owner or 
operator of one of the following businesses and if you also have a 
stationary pesticide container or a pesticide dispensing (including 
container refilling) area:
    (1) Refilling establishments who repackage agricultural pesticides 
and whose principal business is retail sale (i.e., more that 50% of 
total annual revenue comes from retail operations).
    (2) Custom blenders of agricultural pesticides.
    (3) Businesses which apply an agricultural pesticide for 
compensation (other than trading of personal services between 
agricultural producers).
    (c) When do I have to comply? You must comply with all applicable 
containment regulations for new and existing structures as of August 
17, 2009.


Sec.  165.81  Scope of stationary pesticide containers included.

    (a) What is a stationary pesticide container? A stationary 
pesticide container is a refillable container that is fixed at a single 
facility or establishment, or, if not fixed, remains at the facility or 
establishment for at least 30 consecutive days, and that holds 
pesticide during the entire time.
    (b) What stationary pesticide containers are subject to the 
regulations in this subpart? Stationary pesticide containers designed 
to hold undivided quantities of agricultural pesticides equal to or 
greater than 500 gallons (1,890 liters) of liquid pesticide or equal to 
or greater than 4,000 pounds (1,818 kilograms) of dry pesticide are 
subject to the regulations in this subpart and must have a secondary 
containment unit that complies with the provisions of this subpart 
unless any of the following conditions exists:
    (1) The container is empty, that is, all pesticide that can be 
removed by methods such as draining, pumping or aspirating has been 
removed (whether or not the container has been rinsed or washed).
    (2) The container holds only pesticide rinsates or wash waters, and 
is labeled accordingly.
    (3) The container holds only pesticides which would be gaseous when 
released at atmospheric temperature and pressure.
    (4) The container is dedicated to non-pesticide use, and is labeled 
accordingly.


Sec.  165.82  Scope of pesticide dispensing areas included.

    (a) What pesticide dispensing areas are subject to the regulations 
in this subpart? A pesticide dispensing area is subject to the 
containment regulations in this subpart and must have a containment pad 
that complies with the requirements of this subpart if any of the 
following activities occur:
    (1) Refillable containers of agricultural pesticide are emptied, 
cleaned or rinsed.
    (2) Agricultural pesticides are dispensed from a stationary 
pesticide container designed to hold undivided quantities of 
agricultural pesticides equal to or greater than 500 gallons (1,890 
liters) of liquid pesticide or equal to or greater than 4,000 pounds 
(1,818 kilograms) of dry pesticide for any purpose, including refilling 
or emptying for cleaning. This applies when pesticide is dispensed from 
the container into any vessel, including, but not limited to:
    (i) Refillable containers;
    (ii) Service containers;
    (iii) Transport vehicles;
    (iv) Application equipment.
    (3) Agricultural pesticides are dispensed from a transport vehicle 
for purposes of filling a refillable container.
    (4) Agricultural pesticides are dispensed from any other container 
for the purpose of refilling a refillable container for sale or 
distribution. Containment requirements do not apply if the agricultural 
pesticide is dispensed from such a container for use, application or 
purposes other than refilling for sale or distribution.
    (b) What pesticide dispensing areas are exempt from the regulations 
in this subpart? A pesticide dispensing area is exempt from the 
regulations in this subpart if any of the following conditions exist:
    (1) The only pesticides in the dispensing area would be gaseous 
when released at atmospheric temperature and pressure.
    (2) The only pesticide containers refilled or emptied within the 
dispensing area are stationary pesticide containers which are already 
protected by a secondary containment unit that complies with the 
provisions of this subpart.
    (3) The pesticide dispensing area is used solely for dispensing 
pesticide from a rail car which does not remain at a facility long 
enough to meet the definition of a stationary pesticide container; that 
is, 30 days.


Sec.  165.83  Definition of new and existing structures.

    (a) What is a new containment structure? A new containment 
structure is one whose installation began after November 16, 2006. 
Installation is considered to have begun if:
    (1) You, as the owner or operator, have obtained all Federal, 
State, and local approvals or permits necessary to begin physical 
construction of the containment structure; AND
    (2) You have either begun a continuous on-site physical 
construction or installation program OR you have entered into 
contractual obligations. The contract must be such that it cannot be 
canceled or modified without substantial loss, and must be for the 
physical construction or installation of the containment structure 
within a specific and reasonable time frame.
    (b) What is an existing containment structure? An existing 
containment structure is defined as one whose installation began on or 
before November 16, 2006.


Sec.  165.85  Design and capacity requirements for new structures.

    (a) For all new containment structures, what construction materials 
must I use? These are the material specifications for a new containment 
structure:
    (1) The containment structure must be constructed of steel, 
reinforced concrete or other rigid material capable of withstanding the 
full hydrostatic head, load and impact of any pesticides, 
precipitation, other substances, equipment and appurtenances placed 
within the structure. The structure must be liquid-tight with cracks, 
seams and joints appropriately sealed.
    (2) The structure must not be constructed of natural earthen 
material, unfired clay, or asphalt.
    (3) The containment structure must be made of materials compatible 
with the pesticides stored. In this case, compatible means able to 
withstand anticipated exposure to stored or transferred materials and 
still provide secondary containment of those same or other materials 
within the containment area.
    (b) For all new containment structures, what are the general design 
requirements? These are the general design requirements for new 
containment structures:
    (1) You must protect appurtenances and pesticide containers against 
damage from operating personnel and moving equipment. Means of 
protection include, but are not limited to, supports to prevent 
sagging, flexible connections, the use of guard rails, barriers, and 
protective cages.
    (2) Appurtenances, discharge outlets or gravity drains must not be 
configured through the base or wall of the containment structure, 
except for direct interconnections between adjacent containment 
structures which meet the

[[Page 47435]]

requirements of this subpart. Appurtenances must be configured in such 
a way that spills or leaks are easy to see.
    (3) The containment structure must be constructed with sufficient 
freeboard to contain precipitation and prevent water and other liquids 
from seeping into or flowing onto it from adjacent land or structures.
    (4) Multiple stationary pesticide containers may be protected 
within a single secondary containment unit.
    (c) For new stationary liquid pesticide containment and new 
containment pads in pesticide dispensing areas, what are the capacity 
requirements? These are the capacity requirements:
    (1) New secondary containment units for stationary liquid pesticide 
containers, if protected from precipitation, must have a capacity of at 
least 100 percent of the volume of the largest stationary pesticide 
container plus the volume displaced by other containers and 
appurtenances within the unit.
    (2) New secondary containment units for stationary liquid pesticide 
containers, if exposed to or unprotected from precipitation, must have 
a capacity of at least 110 percent of the volume of the largest 
stationary pesticide container plus the volume displaced by other 
containers and appurtenances within the unit.
    (3) New containment pads in pesticide dispensing areas which have a 
pesticide container or pesticide-holding equipment with a volume of 750 
gallons or greater must have a holding capacity of at least 750 
gallons.
    (4) New containment pads in pesticide dispensing areas which do not 
have a pesticide container or pesticide-holding equipment with a volume 
of at least 750 gallons must have a holding capacity of at least 100 
percent of the volume of the largest pesticide container or pesticide-
holding equipment used on the pad.
    (d) For new stationary liquid pesticide containment, what are the 
specific design requirements? You must either anchor or elevate each 
new stationary liquid pesticide container protected by a secondary 
containment unit to prevent flotation in the event that the secondary 
containment unit fills with liquid.
    (e) For new containment pads in pesticide dispensing areas, what 
are the specific design requirements? Each new containment pad in a 
pesticide dispensing area must:
    (1) Be designed and constructed to intercept leaks and spills of 
pesticides which may occur in the pesticide dispensing area.
    (2) Have enough surface area to extend completely beneath any 
container on it, with the exception of transport vehicles dispensing 
pesticide for sale or distribution to a stationary pesticide container. 
For such vehicles, the surface area of the containment pad must 
accommodate at least the portion of the vehicle where the delivery hose 
or device couples to the vehicle. This exception does not apply to 
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides.
    (3) Allow, in conjunction with its sump, for removal and recovery 
of spilled, leaked, or discharged material and rainfall, such as by a 
manually activated pump. Automatically-activated pumps which lack 
automatic overflow cutoff switches for the receiving container are 
prohibited.
    (4) Have its surface sloped toward an area where liquids can be 
collected for removal, such as a liquid-tight sump or a depression, in 
the case of a single-pour concrete pad.
    (f) For new stationary dry pesticide containment, what are the 
specific design requirements? These are the specific design 
requirements for new stationary dry pesticide containment:
    (1) The stationary dry pesticide containers within the containment 
unit must be protected from wind and precipitation.
    (2) Stationary dry pesticide containers must be placed on pallets 
or a raised concrete platform to prevent the accumulation of water in 
or under the pesticide.
    (3) The stationary dry pesticide container storage area must be 
enclosed by a minimum of a 6-inch high curb that extends at least 2 
feet beyond the perimeter of the container.


Sec.  165.87  Design and capacity requirements for existing structures.

    (a) For all existing containment structures, what construction 
materials must I use? These are the material specifications for an 
existing containment structure:
    (1) The containment structure must be constructed of steel, 
reinforced concrete or other rigid material capable of withstanding the 
full hydrostatic head, load and impact of any pesticides, 
precipitation, other substances, equipment and appurtenances placed 
within the structure. The structure must be liquid-tight with cracks, 
seams and joints appropriately sealed.
    (2) The structure must not be constructed of natural earthen 
material, unfired clay, or asphalt.
    (3) The containment structure must be made of materials compatible 
with the pesticides stored. In this case, compatible means able to 
withstand anticipated exposure to stored or transferred materials and 
still provide secondary containment of those same or other materials 
within the containment area.
    (b) For all existing containment structures, what are the general 
design requirements? These are the general design requirements for 
existing containment structures:
    (1) You must protect appurtenances and pesticide containers against 
damage from operating personnel and moving equipment. Means of 
protection include, but are not limited to, supports to prevent 
sagging, flexible connections, the use of guard rails, barriers, and 
protective cages.
    (2) You must seal all appurtenances, discharge outlets and gravity 
drains through the base or wall of the containment structure, except 
for direct interconnections between adjacent containment structures 
which meet the requirements of this subpart.
    (3) The containment structure must be constructed with sufficient 
freeboard to contain precipitation and prevent water and other liquids 
from seeping into or flowing onto it from adjacent land or structures.
    (4) Multiple stationary pesticide containers may be protected 
within a single secondary containment unit.
    (c) For existing stationary liquid pesticide containment and 
existing containment pads in pesticide dispensing areas, what are the 
capacity requirements? These are the capacity requirements:
    (1) Existing secondary containment units for stationary liquid 
pesticide containers must have a capacity of at least 100 percent of 
the volume of the largest stationary pesticide container plus the 
volume displaced by other containers and appurtenances within the unit.
    (2) Existing containment pads in pesticide dispensing areas which 
have a pesticide container or pesticide-holding equipment with a volume 
of 750 gallons or greater must have a holding capacity of at least 750 
gallons.
    (3) Existing containment pads in pesticide dispensing areas which 
do not have a pesticide container or pesticide-holding equipment with a 
volume of at least 750 gallons must have a holding capacity of at least 
100 percent of the volume of the largest pesticide container or 
pesticide-holding equipment used on the pad.
    (d) For existing stationary liquid pesticide containment, what are 
the specific design requirements? You must either anchor or elevate 
each existing

[[Page 47436]]

stationary liquid pesticide container protected by a secondary 
containment unit to prevent flotation in the event that the secondary 
containment unit fills with liquid.
    (e) For existing containment pads in pesticide dispensing areas, 
what are the specific design requirements? Each existing containment 
pad in a pesticide dispensing area must:
    (1) Be designed and constructed to intercept leaks and spills of 
pesticides which may occur in the pesticide dispensing area.
    (2) Have enough surface area to extend completely beneath any 
container on it, with the exception of transport vehicles dispensing 
pesticide for sale or distribution to a stationary pesticide container. 
For such vehicles, the surface area of the containment pad must 
accommodate at least the portion of the vehicle where the delivery hose 
or device couples to the vehicle. This exception does not apply to 
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides.
    (3) Allow, in conjunction with its sump, for removal and recovery 
of spilled, leaked, or discharged material and rainfall, such as by a 
manually activated pump. Automatically-activated pumps which lack 
automatic overflow cutoff switches for the receiving container are 
prohibited.
    (f) For existing stationary dry pesticide containment, what are the 
specific design requirements? These are the specific design 
requirements for existing stationary dry pesticide containment:
    (1) The stationary dry pesticide containers within the containment 
unit must be protected from wind and precipitation.
    (2) Stationary dry pesticide containers must be placed on pallets 
or a raised concrete platform to prevent the accumulation of water in 
or under the pesticide.
    (3) The stationary dry pesticide container storage area must be 
enclosed by a minimum of a 6-inch high curb that extends at least 2 
feet beyond the perimeter of the container.


Sec.  165.90  Operational, inspection and maintenance requirements for 
all new and existing containment structures.

    (a) What are the operating procedures required for all new and 
existing containment structures? As the owner or operator of a new or 
existing pesticide containment structure, you must:
    (1) Manage the structure in a manner that prevents pesticides or 
materials containing pesticides from escaping from the containment 
structure (including, but not limited to, pesticide residues washed off 
the containment structure by rainfall or cleaning liquids used within 
the structure.)
    (2) Ensure that pesticide spills and leaks on or in any containment 
structure are collected and recovered in a manner that ensures 
protection of human health and the environment (including surface water 
and ground water) and maximum practicable recovery of the pesticide 
spilled or leaked. Cleanup must occur no later than the end of each day 
on which pesticides have been spilled or leaked.
    (3) Ensure that all materials resulting from spills and leaks and 
any materials containing pesticide residue are managed according to 
label instructions and applicable Federal, State and local laws and 
regulations.
    (4) Ensure that transfers of pesticides between containers, or 
between containers and transport vehicles are attended at all times.
    (5) Ensure that each lockable valve on a stationary pesticide 
container, if it is required by Sec.  165.45(f), is closed and locked 
whenever the facility is unattended.
    (b) What are the inspection and maintenance requirements for all 
new and existing containment structures? As owner or operator of a new 
or existing pesticide containment structure, you must:
    (1) Inspect each stationary pesticide container and its 
appurtenances at least monthly during periods when pesticides are being 
stored or dispensed on the containment structure. Your inspection must 
look for visible signs of wetting, discoloration, blistering, bulging, 
corrosion, cracks or other signs of damage or leakage.
    (2) Immediately repair any areas showing visible signs of damage 
and seal any cracks and gaps in the containment structure or 
appurtenances with material compatible with the pesticide being stored 
or dispensed.
    (3) Not store any pesticide on a containment structure if the 
structure fails to meet the requirements of this subpart until suitable 
repairs have been made. Prompt removal of pesticides, including 
emptying of stationary pesticide containers, in order to effect repairs 
or recovery of spilled material is acceptable.


Sec.  165.92  What if I need both a containment pad and a secondary 
containment unit?

    You may combine containment pads and secondary containment units as 
an integrated system provided the requirements set out in this subpart 
for containment pads and secondary containment units in Sec. Sec.  
165.85(a) and (b), 165.87(a) and (b) and Sec.  165.90, and as 
applicable, Sec. Sec.  165.85(c)-(f) and 165.87(c)-(f) are satisfied 
separately.


Sec.  165.95  What recordkeeping do I have to do as a facility owner or 
operator?

    As a facility owner or operator subject to the requirements of this 
subpart, you must maintain the following records, and you must furnish 
these records for inspection and copying upon request by an employee of 
EPA or any entity designated by EPA, such as a State, another political 
subdivision or a Tribe:
    (a) Records of inspection and maintenance for each containment 
structure and for each stationary pesticide container and its 
appurtenances must be kept for 3 years and must include the following 
information:
    (1) Name of the person conducting the inspection or maintenance;
    (2) Date the inspection or maintenance was conducted;
    (3) Conditions noted;
    (4) Specific maintenance performed.
    (b) Records for any non-stationary pesticide container designed to 
hold undivided quantities of agricultural pesticides equal to or 
greater than 500 gallons (1,890 liters) of liquid pesticide or equal to 
or greater than 4,000 pounds (1,818 kilograms) of dry pesticide that 
holds pesticide but is not protected by a secondary containment unit 
meeting these regulations must be kept for 3 years. Records on these 
non-stationary pesticide containers must include the time period that 
the container remains at the same location.
    (c) Records of the construction date of the containment structure 
must be kept for as long as the pesticide containment structure is in 
use, and for 3 years afterwards.


Sec.  165.97  States with existing containment programs.

    (a) What options are available to States that already have 
containment regulations? States that have promulgated containment 
regulations effective prior to August 16, 2006, and which also have 
primary enforcement responsibility and/or certification programs, have 
the option of continuing to implement their own programs in lieu of 
these Federal regulations.
    (b) How may a State request authority to continue implementing its 
State containment regulations? A State with pesticide containment 
regulations may request the authority to continue implementing State 
containment regulations by August 16, 2007 in the following manner:
    (1) The State must submit a letter and any supporting documentation 
to EPA.

[[Page 47437]]

 Supporting documentation must demonstrate that the States program is 
providing environmental protection equivalent to or more protective 
than that expected to be provided by the Federal regulations in this 
subpart.
    (2) The State must identify any significant changes to State 
regulations which would be necessary in order to provide environmental 
protection equivalent to the EPA regulations, and develop an estimated 
timetable to effect these changes. The letter must be signed by the 
designated State Lead Agency.
    (c) How will EPA notify the State if its request is granted? EPA's 
Office of Pesticide Programs will review the State's correspondence and 
determine whether the State program is adequate to provide 
environmental protection equivalent to or more protective than these 
Federal regulations for new and existing containment structures. EPA's 
Office of Pesticide Programs will inform the State of its determination 
through a letter authorizing or declining to authorize the State to 
continue implementing its containment regulations and will detail any 
reasons for declining authorization.
    (d) How must a State inform EPA of revisions to its containment 
regulations? Any state that has received authorization to continue 
implementing its state containment regulations must inform EPA by 
letter signed by the designated State Lead Agency within 6 months of 
any revision to the State's containment regulations. EPA will inform 
the state by letter if it determines that the State's containment 
regulations are no longer adequate based on the revisions. The State's 
containment regulations will remain in effect, unless and until EPA 
sends the state a letter making this determination.

[FR Doc. 06-6856 Filed 8-15-06; 8:45 am]
BILLING CODE 6560-50-S


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