[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Rules and Regulations]
[Page 47329-47437]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au06-25]
[[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
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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: fitz.nancy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a
pesticide formulator, agrichemical dealer, or an independent commercial
applicator. Potentially affected categories and entities may include,
but are not limited to:
Pesticide formulators (NAICS 35232, former SIC code 2879),
e.g., establishments that formulate and prepare insecticides,
fungicides, herbicides or other pesticides from technical chemicals or
concentrates produced by pesticide manufacturing establishments. Some
formulating establishments are owned by the large basic pesticide
producers and others are independent.
Agrichemical dealers (NAICS 44422, former SIC code 5191),
e.g., retail dealers that distribute or sell pesticides to agricultural
users.
Independent commercial applicators (NAICS 115112, former
SIC code 0721), e.g., businesses that apply pesticides for compensation
(by aerial and/or ground application) and that are not affiliated with
agrichemical dealers.
Custom blenders (NAICS 44422, former SIC code 5191), e.g.,
most custom blenders are also dealers.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Units II.D., III.,
V.B., VI.C., VII.B., VIII.C. and IX.A. of this document. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov,
you may access this Federal Register document electronically through
the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr/.
You may also access a frequently updated
electronic version of the Code of Federal Regulations (CFR) through the
Government Printing Offices pilot e-CFR site at http://www.gpoaccess.gov/ecfr/
.
II. Background
A. Statutory Authority
These final regulations are issued pursuant to the authority given
the Administrator of EPA in sections 3, 8, 19 and 25 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a,
136f, 136q and 136w.
Sections 19(e) and (f) of FIFRA grant EPA broad authority to
establish standards and procedures to assure the safe use, reuse,
storage, and disposal of pesticide containers. FIFRA section 19(e)
requires EPA to promulgate regulations for the design of pesticide
containers that will promote the safe storage and disposal of
pesticides. The regulations must ensure, to the fullest extent
practicable, that the containers:
(1) Accommodate procedures used for removal of pesticides from the
containers and rinsing of the containers.
(2) Facilitate safe use of the containers, including elimination of
splash and leakage.
(3) Facilitate safe disposal of the containers.
(4) Facilitate safe refill and reuse of the containers.
FIFRA section 19(f) requires EPA to promulgate regulations
prescribing procedures and standards for the removal of pesticides from
containers prior to disposal. The statute states that the regulations
may:
(1) Specify, for each major type of pesticide container, procedures
and standards for, at a minimum, triple rinsing or the equivalent
degree of pesticide removal.
(2) Specify procedures that can be implemented promptly and easily
in various circumstances and conditions.
[[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
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supported by only a portion of the pesticide industry.
EPA has an interest in promoting recycling to minimize the use of
less environmentally-sound methods of disposing of these containers,
such as by landfill or burning, and to reduce the amount of solid waste
produced annually. After considering and evaluating a number of
alternatives to sustain and increase the current level of container
recycling, EPA has initiated development of proposed regulations for
the recycling of plastic pesticide containers to ensure equitable,
safe, effective and robust implementation of recycling programs. We are
exploring a range of regulatory options for requiring participation in
pesticide recycling programs and we will work with stakeholders to
evaluate and pursue the most efficacious of these approaches.
D. Summary of the Final Rule
The Container and Containment Rule is composed of the following
five specific sets of requirements or standards:
Nonrefillable containers (container design and residue
removal);
Refillable containers (container design and residue
removal);
Repackaging pesticide products;
Containment structures; and
Container labeling.
Table 1 provides a brief overview of each portion of today's final
rule. For each section of the regulations, the table identifies the
types of businesses that must comply, the major requirements and the
compliance date. The regulations, along with a summary of comments on
major issues and comments that led to changes to the final regulations
and EPA's responses, are discussed in later units of this preamble. EPA
has also prepared a Response to Comment document that provides
additional details with regard to the comments and EPA's responses
(Ref. 19).
Each portion of the regulations applies to a different subset of
pesticide products. The criteria that define which pesticide products
are subject to which regulations (and which ones are exempt from them)
are relatively complex, but some key points are:
The new label standards apply to all pesticide products.
The containment regulations apply to agricultural
pesticides only.
The nonrefillable container, refillable container and
repackaging regulations apply to the same subset of pesticide products.
These products are described in Table 2 below.
For the refillable container and repackaging regulations,
antimicrobial products that are used only in swimming pools (and
closely related sites like hot tubs, spas and/or whirl pools) are
subject to a reduced set of the requirements.
For the nonrefillable container regulations, some products
are subject to all of the regulations, while others must comply only
with the basic Department of Transportation packaging requirements in
49 CFR 173.24.
Table 1.--Overview of the Pesticide Container and Containment Structure Regulations
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Nonrefillable Repackaging Pesticide Containment
Category Containers Refillable Containers Products Container Labeling Structures
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Who must comply Registrants Registrants Registrants Registrants Ag retailers
Refillers (retailers, Refillers (retailers, Pesticide users (must Ag commercial
distributors). distributors). follow new applicators
directions). Ag custom blenders
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Major Requirements DOT container design, DOT container design, Registrants develop Identify container Secondary containment
construction and construction and information as nonrefillable or structures (dikes)
marking standards marking standards Registrants and refillable (all) around stationary
Container dispensing Serial number marking. others comply with Statements to tanks
capability. One-way valves or specified conditions. prohibit reuse and Containment pads for
Standardized closures. tamper-evident Refillers offer for recycling; pesticide dispensing
Residue removal....... devices. (registrants and batch code (all areas
Recordkeeping......... Stationary container others) obtain and nonrefillables). Good operating
requirements. follow registrant Cleaning instructions procedures
information, and (some Monthly inspections
clean, inspect and nonrefillables). of tanks and
label containers Cleaning instructions structures
before refilling before final Recordkeeping
them. disposal (all Provisions for States
refillables). with existing
programs
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Compliance Date August 17, 2009 August 16, 2011 August 16, 2011 August 17, 2009 August 17, 2009
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Table 2.--Products that are Subject to the Nonrefillable Container, Refillable Container and Repackaging
Regulations
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Nonrefillable Repackaging Pesticide
Category Containers Refillable Containers Products
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Products that are not subject to the (1) Manufacturing use (1) Manufacturing use (1) Manufacturing use
regulations. products, products, products,
(2) Plant-incorporated (2) Plant-incorporated (2) Plant-incorporated
protectants, and. protectants, and. protectants, and
(3) Antimicrobial (3) Antimicrobial (3) Antimicrobial
pesticide products pesticide products pesticide products
that satisfy all four that satisfy all four that satisfy all four
of these criteria:. of the criteria listed of the criteria listed
The product is an in the nonrefillable in the nonrefillable
antimicrobial container column.. container column.
pesticide (as defined
in FIFRA section
2(mm)) or it has
antimicrobial
properties (as defined
in FIFRA section
2(mm)(1)(A)) and is
subject to a tolerance
or a food additive
regulation..
Its label includes
directions for use on
a site in at least one
of the 10
antimicrobial product
use categories
identified as
household, industrial
or institutional..
It is not a hazardous
waste when it is
intended to be
disposed, as defined
in 40 CFR part 261..
EPA has not
specifically found
that the product must
be subject to these
provisions to prevent
an unreasonable
adverse effect on the
environment..
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Products that are subject to the A product is subject to All products not listed All products not listed
regulations ALL nonrefillable above. above.
container requirements
if it satisfies at
least one of the
following criteria:
It meets the criteria
of Toxicity Category I
in 40 CFR 156.62..
It meets the criteria
of Toxicity Category
II in 40 CFR 156.62..
It is a restricted use
product..
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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.
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Therefore, we had to reorganize and renumber the regulations to
accommodate the increased number of separate sections. The changes are
shown in Table 3.
Some sections of today's regulation are presented in the
traditional language or format because these sections are amending or
changing existing regulations. The plain language format was not used
in these existing provisions in an attempt to avoid any possible
confusion or disruption in the flow of the regulations.
Table 3.--Comparison of Proposed Rule and Final Rule Section Numbers
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Format in Proposed Rule Format in Final Rule
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Subpart Section Numbers Subpart Section Numbers
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Part 156
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Subpart H: Container Labeling Sec. Sec. 156.140 - Subpart H: Container Sec. Sec. 156.140 -
156.144 Labeling 156.159
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Part 165
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Subpart A: General Sec. Sec. 165.1 - Subpart A: General Sec. Sec. 165.1 -
165.16 165.3
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Subpart B Reserved Subpart B: Sec. Sec. 165.20 -
Nonrefillable 165.27
Containers
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Subpart C Reserved Subpart C: Refillable Sec. Sec. 165.40 -
Containers. 165.47
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Subpart D Reserved Subpart D: Repackaging. Sec. Sec. 165.60 -
165.70
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Subpart E Reserved Subpart E: Containment Sec. Sec. 165.80 -
Structures. 165.97
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Subpart F: Nonrefillable Containers Sec. Sec. 165.100 - Subpart F Reserved
165.119
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Subpart G: Refillable Containers Sec. Sec. 165.120 - Subpart G.............. Reserved
165.139
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Subpart H: Containment Structures Sec. Sec. 165.140 - Subpart H.............. Reserved
165.157
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2. Reorganization of the rule. In the final rule, we split the
refillable container standards and the repackaging standards into two
separate subparts to reinforce and clarify the differences between
these requirements. The refillable container regulations are mostly
technical and apply mostly to pesticide registrants. On the other hand,
the repackaging requirements are mostly procedural and apply to
registrants and refillers (who could be registrants, distributors or
retailers). EPA believes that separating these regulations into
different subparts will better illustrate the differences and make it
easier for the regulated parties to understand.
3. Scope of products subject to container-related regulations. In
the February 1994 NPRM, EPA proposed that the container standards would
generally apply to all pesticides and all containers except for
manufacturing use products (MUPs). The 1999 supplemental notice
proposed several options for exempting specific subsets of products
from the container standards. Today's final rule exempts MUPs, plant-
incorporated protectants and certain antimicrobial products from the
nonrefillable container, refillable container and repackaging
regulations. All other products are subject to the container-related
regulations, although the number of applicable standards is greatly
reduced for some products. These changes apply only to the container-
related sections of the rule. As we proposed, all pesticide products
are subject to the container labeling requirements in today's final
rule and only agricultural pesticide products are subject to the
containment requirements.
4. Exemption from container-related regulations for certain
antimicrobial products. The FQPA amended section 19 of FIFRA to exempt
certain types of antimicrobial pesticides from the pesticide container
provisions. The amendment exempted household, industrial, or
institutional antimicrobial products which are not subject to the Solid
Waste Disposal Act (SWDA) from the container regulations unless the EPA
Administrator determines that the product causes an unreasonable
adverse effect on the environment. Because the definition of an
antimicrobial product is complex, the phrase ``subject to the SWDA'' is
unclear and ``unreasonable adverse effects on the environment'' from
pesticide containers need to be clarified, EPA conducted many analyses
based on the comments received. According to today's final rule, an
antimicrobial product is exempt from the container standards if meets
all four of the following criteria:
The product is an antimicrobial pesticide as defined in
FIFRA section 2(mm) or it has antimicrobial properties (as defined in
FIFRA section 2(mm)(1)(A)) and is subject to a tolerance or a food
additive regulation.
The product includes directions for use on a site in one
of the antimicrobial product use categories identified as household,
industrial or institutional.
The product is not a hazardous waste when it is intended
to be disposed.
EPA has not specifically determined that the product must
be subject to the container regulations to prevent an unreasonable
adverse effect on the environment.
In addition, antimicrobial products that would not otherwise be exempt
from the regulations and that are used only in swimming pools (and
closely related sites like hot tubs, spas and/or whirl pools) are
subject to a reduced set of the refillable container and repackaging
requirements.
5. Scope of container-related regulations for products other than
antimicrobial products. As proposed in 1994, MUPs are exempt from the
[[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:
Toxicity Category I;
Toxicity Category II;
Restricted use pesticide.
Products that do not meet at least one of these criteria (i.e.,
products that are classified in Toxicity Category III or IV and that
are not restricted use pesticides) are excluded from all of the
nonrefillable container standards except the basic DOT requirements.
In general, products other than MUPs, plant-incorporated
protectants and exempt antimicrobial products are subject to all of the
refillable container and repackaging regulations. One exception is that
antimicrobial products that are used only in swimming pools and closely
related sites are subject to a reduced set of the refillable container
and repackaging requirements.
6. Referring to and adopting some Department of Transportation
regulations. In the 1994 proposed rule, EPA clarified that compliance
with EPA's container regulations would not exempt registrants from
complying with applicable DOT Hazardous Materials Regulations, and that
compliance with DOT's marking and drop test requirements would satisfy
the corresponding EPA requirement for refillable containers. Also, the
preamble of the proposed rule requested comment on several options for
determining who would be responsible for ensuring that containers meet
the standards. In the 1999 supplemental notice, we discussed the
comments on the proposal and discussed a new approach, namely to adopt
and refer to the DOT Packing Group III criteria for both nonrefillable
and refillable containers. Today's final rule includes the same basic
approach as described in the supplemental notice. Specifically:
Pesticide products that are DOT hazardous materials must
be packaged as required by DOT.
Pesticide products that are not DOT hazardous materials
must be packaged in containers that are designed, constructed, and
marked to comply with the cross-referenced and adopted requirements of
DOT regulations, as applicable to a Packing Group III material or the
limited quantity/consumer commodity exception.
All pesticide products must comply with the pesticide-
specific requirements in the nonrefillable and refillable container
regulations.
EPA may modify or waive these requirements under certain,
limited conditions.
If DOT proposes to change any of the regulations that are
incorporated by these regulations, EPA will provide notice to the
public in the Federal Register.
7. Residue removal standard for nonrefillable containers. The 1994
NPRM required that registrants demonstrate at least 99.9999 (six 9's)
percent residue removal using a prescribed testing methodology for
dilutable products in rigid containers. Testing would have been
required on 19 representative samples in accordance with Good
Laboratory Practice (GLP) standards in 40 CFR part 160. We received
many comments opposing virtually every aspect of this proposed
requirement. Today's final rule requires rigid containers of dilutable
liquid formulations to be capable of achieving at least 99.99 percent
(four 9's) residue removal using a defined laboratory triple rinse
method conducted on three representative containers. In addition,
testing and recordkeeping is only required for flowable concentrate
formulations or if EPA requests the tests on a case-by-case basis.
8. Consistency with existing State containment regulations. At
least 19 States have already promulgated and implemented State bulk
containment regulations. EPA's proposed rule included basic standards
generally similar to State standards, although some were more rigorous
and others less stringent than certain State standards. Today's
containment standards are intended to introduce substantial safeguards
in States that currently lack containment regulations and to harmonize
with containment requirements in States where adequate containment
safety programs already exist. While EPA believes a national standard
must provide substantial environmental protection, a mechanism is being
provided to accommodate States that have successfully implemented bulk
containment programs.
9. Hydraulic conductivity standard for containment structures. The
proposed rule would have required that existing and new structures
demonstrate compliance with a hydraulic conductivity standard of 1 x
10-6 cm/sec and 1 x 10-7 cm/sec, respectively.
EPA received many comments opposed to the hydraulic conductivity
standard which was perceived to be too restrictive, not achievable and
too costly. The requirement for a numeric hydraulic conductivity
standard was dropped from the final rule, but all existing and new
structures are required to be liquid-tight, with cracks and seams
sealed.
10. Scope of products subject to label regulations. The final
labeling regulations in today's rule cover the same statements and
topics that were included in the proposed rule. Unlike the container-
related regulations, all products must comply with the container
labeling requirements -- the labeling regulations do not exempt MUPs or
certain antimicrobial products. One exception is that plant-
incorporated protectant container-related labeling instructions will be
determined by EPA on a case-by-case basis until specific labeling
guidance for plant-incorporated protectants are promulgated under 40
CFR part 174.
While today's label requirements generally apply to all pesticide
products, the specific label requirements apply to different groups of
products and containers. In particular:
A statement identifying a container as nonrefillable or
refillable is required on the labels of all products and all
containers.
Statements to prohibit reuse and offer for recycling and a
batch code are required on the labels or container of all products
distributed or sold in nonrefillable containers.
Rinsing instructions are required on the labels of some
products distributed or sold in nonrefillable containers. Specifically,
the requirement for rinsing instructions applies to dilutable products
in rigid nonrefillable containers. Residential/household use pesticide
products are exempt from this requirement.
Instructions for cleaning before final disposal (not
before refilling) are required on the labels of all products
distributed or sold in refillable containers.
III. Container Regulations--Scope
The purpose of Unit III. is to describe the scope of the container-
related regulations, including the standards for nonrefillable
containers in 40 CFR part 165, subpart B, refillable containers in
subpart C and repackaging pesticide products in subpart D. The
regulations themselves are discussed in more detail in Units V., VI.
and VII. for nonrefillable containers, refillable containers and
repackaging, respectively. Unit IV. discusses the relationship between
[[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:
What is the scope of household, industrial, or
institutional antimicrobial products that are not subject to regulation
under the Solid Waste Disposal Act?
Which products must be subject to the container provisions
to prevent an unreasonable adverse effect on the environment?
Based on comments on the proposed rule and supplemental notice and
on several additional analyses, EPA is making a number of changes in
the approach for regulating antimicrobial products in the final
regulations. The approach in the final rule is briefly described here
and the details are provided in the issue-by-issue sections below.
All four of the following criteria must be met for a
product to be exempt from the container regulations:
(1) The product is an antimicrobial pesticide as defined in FIFRA
section 2(mm) or it has antimicrobial properties (as defined in FIFRA
section 2(mm)(1)(A)) and is subject to a tolerance or a food additive
regulation.
(2) The product includes directions for use on a site in one of the
[[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.
EPA will determine which products must be subject to the
container provisions to prevent an unreasonable adverse effect on the
environment on a case-by-case basis as described in the regulations.
The final rule exempts refillable containers used to
distribute antimicrobials used in swimming pools (and that are subject
to the regulations because they do not meet all of the exemption
criteria) from some of the refillable container and repackaging
standards (including, but not limited to, serial number markings, one-
way valves or tamper-evident devices, and some recordkeeping).
The four criteria that identify which antimicrobial products are
exempt from the container regulations are discussed in greater detail
in Units III.C.1. - III.C.4. The other aspects of the approach toward
regulating antimicrobials are discussed in Units III.D. - III.F.
Throughout the preamble, the term ``antimicrobial'' is intended to
be interpreted broadly with the property of destroying or inhibiting
the growth of microorganisms (and as identified in FIFRA section
2(mm)(1)(A)) unless specified otherwise. In other words, we specify
``FIFRA 2(mm) antimicrobial pesticides'' if we are referring to the
more limited definition of antimicrobial pesticides in FIFRA section
2(mm).
1. Exemption criteria: definition of an antimicrobial pesticide--i.
Final regulations. The first of the four criteria that must be met for
an antimicrobial product to be exempt from the container regulations
is:
The pesticide product meets one of the following two criteria:
(1) The pesticide product is an antimicrobial pesticide as defined
in FIFRA section 2(mm); or
(2) The pesticide product:
(i) Is intended to: disinfect, sanitize, reduce or mitigate growth
or development of microbiological organisms; or protect inanimate
objects, industrial processes or systems, surfaces, water, or other
chemical substances from contamination, fouling, or deterioration
caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(ii) In the intended use is subject to a tolerance under section
408 of the Federal Food, Drug, and Cosmetic Act or a food additive
regulation under section 409 of such Act.
ii. Changes. In the supplemental notice, this criterion was limited
to ``The product meets the definition of an antimicrobial pesticide in
FIFRA section 2(mm).'' EPA continues to believe that the most
straightforward approach for defining antimicrobial products is to use
the FIFRA definition of antimicrobial pesticide. The second criterion
was added because, after thorough analysis of the definition of
antimicrobial pesticide, EPA believes that some pesticides that are
excluded from the definition should be eligible for exemption from the
container regulations. Specifically, FIFRA section 2(mm)(1)(B)
explicitly excludes pesticides with antimicrobial properties as
identified in section 2(mm)(1)(A) from being FIFRA section 2(mm)
antimicrobial pesticides if they are subject to a tolerance or a food
additive regulation in their intended use. EPA believes that these
pesticides should be eligible for exemption from the container
regulations along with pesticides that are FIFRA section 2(mm)-defined
antimicrobial pesticides.
Although there is no official legislative history documenting the
intent of the definition of antimicrobial pesticide in FQPA, EPA
acknowledges that FQPA also established time periods in FIFRA section 3
for registration review and action for various kinds of antimicrobial
pesticides. EPA believes it is reasonable to conclude that pesticides
subject to a tolerance or food additive regulation were excluded from
the FIFRA section 2(mm) definition of antimicrobial pesticide at least
partly because these pesticides require more data and analysis than
other antimicrobial pesticides and, therefore, should not be subject to
the registration time periods established in FIFRA section 3.
More importantly, EPA believes that the containers of pesticides
with antimicrobial properties that are subject to a tolerance or food
additive regulation generally pose a limited risk to human health and
the environment. If either EPA or the Food and Drug Administration
(FDA) determine that a pesticide with antimicrobial properties can be
safely used on food or on food contact surfaces, the containers holding
these pesticides are unlikely to pose a significant risk or even a risk
greater than the pesticides that are FIFRA 2(mm) antimicrobial
pesticides. EPA believes that these pesticides should also be eligible
for exemption from the pesticide container regulations and that
exempting these pesticides should not significantly increase the risk
posed by containers of these pesticides. Therefore, it is very unlikely
that such an exemption would pose an unreasonable adverse effect on the
environment. We believe the provisions of FIFRA sections 19 and 25
authorize such an exemption.
While EPA is identifying pesticides with antimicrobial properties
that are subject to a tolerance or food additive regulation as being
eligible for exemption from the container regulations, they are not
automatically exempt. Pesticides with antimicrobial properties that are
subject to a tolerance or food additive regulation must also meet the
other criteria identified by Congress in the FIFRA section 19(h)
language: (1) It is a household, industrial or institutional product;
(2) it is not a hazardous waste when disposed; and (3) EPA has not
determined it must be subject to the regulations to prevent an
unreasonable adverse effect. While EPA believes it is reasonable to
make pesticides with antimicrobial properties that are subject to a
tolerance or food additive regulation eligible for exemption from the
pesticide container regulations, we see no reason that these pesticides
shouldn't be subject to the other criteria that Congress established
for antimicrobial pesticides.
EPA is not implementing similar exemption provisions for the other
pesticide types excluded from the definition of antimicrobial pesticide
in FIFRA section 2(mm), which include:
Wood preservatives with claims for pests other than micro-
organisms;
Antifouling paint products with claims for pesticides
other than micro-organisms;
Agricultural fungicide products; and
Aquatic herbicide products.
EPA does not believe that the pesticides in this list generally
pose a limited risk to human health and the environment, as is the case
with pesticides with antimicrobial properties that are subject to a
tolerance or food additive regulation. EPA analyzed one of its
pesticide data bases (Reference File System or REFS) and identified the
wood preservative and antifouling paint products that claim to control
pests other than micro-organisms. Many of the wood preservative
products that claim to control pests other than micro-organisms also
would be hazardous wastes when they are disposed and many of these are
also restricted use products, such as those containing arsenic acid,
arsenic pentoxide, chromic
[[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:
The pesticide product is intended to: disinfect, sanitize,
reduce or mitigate growth or development of microbiological organisms;
or protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from contamination,
fouling, or deterioration caused by bacteria, viruses, fungi, protozoa,
algae, or slime.
The labeling of the pesticide product includes directions
for use only on a site or sites in the antimicrobial product use
category of swimming pools.
Antimicrobial swimming pool products that are not exempt must
comply with all of the refillable container regulations in subpart C
except for:
Sec. 165.45(d) regarding marking; and
Sec. 165.45(e) regarding openings.
Antimicrobial swimming pool products that are not exempt must
comply with all of the repackaging regulations in subpart D except for
the following requirements:
[[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:
Option 1: Exempt all eligible antimicrobials, but include
a provision to require a specific product or group of products to
comply with the container regulations if a problem becomes evident.
Option 2: Subject eligible antimicrobials classified in
Toxicity Category I to all of the container regulations.
Option 3: Subject eligible antimicrobials classified in
Toxicity
[[Page 47340]]
Category I to a subset of the container regulations.
Option 4: Apply the scope criteria being considered for
other pesticides to eligible antimicrobials.
3. Comments. Two state agencies supported EPA's approach in the
supplemental notice (Option 3). Eighteen commenters, representing the
antimicrobial and/or the swimming pool/spa industries, strongly opposed
EPA's approach, and most supported Option 1. An agricultural registrant
stated that the language in section 19(h) is not a blanket exemption,
and that focusing on only Toxicity Category I (as opposed to Toxicity
Categories I and II in the applicability for all other products) is
unfair and inconsistent.
Many commenters opposed EPA's approach and supported Option 1,
either by specifically identifying it as the option EPA should adopt or
by describing and supporting an approach that is consistent with Option
1. These commenters supported their positions with the following
claims:
i. Statutory intent. Some commenters stated that only Option 1 is
consistent with the statutory language. Several respondents
specifically disagreed with EPA's general criteria approach, saying it
was unnecessary, inappropriate and inconsistent with the statutory
language.
ii. Congress's intent. Similarly, many commenters stated that only
Option 1 is consistent with Congress's intent. The commenters generally
argued that Congress's clear intent was to exempt nearly all eligible
antimicrobials. One commenter referred to testimony received and
comments made at various committee hearings to support its
interpretation of the congressional intent. Several commenters stated
that EPA's approach is contrary to the position of EPA negotiators
during pre-FQPA discussions, which was that the provision constituted
essentially a complete exemption.
iii. No information about unreasonable adverse effects. Many
respondents pointed out that EPA does not have concrete information,
such as documented incidents, of unreasonable adverse effects (UAEs)
caused by antimicrobial pesticides. In addition, several pool supply
companies said that there are no reports of accidents with refillable
containers used for pool chemicals and mentioned that they have used
these containers safely for many years and for large volumes of sodium
hypochlorite.
iv. Standard of unreasonable adverse effect on the environment.
Several commenters stated that the process of registration is intended
to ensure that the pesticide will not cause an UAE, and therefore all
registered products, including those in Toxicity Category I, have been
determined to meet a standard of no UAE. These commenters further
argued that information on specific exposures, leakage or other
problems is needed to overturn the registration decision of no UAE and
to determine that an UAE must be prevented. Another respondent
commented that Congress didn't provide additional insight into what
constitutes an UAE in the context of section 19, so it must have the
same meaning as in the FIFRA registration standard in section 3(c)(5)
and the obligation to report information on UAE in section 6(a)(2).
v. FIFRA section 6(a)(2) reporting. Several commenters stated that
the section 6(a)(2) obligation for registrants to submit factual
information regarding UAE to EPA provides an adequate mechanism for EPA
to identify UAEs caused by antimicrobials eligible for exemption. A few
of these respondents pointed out that the UAE standard in section
6(a)(2) is exactly the same as the standard in section 19(h)(2).
vi. Minimal threat to the environment. Several commenters
specifically addressed sodium hypochlorite and commented that it is not
a threat to the environment because: it has a short half life; it's
final fate is sodium chloride (table salt); it is used widely without
evidence that it is problematic; it's only in Toxicity Category I for
eye effects, unlike the toxic and persistent agricultural pesticides;
it's an inorganic chemical; the institutional/industrial formulation is
only slightly more concentrated than common household bleach; it's less
toxic than many automotive and household chemicals; and the resultant
liquid from hosing down a spill is indistinguishable from drinking
water. An industry association argued that many of these claims apply
to institutional and industrial sanitizers and disinfectants in
general.
vii. No need for additional regulations. Several commenters stated
that there is no need for EPA to regulate institutional and industrial
disinfectants because these products are already adequately regulated
by EPA waste regulations, DOT's packaging requirements, and OSHA's
health and safety standards. One commenter stated that most
manufacturers and formulators of antimicrobial products use containers
that meet at least the DOT Packing Group III standards for all
materials, because it's not feasible to use certain containers for DOT
hazardous materials and other containers for products that aren't DOT
hazardous materials.
4. EPA response. EPA has decided to change its approach for
determining which antimicrobial products that are eligible for
exemption must be subject to the container regulations to prevent an
unreasonable adverse effect. The final rule will implement Option 1
rather than Option 3.
EPA believes that Option 1 is acceptable because it is a
legitimate, reasonable interpretation of the statutory language. In
addition, making determinations for subjecting products to the
container regulations based on specific information, data or other
evidence of a problem to prevent unreasonable adverse effects on the
environment is more straightforward than making such a determination
based on arguments supporting the fact that there could be unreasonable
effects.
In changing the approach to Option 1, EPA was partly convinced by
the comments and observations relating to the standard of unreasonable
adverse effect. The process of registration (including the submission
and review of data plus establishing label restrictions) is intended to
ensure that the pesticide will not cause UAEs on the environment. In
other words, all registered products have been determined to meet a
standard of not causing UAEs on the environment. This determination can
be re-visited and changed by EPA if UAEs are identified during the
process of reregistration or other review, under the ongoing mechanisms
of FIFRA section 6(a)(2) (as implemented by 40 CFR part 159) or when
other relevant information is received by EPA.
If all eligible Toxicity Category I antimicrobial products needed
to be subject to the container regulations to prevent UAEs on the
environment (according to options 2 and 3 in the supplemental notice),
then currently we should be seeing UAEs from the containers of these
products. This is especially true given the relatively large quantities
of antimicrobial pesticides used annually. As described in the
supplemental notice, in 1995 approximately 3,290 million pounds of
antimicrobial active ingredients were used in the United States,
compared to 1,222 million pounds of non-antimicrobial active
ingredients.
However, EPA is unaware of a substantial number of UAEs resulting
from the containers of antimicrobial pesticides. Data from the
California Pesticide Illness Surveillance Program indicate only a
limited number of cases where exposure to antimicrobial pesticides was
very likely to be prevented if the container regulations had been in
place. (Ref.22) Given the
[[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:
EPA obtains information, data or other evidence of a
problem with the containers of a certain pesticide product or related
group of products.
The information, data or other evidence is reliable and
factual.
The problem causes or could reasonably be expected to
cause an unreasonable adverse effect on the environment.
Complying with the container regulations could reasonably
be expected to eliminate the problem.
The process in the final rule for making these determinations is
based on the regulations in 40 CFR 152.164 for classifying products as
restricted use pesticides. If EPA determines that an antimicrobial
pesticide product that would otherwise be exempt must be subject to the
container regulations to prevent an unreasonable adverse effect on the
environment, EPA may:
Require, by rule, that the product be repackaged (if
applicable) and distributed or sold in containers that comply with all
or some of the requirements in these regulations; or
Notify the applicant or registrant of EPA's intent to make
such a determination. After allowing the applicant or registrant a
reasonable amount of time to reply, EPA may require, by notification
and as a condition of registration, that the product be repackaged (if
applicable) and distributed or sold in containers that comply with all
or some of the requirements in these regulations.
For the purposes of notification, 60 days would be a reasonable amount
of time to reply, although EPA may, in its discretion, provide more
time. This process allows EPA to apply all of the requirements in the
nonrefillable container, refillable container and repackaging subparts
to the product. Alternatively, EPA could apply a subset of the
container-related requirements to the product if compliance with some
but not necessarily all of the requirements would eliminate the
problem.
EPA may deny registration or initiate cancellation proceedings if
the registrant fails to comply with the container and, if appropriate,
the repackaging regulations within the time frames established by EPA
in the rule or in its notification.
2. Changes. Because we are finalizing Option 1 rather than Option 3
in the supplemental notice, the final rule provides more specific
criteria and a better-defined process for EPA to make determinations to
prevent an unreasonable adverse effect on the environment. The criteria
and process are outgrowths of comments on the supplemental notice and
the following potential regulatory provision from the supplemental
notice:
EPA may determine that an antimicrobial product or products must
comply with the container standards. EPA may consider evidence such
as field studies, use history, accident data, monitoring data, or
other pertinent evidence in deciding whether the product must comply
with the container standards to prevent an unreasonable adverse
effect on the environment.
3. Comments. Many commenters provided suggestions and information
about how they believe the case-by-case determinations should be made.
While the actual language varied among commenters, the respondents
agreed that EPA needs specific evidence of a problem related to
containers before EPA can determine a product must be subject to the
container regulations to prevent an unreasonable adverse effect.
4. EPA response. EPA believes that the criteria and process in the
final regulations for making determinations to prevent an UAE represent
a legitimate, reasonable, straightforward interpretation of the
statutory language. In addition, we think these criteria and the
process for making determinations are similar to EPA's current systems.
EPA has the ability to re-visit a product's registration standard of
not causing UAEs and change it if UAEs are identified during the
process of reregistration or other review, under the ongoing mechanisms
of FIFRA section 6(a)(2) (as implemented by 40 CFR part 159, PR Notice
98-3 (Ref. 55), PR Notice 98-4 (Ref. 54) and other guidance documents)
or when other relevant information is received by EPA. The criteria and
process included in the final rule are consistent with most comments
received on the supplemental notice.
It is difficult to precisely identify the kind of information that
EPA would consider sufficient and to characterize in great detail the
problems that could trigger this regulatory provision, because we
cannot anticipate every situation that might arise in the future.
However, the following items are intended to provide some guidance on
the different factors that EPA will consider in making determinations
about whether an antimicrobial product
[[Page 47342]]
or products must be subject to the container regulations:
What kind of information, data or other evidence of a
problem with containers has EPA obtained? This could be descriptions of
cases, incidents or examples of problems or it could be some other kind
of information.
How severe are the problems identified in the information,
data or other evidence obtained by EPA? The 6(a)(2) regulations in 40
CFR part 159 define severity categories assigned to incidents and PR
Notice 98-3 (Ref. 55) expands the definitions for incidents involving
humans and domestic animals.
How prevalent are the problems identified in the
information, data or other evidence obtained by EPA? Are the problems
isolated or are they widespread? EPA will evaluate the prevalence of
the problems and the severity of the problems before taking any action
to subject the product or products to the container regulations.
Where do the problems occur in the distribution chain? In
other words, whether the incidents occur predominantly at the
facilities of manufacturers, retailers or end users may affect our
decision. Also, this information may allow EPA to trace a problem back
to a certain facility or a limited number of facilities.
What is the company's history in terms of reacting to
problems of concern?
Do the problems cause an unreasonable adverse effect on
the environment?
Could the problems reasonably be expected to cause an
unreasonable adverse effect on the environment if they continue to
occur? For example, about a decade ago, EPA received a significant
number of reports of a household pesticide that exploded over time.
While these initial incidents may not have directly led to a severe
human injury or illness, it is reasonable to expect that someone could
have been injured or become ill if they were in a garage or storage
area when a container exploded.
Would complying with the container regulations reasonably
be expected to eliminate the problem? If the container regulations
don't address the problem or would not mitigate the problem, then EPA
could consider other approaches (such as establishing conditions
specific to that registration) to mitigate the problem. As an example,
it is possible that a problem could be caused by a problem with a
specific kind of container material. In this case, the solution may be
to require the product to be distributed in a certain container
material or a container material that has been treated, e.g.,
fluorinated high density polyethylene. It is possible that some of
these alternative approaches may have other impacts with respect to the
container regulations. For example, requiring a product to be
distributed in a nonrefillable container that is rigid rather than non-
rigid would increase the number of nonrefillable container standards
the product must comply with.
G. Summary Table of the Scope for Antimicrobial Products
The following tables compare the approach for regulating
antimicrobial products in the final regulations and the supplemental
notice. Table 4 compares the exemption criteria in the final rule with
the criteria discussed in the supplemental notice. Table 5 compares
whether certain kinds of products (assuming they would otherwise be
exempt) are exempt from or subject to the container standards in the
final regulations and the supplemental notice approach.
Table 4.--Exemption Criteria for Antimicrobial Products in the Final
Rule Compared to the Supplemental Notice
------------------------------------------------------------------------
Approach in the
Criterion for Exemption Approach in the Supplemental
Final Rule Notice
------------------------------------------------------------------------
FIFRA section 2(mm) As defined in As defined in
antimicrobial pesticide FIFRA section FIFRA section
2(mm) 2(mm)
------------------------------------------------------------------------
Antimicrobial products that are Criterion is Criterion wasn't
not FIFRA 2(mm) antimicrobial included as an included; these
pesticides because they are additional would have been
subject to a tolerance or food criterion subject to the
additive regulation allowing container
exemption regulations
------------------------------------------------------------------------
Antimicrobial product use 10 antimicrobial 9 antimicrobial
categories that are considered product use product use
household, industrial, or categories are categories were
institutional household, identified as
institutional or household,
industrial. The institutional or
additional industrial. The
antimicrobial additional
product use antimicrobial
categories are: product use
aquatic categories were:
areas; and. aquatic
areas;
agricultural
premises and agricultural
equipment. premises and
equipment; and
human
drinking water
systems
------------------------------------------------------------------------
Is not a hazardous waste when it Is not a hazardous Does not meet the
is intended to be disposed waste as set out criteria for
in 40 CFR part hazardous waste
261 when intended in 40 CFR part
to be disposed 261 when intended
to be disposed
------------------------------------------------------------------------
EPA has not specifically Criteria and a Making case-by-
determined product must be process for case
subject to container making the determinations
regulations to prevent an determination are was discussed as
unreasonable adverse effect included in the an option, but
final rule was not
specifically
included in the
potential
regulatory
language
------------------------------------------------------------------------
[[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:
A product must comply with all of the nonrefillable
container requirements if it is classified in at least one of the
following categories: (1) Toxicity Category I; (2) Toxicity Category
II; or (3) Restricted use product.
All other products (those in Toxicity Category III or IV
that are not restricted use products) must comply only with the basic
DOT requirements in 49 CFR 173.24. If the pesticide product meets the
definition of a hazardous material in 49 CFR 171.8, the DOT requires it
to be packaged according to 49 CFR parts 171-180.
The final rule does not distinguish between higher risk and lower
risk products for the refillable container and repackaging regulations.
In other words, pesticide products other than MUPs, plant-incorporated
protectants and exempt antimicrobial products must comply with all of
the refillable container and repackaging standards. The only exception
is that antimicrobial products that are used in swimming pools and
closely related sites are subject to a reduced number of the
requirements, as described in Unit III.D.
ii. Changes. The 1994 NPRM proposed that the container regulations
would generally apply to all end use pesticide products and all
containers, regardless of the pesticide market sector. The proposed
container regulations included requirements that are equivalent to some
DOT requirements, such as marking, container integrity, reclosing
securely and a drop test, and some requirements that are pesticide-
specific, such as standard closures, one-way valves, and the residue
removal standard. Many commenters opposed the broad scope of the
regulations and requested EPA to exempt one or more subsets of
pesticides from the container requirements.
In the 1999 supplemental notice, EPA described a potential
regulatory option for products other than antimicrobials that would
exempt some pesticides and containers from the final rule. Rather than
exempt products based on the pesticide market sector or the type of
pesticide (as specified by the commenters on the proposal), EPA's
approach was to exempt pesticides based on the relative risk they
posed.
The regulatory approach in the supplemental notice would have
exempted manufacturing use products, as we proposed in 1994, and
included a previously described set of standards for antimicrobial
products that would be eligible for exemption. For all other
[[Page 47344]]
products, a product would be subject to the regulations if it met any
one of the following criteria:
The product is classified in Toxicity Category I or II;
The capacity of the container is equal to or larger than 5
liters (1.3 gal) for liquids or 5 kilograms (11.0 lbs) for solids;
The product's labeling permits outdoor use and includes at
least one of the specified environmental hazard statements.
The container size and environmental hazard label statement criteria
would have captured many products in Toxicity Category III and IV so
they would have been subject to the regulations.
About 18 respondents provided comments on these general (non-
antimicrobial) scope criteria in the supplemental notice, consisting
largely of individual registrants and registrant groups. The commenters
generally agreed that it was appropriate to differentiate the
stringency of the regulations based on the relative risk posed by the
products and containers. None of the commenters wholly supported the
approach in the supplemental notice and there was no general agreement
in an approach among the suggestions provided by the respondents. Some
commenters stated that certain standards (either the DOT Packing Group
III standards or the standards in a DOT limited quantity exception)
should apply to all products. Many commenters suggested changes to the
Toxicity Category and container size criteria. None of the commenters
supported the environmental hazard statement criteria. A few commenters
suggested other exemptions that should be included, such as exempting
all residential use products.
After carefully reviewing these comments and conducting an analysis
of the products that would be regulated using the supplemental notice
criteria, EPA decided to revise the approach in the final rule for
regulating pesticide products other than MUPs, plant-incorporated
protectants and antimicrobials that are exempt. As described above, the
approach for the nonrefillable container standards, which
differentiates between ``higher risk'' and ``lower risk'' products, is
different from the approach for the refillable container and
repackaging requirements, which do not make that distinction.
iii.Refillable container and repackaging regulations. Pesticide
products other than MUPs, plant-incorporated protectants and exempt
antimicrobial products must comply with all of the refillable container
and repackaging standards. One exception is that antimicrobial products
that are used in swimming pools and closely related sites are subject
to a reduced number of the requirements.
2. Alternative approach and rationale for changes. The final rule
approach for regulating pesticide products that are not otherwise
exempt was developed based on the comments on the supplemental notice
and on an analysis conducted by EPA. The broad comments related to
substantial changes in the approach are described in this subunit,
while comments on the specific criteria in the supplemental notice are
discussed individually in subunits below.
i. Comments - overall approach. EPA posed six questions in the
supplemental notice related to the scope of products subject to the
container regulations. The first question was ``Is it appropriate to
apply the container standards only to the higher-risk pesticides?''
Eight respondents specifically addressed this question and seven of
them generally agreed with EPA that it is reasonable to apply different
levels of regulation to higher-risk and lower-risk pesticides. However,
the commenters differed in their recommendations for regulating the
lower-risk pesticides. Only one of the eight commenters, a non-
agricultural registrant group, specifically supported a complete
exemption for the lower-risk pesticides. Some commenters took a middle
ground. In particular, the comments from a registrant group and three
registrants were a bit vague, stating that it is appropriate to apply
the container standards only to the higher risk pesticides and that
lower-risk pesticides should not be subject to the same requirements.
Several commenters opposed the approach of completely exempting some
products. Two registrant groups explicitly supported an option where
lower risk pesticides would be subject to some regulations, although
different standards would be appropriate. Also, the commenter who
didn't support distinguishing between risk levels was a registrant who
stated that the requirements for DOT Class 9 materials should apply to
all pesticides that are not DOT hazardous materials.
The second question was ``Are the criteria being considered by EPA
to distinguish between higher-risk and lower-risk pesticides
appropriate?'' The same eight commenters addressed this question and
none of them believed that the criteria in the supplemental notice were
appropriate for distinguishing between higher-risk and lower-risk
pesticides. An agricultural registrant group commented that toxicity
and container size are generally appropriate criteria, but questioned
the viability of using these criteria because of the wide range of
combinations of toxicity (human health and environmental), container
sizes and distribution and handling practices. This commenter supports
establishing the DOT Packing Group III standards as a minimum for
agricultural pesticides in nonrefillable containers. A registrant group
and a registrant stated that DOT limited quantity provisions should be
authorized for pesticides that are not DOT hazardous materials. The
regulatory language recommended by one of these commenters would
require pesticide products to comply with all nonrefillable container
standards unless they were specifically exempt or subject to a limited
quantity exception. Four commenters--a registrant group and three
registrants--strongly opposed the environmental hazard statement
criterion because they don't believe the environmental hazard
statements on the label are appropriate indicators of risk. One of them
said that toxicity category alone should be used to distinguish between
higher-risk and lower-risk pesticides. A non-agricultural registrant
group questioned the appropriateness of human toxicity characteristics
for packaging regulations that, it claims, deal primarily with storage
and disposal. This commenter urged EPA to develop alternate criteria,
such as the potential for the product to leak from containers and/or to
persist in the environment.
In addition, a registrant group and a registrant who addressed the
above question provided more detailed comments on an alternate
approach. These commenters stated that all agricultural pesticides
distributed in nonrefillable containers should comply with the DOT
packaging standards. Under this option, pesticides that are not DOT
hazardous materials would comply with the Packing Group III standards
or, if appropriate, one of the limited quantity exceptions. The
registrant group stated that having minimum requirements on pesticide
integrity is in the best interest of agriculture, the public and our
industry.
Another registrant provided a detailed description of an alternate
approach. This commenter split the regulations into two primary issues
- (1) container design and integrity testing and (2) container residue
removal standards and others - based on the goals of the rule and their
financial impact. This agricultural registrant strongly believes that
all pesticides in nonrefillable containers should be required to use
DOT Packing Group III containers as a minimum safety standard. On the
other
[[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:
The product's toxicity exceeds one or more of the specific
hazard criteria in 152.170, or evidence substantiates that the product
or use poses a serious hazard that may be mitigated by restricting its
use;
The product's labeling is not adequate to mitigate these
hazards;
Restriction of the product would decrease the risk of
adverse effects; and
The decrease in risks of the pesticide as a result of
restriction would exceed the decrease in benefits.
Section 152.170 lists specific human and ecological toxicity
endpoints that cause a product to be considered for restricted use
classification. In addition, the regulations state that EPA may
consider evidence such as field studies, use history, accident data,
monitoring data or other pertinent evidence in deciding whether the
product or use may pose a serious hazard that could be mitigated by
restricted use classification.
An analysis of products in EPA's REFS data base shows that many
restricted use products are also classified in Toxicity Category I or
II. However, there are about 225 restricted use products in Toxicity
Category III or IV and all of these products were restricted at least
partly for environmental/ecological reasons. (Ref. 45) In particular,
the criteria for restricting the Toxicity Category III/IV products
include ground water contamination; toxicity to fish, birds, or aquatic
organisms; and hazard to wildlife or non-target organisms.
5. Nonrefillable containers: container size criterion--i. Final
regulations. Container size is not a criterion in the final regulations
for determining whether a pesticide product is subject to the
nonrefillable container regulations.
ii. Changes. The approach in the supplemental notice included a
container size limit as one of the criteria for being subject to the
nonrefillable container regulations. Specifically, a product would have
been subject to the nonrefillable container regulations if the
container's capacity was equal to or larger than 5.0 liters (1.3
gallons) for liquid formulations or 5.0 kilograms (11.0 pounds) for
solid formulations. EPA decided not to incorporate the container size
criterion into the final rule for nonrefillable containers because of
other changes in the structure of the final regulations. In particular,
the final rule uses the scope criteria to distinguish between levels of
regulation (subject to all of the nonrefillable container standards
versus subject to the basic DOT standards) rather than to distinguish
between whether the product is regulated or exempt. The criteria in the
final rule subject the most toxic and most risky pesticides -- those in
Toxicity Categories I and II and any others that are restricted use
products -- to the full set of nonrefillable container requirements.
All other products that are not specifically exempt are subject to
basic container integrity and compatibility standards, rather than
being completely exempt. EPA believes the basic DOT packaging standards
offer an acceptable level of protection for the products that are in
Toxicity Categories III and IV and that are not restricted use
products. Therefore, a container size criterion is not necessary for
nonrefillable containers.
6. Refillable containers and repackaging--i. Final regulations.
Pesticide products other than MUPs, plant-incorporated protectants and
exempt antimicrobial products must comply with all of the refillable
[[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:
The label requirements apply to all products.
The containment structure requirements apply to
agricultural products (stored in stationary pesticide containers by
retailers, custom applicators and custom blenders).
The nonrefillable container, refillable container and
repackaging requirements apply to products other than MUPs, plant-
incorporated protectants and certain antimicrobial products, as shown
in Figure 1.
Within Figure 1, there is a box with the question ``Is it an
antimicrobial product that meets all four criteria?'' This box
represents a placeholder for the flow chart in Figure 2.
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IV. Container Regulations--Relationship with the Department of
Transportation Regulations
A. Background
1. Department of Transportation Hazardous Materials Regulations.
The U.S. Department of Transportation (DOT) Hazardous Materials
Regulations (HMR) are based on the authority in the Federal hazardous
materials transportation law, the Hazardous Materials Transportation
Act, and are found in 49 CFR parts 171 through 180. The HMR establish
standards governing a wide range of the safety aspects of
transportation, including requirements for the classification of
materials, packaging (including manufacture, continuing qualification
and maintenance), hazard communication (i.e., package marking,
labeling, placarding, and shipping documentation), transportation,
handling and incident reporting.
Some, but not all, pesticide products are defined as DOT hazardous
materials by 49 CFR 171.8. A pesticide product may be classified as a
DOT hazardous material for displaying any of the hazards identified in
the DOT regulations, which are defined in nine different classes. Some
DOT hazard classes include several different divisions. The most common
hazard classes and divisions for pesticide products include:
Class 3: flammable or combustible liquids;
Division 6.1: poisonous materials;
Class 8: corrosive materials; and
Class 9: miscellaneous hazardous materials, such as marine
pollutants.
Pesticide products that are DOT hazardous materials are required
under existing DOT regulations to comply with all applicable
regulations in all of the safety areas mentioned above -
classification, packaging, hazard communication, transportation and
handling. For pesticide products that are not DOT hazardous materials,
EPA has focused on the DOT requirements for package design (and
manufacture, continuing qualification, and maintenance) and package
marking, because these are the areas that overlap with the proposed
pesticide container regulations. In other words, EPA is not adopting
the HMR standards for DOT labeling, placarding, shipping documentation,
transportation and handling, and incident reporting because these areas
are generally outside the scope of the pesticide container regulations.
The DOT HMR include general packaging requirements that address
areas such as compatibility, closures, venting, and filling limits. The
HMR also set out performance standards and related tests that packaging
must meet, including drop, leakproofness, hydrostatic pressure,
stacking, and vibration tests. The stringency of these tests varies
according to the packing group (PG) of the material being transported.
The packing group represents a measure of the relative hazards, where
PG I includes materials that pose a relatively great hazard and PG III
includes materials that pose a relatively minor hazard. Within a given
hazard class or division, the DOT HMR assign packing groups based on
the materials characteristics, or the regulations refer to the
hazardous materials table in 49 CFR 172.101 for substance-specific
assignments of packing groups. Most pesticide products that are
classified as DOT hazardous materials are in Packing Group III,
although some are in PG II and a few are in PG I.
The HMR include exceptions from some portions of the overall
regulatory scheme in certain situations, e.g., for damaged packages
placed in salvage drums (49 CFR 173.3), for small quantities of
hazardous materials (49 CFR 173.4) and for the shipment of waste
materials (49 CFR 173.12). Also, the regulations in 49 CFR 173.150
through 173.156 set out limited quantity and consumer commodity
exceptions for different hazard classes. The limited quantity
exceptions provide relief from some of the HMR requirements,
specifically the labeling requirements (unless the package is
transported by aircraft), the placarding provisions, and the testing
standards in 49 CFR part 178. Also, if a limited quantity meets the
definition of consumer commodity, relief from the shipping paper
requirements is provided in many cases.
Pesticide products that are classified as DOT hazardous materials
must continue to be packaged in accordance with the DOT HMR. Nothing in
the pesticide container regulations changes the specific requirements
in the HMR that apply to pesticide products based on the criteria in
the DOT regulations. Additionally, the pesticide container regulations
do not change the stringency of the DOT HMR. If a pesticide product is
categorized as a PG II material, it would continue to have to meet the
PG II standards and likewise for products in PG I or PG III.
2. Final regulations (Sec. Sec. 165.25(a), (b) and (c), and
165.45(a), (b) and (c)). The final regulations adopt and refer to some
of the HMR for pesticides that are subject to this final rule. The
approach in the final rule is closely tied to the changes in scope
described in Unit III. Some products, including MUPs, plant-
incorporated protectants, and some antimicrobial products are
completely exempt from the container regulations and are not included
in the following discussion because they are exempt. All other products
are subject to the final regulations.
For pesticide products that are lower risk (in Toxicity Category
III or IV and not restricted use products) in nonrefillable containers,
the nonrefillable containers must comply only with the general
requirements for packagings and packages in 49 CFR 173.24. No other
requirements in EPA's pesticide container regulations apply to these
lower risk products. Of course, if any of these products are DOT
hazardous materials, they must comply with all applicable DOT
regulations. For the purpose of enforcing the pesticide container
regulations, however, EPA is only referring to and adopting 49 CFR
173.24 for any lower risk products that are subject to the regulations,
regardless of whether or not they are classified as DOT hazardous
materials.
Pesticide products that are higher risk (in Toxicity Category I or
II or a restricted use product) in nonrefillable containers and all
products in refillable containers must be packaged in a container that
is designed, constructed, and marked to comply with the requirements of
49 CFR 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213,
173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178 and part 180
that apply to a Packing Group III material. These portions of the DOT
regulations, which are described in more detail in later sections of
this preamble unit, include:
General requirements for packagings and packages
(Sec. Sec. 173.24, 173.24a, 173.24b);
Reuse, reconditioning and remanufacture of packagings
(Sec. 173.28), except for the leakproofness test specified in Sec.
173.28(b)(2);
Exceptions for Class 9 materials, miscellaneous hazardous
materials (Sec. 173.155);
Non-bulk packagings for hazardous materials in Packing
Group III (Sec. 173.203 for liquids and Sec. 173.213 for solids);
Portable tanks, closed bulk bins and intermediate bulk
containers for certain low hazard materials (Sec. Sec. 173.240(c) and
173.240(d) for low hazard solid materials and Sec. Sec. 173.241(c) and
173.241(d) for low hazard liquid and solid materials);
Specifications for Packagings (part 178), including non-
bulk performance-oriented packaging standards (subpart
[[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
Continuing qualification and maintenance of packagings
(part 180)
Again, products that are DOT hazardous materials must comply with
all applicable DOT regulations. For the purposes of enforcing the
pesticide container regulations, the final rule states that a pesticide
product that meets the definition of a hazardous material in 49 CFR
171.8 must be packaged in a container that is ``designed, constructed
and marked'' to comply with the requirements of 49 CFR parts 171-180.
Including the phrase ``designed, constructed and marked'' allows EPA to
focus on the DOT requirements for package design (and manufacture,
continuing qualification, and maintenance) and package marking, as
described above, rather than the HMR standards for DOT labeling,
placarding, shipping documentation, transportation and handling, and
incident reporting.
Because the pesticide container regulations refer to and adopt
certain DOT requirements, these requirements also are EPA standards
that can be enforced by EPA and the State agencies that implement EPA's
pesticide programs. However, EPA and the State pesticide programs will
enforce only the 49 CFR requirements that are referred to and adopted
in the pesticide container regulations; not the full DOT HMR. Clearly,
DOT maintains authority to enforce all of its regulations against
parties that are subject to the HMR.
The final rule includes two other provisions related to the DOT
standards. These provisions are discussed in more detail in Units IV.E.
and IV.F. First, if DOT proposes to change any of the regulations that
are incorporated into the pesticide container regulations, EPA will
provide notice of the proposed changes and an opportunity to comment in
the Federal Register. Following notice and comment, EPA will take final
action regarding whether or not to revise its rules and the extent to
which any such revision will correspond with revised DOT regulation.
Second, the regulations include a provision for modifying or waiving
the adopted standards if EPA determines that an alternative (partial or
modified) set of standards or pre-existing requirements achieves a
level of safety that is at least equal to that specified in the adopted
requirements.
3. Changes. The same general approach that was described in the
1999 supplemental notice is included in the final regulations. The
final rule refers to and adopts some DOT standards for pesticide
products that are not DOT hazardous materials and requires that these
products be packaged in containers that are designed, constructed, and
marked to comply with the adopted requirements for Packing Group III
materials. However, a number of changes are made in the final rule
approach:
The biggest change is related to the changes in the scope
of the nonrefillable container standards. Rather than completely exempt
the lower risk pesticide products (e.g., lower toxicity in small
containers without an environmental hazard statement on the label), the
final rule mandates that the lower risk products must comply with the
general packaging requirements in 49 CFR 173.24.
Some of the specific 49 CFR standards that are adopted for
the higher risk products in nonrefillable containers and for all
products in refillable containers are different in the final rule than
in the supplemental notice approach. In particular, the final
regulations include an exception from 49 CFR 173.28(b)(2), which
requires leakproofness testing every time a non-bulk packaging is
refilled. The final regulations specify that this leakproofness testing
is not required for products that are not DOT hazardous materials if
containers comply with the 40 CFR part 165, subpart C regulations and
the repackaging is done in compliance with the 40 CFR part 165, subpart
D regulations. Also, the final rule refers to and adopts only portions
of 49 CFR 173.240 and 173.241 (bulk packaging for certain low hazard
materials) to clarify that the pesticide container regulations do not
regulate transport vehicles. By referring to and adopting only
paragraphs (c) and (d) in both sections, the final rule incorporates
the standards for portable tanks, bulk bins and intermediate bulk
containers, but not for rail cars, motor vehicles or cargo tanks.
The final regulations specifically refer to and adopt the
terms of the exceptions for Class 9 miscellaneous materials in 49 CFR
173.155 instead of incorporating the relevant text from that section
into the pesticide container regulations, as discussed in the
supplemental notice.
4. Comments on the overall approach. More than 20 respondents
commented on the approach of adopting some DOT requirements at the
Packing Group III level in the supplemental notice. The comments can be
split into two categories according to the type of commenter. State
regulatory agencies and agricultural pesticide registrants and
registrant groups generally supported the overall approach, while
registrants and registrant groups from the non-agricultural pesticide
sector generally opposed the overall approach.
i. Support. Several State regulatory agencies and an agricultural
registrant group supported EPA's approach of adopting some DOT
requirements for pesticide products that are not DOT hazardous
materials. These commenters stated that consistency with DOT should
facilitate compliance and minimize confusion in the regulated community
and will avoid conflicting regulations.
In addition, a few agricultural registrant groups and some
agricultural registrants supported EPA's overall approach, if EPA
incorporates the changes included in their comments on the supplemental
notice. These comments recommended changing several sections of the DOT
regulations that are adopted and extending the compliance period for
refillable containers. One of the registrants commented that all
pesticides in nonrefillable containers should meet the DOT PG III
standards at a minimum to provide an updated level of protection for
the environment and for all who use, store, display, buy or distribute
pesticide products.
ii. Oppose. About 10 respondents clearly opposed the supplemental
notice approach of adopting some DOT Packing Group III standards for
products that are not DOT hazardous materials, including several
nonagricultural registrant groups, a group representing agricultural
formulators and distributors, an institutional formulator/distributor
group and some non-agricultural registrants. These respondents opposed
EPA's approach because they claim that:
There is no need to regulate pesticides that are not DOT
hazardous materials. Several commenters stated that DOT requirements
take into consideration the seriousness of transporting the substances
and that DOT chose not to regulate these substances. Several others
questioned whether there is evidence of a problem with shipping non-DOT
hazardous pesticides.
Costs of packaging would increase, which respondents state
would be burdensome for small businesses. Costs mentioned were $2,500
for design plate changes and about the same amount per package type to
maintain the required certification files.
This approach would be burdensome for EPA to monitor DOT
regulatory changes and to render exemption decisions. A commenter also
[[Page 47352]]
questioned whether EPA had the expertise to make exemption decisions.
EPA's approach would be confusing because it incorporates
some, but not all, of DOT's standards.
EPA's regulations could be different than DOT's. Several
commenters cited the waiver provision and the lack of a consumer
commodity exemption in EPA's approach as examples.
iii. EPA response. EPA continues to believe that the general
approach of referring to and adopting the DOT Packing Group III
packaging design, construction and marking requirements is the best
approach for regulating pesticide containers.
Commenters who opposed this approach in the supplemental notice
must recognize that the alternative to the supplemental notice approach
of referring to and adopting some of DOT's standards is not an option
of declining to establish regulations for container integrity and
construction. Instead, as described in the supplemental notice, the
alternative is to finalize the standards from the 1994 proposed rule
that address container integrity and construction. These standards
include container integrity and compatibility, marking, and reclosing
securely for nonrefillable containers and container integrity, marking
and a drop test for refillable containers. EPA is separately required
under FIFRA to promulgate such regulations for all pesticides. If
Congress had believed that existing Federal requirements promulgated by
DOT were sufficient, or that EPA should restrict its regulation to
pesticides covered as DOT hazardous materials, Congress could have
restricted FIFRA section 19 to that extent. Instead, it appears that,
with limited exceptions, Congress intended all pesticides to be
regulated under section 19.
In fact, the approach to refer to and adopt the DOT Packing Group
III packaging design, construction and marking requirements was based
on suggestions from commenters on the proposed rule, who urged EPA to
be consistent with the DOT regulations. More than 20 respondents,
including individual companies and trade groups from the pesticide
registrant and container manufacturing industries, provided commentary
on the DOT HMR and the United Nations (UN) Recommendations on the
Transport of Dangerous Goods. All of the commenters agreed that EPA
should be consistent with the DOT HMR and the UN standards in terms of
definitions, requirements, and testing. Respondents argued that such
consistency would: (1) Facilitate compliance because the industry is
already familiar with the DOT and UN standards; (2) eliminate the
potential burden of complying with two different, overlapping
regulatory schemes; and (3) not establish additional trade barriers.
Most of the commenters on the DOT issue in the proposed rule
specifically favored the use of DOT's Packing Group III criteria as the
minimum standard for pesticide products not regulated by DOT as
hazardous materials.
B. Leakproofness Testing Before Reuse (49 CFR 173.28(b)(2))
1. Final regulations. The final regulations retain the reference to
49 CFR 173.28, which establishes standards for the reuse,
reconditioning and remanufacture of packagings. Also, the final rule
adds a provision that exempts refillers from the leakproofness test
requirement in 49 CFR 173.28(b)(2) for products that are not DOT
hazardous materials if the refillable container complies with the
refillable container regulations and the refilling is done in
compliance with the repackaging regulations.
2. Changes. The major change to this part of the approach is that
the final regulations add a provision that exempts refillers (which
includes registrants and independent refillers) from the leakproofness
test requirement in 49 CFR 173.28(b)(2) for products that are not DOT
hazardous materials if the refillable container is in compliance with
the subpart C refillable container regulations and the refilling is
done in compliance with the subpart D repackaging regulations. This
exception was added in response to comments on the supplemental notice.
3. Comments. Some commenters - including several registrant groups
and several registrants - opposed the requirement in 49 CFR
173.28(b)(2) for non-bulk packaging to pass a leakproofness test before
every time it is refilled. The test involves applying a raised internal
air pressure to the container and ensuring that no air leaks from it.
The test method for the leakproofness test described in 49 CFR 178.604
specifies restraining the container under water to determine if air
leaks from the container, although alternatives are provided in an
appendix to part 178. The commenters generally requested EPA to delete
the reference to 49 CFR 173.28, although they did not point out
problems with any other provisions of 49 CFR 173.28. One of the
registrants provided the most precise and detailed description of the
potential problems that could result from requiring leakproofness
testing before every refill, including:
It would pose practical problems and increased costs
because refillers and possibly farmers would have to obtain the
training and equipment required to do the leakproofness test.
Due to the logistical and cost problems, the registrant
believes that many non-bulk refillable containers would be replaced by
nonrefillable containers, contrary to EPA's stated goals of pollution
prevention.
This commenter believes that the general packaging
requirements in 49 CFR 173.24 and the container inspection provisions
in subpart D of EPA's regulations are sufficient to ensure the
integrity of non-bulk refillable containers.
In addition to a leakproofness test, 49 CFR 173.28(b)(2)
specifies a marking requirement, which could be interpreted to impose a
testing requirement because of other DOT provisions (such as 49 CFR
171.2(c)), even if the packaging is used to transport only non-
hazardous materials. The commenter stated that DOT provided a verbal
interpretation that 49 CFR 171.2(c) does not require such testing of
non-bulk containers used to transport only non-hazardous materials. The
registrant recommended that EPA consult with DOT to confirm the
approach on this topic. This commenter and a few registrant groups
recommended deleting the reference to 49 CFR 173.28 to avoid confusion
about whether a container must be leakproofness tested before it is
refilled.
4. EPA response. EPA agrees with the commenter's concerns about the
problems that might be caused by requiring a leakproofness test each
time a non-bulk refillable container is refilled with a pesticide
product that is not a DOT hazardous material. However, EPA disagrees
with the commenters that the solution is to delete the reference to 49
CFR 173.28. EPA believes that Sec. 173.28 includes useful provisions
that will help ensure the safe reuse of pesticide containers. In
addition, Sec. 173.28 includes provisions for reconditioning and
remanufacturing containers, which will clarify and allow the
reconditioning of certain kinds of packaging, such as drums. Many
commenters on the proposed rule and supplemental notice identified the
lack of a regulatory option for reconditionable containers as an issue.
Including the reference to Sec. 173.28 solves this problem and allows
drums to be reconditioned and then reused under the pesticide container
regulations.
Rather than deleting the reference to 49 CFR 173.28, EPA is
modifying the final regulations to exempt refillers from the
leakproofness test requirement in 49 CFR 173.28(b)(2) for products that
are
[[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:
DOT provides greater latitude on the construction and less
frequent testing requirements for bulk packages because of their size
and sturdier construction. EPA should follow the same approach and
authorize the same standards for bulk containers used to distribute
pesticides that are not DOT hazardous materials.
These sections of the DOT regulations authorize the use of
certain non-DOT specification bulk packaging, including portable tanks
and bulk bins. A few of these commenters stated that non-DOT
specification packagings that are authorized for DOT Class 9 materials
should also be acceptable for pesticides that are not DOT hazardous
materials. The non-specification packagings must comply with the
general packaging requirements in 49 CFR part 173, but not all of the
testing and marking standards in other portions of the HMR.
In addition, the registrant explained that the HMR do not require
non-DOT specification packagings (which are authorized by 49 CFR
173.240 and 173.241) to have the UN symbol marked on them. This
commenter requested EPA to confirm that the pesticide container
regulations authorize the use of these non-DOT specification
packagings.
On the other hand, a non-agricultural registrant group and several
agricultural registrants opposed the reference to 49 CFR 173.240 and
173.241. Several of the registrants stated that the intent of their
comments on the proposed rule was for EPA to adopt the DOT Packing
Group III standards for non-bulk packagings, not for bulk containers
(which includes intermediate bulk containers by definition). The
registrant group stated that the requirements in Sec. Sec. 173.240 and
Sec. Sec. 173.241 would be burdensome and are not necessary from a
safety standpoint. This commenter also believes that adopting these
requirements would lead to a decrease in the use of refillable
containers.
A registrant requested that EPA re-evaluate the reference to these
sections because they authorize bulk and intermediate bulk containers
and the definitions of these kinds of containers are very different
than the ones customarily used within the agricultural pesticide
industry. A few other commenters also addressed the definition issue by
pointing out that the term minibulk (used in the agricultural pesticide
industry and in the proposed regulations) has no DOT regulatory
definition.
4. EPA response - supplemental notice. EPA is aware that the DOT
regulations do not include a definition of minibulk container. However,
the proposed definitions for dry and liquid minibulks were developed to
intentionally include container sizes in both DOT's non-bulk and
intermediate bulk container categories. As mentioned above, under the
DOT regulations, intermediate bulk containers are a subset of bulk
containers. EPA is not finalizing the definitions of dry and liquid
minibulk (and bulk) containers in the final rule, as described in Unit
V.
EPA intended to refer to and adopt DOT Packing Group III packaging
standards for DOT non-bulk containers and intermediate bulk containers.
EPA disagrees with the commenters who support the DOT standards for
non-bulk containers (less than 119 gallons for liquids or 882 pounds
for solids) but not for the next largest size, intermediate bulk
containers. Minibulk containers used for pesticides include ones with
capacities in the non-bulk classification, e.g., 60 to 110 gallons, and
containers in the intermediate bulk container sizes, e.g., 150 to 250
gallons. EPA believes that it is not logical to require smaller
minibulks to comply with the DOT Packing Group III testing standards,
and to not specify any testing standards for larger minibulks, which
could lead to a bigger spill. EPA believes strongly that both non-bulk
and intermediate bulk containers holding pesticides that are not DOT
hazardous materials should comply with the applicable Packing Group III
packaging construction, testing and marking requirements.
Upon re-evaluation of the reference to 40 CFR 173.240 and 173.241,
however, EPA realized that there may be some confusion caused by the
paragraphs that authorize rail cars, motor vehicles and cargo tanks.
EPA has never intended to regulate transport vehicles. The proposed
rule (in Sec. 165.122(b)(2)) and the final rule (in Sec. 165.43(h))
state that the pesticide container regulations do not apply to
transport vehicles that contain pesticide in pesticide holding tanks
that are an integral part of the transport vehicle and that are the
primary containment for the pesticide. To eliminate potential
confusion, EPA changed the final rule to only include the portions of
49 CFR 173.240 and 173.241 that authorize portable tanks, bulk bins and
intermediate bulk containers.
5. Comments - UN marking. In response to the 2004 reopening of the
comment period, some commenters provided new information and comments
regarding the approach of referring to and adopting a subset of DOT's
hazardous materials packaging regulations. A registrant group and two
registrants commented that, since the supplemental notice was published
in
[[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:
It meets the criteria of Toxicity Category I.
It meets the criteria of Toxicity Category II.
It is classified for restricted use as set out in 40 CFR
152.160 - 152.175.
If a product does not satisfy any of these criteria (and it is not
an MUP, plant-incorporated protectant or an exempt antimicrobial), it
must be packaged in accordance with 49 CFR 173.24. These products do
not have to comply with any other nonrefillable container requirements.
However, if any of these products are DOT hazardous materials, they are
separately obligated under DOT regulations to comply with all
applicable DOT requirements. In other words, nothing in EPA's
regulations changes the requirements in the DOT HMR for products that
meet DOT's criteria for hazardous materials.
2. Changes. In the proposal, only MUPs would have been exempt from
the nonrefillable container regulations (in Sec. 165.100). All other
products would have been subject to the standards. The 1999
supplemental notice discussed regulatory options for exempting some
products (antimicrobials and non-antimicrobials) from the full set of
refillable container regulations and for exempting certain
antimicrobial products from specific requirements.
[[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:
The container is used to distribute or sell a liquid,
agricultural pesticide;
The container is rigid;
The capacity of the container is equal to or greater than
3.0 liters (0.79 gal); and
The container is not an aerosol container or a pressurized
container.
The four closures specified in the regulations are:
Bung, 2 inch pipe size (2.375 inches in diameter),
external threading, 11.5 threads per inch, National Pipe Straight (NPS)
standard.
Bung, 2 inch pipe size (2.375 inches in diameter),
external threading, 5 threads per inch, buttress threads.
Screw cap, 63 millimeters, at least one thread revolution
at 6 threads per inch.
Screw cap, 38 millimeters, at least one thread revolution
at 6 threads per inch. The cap may fit on a separate rigid spout or on
a flexible pull-out plastic spout.
2. Changes. The scope of the requirement for standardized closures
is unchanged from the proposal; it applies to liquid agricultural
pesticides in rigid containers with capacities equal to or greater than
3.0 liters. The closure standard does not apply to aerosol or
pressurized containers. The final regulation made several changes in
the dimensions and other specifications of the closures based on
comments and additional research to accurately reflect
[[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:
Allow the contents of the nonrefillable container to pour
in a continuous, coherent stream.
Allow the contents of the nonrefillable container to be
poured with a minimum amount of dripping down the outside of the
container.
2. Changes. The final rule includes several substantial changes
from the proposal. First, the dispensing requirements in the proposed
rule would have applied to all nonrefillable containers for liquid
pesticides, regardless of the size of the container. The final rule
only applies the dispensing requirements to containers that are less
than 5 gallons (18.9 liters) in size. This change was made in response
to the comments that said large containers should not be subject to the
dispensing standards. Because these standards are intended to minimize
exposure to pesticides when they are poured from containers, EPA agrees
that the requirements should not apply to containers that are too large
to allow their contents to be poured from them. The dispensing
requirements in the final rule apply only to containers with capacities
of 5 gallons (18.93 liters) or less, which we believe are the
containers that can be picked up and the contents poured out.
Second, the final rule clarifies that, like the nonrefillable
container closure requirement, the glugging and dripping standards do
not apply to aerosol containers or pressurized containers. The proposed
dispensing requirements would have applied only to liquid pesticides,
and the final rule maintains this approach. EPA did not intend that
these requirements would apply to aerosol or pressurized containers.
The proposed closure regulation specifically excluded aerosols and
pressurized containers, so the lack of similar language in the
dispensing requirements led some commenters to believe that aerosol and
pressurized containers are subject to the dripping and glugging
standards. To clarify our intent, EPA modified the final rule to
clearly state that the dispensing standards do not apply to aerosol
containers and pressurized containers. As mentioned above, the
dispensing standard is intended to minimize exposure to pesticides when
they are poured from containers, which is not how pesticides are
dispensed from aerosol or pressurized containers.
Third, the requirement in the final rule was modified to also
exclude spray bottles. During a review of products that would be
subject to the final regulation, EPA realized that spray bottles should
also be exempt from the dispensing requirements because the container
contents are sprayed out by a trigger mechanism, rather than poured.
Fourth, the requirement regarding dripping in the final rule
specifies that the contents of a container must be poured with a
minimum amount of dripping, rather than no dripping as proposed. Fifth,
the dripping standard was clarified to specify ``dripping down the
outside of the container'' to distinguish this from when the pesticide
drips out of the container into its target when the material is poured
from the container. Many commenters (registrants, registrant groups, a
grower group, a container manufacturer, and a State regulatory agency)
supported modifying this standard from ``eliminating'' dripping to
``minimizing'' dripping. Most of these respondents commented that
completely eliminating dripping is impractical or impossible and that
the amount of pesticide on the outside of the container is largely a
function of user care. EPA agrees with the commenters that the proposed
standard of eliminating dripping is not practical, particularly without
a specific testing procedure and considering the significant role of
user handling practices in whether the containers drip. Therefore, EPA
is modifying the dripping standard to minimize rather than eliminate
dripping. The structure of the standard was revised to be similar to
the glugging standard so it would be clear that the dripping standard
applies when the contents are poured from the container. Finally, the
requirement refers to minimizing the amount of ``dripping down the
outside of the container.'' EPA believes this phrase clarifies that the
dripping that should be minimized is the trickle or drops of liquid on
the container exterior; not the last few drops of material or rinsate
that leave the container when the contents are poured.
Lastly, the proposed standard for reclosing securely is not being
finalized in the final rule, because there is an equivalent DOT
standard that is being adopted, as explained in Unit V.M.
H. Residue Removal (Sec. 165.25(f))
1. Overview--i. Final rule. Rigid containers with capacities less
than or equal to 5 gallons for liquid formulations or 50 pounds for
solid formulations holding dilutable formulations must be capable of
attaining at least 99.99 percent removal for each active ingredient
when tested using the EPA testing methodology. Percent removal
represents the percent of the original concentration of an active
ingredient in the pesticide product formulation when compared to the
concentration of that active ingredient in an extra rinse following
administration of the triple rinse procedure specified in the testing
methodology, i.e., in the fourth rinse. All dilutable products in these
smaller rigid containers must be capable of meeting the 99.99 percent
removal standard, although the testing must be done only if products
are flowable concentrate formulations or if EPA requests the test data
on a case-by-case basis.
ii. Changes. EPA made many substantive changes to the nonrefillable
container residue removal standard in the final rule based on public
comments and a re-evaluation of currently available data. The
significant changes are listed briefly in this subsection and are
described in more detail below in the response to comment summaries.
The major changes in the residue removal standard are:
The performance standard was changed from 99.9999 percent
removal (``six 9's'') in the proposal to 99.99 percent removal (``four
9's'') in the final rule.
The wording was changed from ``The registrant shall
demonstrate for each container/formulation combination that the
standard is achieved'' in the proposal to ``Each container/formulation
combination must be capable of attaining the standard.'' The language
in the final rule provides more flexibility in showing compliance with
the standard, while still placing the responsibility of meeting the
standard on the registrant.
Testing (and the corresponding recordkeeping in Sec.
165.27(b)(5)) is only required for flowable concentrate formulations or
if EPA specifically requests the records on a case by case basis.
The test procedure will be established as an OPP test
procedure titled ``Rinsing Procedures for Dilutable Pesticide Products
in Rigid Containers,'' which is incorporated into the
[[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.
The residue removal standard only applies to containers
that are small enough to be shaken because the final test procedure and
the supporting data involved shaking the containers during triple
rinsing. As stated in Unit IX.I., EPA generally believes that the
largest containers that users can shake during a triple rinse are those
with capacities of 5 gallons for liquids and 50 pounds for solids.
In addition, the final residue removal test procedures,
incorporated in ``Rinsing Procedures for Dilutable Pesticide Products
in Rigid Containers,'' (Ref. 20) contain several key changes.
In the final test procedure, the test must be conducted on
three containers, rather than the proposed approach of a minimum of 19
containers.
Rather than the proposed statistical standard (at least 95
percent confidence that at least 85 percent of containers tested will
meet the standard), the final test procedure specifies that all three
containers tested must meet the four 9's standard in the final rule.
The final rule approach is similar to the standards for complying with
DOT's drop tests and other performance tests.
The final rule does not specify that the testing must be
conducted in compliance with the full set of Good Laboratory Practice
Standards in 40 CFR part 160. While registrants may comply with the GLP
standards, it is not required. However, some key GLP requirements are
specified in the final test procedure to accomplish the goals of
ensuring adequate quality of the testing and the resulting data.
iii. Comments. Several State regulatory agencies and a container
manufacturer group supported EPA's proposal to require a laboratory
standard for removing residue from nonrefillable containers. These
commenters stated that such a standard would enhance safe use and
recycling, facilitate management of empty containers and provide
flexibility to registrants.
A registrant and a registrant group supported consideration of a
residue removal performance standard but opposed the stringency of
EPA's proposal. Additionally, a few registrants commented that
encouraging the use of containers and formulations that facilitate
residue removal is reasonable, but did not support the proposed
standard.
Many respondents (from nearly all commenter categories, but mostly
the pesticide registrant industry) opposed the establishment of any
numeric standard for residue removal for the following reasons (which
are described in more depth in the Response to Comment document (Ref.
19)):
EPA doesn't demonstrate a problem;
Much of the information cited by EPA isn't relevant/
applicable;
The problem is that users don't rinse containers; not the
container designs; and
The solution is educating users and enforcing rinsing
standards.
Many commenters specifically opposed the six 9's standard as too
stringent. These comments claimed that the six 9's standard is overly
ambitious and that the standard would be too costly for the benefit
obtained. In many cases, commenters said the standard would be
impossible to achieve. While some respondents acknowledged that the six
9's standard is technologically feasible, they said it would not be
practical in application.
iv. EPA response. EPA believes that ensuring adequate residue
removal at the user level to achieve the goal of containers that can be
safely managed for disposal or recycling involves the following steps:
(1) The use of container designs and formulations that facilitate
effective residue removal;
(2) Defining proper cleaning procedures;
(3) Educating users about proper cleaning procedures;
(4) Motivating users to properly clean containers; and
(5) Enforcing proper cleaning in the field.
Problems and breakdowns can occur with any of these steps. If
problems do occur, containers will not be adequately clean when they
are offered for disposal or recycling. EPA acknowledges the commenters'
point that much of the problem with inadequately cleaned containers
lies with the fact that the users don't rinse them properly, implying a
breakdown in items 2, 3, and/or 4. EPA believes that the label
standards associated with these regulations establish proper and clear
cleaning procedures, as described in Units IX.F. - IX.K. EPA agrees
that it is important and appropriate to dedicate adequate resources to
user education and motivation and to enforcing the rinsing standards.
Additional efforts on these points will be discussed in Unit V.H.5.
However, EPA still believes that the first step in adequate
container cleaning - and a responsibility of the registrant - is making
sure that the containers can come clean. Therefore, EPA is retaining a
residue removal performance standard in the final regulations for rigid
nonrefillable containers with dilutable formulations. Additional
information about the many variables observed in more than 20 rinsing
studies and about the FIFRA Section 19 mandates is in the Response to
Comment document. (Ref. 19)
2. Numeric residue removal standard. EPA decided to change the
performance standard from 99.9999 percent removal (``six 9's'') in the
proposal to 99.99 percent removal (``four 9's'') in the final rule.
i. Comments. Several State regulatory agencies and an environmental
group specifically expressed support for the ``six 9's'' standard. One
State regulatory agency said their data show that 99.9999 percent
removal is achievable under field conditions. Another said that the
standard is achievable for most containers, but not for flat-topped
metal cans -- a container type it feels is not suited for use with
pesticides.
On the other hand, many commenters opposed the proposed six 9's
standard, stating that it was overly ambitious and too burdensome.
Specific comments include:
Almost 20 commenters, mostly registrants and registrant
groups, objected to EPA's interpretation of the residue removal data
and particularly opposed EPA's assessment that a level of six 9's was
technologically practicable.
About 20 commenters (mostly registrants and registrant
groups) urged EPA to base the standard on the risks involved. Many of
these respondents commented that there is no risk analysis showing that
residues in existing containers pose a theoretical or real threat or
that reaching a six 9's standard would substantially reduce this risk.
Many commenters, including registrants, registrant groups,
State regulatory agencies, a dealer and a dealer group, questioned the
cost-effectiveness of the six 9's standard.
Some registrants who opposed the six 9's standard favored
adopting a less stringent four 9's requirement. They termed it more
practical, in line with industry expectations, and the only achievable
level of removal.
One registrant group provided comprehensive comments during the
2004 reopening of the comment period based on the Ag Container
Recycling
[[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:
Isanti County: The rejection rate decreased from 20.9
percent in 1990 to 12.9 percent in 1991;
Polk, Pennington and Red Lake Counties: 9.5 percent in
1990 to 2.3 percent in 1991;
Pope County: 13.8 percent in 1990 to 14.1 percent in 1991;
Stevens County: 25.0 percent in 1990 to 0.2 percent in
1991; and
Swift County: 14.6 percent in 1990 to 2.7 percent in 1991.
(Ref. 17)
A 1996 report from the Minnesota Department of Agriculture confirms
that this trend continued over time. (Ref. 13) From 1990 through 1995,
the container rejection rate in Minnesota ranged from 10 percent to 20
percent, with a high of 35 percent. The report stated that ``Pesticide
users had a difficult time rinsing containers to acceptable standards.
Timing of the rinse, poor equipment for rinsing and inadequate rinsing
techniques resulted in many containers not being accepted.'' The
rejection rate for 1996 ranged from 0 percent to 2 percent.
Before 1995, a county in North Carolina collected about 2,500
containers per year and had a container rejection rate around 28
percent. After receiving a grant in 1995 which allowed the county to
expand the program to 12 convenient sites and to provide additional
training on proper rinsing, the county collected about 21,000
containers and the rejection rate dropped to 3 percent. (Ref. 10)
Nebraska and South Carolina report current rejection rates of 2 percent
on their web sites. Virginia reported a rejection rate of 0.5 percent
in 2002, which was higher than the 2000 rate but still deemed to be
acceptable. (Ref. 43)
EPA believes this information shows that the main reason containers
are rejected from pesticide container collection programs is because
they were not rinsed properly. EPA agrees with the States that the
container rejection rates decreased substantially over time as
pesticide users improved their rinsing techniques, rinsed the
containers before residue dried, and gained understanding of the
cleanliness criteria used by the Ag Container Recycling Council (ACRC)
recycling contractors. The ACRC contractors have a strong incentive to
carefully inspect containers to ensure they are clean because
contamination increases the risk to the contractor's workers and
reduces the value of the collected plastic. Therefore, we think it is
accurate to conclude that the lower rejection rates in recent years are
not a reflection of relaxed or reduced inspection standards.
EPA also believes that the container rejection rates from the
container collection and recycling programs show that containers do not
have to meet a standard of six 9's to be adequately cleaned. Table 7
shows that almost 60 percent of the agricultural formulations and
containers tested met a standard of six 9's. Assuming that the tested
formulations/containers are representative of the agricultural market,
we would expect to find a rejection rate of over 40 percent if a six
9's standard was necessary for adequate cleaning. Data from several
States show that currently a maximum of 2 percent of containers are
rejected, which is much lower than 40 percent. EPA interprets this to
indicate that meeting a standard of six 9's is not necessary to ensure
that a container is clean enough to be recycled safely.
EPA disagrees with commenters who stated that the residue removal
standard should be based solely on toxicological significance, because
establishing and proving compliance with such a standard would be very
complex. In addition, any amount of residue in a container could cause
a disruption to its proper disposal or recycling because of the
perception of risk the concentration of active ingredient may not be
relevant in such a situation. However, toxicity and relative risk are
indirectly taken into account for the nonrefillable residue removal
standard in the final rule because of the changes in the scope of the
container regulations. The less toxic/risky pesticide products (those
in Toxicity Categories III and IV and that are not restricted use
pesticides) are subject only to the basic DOT standards, and are exempt
from some of the container requirements, including this one. Only
products that are in Toxicity Category I and II and others that are
restricted use products are subject to the residue removal standard in
the final rule.
Setting the residue removal standard at four 9's in the final rule
will reduce the costs of implementing the regulations because a higher
percentage of existing container/formulations will comply with the
standard. Therefore, fewer container design changes, re-formulations,
and modification or
[[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:
A registrant group and a registrant commented that several
transcription errors were made in constructing Table 1 (triple rinsing
data for agricultural containers/formulations) in the preamble of the
proposed rule. One of the respondents added that these errors undermine
the credibility of the data and the arguments developed that use the
data as their basis.
A registrant questioned whether the research data were
generated under GLPs.
Two registrants questioned whether the data are truly
representative of containers/formulations that are subject to the
regulations.
A registrant commented that data other than EPA's
(Formulogics), NACA's and CSMA's are not relevant because they are not
generated from the same test procedures.
A registrant group and a few registrants expressed concerns that
the EPA data for non-agricultural pesticide markets (in Table 2 of the
preamble of the proposal) are not representative of the household,
industrial and institutional markets. All of these commenters pointed
out that the EPA data do not include tests on dilutable antimicrobial
products or similar formulations. In addition, the registrant group
stated that EPA (Formulogics) did not test formulations containing
active ingredient concentrations lower than 38 percent by weight. This
respondent also added that the data provided by CSMA cover a small but
representative number of nonagricultural container/formulation
combinations and that most of them (10 out of 12) would not meet the
six 9's standard.
ii. EPA response. EPA agrees that residue removal data produced
using a rinsing procedure other than the one identified in the EPA
standard methodology are not relevant to supporting or changing a
regulatory standard. As stated in Unit V.H.2., four sets of data were
developed using a standard testing procedure (that is very similar to
the final test procedure) to test currently used formulations and
container designs. Two sets of data focused on containers and
formulations typical in the agricultural pesticide market and the other
two were intended to represent containers and formulations in the
household, institutional and industrial market. Even though the testing
to develop these four sets of data was done in the early 1990's, EPA
believes that the formulations and containers tested are still commonly
used.
Table 7 presents the results of these studies in terms of the
standard that the container/formulation would meet based on the
concentration of active ingredient in the rinsate from the fourth
rinse. The following table presents the information in a somewhat
different format. In Table 9, each container/formulation combination is
included only once per row in the column for the most stringent
standard it would meet. For example, if the percent removal for a
container/formulation combination was 99.9992 percent, it would be
listed only in the five 9's column (even though it also meets a
standard of four 9's).
Table 9.--Analysis of Residue Removal Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cntr/ Number of Container/Formulation Combinations That:\1\
Form ---------------------------------------------------------------------------
Study Name Combinations Don't meet Four
Tested 9's Meet Four 9's Meet Five 9's Meet Six 9's
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formulogics (agricultural) 19 0 (0%) 2 (11%) 4 (21%) 13 (68%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NACA (triple rinse) 24 0 (0%) 5 (21%) 7 (29%) 12 (50%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formulogics (nonagricultural) 29 0 (0%) 3 (10%) 10 (34%) 16 (55%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CSMA 7 1 (14%) 2 (29%) 3 (43%) 1 (14%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 79 1 (1%) 12 (15%) 24 (30%) 42 (53%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Same note as Table 7.
[[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:
Too many tests required: Some respondents, including
registrants, registrant groups, and a container manufacturer group,
expressed concern that the proposed residue removal standard and the
interpretation of design type as expressed in the proposed rule would
necessitate testing for virtually every container/formulation
combination in every size and variation. They said the costs to
registrants would be crippling and asked EPA to consider alternatives.
Design type clarification: Several commenters asked for
clarification of EPA's criteria for determining whether containers are
the same or different. They urged a broad definition of design type to
reduce the testing burden.
Formulation similarities: Several commenters suggested
ways to eliminate duplicative testing on the basis of formulation, such
as granting waivers to products that meet certain physical property
criteria or to formulations similar to ones that have already passed.
Industry task force: Some agricultural registrants and a
registrant group voiced support for a plan to establish an industry
task force that would conduct studies to determine the physical
properties of formulations and containers that meet the four 9's
standard. Combinations matching those criteria would be exempted from
testing; necessary testing would be limited to broad categories of
product/container combinations developed by the studies.
ii. EPA response. Many of the changes in the residue removal
standard discussed in the previous sections reduce the cost of
complying with this standard, including:
Changing the scope of the nonrefillable container
regulations so only dilutable products in Toxicity Category I or II or
that are restricted use products have to comply with the residue
removal standard;
Reducing the standard from 99.9999 percent to 99.99
percent removal; and
Changing the testing protocol.
Despite these changes, the estimated costs of complying with the
residue removal standard were still a fairly large percentage of the
overall annual costs and costs per facility. Rather than trying to
minimize the burden to registrants by trying to identify and define
substantially similar containers and formulations, EPA believes it is
better to require testing only for formulations and containers that
have shown to be difficult to clean. As stated earlier, EPA believes
the data show that most containers/formulations can meet a four 9's
standard although practical experience with container recycling
programs shows that there are problems with certain formulations.
Because a universal approach (testing all products subject to the
regulations) to identify the exceptions (the problematic formulations)
is inefficient, EPA believes there is a more efficient yet effective
way to implement the residue removal standard in the final regulations.
In particular, the final rule takes the following approach:
All dilutable liquid products in rigid containers must be
capable of meeting the 99.99 percent removal standard. This sets a
minimum standard for all products.
On the basis of the Formulogics and NACA data, EPA is
making the assumption that nearly all products meet a standard of 99.99
percent removal, and therefore is requiring testing only in limited
circumstances. In particular, registrants only have to conduct the
residue removal testing if the products are flowable concentrate
formulations or if EPA requests the test data on a case-by-case basis.
Accordingly, the recordkeeping standards in Sec.
165.27(b)(5) were changed so recordkeeping of test results is only
required for flowable concentrate formulations or if EPA specifically
requests the records on a case-by-case basis.
EPA chose to require testing of flowable concentrate formulations
for several reasons. First, the results of the four studies in Table 7
show that there is a difference in rinsing efficiency between the
formulation types that were tested, specifically flowable concentrates,
emulsifiable concentrates, aqueous solutions, and encapsulated
formulations. Tables 10, 11, and 12 show the data from the studies in
Table 7 with the residue removal performance broken down by formulation
type. The results - particularly for the studies with the most testing
- show that flowable concentrate formulations had the biggest
difference between meeting four 9's and five 9's, which suggests that
these kinds of products may generally be a little more difficult to
remove from containers due to characteristics of the formulation type
in general. The emulsifiable concentrates tested generally reached a
five 9's level of residue removal but showed a similar difficulty as
flowable concentrates in reaching the six 9's level of residue removal
in the Formulogics study of agricultural formulations and containers.
While not completely conclusive, EPA believes these data support the
observation that flowable concentrates may generally be more difficult
to remove from containers than other kinds of formulations.
Table 10.--Analysis of Residue Removal Data by Formulation Type - Agricultural Formulations and Containers
(Formulogics & NACA)
----------------------------------------------------------------------------------------------------------------
Total Cntr/Form Number of Containers/Formulations That Meet:
Formulation Combinations --------------------------------------------------------
Tested Four 9's Five 9's Six 9's
----------------------------------------------------------------------------------------------------------------
Flowable concentrate 15 15 11 10
----------------------------------------------------------------------------------------------------------------
Emulsifiable concentrate 20 20 18 12
----------------------------------------------------------------------------------------------------------------
Encapsulated 4 4 3 1
----------------------------------------------------------------------------------------------------------------
Aqueous Solution 3 3 3 1
----------------------------------------------------------------------------------------------------------------
Dry Flowable 1 1 1 1
----------------------------------------------------------------------------------------------------------------
Total 43 43 36 25
----------------------------------------------------------------------------------------------------------------
[[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.
Sec. 165.25(a): DOT standards for pesticide products that
are not DOT hazardous materials. EPA may waive or modify the
requirements of Sec. 165.25(a) if EPA determines that an alternative
(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in
the requirements of Sec. 165.25(a).
Sec. 165.25(b): DOT standards for pesticide products that
are DOT
[[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.
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.
Sec. 165.25(e): Container dispensing capability. EPA may
waive or modify the standards in Sec. 165.25(e) if EPA determines that
at least one of the following conditions is satisfied:
(1) The product is typically removed from the container by a method
other than pouring.
(2) Compliance with the container dispensing capability standards
would increase exposure to the pesticide container handler.
Sec. 165.25(f): Residue removal standard. EPA may waive
or modify the requirements of Sec. 165.25(f) if EPA determines that
both of the following conditions are satisfied:
(1) The residue remaining in the container would not cause an
unreasonable adverse effect on the environment; and
(2) The product offers significant benefits and cannot be
economically reformulated or repackaged.
2. Changes. The final rule is significantly different than the
proposal. Additional waiver/modification provisions were added and all
of the criteria were consolidated into one section. The proposed rule
included waiver/modification provisions only for the standard closure
and residue removal requirements. The waiver/modification criteria for
the standard closure requirement in the final rule are similar to the
proposed regulations, although a few minor editorial changes were made.
Also, the final rule clarifies that both criteria must be met before
EPA will approve the use of an alternative closure, which was the
intent of the proposed rule. The waiver/modification provision for the
residue removal requirement was modified to add specific criteria that
must be met. This change was made partly because the proposed criterion
for waiving or modifying the residue removal standard was very broad
and partly because a more specific and limited waiver/modification
standard is appropriate with the less stringent residue removal
standard in the final rule. The final rule incorporates a DOT waiver
provision similar to the one set out in the potential alternative
regulatory text in the 1999 supplemental notice. EPA modified the DOT
waiver provision in several ways to address a few comments about the
problems that could be caused if EPA changed the adopted DOT
requirements for pesticides that are DOT hazardous materials. First, a
separate waiver/modification provision is included for pesticides that
are not DOT hazardous materials and for pesticides that are DOT
hazardous materials. Second, the waiver/modification provision for
pesticides that are DOT hazardous materials specifies that EPA will
modify or waive the requirements in Sec. 165.25(b) only after
consulting with DOT to ensure consistency with DOT regulations and
exemptions. The final rule also adds waiver/modification provisions for
the container dispensing standards.
The waiver/modification provisions are included to address
situations where the nonrefillable container requirements might
compromise the success, safety and effectiveness of currently used
containers or those developed in the future. While EPA has attempted to
focus each nonrefillable container requirement on containers and
pesticides for which it is appropriate, we are not familiar with every
container used for every product. It is likely that there are some
problematic situations where existing containers that are specifically
designed for a certain use or adaptation may have difficulty complying
with the final regulations. We may not be aware of these situations and
they may not have been mentioned by commenters. In general, waivers or
modifications are intended to provide relief for a limited number of
situations, and we wanted to provide a mechanism to account for these
situations without having to amend the regulations. Waivers and
modifications are appropriate in a limited number of situations, such
as the use of non-standard closures, since the point of the requirement
is to limit the number of closures (and therefore adapters) to
encourage the use of closed transfer systems.
J. Procedure for Applying for a Waiver or Modification (Sec.
165.25(h))
1. Final regulations. Section 165.25(h) describes the procedure for
registrants to follow if they want to obtain a waiver from or a
modification to any of the nonrefillable container standards. The
regulations specify that a registrant cannot distribute or sell a
pesticide product in a nonrefillable container that does not comply
with all of the nonrefillable container standards unless and until EPA
approves the request for the waiver or modification in writing.
To obtain a waiver or modification, a registrant must submit a
written request for a waiver or a modification to the EPA's Office of
Pesticide Programs at the address provided in the regulations. Two
copies of the following information (which may be part of an
application for registration or amended registration) must be included
with the request:
The name and address of the registrant; the date; and the
name, title, signature, and phone number of the company official making
the request.
The name and EPA registration number of the relevant
pesticide product.
A statement specifying the requirement(s) from which the
waiver or a modification is requested.
A description of the relevant nonrefillable container(s).
Documentation or justification to demonstrate that the
applicable waiver or modification criteria in Sec. 165.25(g) are
satisfied.
2. Changes. The procedure for obtaining all waivers and
modifications is essentially the same as the procedure proposed (in
Sec. 165.119) for obtaining a waiver of the standard closure
requirement. No specific procedure was identified for the residue
removal waiver in the proposed rule or for the waiver from DOT
requirements in the 1999 supplemental notice. Consolidating all of the
waiver criteria in Sec. 165.25(g) and using the same procedure for all
waivers requests should facilitate the process for registrants and EPA.
Therefore, the significant change to the waiver procedure requirements
in the final rule is that they clearly apply to all waiver requests.
Several additional minor modifications were made to the final rule,
including updating the address, clarifying the statement requiring EPA
approval before a pesticide product can be sold or distributed in
containers with waived or modified requirements, broadening several of
the information items to accommodate the additional waiver provisions,
and clarifying that a waiver request could apply to more than
[[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:
The name and EPA registration number of the product.
A description of the container(s) used to distribute or
sell the product.
Documentation of compliance with the closure requirement,
if applicable.
Documentation of compliance with the dispensing
requirement, if applicable.
Documentation of compliance with the residue removal
requirement, if applicable.
The registrant must make these records available for inspection or
copying upon request by an employee of EPA or any entity designated by
EPA, such as a State, another political subdivision or a Tribe.
2. Changes. The requirements are substantially the same as
proposed. Several minor modifications were made in the final rule to
improve the clarity of the recordkeeping requirements, including:
Deleting ``design type'' in several places to clarify that
the requirements apply to the containers used to distribute or sell the
product. However, the specific records for the dispensing and residue
removal recordkeeping allow information for different containers and
products to be used to document compliance, under the specified
conditions.
The first sentence in the recordkeeping requirement in the
final rule was revised to clarify that the recordkeeping applies to
pesticide products distributed or sold in nonrefillable containers and
that are subject to the full set of nonrefillable container regulations
in Sec. Sec. 165.25 - 165.27. In other words, products that are
completely exempt and products that must comply only with the standards
in 49 CFR 173.24 do not have any recordkeeping requirements. This
change was necessary because of the changes in the scope of products
that are subject to the nonrefillable container standards.
Because the requirement for registrants to submit a
certification is not being finalized, the need to keep a record of the
certification is no longer necessary.
For the closure-related records, several minor changes
were made to further describe the kinds of documentation that would be
acceptable.
M. Proposed Standards That Are Not Being Finalized
1. Final regulation/changes. The following requirements relating to
container design from the proposed regulation are not being finalized
in the final rule:
Sec. 165.102(b): Container integrity and compatibility;
Sec. 165.102(c)(1): Permanently marking the EPA
registration number;
Sec. 165.102(c)(2): Permanently marking the container's
material of construction;
Sec. 165.102(d)(3): Requiring the container to reclose
securely; and
Sec. 165.106: Residue removal methodology for dilutable
products in rigid containers
Sec. 165.111: Certification.
Three of these proposed requirements for nonrefillable containers
are not being finalized because they were replaced by equivalent DOT
requirements. The following table lists the non-finalized requirements
from the proposed rule and the DOT equivalent regulations:
Table 13.--Proposed Nonrefillable Container Standards That Were Not
Finalized and Their DOT Equivalents
------------------------------------------------------------------------
Proposed Pesticide Container Proposed 40 CFR Equivalent 49 CFR
Requirement Cite Cite
------------------------------------------------------------------------
Container integrity and Sec. 165.102(b) Sec. Sec.
compatibility 173.24(b),
173.24(e)
------------------------------------------------------------------------
Permanently marking the material Sec. Sec. Sec.
of construction 165.102(c)(2) 178.3(a),
178.503(a)
------------------------------------------------------------------------
Requiring the container to Sec. Sec. 173.24(f)
reclose securely 165.102(d)(3)
------------------------------------------------------------------------
As discussed in Units V.H.1. and V.H.4., the residue removal
testing methodology that was proposed in Sec. 165.106 is not being
finalized in the regulatory language and will be incorporated into
EPA's testing guidelines. The test procedure is established as an OPP
test procedure titled ``Rinsing Procedures for Dilutable Pesticide
Products in Rigid Containers.'' (Ref. 20) The proposed regulatory
language provided some details of the test procedure, which EPA
intended to supplement with guidance. The final rule does not include
the specific testing requirements because we believe it is more
appropriate to provide these details in a test protocol than in the
regulations.
EPA decided not to finalize the proposed requirement in Sec.
165.102(c)(1) that each nonrefillable container be permanently marked
with the EPA registration number of the pesticide in the final rule.
Also, EPA is not finalizing the proposed requirement in Sec. 165.111
for registrants to certify that their nonrefillable containers meet the
standards and to submit the certifications to EPA.
2. Comments - EPA registration number. Several State regulatory
agencies supported requiring the EPA
[[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:
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.
An inadequate transition period would significantly
increase the cost of compliance with this rule. Major costs would be
avoided as long as it is not necessary to dispose of packaging which
has not yet reached the end of its useful life or to recall packaging
which is still in the distribution channels and has not yet reached its
final destination. The suggested transition periods would minimize the
cost impact of the EPA container regulation.
Pesticide products change hands several times as they move
down the distribution chain from the basic producer to the end user
(basic producers, formulators, distributors, retail dealers, brokers,
custom applicators and end users). In many cases, the movement of
materials is reversed when products are not consumed.
The distribution process normally is completed in a given
sales year. However, when materials are not consumed, inventories build
at all levels of the distribution chain. Quite often materials may be
held in inventory for multiple years before re-entering the
distribution network. During periods when materials are being held in
inventory, the pesticide formulators and others are negatively impacted
when regulatory changes are imposed on products in the distribution
chain (rather than on products that will be sold or distributed at some
future date), which involves substantial expenses to producers with, in
most cases, no justifiable gain in safety.
4. EPA response. As described above, EPA is extending the
compliance period for refillable containers to 5 years to provide for a
smoother and less burdensome transition for companies. Companies that
have already made significant investments in refillable containers will
be able to use their existing containers for 5 years, which covers the
average expected lifetime of a plastic minibulk container. Also, the
changes to the refillable container standards will allow existing
refillable containers that meet the DOT Packing Group III standards to
be retrofitted relatively easily (by durably marking each container
with a serial number and having a one-way valve and/or tamper-evident
device on each opening of liquid minibulk containers) so they can
continue being used. EPA believes that the longer compliance period in
the final regulations is reasonable and should apply equally to all
products and all refillable containers.
E. Pesticide Products Included (Sec. 165.43(a) - (g))
1. Final regulations. As described in detail in Unit III., only
certain products have to comply with the refillable container
standards. MUPs, plant-incorporated protectants, and certain
antimicrobial products are completely exempt from the refillable
container requirements. All other pesticide products are subject to the
refillable container regulations.
Some of the antimicrobial pesticides that are subject to the
refillable container regulations are subject to a reduced set of
regulations. In particular, antimicrobial pesticides that are used in
swimming pools and closely related sites (such as hot tubs, spas and
whirlpools) are exempt from the requirements for marking the serial
number and having a one-way valve and/or tamper-evident device on each
opening.
2. Changes. In the proposed rule, only MUPs were exempt from the
refillable container regulations (in Sec. 165.122(b)(1)). All other
products would have been subject to the standards. The 1999
supplemental notice discussed regulatory options for exempting some
products (antimicrobials and non-antimicrobials) from the full set of
refillable container regulations and for exempting certain
antimicrobial products from specific requirements.
The criteria in the final rule for exempting antimicrobials are
different than those discussed in the supplemental notice and the final
rule exempts plant-incorporated protectants. The final refillable
container regulations do not incorporate the toxicity category,
container size or environmental hazard criteria from the supplemental
notice. Also, the final rule changes some aspects of the supplemental
notice approach of subjecting antimicrobial swimming pool products to a
reduced set of requirements.
Table 14 describes the provisions for determining which pesticide
products are subject to which refillable container regulations and a
brief explanation of how (or if) this provision changed from the
proposal and/or the supplemental notice.
Table 14.--Changes to the Scope of the Refillable Container Regulations
------------------------------------------------------------------------
Regulatory Provision Changes
------------------------------------------------------------------------
Manufacturing use products are exempt. No change from proposed rule or
supplemental notice.
------------------------------------------------------------------------
Plant-incorporated protectants are Plant-incorporated protectants
exempt. would have been subject to the
proposed rule. The regulations
for plant-incorporated
protectants were finalized in
2001. We are exempting them
from the final rule because of
their unique nature.
------------------------------------------------------------------------
Certain antimicrobial products are Antimicrobial products would
exempt. have been subject to the
proposed rule. The final rule
implements an approach similar
to option 1 in the
supplemental notice, although
some of the details are
different.
------------------------------------------------------------------------
All other products are subject to the All products other than
refillable container requirements, manufacturing products would
except for certain antimicrobial have been subject to the
swimming pool products. proposed rule. The final rule
is different than the approach
discussed in the supplemental
notice, which would have
exempted products in Toxicity
Category III or IV in small
containers and outdoor use
products without the specified
environmental hazard
statements on their label.
------------------------------------------------------------------------
Antimicrobial products used in swimming Antimicrobial products used in
pools and closely related sites are swimming pools would have been
subject to a reduced set of refillable subject to the proposed rule.
container requirements. The final rule is the result
that was intended in the
supplemental notice, although
the specifics of how it is
implemented in the final rule
are different than in the
supplemental notice.
------------------------------------------------------------------------
[[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:
Chloropicrin is a highly volatile liquid that is shipped
and handled essentially like a gas.
End-use formulations containing chloropicrin are shipped
in refillable steel containers manufactured under the same DOT
specifications as propane cylinders.
Chloropicrin containers typically have only one
specialized valve for filling and emptying the cylinder and specialized
connections are required to fill them.
Chloropicrin cylinders contain screw-on valve protections
known as bonnets. The commenter stated that adding external one-way
valves is not possible due to space limitations and increasing the size
of the bonnets would reduce the ability of the bonnet to protect the
valve.
In addition, the commenter claimed that:
The specialized valve and refilling connections minimize
the chance of contamination or unauthorized filling.
No valves were available in 1994 that were compatible with
chloropicrin and that allow filling and emptying the container through
a one-way valve.
Installing one-way valves on thousands of existing
cylinders could cause unnecessary worker exposure.
6. EPA response - chloropicrin. EPA agrees that the one-way valve/
tamper-
[[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:
Resistant to extreme changes in temperature,
Constructed of materials that are adequately thick and
that are resistant to corrosion, puncture, or cracking, and
Capable of withstanding all operating stresses.
As proposed, these requirements do not apply during a civil
emergency or any unanticipated grave natural disaster or other natural
phenomenon of an exceptional, inevitable and irresistible character,
the effects of which could not have been prevented or avoided by the
exercise of due care or foresight.
Second, several other standards apply only to liquid bulk
containers. Specifically,
They must be equipped with a vent or other device designed
to relieve excess pressure, prevent losses by evaporation, and exclude
precipitation.
External sight gauges are prohibited.
Each container connection below the normal liquid level
must be equipped with a shutoff valve, which is capable of being locked
closed.
Shutoff valves must be located within a secondary
containment unit (if secondary containment is required).
2. Changes. There were several changes in this section from the
proposed rule. First, the description of containers that must comply
with these requirements was changed to be consistent with the
quantities for secondary containment structures
[[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:
Sec. 165.124(b)(1)(i) - (v) and (vii): Permanent marking
other than serial numbers
Sec. 165.124(b)(2): Compliance with DOT's marking
satisfies the corresponding EPA permanent marking requirement
Sec. 165.124(c): General minibulk integrity standard
Sec. 165.124(d): Drop test for minibulk containers
(requirement)
Sec. 165.125: Minibulk container drop test methodology
(test procedure)
Sec. 165.128(a) & (b): Keep records of container
descriptions, minibulk drop test results and the GLP statement
specified for the drop test.
Sec. 165.126: Certification
Sec. 165.128(c): Keep records of the certification.
The first six proposed standards are not being finalized in the
refillable container regulations because the approach of referring to
and adopting a subset of the DOT standards makes them unnecessary. In
particular:
Some of the items for permanent marking in proposed Sec.
165.124(b)(1)--the container manufacturer, date of manufacture, rated
capacity, and material of construction--are not being finalized because
this information is required in the DOT standards that specify marking.
Two other proposed pieces of information--the model number and the
phrase ``Meets EPA
[[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.
The statement proposed in Sec. 165.124(b)(2) is not being
finalized because the final rule specifically refers to the DOT
marking, so it is no longer necessary to include a provision stating
that compliance with DOT's marking satisfies the corresponding EPA
marking requirement.
The proposed general minibulk integrity standard in Sec.
165.124(c) is not being finalized because the DOT regulations address
container integrity in 49 CFR 173.24.
The proposed drop test requirement for minibulks in Sec.
165.124(d) and the proposed minibulk container drop test in Sec.
165.125 are not being finalized because the DOT regulations include a
drop test requirement. The drop test procedure for nonbulk packagings
is defined in 49 CFR 178.603 and the drop test procedure for
intermediate bulk containers is defined in 49 CFR 178.810.
The proposed recordkeeping requirements in Sec.
165.128(a) and (b) for container descriptions, drop test results and a
GLP statement for the drop test are not being finalized because they
are no longer necessary because compliance with the DOT requirements
can be ensured by the structure and certification standards in the DOT
HMR. Because we can rely on the DOT or UN marking to ensure compliance
with the applicable DOT requirements, EPA no longer needs to see
records of the testing to confirm compliance with the drop test (and in
the final rule) and other test requirements.
The final two proposed items listed above--having registrants
certify compliance with the regulations and the associated
recordkeeping--are not being finalized for the same reasons that the
nonrefillable container certification and recordkeeping are not being
finalized, as described in Unit V.M.
N. Options for Implementing the Rule
1. Final regulations. In the preamble to the proposed rule, EPA
discussed three options for implementing the refillable container and
repackaging standards, which were all in one subpart in the proposed
rule. These options covered different approaches for determining who
would be held responsible for ensuring that the refillable containers
meet the refillable container standards. EPA considered several options
because the pesticide products distributed or sold in refillable
containers and the containers themselves often enter the pesticide
distribution chain separately, so identifying responsibility for
compliance is not as straightforward as it is for nonrefillables, which
the registrants fill at their establishments.
In evaluating the options for container design responsibility, EPA
considered the differences among the options in terms of seeking the
least burdensome approach that is also effective, practicable, and
easily enforceable. In the proposal, we identified Option 1 as our
preferred option (as indicated in the proposed regulatory text) because
we thought it was more effective, more practicable, and significantly
more easily enforceable than the other two options. The three options
are described below.
Option 1. Registrants would be responsible for containers
meeting the design standards. The containers would be marked ``Meets
EPA standards for refillable pesticide containers'' and registrants
would maintain records for their containers. The registrants would
develop a list of acceptable containers for each product, identified by
manufacturer and model number, and provide the list to refillers.
Refillers could repackage pesticide only in containers identified on
the registrants list.
Option 2. Anyone could produce containers, certify to EPA
that the containers meet EPA design standards, and receive permission
to mark containers with EPA certification seal. This could be container
manufacturers, but it could also be registrants, refillers, or even end
users. EPA would compile a list of certified container models.
Registrants and refillers could repackage products only into certified
containers. Registrants would develop a list of acceptable container
construction materials for each product and provide the list to
refillers, who could refill only into certified containers made from
materials identified as acceptable by the registrant.
Option 3. Container manufacturers would be responsible for
containers meeting EPA's design standards and would mark containers
with a certification seal. Container manufacturers would keep records
for containers. Registrants would develop a list of acceptable
container materials for each product and provide the list to refillers.
Registrants and refillers would repackage only into containers marked
with the seal and made of materials identified as acceptable by the
registrant.
As discussed in the 1999 supplemental notice, EPA is implementing a
combination of Option 1 and Option 3 in the final rule.
2. Changes. The key change from the proposed rule is that the final
regulations adopt and refer to the DOT standards for container design,
construction and marking, as discussed in Unit IV. Therefore,
registrants only have to ensure that they use containers that meet the
cross-referenced DOT standards for container integrity, construction
and testing, rather than being responsible for the testing themselves.
Registrants must also ensure compliance with the permanent marking
(serial number) and opening (one-way valve/tamper-evident device)
requirements. Because containers will be identifiable by the UN/DOT
marking, some of the repackaging standards can be adjusted to be more
flexible. Specifically, rather than requiring the registrants to
identify acceptable containers by the model numbers and container
manufacturers, they will be able to identify acceptable containers by
the appropriate level of DOT testing (Packing Group I, II or III) and
the container materials that are compatible with the product. The
general structure of the repackaging standards, though, remains as
proposed: (1) Registrants are responsible for developing certain
information and providing it to the refillers; (2) refillers have
certain responsibilities for inspecting, cleaning, and labeling the
container since they are the ones actually handling the containers; and
(3) both registrants and independent refillers have certain
responsibilities if an independent refiller repackages a registrant's
product. The changes to the repackaging regulations are discussed in
more detail in Unit VII.
VII. Repackaging Standards
A. Format Changes
Final regulation and changes. In the proposed regulation, the
refillable container design standards and the repackaging requirements
were included in the same subpart of the regulations. In the final
rule, EPA moved the repackaging requirements into a separate subpart
because we think separating the two kinds of requirements will make the
regulations easier to understand. The container design requirements are
mostly technical and apply mostly to registrants. The repackaging
requirements are mostly procedural and apply to registrants and to
anyone who repackages pesticide products into refillable containers,
which could be registrants, distributors, retailers, or other kinds of
companies.
[[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:
Registrant who distributes or sells a pesticide product in
refillable containers. This means that you conduct all of the
repackaging for a pesticide product and that you do not distribute or
sell your pesticide product to a refiller that is not part of your
company for repackaging into refillable containers.
Registrant who distributes or sells a pesticide product to
a refiller that is not part of your company for repackaging into
refillable containers.
Refiller of a pesticide product and you are not the
registrant of the pesticide product.
As explained in Units VII.J. and VII.K., a registrant may repackage
a product directly into refillable containers for sale or distribution
and distribute or sell that same product to an independent refiller for
repackaging. In this case, the registrant must comply with both sets of
requirements.
2. Changes. The same kinds of businesses that were included in the
proposed rule (in Sec. 165.122(a)(1), (2) and (3)) are subject to the
final rule. One minor modification was to clarify that refillers in the
last two categories are refillers that are not part of the registrant's
company. Registrants can also be refillers, which is the situation
described in the first category; the registrant conducts all of the
packaging and repackaging. Therefore, the changes are intended to
clarify that the second and third category refer to independent
refillers, i.e., refillers that are not part of the registrant's
company.
D. Compliance Dates (Sec. 165.60(c))
1. Final regulations. The final regulations provide a 5-year period
after the date of publication of the final rule in the Federal Register
before compliance with the repackaging standards is required.
Specifically, within 5 years from today's date, all products sold in
refillable containers must be distributed or sold in compliance with
these regulations.
2. Changes. Based on the comments relating to refillable container
design as described in Unit VI.D., EPA decided to extend the compliance
period for the refillable container regulations from the 2-year time
frame that was proposed in Sec. 165.139. The longer time frame is to
provide for a smoother and less burdensome transition for companies.
Because the repackaging regulations require pesticide product to be
repackaged only into containers that meet the refillable container
standards, the compliance date for these regulations needed to be
changed for consistency.
E. Pesticide Products Included (Sec. 165.63(a) - (g))
1. Final regulations. As described in detail in Unit III., only
certain products have to comply with the repackaging standards. MUPs,
plant-incorporated protectants, and certain antimicrobial products are
completely exempt from the repackaging requirements. All other
pesticide products are subject to the repackaging regulations. This is
identical to the scope of the refillable container regulations.
Some of the antimicrobial pesticides that are subject to the
repackaging regulations are subject to a reduced set of regulations. In
particular, antimicrobial pesticides that are used in swimming pools
and closely related sites (such as hot tubs, spas and whirlpools) are
exempt from certain recordkeeping requirements, as well as the parts of
the standards for inspecting and cleaning containers that relate to
serial numbers, one-way valves, and tamper-evident devices.
2. Changes. In the proposed rule, only MUPs were exempt from the
repackaging requirements, which were included in the refillable
container regulations (see Sec. 165.122(b)(1)). All other products
would have been subject to the standards. The 1999 supplemental notice
discussed regulatory options for exempting some products
(antimicrobials and non-antimicrobials) from the full set of refillable
container regulations including the repackaging requirements and for
exempting certain antimicrobial products from specific requirements.
The criteria in the final rule for exempting antimicrobials are
different than those discussed in the supplemental notice and the final
rule exempts plant-incorporated protectants. The final repackaging
regulations do not incorporate the toxicity category, container size or
environmental hazard criteria from the supplemental notice. Also, the
final rule changes some aspects of the supplemental notice approach of
subjecting antimicrobial swimming pool products to a reduced set of
requirements.
The following table describes the provisions for determining which
pesticide products are subject to the repackaging regulations and a
brief explanation of how (or if) this provision changed from the
proposal and/or the supplemental notice.
Table 15.--Changes to the Scope of the Repackaging Regulations
------------------------------------------------------------------------
Regulatory Provision Changes
------------------------------------------------------------------------
Manufacturing use products are exempt. No change from proposed rule or
supplemental notice.
------------------------------------------------------------------------
[[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:
The repackaging results in no change to the pesticide
formulation.
One of the following conditions regarding a registered
refilling establishment is satisfied:
(1) The pesticide product is repackaged at a refilling
establishment registered with EPA as required by Sec. 167.20 of this
chapter.
(2) The pesticide product is repackaged at the site of a user who
intends to use or apply the product by a refilling establishment
registered with EPA as required by Sec. 167.20.
The registrant has entered into a written contract with
the refiller to repackage the pesticide product and to use the label of
the pesticide product.
The pesticide product is repackaged only into refillable
containers that meet the standards of subpart C.
The pesticide product is labeled with the product's label
with no changes except the addition of an appropriate net contents
statement and the refiller's EPA establishment number.
In addition, the regulations (Sec. Sec. 165.67(c) and 165.70(c))
state that repackaging a pesticide product for distribution or sale
without either obtaining a registration or meeting all of the
conditions listed above is a violation of section 12 of FIFRA. Both the
registrant of the product and the refiller that is repackaging the
pesticide product under contract to the registrant may be liable for
violations pertaining to the repackaged product.
3. Changes. One significant change to these conditions for
repackaging pesticide products for distribution or sale is to add the
specification that the pesticide product can be repackaged by a
registered refilling establishment at the site of a user who intends to
use or apply the product as an acceptable alternative to the condition
that the product must be repackaged at a registered refilling
establishment. This change is discussed in detail in Unit VII.I. below.
Another change is that the final rule specifies that the registrant
must enter into a written contract with the refiller. The proposed
option for the registrant to enter into a ``written authorization''
with the refiller is not being finalized for several reasons. First,
EPA believes it is not necessary to have two different mechanisms. It
is more straightforward to specify one method, which should facilitate
compliance and minimize confusion. Second, EPA believes that a
``written contract'' is more familiar to the regulated community and
more defined in law than a ``written authorization,'' which is why we
chose to specify contracts as the mechanism for establishing a
repackaging relationship between the registrant and refiller in the
final rule. Third, in the years since the Bulk Pesticides Enforcement
Policy was issued, the ``written authorizations'' have become virtually
indistinguishable from ``written contracts'' in format, length and
level of detail. Therefore, EPA anticipates that specifying a contract
(and not an authorization) in the final rule should not cause a
substantial impact to the way repackaging is currently being conducted,
particularly considering the 5-year implementation period for the
refillable container and repackaging regulations. The other
modifications were minor formatting changes that were needed to
accommodate: (1) the revision to plain language; (2) needing to include
the conditions in the requirements for registrants who distribute or
sell to independent refillers and in the requirements for independent
refillers; and (3) clarifying that the EPA establishment number added
to the label is the refiller's EPA establishment number.
4. Comments - implementation. One registrant urged EPA not to
eliminate the ability of manufacturers and distributors that are not
registrants of an MUP to repackage that product for distribution and
sale.
5. EPA response - implementation. In the preamble to the proposed
regulations, EPA stated that the Bulk Pesticides Enforcement Policy
would remain in effect until the date specified for compliance with the
refillable container and repackaging regulations, at which point it
would be rescinded. EPA will implement this as discussed in the
preamble to the proposal. The refillable container and repackaging
regulations will supersede the Bulk Policy for products that are
subject to these regulations. Pesticide products that are exempt from
the refillable container and repackaging regulations--MUPs, plant-
incorporated protectants, and some antimicrobials--can only be
repackaged under the limitations established by FIFRA, the registration
requirements in 40 CFR part 152, and the applicable OPP policies. A key
[[Continued on page 47379]]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
]
[[pp. 47379-47428]] Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment
[[Continued from page 47378]]
[[Page 47379]]
limitation is that the products that are exempt from the refillable
container and repackaging regulations must be repackaged by the
registrant or a person under written contract to the registrant. EPA
believes this constraint will not be a problem for MUPs and exempt
antimicrobials because we have received information that these products
are repackaged by the registrants if they are sold or distributed in
refillable containers. In addition, refillable containers are not
appropriate for distributing plant-incorporated protectants, so these
products will also not be adversely affected.
One issue that has been raised is whether registrants and
independent refillers can comply with the regulations (and specifically
the conditions for repackaging pesticide products for distribution or
sale) before the compliance date. This is appealing to registrants and
independent refillers because the regulations allow pesticides to be
repackaged under written contracts into refillable containers of any
size (compared to the 55 gallon container size limit established in the
Bulk Policy and maintained in the 1991 amendment). EPA believes that it
is acceptable for registrants and independent refillers to repackage
pesticide products under the regulations before the 5 year compliance
date as long as they are in full compliance with the refillable
container and repackaging regulations. In other words, registrants can
enter into contracts with independent refillers to refill containers
only if: (1) The containers comply with the refillable container
regulations, i.e., they meet the specified DOT standards, have a
durable serial number or other identifying code, and have one-way
valves and/or tamper-evident devices; (2) the registrant meets the
repackaging conditions and develops and provides the necessary
information, including a description of acceptable containers and a
cleaning procedure; (3) the refillers meet the repackaging conditions
and comply with the operational procedures, including inspecting,
cleaning (if necessary), and labeling the containers; and (4) all other
requirements specified in the refillable container and repackaging
regulations are followed.
H. Product Integrity
1. Background. The Bulk Pesticides Enforcement Policy and both the
proposed and final rules hold the registrant and the refiller (if
different than the registrant) responsible for product integrity of the
pesticide product repackaged by the refiller. ``Product integrity''
means that the pesticide product is not adulterated or different from
the composition described in its confidential statement of formula that
is required under FIFRA section 3. This requirement reflects current
law. Under FIFRA section 12(a)(1), it is unlawful for any person to
distribute or sell to any person a pesticide which is adulterated or
whose composition differs from the composition described in its
confidential statement of formula.
FIFRA Section 12(a)(1) applies to pesticide distributed or sold in
nonrefillable containers and in refillable containers. For pesticides
distributed or sold in nonrefillable containers, it is clear that the
registrants are responsible for product integrity because there are no
other parties involved (except for supplemental registrants, as
regulated by 40 CFR 152.132, and parties acting as agents under
contract to the registrant). Similarly, when a registrant repackages a
product directly into a refillable container for distribution or sale,
it is also clear that the registrant is responsible for product
integrity.
The situation is less clear when a registrant distributes or sells
a product to an independent refiller for repackaging into refillable
containers. Both the registrants and the independent refillers are
selling or distributing the product, so both parties are responsible
for product integrity. The registrant is responsible because the
registrant has authorized the independent refiller to repackage the
registrant's pesticide product and to use the registrant's label
according to the terms of the written contract (or authorization under
the Bulk Policy). The registrant remains accountable for its repackaged
product which is distributed or sold in the refillable container. EPA
believes it is appropriate for registrants to be held responsible for
acts by independent refillers because the repackaging is being done
under the registrant's registration and the independent refillers are
agents of the registrants for purposes of carrying out the written
contract. The independent refiller is responsible for product integrity
because the refiller is the person who physically places the product
into the container for sale or distribution.
In 1996, EPA established a policy on ``Toxicologically Significant
Levels of Pesticide Active Ingredients'' in PR Notice 96-8. (Ref. 58)
This document describes EPA's interpretation of the term
``toxicologically significant'' as it applies to contaminants in
pesticide products that are also active ingredients. The policy
provides risk-based concentration levels of such contaminants that are
generally considered to be toxicologically significant (and therefore
must be reported and accepted as part of product registration according
to 40 CFR 158.167). The concentrations are defined according to the
type of pesticide that is contaminated (insecticide, herbicide, low
dose herbicide, etc.) and the pesticide category of the contaminant.
While PR Notice 96-8 applies to all pesticide products in nonrefillable
and refillable containers, a driving force in developing the policy was
the cross-contamination found in refillable containers in the early
1990's.
2. Final regulations. The repackaging regulations clearly hold all
parties subject to the repackaging standards to be responsible for
product integrity. This includes:
(1) Registrants who distribute or sell a pesticide product in
refillable containers (in Sec. 165.65(b));
(2) Registrants who distribute or sell pesticide products to
independent refillers for repackaging into refillable containers (in
Sec. 165.67(e)); and
(3) Refillers of a pesticide product that are not the registrants
of the pesticide product (in Sec. 165.70(d)).
Specifically, all of these businesses are responsible for the
pesticide product that they distribute or sell not being adulterated or
different from the composition described in the product's confidential
statement of formula that is required under FIFRA section 3.
3. Changes. The language in the final regulation is nearly
identical to the text in the proposed regulation. One slight
modification is that the phrase ``described in its confidential
statement of formula that is required under FIFRA section 3'' is used
in the final regulations because it is more straightforward than the
proposed phrase ``described in the statement required in connection
with registration under section 3 of the Act.'' EPA considers these two
phrases to mean exactly the same thing.
However, one thing that has changed since the proposed rule is
EPA's policy on toxicologically significant levels of pesticide active
ingredients. PR Notice 96-8 defines risk-based concentration levels of
contaminants that are generally considered to be toxicologically
significant. Active ingredient contaminants that are present at lower
concentrations do not have to be reported by registrants and accepted
by EPA as part of product registration. For example, if an herbicide
active ingredient is detected at less than 1,000 ppm in any pesticide
where the contaminant is accepted for use on all
[[Page 47380]]
sites for which the product is labeled, the herbicide active ingredient
is not considered to be toxicologically significant. As described in PR
Notice 96-8, the purpose of this policy is to: (1) Recognize that
cross-contamination is a reality, and that not all cross-contamination
is problematic; (2) set a clear standard that can be readily applied by
EPA, States and the regulated industry; (3) ensure that allowable
cross-contamination does not pose unreasonable adverse effects; (4)
minimize the paperwork burden for EPA and registrants; (5) maintain
accountability for the product from the registrant to the end user; and
(6) not preclude marketplace or private solutions to correct problems
that do arise.
I. Delivery and Repackaging at End User Locations
1. Background. The 1977 Bulk Policy (Ref. 75) provided the
following two examples of acceptable practices for shipping ``bulk''
pesticides to end users:
A registrant ships a bulk pesticide directly to an end
user (custom applicator, farmer, etc.). The label accompanies the
shipment and is placed on the user's tank. No new establishment or
product registration is needed for the bulk container since the labeled
product is fully registered and has been sold intact to the user.
A tank car of pesticide from which commercial applicators
meter off into their own tanks, without being put into a dealer's
holding tank, would be exempt from new producer establishment
registration. It is considered that the original container has not been
changed in delivery to the applicator and the tank car label (placard)
will bear the producer's establishment number.
In the preamble to the 1994 proposed rule, EPA stated that
repackaging by the registrant must be done at a registered
establishment, as required by 40 CFR part 167. In addition, EPA stated
that we saw no reason to continue the exemption from the registered
establishment requirement described in the second bullet in Unit I.1.,
above. We requested comments on the effect of discontinuing this
exception.
On February 3, 1994, EPA released the ``Bulk Pesticide Repackaging
Question & Answer Document'' (Ref. 63) which included the following
question and answer that address the issue of making a bulk delivery
directly to an end user.
18. May a registrant deliver pesticides in bulk directly to a
farm, even if the farm is not registered as a producing
establishment? May someone other than the registrant do this?
Under the bulk pesticide repackaging policy, a registrant may
deliver pesticides directly to a farm, even if the farm is not
registered as a pesticide producing establishment. Someone other
than the registrant could not deliver pesticides in bulk to a farm
unless the farm was registered as a pesticide producing
establishment and that person has received written authorization
from the registrant to deliver the pesticide to the specific farm.
The registrant of the establishment (i.e., the farmer) would also be
required to submit annual production reports. Please note that some
States and most registrants require containment structures for the
storage of bulk pesticides. Most farmers do not have these
containment structures and delivery to these farms may not be
allowed under State law.
After discussion and debate on this question among the regulated
community and regulatory agencies, EPA reconsidered and revised our
position in a memo titled ``Bulk Pesticide Transfers'' dated March 22,
1995. (Ref. 59) The new question 18 supersedes the question in the 1994
Bulk Policy Question & Answer document and is:
18(a). May a registrant deliver pesticides in bulk directly to a
farm, even if the farm is not registered as a producing
establishment? May someone other than the registrant do this?
A registrant, dealer, or other authorized person pursuant to the
``Enforcement Policy Applicable to Bulk Shipments of Pesticides''
(July 11, 1977) may transfer pesticides in bulk at a farm, even if
the farm is not registered as a pesticide producing establishment.
18(b). May a registrant deliver pesticides in bulk directly to
end use sites other than a farm, even if such site is not registered
as a producing establishment? May someone other than the registrant
do this?
Yes. See answer to question 18(a) above. However, the Agency
will continue to pursue enforcement actions against all end users
that use any registered pesticide in a manner inconsistent with its
labeling pursuant to FIFRA 12(a)(2)(G).
The March 22, 1995 memo explained that this revision was made
because end users are not the persons repackaging shipments of bulk
pesticides at the farm and other end use sites. The memo further stated
that the terms and conditions of the 1977 Bulk Policy and 1991
amendment are unchanged. Since the pesticide that is transferred at the
farm or other end use site is not being transferred and held for
further sale, final accountability for meeting the terms of the Bulk
Policy remains with the registrant and the last establishment making a
transfer associated with a pesticide sale, the dealer. Registrant and
dealer establishments are responsible for reporting repackaging as
production pursuant to 40 CFR 167.85. In the memo, EPA recommended (but
did not require) that pesticides be transferred into stationary bulk
containers protected by a secondary containment structure at end user
sites.
2. Final Regulation. One of the requirements specified in
Sec. Sec. 165.67(b) and 165.70(b) for when a registrant may allow a
refiller to repackage its pesticide product into refillable containers
and to distribute or sell such repackaged product under the existing
registration is:
One of the following conditions regarding a registered refilling
establishment is satisfied:
(1) The pesticide product is repackaged at a refilling
establishment registered with EPA as required by Sec. 167.20.
(2) The pesticide product is repackaged at the site of a user who
intends to use or apply the product by a refilling establishment
registered with EPA as required by Sec. 167.20.
3. Changes. The first condition listed above (Unit I.2.(1)) (the
product is repackaged at a registered refilling establishment) is the
same as the proposed regulation. The second condition--the product is
repackaged at the site of a user who intends to use or apply the
product by a registered refilling establishment--was added to the final
rule to be consistent with EPA's revised policy as described in the
March 22, 1995 ``Bulk Pesticide Transfers'' memo. The final regulation
is consistent with EPA's 1995 position that final accountability for
meeting the terms of the Bulk Policy remains with the registrant and
the last establishment making a transfer associated with a pesticide
sale (an independent refiller in this case), because the pesticide that
is transferred at the farm or other end use site is not being
transferred and held for further sale.
EPA has received anecdotal evidence that the practice of refilling
containers (bulk containers, minibulks, application tanks, nurse tanks,
etc.) at end user sites has increased over the past few years and may
continue to increase in the future. Therefore, EPA is concerned about
the potential for spills, leaks and other releases during transfers at
end user sites to cause soil and water contamination. As described in
the preamble to the proposed rule, EPA decided to require containment
structures at dealers, commercial applicators and custom blenders with
bulk storage tanks, largely because these were the kinds of sites where
contamination had been documented. EPA did not and still does not have
documentation of end user site contamination due to repackaging
pesticide product. Therefore, the final pesticide container and
containment
[[Page 47381]]
regulations do not require repackaging at end user sites to be done
within a containment structure. However, EPA strongly recommends that
repackaging at end user sites be conducted over some kind of
containment--whether it is a permanent concrete containment pad or a
portable containment structure. In the future, EPA may revise the
repackaging regulations to require all repackaging (including at end
user sites) to occur over a containment structure if we become aware of
a pattern of end user site contamination being caused by repackaging.
J. Registrants Who Distribute or Sell Pesticide Products in Refillable
Containers - Overview (Sec. 165.65)
1. Final Regulation. The regulations in Sec. 165.65 apply to
registrants who distribute or sell pesticide products in refillable
containers. This means that the registrant conducts all of the
repackaging for the product and does not distribute or sell the product
to a refiller that is not part of its company for refilling.
Of course, a registrant may repackage a product directly into
refillable containers for sale or distribution and distribute or sell
that same product to an independent refiller for repackaging. In this
case, the registrant must comply with both sets of requirements: the
standards in Sec. 165.65 for those quantities the registrant
distributes or sells directly in refillable containers and the
requirements in Sec. 165.67 for those quantities that the registrant
distributes or sells to independent refillers for repackaging.
A registrant who distributes or sells a pesticide product directly
in refillable containers:
Is responsible for the integrity of the product, as
discussed in Unit VII.H.;
Must develop a refilling residue removal procedure, as
discussed in Unit VII.M.;
Must develop a description of acceptable containers, as
discussed in Unit VII.N.;
Must comply with the requirements for refillers (including
having certain information and inspecting, cleaning, and labeling the
refillable containers), as discussed in Unit VII.O. through VII.R.;
Must keep records, including copies of the refilling
residue removal procedure and the description of acceptable containers
and certain information about each instance of repackaging. The
recordkeeping requirements are discussed in Unit VII.S.
2. Changes. All of these requirements for registrants who
distribute or sell pesticide products directly in refillable containers
were included in the proposed regulation. Some of the requirements were
modified based on comments and the change to refer to and adopt some of
the DOT standards. The specific changes to these requirements are
discussed in other sections of Unit VII.
K. Registrants Who Distribute or Sell Pesticide Products to Refillers
for Repackaging - Overview (Sec. 165.67)
1. Final Regulation. The regulations in Sec. 165.67 apply to
registrants who distribute or sell pesticide products to refillers that
are not part of their companies for repackaging into refillable
containers. This is the more common form of repackaging, where the
registrant ships in bulk to a refiller (normally a retailer) who
repackages the product into portable pesticide containers.
As mentioned above, a registrant may repackage a product directly
into refillable containers for sale or distribution and distribute or
sell that same product to an independent refiller for repackaging. In
this case, the registrant must comply with both sets of requirements:
the standards in Sec. 165.65 for those quantities the registrant
distributes or sells directly in refillable containers and the
requirements in Sec. 165.67 for those quantities that the registrant
distributes or sells to independent refillers for repackaging.
A registrant who distributes or sells a pesticide product to an
independent refiller for repackaging:
Must comply with the conditions for allowing a refiller to
repackage his product, as discussed in Unit VII.G.;
Must provide the refiller with the written contract to
repackage before distributing or selling the product to the refiller;
Is responsible for the integrity of the product, as
discussed in Unit VII.H.;
Must develop a refilling residue removal procedure, as
discussed in Unit VII.M.;
Must develop a description of acceptable containers, as
discussed in Unit VII.N.;
Must provide the refilling residue removal procedure,
description of acceptable containers, and the product's label and
labeling to the refiller before or at the time of distribution or sale
to the refiller;
Must keep records of the contracts, the refilling residue
removal procedure, and the description of acceptable containers. The
recordkeeping requirements are discussed in Unit VII.S.
The requirements that are specific to registrants who distribute or
sell pesticide products to independent refillers for repackaging are
the two that establish standards for the timing of when the registrant
provides documents to the refiller. Under Sec. 165.67(d), the
registrant must provide the written contract to repackage the product
before selling or distributing the product to the refiller. Section
165.67(g) specifies that the other information (cleaning procedure,
description of acceptable containers, and label/labeling) can be
provided earlier but must be provided to the refiller at the time of
sale or distribution at the latest. These two provisions are identical
to the proposed regulations.
2. Changes. All of these requirements for registrants who
distribute or sell pesticide products to refillers for repackaging were
included in the proposed regulation. Some of the requirements were
modified based on comments, modifications to some EPA policies, and the
change to refer to and adopt some of the DOT standards. The specific
changes to these requirements are discussed in other sections of Unit
VII.
L. Refillers Who Are Not Registrants - Overview (Sec. 165.70)
1. Final Regulation. The regulations in Sec. 165.70 apply to
refillers who are not registrants of the products that they repackage
for sale or distribution.
A refiller who repackages a product for distribution or sale and is
not the registrant of the product:
Must comply with the conditions for allowing him to
repackage the registrant's product, as discussed in Unit VII.G.;
Is responsible for the integrity of the product, as
discussed in Unit VII.H.;
Must comply with the requirements for refillers (including
having certain information and inspecting, cleaning, and labeling the
refillable containers), as discussed in Unit VII.O. through VII.R.;
Must keep records, including copies of the contract from
the registrant, refilling residue removal procedure, and description of
acceptable containers, and certain information about each instance of
repackaging. The recordkeeping requirements are discussed in Unit
VII.S.
2. Changes. All of these requirements for independent refillers
were included in the proposed regulation. Some of the requirements were
modified based on comments, modifications to some EPA policies, and the
change to refer to and adopt some of the DOT standards. The specific
changes to these requirements are discussed in other sections of Unit
VII.
[[Page 47382]]
3. Comments - whether or not to include custom blending in this
rule. In the preamble to the proposed rule, EPA discussed whether or
not the requirements for independent refillers should apply to custom
blenders, who provide the service of mixing pesticides with fertilizer,
feed, or another pesticide to a customer's specification. The preamble
provided two options for the final rule: (1) Issue a regulation on
refilling practices that is tailored specifically to custom blenders
that distribute pesticide mixtures, or (2) exempt custom blenders from
the repackaging requirements. EPA requested comments on these options.
A few commenters showed lukewarm support for applying the
repackaging regulations to custom blenders. A registrant was unaware of
pressing reasons to exclude custom blenders and pointed out that custom
blenders are usually custom applicators. A State regulatory agency
stated that custom blenders should be required to meet the refilling
requirements if the criteria apply to them. This commenter also pointed
out that custom blends are generally placed into a spreader, not a
container.
A registrant group stated that custom blenders provide valuable
service in reducing pesticide container use and applicator exposure.
This respondent recommended developing standards that are specific to
custom blenders and that address items such as container integrity and
cleaning procedures.
A registrant distinguished between custom blending and selling a
pesticide product in a refillable container with a registrant's label
on it as two different activities. A few dealer groups strongly urged
EPA to exclude custom applicators from the refiller requirements. The
retailer-related commenters believe it is inappropriate to address
custom blenders in a section that focuses on maintaining the original
integrity of repackaged pesticides. They also described current custom
blending practices in the Midwest, including the following points:
Midwest dealers with bulk pesticides are mostly all custom
blenders and custom applicators and have become repackagers recently.
It is common for the volume of bulk pesticides that goes
into custom blends to exceed the volume that is repackaged into
refillable containers.
Custom blends may be loaded into custom application and
nurse vehicles of that dealer, another for-hire custom applicator, or a
customer.
On the other hand, registered bulk pesticides are: (1)
Repackaged into minibulk containers; (2) moved in portable service
containers from the bulk container to supply the dealer's custom
application operation in the field; and (3) loaded into tanks that are
an integral part of application or nurse vehicles for field nursing or
to supply injection systems.
4. EPA response - whether or not to include custom blending in this
rule. In the final rule, EPA decided to exempt custom blending from
having to comply with the repackaging requirements. As stated by
several of the commenters, EPA determined that there is an inherent
difference between custom blending and repackaging pesticide products
for sale or distribution. When a product is repackaged for sale or
distribution, it must maintain the characteristics of the product and
meet the ingredient contents identified on the label and in the
product's registration. On the other hand, a custom blend intentionally
mixes a pesticide with another substance. While the product's labeling
must be consistent with the custom blend (i.e., the labeling directions
do not prohibit the use of the product in such a blend) and the
product's label must be delivered to the end-user, the material in the
custom blend is no longer just the pesticide product identified on the
label. In fact, the custom blender must deliver a statement specifying
the composition of the mixture.
The exemption for custom blending was added to Sec. 165.63(h) of
the final regulation, which asks ``Are there any other exceptions?''
Paragraph (h) in Sec. 165.63 was added to state that custom blending
is exempt from the regulations in this subpart. In addition, Sec.
165.3 of the regulations define custom blending as ``Custom blending
means the service of mixing pesticides to a customer's specifications,
usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a
pesticide-animal feed mixture, when:
(1) The blend is prepared to the order of the customer and is not
held in inventory by the blender;
(2) The blend is to be used on the customer's property (including
leased or rented property);
(3) The pesticide(s) used in the blend bears end-use labeling
directions which do not prohibit use of the product in such a blend;
(4) The blend is prepared from registered pesticides; and
(5) The blend is delivered to the end-user along with a copy of the
end-use labeling of each pesticide used in the blend and a statement
specifying the composition of the mixture.''
This description is based on the definition of ``custom blender''
in 40 CFR 167.3, but was modified to reflect the practice of custom
blending rather than the establishment at which it takes place. The
Sec. 167.3 definition focuses on the establishment, because the part
167 regulations then exempt custom blenders from the requirements to
register their establishments (in Sec. 167.20(a)(1)) and to report
production (in Sec. 167.85(a)). The Sec. 167.3 definition of custom
blender includes a sixth condition--that no other pesticide production
activity is performed at the establishment--because these other
activities would subject a custom blender to the establishment
registration and production reporting requirements. However, this sixth
condition is not relevant to the pesticide product repackaging
requirements in 40 CFR part 165 subpart D because the subpart D
regulations are tied to the process or action of repackaging. As
reported by several commenters, a facility may conduct several
different activities, including repackaging pesticide products into
refillable containers and custom blending. In this case, the
repackaging must be conducted in accordance with the regulations in
this subpart, while the custom blending is exempt from the regulations
in this subpart.
It is worth noting that the containment regulations in subpart E
apply to some custom blenders, specifically ``custom blenders of
agricultural pesticides.''
5. Comments - mixing diluent with pesticides. Several commenters
(dealer groups and a dealer) urged EPA to allow water as a blend
component. One retailer described the awkwardness of the situation when
such mixing is not permitted -- a dealer can put pesticide in a
farmer's application equipment at its facility (with a containment
pad), but the farmer has to return to his own location to add water and
finish preparing the application mixture. The two dealer groups
suggested or stated that using water as a custom blend component is
currently practiced in the Midwest. The two dealer groups also
recommended deleting condition 6 in the Sec. 167.3 definition
of custom blender which specifies that ``no other pesticide production
activity is performed at the establishment.''
6. EPA response - mixing diluent with pesticides. EPA disagrees
with the comment to delete condition 6 in the Sec. 167.3
definition of custom blender that specifies ``no other pesticide
production activity is performed at the establishment.'' As described
above, this condition is intended to distinguish between custom
blenders - who are exempt from the part 167 establishment registration
requirements - and
[[Page 47383]]
producing establishments, who are required to register their
establishments. Condition 6 does not prevent a facility from
conducting custom blending and repackaging (producing). These
facilities must register as establishments because they are producing
establishments. Instead, condition 6 is intended to describe
the facilities that are exempt from the establishment registration
requirements, i.e., facilities that custom blend and do not repackage
or otherwise produce pesticides.
However, EPA considered the request from commenters to allow custom
blends to be diluted with water. Various offices and Regions within
EPA, as well as the States, have not had a consistent policy about
whether custom blends can be diluted with water or another diluent.
After reviewing this issue, it is appropriate to clarify our position
on diluting custom blends. EPA believes that the definition of custom
blender in Sec. 167.3 provides flexibility. Custom blenders are
defined as ``any establishment which provides the service of mixing
pesticides to a customer's specifications, usually a pesticide(s)-
fertilizer(s), pesticide-pesticide, or a pesticide-animal feed mixture,
when'' the six conditions described above are met. In particular, the
word ``usually'' in this definition provides flexibility and allows
water (or other diluents when specified by the labeling of the
pesticide[s] in the blend) to be added to custom blends.
EPA believes that the language of Sec. 167.3 allows custom blends
to be diluted with water or a diluent specified on the labels of all
pesticides in the blend. In many ways, it is more efficient and
possibly more accurate for the facility that is measuring and blending
pesticides, fertilizers and/or animal feed to also measure and blend
the diluent into the custom blend. In addition, custom blends (with
diluents) that are delivered to an end user as a use-dilution (usually
in refillable containers) offer worker exposure and environmental
protection benefits including eliminating the need for end users to
mix, handle and potentially spill the pesticide in the field;
eliminating the need for the end user to rinse containers in the field;
allowing the use of closed systems; and reducing the number of
nonrefillable containers that must be disposed or recycled. However,
EPA wants to clarify that custom blends with a diluent added still must
comply with all five conditions in the definition of custom blend in
Sec. 165.3: ``Custom blending means the service of mixing pesticides
to a customer's specifications, usually a pesticide(s)-fertilizer(s),
pesticide-pesticide, or a pesticide-animal feed mixture, when:
(1) The blend is prepared to the order of the customer and is not
held in inventory by the blender;
(2) The blend is to be used on the customer's property (including
leased or rented property);
(3) The pesticide(s) used in the blend bears end-use labeling
directions which do not prohibit use of the product in such a blend;
(4) The blend is prepared from registered pesticides; and
(5) The blend is delivered to the end-user along with a copy of the
end-use labeling of each pesticide used in the blend and a statement
specifying the composition of the mixture.''
EPA will monitor the practices and procedures that develop and
proliferate in the field with this interpretation. If problems develop,
EPA will consider options, including revising its interpretation,
adding protective conditions if diluents are added to custom blends,
and subjecting custom blending to the repackaging requirements in part
165.
In addition, EPA does not view a difference between custom blending
and custom mixing from a regulatory point of view. A custom mixer is a
facility that stores materials previously purchased by end-users and
that custom mixes the products just prior to application. A custom
mixer does not own, sell or apply the product, although the conditions
in the Sec. 165.3 definition of custom blending are met. Over the
years, there have been different interpretations of whether or not
there is a difference between custom blending and custom mixing. At
least a few businesses have been established as custom mixers under the
determination that they are not custom blenders. This final rule does
not distinguish between custom blenders and custom mixers. Similarly,
the policy of allowing diluents to be added to custom blends applies to
both custom blenders and custom mixers. As discussed above, custom
blending is excluded from the subpart D repackaging requirements.
However, custom blenders (including custom mixers) would be subject to
the subpart E containment standards if they blend (mix) agricultural
pesticides.
7. Comments - service containers. A few dealer groups noted that
the proposed rule does not address service containers, which are used
to move pesticides from bulk storage to end-use applications in the
field, e.g., the tanks that are an integral part of application or
nurse vehicles. These commenters pointed out some advantages of service
containers including: reducing the number of nonrefillable containers
used, keeping pesticides separate from water or fertilizers during
transportation, accommodating on-board injection systems and allowing
the applicator to adjust pesticides in the field. These commenters
urged EPA and industry to consider providing for the expanded use of
service containers, with some exclusions from the refillable container
requirements, to increase the use of bulk pesticides. A State
regulatory agency supported keeping the Bulk Policy because they don't
want to register each facility where bulk pesticides are metered, such
as where pest control operators place pesticides into service
containers.start here
8. EPA response - service containers. The pesticide container and
repackaging regulations do not regulate service containers, because the
container and repackaging regulations only apply to containers that are
used to sell or distribute pesticide products and to the repackaging of
products for sale or distribution. For the purposes of this discussion,
a service container is defined as ``any container used to hold, store,
or transport a pesticide concentrate or a pesticide use-dilution
mixture, other than the original labeled container in which the product
was distributed or sold, the measuring device, or the application
device.''
EPA does not currently regulate service containers. In 1976, EPA
issued a Pesticide Enforcement Policy Statement (PEPS) on ``Structural
Pest Control: Use and Labeling of Service Containers for the
Transportation or Temporary Storage of Pesticides,'' which defined
minimal labeling requirements and several other limitations for the
acceptable use of service containers by structural pest control
operators. (Ref. 76) However, this PEPS was later rescinded. EPA
continues to believe that it is a good management practice to ensure
that the contents of service containers are identified and that the
label of a pesticide product that is in a service container is
available to the person handling and/or applying the pesticide. EPA may
consider developing a separate policy on service containers while the
pesticide container and containment regulations are being phased in.
M. Registrant Refilling Residue Removal Procedure (Sec. 165.65(c)(1)
and 165.67(f)(1))
1. Final Regulation. Registrants who sell or distribute pesticide
products directly in refillable containers and registrants who sell or
distribute products to independent refillers for repackaging must
develop a refilling
[[Page 47384]]
residue removal procedure that describes how to remove pesticide
residue from a refillable container (portable or stationary pesticide
container) before it is refilled. Registrants must specify a cleaning
procedure for each product sold or distributed in refillable
containers, although the same procedure can be used for multiple
products. The refilling residue removal procedure must provide
instructions for removing residues from all refillable containers. The
same procedure can apply to portable and stationary pesticide
containers, or the registrant can describe different procedures if it
is appropriate and necessary. Finally, the refilling residue removal
procedure describes how to remove residue from a refillable container.
While this generally involves rinsing the container with water, the
regulations do not specifically require rinsing with water. If a
different procedure is appropriate for a given formulation, it can be
used as long as it meets the following performance standard.
The refilling residue removal procedure must meet the performance
standard of being adequate to ensure that the composition of the
pesticide product does not differ at the time of its distribution or
sale from the composition described in its confidential statement of
formula. This standard ensures that the products distributed and sold
in refillable containers meet the existing product integrity
requirements, as described in Unit VII.H.
The refilling residue removal procedure must describe how to manage
any rinsate resulting from the procedure in accordance with applicable
Federal and State regulations if: (1) The procedure requires the use of
a solvent other than the diluent used for applying the pesticide, or
(2) there is no diluent used for application. This information is
necessary to help refillers manage rinsate that cannot easily be used
as make-up water in future applications.
2. Changes. This requirement is the same as it was in the proposed
rule. Several minor editing change have been made to improve the
clarity and the different refillable containers are described as
portable and stationary pesticide containers because the definitions of
minibulk and bulk are not being finalized. These modifications have not
changed the requirement or intent of the requirement.
N. Registrant Description of Acceptable Containers (Sec. Sec.
165.65(c)(2) and 165.67(f)(2))
1. Final regulation. Registrants who sell or distribute pesticide
products directly in refillable containers and registrants who sell or
distribute products to independent refillers for repackaging must
develop a description of acceptable refillable containers (portable and
stationary pesticide containers) that can be used for distributing or
selling that pesticide product. An acceptable container is one which
the registrant has determined meets the refillable container standards
in subpart C and is compatible with the pesticide formulation intended
to be distributed and sold using the refillable container. The
registrant must identify the containers by specifying: (1) The
container materials of construction that are compatible with the
pesticide formulation; and (2) information necessary to confirm
compliance with the refillable container requirements in subpart C. The
refillable container requirements include the adopted DOT standards,
being marked with a serial number or other identifying code, having a
one-way valve or tamper-evident device on each opening (other than a
vent) of a portable pesticide container designed for liquids, and the
stationary pesticide container requirements.
Similar to the refilling residue removal procedure, registrants
must specify a description of acceptable containers for each product
sold or distributed in refillable containers, although the same
description can be used for multiple products if it meets the
standards.
2. Changes. This requirement was changed significantly from the
proposed rule. The proposal would have required registrants to develop
lists (not descriptions) of acceptable containers, which would have
been identified by specifying the container manufacturer and model
number of the container. This was proposed because registrants are
responsible for ensuring that the refillable containers used to sell
and distribute their products meet the requirements in the container
regulations. When EPA proposed the rule, specifying the container
manufacturer and model number seemed like a relatively easy way for
registrants to identify acceptable containers for their refillers.
However, the final rule's approach of referring to and adopting
some DOT requirements provides an even easier way for registrants to
identify acceptable containers to the refillers. Rather than citing
specific model numbers, the registrants can provide refillers with a
much less prescriptive approach by identifying characteristics, such as
the material of construction, how to determine if the container meets
the applicable DOT standards, how to comply with the serial number
requirement, how to obtain and apply one-way valves and/or tamper-
evident devices to the openings of portable pesticide containers for
liquids and information for complying with the stationary pesticide
container standards.
3. Comments. Several commenters (registrants and a registrant
group) recommended that instead of a list of acceptable containers, the
registrants should identify acceptable containers by providing the
compatible materials of construction and the necessary information to
apply the DOT standards. The registrant group and a distributor
commented that this requirement will be helpful to ensure that
formulators and subregistrants know and obtain information about the
proper packaging.
4. EPA response. In the final rule, EPA changed the requirement for
identifying acceptable containers so registrants can describe
acceptable containers by specifying compatible materials of
construction and the information necessary to comply with the
refillable container requirements. This includes information for
complying with the adopted DOT standards, but also the other
requirements in subpart C.
O. Requirements for All Refillers (Sec. Sec. 165.65(d) and 165.70(e))
1. Final regulation. All refillers, including those at registrant's
facilities and those who are not part of a registrant's company must
comply with the following provisions regarding repackaging a pesticide
product into refillable containers:
*(1) The establishment must be registered with EPA as a producing
establishment as required by Sec. 167.20 of this chapter.
*(2) The refiller must not change the pesticide formulation unless
he has a registration for the new formulation.
(3) The refiller must repackage a pesticide product only into a
refillable container that is identified on the description of
acceptable containers for that pesticide product.
(4) The refiller may repackage any quantity of a pesticide product
into a refillable container up to the rated capacity of the container.
In addition, there are no general limits on the size of the refillable
containers that can be used.
(5) The refiller must have all of the following items at the
establishment
[[Page 47385]]
before repackaging a pesticide product into any refillable container
for distribution or sale:
*(A) The written contract from the pesticide product's registrant.
[Subparagraph A applies only to independent refillers.]
*(B) The pesticide product's label and labeling.
(C) The written refilling residue removal procedure for the
pesticide product.
(D) The written description of acceptable containers for the
pesticide product.
(6) Before repackaging a pesticide product into any refillable
container for distribution or sale, the refiller must identify the
pesticide product previously contained in the refillable container to
determine whether a residue removal procedure must be conducted in
accordance with the cleaning requirements described in Unit VII.Q. The
refiller may identify the previous pesticide product by referring to
the label or labeling.
(7) The refiller must inspect each refillable container as
discussed in Unit VII.P.
(8) The refiller must clean each refillable container, if required,
as discussed in Unit VII.Q.
*(9) The refiller must ensure that each refillable container is
properly labeled as discussed in Unit VII.R.
(10) The refiller's establishment must maintain records, as
discussed in Unit VII.S.
*(11) The refiller's establishment must maintain records as
required by 40 CFR part 169.
*(12) The refiller's establishment must report as required by 40
CFR part 167.
(13) Stationary pesticide containers (that meet the specified size
criteria) at the establishments of independent refillers must meet the
standards in Sec. 165.45(f). [Paragraph 13 is only included in the
regulations in Sec. 165.70(e) for independent refillers. The
refillable container regulations state that both the registrant and
independent refillers are responsible for complying with the stationary
pesticide container requirements.]
(14) Refillers may be required to comply with the containment
standards in subpart E. [Paragraph 14 applies only to independent
refillers.]
These requirements, except for items 5(A), 13 and 14 which apply
only to independent refillers, apply to any refiller that repackages a
product subject to the regulations regardless of the main business of
the refiller (registrant, retailer, etc.). Some of these conditions
(indicated by an asterisk) simply refer to or reinforce key
requirements in existing regulations, including 40 CFR parts 156, 167
and 169 or incorporate existing standards of the Bulk Policy (having a
copy of the registrant's contract). These provisions are included here
for the sake of completeness and as a reference for refillers.
In other words, the new provisions for refillers are that each
refiller:
Must repackage a product only into a container identified
on the registrant's description of acceptable containers;
May repackage any quantity of a product into a refillable
container (up to its rated capacity) and there are no general limits on
the size of the refillable containers;
Must have certain documents before repackaging;
Must identify the product previously in the container by
its label;
Must inspect and, if necessary, clean the container; and
Must maintain certain records.
EPA believes that these provisions are good management practices
that are intended to ensure product and container integrity. The second
provision actually removes a condition on container size from the bulk
policy. In other words, it provides more flexibility to registrants and
refillers than currently exists.
2. Changes. Regarding the list of requirements for refillers, the
final regulations are very similar to the proposed rule. However, the
structure and order of the final rule was revised to list these
requirements in one section. EPA believes this makes the regulations
more clear, which should facilitate compliance. The items that refer to
existing requirements in 40 CFR parts 167 and 169 were added to the
list to provide a more complete reference for refillers. However, these
statements simply refer to existing requirements; they don't add new
ones.
Adjustments were made to a few of the provisions. Specifically, the
requirements in the proposed rule that referred to the registrant's
list of acceptable containers were changed to refer to the registrant's
description of acceptable containers (see items 3 and 5 above), to
accommodate the changes described in Unit VII.N. Also, the proposed
regulatory text did not explicitly allow any size refillable container
to be used, although the preamble discussed removing the size limit in
the Bulk Policy in some detail. Therefore, a sentence clarifying that
there are no general limits for the size of refillable containers was
added to the statement allowing any quantity of pesticide (up to the
container's rated capacity) to be repackaged. (See item 4.)
Specific modifications made to the inspecting, cleaning, labeling
and recordkeeping requirements and comments on these standards are
discussed in detail in Units VII.P. - VII.S.
The refillable container regulations were modified to clarify that
both registrants and refillers are responsible for complying with the
stationary pesticide container requirements in Sec. 165.45(f). The
final repackaging rule includes this provision in the list of
requirements as a reminder for independent refillers.
P. Inspecting Refillable Containers (Sec. Sec. 165.65(e)and 165.70(f))
1. Final regulation. Before repackaging pesticide products into
refillable containers, refillers must visually inspect the exterior and
(if possible) the interior of the container and the exterior of
appurtenances. The purpose of the inspection is to determine whether
the container meets the necessary criteria with respect to continued
container integrity, required markings and openings (tamper-evident
devices or one-way valves). As with the proposed regulations,
inspecting the containers is the responsibility of the refillers, since
they are the ones who are actually handling and refilling the
containers. If any of the failure conditions in this section are
observed during the inspection, the container cannot be refilled unless
the problems are rectified and the associated acceptability criterion
(either reconditioning according to DOT's requirements or coming into
compliance with the refillable container standards in subpart C) is
satisfied.
The container fails the inspection and must not be refilled (unless
the applicable DOT standards for reconditioning are met) if the
integrity of the container is compromised in any of the following ways:
The container shows signs of rupture or other damage which
reduces its structural integrity. [Based on the criterion in 49 CFR
173.28(a)]