47330 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

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. 

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 

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. 


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(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

Category Nonrefillable Containers Refillable Containers Repackaging Pesticide 

Products Container Labeling Containment Structures 

Who must comply Registrants Registrants 

Refillers (retailers, distributors) 

Registrants 

Refillers (retailers, distributors) 

Registrants 

Pesticide users (must 

follow new directions) 

Ag retailers 

Ag commercial applicators 

Ag custom blenders 

Major Requirements DOT container design, 

construction and 

marking standards 

Container dispensing 

capability 

Standardized closures 

Residue removal 

Recordkeeping 

DOT container design, 

construction and 

marking standards 

Serial number marking 

One-way valves or 

tamper-evident devices 

Stationary container 

requirements 

Registrants develop information 

Registrants and others 

comply with specified conditions 

Refillers (registrants 

and others) obtain 

and follow registrant 

information, and 

clean, inspect and 

label containers before refilling them 

Identify container as 

nonrefillable or refillable (all) 

Statements to prohibit 

reuse and offer for 

recycling; batch 

code (all 

nonrefillables) 

Cleaning instructions 

(some nonrefillables) 

Cleaning instructions 

before final disposal 

(all refillables) 

Secondary containment structures 

(dikes) around stationary tanks 

Containment pads for 

pesticide dispensing 

areas 

Good operating procedures 

Monthly inspections of 

tanks and structures 

Recordkeeping 

Provisions for States 

with existing programs 

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

Category Nonrefillable Containers Refillable Containers Repackaging Pesticide Products 

Products that are not 

subject to the regulations. 

(1) Manufacturing use products, 

(2) Plant-incorporated 

protectants, and 

(3) Antimicrobial pesticide products that satisfy all four of 

these 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. 

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. 

(1) Manufacturing use products, 

(2) Plant-incorporated protectants, and 

(3) Antimicrobial pesticide products that 

satisfy all four of the criteria listed in 

the nonrefillable container column. 

(1) Manufacturing use products, 

(2) Plant-incorporated protectants, and 

(3) Antimicrobial pesticide products that 

satisfy all four of the criteria listed in 

the nonrefillable container column. 

Products that are subject to the regulations A product is subject to ALL 

nonrefillable 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. 

All products not listed above. All products not listed above. 

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. 

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

Format in Proposed Rule Format in Final Rule 

Subpart Section Numbers Subpart Section Numbers 

Part 156 

Subpart H: Container Labeling §§ 156.140 - 156.144 Subpart H: Container Labeling §§ 156.140 - 156.159 

Part 165 

Subpart A: General §§ 165.1 - 165.16 Subpart A: General §§ 165.1 - 165.3 

Subpart B Reserved Subpart B: Nonrefillable Containers §§ 165.20 - 165.27 

Subpart C Reserved Subpart C: Refillable Containers §§ 165.40 - 165.47 

Subpart D Reserved Subpart D: Repackaging §§ 165.60 - 165.70 

Subpart E Reserved Subpart E: Containment Structures §§ 165.80 - 165.97 

Subpart F: Nonrefillable Containers §§ 165.100 - 165.119 Subpart F Reserved 

Subpart G: Refillable Containers §§ 165.120 - 165.139 Subpart G Reserved 

Subpart H: Containment Structures §§ 165.140 - 165.157 Subpart H Reserved 

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 


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container regulations. Plantincorporated 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 


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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 plantincorporated 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, plantincorporated 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 

(§§ 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 (§§ 165.23(b), 165.43(b) and 

165.63(b)) 

1. Final regulations. Plantincorporated 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]lantincorporated 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 (§§ 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 


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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 microorganisms; 

• 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 microorganisms also would be hazardous 

wastes when they are disposed and 

many of these are also restricted use 

products, such as those containing 

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acid, coal tar, creosote and 

pentachlorophenol. Many of the 

antifouling paint products that claim to 

control pests other than microorganisms 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 

(§§ 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, plantincorporated 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: 

• § 165.45(d) regarding marking; and 

• § 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: 


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Requirement Requirement for registrants who distribute or sell directly in refillable containers Requirement for refillers who are not registrants 

Recordkeeping specific to 

each instance of repackaging 

§ 165.65(i)(2) § 165.70(j)(2) 

Container inspection: criteria regarding a serial 

number or other identifying code 

§ 165.65(e)(3) § 165.70(f)(3) 

Container inspection: criteria regarding one-way 

valve or tamper-evident 

device 

§ 165.65(e)(4) § 165.70(f)(4) 

Cleaning requirement: criteria regarding one-way 

valve or tamper-evident 

device 

§ 165.65(f)(1) § 165.70(g)(1) 

Cleaning if the one-way 

valve or tamper-evident 

device is not intact 

§ 165.65(g) § 165.70(h) 

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 §§ 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 

§§ 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 


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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 preFQPA 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 nonantimicrobial 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 


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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 (§§ 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 


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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

Criterion for Exemption Approach in the Final Rule Approach in the Supplemental Notice 

FIFRA section 2(mm) antimicrobial 

pesticide 

As defined in FIFRA section 2(mm) As defined in FIFRA section 2(mm) 

Antimicrobial products that are not 

FIFRA 2(mm) antimicrobial pesticides because they are subject 

to a tolerance or food additive 

regulation 

Criterion is included as an additional criterion allowing exemption Criterion wasn’t included; these would have been 

subject to the container regulations 

Antimicrobial product use categories that are considered 

household, industrial, or institutional 

10 antimicrobial product use categories are household, institutional or industrial. The additional 

antimicrobial product use categories are: 

• aquatic areas; and 

• agricultural premises and equipment 

9 antimicrobial product use categories were identified as household, institutional or industrial. The 

additional antimicrobial product use categories 

were: 

• aquatic areas; 

• agricultural premises and equipment; and 

• human drinking water systems 

Is not a hazardous waste when it 

is intended to be disposed 

Is not a hazardous waste as set out in 40 CFR part 

261 when intended to be disposed 

Does not meet the criteria for hazardous waste in 

40 CFR part 261 when intended to be disposed 

EPA has not specifically determined product must be subject 

to container regulations to prevent an unreasonable adverse 

effect 

Criteria and a process for making the determination 

are included in the final rule 

Making case-by-case determinations was discussed as an option, but was not specifically included in the potential regulatory language 


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TABLE 5.—ANALYSIS OF WHETHER CERTAIN TYPES OF ANTIMICROBIAL PRODUCTS1 WOULD BE SUBJECT TO OR EXEMPT

FROM THE CONTAINER REGULATIONS - COMPARING THE FINAL RULE TO THE SUPPLEMENTAL NOTICE2

Antimicrobial Product Description Final Rule Supplemental Notice(Option 3) 

Products that are subject to a tolerance or food additive regulation Exempt from the regulations3 Subject to the regulations according to 2(mm) definition 

Products that are exempt from, or 

otherwise not subject to a tolerance or food additive regulation 

Exempt from the regulations according to 2(mm) 

definition3

Exempt from the regulations according to 2(mm) 

definition3

Wood preservative or antifouling 

paint intended to control only 

micro-organisms 

Exempt from the regulations according to 2(mm) 

definition3

Exempt from the regulations according to 2(mm) 

definition3

Wood preservative or antifouling 

paint intended to control macroorganisms as well as micro-organisms 

Subject to the regulations according to 2(mm) definition Subject to the regulations according to 2(mm) definition 

Agricultural fungicide or aquatic 

herbicide 

Subject to the regulations according to 2(mm) definition Subject to the regulations according to 2(mm) definition 

Product in Toxicity Category I Exempt from the regulations3 Subject to all 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, III 

or IV 

Exempt from the regulations3 Exempt from the regulations3

Product used only in swimming 

pools and closely related sites 

Exempt from some refillable container and repackaging requirements if subject to the regulations 

for any reason 

Exempt from some refillable container and repackaging requirements if it met all of the exemption 

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). 

2All 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. 3The 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 (§§ 165.23 (e), 

165.43(f) and 165.63(f)) 

1. Overview—i. Final regulations. For 

nonrefillable containers, all pesticide 

products other than MUPs, plantincorporated 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 pesticidespecific, such as standard closures, oneway 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 


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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 (nonantimicrobial) 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, plantincorporated 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, plantincorporated 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 


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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 lowerrisk 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 § 165.102(b) and 

reclosing containers securely in 

§ 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/ 

ghslrev01/01filesle.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 § 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 


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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 reevaluating 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 


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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 crosscontamination 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. 

BILLING CODE 6560–50–S 


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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 (§§ 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, plantincorporated 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 (§§ 173.24, 

173.24a, 173.24b); 

• Reuse, reconditioning and 

remanufacture of packagings (§ 173.28), 

except for the leakproofness test 

specified in § 173.28(b)(2); 

• Exceptions for Class 9 materials, 

miscellaneous hazardous materials 

(§ 173.155); 

• Non-bulk packagings for hazardous 

materials in Packing Group III 

(§ 173.203 for liquids and § 173.213 for 

solids); 

• Portable tanks, closed bulk bins and 

intermediate bulk containers for certain 

low hazard materials (§§ 173.240(c) and 

173.240(d) for low hazard solid 

materials and §§ 173.241(c) and 

173.241(d) for low hazard liquid and 

solid materials); 

• Specifications for Packagings (part 

178), including non-bulk performanceoriented packaging standards (subpart 


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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 nonbulk 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 nonagricultural 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 


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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 § 173.28 

includes useful provisions that will help 

ensure the safe reuse of pesticide 

containers. In addition, § 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 

§ 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 


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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 §§ 173.240 and 

§§ 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 reevaluate 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 § 165.122(b)(2)) and 

the final rule (in § 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 


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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 nonhazardous 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 nonDOT 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. 


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E. Waiving or Modifying the 

Requirement to Comply with Some DOT 

Regulations (§§ 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 § 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 

(§§ 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 (§ 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. 


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2. Changes. This is nearly the same as 

the proposed purpose (in § 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 (§ 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 § 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 (§ 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 § 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 

(§ 165.23) 

1. Final regulations. As described in 

detail in Unit III., only certain products 

have to comply with the nonrefillable 

container standards. MUPs, plantincorporated 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 § 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 nonantimicrobials) from the full set of 

refillable container regulations and for 

exempting certain antimicrobial 

products from specific requirements. 


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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 plantincorporated 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 exempt. Plant-incorporated protectants 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 exempt. Antimicrobial products would 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 are subject to all of the nonrefillable container requirements. No change from the supplemental notice approach. 

Restricted use products are subject to all of the nonrefillable container 

requirements. 

This is different from the other two criteria discussed 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 Category III or IV and that are not 

restricted use products) must comply only with the basic DOT packaging requirements in 49 CFR 173.24. 

This category of lowest regulation is different from the supplemental 

notice in two ways. First, these 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). 

1The 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 (§ 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 (§ 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 


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47358 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

the closures that are most commonly 

used in the agricultural pesticide 

industry. Also, the proposed provision 

that would allow the use of nonstandard closures was moved to a 

separate section of the final rule 

(§ 165.25(g)) along with the other waiver 

and modification provisions, as 

described in Unit V.I. 

G. Dispensing Capability - Glugging and 

Dripping (§ 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 (§ 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 § 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 


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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 costeffectiveness 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 


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47360 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

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

Study Name Total Cntr/Form Combinations Tested 

Number of Container/Formulations That Meet* 

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. 


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TABLE 8.—RESULTS FROM EARLY PESTICIDE CONTAINER COLLECTION PROGRAMS (REF. 43) 

State Year 

Number of Containers Rejection 

Rate 

(percent) 

Reference 

Accepted Rejected Brought 

In 

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, reformulations, and modification or 


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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

Study Name 

Total 

Cntr/Form 

Combinations 

Tested 

Number of Container/Formulation Combinations That:1

Don’t meet Four 

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. 


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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 


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47364 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

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 § 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) 

Formulation 

Total Cntr/Form 

Combinations 

Tested 

Number of Containers/Formulations That Meet: 

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 


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TABLE 11.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE—HOUSEHOLD, INDUSTRIAL AND INSTITUTIONAL

CONTAINERS (FORMULOGICS) 

Formulation 

Total Cntr/Form 

Combinations 

Tested 

Number of Containers/Formulations That Meet: 

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) 

Formulation 

Total Cntr/Form 

Combinations 

Tested 

Number of Containers/Formulations That Meet: 

Four 9’s Five 9’s Six 9’s 

Flowable concentrate1 1 1 1 0 

Emulsifiable concentrate1 2 2 1 0 0 

Aqueous solution1 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 hardto-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 

(§ 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. 

• § 165.25(a): DOT standards for 

pesticide products that are not DOT 

hazardous materials. EPA may waive or 

modify the requirements of § 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 

§ 165.25(a). 

• § 165.25(b): DOT standards for 

pesticide products that are DOT 


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hazardous materials. EPA may waive or 

modify the requirements of § 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 

§ 165.25(b). EPA will modify or waive 

the requirements of § 165.25(b) only 

after consulting with DOT to ensure 

consistency with DOT regulations and 

exemptions. 

• § 165.25(d): Container closures. 

EPA may approve a non-standard 

closure (that is, a closure not listed in 

§ 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. 

• § 165.25(e): Container dispensing 

capability. EPA may waive or modify 

the standards in § 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. 

• § 165.25(f): Residue removal 

standard. EPA may waive or modify the 

requirements of § 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 § 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 nonstandard 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 (§ 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 § 165.25(g) 

are satisfied. 

2. Changes. The procedure for 

obtaining all waivers and modifications 

is essentially the same as the procedure 

proposed (in § 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 § 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 


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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 (§ 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 (§ 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 §§ 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: 

• § 165.102(b): Container integrity 

and compatibility; 

• § 165.102(c)(1): Permanently 

marking the EPA registration number; 

• § 165.102(c)(2): Permanently 

marking the container’s material of 

construction; 

• § 165.102(d)(3): Requiring the 

container to reclose securely; and 

• § 165.106: Residue removal 

methodology for dilutable products in 

rigid containers 

• § 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 Requirement Proposed 40 CFR Cite Equivalent 49 CFR Cite 

Container integrity and compatibility § 165.102(b) §§ 173.24(b), 173.24(e) 

Permanently marking the material of 

construction 

§ 165.102(c)(2) §§ 178.3(a), 178.503(a) 

Requiring the container to reclose securely § 165.102(d)(3) § 173.24(f) 

As discussed in Units V.H.1. and 

V.H.4., the residue removal testing 

methodology that was proposed in 

§ 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 § 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 § 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 


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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 § 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 


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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 

§ 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 

§ 165.45(e) as ‘‘a refillable container that 

is a portable pesticide container that is 

designed to hold liquid pesticide 

formulations...’’

B. Purpose (§ 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 § 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 (§ 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 § 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 

§§ 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 

§ 165.45(f). EPA believes it is reasonable 

to hold both the registrants and refillers 

responsible for meeting the stationary 

pesticide container standards in 

§ 165.45(f) because they are both selling 

and distributing the pesticide that is 

held in those containers. 

D. Compliance Dates (§ 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 § 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 


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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 tamperevident 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 

(§ 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, plantincorporated 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 

§ 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 exempt. Plant-incorporated protectants 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 exempt. Antimicrobial products would 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 refillable container requirements, except for certain antimicrobial swimming pool products. All products other than manufacturing products would have been subject 

to the 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 pools and closely related 

sites are subject to a reduced set of refillable container requirements. 

Antimicrobial products used in swimming pools would have been subject 

to the proposed rule. 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. 


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F. Other Exemptions (§ 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 

§ 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 (§ 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 (§ 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 


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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 (§ 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 oneway 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/tamperVerDate Aug<31>2005 17:47 Aug 15, 2006 Jkt 208001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 E:\FR\FM\16AUR2.SGM 16AUR2

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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 § 165.43(h)(2). 

EPA believes that the chloropicrin 

cylinders described by the commenter 

should not have to comply with the oneway 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 (§ 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 


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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 § 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 § 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 

(§ 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 § 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 

§ 165.45(h) is identical to the procedure 

for obtaining waivers from or 

modifications to the nonrefillable 

container regulations in § 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 (§ 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: 

• § 165.124(b)(1)(i) - (v) and (vii): 

Permanent marking other than serial 

numbers 

• § 165.124(b)(2): Compliance with 

DOT’s marking satisfies the 

corresponding EPA permanent marking 

requirement 

• § 165.124(c): General minibulk 

integrity standard 

• § 165.124(d): Drop test for minibulk 

containers (requirement) 

• § 165.125: Minibulk container drop 

test methodology (test procedure) 

• § 165.128(a) & (b): Keep records of 

container descriptions, minibulk drop 

test results and the GLP statement 

specified for the drop test. 

• § 165.126: Certification 

• § 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 § 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 


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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 

§ 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 § 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 § 165.124(d) and the 

proposed minibulk container drop test 

in § 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 § 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. 


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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 (§ 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 § 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 (§§ 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 § 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 (§ 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 

§ 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 

(§ 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 § 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 nonantimicrobials) 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. 


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TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS—Continued 

Regulatory Provision Changes 

Plant-incorporated protectants are exempt. Plant-incorporated protectants 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 exempt. Antimicrobial products would 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 of the repackaging requirements, except for certain antimicrobial swimming pool products. All products other than manufacturing use products would have been subject 

to the 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 pools and closely related sites are subject to a reduced set of repackaging requirements. Antimicrobial products used in swimming pools would have been subject to 

the proposed rule. 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 (§ 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 § 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-bysection 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 


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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 

§§ 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 §§ 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, §§ 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 

§ 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 § 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 

(§§ 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 


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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 § 165.65(b)); 

(2) Registrants who distribute or sell 

pesticide products to independent 

refillers for repackaging into refillable 

containers (in § 165.67(e)); and 

(3) Refillers of a pesticide product that 

are not the registrants of the pesticide 

product (in § 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 


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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 crosscontamination 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 §§ 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 

§ 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 § 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 


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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 (§ 165.65) 

1. Final Regulation. The regulations in 

§ 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 § 165.65 for those 

quantities the registrant distributes or 

sells directly in refillable containers and 

the requirements in § 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 (§ 165.67) 

1. Final Regulation. The regulations in 

§ 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 § 165.65 

for those quantities the registrant 

distributes or sells directly in refillable 

containers and the requirements in 

§ 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 § 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 (§ 165.70) 

1. Final Regulation. The regulations in 

§ 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. 


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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 § 165.63(h) of the final 

regulation, which asks ‘‘Are there any 

other exceptions?’’ Paragraph (h) in 

§ 165.63 was added to state that custom 

blending is exempt from the regulations 

in this subpart. In addition, § 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 enduser 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 § 167.3 definition focuses on 

the establishment, because the part 167 

regulations then exempt custom 

blenders from the requirements to 

register their establishments (in 

§ 167.20(a)(1)) and to report production 

(in § 167.85(a)). The § 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 § 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 

§ 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 


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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 

§ 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), pesticidepesticide, 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 

§ 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 usedilution (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 

§ 165.3: ‘‘Custom blending means the 

service of mixing pesticides to a 

customer’s specifications, usually a 

pesticide(s)-fertilizer(s), pesticidepesticide, 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 enduser 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 § 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 (§ 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 


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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 (§§ 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 tamperevident 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 

(§§ 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 § 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 


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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 

§ 165.45(f). [Paragraph 13 is only 

included in the regulations in 

§ 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 

§ 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 

(§§ 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)] 

• The container has visible pitting, 

significant reduction in material 

thickness, metal fatigue, damaged 

threads or closures, or other significant 

defects. [Based on the criterion in 49 

CFR 173.28(c)(1)(iii)] 

• The container has cracks, warpage, 

corrosion or any other damage which 

might render it unsafe for 

transportation. [Based on the criterion 

in 49 CFR 180.352(b)(2)(iii)] 

• There is damage to the fittings, 

valves, tamper-evident devices or other 

appurtenances that may cause failure of 

the container. [Similar to the criterion in 


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49 CFR 180.352(b)(2)(ii) for service 

equipment.] 

If either of the following conditions 

exists (or both), the container fails the 

inspection and must not be refilled until 

the container meets the refillable 

standards specified in subpart C. The 

conditions are: 

• The container does not bear the 

markings required by subpart C or such 

markings are not legible. 

• The container does not have an 

intact and functioning one-way valve or 

tamper-evident device on each opening 

other than a vent, if required. 

Note that these two conditions are 

written so refillers of antimicrobial 

products used in swimming pools and 

related sites would not have to inspect 

for a serial number (because it’s not a 

marking required by subpart C for these 

products) or for an intact and 

functioning one-way valve or tamperevident device on each opening, 

because neither is required for these 

products. 

2. Changes. The general obligation to 

inspect refillable containers before 

repackaging pesticide products into 

them is the same as the proposed rule. 

However, EPA made several changes to 

the details of the inspection. First, we 

based the conditions for failing the 

inspection on conditions specified in 

the DOT regulations in 49 CFR 173.28 

and 180.352(b)(2). A commenter 

suggested this change and EPA believes 

it is an appropriate modification and is 

consistent with other changes in the 

regulation to refer to and adopt the DOT 

standards for container design, 

construction and marking. While we 

don’t think the criteria in the final rule 

are necessarily more stringent than 

those in the proposed rule, we believe 

that consistency with DOT is beneficial. 

Second, the inspection requirement was 

modified to clarify that if problems 

found during the inspection are fixed 

and certain criteria are met, the 

container can be refilled. Under the 

proposed standard, it was not clear that 

a container could be reconditioned or 

brought into compliance with the 

refillable container standards and then 

refilled. Several other minor 

modifications were made to account for 

changes in the regulations, including: 

(1) removing the reference to a standard 

for the age of the container and (2) 

clarifying that vents do not need to have 

one-way valves or tamper-evident 

devices. Because the refillable container 

regulations in subpart C exempt 

antimicrobial products used in 

swimming pools and related sites from 

the serial number requirement and the 

standard requiring a one-way valve or 

tamper-evident device, the final rule 

was written so that refillers of these 

products are not subject to the failure 

criteria that address serial numbers, 

one-way valves, or tamper-evident 

devices. 

Q. Cleaning Refillable Containers 

(§§ 165.65(f) - (g) and 165.70(g) - (h)) 

1. Final regulation. Refillers must 

clean refillable containers by 

conducting the pesticide product’s 

refilling residue removal procedure 

before repackaging the product into the 

refillable container, unless condition #1 

and either condition #2 or #3 are 

satisfied: 

(1) Each tamper-evident device and 

one-way valve is intact (if required). 

(2) The refillable container is being 

refilled with the same pesticide product. 

(3) Both of the following conditions 

are satisfied. 

(A) The container previously held a 

pesticide product with a single active 

ingredient and is being used to 

repackage a pesticide product with the 

same single active ingredient. 

(B) There is no change that would 

cause the composition of the product 

being repackaged to differ from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

Examples of unallowable changes 

include the active ingredient 

concentration increasing or decreasing 

beyond the limits established by the 

confidential statement of formula or a 

reaction or interaction between the 

pesticide product being repackaged and 

the residue remaining in the container. 

If a tamper-evident device or one-way 

valve is not intact, the refiller must 

clean the container according to the 

product’s refilling residue removal 

procedure. In addition, the final 

regulations state in § 165.65(g) for 

registrants who refill and in § 165.70(h) 

for independent refillers that other 

procedures may be necessary in this 

case to assure that product integrity is 

maintained. 

The first condition is written so it 

would not apply to refillers of 

antimicrobial products used in 

swimming pools because neither a oneway valve or tamper-evident device is 

required. 

2. Changes. The biggest change from 

the proposed regulations is adding the 

condition where the container is being 

refilled with the same pesticide product 

as a case for not needing to clean the 

container. Some commenters pointed 

out that the conditions in the proposed 

regulation and the 1991 amendment to 

the Bulk Pesticides Enforcement Policy 

(Ref. 71) would require a refillable 

container holding a product with 

multiple active ingredients to be 

cleaned even when it was refilled with 

that product. This is true because the 

proposed rule, based on the 1991 

amendment to the Bulk Policy, specified 

a product with a single active ingredient 

in a compatible formulation as an 

acceptable condition for refilling 

without cleaning. EPA corrected this 

oversight in the final rule, because 

refilling with the same product 

(regardless of how many active 

ingredients there are) is certainly the 

most clear way to ensure product 

integrity and should be allowed 

(assuming any tamper-evident devices 

and one-way valves are intact). 

Several other minor changes include: 

(1) Changing the first condition so it 

includes one-way valves and not just 

tamper-evident devices like in the 

proposal; 

(2) Adding ‘‘if required’’ to the first 

condition, since one-way valves or 

tamper-evident devices are only 

required on portable pesticide 

containers for liquids and are not 

required on the containers of 

antimicrobial products used in 

swimming pools; 

(3) Using the phrase ‘‘described in its 

confidential statement of formula that is 

required under FIFRA section 3’’

because it is more straightforward than 

the proposed phrase as described in 

Unit VII.H.; 

(4) The condition in criterion 3(B) was 

modified to be more general to account 

for situations other than reactions or 

interactions between the two products 

such as very different active ingredient 

concentrations that could cause the 

repackaged product to differ from the 

confidential statement of formula; and 

(5) Splitting the situation of a broken 

tamper-evident device or one-way valve 

into a separate paragraph for clarity. 

R. Labeling Refillable Containers 

(§§ 165.65(h) and 165.70(i)) 

1. Final regulation. Before distributing 

or selling a pesticide product in 

refillable containers, refillers must 

ensure that the label of the product is 

securely attached to the refillable 

containers such that the label can 

reasonably be expected to remain 

affixed during the foreseeable 

conditions and period of use. The label 

and labeling must comply in all respects 

with the requirements of 40 CFR part 

156. In particular, refillers must ensure 

that the net contents statement and EPA 

establishment number appear on the 

label. This part of the regulations simply 

re-states requirements from 40 CFR part 

156 and FIFRA for clarity. 

2. Changes. The major change to the 

labeling requirement was to change it 


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from an ‘‘active’’ standard (i.e., the 

refiller must securely attach the label) to 

a ‘‘passive’’ standard (i.e., the refiller 

must ensure that the label is securely 

attached). Also, the regulatory text was 

modified to state that the net contents 

and EPA establishment number appear 

on the label (rather than the new label 

as proposed). Both of these changes 

account for situations where the label is 

embossed on the container or the 

container already has an intact label that 

meets all the requirements. For 

example, a commenter said that 1–

gallon refillable containers for the 

swimming pool market are embossed 

with label information because they are 

refilled automatically at a rate of 100–

120 bottles per minute. 

S. Recordkeeping (§§ 165.65(i), 

165.67(h), 165.70(j)) 

1. Final regulation. All of the 

companies subject to the repackaging 

standards must keep certain records, 

although the specific records vary 

according to who the company is and 

what it does. These records must be 

furnished and made available for 

inspection and copying upon request of 

EPA or our designee, such as a State or 

Tribe. Informational records (listed in 

the first few rows of Table 16) must be 

maintained for the current operating 

year and for 3 years after that. The 

repackaging records (listed in the last 

three rows of Table 16) must be 

generated each time a product is 

repackaged into a refillable container for 

distribution or sale and must be 

maintained for at least 3 years after the 

date of repackaging. All of the records 

are product-specific. In other words, 

this information must be kept for each 

product distributed or sold in refillable 

containers. The same cleaning 

procedure or description of containers 

can be used for different products, but 

there must be a record documenting a 

procedure and a description for each 

product distributed or sold in 

refillables. 

TABLE 16.—RECORDKEEPING REQUIREMENTS IN THE REPACKAGING REGULATIONS

Product-Specific Record 

Registrants who d/s directly in refillables1 Registrants who d/s to 

refillers for repackaging into refillables 1

Refillers who aren’t registrants 

Swim pool products2 All other products 

All products 

Swim pool products2

All other products 

Informational Records 

Contract to repackage No No Yes Yes Yes 

Refilling residue removal procedure Yes Yes Yes Yes Yes 

Description of acceptable 

containers 

Yes Yes Yes Yes Yes 

Repackaging Records 

EPA registration number of 

the product distributed or 

sold in the container 

No Yes No No Yes 

Date of the repackaging No Yes No No Yes 

Serial number of the container No Yes No No Yes 

1 ‘‘d/s’’= distributed or sold. 2Swim pool products = antimicrobial products used in swimming pools and closely related sites, that are subject to the pesticide container-related regulations. 

EPA reminds registrants and refillers 

that the records identified in 

§§ 165.65(i), 165.6(h) and 165.70(j) of 

the repackaging regulations do not 

change other recordkeeping 

requirements that currently apply to 

them, such as restricted use product 

records or applicable records required 

in 40 CFR parts 167 and 169. 

2. Changes. EPA made the following 

significant changes in the recordkeeping 

requirements in the final regulations: 

• The informational records must be 

kept for the current operating year and 

for 3 years after that rather than the 

proposed time period of as long as the 

pesticide product is distributed or sold 

in refillable containers and for 3 years 

thereafter. The specific informational 

records kept by each of the three 

categories of businesses is the same in 

the final rule as in the proposal, 

although the list of acceptable 

containers was changed to the 

description of acceptable containers. 

• The repackaging records in the final 

rule are a subset of what was included 

in the proposed rule. The final 

regulations do not include the name or 

quantity of the product, the name and 

address of the consignee, a record that 

the refiller has inspected the container 

(and the results), and a record of 

whether a refilling residue removal 

procedure was conducted (and, if not, 

why not). Additionally, the date of the 

distribution or sale (in the proposal) was 

changed to the date of the repackaging 

in the final rule. 

• Refillers that repackage 

antimicrobial products used only in 

swimming pools or closely related sites 

would not have to comply with the 

repackaging recordkeeping. However, 

these refillers would have to comply 

with the informational recordkeeping. 

• The proposed regulations would 

have required refillers to maintain 

certain records of containers that were 

received by them to be refilled, 

including the name and address of the 

person providing the container, its serial 

number, the date it was received and the 

name and EPA registration number of 

the product that was last distributed or 

sold in the refillable container. These 

records are not being finalized in 

today’s final regulations. 


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3. Comments - refiller records. Many 

commenters (registrants, registrant 

groups, State regulatory agencies, a 

dealer, a dealer group, and an 

equipment manufacturer) opposed the 

recordkeeping requirements for refillers. 

Most of these respondents commented 

that the proposed recordkeeping 

requirements were too burdensome and 

several stated that these standards will 

discourage the use of refillable 

containers. A registrant group 

recommended requiring refillers to 

maintain records of the serial number, 

the amount of product placed in the 

container and the date the refilling took 

place. 

4. EPA response - refiller records. EPA 

modified the refiller recordkeeping 

requirements to minimize the 

paperwork burden of maintaining these 

records. However, EPA believes that 

some records are necessary to ensure 

safe repackaging and compliance with 

these requirements. First, the refiller 

must have the informational records, 

including the registrant’s contract (if 

applicable), the refilling residue 

removal procedure and the description 

of acceptable containers. These records 

are necessary so the refiller has the 

information needed to properly 

repackage a product into refillable 

containers and to ensure that an 

independent refiller has the proper 

approval from a registrant to repackage 

the product. 

Second, certain information about 

when a product is repackaged into a 

refillable container is needed in case 

there is a problem with a product sold 

in refillable containers, i.e., it is 

adulterated or contaminated or it causes 

damage to the site after application. 

However, EPA pared the repackaging 

records down to the minimum amount 

of information that would allow the 

refiller and investigators to identify the 

product, the container, and the date of 

the repackaging. All of this information 

is readily available at the time the 

pesticide product is repackaged into the 

refillable container, unlike in the 

proposed rule where the information 

also included the name and address of 

the person receiving the container. EPA 

deleted the requirement to record the 

results of the inspection and whether 

the container was cleaned because these 

records would probably not be useful in 

enforcement cases. We will be able to 

determine that a container was not 

inspected if a container in poor 

condition (that did not just sustain 

recent damage) is found and, similarly, 

we’ll be able to tell if a container was 

not properly cleaned if we find high 

levels of contamination in the product 

in that refillable container. 

5. Comments - sodium hypochlorite. 

Several respondents from the sodium 

hypochlorite industry commented on 

the proposed rule and stated that the 

refiller recordkeeping requirements 

would be especially burdensome for this 

market. One registrant group described 

a typical sodium hypochlorite delivery, 

where a truck holding up to 4,000, 1–

gallon refillable containers stops at 

several locations, delivers various 

volumes of product, and picks up empty 

containers. This commenter estimated 

all the recordkeeping standards could 

triple the time for deliveries and 

increase the cost of the product by 100 

percent. An association representing 

many businesses involved with 

swimming pools commented that the 

requirement for individual serial 

numbers and the recordkeeping 

requirements attendant to the serial 

number marking would be completely 

unworkable for refillable pool chemical 

containers. These respondents and a 

swimming pool supply company stated 

that the recordkeeping would 

discourage the use of refillables in the 

pool chemical industry. 

When commenting on the 

supplemental notice, the registrant 

group representing the sodium 

hypochlorite industry reiterated its 

estimate of the increase in time and 

costs that could be attributed to the 

proposed recordkeeping. In addition, a 

sodium hypochlorite manufacturer 

requested EPA to exempt all refillable 

plastic containers of sodium 

hypochlorite from the requirements for 

serial numbers, one-way valves, tamperevident devices and burdensome 

recordkeeping that would negatively 

impact the currently used refillable 

container system. 

6. EPA response - sodium 

hypochlorite. EPA was persuaded by the 

arguments from the companies who 

repackage sodium hypochlorite into 

refillable containers for use in 

swimming pools. Because of the huge 

number of small (1– and 2.5–gallon) 

refillable containers used in this market 

segment, EPA acknowledges that 

compliance with this recordkeeping 

would be burdensome. Therefore, the 

final rule exempts refillers of 

antimicrobials used in swimming pools 

and similar sites from the repackaging 

recordkeeping, although they must 

comply with the informational 

recordkeeping. 

T. Proposed Standards That Are Not 

Being Finalized 

Final regulation/changes. The 

following proposed requirements 

relating to repackaging are not being 

finalized in today’s final rule: 

• § 165.134(f): Age of plastic liquid 

minibulk containers; and 

• § 165.136(b): Records on the return 

of refillable containers to refillers. 

The proposed rule would have 

prohibited a refiller from repackaging a 

product into a plastic liquid minibulk 

container more than 6 years after the 

container’s date of manufacture. EPA 

decided not to finalize this provision to 

be consistent with the DOT regulations, 

which do not establish a life limit for 

plastic nonbulk containers (which may 

be portable pesticide containers under 

our regulations) or for plastic 

intermediate bulk containers (which 

also may be portable pesticide 

containers under our regulations). 

As discussed in Unit VII.S., EPA is 

not finalizing the requirement for 

refillers to keep records on the return of 

refillable containers to minimize the 

burden on refillers. Also, this 

information would have been of limited 

use because it would not have been 

sufficient to conclusively identify where 

a container had been and who had had 

possession of it. 

VIII. Containment 

A. Introduction 

1. Regulatory background. In 1994, 

EPA proposed standards in subpart H of 

40 CFR part 165 for containment of large 

pesticide containers and procedures for 

container refilling operations. Standards 

for pesticide containers, including large 

storage containers, are covered in Units 

III. through VII. of this notice, and apply 

to all pesticides unless specifically 

exempted. The requirements for a 

secondary containment unit (either a 

containment structure around a 

stationary container, or a containment 

pad under a container refilling 

operation) only apply to agricultural 

pesticides. The requirements are 

intended to protect human health and 

the environment from contamination by 

spills and leaks which may occur during 

container filling or when a stationary 

container fails. Affected facilities are 

required to have structures which 

intercept and contain spills and leaks of 

agricultural pesticides in areas where 

stationary containers are stored and 

agricultural containers are refilled or 

cleaned. 

Secondary containment means a 

structure, such as rigid diking, berms or 

walls, designed to intercept and contain 

leaks and spills from the enclosed 

containers. Some States define bulk 

quantities as a pesticide container with 

a volume exceeding 55 gallons; others 

use 210, 300, or 500 gallon criteria. 

EPA’s proposed definition of bulk 

quantities was 3,000 liters (793 gallons) 


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for liquid pesticides and 2,000 

kilograms (4,409 pounds) for dry 

pesticides. The final rule establishes 

quantities of 500 gallons (1,890 liters) 

for liquids and 4,000 pounds (1,818 

kilograms) as the threshold for requiring 

secondary containment. Thus, EPA’s 

regulations cover only relatively large 

containers which pose the greatest risk 

of catastrophic contamination in case of 

failure. 

EPA believes the Federal containment 

standards, together with requirements 

for container design and residue 

removal, are essential for ensuring the 

safe use, reuse and refill of containers as 

required by FIFRA section 19. The 

regulations promulgated today will be 

located in 40 CFR part 165 in § §165.80 

- 165.97. 

2. Summary of proposed and final 

containment standards. The proposed 

and final standards include criteria for 

design, maintenance and operation of 

containment structures (units and pads) 

at certain facilities. The design criteria 

include standards for material of 

construction, capacity, and protection 

from stormwater and precipitation. The 

facilities subject to the requirements are 

agricultural pesticide refilling 

establishments and custom blenders (as 

defined in § 167.3), and facilities of 

businesses that apply agricultural 

pesticides for compensation (also 

referred to as for-hire applicators in this 

preamble). In the preamble to the 

proposal, the Agency explained its 

rationale for choosing these facilities. 

Although spills can occur throughout 

the chain of pesticide commerce (from 

manufacturer to user), the accumulated 

evidence points to agrichemical 

dealerships, custom blenders, and forhire applicators as facilities where 

pesticide contamination of soil and 

water is most frequently documented. 

(See 59 FR 6750 (Ref. 66) and Unit 

VIII.C. for a detailed discussion.) The 

agricultural chemical distribution 

system has the most potential for spills 

and a requirement for reporting spills, 

and is uniquely characterized by the use 

of large tanks and container refilling 

operations, often outdoors, while other 

sectors generally use smaller containers, 

pre-packaged indoors by a 

manufacturer. 

Standards which are considered 

critical are required for all existing and 

new containment units and pads, and 

some additional criteria are imposed for 

new containment structures. For this 

final rule, the criteria identified as 

critical reflect the comments received 

and new information, and are not 

necessarily the same criteria used in the 

proposed rule. For example, hydraulic 

conductivity criteria were considered 

critical in the proposed rule, but, as a 

result of comments we received on 

hydraulic conductivity, are not being 

finalized in the final rule (see 

discussion in VIII.H). 

Many respondents provided 

comments on specific provisions of the 

containment regulations. EPA has made 

certain revisions to the proposed 

regulations based on these comments. 

The following units of the preamble 

discuss the comments received on each 

of the major issues raised in the 

proposed rule, any differences between 

the proposal and the final rule, and the 

Agency’s reasons for making the 

changes. 

Costs and benefits of the rule have 

been revised from those projected at the 

time of the proposed rule. Total costs 

are predicted to be less than estimated 

in the proposal, due to the changes 

made as a result of comments and new 

information. 

3. State secondary containment 

regulations. At least 19 States have 

already promulgated and begun 

implementing their own secondary 

containment regulations for bulk storage 

of pesticides. The 1992 State of the 

States Report (Pesticide Storage, 

Disposal and Transportation, Ref. 70) 

cited in the proposed rule showed the 

wide variety of containment regulations 

among States. There are variations in 

the facilities affected, the container 

volume triggering the requirement for 

secondary containment, etc. The 

economic assessment for the proposed 

rule estimated the number of facilities 

with bulk pesticide storage in each State 

based on commercial, State and 

government business census data. EPA 

estimated that a total of 5,214 

agrichemical dealers in all States and 

the District of Columbia have containers 

of a size defined in the proposed rule as 

bulk (greater than 3,000 liters liquid or 

2,000 kilograms dry). (Ref. 21) EPA has 

reviewed the secondary containment 

regulations in all 19 States and has 

found that they are generally 

comparable to or more stringent than 

the requirements in today’s final rule. 

These 19 States contain 81 percent 

(4,220) of the agrichemical facilities 

regulated by this final rule. 

EPA received many comments on the 

negative impact of the proposed 

regulations on facilities in States with 

preexisting regulations. Today’s 

containment standards are intended to 

introduce basic safeguards in States that 

currently lack containment regulations 

and to harmonize with containment 

requirements in States where adequate 

containment safety programs already 

exist. While EPA believes a national 

standard must provide baseline 

environmental protection, a mechanism 

is being provided to accommodate 

States that are already successfully 

implementing pesticide containment 

programs. 

4. Key terms for understanding the 

requirements of subpart E. The 

following terms, defined in § 165.3 of 

subpart A, are key to understanding the 

containment standards in subpart E: 

(1) Agricultural pesticide. 

(2) Appurtenances. 

(3) Container. 

(4) Containment pad. 

(5) Containment structure. 

(6) Dry pesticide. 

(7) Establishment. 

(8) Facility. 

(9) Owner. 

(10) Operator. 

(11) Pesticide compatible. 

(12) Pesticide dispensing area. 

(13) Refillable container. 

(14) Refilling establishment. 

(15) Rinsate. 

(16) Secondary containment unit. 

(17) Stationary pesticide container. 

(18) Transport vehicle. 

(19) Washwater. 

i. Changes. Based on commenters’

suggestions and additional research, the 

definitions of the following terms were 

added to the final rule to clarify the 

requirements: facility, pesticide 

compatible, and rinsate. 

ii. Comments. A regulatory agency in 

a State with many bulk containment 

facilities commented that the definition 

of a stationary bulk container uses the 

words ‘‘facility’’ and ‘‘establishment,’’

but only defines the latter. The State 

agency advised that those trying to 

avoid the costly container and 

containment requirements might choose 

to view this as a legal loophole, and that 

the term facility should also be defined. 

Several State agencies requested that 

EPA clarify the phrase ‘‘resistant to 

pesticide,’’ because its meaning could 

be either compatible or unreactive and 

could be difficult or burdensome to 

enforce. Alternatives were proposed, 

including ‘‘chemically compatible,’’

defined as the ability of the containment 

structure materials to withstand 

anticipated exposure to stored or 

transferred materials without losing the 

ability to provide the required 

secondary containment of the same or 

other materials within the containment 

area. 

Several State regulatory agencies 

commented that their regulations 

require containment of rinsate, and 

recommend containment for wash 

waters, because hazardous waste 

violations at pesticide facilities are often 

linked to problems with rinsate/wash 

waters. One State agency asked if a 300–


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gallon spill mixed with 600 gallons of 

cleanup water can be considered 

rinsate. Another State agency has an 

expanded definition of rinsate to 

include recovered sedimentation, 

washwater, contaminated precipitation, 

or other contaminated debris. 

iii. EPA response. The word facility 

has been added to the list of definitions. 

The Agency agrees that the phrase 

pesticide compatible is clearer than 

pesticide resistant and has changed the 

regulation accordingly. For the purpose 

of this regulation, rinsate is being 

defined as the liquid (usually water) 

used to rinse the interior of any 

equipment or container that has come in 

direct contact with any pesticide. The 

Agency agrees that it is a good 

management practice to place rinsate 

tanks within containment and is 

recommending that practice, but does 

not have information on the risks of 

storage of such dilute pesticides. 

B. Purpose (§ 165.80(a)) 

1. Final regulations. The purpose of 

the containment standards is to protect 

people and the environment from 

exposure to agricultural pesticides from 

spills and leaks, and to reduce wastes 

produced during pesticide storage, 

handling or refilling of pesticide 

containers. 

2. Changes. This is the same as the 

proposed purpose in § 165.140. 

C. Who Must Comply (§ 165.80(b)) 

1. Final regulations. You must comply 

with these regulations if you are the 

owner or operator of a facility that stores 

pesticides in a stationary pesticide 

container or conducts any of the 

regulated pesticide transferring 

activities and if you are a retailer, forhire applicator, or custom blender (as 

defined in 40 CFR 167.3) of agricultural 

pesticides. 

2. Changes. This is the same approach 

and scope that we proposed in 

§ 165.141. The proposed regulations 

included only retailers, for-hire 

applicators, and custom blenders 

because they are the three categories for 

which EPA has accumulated the most 

substantial evidence of soil and 

groundwater contamination by 

pesticides. The final rule maintains the 

same scope. These facilities represent 

only a subset of the realm of operations 

where containment requirements might 

be appropriate. The Agency may 

consider further containment 

rulemaking for other elements of the 

pesticide industry if further information 

indicates that such requirements are 

needed. In addition, the final rule 

revises the regulatory language to clarify 

that the containment regulations only 

apply to agricultural pesticides. (See 

Unit VII.L. for a discussion of custom 

blending and custom mixing.) Also, a 

description of ‘‘principal business is 

retail sale’’ — more than 50% of total 

annual revenue comes from retail 

operations — was added to the final 

regulation for clarity. 

3. Comments. Many commenters 

(dealer groups, dealers, State regulatory 

agencies, and a distributor/registrant) 

responding to both the 1994 proposal 

and the 2004 reopening of the comment 

period argued for a level playing field 

and urged EPA to expand the scope of 

the containment standards to include 

manufacturing plants, distributors, 

farms, and non-agricultural facilities. 

Commenters argued that there are 

similar potential risks of environmental 

contamination at any facility that meets 

the volume, time or activity criteria, 

regardless of the location of the facility 

or the type of pesticide, Many 

commenters (State regulatory agencies, a 

dealer, a dealer group, an aerial 

applicator and an aerial applicator 

group) stated that there are some farms 

which store and handle more pesticides 

than some small retailers, and that the 

regulations should focus on the activity 

and/or the quantity stored, not the 

individual storing it. 

Commenters to the 2004 Federal 

Register Notice reopening the comment 

period stated that there have been 

changes in pesticide use patterns in the 

11 years since the regulations were 

proposed. They stated that equipment 

technology developments in the 

handling and application of bulk 

agricultural chemicals have advanced 

dramatically, and that these new 

technologies coupled with the increase 

in the number of farms with large 

acreage have led to end users becoming 

a dramatic growth sector of purchasers 

of commercial application equipment. A 

dealer association stated it had surveyed 

chemical equipment dealers in Kansas 

and that 20 to 25 percent of all new 

large commercial application rigs and 

80 percent of all used application 

equipment is currently purchased by 

end users, most of whom are farmers. 

The commenter said that using such 

equipment requires large quantities of 

chemicals on site and concluded that 

on-farm bulk storage is growing. 

Another dealer association 

commented in 2004 that by the end of 

2006, 70 percent of all crop protection 

products, mainly herbicides, will be offpatent, creating a marketing opportunity 

for non-traditional suppliers and 

chemical brokers. They noted that end 

users could become direct crop 

protection customers without 

appropriate facilities, resulting in 

increased environmental incidents. The 

association also stated that at least 58 

percent of U.S. farmland is not farmed 

by the landowner, countering the belief 

that farmers are better stewards because 

they have a vested interest in protecting 

their farmland from contamination. 

They commented that retailers are 

professionals trained in handling 

hazardous materials compared to end 

users, who tend to have less knowledge 

and training in safety, containment, and 

cleanup procedures. A dealer stated that 

some farmers have become tool shed 

dealers who store bulk without 

containment and repackage for 

neighboring farmers. This point was 

reinforced by retailers during a meeting 

in 2004 following the reopening of the 

comment period (Ref. 31), where the 

dealer associations and individual 

dealers reiterated their submitted 

written comments and cited a growing 

problem of cash and carry dealers who 

repackage product on farms illegally 

without a license. 

Several commenters opposed 

expanding the scope to include farmers. 

In 2004, the Farm Bureau and associated 

grower groups opposed any change in 

the proposed scope. A registrant group 

recommended that EPA work jointly 

with State pesticide regulatory officials 

and industry to devise a method for 

obtaining reliable data on the number of 

farmers storing bulk nationwide. The 

Association of American Pest Control 

Officials recommended that EPA not 

expand the scope to farmers without 

first researching the number, volumes 

and other pertinent data regarding onfarm bulk practices, an assessment of 

the risks of on-farm operations, and an 

analysis of the costs and benefits of onfarm bulk containment. 

Several commenters specifically 

supported requiring non-agricultural 

pesticides stored in bulk to be subject to 

the rule. They state that bulk pesticide 

storage presents potential hazards 

regardless of use or activity, and that 

risk may be even higher due to greater 

population density compared to rural 

agricultural settings. 

EPA response. Due to the large 

number of commenters in 1994 and 

2004 from all sectors who supported 

requiring farms to have containment for 

stationary container pesticide storage, 

the Agency considered the option of 

expanding the scope of the rule to 

include farms and other entities. 

Although the Agency had solicited data 

on bulk pesticide storage on farms and 

at non-agricultural facilities in both the 

1994 proposed rule and the 1999 

supplemental notice, only anecdotal 

information was received alleging an 


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increase of stationary container 

pesticide storage on farms. (Ref. 27) 

The Agency therefore researched the 

issue of whether pesticide storage on 

farms is a significant problem. The 

Agency contacted several commenters 

to the rule for clarification and was 

unable to confirm that the use of larger 

spray equipment relates to increased 

bulk pesticide storage or only to 

fertilizer storage and application. In 

cases where bulk storage of pesticide 

most likely occurs on large farms, such 

as with metam-sodium, it is not clear 

that pesticide remains in the tank for 30 

days or more. The Agency asked the 

USDA to contact its sources in the 

extension network, and Agency staff 

contacted regulatory representatives and 

dealers in several States, particularly 

those with large areas under field crops. 

In general, the persons contacted knew 

of few, if any, farms with bulk pesticide 

storage, with the definition of bulk as 

500 gallon containers or greater. 

USDA contacted Colorado, where less 

than 1 percent of farmers potentially 

store pesticides in bulk, and where 

minibulks up to 660 gallons are exempt 

from the requirement for containment if 

they are approved by DOT or MACA. 

USDA also contacted Illinois, Kansas 

and Nebraska. Illinois has implemented 

new regulations which require farmers 

to have secondary containment if they 

meet the volume criteria, so any farmers 

with large tanks are taking them out of 

service. They learned that Kansas has 

three to six farms with bulk pesticides, 

and most farmers are using 250 gallon 

minibulks. Nebraska representatives 

could not estimate how many farms 

have bulk pesticide, but the most 

commonly used containers are 85 to 250 

gallon minibulks. The only State with 

hard data was Indiana, which has 65 

farmers with bulk storage (defined as 

larger than 55 gallons), of which 31 

reportedly had tanks larger than 500 

gallons. 

EPA has no data on the existence of 

bulk storage in non-agricultural 

facilities. EPA assumes that at such 

facilities, pesticides are often stored 

indoors, where the building itself 

affords some measure of containment. 

EPA is aware of some isolated mosquitocontrol facilities which may store 

pesticides in large stationary tanks 

during the treatment period, but does 

not have any way to estimate the 

existence of such facilities nationwide. 

In short, EPA has not received 

sufficient evidence of contamination at 

manufacturing plants, distributors, 

farms and non-agricultural sites to 

justify regulating them. In the proposed 

rule, we outlined the data available to 

the Agency documenting contamination 

at agricultural retailers, refilling 

establishments and commercial 

applicator sites. At least 30 of the 

references to the proposed rule were 

State monitoring studies showing 

contamination at such sites. Data 

documenting widespread contamination 

at other facilities were not submitted, 

and have not been identified. 

The consensus, even from 

commenters who support expansion of 

the scope to include farmers, is that onfarm bulk storage is still rare. The 

Agency does not wish to regulate in 

anticipation of a potential problem, 

particularly since it is questionable that 

such a regulation could be enforced on 

an equitable basis. We recognize the 

staff and resource restrictions of State 

agencies, and do not wish to add to their 

burden in anticipation of a problem 

which may or may not occur in the 

future. 

The Agency recognizes that all large, 

stationary tanks have the potential to 

leak or burst, and considered requiring 

all stationary tanks, regardless of 

location, to conform to the containment 

standards. However, the Agency also 

believes that the volume through-put of 

tanks used for retail sale or commercial 

application of pesticides is higher than 

that expected for individual farms, 

resulting in a higher potential risk 

associated with their usage. The Agency 

further believes that an end-user who is 

not significantly involved in resale of 

product has less opportunity and 

motivation to finance the purchase of 

large tanks and the construction of 

secondary containment. 

EPA added a description of the phrase 

‘‘principal business is retail sale’’ to the 

final rule so § 165.180(b)(1) states that 

refilling establishments who repackage 

agricultural pesticides and whose 

principal business is retail sale (i.e., 

more than 50% of total annual revenue 

comes from retail operations) must 

comply with the containment 

regulations. EPA’s intent of including 

the phrase principal business in the 

1994 proposed rule was to distinguish 

between refilling establishments whose 

principal business is retail sale and 

refilling establishments whose primary 

function is formulation or 

manufacturing of pesticides. The 

description of principal business was 

added to the final rule to provide 

clarification on how to make this 

distinction. In addition, the information 

we received during the 2004 comment 

period about some farmers reportedly 

repackaging pesticides for sale further 

supported the need to clarify the 

meaning of principal business is retail 

sale. For the reasons discussed in this 

section, EPA decided not to apply the 

final containment regulations to 

farmers. We believe that adding the 

clarification of principal business to the 

final rule will help identify the retail 

facilities that we intend to regulate with 

§ 165.180(b)(1). However, EPA wants to 

clarify that anyone including a farmer - 

who is repackaging pesticides for sale or 

distribution must comply with the 

existing requirements in 40 CFR part 

167 to register their establishments and 

report their production (repackaging) to 

EPA and must also keep records of 

pesticide production according to 40 

CFR part 169. In addition, such facilities 

would be regulated as refillers under 

this final rule and would have to 

comply with the refiller requirements in 

subpart D, Standards for Repackaging 

Pesticide Products into Refillable 

Containers. These facilities would have 

to comply with the containment 

requirements in subpart E if they 

repackage agricultural pesticides and if 

more than 50% of their total annual 

revenue comes from retail operations. 

The Agency is willing to amend the 

regulation to include such sites if a 

pervasive pattern of contamination or 

other handling problems appear at other 

sites in the future. It is recommended 

that State and local agencies regulate 

such facilities at the local level as 

needed. 

D. Compliance Dates (§ 165.80(c)) 

1. Final regulations. All containment 

structures subject to today’s rule must 

comply with all applicable containment 

regulations for new and existing 

structures within 3 years of today’s date. 

2. Changes. The proposed rule 

required new structures to comply with 

the containment standards beginning 2 

years after publication of the final rule. 

Existing structures would have been 

required to comply with interim 

standards for a period of 8 years, 

beginning 2 years after publication of 

the final rule, and then existing 

structures would have to comply with 

the same standards as new structures. 

The interim standards were defined as 

critical to safe containment, and 

considered readily implemented within 

2 years. The interim period was 

intended to allow existing structures 

which have design or structural features 

not amenable to upgrading without 

major modification to phase in those 

modifications over time. The final rule 

has no provision for an interim period; 

the final rule applies only one set of 

requirements to existing structures over 

their life spans. Both new and existing 

structures must comply with applicable 

standards beginning 3 years after 

publication of the final rule. 


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3. Comments. Many commenters had 

objections or changes to propose on the 

interim period. Several respondents 

commented specifically on the length of 

the interim period. A registrant thought 

it should be longer and a State 

regulatory agency said it should be 

shortened to 5 years and be based on the 

structure’s age and performance. A State 

regulatory agency said that the nine 

critical standards were sufficient and 

that the only distinction between new 

and existing facilities should be the 

compliance date. A dealer opposed the 

interim period because States already 

have containment standards and would 

have to learn two new sets of standards 

above and beyond existing State rule. 

Several respondents commented on the 

different possibilities for an interim 

period discussed in the preamble. A 

State regulatory agency supported an 

age-based approach of setting the 

compliance date on a formula using 20 

years minus the existing containment 

facility’s age. Many commenters 

(dealers, a dealer group and a State 

regulatory agency group) opposed 

setting any standards that are more 

stringent than existing State standards. 

A principal reason for opposition was 

that interim requirements would 

comprise an extra, unnecessary set of 

requirements to be learned by regulators 

and regulated parties, particularly in 

States with containment programs in 

place. It would also be costly for 

existing structures to have to retrofit, 

particularly in States where facilities 

had already been constructed to 

conform with State requirements. 

Several commenters (State regulatory 

agencies, a dealer, and a grower group) 

recommended that EPA grandfather 

existing containment facilities that are 

already in compliance with State 

standards. A State regulatory agency 

group requested EPA to seriously 

consider accepting small discrepancies 

in some standards due to differences in 

existing State rules and legislation. This 

commenter said that national uniformity 

in regulation is desirable, although 

progress toward this goal should not be 

at the expense of States that have 

already enacted rules and statutes that 

vary slightly from the proposed Federal 

regulations. A dealer group suggested 

that EPA set the Federal standards as a 

baseline, which would allow the 

proactive work of some States to stand. 

Many dealers recommended that EPA 

adopt the Iowa standards in lieu of 

those in the proposal. A dealer said that 

making States enforce standards 

different from their own would cause 

difficulties for enforcing agencies, 

distributors, retailers and end users, and 

a State regulatory agency elaborated, 

stating that States with containment 

requirements would have to reinitiate 

their compliance efforts and would lose 

credibility and trust of the regulated 

community. A few State regulatory 

agencies suggested adding a provision 

that would use the time during the 

interim period to collect data about the 

adequacy of State regulations. If the 

collected information indicated a State’s 

requirements weren’t adequate, EPA 

could justify compliance with the 

Federal standards. 

4. EPA response. The interim period 

was intended to allow substandard 

facilities sufficient time to retrofit and 

come into full compliance with the 

regulations and for owners to recoup the 

benefits from the depreciation of their 

capital investment and financially 

prepare to upgrade their structure. EPA 

has maintained a dialogue and 

information exchange with States and 

the regulated community (facilities and 

their associations) since the rule was 

published in 1994. EPA has decided not 

to finalize the most onerous and 

contentious standards from the 

requirements for existing facilities, such 

as a hydraulic conductivity standard, 

thereby significantly reducing the effort 

and expense needed to comply. EPA 

believes that 33 months between the 

reference date for new structures (3 

months after publication) and the 

compliance date (36 months after 

publication) would provide a reasonable 

period of time for new structures to be 

planned and built in compliance with 

the full requirements of subpart E. If an 

existing structure does not already 

comply with the standards for existing 

structures, EPA believes that the 

remaining modifications can be readily 

implemented at existing structures 

within 3 years. The proposed period of 

2 years before compliance may not have 

provided ample time for facilities to 

meet the requirements, particularly 

facilities in locales with significant 

seasonal constraints on construction. In 

addition, allowing 3 years as a 

compliance date for both new and 

existing structures will allow one year 

for States with their own containment 

regulations to apply for an equivalency 

determination, and still avoid confusion 

by retaining the same compliance date 

for all facilities. EPA believes that 

allowing one more year before 

implementation will not have a 

significant adverse impact on the 

environment, particularly given the 

many State regulations that are already 

in effect. This is a shorter time frame 

than the 5–year phase-in period allowed 

for the refillable container and 

repackaging regulations, but given that 

most States with dealerships have 

already implemented containment 

regulations, the Agency considers 3 

years sufficient time for facilities to 

comply. The Agency is allowing 5 years 

for compliance with the refillable 

container standards because registrants 

need to phase out existing containers 

without recalling them prior to the 

completion of their normal usable life. 

The transition period helps distribute 

costs over time and improve regulatory 

compliance. 

The critical standards cited in the 

preamble of the proposed rule (59 FR 

6765, February 11, 1994) for 

implementation during the interim 

period have been modified based on 

comments, additional research, and 

evaluation of existing State regulations. 

The modified standards for existing 

structures are considered crucial to safe 

containment and comprise the basic 

standards demonstrated to be effective 

for existing structures in States with 

containment regulations. The following 

table compares standards in the 

proposed rule to today’s final standards 

for existing structures. New structures 

are subject to these standards plus 

additional standards representing 

further protectiveness. 

TABLE 17.—COMPARISON OF STANDARDS FOR PROPOSED AND FINAL RULE

Standard in Proposed Rule for Existing Structures Standard in Final Rule for Existing Structures Additional Standard in Final Rule for New 

Structures 

Construction with rigid materials. Same. NA 

Use of pesticide-resistant materials. Use of pesticide-compatible materials. NA 


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TABLE 17.—COMPARISON OF STANDARDS FOR PROPOSED AND FINAL RULE—Continued 

Standard in Proposed Rule for Existing Structures Standard in Final Rule for Existing Structures Additional Standard in Final Rule for New 

Structures 

Hydraulic conductivity no greater than 1 x 10-6

cm/sec during interim, 1 x 10-7 cm/sec after 

10 years. 

None. Liquid-tight. NA 

Withstand full hydrostatic head. Same. NA 

Stormwater run-on protection for a 25-year, 

24-hour storm. 

Sufficient freeboard to contain precipitation 

and prevent water and other liquids from 

seeping into or flowing onto it. 

NA 

Protection of appurtenances and containers. Same. Appurtenances configured so leaks can be 

observed. 

Seal joints and cracks and repair any visible 

damage. 

Same. NA 

Inventory reconciliation of liquid remaining in 

tank during interim only. 

None. NA 

Pad capacity 1,000 gallons. Pad capacity 750 gallons. Sloped to liquid-tight sump. 

Liquid stationary containers - unit capacity 

100 percent/110 percent indoor/outdoor 

minimum during interim, 110 percent/125 

percent indoor/outdoor after 10 years. 

Liquid stationary containers - unit capacity 

100 percent indoor/outdoor minimum. 

Liquid stationary - outdoor capacity 110 percent minimum. 

Anchoring liquid stationary containers. Anchoring or elevating liquid stationary containers. NA 

Prevent pesticide-containing material from escaping from containment. Seal appurtenances, discharge outlets and 

gravity drains through base or wall of containment unit, including sump. Containment 

pads may drain to a watertight sump with 

method of removing accumulated liquids, 

such as a pump, which transfers contents 

to aboveground container. 

Appurtenances must be configured in such a 

way that spills or leaks are easy to see. 

Dry product stationary container - no capacity 

requirement during interim, 100% after 10 

years. 

Dry product stationary container protected 

from wind/rain with 6-inch berm at least 2 

feet from container. 

NA 

Attended transfers; locked valves; cleanup by 

the end of day of spill; monthly inspection. 

Same. NA 

E. Stationary Containers Included 

(§ 165.81) 

1. Final regulations. Stationary 

pesticide containers designed to hold 

undivided quantities of agricultural 

pesticides equal to or greater than 500 

gallons (1,890 liters) of liquid pesticide 

or equal to or greater than 4,000 pounds 

(1,818 kilograms) of dry pesticide are 

subject to the containment regulations. 

Containers of less than these volume/ 

weight capacities are not required to be 

protected with a secondary containment 

unit. The definition of stationary 

pesticide container includes transport 

vehicles that are fixed or remain at a 

facility for at least 30 consecutive days. 

A stationary pesticide container is 

subject to the containment regulations 

and must have a secondary containment 

unit unless it satisfies any one of the 

following conditions: 

• The container is empty, which 

means that it has been cleared of all 

pesticide that can be removed by 

customary methods such as draining, 

pumping, or aspirating (whether or not 

residues have been removed by washing 

or rinsing). 

• The container holds pesticide 

rinsates or wash waters and is so 

labeled. 

• The container holds only pesticides 

which would be gaseous when released 

at atmospheric temperature and 

pressure. 

• The container is dedicated and 

labeled for non-pesticide use. 

2. Changes. This is not the same 

subset of stationary containers proposed 

in § 165.142(a) as subject to, or exempt 

from, the standards. The three 

differences are that the: (1) Liquid 

container size subject to the rule is 500 

gallons rather than 793 gallons; (2) dry 

container size subject to the rule is 

4,000 pounds rather than 4,409 pounds; 

and (3) period of time that a container 

can remain fixed or at a single facility 

in order to be considered stationary is 

30 days, rather than the 14–day period 

in the proposed rule. 

3. Comments - holding capacity. 

Many commenters (State regulatory 

agencies, dealer groups, and another 

government agency) urged EPA to 

reduce the capacity threshold for 

containers for which secondary 

containment is required. Specific 

alternative suggestions included: (1) 300 

gallons for liquids or 100 pounds for dry 

products; (2) 300 gallons for liquids or 

500 pounds for dry products; (3) 500 

gallons for liquids or 2,000 pounds for 

dry products. A registrant group 

commented in 2004 that packaging 

experts believe plastic containers larger 

than 330 gallons would not meet DOT 


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Packing Group III standards, which they 

cite as further evidence that containers 

that size and larger need secondary 

containment. A State agency stated that 

they are already seeing a shift in 

container size (below the regulatory cutoff) in order to be exempt from the 

State’s containment regulations. 

Another State agency suggested that 

States have geographical differences and 

that perhaps EPA should allow 

individual States to mandate storage 

limits based on their individual 

situation. A dealer group and a 

registrant group jointly commented that 

containers with a liquid capacity of 

greater than 330 gallons should be 

protected by containment. There were 

no commenters who thought the 

container size of 793 gallons was 

appropriate or that it should be larger. 

4. EPA response - holding capacity - 

liquids. The Agency recognized that the 

liquid capacity proposed was 

substantially greater than volume 

criteria adopted by many States with 

containment regulations. These States 

use lower limit ‘‘bulk’’ criteria ranging 

from 55 to 500 gallons to trigger 

secondary containment requirements for 

liquid pesticides. The reasoning for the 

proposed definition (793 gallons) of 

liquid bulk container was to be 

consistent with the DOT definitions in 

distinguishing between intermediate 

bulk containers and bulk containers. 

Since the final containment regulations 

do not use definitions of bulk or 

intermediate bulk, the DOT definitions 

are irrelevant here. As discussed in Unit 

VI.A., EPA is not finalizing the 

definitions of minibulk and bulk 

containers in the final rule. The 

Agency’s intent for the secondary 

containment requirement is to prevent 

the most catastrophic spills, and the 

larger the container, the greater the risk 

of contamination. The Agency believes 

contamination from failure of a 500–

gallon container would be significant, 

and agrees with commenters that a 330–

gallon container is generally considered 

the largest size container that can be 

moved by a fork lift and can be 

considered mobile. The next most 

common size used in the field is 500 

gallons. The Agency agrees with States 

that those 500 gallon tanks should be 

required to have secondary 

containment, and is lowering the size 

cut off to capture those tanks and 

harmonize with existing regulations. 

The Agency has confirmed by personal 

communication with some State 

regulators and extension staff (Ref. 28) 

that there are few, if any, containers 

between the sizes of 500 and 793 

gallons, (the next most common size 

after 500 gallons is 1,000 gallons) and 

expects that today’s rule will discourage 

demand for container sizes in that range 

in an attempt to be exempt from the 

containment regulations. The Agency 

confirmed that 500–gallon tanks are 

common in the field, and recognizes 

that the regulations may prompt some 

demand for tanks slightly smaller (e.g., 

450 gallons) in order to be exempt from 

the Federal requirement. There may 

always be facilities which try to skirt the 

law in such ways, but the Agency 

intended the containment regulations to 

prevent the environmental 

consequences from the most 

catastrophic spills. The smaller the tank 

size, the less contamination will result 

from leaks or spills. The Agency also 

reviewed containment regulations in the 

19 States which have them, and 

determined that the size cut-off which 

triggers the requirement for secondary 

containment varies from 55 to 550 

gallons, with many states selecting 300–

or 330–gallon tanks as the cut-off size. 

The Agency believes that selecting a 

volume cut off between 55 and 500 

gallons would conflict with some State 

regulations at a cost to both States and 

facilities, with no measurable benefit to 

the environment (Ref. 25) and has 

therefore selected 500 gallons as a 

realistic, practical and protective size 

which triggers the need for secondary 

containment. 

5. EPA response - holding capacity - 

dry pesticides. As with liquid 

pesticides, the Agency’s goal in 

proposing larger weight criteria for dry 

pesticides, was to target containers that 

pose the greatest risk of catastrophic 

consequences in the event of failure. 

The proposed size criterion for dry 

pesticide containers was 4,409 pounds 

(2,000 kilograms). There were many 

comments on the size criterion for dry 

pesticide containers in 1994. Those 

comments objected specifically to the 

proposed standard for 100 percent 

containment capacity for such 

containers based on the physical nature 

of a dry spill. The Agency has 

confirmed with the packaging industry 

(Ref. 29) that dry pesticides are not 

packaged in containers between the 

sizes of 4,000 and 4,409 pounds. 

Therefore, EPA is lowering the size of 

the container for which containment is 

required to 4,000 pounds (1,818 

kilograms) for simplicity and clarity, 

since 4,000 is an easier number to 

remember for compliance and 

enforcement purposes, and there is no 

functional difference between 4,000 and 

4,409 pounds for refillable dry bulk 

containers, since neither size exists. In 

addition, EPA has replaced the 

requirement for 100 percent 

containment capacity for dry pesticides 

with a requirement for a 6–inch berm in 

the final rule. 

6. Comments - 14–day residence. 

Several commenters suggested 

increasing the time criterion to 30 days 

to account for factors beyond the control 

of the facility. One commenter 

questioned the associated recordkeeping 

as burdensome and unclear as to what 

was required. A registrant requested that 

EPA exempt packaged product in 

nonrefillable containers from the 14–

day time trigger because it would 

burden small facilities. 

7. EPA response - 14–day residence. 

Although most large containers used at 

commercial agrichemical facilities are 

stationary, some containers are actually 

vehicles (such as tank trucks) used for 

prolonged storage or repeated on-site 

dispensing of pesticide at one location. 

In this case, the primary function of the 

vessels shifts from pesticide transport to 

pesticide storage or handling, and 

therefore containment is required. Since 

monthly inspection is required at such 

facilities, EPA believes that it would be 

reasonable to allow a 30–day maximum 

residence time without containment 

requirements, since any transport 

vehicles temporarily stored would have 

to be inspected by the owner or operator 

within that period. The recordkeeping 

required for stationary containers which 

do not have secondary containment 

could simply be a signature of the driver 

and/or facility owner/operator on a 

paper listing the driver’s arrival date. 

The regulation is not intended to 

impose burdensome recordkeeping. The 

regulations will not affect packaged 

pesticide in small quantities used by 

small entities, since the quantities 

required that would trigger containment 

requirements are 500 gallons liquid or 

4,000 pounds dry pesticide. 

F. Pesticide Dispensing Areas Included 

(§ 165.82) 

1. Final regulations. Dispensing areas 

are subject to the requirements for a 

containment pad if one of the following 

activities is conducted in the dispensing 

area: 

• Emptying, cleaning, and rinsing of 

refillable containers that hold 

agricultural pesticides. 

• Dispensing of an agricultural 

pesticide from a stationary pesticide 

container of a size holding 500 gallons 

or more of liquid or 4,000 pounds or 

more of dry pesticide for any purpose. 

• Dispensing of an agricultural 

pesticide from a transport vehicle to fill 

a refillable container. 

• Dispensing of an agricultural 

pesticide from any other container for 


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the purpose of refilling a refillable 

container for sale or distribution. 

A dispensing area is exempt from 

subpart E requirements for a 

containment pad if it satisfies any of the 

following conditions: 

(1) The only pesticides handled in the 

pesticide dispensing area are pesticides 

which would be gaseous if released at 

atmospheric temperature and pressure. 

(2) The only pesticide containers 

refilled within the pesticide dispensing 

area are stationary pesticide containers 

protected by a secondary containment 

unit that complies with the 

requirements of this subpart. 

(3) The pesticide dispensing area is 

used solely for dispensing pesticide 

from a rail car that is not a stationary 

pesticide container. However, if a rail 

car is used as a stationary pesticide 

container, secondary containment is 

required. 

2. Changes. This is the same approach 

and scope that was proposed in 

§ 165.142(b) for including and 

exempting pesticide dispensing areas 

from the requirement for a containment 

pad. The language in § 165.82(a)(2) has 

been slightly revised to reflect the lower 

container sizes, and all of the conditions 

have been slightly revised to be clearer. 

3. Comments. As with the scope of 

facilities subject to the containment 

requirements above, many commenters 

responding to both the 1994 proposal 

and the 2004 Notice (State regulatory 

agencies, a few dealer groups and a 

registrant) urged EPA to expand the 

scope to all permanent areas where the 

transfer of pesticides from any container 

occurs, regardless of container size or 

pesticide type. In particular, they argued 

for requiring containment pads for 

mixer/loader activities by farmers or forhire applicators, citing significant soil 

and groundwater contamination in 

agricultural States, and equivalent risk 

whenever large quantities of pesticides 

are handled. They noted the possibility 

that farmers are less well-trained in 

pesticide management than commercial 

dealers. State agencies supported 

including farmer mixer/loader pads in 

order to strengthen their own 

regulations. 

Arguments by State regulatory 

agencies, user groups, a registrant, and 

a registrant group against including 

farmers in the scope cited the difficulty 

of monitoring numerous individual 

farms and lower quantities of pesticides 

used. Two user groups opposed 

including farmers because the costs 

would be significant to farmers and 

could not be passed on; the costs of 

monitoring the large number of farm 

sites would be burdensome; and farm 

sites generally handle less material, 

which should result in fewer spills. 

4. EPA response. As discussed above 

in Unit VIII.C., Who Must Comply, EPA 

focused on commercial agrichemical 

facilities because these have the clearest 

pattern of soil and ground water 

contamination by pesticides. EPA did 

not include farms because farms 

conduct operations on an occasional 

basis and would not have the same 

environmental impacts as refilling 

establishments. Containment on a farm 

would also be expensive and require 

year-round maintenance but only be 

needed on a seasonal basis. EPA does 

not have a good estimate of the number 

of farms with stationary bulk storage, 

nor evidence that significant 

contamination is occurring at farm sites. 

Although it follows logically that any 

area where pesticides are transferred 

between containers and application 

equipment may become contaminated, 

the quantities transferred at dealer and 

commercial sites for sale to multiple 

customers are expected to far exceed 

quantities transferred at individual 

farms. 

EPA noted that the language in 

§ 165.82(a)(4) did not fit the plainEnglish standard for simplicity and 

revised it to clarify that the activity of 

refilling refillable containers for sale or 

distribution, even if the source 

container is smaller than the size 

requiring secondary containment, 

requires a secondary containment pad. 

For example, refilling a 15–gallon 

minibulk from a 400–gallon stationary 

tank would still require a containment 

pad if the product was intended to be 

sold or distributed. 

G. Definition of New and Existing 

Structures (§ 165.83) 

1. Final regulations. A new 

containment structure is one whose 

installation begins more than 3 months 

after the final rule is published. 

Installation is considered to have begun 

if: 

(1) You, as the owner or operator, 

have obtained all Federal, State, and 

local approvals or permits necessary to 

begin physical construction of the 

containment structure; AND 

(2) You have either begun a 

continuous on-site physical 

construction or installation program OR 

you have entered into contractual 

obligations for physical construction of 

the containment structure. The contract 

must be such that it cannot be canceled 

or modified without substantial loss, 

and must be for the physical 

construction or installation of the 

containment structure within a specific 

and reasonable time frame. 

An existing containment structure is 

one whose installation began on or 

before the date 3 months after the final 

rule is published. 

2. Changes. This is identical to the 

definitions of new and existing 

containment structures proposed in 

§ 165.144. However, the general 

structure of the final rule is different 

from the proposal, as explained in more 

detail in Unit VIII.K. The proposed rule 

would have required existing structures 

to comply with interim standards for a 

period of 8 years, beginning 2 years after 

publication of the final rule, and then 

existing structures would have had to 

comply with the same standards as new 

structures. Instead, the final rule 

establishes critical design standards for 

both new and existing structures, and 

several additional standards for new 

structures. In other words, certain 

standards in the final rule apply to all 

existing structures for their lifetimes. 

Similar but slightly different standards 

apply to all new containment structures. 

As noted earlier, these standards would 

not apply in States that show that their 

regulations afford environmental 

protection at least equivalent to that 

provided by EPA’s regulations. 

Also, EPA reorganized the regulatory 

text so all the design and capacity 

standards for new structures are 

grouped together in § 165.85. (See Unit 

VIII.H.) All the design and capacity 

standards for existing structures are 

grouped together in § 165.87. (See Unit 

VIII.I.) The regulations that follow these 

two groupings of standards, including 

but not limited to operational, 

inspection, maintenance and 

recordkeeping requirements, apply to 

both new and existing structures. EPA 

believes this format is clearer and 

should facilitate compliance compared 

to the structure of the proposed rule, 

which intermingled requirements for 

the interim period and for new 

structures. 

H. Design and Capacity Requirements 

for All New Structures (§ 165.85) 

1. Construction materials for new 

containment structures (§ 165.85(a))—i. 

Final regulations. New containment 

structures must be made of steel, 

reinforced concrete or other rigid 

material which will withstand the full 

hydrostatic head, load and impact of 

any pesticides, precipitation, other 

substances, equipment and 

appurtenances placed within the 

structure. The construction material 

must not be natural earthen material, 

unfired clay, or asphalt, and must be 

compatible with the stored pesticide. 

ii. Changes. The proposed rule stated 

that the construction material had to be 


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resistant to pesticide. The final rule 

states that the material must be 

compatible with the pesticide. The 

proposed rule also had the following 

additional requirement for new 

structures, which is not being finalized 

in the final rule: 

Each new containment structure must 

have a hydraulic conductivity less than 

or equal to 1 x 10-7 centimeters per 

second. During the interim period, each 

existing structure must have a hydraulic 

conductivity standard less than or equal 

to 1 x 10-6 centimeters per second. 

iii. Comments - rigid structures. A few 

State regulatory agencies supported 

requiring rigid structures. One 

recommended allowing flexible 

synthetic liners in the base. A university 

and a registrant supported the use of 

steel structures. A few State regulatory 

agencies and a containment materials 

supplier supported portable rigid or 

non-rigid structures. 

iv. EPA response - rigid structures. 

EPA does not believe that flexible, 

portable, or non-rigid structures can 

adequately ensure the permanent and 

continuous liquid-tight containment of 

large quantities of agricultural 

pesticides or of areas where pesticides 

are transferred and handled regularly. 

Years of State experience with 

secondary containment has shown that 

structures of concrete, steel or other 

rigid material are effective in containing 

spills and leaks. Furthermore, as stated 

in the proposed rule, key technical 

guidance documents recommend that 

rigid materials, especially reinforced 

concrete, be used for structural support 

in pesticide containment facilities. 

Industry guidance (Ref. 11) indicates 

that water-tight concrete can be 

achieved with nonporous aggregate, 

high-quality cement paste, proper 

curing, etc., and that maintenance plays 

an important role in keeping the 

structure impermeable to liquids. 

Although flexible, portable containment 

structures may be appropriate in certain 

other situations, EPA believes that 

durable, rigid materials should be 

required for stationary pesticide 

containment at facilities covered in 

today’s final rule. 

v. Comments - hydraulic conductivity. 

Several State regulatory agencies 

supported the hydraulic conductivity 

standard as proposed. Many 

commenters (including State regulatory 

agencies, another agency, registrants, a 

registrant group, dealer groups, and a 

dealer) commented that a hydraulic 

conductivity standard would be difficult 

to implement, generally citing a lack of 

methods to verify compliance with such 

a standard. Some respondents (dealers, 

State regulatory agencies, registrants 

and a registrant group) commented that 

there are no on-site, non-destructive 

tests to verify hydraulic conductivity. 

Respondents from a variety of 

commenter categories opposed the 

standard as too restrictive, unnecessary, 

unachievable, and too costly. Some 

commenters (registrants, a registrant 

group, and State regulatory agencies) 

pointed out that RCRA-mandated wood 

preservative drip pads serve as primary 

containment, whereas the proposed 

regulations apply to secondary 

containment, arguing that the same 

standard should not apply in both cases. 

A few State regulatory agencies 

expressed concern that construction 

modifications of existing structures to 

comply with the capacity and hydraulic 

conductivity standards may not be 

technically feasible and could penalize 

proactive States. A few State regulatory 

agencies and a dealer group commented 

that there is no evidence of pesticide 

moving through concrete slabs or 

unsatisfactory performance by existing 

concrete structures, and one commenter 

observed that most releases from 

secondary containment are through 

unsealed cracks and installed drains. 

Respondents commented on the 

methods needed to achieve a hydraulic 

conductivity standard, such as use of 

coatings, sealants, and liners. A State 

regulatory agency supported the use of 

sealants and coatings and a few dealer 

groups acknowledged that coatings on 

concrete would extend the useful life of 

the structure and make it less 

permeable. Many commenters expressed 

concerns about the use of coatings and 

sealants on containment structures, for 

reasons such as: coatings can cover 

cracks and problems that would not be 

visible (dealer, dealer association and a 

State regulatory agency); abrasion from 

traffic (State regulatory agency) and 

deterioration of sealants due to 

ultraviolet light (registrant group and 

several registrants) could prevent a 

structure from maintaining compliance; 

and high cost of maintenance and 

replacement. Some commenters (dealer 

groups, State regulatory agencies) 

suggested qualitative alternative ways to 

implement an impermeability standard: 

liquid-tight with cracks, seams and 

joints sealed; spill retention; leakproof, 

coupled with permit and other 

requirements; leakproof and constructed 

with materials resistant to pesticides. A 

State regulatory agency observed that 

most releases from secondary 

containment are through unsealed 

cracks or installed drains. 

vi. Comments - hydrostatic head. A 

few State regulatory agencies argued 

that a requirement for construction to 

withstand full hydrostatic head would 

require dike walls to be unreasonably 

thick in order to withstand a very rare 

but not impossible tidal wave impact of 

a large tank rupture. A dealer group 

urged EPA to replace the standard with 

the following language from the 

Association of American Pest Control 

Officials (AAPCO) model rule: 

‘‘Secondary containment shall be 

constructed of sufficient thickness, 

density, and composition so as to 

contain any discharged material...’’

vii. EPA response - hydraulic 

conductivity and hydrostatic head. 

Based on the comments and additional 

research, EPA agrees that the proposed 

hydraulic conductivity requirements 

would be unnecessarily burdensome, 

and that rigid walls of chemically 

compatible material have been proven 

effective in controlling accidental spills. 

The 1 x 10-7 cm/sec standard was based 

on the hydraulic conductivity 

requirement found in current RCRA 

requirements for wood preservative drip 

pads in subpart W of 40 CFR parts 264 

and 265. EPA agrees that secondary 

containment structures are intended to 

catch and briefly retain spills and 

releases, not store them indefinitely, 

and recognizes the difficulty in 

verifying hydraulic conductivity. The 

Agency has therefore decided not to 

finalize the standards for hydraulic 

conductivity. The Agency disagrees that 

the requirement to withstand full 

hydrostatic head is unreasonable. It is a 

requirement in many State containment 

regulations. The final rule was modified 

slightly to delete the phrase (dynamic or 

static) because that phrase adds more 

confusion than clarity. However, EPA 

believes that the standard of being 

‘‘capable of withstanding the full 

hydrostatic head, load and impact of 

any pesticides, precipitation...’’ requires 

the secondary containment unit to be 

able to contain a catastrophic spill. EPA 

believes that using industry 

construction guidance on concrete 

quality and reinforcement bars will 

ensure that containment structure’s 

integrity in the case of a catastrophic 

spill of a large tank. 

2. General design requirements for all 

new containment structures 

(§ 165.85(b))—i. Final regulations. These 

are the general design requirements for 

new containment structures: 

(1) You must protect appurtenances 

and pesticide containers against damage 

from operating personnel and moving 

equipment. Means of protection 

include, but are not limited to, supports 

to prevent sagging, flexible connections, 

the use of guard rails, barriers, and 

protective cages. 

(2) Appurtenances, discharge outlets, 

or gravity drains must not be configured 


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through the base or wall of the 

containment structure, except for direct 

interconnections between adjacent 

containment structures which meet the 

requirements of this subpart. 

Appurtenances must be configured in 

such a way that spills or leaks are easy 

to see. 

(3) The containment structure must be 

constructed with sufficient freeboard to 

contain precipitation and prevent water 

and other liquids from seeping into or 

flowing onto it from adjacent land or 

structures. 

(4) Multiple stationary pesticide 

containers may be protected within a 

single secondary containment unit. The 

volume of the largest container 

determines the capacity requirement of 

the unit. 

ii. Changes. Requirements in 

§ 165.85(b)(1) and (2) are identical to 

those proposed in § 165.146(b). 

Paragraph (4) is added to clarify a 

statement in the proposed rule under 

§ 165.152. The requirement in 

§ 165.85(b)(3) has been changed. In the 

proposed rule, the requirement was to 

prevent storm water run-on from 

seeping into or flowing onto it from 

adjacent land or structures during a 25–

year, 24–hour rainfall event. 

iii. Comments - storm protection. 

Several respondents (a registrant and 

two State regulatory agencies) supported 

the stormwater control provision. 

Several others (a dealer group and two 

State regulatory agencies) suggested 

alternative language, such as diverts 

water, no discharge, or constructed to 

prevent any surface water from moving 

onto or across the structure. Several 

commenters (a dealer group, a registrant 

group and two State regulatory agencies) 

noted that it would be difficult to 

comply because (1) a watershed runoff 

study would be needed; (2) the 25–year, 

24–hour criterion would be difficult to 

determine at different sites; (3) rainfall 

varies substantially from year to year. A 

few State regulatory agencies 

commented that the stormwater control 

standard doesn’t adequately address 

precipitation and stated that the 

containment capacity requirements 

must be based on rainfall volume, such 

as a 25–year, 24–hour rainfall event. A 

few dealers recommended the example 

of the Illinois pesticide containment 

rule, which requires that stormwater be 

diverted from containment structures. 

iv. EPA response - storm protection. A 

25–year, 24–hour storm is commonly 

used as a benchmark for the capacity of 

secondary containment structures, and 

is recommended in the National 

Pollution Discharge Elimination System 

(NPDES) Best Management Practices 

Guidance Document.(Ref. 74) EPA 

believes that, just as a 25–year, 24–hour 

storm is a reasonable criterion for 

stormwater retention (prevention of runoff), it would also serve as sufficient 

freeboard and a reasonable standard for 

prevention of stormwater seepage and 

run-on from adjacent lands or 

structures. Such a standard allows 

flexibility for varying climatic 

conditions. It is also the standard 

required for certain tank systems storing 

or treating hazardous waste. See, for 

example, 40 CFR 265.1(e)(1)(ii) and 

(e)(2)(ii). However, the Agency has 

decided not to require a 25–year, 24–

hour storm criterion here in order to be 

consistent with the final EPA rule on 

Oil Pollution Prevention and Response: 

Non-Transportation-Related Onshore 

and Offshore Facilities (67 FR 47042, 

Ref. 47). The Oil Prevention Rule states 

that while a 25–year, 24–hour storm 

event standard is appropriate for most 

facilities and protective of the 

environment, it may be difficult and 

expensive for some facilities to secure 

recent information concerning such 

storm events at this time. Recent data do 

not exist for all areas of the United 

States, or may be costly for small 

operators to secure. Should recent and 

inexpensive information concerning a 

25–year, 24–hour storm event become 

easily accessible for every part of the 

United States, we will reconsider 

proposing such a standard. Instead, at 

this time, we are requiring, as a few 

commenters suggested, that the 

containment structure have sufficient 

freeboard to contain precipitation and 

prevent water and other liquids from 

seeping into or flowing onto it from 

adjacent land or structures. Most States 

with containment regulations do not use 

a 25–year, 24–hour storm criterion, and 

have indicated that, in their experience, 

requiring a numerical capacity (110 

percent) or sufficient freeboard to 

accommodate local precipitation 

conditions provides adequate 

protection. 

3. Capacity requirements for new 

stationary liquid pesticide containment 

units and new containment pads in 

pesticide dispensing areas 

(§ 165.85(c))—i. Capacity for new 

stationary liquid pesticide containment 

units—Final regulations. These are the 

capacity requirements: 

• New secondary containment units 

for stationary liquid containers, if 

protected from precipitation, must have 

a capacity of at least 100 percent of the 

volume of the largest stationary 

container plus the volume displaced by 

other containers and appurtenances 

within the unit. 

• New secondary containment units 

for stationary liquid containers, if 

exposed to or unprotected from 

precipitation, must have a capacity of at 

least 110 percent of the volume of the 

largest stationary container plus the 

volume displaced by other containers 

and appurtenances within the unit. 

a. Changes. The proposed rule 

required higher capacity of 110 percent 

for units protected from precipitation 

and 125 percent for units exposed to 

precipitation. 

b. Comments. Several State regulatory 

agencies supported the proposed 

standards, stating that adjusting the 

standard to reflect variable rainfall 

would add confusion. Many 

commenters (dealers, dealer groups and 

a State regulatory agency) supported 

instead the standard that EPA had 

proposed for the interim period for 

existing structures, namely 100 percent/ 

110 percent capacity (indoor/outdoor). 

Reasons cited included: (1) Many dikes 

that meet this standard have been in 

place for years with no overflows; (2) 

EPA provides little or no justification 

that capacity in excess of 100 percent of 

the volume of the largest container is 

necessary; (3) modifying a dike to add 

additional capacity would be expensive; 

and (4) many Midwestern States have 

adopted the 100 percent/110 percent 

standard from the AAPCO model rule. 

c. EPA response. EPA agrees with 

comments based on practical field 

experience and has reduced the 

volumes needed to 100 percent and 110 

percent, respectively for indoor and 

outdoor units. The 110 percent criterion 

for storage areas without roofing adds an 

extra margin of safety for retention of 

precipitation. An extra 10% is not 

needed indoors as long as the displaced 

volume or other containers is added. 

However, the Agency recognizes that, 

for enforcement purposes, it may be 

difficult to reconcile capacity with 

climatic conditions. For example, in the 

case of a 2–inch rain, capacity at a new 

outdoor liquid pesticide facility could 

be temporarily reduced to less than 110 

percent of the largest tank if that tank 

were full, and the facility would no 

longer be in compliance. To avoid 

disputed calculations of capacity, the 

Agency recommends that facilities make 

allowances for additional capacity 

beyond the 110 percent required, such 

as 125 percent, to build in a margin of 

error. 

ii. Capacity for new containment pads 

in pesticide dispensing areas—i. Final 

regulations. These are the capacity 

requirements: 

• New containment pads in pesticide 

dispensing areas subject to the 

regulations in this subpart which have 

a pesticide container or pesticideholding equipment with a volume of 


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750 gallons or greater must have a 

holding capacity of at least 750 gallons. 

• New containment pads in pesticide 

dispensing areas subject to the 

regulations in this subpart which do 

NOT have a pesticide container or 

pesticide-holding equipment with a 

volume of at least 750 gallons must have 

a holding capacity of at least 100 

percent of the volume of the largest 

pesticide container or pesticide-holding 

equipment used on the pad. 

ii. Changes. The proposal required 

that pads have a minimum holding 

capacity of 1,000 gallons, or, if no 

equipment used on the pad exceeded 

1,000 gallons, at least 100% of the 

capacity of the largest container or 

equipment used on the pad. Today’s 

rule reduces the minimum pad holding 

capacity to 750 gallons in the most 

likely scenario where large (greater than 

750 gallon) containers or pesticideholding equipment will be on the pad. 

Additionally, the capacity requirement 

refers to gravity capacity, as defined in 

oral comments by Wisconsin state 

regulatory officials (Ref. 46) in 2003. 

The gravity capacity of a sump or 

containment structure is the capacity 

before any method of removing or 

transferring the contained liquid by 

pump or other means is employed. For 

example, a facility is prohibited from 

claiming a capacity of 750 gallons if the 

sump or containment structure has an 

actual capacity of less than 750 gallons 

but is serviced by a pump which 

transfers accumulated liquid into 

holding tanks such that the effective 

capacity would be 750 gallons. Since 

achieving 750–gallon storage capacity 

under those circumstances relies on the 

proper and dependable functioning of a 

pump as well as a continual supply of 

fuel or electrical current to run the 

pump, this is not an acceptable way of 

achieving the required capacity because 

if these conditions are not met, a spill 

is more likely. 

iii. Comments. Indiana state 

regulators argued that the state had 

spent three difficult years and had 

invested considerable resources in 

implementing its regulations, which 

require a pad capacity of 750 gallons. 

They stated that to get the cooperation 

and voluntary compliance of the 

impacted industries, they had to suggest 

to those making the investment that 

there would be no significant changes in 

requirements. To reverse themselves 

now, they stated, would jeopardize their 

credibility. Illinois, a state with over 

1,000 bulk facilities, suggested that the 

pad capacity requirement should take 

into account the additional volume of a 

6–inch rainfall (the volume expected 

from a 24–year, 25–hour storm). A few 

State regulatory agencies did not object 

to EPA’s proposed pad capacity 

requirements, although their State 

regulations are slightly more stringent. 

A State regulatory agency noted that the 

difference between 750 gallon and 1,000 

gallon capacity would do little to 

accommodate a spill from a 3,000 gallon 

delivery truck. 

iv. EPA response. The Agency did not 

have a technical basis for choosing the 

1,000 gallon capacity in the proposed 

rule, but based it on a review of 

proposed and actual State containment 

regulations. Based on comments and 

subsequent research, we determined 

that the criteria of 750 gallons used in 

some States has proven adequate. We 

believe that in most actual situations of 

spillage on a pad, 750 gallons would be 

adequate, especially since product 

transfers must be attended under the 

requirements of this subpart. In a 

catastrophic event, neither 750 gallons 

nor 1,000 gallons would be sufficient to 

contain a large spill, and the added cost 

of increasing capacity to 1,000 from 750 

would exceed any marginal 

environmental benefit. The Agency also 

agrees with Wisconsin State regulators 

that a 750–gallon pad may be as small 

as 12 feet square, and that a top-loaded 

tank may risk splashing during the 

refilling process. Consequently, while 

we are lowering the gallon capacity to 

750 gallons of gravity capacity, we are 

recommending that the pad have a 

minimum size of 15 feet by 15 feet (or 

225 square feet). Additionally, for new 

operational pads unprotected from 

precipitation, we recommend 

constructing a pad with a gravity 

capacity of 1,000 gallons. 

4. Specific requirements for new 

stationary liquid pesticide containment 

units (§ 165.85(d))—i. Final regulations. 

In addition to meeting the requirements 

of § 165.85(a), (b) and (c), each new 

stationary liquid container protected by 

a secondary containment unit must 

either be anchored or elevated to 

prevent flotation in the event that the 

secondary containment unit fills with 

liquid. 

ii. Changes. The proposed rule 

required that the containment unit had 

to allow for observation of leakage from 

the base of any enclosed stationary 

pesticide container. Thus, a flatbottomed container would have had to 

be elevated so that leakage would be 

visible. In addition, the proposed rule 

required that flotation of the container, 

in the event the containment filled with 

liquid, be prevented by either elevating 

or anchoring the container. The final 

rule requires either elevation or 

anchoring in response to comments that 

argued that elevating containers is not 

necessary to detect leaks and may 

engender risks from inadequate support 

devices. 

5. Specific requirements for new 

containment pads in pesticide 

dispensing areas (§ 165.85(e))—i. Final 

regulations. In addition to meeting the 

requirements for § 165.85(a), (b) and (c), 

each new containment pad in a 

pesticide dispensing area must: 

• Be designed and constructed to 

intercept leaks and spills of pesticides 

which may occur in the pesticide 

dispensing area. 

• Have enough surface area to extend 

completely beneath any container on it, 

with the exception of transport vehicles 

dispensing pesticide for sale or 

distribution to a stationary container. 

For such vehicles, the surface area of the 

containment pad must accommodate at 

least the portion of the vehicle where 

the delivery hose or device couples to 

the vehicle. This exception does not 

apply to transport vehicles that are used 

for prolonged storage or repeated on-site 

dispensing of pesticides. 

• Allow, in conjunction with its 

sump, for removal and recovery of 

spilled, leaked, or discharged material 

and rainfall, such as by a manually 

activated pump. Automatically 

activated pumps which lack automatic 

overflow cutoff switches for the 

receiving container are prohibited. 

• Have its surface sloped toward a 

liquid-tight sump where liquids can be 

collected for removal. 

ii. Changes. These requirements are 

identical to those in § 165.152(b) of the 

proposed rule. The proposed rule noted 

that tanker trucks are considerably 

larger than containers or equipment 

normally used on the containment pad, 

but that such deliveries are not expected 

to be frequent, and did not propose that 

the pad had to be large enough to 

accommodate the entire vehicle. This 

exception does not apply to transport 

vehicles that are used for prolonged 

storage or repeated on-site dispensing of 

pesticides, since the primary function of 

such a vehicle would be pesticide 

storage rather than transport. EPA 

reasons that the full containment 

requirements imposed on fixed 

containers would also apply to nonfixed containers that remain at an 

applicable facility for at least 30 days. 

6. Specific Requirements for new 

stationary dry pesticide containment 

units (§ 165.85(f))—i. Final regulations. 

In addition to the requirements in 

§ 165.85(a) and (b), each new stationary 

dry pesticide containment must meet 

the following requirements: 

• The stationary dry pesticide 

containers within the containment unit 


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must be protected from wind and 

precipitation. 

• Stationary dry pesticide containers 

must be placed on pallets or a raised 

concrete platform to prevent the 

accumulation of water in or under the 

pesticide. 

• The stationary dry pesticide 

container storage area must be enclosed 

by a curb that is a minimum of a 6 

inches high and that extends at least 2 

feet beyond the perimeter of the 

container. 

ii. Changes. The proposal required 

that dry bulk secondary containment 

units have a capacity of 100 percent of 

the largest container plus the volume 

displaced by other containers and 

appurtenances within the containment. 

The Agency was concerned that dry 

pesticide could still mix with rainwater, 

fire suppression water, etc., to reach and 

contaminate groundwater and soil. The 

proposed rule did not have any 

provisions for protection from wind and 

precipitation, nor for elevated storage to 

prevent water accumulation under the 

pesticide, but did request comment on 

such options. The final rule does not 

have a numerical capacity requirement. 

iii. Comments. Several commenters 

(State regulatory agencies and a dealer 

group) opposed the 100 percent 

proposed capacity as excessive, since 

dry materials do not spread and 

disperse like liquid materials. Several 

State regulatory agencies suggested that 

dry bulk secondary containment should 

be protected by roofing or similar cover 

from wind and precipitation, which 

would make 100 percent capacity 

unnecessary. One State noted that it 

already has dry bulk containment 

regulations which require that the 

containers be raised off the floor, and 

several States require at least a 6–inch 

curb around an area extending at least 

2 feet beyond the perimeter of the bulk 

tank. A registrant stated that the typical 

practice is to store dry pesticides under 

a roof. Some commenters offered 

alternative strategies, generally based on 

existing State regulations, including a 

curb 6 inches high at least 2 to 3 feet 

beyond the perimeter. 

iv. EPA response. EPA has reviewed 

State bulk storage regulations and best 

management practices for storing dry 

bulk pesticides and has noted that 

States require storage under a roof and, 

if outdoors, on pallets or raised concrete 

platforms, and that the most common 

requirement for dry bulk is a 6–inch 

berm at least 2 to 3 feet from the 

container. (Ref. 34) Given that the States 

with the most experience with dry bulk 

storage have the most practical 

experience with dry spill containment, 

EPA agrees with the common sense 

arguments of commenters regarding 

protection from precipitation, elevation, 

and the flow properties of dry material, 

and has changed the dry containment 

requirement accordingly. In regard to 

roofing, EPA believes that the 

advantages of keeping rainwater out of 

containment will outweigh the cost of 

installing a roof. However, in arid 

regions, a roof may not be cost-effective, 

and if EPA provided roofing 

specifications, it is possible that they 

would conflict with local construction 

requirements and building codes. 

Therefore, the final rule requires 

protection from wind and precipitation 

rather than specifically requiring a roof 

to allow some flexibility. The Agency 

agrees that 100 percent capacity, given 

that dry materials spread differently that 

liquids, would be excessive. We also 

recognize that significant quantities of 

dust may be generated during the 

refilling process, where the dry product 

is a dust, granules or flowable 

formulation. While today’s rule makes 

no requirement for dust minimization or 

collection, we recommend that every 

effort be made to contain the dust 

generated, both for the respiratory 

protection of the persons attending the 

transfer and for the preservation of air 

and soil quality in the vicinity of the 

facility. 

I. Design and Capacity Requirements for 

Existing Structures (§ 165.87) 

1. Construction Materials for all 

existing containment structures 

(§ 165.87(a))—i. Final regulations. 

Existing containment structures must be 

made of steel, reinforced concrete or 

other rigid material which will 

withstand the full hydrostatic head, 

load and impact of any pesticides, 

precipitation, other substances, 

equipment and appurtenances placed 

within the structure. The construction 

material must not be natural earthen 

material, unfired clay, or asphalt, and 

must be compatible with the stored 

pesticide. 

ii. Changes. The requirements in 

§ 165.87(a) for existing structures are 

identical to the requirements for 

construction materials for new 

containment structures in § 165.85(a). 

The proposed rule stated that the 

construction material had to be resistant 

to pesticide, while the final rule 

requires the material to be compatible 

with the stored pesticides. In addition, 

the following proposed standard for 

existing structures is not being finalized: 

During the interim period, each 

existing structure must have a hydraulic 

conductivity standard less than or equal 

to 1 x 10-6 centimeters per second. After 

the interim period, each new 

containment structure must meet the 

hydraulic conductivity standard for new 

structures of less than or equal to 1 x 

10-7 centimeters per second. 

iii. Comments. General comments and 

EPA’s response on construction material 

are discussed in Unit VIII.H.1. EPA 

believes that existing structures should 

easily meet these requirements based on 

the information we have gathered. We 

are not aware of secondary containment 

units being constructed of any of the 

prohibited materials. We are aware of 

the existence of some asphalt 

containment pads, but we believe these 

are mostly used by aerial applicators 

that probably are not subject to these 

regulations because they do not have 

large stationary pesticide containers. 

2. General design requirements for all 

existing containment structures 

(§ 165.87(b))—i. Final regulations. These 

are the general design requirements for 

existing containment structures: 

(1) Protect appurtenances and 

pesticide containers against damage 

from operating personnel and moving 

equipment. Means of protection 

include, but are not limited to, supports 

to prevent sagging, flexible connections, 

the use of guard rails, barriers, and 

protective cages. 

(2) Seal (permanently close) all 

appurtenances, discharge outlets and 

gravity drains through the base or wall 

of the containment structure, except for 

direct interconnections between 

adjacent containment structures which 

meet the requirements of this subpart. 

(3) Construct the containment 

structure with sufficient freeboard to 

contain precipitation and prevent water 

and other liquids from seeping into or 

flowing onto it from adjacent land or 

structures. 

(4) Multiple stationary pesticide 

containers may be protected within a 

single secondary containment unit. 

ii. Changes. Requirements are similar 

to those proposed in proposed 

§ 165.146, except that (4) is added to 

clarify a statement in the proposed rule 

under § 165.152. The requirement in 

paragraph (2) was proposed for existing 

structures 10 years after the publication 

date of the rule (at the expiration of an 

interim period that was proposed for 

existing units. See discussion on 

compliance dates in Unit VIII.D. above.) 

In addition, at the end of the interim 

period, existing structures had to meet 

the requirements for new structures, 

including configuring appurtenances in 

such a way that leaks and spills could 

be readily observed. The final rule 

requires facilities with existing 

structures to seal appurtenances, 

discharge outlets and gravity drains at 

the base and walls. EPA believes it is 


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necessary for existing structures to 

comply with this requirement because 

some studies cited in the proposed rule 

estimated that 30 percent of the reported 

pesticide spill incidents resulted from 

appurtenance failure, and many releases 

were reported from discharge outlets 

and gravity drains. Requirements in 

paragraph (3) have also been changed. 

In the proposed rule, the requirement 

was to prevent storm water run-on from 

seeping into or flowing onto it from 

adjacent land or structures during a 25–

year, 24–hour rainfall event. The 

requirement has been changed to 

ensuring sufficient freeboard to prevent 

run-on. The comments on general 

design requirements and EPA’s 

responses are discussed in Unit VIII.H.2. 

3. Capacity requirements for existing 

stationary liquid pesticide containment 

units and existing containment pads in 

pesticide dispensing areas 

(§ 165.87(c))—i. Capacity for existing 

stationary liquid pesticide containment 

units—a. Final regulations. Each 

existing stationary liquid pesticide 

containment unit must have a capacity 

of at least 100 percent of the volume of 

the largest stationary pesticide container 

plus the volume displaced by other 

containers and appurtenances within 

the unit. 

b. Changes. The proposed rule 

required a capacity of 100 percent for 

existing liquid bulk containment units 

protected from precipitation and 110 

percent for units exposed to 

precipitation for the 8–year interim 

compliance period. At the expiration of 

the interim period, the capacity 

requirements would be the same as 

those proposed for new structures, that 

is, 110 percent for units protected from 

precipitation and 125 percent for 

outdoor, unprotected units. The 

approach of having an interim period is 

not being finalized. The final rule 

requires existing liquid pesticide 

containment units to have capacities of 

100 percent whether protected from 

precipitation or not. 

c. Comments. The comments on 

capacity requirements for new and 

existing stationary liquid pesticide 

containment units are discussed in the 

comment section under Unit VIII.H.3.a. 

In addition, many commenters noted 

that changes in capacity requirements 

for existing structures would require 

major modification, re-certification by 

an engineer and significant costs. A few 

State regulatory agencies noted that 

little if any additional benefit will be 

afforded by requiring extra capacity, and 

that they had never experienced a 

breach of containment structure based 

on existing laws. 

d. EPA response. As discussed in Unit 

VIII.H.3., EPA agrees, based on field 

experience, that the proposed capacity 

requirements were excessive and has 

reduced the capacity requirements in 

the final rule. In addition, the Agency is 

not requiring a numerical standard of 

110 percent for existing unprotected 

units (in contrast to the requirements for 

new unprotected units) in order to 

harmonize with existing State 

containment regulations which have 

chosen to require unprotected units to 

have 100 percent capacity plus either a 

6–inch freeboard or capacity to 

withstand a 25–year/24–hour storm. 

The Agency understands that some 

existing units would need to retrofit to 

meet a 110 percent capacity 

requirement, and that the burden of 

adding the extra capacity appears to 

outweigh any benefit of the extra 

capacity. The Agency recognizes that 

States may have existing structures in 

low-precipitation areas, and is allowing 

them the flexibility to define capacity 

requirements above 100 percent 

according to local conditions. 

ii. Capacity for Existing containment 

pads in pesticide dispensing areas— a. 

Final regulations. Existing containment 

pads with pesticide-holding equipment 

with a volume of 750 gallons or greater 

must have a holding capacity of at least 

750 gallons. Pads which do not have a 

pesticide container or pesticide-holding 

equipment with a volume of at least 750 

gallons must have a holding capacity of 

at least 100 percent of the volume of the 

largest pesticide container or pesticideholding equipment used on the pad. 

b. Changes. The proposal required 

that existing pads have a minimum 

holding capacity of 1,000 gallons or 100 

percent of the capacity of the largest 

container or equipment used on the pad. 

The final rule reduces the minimum pad 

holding capacity to 750 gallons in the 

most likely scenario where large (greater 

than 750 gallon) containers or pesticideholding equipment will be on the pad. 

Comments and EPA responses apply as 

discussed in Unit VIII.H.3. for new 

containment pads. 

4. Specific design requirements for 

existing stationary liquid pesticide 

containment units (§ 165.87(d))—i. 

Final regulations. In addition to the 

requirements in § 165.87(a), (b) and (c), 

each existing stationary liquid pesticide 

container protected by a secondary 

containment unit must be adequately 

elevated or anchored to prevent 

flotation in the event that the secondary 

containment unit fills with liquid. 

ii. Changes. This requirement is 

identical to that proposed in 

§ 165.148(b)(2). In the proposed rule, 

existing secondary containment units 

would have had to allow for the 

observation of leakage from the base of 

all stationary bulk containers after the 

interim period expired. As explained in 

Unit VIII.H.4., the standard for 

observing leakage from the base of 

stationary bulk containers is not being 

finalized. 

5. Specific design requirements for 

existing containment pads in pesticide 

dispensing areas (§ 165.87(e))—i. Final 

regulations. In addition to meeting the 

requirements for § 165.87(a), (b) and (c), 

each existing containment pad in a 

pesticide dispensing area must: 

• Be designed and constructed to 

intercept leaks and spills of pesticides 

which may occur in the pesticide 

dispensing area. 

• Have enough surface area to extend 

completely beneath any container on it, 

with the exception of transport vehicles 

dispensing pesticide for sale or 

distribution to a stationary container. 

For such vehicles, the surface area of the 

containment pad must accommodate at 

least the portion of the vehicle where 

the delivery hose or device couples to 

the vehicle. This exception does not 

apply to transport vehicles that are used 

for prolonged storage or repeated on-site 

dispensing of pesticides. 

• Allow, in conjunction with its 

sump, for removal and recovery of 

spilled, leaked, or discharged material 

and rainfall, such as by a manually 

activated pump. Automaticallyactivated pumps which lack automatic 

overflow cutoff switches for the 

receiving container are prohibited. 

ii. Changes. The requirements in the 

final rule are identical to those in the 

proposal. The proposed rule noted that 

tanker trucks are considerably larger 

than containers or equipment normally 

used on the containment pad, but that 

such deliveries are not expected to be 

frequent, and did not propose that the 

pad had to be large enough to 

accommodate the entire vehicle. This 

exception does not apply to transport 

vehicles that are used for prolonged 

storage or repeated on-site dispensing of 

pesticides, since the primary function of 

such a vehicle would be pesticide 

storage rather than transport. In 

addition, the proposed rule required 

that, at the expiration of the interim 

period, each existing containment pad 

would be sloped to a liquid-tight sump 

where liquids can be collected for 

removal. The interim period has been 

deleted, and the requirement for sloped 

pads is not being finalized for existing 

containment pads. The requirement for 

sloped pads applies only to new 

containment pads in the final rule. 

6. Specific design requirements for 

existing stationary dry pesticide 


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containment units (§ 165.87(f))—i. Final 

regulations. In addition to the 

requirements in § 165.87(a) and (b), each 

existing dry stationary pesticide 

containment must meet the following 

requirements: 

• The containment must protect 

stationary dry pesticide containers 

within it from wind and precipitation. 

• Dry stationary pesticide containers 

must be stored on pallets or a raised 

concrete platform to prevent the 

accumulation of water in or under the 

pesticide. 

• The container storage area must be 

enclosed by a minimum of a 6–inch 

high curb that extends at least 2 feet 

beyond the perimeter of the container. 

ii. Changes. The proposal required 

that dry bulk secondary containment 

units have a capacity of 100 percent of 

the largest container plus the volume 

displaced by other containers and 

appurtenances within the containment. 

The proposed rule did not have any 

provisions for protection from wind and 

precipitation, nor for elevated storage to 

prevent water accumulation under the 

pesticide. The final rule does not have 

a numerical capacity requirement. All 

modifications must now be made within 

3 years instead of the 10 years in the 

proposed rule, but the requirements are 

modified and simplified such that the 

Agency believes they are feasible within 

the 3–year period. See Unit VIII.H.6. for 

a summary of the significant comments 

and EPA’s responses. 

J. Operational, Inspection and 

Maintenance Requirements (§ 165.90) 

1. Operating procedures for all new 

and existing pesticide containment 

structures (§ 165.90(a))—i. Final 

regulations. An owner or operator of a 

new or existing pesticide containment 

structure must: 

• Manage the structure in a manner 

that prevents pesticides or materials 

containing pesticides from escaping 

from the containment structure 

(including, but not limited to, pesticide 

residues washed off the containment 

structure by rainfall or cleaning liquids 

used within the structure.) 

• Ensure that pesticide spills and 

leaks on or in any containment structure 

are collected and recovered in a manner 

that ensures protection of human health 

and the environment (including surface 

water and ground water) and maximum 

practicable recovery of the pesticide 

spilled or leaked. Cleanup must occur 

no later than the end of each day on 

which pesticides have been spilled or 

leaked. 

• Ensure that all materials resulting 

from spills and leaks and any materials 

containing pesticide residue are 

managed according to label instructions 

and applicable Federal, State and local 

laws and regulations. 

• Ensure that transfers of pesticides 

between containers, or between 

containers and transport vehicles are 

attended at all times. 

• Ensure that each lockable valve on 

a stationary pesticide container, if it is 

required by § 165.45(f), is closed and 

locked whenever the facility is 

unattended. 

ii. Changes. These requirements are 

substantially the same as those 

proposed in § 165.146(c). The order of 

the standards and several minor 

wording modifications were made to 

improve the clarity of the requirements. 

2. Inspection and maintenance of all 

new and existing pesticide containment 

structures (§ 165.90(b))—i. Final 

regulations. The owner or operator of 

each pesticide containment structure 

must: 

• Inspect each stationary pesticide 

container and its appurtenances at least 

monthly during periods when pesticides 

are being stored or dispensed on the 

containment structure. Your inspection 

must look for visible signs of wetting, 

discoloration, blistering, bulging, 

corrosion, cracks or other signs of 

damage or leakage. 

• Immediately repair any areas 

showing visible signs of damage and 

seal any cracks and gaps in the 

containment structure or appurtenances 

with material compatible with the 

pesticide being stored or dispensed. 

• Not store any pesticide on a 

containment structure if the structure 

fails to meet the requirements of this 

subpart until suitable repairs have been 

made. Prompt removal of pesticides, 

including emptying of stationary 

containers, in order to effect repairs or 

recovery of spilled material is 

acceptable. 

ii. Changes. These inspection and 

maintenance requirements are 

substantially the same as those 

proposed in § 165.146(d). A few minor 

modifications were made to improve the 

clarity of the language. In addition, 

several changes were made to be 

consistent with other changes in the 

regulations. In particular, EPA decided 

not to finalize the hydraulic 

conductivity standard, so the 

corresponding inspection and 

maintenance requirement is also not 

being finalized. Also, the final rule 

specifies that the containment structure 

be compatible with the pesticides, 

rather than resistant as proposed. The 

corresponding inspection and 

maintenance standard was changed 

accordingly. 

K. Combined Pads and Units (§ 165.92) 

1. Final Regulation. Facility owners 

and operators may combine 

containment pads and secondary 

containment units as an integrated 

system provided the requirements set 

out in this subpart for pads and units in 

§§ 165.85(a) and (b), 165.87(a) and (b) 

and 165.190, and as applicable, 

§§ 165.85(c)-(f) and 165.87(c)-(f) are 

satisfied separately. 

2. Changes. This provision for 

allowing integrated containment 

systems is substantially the same as that 

proposed in § 165.153. 

L. Recordkeeping (§ 165.95) 

1. Final regulations. Facility owners 

and operators subject to the 

requirements of this rule must maintain 

the following records, and must furnish 

these records for inspection and copying 

upon request by any employee of EPA 

or any entity designated by EPA, such 

as a State, another political subdivision 

or a Tribe: 

• Records of inspection and 

maintenance for each containment 

structure and for each stationary 

pesticide container and its 

appurtenances must be kept for 3 years 

and must include the following 

information: 

• name of the person conducting the 

inspection or maintenance; 

• date the inspection or maintenance 

was conducted; 

• conditions noted; 

• specific maintenance performed. 

• Records for any non-stationary 

container designed to hold undivided 

quantities of agricultural pesticides 

equal to or greater than 500 gallons 

(1,890 liters) of liquid pesticide or equal 

to or greater than 4,000 pounds (1,818 

kilograms) of dry pesticide that holds 

pesticide but is not protected by a 

secondary containment unit meeting 

today’s regulations must be kept for 3 

years. Records on these non-stationary 

pesticide containers must include the 

time period that the container remains 

at the same location. 

• Records of the construction date of 

the containment structure must be kept 

for as long as the pesticide containment 

structure is in use, and for 3 years 

afterwards. 

2. Changes. The proposed rule 

required additional recordkeeping of 

inventory reconciliation for existing 

bulk liquid containers that were not 

elevated during the interim period. The 

proposed rule also required owners and 

operators to maintain records of written 

confirmation of hydraulic conductivity 

and statements of resistance to pesticide 

for as long as the structure was in use, 


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and for 3 years thereafter. These 

requirements are not being finalized, so 

the corresponding recordkeeping 

requirements are also not being 

finalized. Since the standards differ 

depending on whether the facility was 

considered existing or new at the time 

of this final rule, a new recordkeeping 

requirement has been added: each 

facility must maintain records of the 

construction date of the containment 

structure for as long as the pesticide 

containment structure is in use, and for 

3 years afterwards. 

M. States With Existing Containment 

Programs (§ 165.97) 

1. Final regulations. States that have 

promulgated containment regulations 

effective prior to August 16, 2006, and 

which also have primary enforcement 

responsibility and/or certification 

programs, have the option of continuing 

to implement their own programs in 

lieu of today’s Federal regulations under 

certain conditions. 

A State that wishes to continue 

implementing the State’s containment 

regulations must request the authority to 

do so by August 16, 2007 in the 

following manner: 

• The State must submit a letter and 

any supporting documentation to EPA. 

Supporting documentation must 

demonstrate that the State’s program is 

providing environmental protection 

equivalent to that expected to be 

provided by the Federal regulations in 

40 CFR subpart E. 

• The State must identify any 

significant changes to State regulations 

which would be necessary in order to 

provide environmental protection 

equivalent to the EPA regulations, and 

develop an estimated timetable to effect 

these changes. The letter must be signed 

by the designated State Lead Agency 

(SLA). 

EPA’s Office of Pesticide Programs 

(OPP), in collaboration with the EPA 

Regions and other EPA offices, will 

review the State’s correspondence and 

determine whether the State’s program 

is adequate to provide environmental 

protection equivalent to or more 

protective than these Federal 

regulations for new and existing 

containment structures. OPP will inform 

the State of its determination through a 

letter authorizing or declining to 

authorize the State to continue 

implementing its containment 

regulations and will detail any reasons 

for declining authorization. 

Any State that has received 

authorization to continue implementing 

its State containment regulations must 

inform EPA by letter signed by the 

designated State Lead Agency within 6 

months of any revision to the State 

containment regulations. EPA will 

inform the State by letter if it 

determines that the State’s containment 

regulations are no longer adequate based 

on the revisions. The State containment 

regulations will remain in effect, unless 

and until EPA sends the State a letter 

making this determination. 

2. Changes. The proposed rule made 

no provision for States to implement 

their own containment regulations in 

lieu of EPA’s rule. 

3. Comments. Many commenters to 

the 1994 proposed rule (dealers, a dealer 

group, a State regulatory agency group 

and individual State regulatory 

agencies) opposed setting any Federal 

standards that are more stringent than 

existing State requirements. They 

requested that EPA accept current State 

rules and statutes where the 

discrepancies are not significant from 

Federal standards. The State regulatory 

agency group requested EPA to 

seriously consider accepting small 

discrepancies in some standards due to 

differences in existing State legislation, 

and said that while national uniformity 

in regulation is desirable, it should not 

be at the expense of States that have 

already enacted rules that vary slightly 

from the Federal rule. A dealer group 

suggested that EPA set the Federal 

standards as a baseline, which would 

allow the proactive work of some States 

to stand and would preclude dealers 

from incurring the same economic 

burdens twice (i.e., to build and then 

rebuild containment structures). 

Several commenters (State regulatory 

agencies, a dealer, and a grower group) 

recommended that EPA grandfather 

existing containment facilities that are 

in compliance with State standards or 

that are comparable in function, design, 

and construction. Similarly, a grower 

group said that State rules for bulk 

containment should take precedence 

over this proposal. A State regulatory 

agency elaborated on these difficulties, 

stating that States with containment 

requirements would have to reinitiate 

their compliance efforts and would lose 

credibility and the trust of the regulated 

industry, with whom they worked 

closely to develop and implement the 

State rules. 

A dealer commented that forcing 

States to enforce different rules from 

their own would cause difficulties for 

the enforcing agency, distributors, 

retailers and end users who will have to 

learn an extra set of requirements. A few 

State regulatory agencies commented 

that millions of dollars have been spent 

by industry on compliance with State 

regulations, some of which have been in 

place since 1985, and that containment 

structures have not had failures when 

built to State standards. They 

recommended that the final rule be 

crafted to harmonize with State or other 

environmental statutes, and that it 

should not penalize States which have 

spent years building effective 

relationships with the regulated 

community for safe pesticide handling. 

Similarly, many commenters to the 

2004 Notice reiterated these arguments 

and said States have taken a pro-active 

role and have enacted pesticide 

containment regulations which have 

proven to be protective of the 

environment and which EPA should 

accept by a grandfather clause. A few 

commenters in 2004 pointed out that in 

some States it is not the State lead 

pesticide regulatory agency (usually, 

department of agriculture) that has 

authority for regulating the storage of 

hazardous materials/pesticides, but 

instead the State environmental 

protection or pollution control agency. 

They argued that situations where one 

State agency does the comprehensive 

pesticide regulatory work but another is 

charged with the containment 

regulations begs questions about 

responsibilities for and resources 

necessary to accomplish expected 

compliance monitoring and 

enforcement response. 

4. EPA response. The Agency agrees 

that Federal regulations should 

reinforce, rather than undermine or 

conflict with the efforts of proactive 

States. While the Agency believes in the 

need for national standards, EPA does 

not want to burden proactive States and 

facilities in those States with additional 

expenditures to revise their regulatory 

implementation system if the 

differences between their containment 

regulations and today’s rule are 

minimal, and especially where State 

standards are more stringent than 

Federal standards. EPA has evaluated 

the pesticide containment regulations in 

those States that have promulgated 

them, and believes that the regulations 

in those States have generally brought 

facilities into compliance with today’s 

regulations, with some potential 

deficiencies in certain States. EPA 

recognizes that simply reading 

regulations without awareness of the 

field reality, State enforcement 

discretion, and policy and guidance 

directives provided to inspectors may 

provide a less accurate reading of the 

equivalency of regulations. 

Consequently, EPA expects that States 

will be able to readily document their 

equivalency by providing existing 

information or pre-existing documents. 

EPA does not anticipate a significant 

paperwork burden for States, and is 


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offering this opportunity in response to 

States’ requests in comments to be 

allowed to continue to implement their 

own regulations. EPA believes that in 

States where the lead pesticide agency 

is not responsible for enforcing 

containment regulations, collaboration 

between the State’s agencies will be 

feasible. State regulators are encouraged 

to consult with EPA prior to preparing 

their submission. 

IX. Labeling Requirements for 

Pesticides and Devices 

A. Overview 

1. Final regulations. Today’s final rule 

changes the requirements for labeling 

pesticides in 40 CFR part 156 in several 

ways. First, these regulations add a new 

subpart H, entitled Container Labeling 

to part 156. The new container labeling 

regulations include the following 

requirements: 

• A statement identifying the 

container as nonrefillable or refillable is 

required on all pesticide labels. In 

addition, nonrefillable container labels 

must include several statements 

providing basic instructions for 

managing the container and a batch 

code for the product. (See Units IX.B. - 

IX.D. for more details.) 

• Cleaning instructions for some 

nonrefillable containers, specifically for 

dilutable products that are sold or 

distributed in rigid containers and that 

are not household/residential. (See 

Units IX.E. - IX.K. for more details.) 

• Instructions for cleaning all 

refillable containers before disposal. 

(See Units IX.E. and IX.L. for more 

details.) 

In addition, today’s final rule 

modifies several existing requirements 

in 40 CFR 156.10 to allow for blank 

spaces on the labels of some refillable 

containers for the net contents and EPA 

establishment number. In addition, the 

paragraph in 40 CFR 156.10 that 

requires storage and disposal statements 

is being changed to be consistent with 

the label requirements added to 40 CFR 

part 156 in subpart H and the container 

regulations being added to 40 CFR part 

165 in today’s rule. (See Unit IX.M.) 

Container-related labeling 

instructions for plant-incorporated 

protectants will be determined on a 

case-by-case basis until specific labeling 

guidance for plant-incorporated 

protectants are promulgated under 40 

CFR part 174. 

Existing EPA guidance on label 

statements for cleaning, recycling and 

disposing of pesticide containers, 

includes: 

• The Label Review Manual (Ref. 44); 

• PR Notice 83–3, Label Improvement 

Program — Storage and Disposal Label 

Statements (Ref. 73); 

• PR Notice 84–1, Clarification of 

Label Improvement Program (Ref. 72); 

• PR Notice 94–2, Recycling Empty 

Aerosol Pesticide Containers (Ref. 65); 

• PR Notice 98–10, Notifications, 

Non-Notifications and Minor 

Formulation Amendments (Ref. 56); and 

• PR Notice 2001–6, Disposal 

Instructions on Non-Antimicrobial 

Residential/Household Use Pesticide 

Product Labels (Ref. 49). 

This guidance will be revised, if 

necessary, to be consistent with the 

requirements in today’s final regulation. 

2. Changes. The final labeling 

regulations in today’s rule cover the 

same statements and topics that were 

included in the proposed rule. However, 

a number of changes have been made to 

the regulations, including but not 

limited to modifying specific 

statements, adding alternative 

statements, restructuring the regulations 

based on the plain language format, and 

exempting household/residential 

pesticide products from the 

requirements for cleaning instructions 

on nonrefillable container labels. The 

specific changes are described in the 

section-by-section discussion below. 

B. Identification of Container Types 

(§ 156.140) 

1. Final regulations. This section 

applies to all pesticide products and 

requires statements that, among other 

things, identify the container as 

nonrefillable or refillable. These 

statements must be placed on the label 

or container. The regulations in 40 CFR 

156.10(a)(4)(i) require the label to 

‘‘appear on or be securely attached to 

the immediate container of the pesticide 

product.’’ Therefore, the statements 

required by § 156.140 cannot be placed 

only on labeling that is not attached to 

the container, because it may become 

separated. The information may be 

located on any part of the container 

except the closure. If the statements are 

placed on the container, they must be 

durably marked on the container. 

Durable marking includes, but is not 

limited to etching, embossing, ink 

jetting, stamping, heat stamping, 

mechanically attaching a plate, molding, 

or marking with durable ink. 

2. Changes. In the final rule, EPA has 

changed the word ‘‘permanent’’ to 

‘‘durable’’ to describe the required 

container marking. In addition, the 

language from the preamble of the 

proposed rule that lists acceptable 

formats of the marking was added to the 

regulations to clearly establish our 

intent. Finally, the phrase ‘‘as 

applicable’’ was added to the first 

sentence to accommodate the fact that 

the statements in paragraph (a) apply 

only to labels on nonrefillable 

containers and the statements in 

paragraph (b) apply only to the labels on 

refillable containers. 

C. Statements Required for Nonrefillable 

Containers (§ 156.140(a)) 

1. Final regulations. The final rule 

requires all nonrefillable containers to 

have the following four items on the 

label or the container: 

• The phrase ‘‘Nonrefillable 

container;’’

• A statement regarding reuse; 

• A statement about recycling or 

reconditioning; and 

• A batch code. 

If the first three items are placed on 

the label, they must be put under an 

appropriate heading under the heading 

‘‘Storage and Disposal.’’ If any of the 

first three items are placed on the 

container, an appropriate referral 

statement, such as the statement in 

§ 156.140(a), must be placed on the label 

under the heading ‘‘Storage and 

Disposal.’’

2. Changes. These statements were 

reorganized by separating each phrase 

or statement into a different regulatory 

paragraph to accommodate the addition 

of alternative statements. The proposed 

rule included all four items, but 

included the first three as one 

statement: ‘‘Nonrefillable container. Do 

not reuse or refill this container. Offer 

for recycling if possible.’’ Also, the final 

rule specifies that if the first three 

statements are placed on the label 

(rather than on the container), they must 

be placed under the ‘‘Storage and 

Disposal’’ heading on the label. EPA 

added this language to reinforce the 

requirement in § 156.10(i)(2)(ix) for the 

instructions in subpart H to appear 

under the ‘‘Storage and Disposal’’

heading. These three statements must be 

under an appropriate heading under the 

storage and disposal heading, although 

they may be in any order. EPA believes 

it is better to provide registrants 

flexibility in where to place these 

statements. Some registrants may 

choose to place them all together, while 

others may choose to place the recycling 

statement after the cleaning (residue 

removal) instructions. 

The final rule was revised to require 

a referral statement on the label if any 

of the statements except the batch code 

are placed on the container. Examples of 

appropriate referral statements are ‘‘See 

container for handling and recycling 

statements.’’; ‘‘Recycling information is 

located on the container.’’; and ‘‘See the 

container for refill limitations.’’ The 


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referral statement will provide 

information to allow users who look for 

refill prohibitions or recycling 

statements in the storage and disposal 

section of the label to find the 

information. 

i. Statement identifying a 

nonrefillable container—Final 

regulations and changes. The 

identifying phrase ‘‘Nonrefillable 

container’’ is identical to the identifying 

phrase in the proposed regulations. 

ii. Reuse Statement—Final 

regulations. Registrants must choose to 

use one of the following reuse 

statements, as appropriate. Products 

with labels that allow household/ 

residential use must use the statement 

in item (1) or (3). All other products 

must use one of the three statements. 

(1) ‘‘Do not reuse or refill this 

container.’’

(2) ‘‘Do not reuse this container to 

hold materials other than pesticides or 

dilute pesticides (rinsates). After 

emptying and cleaning, it may be 

allowable to temporarily hold rinsate or 

other pesticide-related materials in the 

container. Contact your state regulatory 

agency to determine allowable practices 

in your state.’’

(3) The following statement may be 

used if a product is ‘‘ready-to-use’’ and 

its directions for use allow a different 

product (that is a similar, but 

concentrated formulation) to be poured 

into the container and diluted by the 

end user: ‘‘Do not reuse or refill this 

container unless the directions for use 

allow a different (concentrated) product 

to be diluted in the container.’’

iii. Changes. The proposed rule 

required the first statement, ‘‘Do not 

reuse or refill this container.’’ The 

second statement was added to address 

a common practice where pesticide 

applicators use plastic jugs to hold 

rinsate that contains the pesticide on the 

label, which could be interpreted as a 

violation of a ‘‘Do not reuse’’ statement. 

While EPA has some concerns about the 

widespread storage of rinsate or other 

pesticide-containing materials in 

pesticide containers (without proper 

management practices such as marking 

the contents and date on the container), 

we acknowledge the day-to-day reality 

of pesticide operations that sometimes 

there are materials such as rinsates or 

leftover tank mix that must be dealt 

with. While temporarily storing these 

materials in pesticide containers can 

create disposal problems if the material 

is not managed properly and promptly, 

temporary storage is better than most of 

the other low-cost, practical alternatives 

such as dumping the rinsate or leftover 

material. Therefore, the second 

statement was added to provide some 

flexibility while still prohibiting the 

reuse of nonrefillable containers for 

materials other than pesticides, 

including but not limited to water, food, 

feed and oil. However, EPA does not 

believe that household/residential 

pesticide users are likely to be able to 

properly manage rinsate and other 

pesticide-containing materials in this 

way, so this statement cannot be used 

on household/residential use products. 

The third statement was added in 

response to comments describing readyto-use products in containers that are 

intended to be sold or distributed only 

once, but that can be refilled by the end 

user with a concentrate (a different 

product) and then diluted. The third 

statement gives registrants the option to 

continue distributing products in this 

way, but still provides end users with 

the message that these containers 

should generally not be reused or 

refilled. 

iv. Comments - refill with concentrate. 

Several commenters noted that a 

prohibition on reuse or refill would 

make a common practice illegal. 

Specifically, some ready-to-use products 

are distributed or sold in containers that 

are intended to be sold or distributed 

only once (and therefore meet the 

definition of nonrefillable containers). 

However, these containers can be 

refilled by the end user (generally a 

household user) with a concentrate and 

then diluted. A few respondents 

suggested not requiring the reuse 

statement on ready-to-use product 

containers and several others offered an 

alternative statement for these products. 

v. EPA response - refill with 

concentrate. EPA agrees that the use of 

containers of ready-to-use products to 

be refilled with a different product (that 

is a similar, but concentrated 

formulation) and diluted by the end 

user should be allowed to continue. In 

a relatively quick search of product 

labels, EPA found a number of 

household/residential use herbicides 

with label directions that allowed this 

practice. This environmentally 

beneficial practice reduces the amount 

of packaging used and packaging waste 

produced, since a smaller container can 

be used to distribute the concentrate. 

Therefore, the final regulation includes 

an alternative statement that allows this 

practice to continue. Currently, we 

believe this situation is most commonly 

used for household products, although 

the final regulations were written to 

allow any products (not just household/ 

residential use products) to be able to 

use the appropriate refill/reuse 

statement on their labels. 

3. Recycling or reconditioning 

statement—i. Final regulations. 

Registrants must use at least one of the 

following statements: 

(1) ‘‘Offer for recycling if available.’’

(2) ‘‘Once cleaned, some agricultural 

plastic pesticide containers can be taken 

to a container collection site or picked 

up for recycling. To find the nearest site, 

contact your chemical dealer or 

manufacturer or contact [a pesticide 

container recycling organization] at 

[phone number] or [web site]. For 

example, this statement could be ‘‘Once 

cleaned, some agricultural plastic 

pesticide containers can be taken to a 

container collection site or picked up 

for recycling. To find the nearest site, 

contact your chemical dealer or 

manufacturer or contact the Ag 

Container Recycling Council (ACRC) at 

1–877–952–2272 (toll-free) or 

www.acrecycle.org.’’

(3) A recycling statement approved by 

EPA and published in an EPA 

document, such as a Pesticide 

Registration Notice. 

(4) An alternative recycling statement 

that has been reviewed and approved by 

EPA. 

(5) ‘‘Offer for reconditioning if 

appropriate.’’

ii. Changes. The final rule includes 

options for container recycling 

statements to account for differences in 

the process for recycling different kinds 

of containers (e.g., aerosol cans or 

plastic jugs) and differences in recycling 

among markets (agricultural or 

household). In addition, the proposed 

rule specified the statement ‘‘Offer for 

recycling if possible.’’ In the final rule, 

EPA changed the word possible to 

available. Finally, EPA added a 

statement ‘‘Offer for reconditioning if 

appropriate’’ as an alternative. 

iii. Comments - recycling. Several 

commenters addressed the issue of 

recycling. A user group supported the 

continued development of container 

collection and recycling programs. A 

registrant endorsed recycling but 

commented that the language must 

comply with Federal Trade Commission 

(FTC) guidance. A registrant group 

requested that the terms of PR Notice 

94–2 ‘‘Recycling Empty Aerosol 

Pesticide Containers’’ as amended by 

letter on June 9, 1994, be codified into 

regulation. A State regulatory agency 

urged EPA to specifically direct users to 

agricultural pesticide container 

collection programs to prevent 

agricultural pesticide containers being 

offered for household recycling 

collection. Another State regulatory 

agency suggested a label statement 

requiring small rinsed containers to be 

delivered to State-authorized container 

collection programs. This commenter 

stated that use of the word ‘‘possible’’


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would be problematic because while it 

is possible for farmers to travel more 

than 100 miles to a recycling center, it 

would be unreasonable to expect that. A 

group of people involved with pesticide 

container recycling in Washington State 

submitted suggestions for changing the 

storage and disposal statements on 

pesticide containers. These comments 

specifically supported the efforts of the 

Ag Container Recycling Council (ACRC) 

and recommended a statement that 

refers to the ACRC and provides the 

ACRC web site. 

In response to the 2004 notice, four 

State regulatory agencies and a 

registrant group urged the Agency to do 

more to encourage recycling of pesticide 

containers and to remove label 

references to burning or burying 

containers. A few State agencies noted 

efforts by ACRC, Earth 911 and the 

National Pesticide Stewardship Alliance 

to promote recycling and reform label 

language. These respondents noted that 

the Agency needs to go further than 

what was proposed in the rule in order 

to improve labeling such that burning 

and burying of containers is no longer 

allowed. 

iv. EPA response - recycling. EPA 

agrees with intent of the commenter 

who suggested codifying PR Notice 94–

2. The third option included in the final 

rule, a recycling statement approved by 

EPA and published in an EPA 

document, is included to account for PR 

Notice 94–2, other PR Notices, the label 

review manual, and other documents. 

EPA agrees with the State regulatory 

agencies and Washington container 

recycling group that it may be beneficial 

to provide more specific information 

about pesticide container collection and 

recycling programs in this statement, 

particularly for agricultural pesticide 

products. Therefore, the final 

regulations allow the use of a new 

recycling statement that provides details 

about how to obtain more information 

on agricultural pesticide container 

collection and recycling programs such 

as the ACRC. The ACRC is a non-profit 

organization that promotes and supports 

the collection and recycling of plastic 

pesticide containers in the U.S. The 

collection and recycling programs 

conducted by the ACRC grew 

significantly during the 1990’s, so EPA 

is adding this statement to reflect 

currently available programs (that were 

in the developmental stage when the 

proposed regulations were being 

written). For example, in 1993 the 

ACRC collected about 2.5 million 

pounds of plastic containers. In 2001, 

ACRC collected over 7 million pounds 

of plastic containers, which represents 

about 25 percent of the plastic 

containers distributed by the ACRC 

member companies. (Ref. 1) EPA has 

been told by ACRC recyclers and 

member companies and by ACRC’s State 

partners that participation could be 

increased if the label specifically 

referred to the ACRC program. EPA 

hopes to encourage the recycling of 

pesticide containers by including this 

recycling statement as an option. EPA 

also recognizes the need for flexibility 

in the label instructions, as other, 

equally effective organizations may 

come into existence in the future, and 

that the organization Earth 911 

(www.earth911.org), a clearinghouse of 

information on household hazardous 

waste disposal and recycling, may 

eventually include information 

resources specifically for managing 

agricultural chemicals and containers. 

EPA agrees that the word ‘‘possible’’

may not be clear, and has replaced it 

with the word ‘‘available.’’ ACRC 

programs are available that is, accessible 

for agricultural pesticide users across 

much of the U.S., but not all areas have 

local collection programs. EPA believes 

that a reasonable interpretation of 

‘‘available’’ is that pesticide containers 

are collected at a location that is the 

same distance or closer than the 

distance the user traveled to purchase 

the pesticides. It is worth noting that the 

statement ‘‘Offer for recycling if 

available’’ and the other statements in 

§ 156.140(a)(3) give pesticide users an 

option for managing the containers. 

These statements do not require the 

recycling or reconditioning of 

containers. EPA believes that recycling 

or reconditioning pesticide containers is 

a responsible, preferable way of 

managing pesticide containers. We 

encourage these practices to save 

resources and minimize the amount of 

material being disposed, although there 

are other legal ways of managing the 

containers. 

The final rule also includes the option 

for a registrant to offer an alternative 

recycling statement. This is intended to 

allow for the possibility of changes in 

the extent to which and the manner in 

which pesticide containers are recycled 

over time. EPA must review and 

approve an alternative recycling 

statement before it can be placed on a 

pesticide label. One part of our review 

will involve considering whether the 

alternative statement is consistent with 

the FTC guidelines on environmental 

statements in 16 CFR part 260, ‘‘Guides 

for the Use of Environmental Marketing 

Claims.’’ (Ref. 5) (http://www.ftc.gov/ 

bcp/conline/edcams/eande/index.html) 

EPA agrees with commenters that 

label language regarding burning and 

burying containers needs to be 

improved and is engaged in discussions 

with stakeholders to address this issue. 

Container disposal instructions were not 

addressed in the proposed container 

and containment regulations and 

therefore are outside the scope of the 

final regulations. In addition, EPA staff 

are actively working on improving the 

label manual. 

v. Comments - reconditioning. Many 

commenters on the proposed 

regulations, including container 

manufacturer and registrant groups, 

stated that the regulations do not 

account for the reconditioning of 

containers and opposed many proposed 

provisions because they would be 

problematic for reconditioning. These 

respondents also commented that some 

containers are commonly reconditioned, 

particularly plastic and steel drums 

holding non-agricultural pesticides. 

vi. EPA response - reconditioning. 

EPA added a statement about 

reconditioning to the final rule as an 

alternative for containers that are 

commonly reconditioned. The statement 

says ‘‘Offer for reconditioning if 

appropriate’’ because reconditioning is a 

logical, reasonable option only for 

certain containers, specifically drums, 

and not others, such as plastic jugs and 

aerosol cans. EPA believes this 

flexibility should alleviate some of the 

commenters’ concerns about the 

apparent disregard for reconditioning. 

4. Batch code—i. Final regulations. A 

lot number, or other code used by the 

registrant or producer to identify the 

batch of the pesticide product, is 

required for each nonrefillable container 

either on the label or the container. 

ii. Changes. The text specifying a lot 

number or other code in the final rule 

is identical to the text in the proposal. 

In the final rule, though, the 

introductory paragraph was modified to 

clarify that the lot number/batch code 

could be placed anywhere on the label 

or durably (not permanently) marked on 

the container. 

D. Statements Required for Refillable 

Containers (§ 156.140(b)) 

1. Final regulations. For refillable 

containers, one of the following 

statements is required on the label or 

the container: 

(1) ‘‘Refillable Container. Refill this 

container with pesticide only. Do not 

reuse this container for any other 

purpose.’’

(2) ‘‘Refillable Container. Refill this 

container with [common chemical 

name] only. Do not reuse this container 

for any other purpose.’’

If the statement is on the label, it must 

be placed under the ‘‘Storage and 

Disposal’’ heading. If the statement is 


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put on the container, the label must 

include an appropriate referral 

statement under the ‘‘Storage and 

Disposal’’ heading. 

2. Changes. The proposed rule 

specified only the first statement. In 

response to comments, the second 

statement was added to the final rule as 

an option to accommodate containers 

that may be filled with a chemical that 

has both pesticidal and non-pesticidal 

uses. Also, the phrase ‘‘Refillable 

container’’ was added to both 

statements to allow pesticide users, 

registrants and government regulators to 

clearly identify whether a container is 

nonrefillable or refillable. The final rule 

specifies that if the statement is placed 

on the label (rather than on the 

container), it must be placed under the 

‘‘Storage and Disposal’’ heading. EPA 

added this language to reinforce the 

requirement in § 156.10(i)(2)(ix) for the 

instructions in subpart H to appear 

under the ‘‘Storage and Disposal’’

heading. Lastly, the final rule was 

revised to require a referral statement on 

the label if the statement is placed on 

the container. An example of an 

appropriate referral statement is 

‘‘Refilling limitations are on the 

container.’’ The referral statement will 

provide information to allow users who 

look for refill prohibitions in the storage 

and disposal section of the label to find 

the information. 

E. Residue Removal Instructions - 

General (§ 156.144) 

1. Final regulations. Unless exempt 

from these requirements, the label of 

each pesticide product must have 

instructions on the removal of pesticide 

residue prior to disposal, as specified in 

§§ 156.146 and 156.156. The regulations 

in § 156.144 include the following 

specifications: 

• Residue removal statements are 

required for both nonrefillable and 

refillable containers. 

• Residue removal statements must 

be placed under the heading ‘‘Storage 

and Disposal.’’

• Residential/household use pesticide 

products are exempt from the residue 

removal statement requirements. 

• EPA may modify or waive the 

residue removal requirements or permit 

or require alternative labeling 

statements. 

2. Changes. The most significant 

change to this section is that the final 

rule exempts residential/household use 

pesticide products from the residue 

removal statement requirements. The 

proposed rule would have applied to 

the labels of all products, regardless of 

the pesticide market in which they are 

sold, distributed and used. EPA also 

made a few minor changes in the final 

rule. The proposed rule specified a 

subheading entitled ‘‘Container 

Cleaning’’ under the heading ‘‘Storage 

and Disposal.’’ In the final rule, EPA 

deleted this subheading because it is 

unnecessary. Section 156.144(b) 

regarding placement of the residue 

removal statements was shortened by 

deleting the reference to Directions for 

Use, which isn’t necessary. EPA 

believes requiring the statements to be 

placed under the heading ‘‘Storage and 

Disposal’’ is sufficient because 

§ 156.10(i)(2)(ix) requires this heading to 

be included in the directions for use. 

Finally, a few editorial changes were 

made to shorten the phrase ‘‘residue 

removal statements and instructions’’ to 

‘‘residue removal instructions’’ to be 

more precise and consistent. The rest of 

the requirements of § 156.144 are 

identical to those in the proposed rule. 

FIFRA section 19(f) mandates 

‘‘regulations prescribing procedures and 

standards for the removal of pesticides 

from containers prior to disposal’’ and 

says that EPA ‘‘may, at the discretion of 

the Administrator, exempt products 

intended solely for household use’’ from 

these requirements. In the proposed 

rule, EPA chose not to exercise this 

discretion and proposed to require 

cleaning instructions on the labels of 

household products because the 

preamble of the proposed rule stated 

that, in many instances, the same 

pesticide product in the same container 

is sold for agricultural or industrial use, 

as well as for use in the home, yard, or 

garden. 

The 1999 Supplemental Notice (Ref. 

53) stated that the changes in scope 

would only apply to the container 

standards and that: 

EPA believes that it is appropriate to have 

container cleaning and disposal instructions 

on the labels of all pesticides because of 

safety and environmental protection 

considerations for recycling operations. It is 

necessary for pesticide containers to be 

properly emptied and cleaned prior to being 

recycled to protect workers who handle the 

recyclable material and to prevent releases of 

pesticides to the environment. Because 

pesticide containers from all segments of the 

pesticide industry are currently being 

recycled, container cleaning and disposal 

instructions are needed on the labels of all 

pesticides. ... 

During the development of the final 

PR Notice 2001–6, ‘‘Disposal 

Instructions on Non-Antimicrobial, 

Residential/Household Use Pesticide 

Product Labels,’’ however, EPA decided 

to change this position for nonantimicrobial, residential/household use 

pesticide products. (Ref. 49). As stated 

in PR Notice 2001–6: 

Specific instructions to consumers to rinse 

their empty containers have been left out of 

these revised instructions. Experience has 

shown that many consumers are confused by 

rinsing procedures and often incorrectly 

dispose of the rinse water down the drain or 

down sewers. States have reported some 

detections of pesticides in drinking water 

that appear, in some cases, to be linked to 

disposal or rinsing in residential waste water 

systems. In addition, storage of rinsate is 

highly discouraged because of the absence of 

adequate labeling or packaging. There is also 

the potential risk of adverse chemical 

reactions occurring when products are 

poured down drains, singly, or in 

combination with other products. 

One potential solution that EPA 

considered but rejected when finalizing 

PR Notice 2001–6 was to require rinsing 

of non-antimicrobial, residential/ 

household use pesticide containers and 

to include instructions on the label for 

how to manage the rinse water. For 

example, the label statement in PR 

Notice 2001–6 could have instructed the 

user to add the rinse water to the 

pesticide mixture that will be applied, 

or if that isn’t feasible, the rinse water 

could be applied to a site on the label 

in accordance with the other label 

provisions. EPA rejected this option 

because it could confuse consumers, it 

could lead to the storage of rinse water 

in the absence of adequate labeling or 

packaging, and it would require several 

additional sentences on an already 

crowded label. 

Therefore, EPA has decided to omit 

rinsing instructions from the label 

directions specified for nonantimicrobial, residential/household 

pesticide products in PR Notice 2001–

6. In markets where empty containers of 

these pesticides are recyclable, it is 

assumed that the recycling programs 

will provide consumers with 

instructions to rinse the containers if the 

recycling program believes it is 

necessary. Additionally, if a 

manufacturer wants to include a rinsing 

statement on the labels of these 

pesticides, EPA would consider such a 

request. However, if a manufacturer 

chooses to include a rinsing statement, 

it should also include instructions about 

how to manage the rinse water. 

In the final rule, EPA is continuing 

the policy to omit rinsing instructions 

from the label directions for nonantimicrobial, residential/household 

pesticide products. In addition, EPA 

decided to extend this policy to 

antimicrobial, residential/household 

pesticide products in the final rule. 

Antimicrobial products were not 

included in the scope of PR Notice 

2001–6 because of differences of 

opinions on the disposal statements in 

the PR Notice, not because of problems 


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with applying the no-rinsing policy to 

household/residential antimicrobial 

products. EPA believes that some of the 

same concerns about household/ 

residential pesticide users, including 

users being confused and trying to 

prevent the storage of rinsate, apply 

equally to antimicrobial and nonantimicrobial products used by these 

household/residential pesticide users. 

F. Residue Removal Instructions for 

Nonrefillable Containers - General 

(§ 156.146) 

1. Final regulations. Section 156.146 

sets out the residue removal instructions 

for nonrefillable containers. The label of 

a product must comply with these 

instructions if all of the following 

criteria are met: 

• The product must comply with the 

residue removal instructions based on 

§ 156.144 (i.e., it is not a residential/ 

household product, EPA has not waived 

the requirement, or EPA has not 

established an alternative requirement); 

• The product is dilutable (it could be 

a liquid or a solid); and 

• The product is distributed or sold 

in a nonrefillable container that is rigid. 

The preamble to the proposed rule 

stated that EPA was holding sections in 

reserve for residue removal instructions 

for other formulation/container 

combinations, such as dilutable 

products in non-rigid containers. While 

EPA may address other kinds of 

nonrefillable containers in the future, 

the final rule establishes residue 

removal instructions only for dilutable 

products in rigid nonrefillable 

containers. 

The labels of dilutable products that 

are subject to this requirement and that 

are sold or distributed in rigid, 

nonrefillable containers must comply 

with the following standards: 

• A statement instructing the user to 

clean the container promptly after 

emptying is mandatory; 

• Triple rinsing instructions are 

mandatory; 

• Pressure rinsing instructions are 

optional; and 

• A registrant must obtain EPA 

approval before including a rinsing 

procedure that specifies a diluent other 

than water. 

These requirements are discussed in 

more detail in Units IX.G. through IX.K. 

below. 

2. Changes. The final regulation 

includes several changes from the 

proposal. The most significant changes 

are that the final rule requires 

registrants to place the triple rinse 

instructions on all labels and provides 

registrants the option to also include the 

pressure-rinse instructions. The 

proposed rule gave registrants the 

option to include either triple rinsing or 

pressure rinsing or both. Based on 

comments, EPA changed the final rule 

because triple rinsing is always 

possible, whereas pressure rinsing 

requires specific equipment. Other 

substantial changes to the residue 

removal instructions include: 

• Adding the phrase ‘‘or equivalent’’

as an option so labels allow equivalent 

means of rinsing containers. This was 

added to account for systems (such as 

closed system rinsing or home-made 

pressure rinsing systems) that are 

designed to clean containers thoroughly 

but do not technically triple rinse the 

containers. This change was made to the 

statement identifying when containers 

must be rinsed and is discussed in more 

detail in Unit IX.G. 

• Both the triple rinse and pressure 

rinse procedures were modified so they 

would take less time. For example, the 

intervals of time for draining and 

shaking the containers were reduced. 

These changes are intended to make the 

procedures more practical and therefore 

more likely to be followed by end users. 

These changes are discussed in more 

detail in Unit IX.H. 

Numerous other minor modifications, 

which are described in Units IX.G. - 

IX.K., were made to the residue removal 

instructions for nonrefillable containers. 

3. Comments - which procedure? The 

proposed rule would have required the 

placement of either the triple rinse or 

the pressure rinse procedure on the 

label, with the option of including both. 

The preamble requested comments on 

this approach. The following comments 

addressed this question. 

i. Both procedures. Several State 

regulatory agencies and a registrant 

group supported including both triple 

and pressure rinsing instructions on 

labels. A few of these commenters 

pointed out that pressure rinsing alone 

is not available to all applicators. 

ii. Alternative approach. A few dealer 

groups recommended using the 

statement ‘‘Pressure rinse or triple 

rinse’’ so users and dealers will not have 

to worry about having both rinse 

systems available. 

iii. Either or both procedures. A 

registrant group supported the approach 

of allowing the registrant to put either 

or both of the statements on the label, 

because pressure rinsing would not be 

appropriate for institutional products 

and including both would crowd the 

label. 

iv. Limit pressure rinsing. Some 

commenters, including registrants, 

registrant groups, and a State regulatory 

agency, expressed concern about 

household users pressure rinsing small 

containers. Many of these respondents 

suggested excluding pressure rinsing 

from household product labels. A 

registrant group also added institutional 

and industrial products to this 

suggested exclusion. Similarly, another 

registrant group commented that 

pressure rinsing is not common in the 

institutional sector. Alternatively, a few 

registrant groups and a registrant 

recommended that pressure rinsing 

instructions be permitted only on 

containers with capacities larger than 

one gallon. 

v. Decision making process. Some 

registrants and registrant groups 

commented that EPA implies that some 

sort of decision making process must be 

used to determine if triple rinsing, 

pressure rinsing, or both should be 

included and requested EPA to clarify 

this. For example, does a container have 

to meet a six 9’s standard by a 

laboratory pressure rinsing test for 

pressure rinsing instructions to be 

included on the label? If so, EPA has to 

specify the pressure rinsing test 

procedure. 

vi. Effectiveness of procedures. 

Several commenters addressed the 

efficacy of pressure rinsing vs. triple 

rinsing. A registrant group and two 

registrants commented that pressure 

rinsing should be recommended on 

labels only if it has been shown to be 

as effective as triple rinsing. Another 

registrant stated that their studies (in 

addition to the work of other 

companies) shows that pressure rinsing 

is not as effective as triple rinsing. A 

State regulatory agency commented that 

pressure rinsing is a more effective 

method of cleaning containers. 

vii. Advantages of pressure rinsing. A 

State regulatory agency and a registrant 

commented that pressure rinsing is 

advantageous to the pesticide users 

because it is a faster procedure. 

4. EPA response - which procedure? 

EPA agrees with several of the points 

made by commenters, in particular, that 

pressure rinsing alone is not available to 

all applicators, that pressure rinsing 

isn’t appropriate for certain containers 

based on the pesticide market and/or 

container size, and that pressure rinsing 

is attractive to pesticide users because it 

is a faster procedure. Therefore, EPA 

changed the approach so the final 

regulation requires labels to include the 

triple rinse procedure and gives 

registrants the option to also include the 

pressure rinse procedure. This approach 

provides a rinse procedure (triple 

rinsing) that all pesticide users can 

follow. It also gives registrants the 

option to include pressure rinsing if 

they believe it is appropriate (with EPA 

concurrence during the review of 


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labels), which is preferable to 

establishing criteria for appropriate (or 

inappropriate) pressure rinsing 

situations in the regulations. 

EPA believes that both triple rinsing 

and pressure rinsing are effective ways 

for users to clean most containers (with 

possible exceptions for size and other 

situations) in the field. This conclusion 

is based on the rinsing studies described 

in Reference 40 and on the field 

experience of people who have 

inspected containers over the past 

decade of pesticide container recycling 

programs. One registrant group 

provided comprehensive comments 

during the 2004 reopening of the 

comment period based on the ACRC’s 

experience over the past 10 years. This 

commenter described ACRC’s efforts to 

assess and control the risk from using 

the recycled plastic and noted that, 

since ACRC’s inception in 1992, there 

have been no reports of incidents where 

public health or safety has been 

compromised as a result of exposure to 

the minimal residues found in recycled 

plastic pesticide containers. This 

registrant group also stated that ACRC’s 

experience with recycling clean, rinsed 

one-way pesticide containers for more 

than a decade leads them to believe that 

residue removal is an issue of 

instructing applicators to triple or 

pressure rinse containers immediately 

after use. 

EPA’s goal is to establish a situation 

where all containers are adequately 

cleaned before they are recycled, 

disposed, or otherwise managed. As 

stated in Unit V.H.1., one regulatory 

contribution to achieving this goal is 

ensuring that pesticide users have 

access to clear, detailed instructions for 

how to clean the containers. In the final 

rule, pesticide labels must include triple 

rinse instructions and may also include 

pressure rinse instructions. 

Another regulatory contribution is to 

ensure the use of container designs and 

formulations that facilitate effective 

residue removal, which is the intent of 

the residue removal standard for 

nonrefillable containers in § 165.25(f). 

The residue removal test procedure 

requires containers to be triple rinsed. 

In this case, triple rinsing is used as an 

indication of how easily the pesticide 

can be removed from the container. The 

residue removal test procedure does not 

require containers to be pressure rinsed 

nor is it intended to evaluate whether 

triple rinsing or pressure rinsing is more 

effective for a certain container and 

pesticide formulation. Therefore, the 

decision of whether or not to include 

pressure rinsing instructions on the 

pesticide label is not tied to the results 

of laboratory residue removal testing. 

Instead, registrants have the option to 

include pressure rinsing if they believe 

it is appropriate (with EPA concurrence 

during the review of labels). 

There are other integral parts to 

achieving the goal of having clean 

containers before they are disposed or 

recycled, including educating pesticide 

users on the importance of rinsing and 

the proper procedures, potential spot 

checks/inspections to ensure that the 

labels and regulations are being 

complied with, and creating an 

incentive for pesticide users to comply 

(or a disincentive for non-compliance). 

EPA looks forward to working with all 

stakeholders, including State regulatory 

agencies, pesticide registrants, 

distributors and dealers, pesticide users, 

pesticide educators, and trade 

associations in accomplishing this goal. 

G. Timing of the Residue Removal 

Procedure (§ 156.146(a)) 

1. Final regulations. For products that 

are subject to the requirements for 

residue removal instructions, the label 

of each nonrefillable container must 

include one of the following statements: 

(1) ‘‘Clean container promptly after 

emptying.’’

(2) ‘‘Triple rinse or pressure rinse 

container (or equivalent) promptly after 

emptying.’’

(3) ‘‘Triple rinse container (or 

equivalent) promptly after emptying.’’

The statement about timing must 

immediately precede the rinsing 

instructions and must be consistent 

with the rinsing instructions (triple 

rinse or both triple and pressure rinse) 

that are include on the label. 

2. Changes. This section of the final 

rule includes three changes from the 

proposed regulation. First, the proposed 

requirement to rinse ‘‘immediately’’

after emptying was replaced in the final 

rule by requiring the container to be 

rinsed ‘‘promptly’’ after emptying it. 

Second, the final rule adds the phrase 

‘‘(or equivalent)’’ to the two statements 

that identify a specific cleaning 

procedure, e.g., triple rinsing. Third, the 

proposed rule included four options for 

statements to include on the label. EPA 

is not finalizing one of these statements 

in the final rule--‘‘Pressure rinse 

container immediately after emptying’’

--because it is no longer needed. The 

final rule does not allow pressure 

rinsing to be the only procedure listed 

on the label, so this statement is 

irrelevant. 

3. Comments - clean promptly. Some 

State regulatory agencies supported the 

statement regarding the timing of 

rinsing, stating that it should improve 

the management of the containers. Two 

other State regulatory agencies stated 

that, based on results from their 

container collection and recycling 

programs in the early 1990’s, it is 

obvious that not all containers are 

rinsed immediately. A registrant group 

suggested using the phrase ‘‘reasonably 

promptly’’ rather than ‘‘immediately’’ to 

account for industrial situations where 

its not practical to rinse immediately 

such as when multiple oil wells are 

treated from the same drum of an 

industrial biocide and rinsing 

equipment is not available. An 

agricultural pesticide registrant 

supported immediate rinsing in a farm 

context so that the rinsate could be 

added to the application mixture, but 

noted that clean water may not be 

available at every loading site. 

4. EPA response - clean promptly. 

EPA considers the timing of the residue 

removal procedure to be a critical factor 

in effectiveness, and is maintaining the 

approach in the proposed rule that 

requires users to rinse containers within 

a certain (short) time period after 

emptying them. When rinsing is not 

performed soon after emptying the 

container, the residue can dry and 

adhere to the inside and outside of the 

container, and is then more difficult to 

remove. Containers with dried residue 

are likely to be rejected by pesticide 

container recycling and collection 

programs as well as at solid waste 

landfills. 

EPA believes that requiring pesticide 

users to rinse containers promptly after 

emptying them is the best approach for 

the final rule. Specifying that the 

containers are cleaned promptly 

accomplishes the goal of rinsing them 

soon after they are emptied and before 

the residue dries in the containers. Also, 

prompt rinsing provides a little more 

flexibility than immediate rinsing. As an 

example, consider a pesticide applicator 

who pours product from one container, 

sets it down to pour out another 

container, and then rinses both 

containers. Technically, this could be 

considered a violation if the label 

specified immediate rinsing, because 

some time passed between the emptying 

and the rinsing of the first container. 

However, this example fits within EPA’s 

understanding of prompt action. 

Requiring that containers be rinsed 

promptly gives pesticide users, 

regulatory agencies and inspectors some 

discretion in determining appropriate 

time spans. It is beyond the scope of this 

preamble to describe every situation 

that is or is not appropriate, so EPA is 

relying on the good judgement of 

applicators, regulatory agencies and 

inspectors to assess the specific 

conditions of the situation. However, 

EPA believes that situations where the 


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time between emptying and rinsing is 

days or weeks and where the residue 

has completely dried inside the 

container are definitely beyond the 

boundaries of prompt rinsing. In 

addition, EPA strongly recommends that 

pesticide users rinse containers when 

the application mixture is being 

prepared so the rinsate can be added to 

the application mixture. This provides 

many benefits, including getting all of 

the value out of the product and 

avoiding the creation of a potential 

waste (which could happen if the 

rinsate was collected separately). 

5. Comments - equivalency. In 

commenting on the proposed approach 

for residue removal instructions, a few 

commenters (a State regulatory agency 

and a registrant) supported maintaining 

the current cleaning statement of 

‘‘Triple rinse (or equivalent)’’ because it 

is sufficient if followed and it offers 

flexibility. 

6. EPA response - equivalency. EPA 

agrees with the commenters that 

including the phrase ‘‘(or equivalent)’’

that is on current labels is beneficial and 

the final rule adds this phrase as an 

option to the ‘‘rinse promptly’’

statement. This phrase was added to 

account for systems (such as closed 

system rinsing or home-made pressure 

rinsing systems) that are designed to 

clean containers thoroughly but do not 

technically triple rinse the containers. 

The alternative rinsing system should be 

thorough and it is the responsibility of 

the pesticide user to ensure that it is 

equivalent to triple rinsing. 

H. Duration of Triple and Pressure 

Rinse Procedures (§ 156.146(b) and 

156.146(c)) 

1. Final regulations. As discussed in 

Unit IX.I. for triple rinsing and Unit IX.J. 

for pressure rinsing, the rinsing 

procedures for containers that are small 

enough to shake that are defined in the 

final regulation take less time to 

conduct than the proposed procedures. 

The key time intervals identified in the 

procedures are: 

• How long to drain liquid product 

from containers (both triple and 

pressure rinsing); 

• How long to agitate/shake 

containers during triple rinsing; 

• How long to drain rinsate from 

containers after each shaking interval 

during triple rinsing; and 

• How long to pressure rinse the 

container during pressure rinsing. 

2. Changes. The procedures in the 

final rule specify the following times for 

each of these intervals for containers 

that are small enough to shake: 

• 10 seconds to drain liquid product 

from containers for both triple and 

pressure rinsing (changed from 30 

seconds in the proposal); 

• 10 seconds to agitate/shake 

containers during triple rinsing 

(changed from 30 seconds in the 

proposal); 

• 10 seconds to drain rinsate from 

containers after each shaking interval 

during triple rinsing (changed from 30 

seconds in the proposal); and 

• At least 30 seconds to pressure 

rinse the container during pressure 

rinsing. (The proposed rule specified 30 

seconds; the phrase ‘‘at least’’ was 

added to compensate for variations in 

pressure rinsing equipment and in 

pressure.) 

3. Comments. A registrant group, a 

registrant and two State regulatory 

agencies commented that a shorter rinse 

time would be better and would 

encourage user compliance, although 

the two State regulatory agencies 

supported a shorter rinse time only if it 

was demonstrated that the containers 

are cleaned adequately. Another State 

regulatory agency stated that, in a 1991 

survey, 43 percent of private applicators 

and 11 percent of commercial 

applicators responded that they did not 

rinse containers because it took too 

much time. A registrant group opposed 

the initial drain time of 30 seconds as 

too long and inappropriate for closed 

systems. This commenter also 

responded that some states have 

requirements different than a 30–second 

drain and urged EPA to consider these 

alternatives. A registrant commented 

that the times of the proposed rinsing 

procedures seemed reasonable and 

expressed doubts that the triple rinse 

procedure could be shortened much. 

This commenter added that a 40–second 

pressure rinse is inadequate to achieve 

99.9999 percent removal. 

4. EPA response. In the preamble of 

the proposed rule, EPA estimated that 

the proposed triple rinsing instructions 

would take approximately 5 minutes to 

perform and the pressure rinsing 

procedure would take approximately 2 

minutes. EPA also requested comments 

on the time burden of the proposed 

rinsing procedures, and the voluntary 

submission of data on residue removal, 

including in particular the cleaning 

efficiency of any suggested shorter triple 

rinse and pressure rinse procedures. 

EPA agrees with the commenters that 

a shorter rinse time would be better and 

would encourage user compliance with 

the requirement to rinse pesticide 

containers. In particular, we believe it is 

relatively unlikely that a pesticide user 

would spend about 5 minutes triple 

rinsing each container. The 30–second 

intervals for the initial container drain 

time, the shaking time and the rinsatedraining times were based on the 

rinsing instructions of many States, 

which were incorporated into the 

laboratory triple rinse test methodology 

for the proposed nonrefillable container 

residue removal standard. 

EPA contracted for two studies on the 

effectiveness of shorter triple rinse 

procedures. In a study conducted by 

Formulogics (Refs. 7 and 38), a flowable 

concentrate product was tested in three 

containers: 1–gallon and 2.5–gallon 

plastic jugs and a 5–gallon steel flathead 

can. Nine different rinsing procedures 

were conducted for each container size 

by varying the initial drain, shake and 

rinsate drain times between 5, 10 and 30 

seconds. The shake and rinsate drain 

times were always the same. For 

example, the three variations for the 

initial drain time of 5 seconds were: 5 

second shake and 5 second rinsate 

drain; 10 second shake and 10 second 

rinsate drain; and 30 second shake and 

30 second rinsate drain. These same 

three shake and rinsate drain times were 

conducted for the initial drain times of 

10 second and of 30 seconds. The 

pesticide concentration in the second 

through fifth rinses was measured. EPA 

concludes that all nine rinsing 

procedures tested were effective in 

cleaning all three containers because the 

active ingredient concentration in the 

fourth rinse showed at least 99.99% 

removal in all rinse time iterations. Two 

of the rinse procedures for the 5–gallon 

container (5 sec. initial drain/5 sec. 

shake & rinsate drain and 30 sec. initial 

drain/5 sec. shake & rinsate drain) 

resulted in 99.99 percent removal; all 

other rinse procedures for all containers 

met at least five 9’s percent removal and 

most resulted in six 9’s percent removal. 

In a study conducted by the 

University of Florida (Refs. 14 and 41), 

two formulations were tested in three 

containers, 1–gallon, 2.5–gallon and 5–

gallon plastic jugs. The flowable 

concentrate was tested in all three 

containers and the emulsifiable 

concentrate was tested in the 2.5–gallon 

and 5–gallon containers. Four different 

rinsing procedures were conducted for 

each container size by varying the initial 

drain, shake and rinsate drain times 

between 10 and 30 seconds where the 

shake and rinsate drain times were 

always the same. Again, EPA concludes 

that all four rinsing procedures tested 

were effective in cleaning both 

formulations from all of the containers 

because the active ingredient 

concentration in the fourth rinse 

showed at least 99.99% removal in all 

rinse time iterations. 

The triple rinse procedure for labels 

in the final rule includes 10 second 

initial drain, shake and rinsate drain 


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times. EPA believes the data described 

above shows that this shorter triple 

rinsing procedure, which should 

encourage end user compliance with the 

requirement to triple rinse, will 

adequately clean containers prior to 

recycling or disposal. 

In addition, EPA has lowered the 

residue removal requirement in the final 

nonrefillable container regulations from 

six 9’s (99.9999 percent) to four 9’s 

(99.99 percent), as discussed in Unit 

V.H. The shorter rinse procedures 

reached at least 99.99 percent removal 

in all of the containers and formulations 

tested. As cited by one of the State 

regulatory agencies in its comments, the 

field reality is that many users who do 

not rinse claim the time factor as the 

reason. By reducing the time frames in 

the cleaning instructions, EPA hopes to 

increase compliance within the 

pesticide user community. 

I. Triple Rinse Instructions 

(§ 156.146(b)) 

1. Final regulations. For products that 

are subject to the requirements for 

residue removal instructions, the label 

of each nonrefillable container must 

include triple rinse instructions. There 

are three different sets of triple rinsing 

instructions: 

• For containers that are small 

enough for users to shake them, holding 

dilutable liquid pesticides; 

• For containers that are small 

enough for users to shake them, holding 

dilutable solid pesticides; and 

• For containers that are too large for 

users to shake. 

In general, EPA believes that the largest 

containers that users can shake during 

a triple rinse are those with capacities 

of 5 gallons for liquids and 50 pounds 

for solids. 

The triple rinse instructions for liquid 

dilutable pesticide products in 

containers small enough for users to 

shake are: 

Triple rinse as follows: Empty the 

remaining contents into application 

equipment or a mix tank, and drain for 10 

seconds after the flow begins to drip. Fill the 

container 1/4 full with water and recap. 

Shake for 10 seconds. Pour rinsate into 

application equipment or a mix tank or store 

rinsate for later use or disposal. Drain for 10 

seconds after the flow begins to drip. Repeat 

this procedure two more times. 

The final rule specifies slightly 

different instructions for solid dilutable 

pesticide products in ‘‘shake-able’’

containers, because solid materials do 

not ‘‘drip’’ as liquids do. The only 

difference for solid dilutable pesticide 

products is that the first line is ‘‘Triple 

rinse as follows: Empty the remaining 

contents into application equipment or 

a mix tank. Fill the container 1/4 full...’’

The rest of the procedure is identical to 

the one for liquids. 

For containers that are too large for 

users to shake (i.e., containers larger 

than 5 gallons for liquids or 50 pounds 

for solids), the triple rinse instructions 

are: 

Triple rinse as follows: Empty remaining 

contents into application equipment or a mix 

tank. Fill the container 1/4 full with water. 

Replace and tighten closures. Tip container 

on its side and roll it back and forth, ensuring 

at least one complete revolution, for 30 

seconds. Stand the container on its end and 

tip it back and forth several times. Turn the 

container over onto its other end and tip it 

back and forth several times. Empty the 

rinsate into application equipment or a mix 

tank or store rinsate for later use or disposal. 

Repeat this procedure two more times. 

2. Changes. One significant change 

from the proposed rule is that the final 

regulation requires a triple rinse 

procedure to be on the label, where the 

proposal gave registrants the option to 

include triple rinsing or pressure rinsing 

or both. Another modification is that the 

final regulations provide a defined 

procedure for containers that are too 

large for users to shake. Also, the phrase 

‘‘or a mix tank’’ was added as an option 

for where the product or the rinsate can 

be placed. In addition, the following 

clarifying changes were made to both 

sets of instructions for triple rinsing 

smaller containers that can be shaken: 

• The introductory text specifies that 

the instructions apply to ‘‘containers 

small enough to shake’’; 

• The instruction to ‘‘agitate’’ was 

changed to ‘‘shake’’; and 

• As discussed in Unit IX.H., the time 

intervals were changed from 30 seconds 

to 10 seconds for the initial draining of 

the container (for liquid products only), 

the time the container needs to be 

shaken, and for the draining of the 

rinsate. 

3. Comments - general. A State 

regulatory agency pointed out that the 

directions prohibit preparing the use 

dilution in a mix tank, which is a 

common practice. A registrant 

commented that the degree of agitation 

needs to be specified, e.g., shake 

vigorously for 30 seconds. 

4. EPA response - general. EPA did 

not intend to prohibit users from 

pouring a product into a mix tank or 

diluting a product in a mix tank, and we 

have amended the triple rinse 

procedures to address this oversight. 

The phrase ‘‘or a mix tank’’ was added 

to the instructions for emptying 

containers and to the rinsate 

management instructions to allow the 

product and rinsate to be placed into 

application equipment or a mix tank. 

EPA agrees with the registrant and 

believes that ‘‘shake’’ is a better 

description of the intended activity than 

‘‘agitate.’’ We decided not to include the 

qualifier ‘‘vigorously’’ to keep the 

statement as succinct as possible. This 

kind of information could be passed 

along to users during training and 

outreach. 

5. Comments - large containers. 

Several commenters described problems 

with cleaning drums according to the 

proposed triple rinse statement. A 

registrant group stated that it is 

impractical to fill a 55–gallon drum one 

quarter full because more than 40 

gallons of rinsate would be produced. A 

different registrant group and a 

registrant recommended directing the 

user to place the drum on its side and 

roll it, because it is extremely difficult 

to shake a large container that is onequarter full. Another registrant 

commented that an additional statement 

that describes rinsing by recirculation 

would be helpful, but pointed out that 

many drum users don’t use pumps to 

empty them. 

6. EPA response - large containers. 

EPA agrees with the suggestion by the 

commenters who recommended 

directing the user to place a drum on its 

side and roll it. EPA is hesitant to 

recommend a cleaning procedure for 

larger containers that requires 

equipment that a pesticide user may not 

have, such as a pump, or an 

appropriately sized, heavy-duty 

pressure rinse nozzle. Therefore, we 

decided to define a triple rinse 

procedure in the final regulation for 

containers that are too large to be 

shaken. This is consistent with the 

approach in the final rule to require 

triple rinsing because all pesticide users 

can comply with these instructions and 

to allow pressure rinsing as an optional, 

additional statement. 

J. Pressure Rinse Instructions 

(§ 156.146(c)) 

1. Final regulations. For products that 

are subject to the requirements for 

residue removal instructions, the label 

of each nonrefillable container may 

include pressure rinse instructions. The 

decision regarding whether to include 

pressure rinsing instructions as an 

option is at the discretion of the 

registrant, based on the registrant’s 

assessment of the procedure’s 

effectiveness and appropriateness for 

the formulation/container combination. 

However, if the statement ‘‘Triple rinse 

or pressure rinse container (or 

equivalent) promptly after emptying’’ is 

used on the label as the statement about 

timing, pressure rinse instructions must 

be placed on the label. If a registrant 


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chooses to include pressure rinsing 

instructions on the label as an option for 

cleaning a liquid dilutable pesticide 

product, the statement must 

immediately follow the triple rinse 

instructions. 

The pressure rinse instructions for 

liquid dilutable pesticide products are: 

Pressure rinse as follows: Empty the 

remaining contents into application 

equipment or a mix tank and continue to 

drain for 10 seconds after the flow begins to 

drip. Hold container upside down over 

application equipment or mix tank or collect 

rinsate for later use or disposal. Insert 

pressure rinsing nozzle in the side of the 

container, and rinse at about 40 PSI for at 

least 30 seconds. Drain for 10 seconds after 

the flow begins to drip. 

Slightly different instructions are 

required for pressure rinsing dilutable 

liquid and dilutable solid pesticide 

formulations, because dry materials do 

not ‘‘drip’’ like liquids do. The pressure 

rinsing procedure specified in the final 

regulations for dilutable solid pesticides 

is identical to the one for liquids, except 

it does not include the initial 10–second 

draining prior to rinsing. 

2. Changes. One significant change is 

that pressure rinsing instructions are 

optional in the final rule, which 

requires a triple rinse procedure to be 

included on the labels of products that 

must comply. The proposal gave 

registrants the option to include triple 

rinsing or pressure rinsing or both. In 

addition, the following changes were 

made to both sets of instructions for 

pressure rinsing: 

• The phrase ‘‘or a mix tank’’ was 

added as an option for where the 

product or the rinsate can be placed. 

• As discussed in Unit IX.H., several 

of the time intervals were changed from 

30 seconds to 10 seconds for the initial 

draining of the container (for liquid 

products only) and for the draining of 

the rinsate after the pressure rinse. The 

length of the pressure rinse interval was 

changed from ‘‘30 seconds’’ to ‘‘at least 

30 seconds.’’

• Several details about the orientation 

of the container were added, including 

that the user must hold the container 

upside down and insert the rinsing 

nozzle in the side of the container. 

• The pressure requirement was 

changed from exactly 40 PSI to ‘‘about 

40 PSI’’ to allow a range of pressures in 

response to several comments 

expressing concern about requiring a 

pressure of exactly 40 PSI in the field. 

3. Comments - container orientation. 

A few commenters noted that the 

instructions are not clear in stating that 

the container must be inverted and that 

the rinse nozzle must be inserted on the 

side (or bottom) of the container. A 

registrant group suggested inserting the 

nozzle ‘‘on the side of the container 

opposite the closure and in a direction 

towards the bottom of the container.’’ A 

registrant recommended instructing the 

user to ‘‘Force pressure rinsing nozzle 

through what was the bottom of the 

container or through the side of the 

container and...’’ and also recommended 

that the instructions specify holding the 

container upside-down during the rinse 

process. 

4. EPA response - container 

orientation. EPA agrees with these 

commenters that more details about 

how to hold the container and where 

the nozzle should be inserted should be 

included. Therefore, the procedure was 

modified to instruct the user to hold the 

container upside down and to insert the 

rinsing nozzle in the side of the 

container. 

K. Non-Water Diluents (§ 156.146(d)) 

1. Final regulations. A registrant who 

wishes to require users to clean a 

container with a diluent other than 

water (e.g. solvents) must submit a 

written request to EPA to modify the 

residue removal instructions of this 

section. EPA may grant the request if 

certain conditions are met. The 

registrant must indicate why a nonwater diluent is necessary and must 

propose appropriate residue removal 

instructions and disposal instructions 

that identify the diluent. If the nonwater diluent is permitted by the label 

to be used in application, the 

instructions may allow the rinsate to be 

added to application equipment or mix 

tank. If use of the diluent in application 

is not permitted, the rinsate must be 

collected and stored for eventual 

disposal. EPA must approve, in writing, 

the modification of the residue removal 

instructions before the pesticide product 

can be distributed or sold. 

2. Changes. The final regulations are 

almost identical to the proposed 

regulations regarding non-water 

diluents. The final rule adds the 

requirement for the registrant to propose 

disposal instructions to ensure that end 

users have information about how to 

appropriately dispose of rinsate from a 

diluent other than water. One minor 

modification was to add ‘‘or mix tank’’

as an option for where rinsate may be 

added if the label allows the non-water 

diluent to be part of the application 

mixture. This change was made to be 

consistent with the changes in the triple 

rinse and pressure rinse instructions. In 

addition, several minor editorial 

changes were made to make this section 

more clear. 

L. Residue Removal Instructions for 

Refillable Containers (§ 156.156) 

1. General (Introductory Text for 

§ 156.156)—i. Final regulations. The 

label of each pesticide product packaged 

in a refillable container must include 

the residue removal instructions 

specified in § 156.156. The residue 

removal instructions must be given for 

all pesticide products that are 

distributed or sold in refillable 

containers, including those that do not 

require dilution prior to application. 

ii. Changes. This requirement is 

substantively the same as it was in the 

proposed regulation. Some minor 

editorial and format changes were made 

to improve the clarity of the regulatory 

text. In addition, the second sentence, 

which reinforces that the instructions 

apply to all products that are distributed 

or sold in refillable containers, 

including those that do not require 

dilution prior to disposal, was moved 

from the subsection on instructions for 

residue removal to the introductory text. 

EPA made this change because the 

explanatory language applies to the 

whole section (including instructions on 

the timing of the procedures). 

2. Timing of residue removal 

procedures (§ 156.156(a))—i. Final 

regulations. The label of a pesticide 

product packaged in a refillable 

container (and that is subject to this 

requirement) must have one of the 

following sets of instructions on the 

timing of container cleaning: 

• ‘‘Cleaning the container before final 

disposal is the responsibility of the 

person disposing of the container. 

Cleaning before refilling is the 

responsibility of the refiller.’’

• ‘‘Pressure rinsing the container 

before final disposal is the 

responsibility of the person disposing of 

the container. Cleaning before refilling 

is the responsibility of the refiller.’’

The statement must immediately 

precede the residue removal 

instructions and must be consistent 

with those instructions. 

ii. Changes. These statements were 

expanded in the final regulation to 

distinguish between cleaning before 

disposal and cleaning before refilling in 

response to comments. The proposed 

statements simply said ‘‘Clean [or 

pressure rinse] container before 

disposal.’’ The changes in the final rule 

include adding ‘‘final’’ to the 

description of disposal, adding that the 

person disposing of the container is 

responsible for cleaning it, and 

including the additional statement of 

‘‘Cleaning before refilling is the 

responsibility of the refiller.’’

3. Residue removal instructions prior 

to container disposal (§ 156.156(b))—i. 


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47412 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

Final regulations. For pesticide products 

sold or distributed in refillable 

containers, the label must include 

instructions for cleaning the container 

prior to disposal. The instructions must 

be appropriate for the characteristics of 

the product and adequate to protect 

human health and the environment. The 

instructions could include any one of 

the following, as long as the instructions 

meet the standards described in the 

previous sentence: 

• The refilling residue removal 

procedure developed by the registrant 

for the pesticide product. 

• Standard industry practices for 

cleaning refillable containers. 

• For pesticides that require dilution 

prior to application, the following 

statement: 

‘‘To clean container before final 

disposal, empty the remaining contents 

from this container into application 

equipment or a mix tank. Fill the 

container about 10% full with water. 

Agitate vigorously or recirculate water 

with the pump for 2 minutes. Pour or 

pump rinsate into application 

equipment or rinsate collection system. 

Repeat this rinsing procedure two more 

times.’’

• Any other statement the registrant 

considers appropriate. 

ii. Changes. The final regulations are 

almost identical to those in the 

proposed rule, except for a few editorial 

and format changes. The phrase ‘‘To 

clean container before final disposal’’

was added to the specified procedure to 

emphasize that users should only clean 

the container before disposal and not 

before having the container refilled. The 

phrase ‘‘into application equipment or a 

mix tank’’ was added to be consistent 

with the emptying instructions for 

nonrefillable containers. One sentence 

that helps clarify the scope of the 

requirement for residue removal 

instructions on refillable containers was 

moved from this section to the 

introductory text since it applies to the 

whole section. 

M. Amendments to Existing § 156.10 

1. Final regulations. The final rule 

modifies the existing regulations in 40 

CFR 156.10 in the following three ways: 

• A new § 156.10(d)(7) is added that 

allows the labels for refillable containers 

to have a blank space to allow the net 

weight or contents to be marked in by 

a refiller according to 40 CFR 165.65(h) 

or 165.70(i); 

• The existing § 156.10(f) was 

modified to allow labels for refillable 

containers to have a blank space to 

allow the EPA establishment number to 

be marked in by a refiller according to 

40 CFR 165.65(h) or 165.70(i); and 

• The existing § 156.10(i)(2)(ix) 

regarding storage and disposal 

instructions was modified to refer to the 

applicable requirements in the rest of 

today’s final rule. 

2. Changes. The most significant 

change to the approach taken in the 

proposed regulation is that ‘‘shall’’ was 

changed to ‘‘may’’ in the two paragraphs 

establishing blank spaces, thus changing 

them from requirements to options for 

pesticide registrants. This change was 

made to provide flexibility to registrants 

in response to comments. EPA decided 

to make several minor revisions to the 

paragraphs allowing blank spaces to 

link the 40 CFR part 156 regulations to 

the 40 CFR part 165 repackaging 

regulations and to clarify that the blank 

space does not change the requirement 

for having the net contents or EPA 

establishment number on the label. 

First, the regulatory text allowing blank 

spaces was modified to refer to the 40 

CFR part 165 regulations that require 

refillers to ensure that the net contents 

and EPA establishment number appear 

on the label. Second, the new paragraph 

in § 156.10(d)(7) was amended to clarify 

that § 156.10(a)(1)(iii) requires the net 

contents to be shown clearly and 

prominently on the label. 

The paragraph on storage and 

disposal instructions was modified to 

account for changes in the structure of 

the container-related labeling, so it 

refers to subpart H of part 156 rather 

than specific sections. Finally, a 

requirement about the type size of the 

storage and disposal heading was added 

to § 156.10(i)(2)(ix) after the container 

regulations were proposed in 1994. 

Today’s final rule maintains this 

requirement and corrects the reference 

to the child hazard warnings, which are 

located in § 156.60(b). 

N. Compliance Date (§ 156.159) 

1. Final regulations. The final 

regulations provide a 3–year compliance 

period. Specifically, within 3 years from 

today’s date, all pesticide products 

distributed or sold by a registrant must 

have labels that comply with the 40 CFR 

part 156 requirements established in the 

final rule. This gives registrants a phase 

in period of 3 years to comply with the 

labeling requirements in §§ 156.10(d)(7), 

156.10(f), 156.10(i)(2)(ix), 156.140, 

156.144, 156.146, and 156.156. 

2. Changes. The most significant 

change is that the phase-in period was 

extended from 2 years to 3 years from 

the publication of the final rule. In 

addition, the regulatory language was 

revised to make it more clear. EPA 

agrees with some of the commenters 

that a longer compliance period will 

make it easier and less burdensome to 

comply with the label standards. To 

facilitate compliance while trying to 

minimize the impact on companies, 

EPA lengthened the compliance period 

for the label standards to 3 years. EPA 

believes that a 3–year period is 

sufficient based on the results of the 

economic analysis. In addition, 3 years 

is consistent with the phase-in period 

for the nonrefillable container 

regulations. 

X. Relationship to Other Programs and 

Agencies 

Certain laws administered by EPA 

and other agencies may affect the design 

of pesticide containers or procedures 

and standards for removal of residue 

from pesticide containers. This section 

identifies the laws that EPA considers to 

have the most significant impact on 

pesticide containers and containment. 

The description of these laws is for 

informational purposes only; no 

changes are being made in the laws 

described below. Nothing in this final 

rule is intended to alter obligations 

under other statutes. 

A. Resource Conservation and Recovery 

Act (RCRA) 

Requirements under RCRA may affect 

the handling of pesticide containers 

under certain circumstances. RCRA 

Subtitles C and I are described briefly 

below. 

FIFRA sections 19(f)(3) and 19(h) 

specify that FIFRA section 19 does not 

affect the requirements or authorities of 

RCRA. Accordingly, today’s rule does 

not alter any existing RCRA 

requirements, and any applicable RCRA 

provisions will apply in addition to the 

provisions of any final rule issued under 

FIFRA section 19. In addition, FIFRA 

section 19(f)(1)(B)(iv) specifies that the 

residue removal regulations may be 

coordinated with requirements for 

container rinsing under RCRA. As 

outlined below, this rule provides for 

coordination in this area. 

1. Hazardous waste requirements. 

Subtitle C of RCRA creates a cradle-tograve system for managing hazardous 

wastes. RCRA Subtitle C regulations 

include requirements for generators, 

transporters, and others who handle 

hazardous wastes. The regulations cover 

any ‘‘solid waste’’ (defined at 42 U.S.C. 

1004 and 40 CFR 261.2) that is listed as 

a hazardous waste or exhibits a 

characteristic of hazardous waste, as set 

out in part 261. Pesticides (including 

pesticide residues in containers that are 

not empty per the RCRA definition in 

§ 261.7) that are discarded or intended 

to be discarded may qualify as 

hazardous wastes, if the pesticide is a 

hazardous waste as defined in § 261.33 


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(discarded commercial chemical 

products, off-specification products or 

manufacturing intermediates, container 

residues, and spill residues), or if they 

exhibit a characteristic of hazardous 

waste as described in part 261 subpart 

C, and are not otherwise exempt from 

regulation. A hazardous waste 

remaining in a container is not subject 

to Subtitle C regulation if, among other 

things, the container is ‘‘empty’’ as 

defined in § 261.7. A container is 

‘‘empty’’ if the wastes are removed 

pursuant to § 261.7(b)(1) or (b)(2), or, in 

the case of an acute hazardous waste, 

the container has been triple rinsed or 

otherwise cleaned pursuant to 

§ 261.7(b)(3). EPA believes that the 

triple rinsing procedure provided in 

today’s final rule meets the 

requirements of § 261.7(b)(3), thus 

meeting the directive in FIFRA section 

19(f)(1)(B)(iv). 

2. Underground storage tanks. RCRA 

Subtitle I provides for the development 

and implementation of a comprehensive 

regulatory program for ‘‘underground 

storage tanks’’ (USTs), defined at 42 

U.S.C. 6991 and 40 CFR 280.12 as tanks 

that are used to contain an 

accumulation of ‘‘regulated substances’’

and whose volume (including 

underground pipes connected thereto) is 

10 percent or more below ground. 

Regulated substances include petroleum 

or substances defined as hazardous 

under the Comprehensive 

Environmental Response, 

Compensation, and Liability Act of 1980 

(CERCLA) (except hazardous wastes 

regulated under RCRA Subtitle C). 

CERCLA hazardous substances, 

enumerated at 40 CFR part 302, include 

a number of pesticides. UST 

requirements at 40 CFR part 280 include 

standards for new tanks as well as 

requirements for leak detection, closure, 

corrective action, and financial 

responsibility. 

EPA is not aware of the extent of 

industry use of USTs to store 

agricultural pesticides, and solicited 

comment on the use of underground 

tanks to store agricultural pesticides and 

on the preferred means of coordinating 

UST and FIFRA requirements. No 

comments were received on the topic. 

Because today’s final rule requires 

secondary containment of any bulk 

container holding pesticide, 

underground storage would be 

precluded unless the secondary 

containment structure was also 

underground. EPA considers that the 

expense of such a construction makes it 

unlikely that a facility would use 

underground storage, and assumes that 

since no comments were received, 

underground storage of agricultural 

pesticides is generally avoided in the 

industry. Furthermore, EPA has noted, 

in its review of State regulations, that 

underground storage of pesticides is 

forbidden by States with bulk 

containment regulations. 

B. Clean Water Act 

EPA has issued several regulations 

under the Clean Water Act (CWA) (33 

U.S.C. 1251 et seq.) that are related to 

today’s rule and that affect some sectors 

of the pesticide industry. The goal of the 

CWA is to achieve zero discharge of 

wastewater pollutants. 

1. Pesticide chemicals category, 

formulating, packaging and repackaging 

effluent limitations guidelines, 

pretreatment standards, and new source 

performance standards: Final rule. On 

November 6, 1996, EPA promulgated 

regulations governing effluents from 

pesticide formulating, packaging and 

repackaging facilities (61 FR 57518, Ref. 

57). Effluent guidelines establish 

limitations on the pollutants discharged 

into waters of the United States from 

industrial point sources. The Pesticide 

Formulating, Packaging and 

Repackaging (PFPR) effluent guidelines 

apply to facilities engaged in 

formulating, packaging or repackaging 

pesticides. The PFPR effluent guidelines 

regulation set limitations for facilities in 

two different regulatory subparts of 40 

CFR part 455 (subparts C and E). 

Subpart C applies to facilities that 

discharge (or have the potential to 

discharge) wastewater from pesticide 

formulating, packaging, and/or 

repackaging operations. All pesticides 

with the exception of a few specific 

exemptions are included under subpart 

C. Subpart E applies only to refilling 

establishments that repackage 

agricultural pesticides into refillable 

containers. Subpart E does not apply to 

facilities that repackage non-agricultural 

pesticides. The same formulators, 

packagers, and repackagers (subpart E) 

and refilling establishments (subpart E) 

are affected by today’s final pesticide 

container and containment rule. 

However, the PFPR effluent guidelines 

regulation does not include the other 

types of facilities covered by today’s 

containment rule, namely commercial 

applicators and custom blenders. 

Under the effluent guidelines rule, 

refilling establishments are required to 

achieve zero discharge of wastewater 

pollutants. For these facilities, the zero 

discharge regulation was based on 

reuse, recycle and water conservation 

practices, as well as contract hauling of 

any non-reusable wastewater for off-site 

disposal, if necessary. However, effluent 

guidelines do not require specific 

practices or control technologies. Many 

refilling establishments achieve the zero 

discharge requirement through water 

conservation and good housekeeping, 

which includes repairing leaking valves 

and fittings and collecting drips in pans 

under appurtenances. Facilities that also 

provide application services typically 

reuse rinsate as make-up water for 

application in accordance with the 

label. Compliance with today’s pesticide 

container and containment rule 

regarding requirements for containment 

structures, and adherence to the 

recommendations regarding rinsate 

collection will assist refilling 

establishments in achieving the zero 

discharge of pollutants required by the 

effluent guidelines. 

Under the PFPR effluent guidelines, 

subpart C facilities (formulators, 

packagers, and repackagers) are required 

to either achieve zero discharge of 

wastewater pollutants or to implement 

specific reuse, recycle, and water 

conservation practices (Pollution 

Prevention Alternative). For example, 

under the pollution prevention 

alternative, facilities must reuse their 

rinsates directly into the formulation or 

store rinsates for use in future 

formulation of the same or a compatible 

product. 

When the PFPR effluent regulations 

were proposed in April 1994 (Ref. 64), 

the scope of subpart C included all 

pesticide active ingredients (PAIs) (with 

the exception of sodium hypochlorite 

and the partial exemption of specified 

sanitizers) and a wide variety of 

associated wastewater sources. EPA 

published a supplemental notice on 

June 8, 1995 (Ref. 61) which refined the 

scope of PAIs and wastewater sources. 

In the final rule, most sanitizer products 

were excluded, based on a number of 

factors, such as: 

• Sanitizer products are formulated 

for the purposes of their labeled end use 

to ‘‘go down the drain;’’

• Sanitizer active ingredients are 

more likely to be sent to Publicly 

Owned Treatment Works (POTWs) in 

greater concentrations and volumes 

from their labeled end use than from 

rinsing formulating equipment at the 

PFPR facility; 

• Biodegradation data received with 

comments on some of these sanitizer 

active ingredients support the 

hypothesis that they do not pass 

through POTWs; 

• These sanitizer active ingredients 

represent a large portion of the low 

toxicity PAIs considered for regulation 

at the time of proposal; and 

• Many sanitizer solutions containing 

these active ingredients are cleared by 

the Food and Drug Administration 


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(FDA) as indirect food additives under 

21 CFR 178.1010. 

The final PFPR effluent guidelines 

rule (subpart C) combined the pool 

chemicals exemption into the sanitizer 

exemption and exempted other pool 

chemicals in addition to the only pool 

chemical in the proposal, sodium 

hypochlorite. The additional chemicals 

that are included in the definition of 

pool chemicals in 40 CFR 455.10 

include calcium hypochlorite, lithium 

hypochlorite, potassium hypochlorite, 

chlorinated isocyanurate compounds 

and halogenated hydantoins. 

The bulk containment requirements 

in today’s rule are consistent with the 

control technologies which are the basis 

for the PFPR effluent guidelines for 

refilling establishments (subpart E). In 

addition, the repackaging and refillable 

container requirements of today’s rule, 

particularly the adherence to the 

recommendations regarding rinsate 

collection, will aid facilities in 

collecting and reusing rinsates to meet 

the zero discharge/pollutant prevention 

alternative requirements of subpart C of 

the PFPR effluent guidelines. 

2. National Pollutant Discharge 

Elimination System (NPDES) - Storm 

Water Phase II Final Rule. EPA issued 

final regulations on December 8, 1999 

(64 FR 68722, Ref. 52) addressing storm 

water discharges. The regulation 

established a ‘‘no exposure’’ exemption 

for storm water discharges from 

facilities where industrial materials and 

activities are not exposed to storm 

water. Upon review of earlier 

regulations that excluded storm water 

discharges from certain categories of 

light industry from NPDES permit 

requirements, a court invalidated the 

light industry exemption. In 1992, the 

Ninth Circuit court concluded that the 

exemption impermissibly relied on the 

unsubstantiated judgment of the facility 

operator to determine applicability of 

the exemption. The new rule 

established in 1999 now allows the 

exemption, but requires that the facility 

meet certain conditions and provide a 

certification for tracking and 

accountability. ‘‘No exposure’’ means 

that all industrial materials or activities 

are protected by storm-resistant 

sheltering so they are not exposed to 

rain, snow, snowmelt or runoff. (40 CFR 

122.26(g)) 

Pesticide refilling operations and bulk 

storage operations required to apply for 

and obtain NPDES permits for storm 

water discharges associated with such 

operations may take advantage of this 

exemption if they provide a certification 

of ‘‘no exposure’’ and maintain the 

certified conditions at the facility. Even 

when an owner/operator certifies to no 

exposure, the NPDES permitting 

authority may still require a permit if it 

determines that there is a discharge 

interfering with water quality standards. 

This will provide an added incentive to 

place all tanks within secondary 

containment that is protected from the 

elements. Facilities that are not exempt 

will have to get a discharge permit. 

3. Effluent guidelines and standards 

for the transportation equipment 

cleaning (TEC) Industry. On August 14, 

2000, EPA published a final rule (65 

CFR 49665, Ref. 51) establishing 

restrictions on the discharge of 

wastewater from cleaning the interiors 

of tank trucks, rail tank cars, inland tank 

barges, ocean/sea tankers, and other 

similar tanks used to transport 

materials, including agricultural 

chemicals and fertilizers. The TEC 

regulations do not apply to wastewaters 

generated from cleaning the interiors of 

pesticide drums or intermediate bulk 

containers (IBCs), defined as portable 

containers with 450 liters (119 gallons) 

to 3,000 liters (793 gallons) capacity. 

EPA subsequently studied the Industrial 

Container and Drum Cleaning Industry. 

The Preliminary Data Summary - 

Industrial Container and Drum Cleaning 

Industry (EPA–821–R–02–011 and Ref. 

48) can be downloaded from the 

following link: http://www.epa.gov/ 

waterscience/pollcontrol/drum/ 

index.html. 

4. Spill prevention control and 

countermeasures (SPCC). On July 17, 

2002, (67 FR 47042, Ref. 47), EPA 

promulgated regulations under section 

311(j)(1)(C) of the Clean Water Act 

(known as the SPCC regulations) for the 

prevention of oil spills into navigable 

waters and adjoining shorelines. The 

regulations apply to facilities that, 

because of their location, could 

reasonably be expected to discharge oil 

into navigable waters or adjoining 

shorelines. Part 112 of 40 CFR outlines 

requirements for both the prevention 

and the response to oil spills. Facilities 

that are subject to the SPCC regulations 

include any non-transportation-related 

onshore or offshore facility engaged in 

drilling, producing, gathering, storing, 

processing, refining, transferring, 

distributing, using, or consuming oil 

and oil products, which due to its 

location, could reasonably be expected 

to discharge oil, in quantities that may 

be harmful, into navigable waters of the 

United States or adjoining shorelines. 

Because the definition of ‘‘oil’’ under 

CWA section 311 is very broad 

(including oil ‘‘of any kind and in any 

form’’), it could potentially include 

pesticides that contain oil or are oilbased. EPA expects that comparatively 

few, if any, of the facilities covered by 

today’s pesticide container and 

containment rule are also subject to 

SPCC requirements, but if any are, both 

today’s rule and SPCC requirements 

apply. On December 12, 2005, EPA 

proposed two separate amendments to 

the SPCC Rule. One of them (Ref. 24) 

streamlines the regulatory requirements 

for qualified facilities and equipment 

regulated under 40 CFR part 112 and 

proposes a separate extension of the 

compliance date for farms. The other 

amendment (Ref. 23) extends the SPCC 

compliance dates for all facilities. 

C. Occupational Safety and Health 

Administration Requirements 

The Occupational Safety and Health 

Act (U.S.C. 2601 et seq.) addresses 

occupational safety and health hazards 

by establishing requirements for 

employers and employees and 

authorizing the Occupational Safety and 

Health Administration (OSHA) to 

establish mandatory occupational safety 

and health standards. 

Tanks and containers that are used to 

store flammable and combustible 

liquids in occupational settings are 

subject to OSHA requirements under 29 

CFR 1910.106. For storage tanks, 

§ 1910.106(b) contains design and 

construction requirements, including 

standards for materials, spacing, 

venting, drainage and diking, fire and 

flood resistance, and testing for strength 

and tightness. Section 1910.106(c) 

contains specifications for piping, 

valves, and fittings. Section 1910.106(d) 

sets out design and construction 

requirements for containers and 

portable tanks, and also contains 

specifications for storage areas. Today’s 

regulations do not contradict or 

supercede any existing OSHA 

requirements, and any applicable OSHA 

provisions will apply in addition to the 

provisions of today’s rule. 

D. Department of Transportation 

Hazardous Materials Regulations 

The Hazardous Materials 

Transportation Act of 1974, (49 U.S.C. 

1801 et seq) authorizes DOT to 

designate as hazardous materials those 

materials that may pose unreasonable 

risk to health and safety or property, 

and regulate the handling and 

transportation of such materials. The 

DOT regulations and their relationship 

to today’s final pesticide container and 

containment regulations are discussed 

in detail in Unit IV. and many other 

places throughout this preamble. 

XI. FIFRA Mandated Reviews 

In accordance with FIFRA sec. 25(a), 

the Agency submitted a draft of this 

final rule to the FIFRA Scientific 


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Advisory Panel (SAP), the Secretary of 

Agriculture, and the Committee on 

Agriculture in the House of 

Representatives, and the Committee on 

Agriculture, Nutrition, and Forestry in 

the United States Senate. 

The FIFRA SAP waived its review of 

this final rule because the significant 

scientific issues involved have already 

been reviewed by the SAP and 

additional review isn’t necessary. The 

USDA did not submit any official 

comments. 

XII. References 

The following is a listing of the 

documents that are specifically 

referenced in this final rule. These 

documents, and other supporting 

materials, are included in the docket 

established for this rulemaking under 

docket ID No.EPA-HQ-OPP–2005–0327 

at http://www.regulations.gov. 

1. Ag Container Recycling Council. 

‘‘ACRC Celebrates 10 Years’’, in ‘‘News 

Bits from the Ag Container Recycling 

Council,’’ Summer (2002). 

2. Beaver, B.A. and W.D. Goetsch. 

‘‘Container Recycling in Illinois,’’ 1994 

Illinois Agricultural Pesticides 

Conference, (1994). 

3. Dwinell, S., 1992. Florida 

Department of Environmental 

Regulation, ‘‘Final Report: Jackson 

County Pesticide Container Recycling 

Demonstration Project,’’ (1992). 

4. Dwinell, S., 1991. Florida 

Department of Environmental 

Regulation, ‘‘Final Report: South Florida 

Pesticide Container Recycling 

Demonstration Project,’’ (1991). 

5. Federal Trade Commission. 

‘‘Guides for the Use of Environmental 

Marketing Claims,’’ 16 CFR 260, (2006). 

6. Formulogics, 1991. ‘‘Report to 

Mitchell System: Data Generation - 

Rinsing Studies,’’ September 24 (1991). 

7. Formulogics, 1991. ‘‘Triple Rinsing 

of Containers: Rinsing Variables,’’

results of a study conducted for U.S. 

EPA, December 2 (1991). 

8. Formulogics, 1990. ‘‘Container 

Rinsing: Methodology Support,’’ testing 

conducted for the U.S. EPA, 1990. 

9. Frieberg, D. Iowa Fertilizer and 

Chemical Association, ‘‘Environmental 

Cleanup of Fertilizer and Agricultural 

Chemical Dealer Sites,’’ (1991). 

10. Hudak, C.M., North Carolina 

Department of Agriculture and 

Consumer Services. ‘‘Pesticide 

Container Recycling in North Carolina’’

presented at 2000 National Pesticide 

Stewardship Alliance Conference, 

(2000). 

11. Kammel, D., R. Noyes, G. 

Riskowski, and V. Hofman. ‘‘Designing 

Facilities for Pesticide and Fertilizer 

Containment,’’ MidWest Plan Service–

37, Iowa State University, Ames, Iowa 

(1991). 

12. Michigan Department of 

Agriculture. ‘‘Environmental 

Stewardship and the Michigan 

Department of Agriculture: A Report to 

Governor John Engler’’ (1993). 

13. Minnesota Department of 

Agriculture. ‘‘Empty Pesticide Container 

Collection and Recycling Program: 

Annual Report,’’ (1996). 

14. Moye, Anson H., et al. ‘‘Final 

Report: Work Assignment - Triple 

Rinse,’’ research conducted for U.S. 

EPA, January 31 (1995). 

15. National Agricultural Chemicals 

Association, ‘‘NACA Container 

Management Task Force Empty 

Pesticide Container Rinsing Study: 

Product Information and Analytical 

Results,’’ October 16 (1990). 

16. United Nations Economic 

Commission for Europe (UNECE). 

‘‘Globally Harmonized System of 

Classification and Labeling of Chemicals 

(GHS)’’ (2005). 

17. Palmer, L. and R. Hansen. 

Minnesota Department of Agriculture 

[Information on pesticide container 

collection programs], Personal 

communication to members of the 

Minnesota Pesticide Container Advisory 

Committee, September 30 (1991). 

18. Poncin, S. Minnesota Department 

of Agriculture. ‘‘Rinsing Problems 

Associated with Pesticides that are 

Formulated as Flowable,’’ September 

(1995). 

19. U.S. EPA, 2006. ‘‘Response to 

Comment Document: Standards for 

Pesticide Containers and Containment,’’

(2006). 

20. U.S. EPA, 2006. ‘‘Rinsing 

Procedures for Dilutable Pesticide 

Products in Rigid Containers,’’ (2006). 

21. U.S. EPA, 2005. ‘‘Economic 

Analysis of the Bulk Pesticide 

Containment Structures Final 

Regulation,’’ November 15 (2005). 

22. U.S. EPA, 2005. ‘‘Economic 

Analysis of the Pesticide Container 

Design and Residue Removal 

Standards,’’ November 21 (2005). 

23. U.S. EPA, 2005. ‘‘Oil Pollution 

Prevention; Non-Transportation Related 

Onshore Facilities: Proposed Rule,’’ 70 

FR 73517, December 12 (2005). 

24. U.S. EPA, 2005. ‘‘Oil Pollution 

Prevention; Spill Prevention, Control, 

and Countermeasure Plan Requirements 

- Amendments: Proposed Rule,’’ 70 FR 

73523, December 12 (2005). 

25. U.S. EPA, 2005. ‘‘State Bulk 

Pesticide Containment Regulations - 

Scope and Definition of Bulk,’’ February 

2 (2005). 

26. U.S. EPA, 2005. ‘‘Summary of 

Discussions re: Pesticide Container 

Collection Program Observations,’’

November 15 (2005). 

27. U.S. EPA, 2005. ‘‘Summary of 

Information on On-Farm Bulk Storage 

and Repackaging from State Contacts 

from States with Regulations that 

Include Farms,’’ February 14 (2005). 

28. U.S. EPA, 2005. ‘‘Summary of 

State Responses to EPA Inquiries About 

Bulk Storage on Farms,’’ February 14 

(2005). 

29. U.S. EPA, 2005. ‘‘Summary of 

Telephone Conversations with 

Packaging Industry re: Dry Bulk 

Containers,’’ February (2005). 

30. U.S. EPA, 2006. ‘‘Supporting 

Statement for an Information Collection 

Request: Standards for Pesticide 

Containers and Containment (Final 

Rule), June 21, (2006). 

31. U.S. EPA, 2004. ‘‘Meeting 

Summary,’’ July 19 (2004). 

32. U.S. EPA, 2004. ‘‘Standards for 

Pesticide Containers and Containment: 

Proposed Rule; Extension of Comment 

Period,’’ 69 FR 50114, August 13 (2004). 

33. U.S. EPA, 2004. ‘‘Standards for 

Pesticide Containers and Containment: 

Proposed Rule; Partial Reopening of the 

Comment Period,’’ 69 FR 39392, June 30 

(2004). 

34. U.S. EPA, 2004. ‘‘Summary Tables 

of State Bulk Pesticide Containment 

Regulations,’’ January 23 (2004). 

35. U.S. EPA, 2003. ‘‘Analysis and 

Summary of CSMA Data,’’ March 5 

(2003). 

36. U.S. EPA, 2003. ‘‘Analysis and 

Summary of Formulogics Agricultural 

Formulation/Container Data,’’ February 

24 (2003). 

37. U.S. EPA, 2003. ‘‘Analysis and 

Summary of Formulogics Household, 

Institutional and Industrial Data,’’

March 5 (2003). 

38. U.S. EPA, 2003. ‘‘Analysis and 

Summary of Formulogics Quick Rinse 

Data,’’ February 26 (2003). 

39. U.S. EPA, 2003. ‘‘Analysis and 

Summary of NACA Triple Rinse data,’’

March 4 (2003). 

40. U.S. EPA, 2003. ‘‘Analysis and 

Summary of Pressure Rinse Data,’’

March 5 (2003). 

41. U.S. EPA, 2003. ‘‘Analysis and 

Summary of University of Florida Quick 

Rinse Data,’’ February 26 (2003). 

42. U.S. EPA, 2003. ‘‘Comparison of 

Triple Rinsing Data for Proposed and 

Final Rule,’’ July 7 (2003). 

43. U.S. EPA, 2003. ‘‘Information 

About Container Rejections from 

Recycling Programs,’’ July 15 (2003). 

44. U.S. EPA, 2003. ‘‘Label Review 

Manual: Third Edition,’’ EPA 735–B–

03–001, August (2003). 

45. U.S. EPA, 2003. ‘‘Revised Scope of 

the Container Regulations (NonAntimicrobial Products,’’ January 6 

(2003). 


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46. U.S. EPA, 2003. ‘‘Summary of 

Conference Call with Wisconsin 

Department of Agriculture Staff on 

Containment Regulations,’’ July 29 

(2003). 

47. U.S. EPA, 2002. ‘‘Oil Pollution 

Prevention and Response: NonTransportation-Related Onshore and 

Offshore Facilities: Final Rule,’’ 67 FR 

47042, July 17 (2002). 

48. U.S. EPA, 2002. ‘‘Preliminary Data 

Summary for Industrial Container and 

Drum Cleaning Industry,’’ EPA–821–R–

02–011, June (2002). 

49. U.S. EPA, 2001. ‘‘Disposal 

Instructions on Non-Antimicrobial 

Residential/Household Use Pesticide 

Product Labels,’’ Pesticide Registration 

Notice 2001–6, September 7 (2001). 

50. U.S. EPA, 2001. ‘‘Regulations 

Under the Federal Insecticide, 

Fungicide, and Rodenticide Act for 

Plant-Incorporated Protectants 

(Formerly Plant-Pesticides): Final Rule,’’

66 FR 37771, July 19 (2001). 

51. U.S. EPA, 2000. ‘‘Effluent 

Limitations Guidelines, Pretreatment 

Standards, and New Source 

Performance Standards for the 

Transportation Equipment Cleaning 

Point Source Category: Final Rule,’’ 65 

FR 49665, August 14 (2000). 

52. U.S. EPA, 1999. ‘‘National 

Pollutant Discharge Elimination SystemRegulations for Revision of the Water 

Pollution Control Program Addressing 

Storm Water Discharges: Final Rule,’’ 64 

FR 68722, December 8 (1999). 

53. U.S. EPA, 1999. ‘‘Standards for 

Pesticide Containers and Containment: 

Proposed Rule; Partial Reopening of the 

Comment Period,’’ 64 FR 56918, 

October 21 (1999). 

54. U.S. EPA, 1998. ‘‘Additional 

Guidance on Final FIFRA Section 

6(a)(2) Regulations for Pesticide Product 

Registrants,’’ Pesticide Registration 

Notice 98–4, August 4 (1998). 

55. U.S. EPA, 1998. ‘‘Guidance on 

Final FIFRA Section 6(a)(2) Regulations 

for Pesticide Product Registrants,’’

Pesticide Registration Notice 98–3, 

April 3 (1998). 

56. U.S. EPA, 1998. ‘‘Notifications, 

Non-notifications and Minor 

Formulation Amendments,’’ Pesticide 

Registration Notice 98–10, October 22 

(1998). 

57. U.S. EPA, 1996. ‘‘Pesticide 

Chemicals Category, Formulating, 

Packaging and Repackaging Effluent 

Limitations Guidelines, Pretreatment 

Standards, and New Source 

Performance Standards: Final Rule,’’ 61 

FR 57518, November 6 (1996). 

58. U.S. EPA, 1996. ‘‘Toxicologically 

Significant Levels of Pesticide Active 

Ingredients,’’ Pesticide Registration 

Notice 96–8, October 31 (1996). 

59. U.S. EPA, 1995. ‘‘Bulk Pesticide 

Transfers,’’ Memorandum from Jesse 

Baskerville, U.S. EPA, to U.S. EPA 

Regional Pesticides and Toxics Division 

Directors and Regional Counsels, March 

22 (1995). 

60. U.S. EPA, 1995. ‘‘Notice of Interim 

Determination of Adequacy of Certain 

State and Territorial Programs,’’ 60 FR 

24855, May 10 (1995). 

61. U.S. EPA, 1995. ‘‘Pesticide 

Chemicals Category, Formulating, 

Packaging and Repackaging Effluent 

Limitations Guidelines, Pretreatment 

Standards, and New Source 

Performance Standards: Supplemental 

Notice,’’ 60 FR 30217, June 8 (1995). 

62. U.S. EPA, 1995. ‘‘Pesticides; 

Technical Amendments: Final Rule,’’ 60 

FR 32094, June 19 (1995). 

63. U.S. EPA, 1994. ‘‘Bulk Policy 

Question & Answer Document,’’

February 3 (1994). 

64. U.S. EPA, 1994. ‘‘Pesticide 

Chemicals Category, Formulating, 

Packaging and Repackaging Effluent 

Limitations Guidelines, Pretreatment 

Standards, and New Source 

Performance Standards: Proposed 

Rule,’’ April 14 (1994). 

65. U.S. EPA, 1994. ‘‘Recycling Empty 

Aerosol Pesticide Containers,’’ Pesticide 

Registration Notice 94–2, May 16 (1994). 

66. U.S. EPA, 1994. ‘‘Standards for 

Pesticide Containers and Containment: 

Proposed Rule,’’ 59 FR 6712, February 

11 (1994). 

67. U.S. EPA, 1994. ‘‘State Pesticide 

Residue Removal Compliance Programs; 

Notice of Interim Determination of 

Adequacy; Correction,’’ 59 FR 9214, 

February 25 (1994). 

68. U.S. EPA, 1993. ‘‘Interim 

Determination of Adequacy of State 

Pesticide Residue Removal Programs,’’

58 FR 43994, August 18 (1993). 

69. U.S. EPA, 1993. ‘‘Notice of Interim 

Determination of Adequacy of Certain 

State Programs,’’ 58 FR 65989, 

December 17 (1993). 

70. U.S. EPA, 1992. ‘‘State of the 

States: Pesticide Storage, Disposal and 

Transportation,’’ prepared for EPA by 

Mitchell Systems Corporation, EPA 

publication number EPA 734–R–92–12 

(1992). 

71. U.S. EPA, 1991. ‘‘Amendment to 

the July 11, 1977 Enforcement Policy 

Applicable to Bulk Shipment of 

Pesticides,’’ March 4 (1991). 

72. U.S. EPA, 1984. ‘‘Clarification of 

Label Improvement Program for 

Farmworker Safety and Pesticide 

Storage and Disposal Instructions,’’

Pesticide Registration Notice 84–1, 

February 17 (1984). 

73. U.S. EPA, 1983. Office of Pesticide 

Programs, ‘‘Label Improvement Program 

- Storage and Disposal Label 

Statements,’’ Pesticide Registration 

Notice 83–3 (1983). 

74. U.S. EPA, 1979. ‘‘National 

Pollution Discharge Elimination System 

(NPDES) Best Management Practices 

Guidance Document,’’ EPA–600/9–79–

045, December (1979). 

75. U.S. EPA, 1977. ‘‘Enforcement 

Policy Applicable to Bulk Shipment of 

Pesticides,’’ July 11 (1977). 

76. U.S. EPA, 1976. ‘‘Pesticide 

Enforcement Policy Statement on 

Structural Pest Control: Use and 

Labeling of Service Containers for the 

Transportation or Temporary Storage of 

Pesticides,’’ (1976). 

77. Viera, K. Clorox [Data from 

container rinsing tests conducted by 

Chemical Specialties Manufacturers 

Association], Personal communication 

to U.S. EPA, July 13 (1993). 

78. U.S., EPA, 2000. ‘‘Analysis of 

Products that Meet the Scope Criteria: 

Toxicity Category III Only,’’ November 

27 (2000). 

XIII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

Under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

the Office of Management and Budget 

(OMB) has determined that this final 

rule is a ‘‘significant regulatory action’’

because these requirements may raise 

novel legal or policy issues arising out 

of legal mandates, the President’s 

priorities, or the principles set forth in 

the Executive Order. Accordingly, EPA 

submitted a draft final rule to OMB for 

review under Executive Order 12866 

and any changes made in response to 

OMB recommendations have been 

documented in the docket for this 

rulemaking as required by sec. 6(a)(3)(E) 

of the Executive Order. 

In addition, EPA has prepared two 

Economic Analyses (EAs) of the 

potential costs and benefits associated 

with this rule, one for the container 

requirements and another for the 

containment requirements. The reason 

for having two EAs is because the 

regulated community differs in each 

case. For example, the container 

requirements affect pesticide 

formulators and refillers of all pesticides 

while the containment requirements 

affect retailers, for-hire applicators and 

custom blenders of agricultural 

pesticides. The EAs, entitled Economic 

Analysis of the Pesticide Container 

Design and Residue Removal Standards 

(Ref. 22) and Economic Analysis of the 

Bulk Pesticide Containment Structure 

Regulations (Ref. 21), are available in 


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the docket for this rule and are briefly 

summarized here. 

EPA estimates the total cost of the 

final rule to be $11.3 million ($8.37 

million for containers + $2.93 million 

for containment) and the total benefits 

from the final rule to be $17 - 23.4 

million. When the estimated cost of the 

final rule is compared to the estimated 

cost for the proposed rule, there is an 

annual cost reduction of approximately 

$27.4 - $38.6 million. This reduction in 

estimated cost is due to the choices 

made in the final rule that lead to a 

narrowing in the scope of regulated 

entities and products that are subject to 

the final rule. During the first year, 

regulated facilities will experience an 

increase in total paperwork cost burden 

of $1 million (containment) and $7.0 

million (containers) due primarily to 

inspection and recordkeeping costs. For 

containers, in the second year and 

continuing thereafter, total paperwork 

cost burden per facility will decrease to 

25 hours from 81 hours in the first year, 

reducing paperwork burden costs to 

$4.1 million annually. 

Over 20 respondents submitted 

general comments on the Regulatory 

Impact Analyses (RIAs) or EAs for the 

proposed rule. Nearly all of the 

commenters wanted EPA to reevaluate 

the economic assessments. The most 

common comments were: 1) The costs 

far outweigh the benefits; 2) costs were 

underestimated; 3) benefits were 

overestimated; 4) this is a major rule, 

contrary to EPA’s assessment; 5) the rule 

will have a significant impact on 

medium and large formulators as well as 

small formulators; 6) the rule will have 

a general impact on various industry 

segments; and 7) the rule does not 

comply with the standards of the 

Executive Order. Commenters who 

objected to the cost estimates mainly 

disagreed with EPA’s estimate of the 

cost of complying with the six 9’s 

residue removal standard. State 

regulatory agencies predicted that the 

rule would increase their workload and 

expressed the hope that EPA would 

increase State funding. 

EPA reopened the comment period on 

the proposed rule on October 21, 1999 

(64 FR 56918, Ref. 53) on three issues, 

proposing to reduce the scope of the 

container standards, add an exemption 

for certain antimicrobial pesticides, and 

adopt some of the Department of 

Transportation (DOT) hazardous 

materials regulations. These potential 

changes decreased the estimated 

economic impact by reducing the 

number of pesticide products subject to 

the container requirements compared to 

the original proposal. 

Major changes resulted in cost 

reduction from the economic analysis 

for the proposed rule. Among these is 

the elimination of the requirement to 

demonstrate the hydraulic conductivity 

of containment structures, lowering of 

the residue removal standard from six 

9’s to four 9’s, and limiting of rinsetesting requirement to those 

formulations expected to be 

problematic. 

B. Paperwork Reduction Act (PRA) 

The information collection 

requirements in this final rule have been 

submitted to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq. The Information Collection Request 

(ICR) document prepared by EPA for 

this final rule has been assigned EPA 

ICR No. 1631.02, and OMB control 

number 2070–0133. Consistent with the 

procedures at 5 CFR 1320.11, EPA 

sought comment on two Information 

Collection Request (ICR) documents that 

were submitted to OMB in conjunction 

with issuing the proposed rule 

(identified under EPA ICR No. 1631.01 

and No. 1632.01). For the final rule, the 

two ICR documents were combined into 

one ICR document, which reflects the 

information collection provisions in this 

final rule. The ICR document for this 

final rule (identified under EPA ICR No. 

1631.02) (Ref. 30) is included in the 

docket for the final rule. 

Under the PRA, an agency may not 

conduct or sponsor, and a person is not 

required to respond to a collection of 

information unless it displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations codified in Chapter 40 of the 

CFR, after appearing in the preamble of 

the final rule, are listed in 40 CFR part 

9, are displayed either by publication in 

the Federal Register or by other 

appropriate means, such as on the 

related collection instrument or form, if 

applicable. The display of OMB control 

numbers in certain EPA regulations is 

consolidated in 40 CFR part 9. For the 

ICR activity contained in this final rule, 

in addition to displaying the applicable 

OMB control number in this Unit, the 

Agency is amending the table in 40 CFR 

9.1 to list the OMB control number 

assigned to this ICR activity. Due to the 

technical nature of the table, EPA finds 

that further notice and comment about 

amending the table is unnecessary. As a 

result, EPA finds that there is good 

cause under section 553(b)(B) of the 

Administrative Procedures Act (APA), 5 

U.S.C. 553(b)(B), to amend this table 

without further notice and comment. 

Under the PRA, burden means the 

total time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, disclose or provide 

information to or for a Federal agency. 

This includes the time needed to review 

instructions; develop, acquire, install, 

and utilize technology and systems for 

the purposes of collecting, validating, 

and verifying information, processing 

and maintaining information, and 

disclosing and providing information; 

adjust the existing ways to comply with 

any previously applicable instructions 

and requirements; train personnel to be 

able to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

In this final rule, the information 

collection requirement burden on the 

regulated community includes the 

administrative burden associated with 

keeping monthly inspection and 

maintenance records for bulk pesticide 

containment structures. The regulated 

community’s administrative burden is 

defined as the time spent to record and 

file the inspection and maintenance of 

the bulk pesticide containment 

structures per month. There is not a 

requirement to submit the records or 

reports to the Agency, however, EPA or 

its representatives may, from time to 

time, request information under these 

regulations to ensure compliance with 

the regulation. 

The two ICRs for the proposed rule 

were combined into a single ICR for the 

final rule. This ICR document provides 

detailed presentations of the estimated 

annual burden and costs for 3 years, 

which represents the maximum OMB 

approval period for any collection 

activity, after which the Agency must 

seek renewal of the ICR approval from 

OMB every 3 years for as long as the 

requirements exist. 

1. Container burden. The public 

reporting burden for this collection of 

information is estimated to be 66 hours 

in the first year of compliance with this 

rule for approximately 1,804 pesticide 

registrant respondents, and 10 hours in 

subsequent years. For an estimated 

16,795 agricultural pesticide refiller 

respondents, the reporting burden is 7.5 

hours per year. For an estimated 322 

swimming pool supply companies, the 

reporting burden is 7.5 hours per year. 

The total annual paperwork burden 

across all pesticide registrant 

respondents, assuming that 1,804 

facilities will be affected by the 

requirements, is 112,209 hours in first 

year, and 11,185 hours in all other 

years. The total annual paperwork 

burden across all agricultural pesticide 

refiller respondents, assuming 16,795 

facilities will be affected by the 


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requirements, is 125,963 hours. The 

total annual paperwork burden across 

all swimming pool supply companies, 

assuming 322 facilities will be affected 

by the requirements, is 2,415 hours. 

2. Containment burden. The public 

recordkeeping burden for this collection 

of information is estimated to be 7.5 

hours for approximately 4,665 

respondents in the first year after 

promulgation of this rule, which 

includes initial rule familiarization. The 

average annual burden per respondent 

for subsequent years is estimated to be 

7.5 hours. The total annual paperwork 

burden across all respondents, assuming 

that 4,665 facilities will be affected by 

the requirement, is 34,988 hours per 

year. 

In comments filed after reviewing the 

proposed ICRs in 1994, OMB 

commented that EPA should consider 

less burdensome testing requirements 

that meet the objective that disposal of 

containers poses no unreasonable risk to 

health of the environment. As discussed 

previously, EPA has modified the 

requirements to be less burdensome, 

decreasing the total industry burden for 

the final rule. The decrease in burden 

results mainly from the elimination of 

the hydraulic conductivity standard for 

containment structures, lowering of the 

residue removal standard to four 9’s, 

and requiring residue removal testing 

only for problematic formulations. 

The Agency is seeking additional 

comments on the paperwork burden 

estimates related to the provision in the 

final rule that allows States with 

existing regulations (§ 165.97) to request 

the authority to continue implementing 

its State containment regulations in lieu 

of EPA’s regulations. As discussed 

previously, EPA added this provision in 

response to comments asking EPA to 

consider existing State regulations. 

Since this provision and related burden 

estimates were not part of the ICRs that 

were prepared and for which public 

comment was sought in conjunction 

with the proposed rule, EPA is 

providing this opportunity for public 

comment. Direct your comments on this 

to EPA using the public docket that has 

been established for this final rule 

(docket ID number EPA–HQ–OPP–

2005–0327) at http:// 

www.regulations.gov. In addition, send 

a copy of your comments to OMB at: 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, 725 17th St., NW., Washington, 

DC 20503, Attention: Desk Office for 

EPA ICR No. 1361.02. Since OMB is 

required to complete its review of the 

ICR between 30 and 60 days after 

August 16, 2006, please submit your 

comments no later than September 15, 

2006. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that this final rule will not have 

a significant adverse economic impact 

on a substantial number of small 

entities. This determination is based on 

the Agency’s two economic analyses 

performed for this rulemaking, which 

are briefly summarized in Unit XIII.A., 

and copies of which are available in the 

docket for this rulemaking (Refs. 21 and 

22). The following is a brief summary of 

the factual basis for this certification. 

Under the RFA, small entities include 

small businesses, small organizations, 

and small governmental jurisdictions. 

For purposes of assessing the impacts of 

today’s rule on small entities, small 

entity is defined in accordance with the 

RFA as: (1) A small business as defined 

by the Small Business Administration’s 

(SBA) regulations at 13 CFR 121.201; (2) 

a small governmental jurisdiction that is 

a government of a city, county, town, 

school district, or special district with a 

population of less than 50,000; and (3) 

a small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. Based on the 

industry profiles for this rulemaking 

that EPA prepared as part of the 

Economic Analyses, EPA has 

determined that this final rule is not 

expected to impact any small not-forprofit organizations or small 

governmental jurisdictions. As such, 

small entity for purposes of this final 

rule is synonymous with small business. 

In addition, for purposes of analyzing 

the potential impacts of this final rule 

on small businesses, the Agency 

disaggregated the universe of potentially 

impacted small business into 

subcategories of large-small businesses, 

medium-small businesses, and smallsmall businesses. The analysis 

disaggregated the impacts of small 

businesses into these sub-categories 

because the SBA size standard for small 

businesses, which are primarily 

intended to define whether a business 

entity is eligible for Federal government 

programs and preferences reserved for 

small businesses (13 CFR 121.101), may 

not be representative of all small 

businesses in the industry sectors 

impacted by this rulemaking. (See 

section 632(a)(1) of the Small Business 

Act.) The SBA size standard is generally 

based on the number of employees an 

entity in a particular industrial sector 

may have. For example, in the Pesticide 

and Other Agricultural Chemical 

Manufacturing sector (i.e., NAICS code 

325320) approximately 92% of the 

industries would be classified as small 

businesses under the SBA definition 

(500 or fewer employees). However, 

60% of the SBA defined small 

companies have 1 to 19 employees, 

which are considered small-small 

businesses in the Agency’s analysis. By 

disaggregating the potential impacts of 

this final rule on small businesses, the 

Agency was able to consider the 

distribution of the estimated impacts 

among the universe of potentially 

impacted small businesses, particularly 

potential impacts on the small-small 

businesses. 

Considering just the container 

requirements, the estimated costs of 

compliance for the universe of 

potentially impacted small businesses 

in each of the regulated industries as a 

proportion of their current revenues are 

estimated to be less than 1 percent. 

Specifically, using the SBA definition of 

small businesses, the costs of 

compliance for all small businesses are 

estimated to be less than 0.02 percent of 

the current average entity revenues. 

Looking at the estimated impacts using 

the disaggregated small business subcategories used in the Agency’s analysis 

(which further divides small businesses 

into large-small, medium-small and 

small-small business within each of the 

regulated industries), no small-small 

business is estimated to incur costs 

which account for more than 0.04 

percent of current average entity 

revenues. 

Considering just the containment 

requirements, the estimated costs of 

compliance for the universe of 

potentially impacted small businesses 

as a proportion of their current revenues 

are estimated to be less than 1 percent, 

except for small commercial applicators. 

When only looking at commercial 

applicators, and using the SBA 

definition of small business, the costs of 

compliance for potentially impacted 

small commercial applicators to install 

new secondary containment units are 

estimated to be as high as 2.7 percent of 

the current average entity revenues. 

Small-small commercial applicators, 

based on the disaggregated small 

business sub-categories used in the 

Agency’s analysis, may face costs of 

compliance that are as much as 7.8 

percent of the current average entity 

revenues. However, only 6 of the 3,000 

small commercial applicators were 

identified as small-small commercial 

applicators that will need to install both 

a secondary containment unit and a 

containment pad and thus are estimated 

to be impacted in this way. The costs of 

compliance for potentially impacted 


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small commercial applicators to retrofit 

existing containment structures are 

estimated to be less than 1 percent of 

the current average entity revenues. 

For agricultural pesticide refillers, the 

other industry estimated to be impacted 

by the containment regulations, the 

costs of compliance for small 

agricultural pesticide refillers are 

estimated to be less than 0.18 percent of 

current average entity revenues using 

the SBA definition of small businesses, 

and less than 0.34 percent of current 

average entity revenues based on the 

disaggregated small-small business subcategory used in the Agency’s analysis. 

Considering the overall impact of this 

final rule on the universe of potentially 

impacted small businesses using the 

SBA definition for small business, the 

Agency has determined that this final 

rule will not have a significant adverse 

economic impact on a substantial 

number of small entities. 

In general, EPA strives to minimize 

potential adverse impacts on small 

entities when developing regulations to 

achieve the environmental and human 

health protection goals of the statute 

and the Agency. In doing so for this 

particular rule, as discussed in more 

detail previously, the major changes that 

EPA made to the proposed requirements 

resulted in significant reductions in the 

potential costs of compliance for this 

rulemaking. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Pursuant to Title II of the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4), EPA has determined that 

this action does not contain a Federal 

mandate that may result in expenditures 

of $100 million or more for State, local, 

and tribal governments, in the aggregate, 

or for the private sector in any one year. 

As described in Unit XIII.A., the annual 

costs associated with this action are 

estimated to total $11.3 million ($8.37 

millioin for containers + $2.93 million 

for containment). This cost represents 

the incremental cost to registrants, 

pesticide dealers, commercial 

applicators and custom blenders 

attributed to the requirements in this 

action. Accordingly, this action is not 

subject to the requirements of sections 

202 and 205 of UMRA. 

E. Executive Order 13132 

Pursuant to Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this final rule does not have 

federalism implications, because it 

would not have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in the Order. Under 

cooperative agreements with EPA, 

States will be involved in compliance 

monitoring and enforcement activities, 

but are not otherwise expected to engage 

in the activities regulated by this rule. 

Thus, Executive Order 13132 does not 

apply to this rule. 

F. Executive Order 13175 

As required by Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 22951, November 

6, 2000), EPA has determined that this 

action does not have tribal implications 

because it will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes, as 

specified in the Order. EPA is not aware 

of any tribal governments which are 

pesticide registrants, refillers or dealers 

storing large quantities of pesticides. 

Thus, Executive Order 13175 does not 

apply to this action. 

G. Executive Order 13045 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997), 

does not apply to this action because it 

is not designated as an economically 

significant regulatory action as defined 

by Executive Order 12866 (see Unit 

XIII.A.). Further, this action does not 

establish an environmental standard 

that is intended to have a negatively 

disproportionate effect on children. To 

the contrary, this action will provide 

added protection for children from 

pesticide risk by ensuring the integrity 

of pesticide container design, as well as 

secure pesticide storage and disposal. 

H. Executive Order 13211 

This rule is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) because it is not likely to have 

a significant adverse effect on the 

supply, distribution, or use of energy. 

I. National Technology Transfer 

Advancement Act (NTTAA) 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), 15 U.S.C. 272 

note) directs EPA to use voluntary 

consensus standards in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, 

business practices, etc.) that are 

developed or adopted by voluntary 

consensus standards bodies. NTTAA 

directs EPA to provide Congress, 

through OMB, explanations when the 

Agency decides not to use available and 

applicable voluntary consensus 

standards. This action requires 

performance standards for containment 

structures and residue removal testing 

for containers of certain pesticide 

formulations, but does not require 

specific methods or standards. 

Therefore, this action does not impose 

any technical standards that would 

require Agency consideration of 

voluntary consensus standards. 

J. Executive Order 12898 

This action does not have an adverse 

impact on the environmental and health 

conditions in low-income and minority 

communities. Therefore, under 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994), the Agency has not 

considered environmental justicerelated issues. Although not directly 

impacting environmental justice-related 

concerns, the Agency believes that the 

requirements in this rule will assist EPA 

and others in reducing potential 

exposures associated with the handling, 

storage, management and disposal of 

pesticide containers covered by the rule. 

XIV. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and the Comptroller General of 

the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This rule is not a 

major rule as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

List of Subjects in 40 CFR Part 156 

Environmental protection, Labeling, 

Pesticides and pests. 


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47420 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

List of Subjects in 40 CFR Part 165 

Environmental protection, Packaging 

and containers, Containment structures, 

Pesticides and pests. 

Dated: August 3, 2006. 

Stephen L. Johnson, 

Administrator. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

■ 1. Part 9 is amended as follows: 

PART 9—[AMENDED] 

■ a. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671, 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ b. In § 9.1 the table is amended by 

adding a new center heading entitled 

‘‘Pesticide Management and Disposal’’

and an entry for new part 165 after the 

center heading and entries for ‘‘State 

Registration of Pesticide Products,’’ to 

read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB Control No. 

* * * * * * * 

Pesticide Management and Disposal 

Part 165 ........................................................................... 2070–0133 

* * * * * * * 

PART 156—[AMENDED] 

■ 2. Part 156 is amended as follows: 

■ a. The authority citation for part 156 

continues to read as follows: 

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

■ b. In § 156.10 by adding paragraph 

(d)(7), and by revising paragraphs (f) 

and (i)(2)(ix) to read as follows: 

§ 156.10 Labeling requirements. 

* * * * * 

(d)* * * 

(7) For a pesticide product packaged 

in a refillable container, an 

appropriately sized area on the label 

may be left blank to allow the net 

weight or measure of content to be 

marked in by the refiller according to 40 

CFR 165.65(h) or 165.70(i) prior to 

distribution or sale of the pesticide. As 

required in paragraph (a)(1)(iii) of this 

section, the net contents must be shown 

clearly and prominently on the label. 

* * * * * 

(f) Producing establishment’s 

registration number. The producing 

establishment registration number 

preceded by the phrase ‘‘EPA Est.’’, of 

the final establishment at which the 

product was produced may appear in 

any suitable location on the label or 

immediate container. It must appear on 

the wrapper or outside container of the 

package if the EPA establishment 

registration number on the immediate 

container cannot be clearly read through 

such wrapper or container. For a 

pesticide product packaged in a 

refillable container, an appropriately 

sized area on the label may be left blank 

after the phrase ‘‘EPA Est.’’ to allow the 

EPA establishment registration number 

to be marked in by the refiller according 

to 40 CFR 165.65(h) or 165.70(i) prior to 

distribution or sale of the pesticide. 

* * * * * 

(i) * * * 

(2)* * * 

(ix) Specific directions concerning the 

storage, residue removal and disposal of 

the pesticide and its container, in 

accordance with subpart H of this part 

and part 165 of this chapter. These 

instructions must be grouped and 

appear under the heading, ‘‘Storage and 

Disposal.’’ This heading must be set in 

type of the same minimum sizes as 

required for the child hazard warning. 

(See table in § 156.60(b)) 

* * * * * 

■ c. By adding Subpart H entitled 

‘‘Container Labeling’’ to read as follows: 

Subpart H—Container Labeling 

Sec. 

156.140 Identification of container types. 

156.144 Residue removal instructions - 

general. 

156.146 Residue removal instructions for 

nonrefillable containers - rigid 

containers with dilutable pesticides. 

156.156 Residue removal instructions for 

refillable containers. 

156.159 Compliance date. 

Subpart H—Container Labeling 

§ 156.140 Identification of container types. 

For products other than plantincorporated protectants, the following 

statements, as applicable, must be 

placed on the label or container. The 

information may be located on any part 

of the container except the closure. If 

the statements are placed on the 

container, they must be durably marked 

on the container. Durable marking 

includes, but is not limited to etching, 

embossing, ink jetting, stamping, heat 

stamping, mechanically attaching a 

plate, molding, or marking with durable 

ink. 

(a) Nonrefillable container. For 

nonrefillable containers, the statements 

in paragraphs (a)(1) through (a)(4) of this 

section are required. If placed on the 

label, the statements in paragraphs (a)(1) 

through (a)(3) of this section must be 

under an appropriate heading under the 

heading ‘‘Storage and Disposal.’’ If any 

of the statements in paragraphs (a)(1) 

through (a)(3) of this section are placed 

on the container, an appropriate referral 

statement such as ‘‘See container for 

recycling [or other descriptive word] 

information.’’ must be placed on the 

label under the heading ‘‘Storage and 

Disposal.’’

(1) Statement identifying a 

nonrefillable container. The following 

phrase is required: ‘‘Nonrefillable 

container.’’

(2) Reuse statement. One of the 

following statements is required. 

Products with labels that allow 

household/residential use must use the 

statement in paragraph (a)(2)(i) or 

(a)(2)(iii) of this section. All other 

products must use the statement in 

paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) 

of this section. 

(i) ‘‘Do not reuse or refill this 

container.’’

(ii) ‘‘Do not reuse this container to 

hold materials other than pesticides or 

dilute pesticides (rinsate). After 

emptying and cleaning, it may be 

allowable to temporarily hold rinsate or 

other pesticide-related materials in the 

container. Contact your state regulatory 

agency to determine allowable practices 

in your state.’’

(iii) The following statement may be 

used if a product is ‘‘ready-to-use’’ and 


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its directions for use allow a different 

product (that is a similar, but 

concentrated formulation) to be poured 

into the container and diluted by the 

end user: ‘‘Do not reuse or refill this 

container unless the directions for use 

allow a different (concentrated) product 

to be diluted in the container.’’

(3) Recycling or reconditioning 

statement. One of the following 

statements is required: 

(i) ‘‘Offer for recycling if available.’’

(ii) ‘‘Once cleaned, some agricultural 

plastic pesticide containers can be taken 

to a container collection site or picked 

up for recycling. To find the nearest site, 

contact your chemical dealer or 

manufacturer or contact [a pesticide 

container recycling organization] at 

[phone number] or [web site]. For 

example, this statement could be ‘‘Once 

cleaned, some agricultural plastic 

pesticide containers can be taken to a 

container collection site or picked up 

for recycling. To find the nearest site, 

contact your chemical dealer or 

manufacturer or contact the Ag 

Container Recycling Council (ACRC) at 

1–877–952–2272 (toll-free) or 

www.acrecycle.org.’’

(iii) A recycling statement approved 

by EPA and published in an EPA 

document, such as a Pesticide 

Registration Notice. 

(iv) An alternative recycling statement 

that has been reviewed and approved by 

EPA. 

(v) ‘‘Offer for reconditioning if 

appropriate.’’

(4) Batch code. A lot number, or other 

code used by the registrant or producer 

to identify the batch of the pesticide 

product which is distributed and sold is 

required. 

(b) Refillable container. For refillable 

containers, one of the following 

statements is required. If placed on the 

label, it must be under the heading 

‘‘Storage and Disposal.’’ If the statement 

is placed on the container, an 

appropriate referral statement, such as 

‘‘Refilling limitations are on the 

container.’’ must be placed under the 

heading ‘‘Storage and Disposal.’’

(1) ‘‘Refillable Container. Refill this 

container with pesticide only. Do not 

reuse this container for any other 

purpose.’’

(2) ‘‘Refillable Container. Refill this 

container with [common chemical 

name] only. Do not reuse this container 

for any other purpose.’’

§ 156.144 Residue removal instructions - 

general. 

(a) General. Except as provided by 

paragraphs (c) and (d) of this section, 

the label of each pesticide product must 

include the applicable instructions for 

removing pesticide residues from the 

container prior to container disposal 

that are specified in §§ 156.146 and 

156.156. The residue removal 

instructions are required for both 

nonrefillable and refillable containers. 

(b) Placement of residue removal 

statements. All residue removal 

instructions must be placed under the 

heading ‘‘Storage and Disposal.’’

(c) Exemption for residential/ 

household use products. Residential/ 

household use pesticide products are 

exempt from the residue removal 

instruction requirements in this section 

through § 156.156. 

(d) Modification. EPA may, on its own 

initiative or based on data submitted by 

any person, modify or waive the 

requirements of this section through 

§ 156.156, or permit or require 

alternative labeling statements. 

§ 156.146 Residue removal instructions for 

nonrefillable containers - rigid containers 

with dilutable pesticides. 

The label of each dilutable (liquid or 

solid) pesticide product packaged in a 

rigid nonrefillable container must 

include the following residue removal 

instructions as appropriate. 

(a) Timing of the residue removal 

procedure. One of the following 

statements must immediately precede 

the instructions required in paragraph 

(b) of this section and must be 

consistent with the instructions in 

paragraphs (b) and (c) of this section: 

(1) ‘‘Clean container promptly after 

emptying.’’

(2) ‘‘Triple rinse or pressure rinse 

container (or equivalent) promptly after 

emptying.’’

(3) ‘‘Triple rinse container (or 

equivalent) promptly after emptying.’’

(b) Triple rinse instructions. The label 

of each dilutable pesticide product 

packaged in rigid nonrefillable 

containers must include one of the 

following sets of instructions. 

(1) For liquid dilutable pesticide 

products in containers small enough to 

shake, use the following instructions: 

‘‘Triple rinse as follows: Empty the 

remaining contents into application 

equipment or a mix tank and drain for 

10 seconds after the flow begins to drip. 

Fill the container 1/4 full with water 

and recap. Shake for 10 seconds. Pour 

rinsate into application equipment or a 

mix tank or store rinsate for later use or 

disposal. Drain for 10 seconds after the 

flow begins to drip. Repeat this 

procedure two more times.’’

(2) For solid dilutable pesticide 

products in containers small enough to 

shake, use the following instructions: 

‘‘Triple rinse as follows: Empty the 

remaining contents into application 

equipment or a mix tank. Fill the 

container 1/4 full with water and recap. 

Shake for 10 seconds. Pour rinsate into 

application equipment or a mix tank or 

store rinsate for later use or disposal. 

Drain for 10 seconds after the flow 

begins to drip. Repeat this procedure 

two more times.’’

(3) For containers that are too large to 

shake, use the following instructions: 

‘‘Triple rinse as follows: Empty 

remaining contents into application 

equipment or a mix tank. Fill the 

container 1/4 full with water. Replace 

and tighten closures. Tip container on 

its side and roll it back and forth, 

ensuring at least one complete 

revolution, for 30 seconds. Stand the 

container on its end and tip it back and 

forth several times. Turn the container 

over onto its other end and tip it back 

and forth several times. Empty the 

rinsate into application equipment or a 

mix tank or store rinsate for later use or 

disposal. Repeat this procedure two 

more times.’’

(c) Pressure rinse instructions. The 

label of each dilutable pesticide product 

packaged in rigid nonrefillable 

containers may include one of the 

following sets of instructions, and one 

of them must be used if the statement 

in paragraph (a)(2) of this section is 

used. If one of these statements is 

included on the label, it must 

immediately follow the triple rinse 

instructions specified in paragraph (b) 

of this section. 

(1) For liquid dilutable pesticide 

products, use the following label 

instruction: ‘‘Pressure rinse as follows: 

Empty the remaining contents into 

application equipment or a mix tank 

and continue to drain for 10 seconds 

after the flow begins to drip. Hold 

container upside down over application 

equipment or mix tank or collect rinsate 

for later use or disposal. Insert pressure 

rinsing nozzle in the side of the 

container, and rinse at about 40 PSI for 

at least 30 seconds. Drain for 10 seconds 

after the flow begins to drip.’’

(2) For solid dilutable pesticide 

products, use the following label 

instruction: ‘‘Pressure rinse as follows: 

Empty the remaining contents into 

application equipment or a mix tank. 

Hold container upside down over 

application equipment or mix tank or 

collect rinsate for later use or disposal. 

Insert pressure rinsing nozzle in the side 

of the container, and rinse at about 40 

PSI for at least 30 seconds. Drain for 10 

seconds after the flow begins to drip.’’

(d) Non-water diluent. (1) A registrant 

who wishes to require users to clean a 

container with a diluent other than 

water (e.g., solvents) must submit to 

EPA a written request to modify the 


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residue removal instructions of this 

section. The registrant may not 

distribute or sell the pesticide with the 

modified residue removal instructions 

until EPA approves the request in 

writing. 

(2) The registrant must indicate why 

a non-water diluent is necessary for 

efficient residue removal, and must 

propose residue removal instructions 

and disposal instructions that are 

appropriate for the characteristics and 

formulation of the pesticide product and 

non-water diluent. The proposed 

residue removal instructions must 

identify the diluent. If the Directions for 

Use permit the application of a mixture 

of the pesticide and the non-water 

diluent, the instructions may allow the 

rinsate to be added to the application 

equipment or mix tank. If the Directions 

for Use do not identify the non-water 

diluent as an allowable addition to the 

pesticide, the instructions must require 

collection and storage of the rinsate in 

a rinsate collection system. 

(3) EPA may approve the request if 

EPA finds that the proposed 

instructions are necessary and 

appropriate. 

§ 156.156 Residue removal instructions for 

refillable containers. 

The label of each pesticide product 

packaged in a refillable container must 

include the residue removal instructions 

in this section. Instructions must be 

given for all pesticide products that are 

distributed or sold in refillable 

containers, including those that do not 

require dilution prior to application. 

(a) Timing of the residue removal 

procedure. One of the following 

statements must immediately precede 

the instructions required in paragraph 

(b) of this section and must be 

consistent with the instructions in 

paragraph (b) of this section: 

(1) ‘‘Cleaning the container before 

final disposal is the responsibility of the 

person disposing of the container. 

Cleaning before refilling is the 

responsibility of the refiller.’’

(2) ‘‘Pressure rinsing the container 

before final disposal is the 

responsibility of the person disposing of 

the container. Cleaning before refilling 

is the responsibility of the refiller.’’

(b) Residue removal instructions prior 

to container disposal. (1) Instructions 

for cleaning each refillable container 

prior to disposal are required. The 

residue removal instructions must be 

appropriate for the characteristics and 

formulation of the pesticide product and 

must be adequate to protect human 

health and the environment. 

(2) Subject to meeting the standard in 

paragraph (b)(1) of this section, the 

statement on residue removal 

instructions could include any one of 

the following: 

(i) The refilling residue removal 

procedure developed by the registrant 

for the pesticide product. 

(ii) Standard industry practices for 

cleaning refillable containers. 

(iii) For pesticides that require 

dilution prior to application, the 

following statement: ‘‘To clean the 

container before final disposal, empty 

the remaining contents from this 

container into application equipment or 

a mix tank. Fill the container about 10 

percent full with water. Agitate 

vigorously or recirculate water with the 

pump for 2 minutes. Pour or pump 

rinsate into application equipment or 

rinsate collection system. Repeat this 

rinsing procedure two more times.’’

(iv) Any other statement the registrant 

considers appropriate. 

§ 156.159 Compliance date. 

As of August 17, 2009, all pesticide 

products distributed or sold by a 

registrant must have labels that comply 

with §§ 156.10(d)(7), 156.10(f), 

156.10(i)(2)(ix), 156.140, 156.144, 

156.146, and 156.156. 

■ 3. By adding a new part 165 to read 

as follows: 

Part 165—Pesticide Management and 

Disposal 

Sec. 

Subpart A—General 

165.1 Scope. 

165.3 Definitions. 

165.4–165.19 [Reserved] 

Subpart B—Nonrefillable Container 

Standards: Container Design and Residue 

Removal 

165.20 General provisions. 

165.23 Scope of pesticide products 

included. 

165.25 Nonrefillable container standards. 

165.27 Reporting and recordkeeping. 

165.28–165.39 [Reserved] 

Subpart C—Refillable Container Standards: 

Container Design 

165.40 General provisions. 

165.43 Scope of pesticide products 

included. 

165.45 Refillable container standards. 

165.47 What information must I report 

about my refillable containers? 

165.48–165.59 [Reserved] 

Subpart D—Standards for Repackaging 

Pesticide Products into Refillable 

Containers 

165.60 General provisions. 

165.63 Scope of pesticide products 

included. 

165.65 Registrants who distribute or sell 

pesticide products in refillable 

containers. 

165.67 Registrants who distribute or sell 

pesticide products to refillers for 

repackaging. 

165.70 Refillers who are not registrants. 

165.71–165.79 [Reserved] 

Subpart E—Standards for Pesticide 

Containment Structures 

165.80 General provisions. 

165.81 Scope of stationary pesticide 

containers included. 

165.82 Scope of pesticide dispensing areas 

included. 

165.83 Definition of new and existing 

structures. 

165.85 Design and capacity requirements 

for new structures. 

165.87 Design and capacity requirements 

for existing structures. 

165.90 Operational, inspection and 

maintenance requirements for all new 

and existing containment structures. 

165.92 What if I need both a containment 

pad and a secondary containment unit? 

165.95 What recordkeeping do I have to do 

as a facility owner or operator? 

165.97 States with existing containment 

programs. 

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

Subpart A—General 

§ 165.1 Scope. 

The Part 165 regulations establish 

standards and requirements for 

pesticide containers, repackaging 

pesticides, and pesticide containment 

structures. 

§ 165.3 Definitions. 

Act means the Federal Insecticide, 

Fungicide, and Rodenticide Act. 

Agricultural pesticide means any 

pesticide product labeled for use in a 

nursery or greenhouse or for use in the 

production of any agricultural 

commodity, including any plant, plant 

part, animal, or animal product 

produced by persons (including farmers, 

ranchers, vineyardists, plant 

propagators, Christmas tree growers, 

aquaculturalists, horticulturists, 

orchardists, foresters, or other 

comparable persons) primarily for sale, 

consumption, propagation or other use 

by man or animals. 

Appurtenance means any equipment 

or device which is used for the purpose 

of transferring a pesticide from a 

stationary pesticide container or to any 

refillable container, including but not 

limited to, hoses, fittings, plumbing, 

valves, gauges, pumps and metering 

devices. 

Container means any package, can, 

bottle, bag, barrel, drum, tank, or other 

containing-device (excluding any 

application tanks) used to enclose a 

pesticide. Containers that are used to 

sell or distribute a pesticide product and 

that also function in applying the 

product (such as spray bottles, aerosol 


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cans and containers that become part of 

a direct injection system) are considered 

to be containers for the purposes of this 

part. 

Containment pad means any structure 

that is designed and constructed to 

intercept and contain pesticides, 

rinsates, and equipment wash water at 

a pesticide dispensing area. 

Containment structure means either a 

secondary containment unit or a 

containment pad. 

Custom blending means the service of 

mixing pesticides to a customer’s 

specifications, usually a pesticide(s)- 

fertilizer(s), pesticide-pesticide, or a 

pesticide-animal feed mixture, when: 

(1) The blend is prepared to the order 

of the customer and is not held in 

inventory by the blender; 

(2) The blend is to be used on the 

customer’s property (including leased or 

rented property); 

(3) The pesticide(s) used in the blend 

bears end-use labeling directions which 

do not prohibit use of the product in 

such a blend; 

(4) The blend is prepared from 

registered pesticides; and 

(5) The blend is delivered to the enduser along with a copy of the end-use 

labeling of each pesticide used in the 

blend and a statement specifying the 

composition of the mixture. 

Dry pesticide means any pesticide 

that is in solid form and that has not 

been combined with liquids; this 

includes formulations such as dusts, 

wettable powders, dry flowable 

powders, granules, and dry baits. 

Establishment means any site where a 

pesticidal product, active ingredient, or 

device is produced, regardless of 

whether such site is independently 

owned or operated, and regardless of 

whether such site is domestic and 

producing a pesticidal product for 

export only, or whether the site is 

foreign and producing any pesticidal 

product for import into the United 

States. 

Facility means all buildings, 

equipment, structures, and other 

stationary items which are located on a 

single site or on contiguous or adjacent 

sites and which are owned or operated 

by the same person (or by any person 

who controls, who is controlled by, or 

who is under common control with 

such person). 

Flowable concentrate means a stable 

suspension of active ingredients in a 

liquid intended for dilution with water 

before use. 

Nonrefillable container means a 

container that is not a refillable 

container and that is designed and 

constructed for one time containment of 

a pesticide for sale or distribution. 

Reconditioned containers are 

considered to be nonrefillable 

containers. 

One-way valve means a valve that is 

designed and constructed to allow 

virtually unrestricted flow in one 

direction and no flow in the opposite 

direction, thus allowing the withdrawal 

of material from, but not the 

introduction of material into, a 

container. 

Operator means any person in control 

of, or having responsibility for, the daily 

operation of a facility at which a 

containment structure is located. 

Owner means any person who owns a 

facility at which a containment 

structure is required. 

Pesticide compatible means, as 

applied to containers, that the container 

construction materials will not 

chemically react with the formulation. 

A container is not compatible with the 

formulation if, for example, the 

formulation: 

(1) Is corrosive to the container; 

(2) Causes softening, premature aging, 

or embrittlement of the container; 

(3) Otherwise causes the container to 

weaken or to create the risk of 

discharge; 

(4) Reacts in a significant chemical, 

electrolytic, or galvanic manner with the 

container, or 

(5) Interacts in a way, such as the 

active ingredient permeating the 

container wall, that would cause the 

formulation to differ from its 

composition as described in the 

statement required in connection with 

its registration under FIFRA section 3. 

Pesticide compatible means, as 

applied to secondary containment, that 

the containment construction materials 

are able to withstand anticipated 

exposure to stored or transferred 

materials without losing the capacity to 

provide the required secondary 

containment of the same or other 

materials within the containment area. 

Pesticide dispensing area means an 

area in which pesticide is transferred 

out of or into a container. 

Portable pesticide container means a 

refillable container that is not a 

stationary pesticide container. 

Pressure rinse means the flushing of 

the container to remove pesticide 

residue by using a pressure method with 

a pressure of at least 40 PSI. 

Produce means to manufacture, 

prepare, propagate, compound, or 

process any pesticide, including any 

pesticide produced pursuant to section 

5 of the Act, and any active ingredient 

or device, or to package, repackage, 

label, relabel, or otherwise change the 

container of any pesticide or device. 

Producer means any person, as 

defined by the Act, who produces any 

pesticide, active ingredient, or device 

(including packaging, repackaging, 

labeling and relabeling). 

Refillable container means a container 

that is intended to be filled with 

pesticide more than once for sale or 

distribution. 

Refiller means a person who engages 

in the activity of repackaging pesticide 

product into refillable containers. This 

could include a registrant or a person 

operating under contract to a registrant. 

Refilling establishment means an 

establishment where the activity of 

repackaging pesticide product into 

refillable containers occurs. 

Repackage means, for the purposes of 

this part, to transfer a pesticide 

formulation from one container to 

another without a change in the 

composition of the formulation, the 

labeling content, or the product’s EPA 

registration number, for sale or 

distribution. 

Rinsate means the liquid produced 

from the rinsing of the interior of any 

equipment or container that has come in 

direct contact with any pesticide. 

Runoff means surface water leaving 

the target site. 

Secondary containment unit means 

any structure, including rigid diking, 

that is designed and constructed to 

intercept and contain pesticide spills 

and leaks and to prevent runoff and 

leaching from stationary pesticide 

containers. 

Stationary pesticide container means 

a refillable container that is fixed at a 

single facility or establishment or, if not 

fixed, remains at the facility or 

establishment for at least 30 consecutive 

days, and that holds pesticide during 

the entire time. 

Tamper-evident device means a 

device which can be visually inspected 

to determine if a container has been 

opened. 

Transport vehicle means a cargocarrying vehicle such as an automobile, 

van, tractor, truck, semitrailer, tank car 

or rail car used for the transportation of 

cargo by any mode. 

Triple rinse means the flushing of the 

container three times to remove 

pesticide residue by using a nonpressurized method. 

Washwater means the liquid 

produced from the rinsing of the 

exterior of any equipment or containers 

that have or may have come in direct 

contact with any pesticide or system 

maintenance compound. 


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47424 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

§§ 165.4–165.19 [Reserved] 

Subpart B—Nonrefillable Container 

Standards: Container Design and 

Residue Removal 

§ 165.20 General provisions. 

(a) What is the purpose of the 

regulations in this subpart? The 

regulations in this subpart establish 

design and construction requirements 

for nonrefillable containers used for the 

distribution or sale of some pesticide 

products. 

(b) Do I have to comply with the 

regulations in this subpart? You must 

comply with the regulations in this 

subpart if you are a registrant who 

distributes or sells a pesticide product 

in nonrefillable containers. If your 

pesticide product is subject to the 

regulations in this subpart as set out in 

§ 165.23, your pesticide product must be 

distributed or sold in a nonrefillable 

container that meets the standards of 

these regulations. 

(c) When do I have to comply? As of 

August 17, 2009, all pesticide products 

distributed or sold by you in 

nonrefillable containers must be 

distributed or sold in compliance with 

these regulations. 

§ 165.23 Scope of pesticide products 

included. 

(a) Are manufacturing use products 

subject to the regulations in this 

subpart? No, the regulations in this 

subpart do not apply to manufacturing 

use products, as defined in § 158.153(h) 

of this chapter. 

(b) Are plant-incorporated protectants 

subject to the regulations in this 

subpart? No, the regulations in this 

subpart do not apply to plantincorporated protectants, as defined in 

§ 174.3 of this chapter. 

(c) Which antimicrobial pesticide 

products are not subject to the 

regulations in this subpart? The 

regulations in this subpart do not apply 

to a pesticide product if it satisfies all 

of the following conditions: 

(1) The pesticide product meets one of 

the following two criteria: 

(i) The pesticide product is an 

antimicrobial pesticide as defined in 

FIFRA section 2(mm); or 

(ii) The pesticide product: (A) Is 

intended to: disinfect, sanitize, reduce 

or mitigate growth or development of 

microbiological organisms; or protect 

inanimate objects, industrial processes 

or systems, surfaces, water, or other 

chemical substances from 

contamination, fouling, or deterioration 

caused by bacteria, viruses, fungi, 

protozoa, algae, or slime; and 

(B) In the intended use is subject to 

a tolerance under section 408 of the 

Federal Food, Drug, and Cosmetic Act 

or a food additive regulation under 

section 409 of such Act. 

(2) The labeling of the pesticide 

product includes directions for use on a 

site in at least one of the following 

antimicrobial product use categories: 

food handling/storage establishments 

premises and equipment; commercial, 

institutional, and industrial premises 

and equipment; residential and public 

access premises; medical premises and 

equipment; human drinking water 

systems; materials preservatives; 

industrial processes and water systems; 

antifouling coatings; wood 

preservatives; or swimming pools. 

(3) The pesticide product is not a 

hazardous waste as set out in part 261 

of this chapter when the pesticide 

product is intended to be disposed. 

(4) EPA has not specifically 

determined that the pesticide product 

must be subject to the regulations in this 

subpart to prevent an unreasonable 

adverse effect on the environment 

according to the provisions of paragraph 

(d) of this section. 

(d) How will EPA determine if an 

‘‘antimicrobial’’ pesticide product 

otherwise exempted must be subject to 

the regulations in this subpart to 

prevent an unreasonable adverse effect 

on the environment? (1) EPA may 

determine that an antimicrobial 

pesticide product otherwise exempted 

by paragraph (c) of this section must be 

subject to the nonrefillable container 

regulations in this subpart to prevent an 

unreasonable adverse effect on the 

environment if all of the following 

conditions exist: 

(i) EPA obtains information, data or 

other evidence of a problem with the 

containers of a certain pesticide product 

or related group of products. 

(ii) The information, data or other 

evidence is reliable and factual. 

(iii) The problem causes or could 

reasonably be expected to cause an 

unreasonable adverse effect on the 

environment. 

(iv) Complying with the container 

regulations could reasonably be 

expected to eliminate the problem. 

(2) If EPA determines that an 

antimicrobial pesticide product 

otherwise exempted by paragraph (c) of 

this section must be subject to the 

nonrefillable container regulations in 

this subpart to prevent an unreasonable 

adverse effect on the environment, EPA 

may require, by rule, that the product be 

distributed or sold in nonrefillable 

containers that comply with all or some 

of the requirements in this subpart. 

Alternatively, EPA may notify the 

applicant or registrant of its intent to 

make such a determination. After 

allowing the applicant or registrant a 

reasonable amount of time to reply, EPA 

may require, by notification and as a 

condition of registration, that the 

product be distributed or sold in 

nonrefillable containers that comply 

with all or some of the requirements in 

this subpart. For the purpose of the 

previous sentence, 60 days would be a 

reasonable amount of time to reply, 

although EPA may, in its discretion, 

provide more time. EPA may deny 

registration or initiate cancellation 

proceedings if the registrant fails to 

comply with the nonrefillable container 

regulations within the time frames 

established by EPA in the rule or in its 

notification. 

(e) What other pesticide products are 

subject to the regulations in this 

subpart? (1) Except for manufacturing 

use products, plant-incorporated 

protectants, and antimicrobial products 

that are exempt under paragraph (c) of 

this section, all of the regulations in this 

subpart apply to a pesticide product if 

it satisfies at least one of the following 

criteria: 

(i) The pesticide product meets the 

criteria of Toxicity Category I as set out 

in § 156.62 of this chapter. 

(ii) The pesticide product meets the 

criteria of Toxicity Category II as set out 

in § 156.62 of this chapter. 

(iii) The pesticide product is 

classified for restricted use as set out in 

§§ 152.160 - 152.175 of this chapter. 

(2) Except for manufacturing use 

products, plant-incorporated 

protectants, antimicrobial products that 

are exempt under (c) of this section, and 

other pesticide products that are 

regulated under paragraph (e)(1) of this 

section, a pesticide product must be 

packaged in compliance with 49 CFR 

173.24. If the pesticide product meets 

the definition of a hazardous material in 

49 CFR 171.8, the Department of 

Transportation requires it to be 

packaged according to 49 CFR parts 

171–180. 

(f) What does ‘‘pesticide product’’ or 

‘‘pesticide’’ mean in the rest of this 

subpart? In §§ 165.25 through 165.27, 

the term ‘‘pesticide product’’ or 

‘‘pesticide’’ refers only to a pesticide 

product or a pesticide that is subject to 

the regulations in this subpart as 

described in paragraphs (a) through (e) 

of this section. 

§ 165.25 Nonrefillable container standards. 

(a) What Department of 

Transportation (DOT) standards do my 

nonrefillable containers have to meet 

under this part if my pesticide product 

is not a DOT hazardous material? A 

pesticide product that does not meet the 

definition of a hazardous material in 49 


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Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 47425 

CFR 171.8 must be packaged in a 

nonrefillable container that is designed, 

constructed, and marked to comply with 

the requirements of 49 CFR 173.24, 

173.24a, 173.24b, 173.28, 173.155, 

173.203, 173.213, 173.240(c), 

173.240(d), 173.241(c), 173.241(d), part 

178, and part 180 that are applicable to 

a Packing Group III material. 

(b) What DOT standards do my 

nonrefillable containers have to meet 

under this part if my pesticide product 

is a DOT hazardous material? (1) If your 

pesticide product meets the definition 

of a hazardous material in 49 CFR 171.8, 

the DOT requires your pesticide product 

to be packaged according to 49 CFR 

parts 171–180. 

(2) For the purposes of these 

regulations, a pesticide product that 

meets the definition of a hazardous 

material in 49 CFR 171.8 must be 

packaged in a nonrefillable container 

that is designed, constructed, and 

marked to comply with the 

requirements of 49 CFR parts 171–180. 

(c) What will EPA do if DOT proposes 

to change any of the cross-referenced 

regulations? If the DOT proposes to 

change any of the regulations that are 

incorporated in paragraphs (a) and (b) of 

this section, EPA will provide notice of 

the proposed changes and an 

opportunity to comment in the Federal 

Register. Following notice and 

comment, EPA will take final action 

regarding whether or not to revise its 

rules, and the extent to which any such 

revision will correspond with revised 

DOT regulations. 

(d) What standards for closures do my 

nonrefillable containers have to meet? If 

your nonrefillable container is a rigid 

container with a capacity equal to or 

greater than 3.0 liters (0.79 gallons), if 

the container is not an aerosol container 

or a pressurized container, and if the 

container is used to distribute or sell a 

liquid agricultural pesticide, each 

nonrefillable container must have at 

least one of the following standard 

closures: 

(1) Bung, 2 inch pipe size (2.375 

inches in diameter), external threading, 

11.5 threads per inch, National Pipe 

Straight (NPS) standard. 

(2) Bung, 2 inch pipe size (2.375 

inches in diameter), external threading, 

5 threads per inch, buttress threads. 

(3) Screw cap, 63 millimeters, at least 

one thread revolution at 6 threads per 

inch. 

(4) Screw cap, 38 millimeters, at least 

one thread revolution at 6 threads per 

inch. The cap may fit on a separate rigid 

spout or on a flexible pull-out plastic 

spout. 

(e) What standards for dispensing do 

my nonrefillable containers have to 

meet? If your nonrefillable container has 

a capacity of 5 gallons (18.9 liters) or 

less, if the container is not an aerosol 

container, a pressurized container, or a 

spray bottle, and if the container holds 

a liquid pesticide, your nonrefillable 

container must do both of the following: 

(1) Allow the contents of the 

nonrefillable container to pour in a 

continuous, coherent stream. 

(2) Allow the contents of the 

nonrefillable container to be poured 

with a minimum amount of dripping 

down the outside of the container. 

(f) What standards for residue 

removal do my nonrefillable containers 

have to meet? Each nonrefillable 

container and pesticide formulation 

combination must meet the applicable 

residue removal standard of this section. 

(1) If the nonrefillable container is 

rigid and has a capacity less than or 

equal to 5 gallons (18.9 liters) for liquid 

formulations or 50 pounds (22.7 

kilograms) for solid formulations and if 

the pesticide product’s labeling allows 

or requires the pesticide product to be 

mixed with a liquid diluent prior to 

application (that is, if the pesticide is 

dilutable), each container/formulation 

combination must be capable of 

attaining at least 99.99 percent removal 

of each active ingredient when tested 

using the EPA test procedure ‘‘Rinsing 

Procedures for Dilutable Pesticide 

Products in Rigid Containers.’’

(2) The test must be conducted only 

if the pesticide product is a flowable 

concentrate or if EPA specifically 

requests the records on a case by case 

basis. 

(3) For the rigid container/dilutable 

product standard in paragraph (f)(1) of 

this section, percent removal represents 

the percent of the original concentration 

of the active ingredient in the pesticide 

product when compared to the 

concentration of that active ingredient 

in the fourth rinse. Percent removal is 

calculated by the formula: 

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

RR = rinsate ratio = Active ingredient 

concentration in fourth rinsate/Original 

concentration of active ingredient in the 

product 

(g) Can I obtain a waiver from or a 

modification to any of the nonrefillable 

container standards? Yes, it is possible 

for you to obtain a waiver from or a 

modification to the nonrefillable 

container standards, as follows: 

(1) EPA may waive or modify the 

requirements of paragraph (a) of this 

section regarding the DOT standards for 

pesticide products that are not DOT 

hazardous materials if EPA determines 

that an alternative (partial or modified) 

set of standards or pre-existing 

requirements achieves a level of safety 

that is at least equal to that specified in 

the requirements of paragraph (a) of this 

section. 

(2) EPA may waive or modify the 

requirements of paragraph (b) of this 

section regarding the DOT standards for 

pesticide products that are DOT 

hazardous materials if EPA determines 

that an alternative (partial or modified) 

set of standards or pre-existing 

requirements achieves a level of safety 

that is at least equal to that specified in 

the requirements of paragraph (b) of this 

section. EPA will modify or waive the 

requirements of paragraph (b) of this 

section only after consulting with DOT 

to ensure consistency with DOT 

regulations and exemptions. 

(3) EPA may approve a non-standard 

closure (that is, a closure not listed in 

paragraph (d) of this section) if EPA 

determines that both of the following 

conditions are satisfied: 

(i) The non-standard closure is 

necessary for the proper mixing, 

loading, or application of the pesticide 

product. 

(ii) The non-standard closure offers 

exposure protection to handlers during 

mixing and loading that is the same or 

greater than that provided by the 

standard closures. 

(4) EPA may waive or modify the 

container dispensing capability 

standards in paragraph (e) of this 

section if EPA determines that at least 

one of the following conditions is 

satisfied: 

(i) The product is typically removed 

from the container by a method other 

than pouring. 

(ii) Compliance with the container 

dispensing capability standards would 

increase exposure to the pesticide 

container handler. 

(5) EPA may waive or modify the 

requirements of paragraph (f) of this 

section regarding the residue removal 

standard if EPA determines that both of 

the following conditions are satisfied: 

(i) The residue remaining in the 

container would not cause an 

unreasonable adverse effect on the 

environment; and 

(ii) The product offers significant 

benefits and cannot be economically 

reformulated or repackaged. 

(h) How do I obtain a waiver from or 

a modification to any of the 

nonrefillable container standards? To 

obtain a waiver from or a modification 

to any of the nonrefillable container 

standards, you must submit a written 

request for a waiver or a modification to 

the EPA to the following address: Office 

of Pesticide Programs (7504P); U.S. 

Environmental Protection Agency; Ariel 

Rios Building; 1200 Pennsylvania 


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Avenue, N.W., Washington, DC 20460. 

You cannot distribute or sell the 

pesticide product in a nonrefillable 

container that does not comply with all 

of the nonrefillable container standards 

unless and until EPA approves the 

request for the waiver or modification in 

writing. You must include two copies of 

the following information (which may 

be part of an application for registration 

or amended registration) with your 

written request: 

(1) The name and address of the 

registrant; the date; and the name, title, 

signature, and phone number of the 

company official making the request. 

(2) The name and EPA registration 

number of the pesticide product for 

which the waiver or modification is 

requested. 

(3) A statement specifying the 

requirement or requirements from 

which you are requesting a waiver or a 

modification. 

(4) A description of the nonrefillable 

container or containers for which the 

waiver or modification is requested. 

(5) Documentation or justification to 

demonstrate that the applicable waiver 

or modification criteria in paragraph (g) 

of this section are satisfied. 

§ 165.27 Reporting and recordkeeping. 

(a) What information must I report 

about my nonrefillable containers? You 

are not required to report to EPA with 

information about your nonrefillable 

containers under the regulations in this 

subpart. You should refer to the 

reporting standards in part 159 of this 

chapter to determine if information on 

container failures or other incidents 

involving pesticide containers must be 

reported to EPA under FIFRA section 

6(a)(2) (7 U.S.C. 136d(a)(2)). 

(b) What recordkeeping do I have to 

do for my nonrefillable containers? For 

each pesticide product that is subject to 

§ 165.25 - 165.27 and is distributed or 

sold in nonrefillable containers, you 

must maintain the records listed in this 

section for as long as a nonrefillable 

container is used to distribute or sell the 

pesticide product and for 3 years after 

that. You must furnish these records for 

inspection and copying upon request by 

an employee of EPA or any entity 

designated by EPA, such as a State, 

another political subdivision or a Tribe. 

You must keep the following records: 

(1) The name and EPA registration 

number of the pesticide product. 

(2) A description of the nonrefillable 

container(s) in which the pesticide 

product is distributed or sold. 

(3) At least one of the following 

records to document compliance with 

the requirement for closures in 

§ 165.25(d) for each nonrefillable 

container used to distribute or sell the 

pesticide product that must comply 

with § 165.25(d): 

(i) A letter or document from the 

container supplier that describes the 

closure. 

(ii) A specification about the closure 

in the contract between the registrant or 

applicant and the container supplier. 

(iii) A copy of EPA’s approval of any 

non-standard closure. 

(4) At least one of the following 

records pertaining to the container 

dispensing capability requirements in 

§ 165.25(e) for each nonrefillable 

container used to distribute or sell the 

pesticide product that must comply 

with § 165.25(e): 

(i) Test data or documentation 

demonstrating that the nonrefillable 

container meets the standards in 

§ 165.25(e) when it contains the 

pesticide product. 

(ii) Test data or documentation 

demonstrating that a different 

nonrefillable container meets the 

standards in § 165.25(e) when it 

contains the pesticide product or even 

a different pesticide product and a 

written explanation of why such data or 

documentation demonstrates that the 

container meets the standards in 

§ 165.25(e) for the pesticide product. 

(5) At least one of the following 

records pertaining to the nonrefillable 

container residue removal requirement 

in § 165.25(f) if the pesticide product is 

a flowable concentrate or if EPA 

specifically requests the records on a 

case by case basis: 

(i) Test data showing that the 

nonrefillable container and pesticide 

formulation meet the standard in 

§ 165.25(f) . 

(ii) Test data showing that a different 

nonrefillable container with the same or 

a different pesticide formulation meets 

the standard in § 165.25(f), together with 

a written explanation of why such data 

demonstrate that the nonrefillable 

container and pesticide formulation 

meet the standard in § 165.25(f). 

§§ 165.28–165.39 [Reserved] 

Subpart C—Refillable Container 

Standards: Container Design 

§ 165.40 General provisions. 

(a) What is the purpose of the 

regulations in this subpart? The 

regulations in this subpart establish 

design and construction requirements 

for refillable containers used for the 

distribution or sale of some pesticide 

products. 

(b) Do I have to comply with the 

regulations in this subpart? (1) You 

must comply with all of the regulations 

in this subpart if you are a registrant 

who distributes or sells a pesticide 

product in refillable containers. If your 

pesticide product is subject to the 

regulations in this subpart as set out in 

§ 165.43, your pesticide product must be 

distributed or sold in a refillable 

container that meets the standards of 

these regulations. This includes your 

pesticide products that are repackaged 

according to subpart D of this part. 

(2) You must comply with the 

regulations in § 165.45(f) for stationary 

pesticide containers if you are a refiller 

of a pesticide product and you are not 

the registrant of the pesticide product. If 

the pesticide product is subject to the 

regulations in this subpart as set out in 

§ 165.43, the stationary pesticide 

containers used to distribute or sell the 

product must meet the standards of 

§ 165.45(f). 

(c) When do I have to comply? As of 

August 16, 2011, all pesticide products 

distributed or sold by you in refillable 

containers must be distributed or sold in 

compliance with these regulations. 

§ 165.43 Scope of pesticide products 

included. 

(a) Are manufacturing use products 

subject to the regulations in this 

subpart? No, the regulations in this 

subpart do not apply to manufacturing 

use products, as defined in § 158.153(h) 

of this chapter. 

(b) Are plant-incorporated protectants 

subject to the regulations in this 

subpart? No, the regulations in this 

subpart do not apply to plantincorporated protectants, as defined in 

§ 174.3 of this chapter. 

(c) Which ‘‘antimicrobial’’ pesticide 

products are not subject to the 

regulations in this subpart? The 

regulations in this subpart do not apply 

to a pesticide product if it satisfies all 

of the following conditions: 

(1) The pesticide product meets one of 

the following two criteria: 

(i) The pesticide product is an 

antimicrobial pesticide as defined in 

FIFRA section 2(mm); or 

(ii) The pesticide product: (A) Is 

intended to: disinfect, sanitize, reduce 

or mitigate growth or development of 

microbiological organisms; or protect 

inanimate objects, industrial processes 

or systems, surfaces, water, or other 

chemical substances from 

contamination, fouling, or deterioration 

caused by bacteria, viruses, fungi, 

protozoa, algae, or slime; and 

(B) In the intended use is subject to 

a tolerance under section 408 of the 

Federal Food, Drug, and Cosmetic Act 

or a food additive regulation under 

section 409 of such Act. 


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(2) The labeling of the pesticide 

product includes directions for use on a 

site in at least one of the following 

antimicrobial product use categories: 

food handling/storage establishments 

premises and equipment; commercial, 

institutional, and industrial premises 

and equipment; residential and public 

access premises; medical premises and 

equipment; human drinking water 

systems; materials preservatives; 

industrial processes and water systems; 

antifouling coatings; wood 

preservatives; or swimming pools. 

(3) The pesticide product is not a 

hazardous waste as set out in part 261 

of this chapter when the pesticide 

product is intended to be disposed. 

(4) EPA has not specifically 

determined that the pesticide product 

must be subject to the regulations in this 

subpart to prevent an unreasonable 

adverse effect on the environment 

according to the provisions of paragraph 

(e) of this section. 

(d) Which requirements must an 

‘‘antimicrobial’’ swimming pool product 

comply with if it is not exempt from 

these regulations? An antimicrobial 

swimming pool product that is not 

exempt by paragraph (a), (b), or (c) of 

this section must comply with all of the 

regulations in this subpart except 

§ 165.45(d) regarding marking and 

§ 165.45(e) regarding openings. For the 

purposes of this subpart, an 

antimicrobial swimming pool product is 

a pesticide product that satisfies both of 

the following conditions: 

(1) The pesticide product is intended 

to: disinfect, sanitize, reduce or mitigate 

growth or development of 

microbiological organisms; or protect 

inanimate objects, industrial processes 

or systems, surfaces, water, or other 

chemical substances from 

contamination, fouling, or deterioration 

caused by bacteria, viruses, fungi, 

protozoa, algae, or slime. 

(2) The labeling of the pesticide 

product includes directions for use on 

only a site or sites in the antimicrobial 

product use category of swimming 

pools. 

(e) How will EPA determine if an 

‘‘antimicrobial’’ pesticide product 

otherwise exempted must be subject to 

the regulations in this subpart to 

prevent an unreasonable adverse effect 

on the environment? (1) EPA may 

determine that an antimicrobial 

pesticide product otherwise exempted 

by paragraph (c) of this section must be 

subject to the refillable container 

regulations in this subpart to prevent an 

unreasonable adverse effect on the 

environment if all of the following 

conditions exist: 

(i) EPA obtains information, data or 

other evidence of a problem with the 

containers of a certain pesticide product 

or related group of products. 

(ii) The information, data or other 

evidence is reliable and factual. 

(iii) The problem causes or could 

reasonably be expected to cause an 

unreasonable adverse effect on the 

environment. 

(iv) Complying with the container 

regulations could reasonably be 

expected to eliminate the problem. 

(2) If EPA determines that an 

antimicrobial pesticide product 

otherwise exempted by paragraph (c) of 

this section must be subject to the 

refillable container regulations in this 

subpart to prevent an unreasonable 

adverse effect on the environment, EPA 

may require, by rule, that the product be 

distributed or sold in refillable 

containers that comply with all or some 

of the requirements in this subpart. 

Alternatively, EPA may notify the 

applicant or registrant of its intent to 

make such a determination. After 

allowing the applicant or registrant a 

reasonable amount of time to reply, EPA 

may require, by notification and as a 

condition of registration, that the 

product be distributed or sold in 

refillable containers that comply with 

all or some of the requirements in this 

subpart. For the purpose of the previous 

sentence, 60 days would be a reasonable 

amount of time to reply, although EPA 

may, in its discretion, provide more 

time. EPA may deny registration or 

initiate cancellation proceedings if the 

registrant fails to comply with the 

refillable container regulations within 

the time frames established by EPA in 

the rule or in its notification. 

(f) What other pesticide products are 

subject to the regulations in this 

subpart? The regulations in this subpart 

apply to all pesticide products other 

than manufacturing use products, plantincorporated protectants, and 

antimicrobial products that are exempt 

by paragraph (c) of this section. 

Antimicrobial products covered under 

by paragraph (d) of this section are 

subject to the regulations indicated in 

that section. 

(g) What does ‘‘pesticide product’’ or 

‘‘pesticide’’ mean in the rest of this 

subpart? In §§ 165.43(h) through 165.47, 

the term ‘‘pesticide product’’ or 

‘‘pesticide’’ refers only to a pesticide 

product or a pesticide that is subject to 

the regulations in this subpart as 

described in paragraphs (a) through(f) of 

this section. 

(h) Are there any other exceptions? (1) 

The regulations in this subpart do not 

apply to transport vehicles that contain 

pesticide in pesticide-holding tanks that 

are an integral part of the transport 

vehicle and that are the primary 

containment for the pesticide. 

(2) The regulations in this subpart do 

not apply to containers that hold 

pesticides that are gaseous at 

atmospheric temperature and pressure. 

§ 165.45 Refillable container standards. 

(a) What Department of 

Transportation (DOT) standards do my 

refillable containers have to meet under 

this part if my pesticide product is not 

a DOT hazardous material? (1) A 

pesticide product that does not meet the 

definition of a hazardous material in 49 

CFR 171.8 must be packaged in a 

refillable container that is designed, 

constructed, and marked to comply with 

the requirements of 49 CFR 173.24, 

173.24a, 173.24b, 173.28, 173.155, 

173.203, 173.213, 173.240(c), 

173.240(d), 173.241(c), 173.241(d), part 

178, and part 180 that are applicable to 

a Packing Group III material. 

(2) A refiller is not required to comply 

with 49 CFR 173.28(b)(2) for pesticide 

products that are not DOT hazardous 

materials if the refillable container to be 

reused complies with the refillable 

container regulations in this subpart and 

the refilling is done in compliance with 

the repackaging regulations in subpart D 

of this part. 

(b) What DOT standards do my 

refillable containers have to meet under 

this part if my pesticide product is a 

DOT hazardous material? (1) If your 

pesticide product meets the definition 

of a hazardous material in 49 CFR 171.8, 

the DOT requires your pesticide product 

to be packaged according to 49 CFR 

parts 171–180. 

(2) For the purposes of these 

regulations, a pesticide product that 

meets the definition of a hazardous 

material in 49 CFR 171.8 must be 

packaged in a refillable container that is 

designed, constructed, and marked to 

comply with the requirements of 49 CFR 

parts 171–180. 

(c) What will EPA do if DOT proposes 

to change any of the cross-referenced 

regulations? If the DOT proposes to 

change any of the regulations that are 

incorporated in paragraphs (a) and (b) of 

this section, EPA will provide notice of 

the proposed changes and an 

opportunity to comment in the Federal 

Register. Following notice and 

comment, EPA will take final action 

regarding whether or not to revise its 

rules, and the extent to which any such 

revision will correspond with revised 

DOT regulations. 

(d) What standards for marking do my 

refillable containers have to meet? Each 

refillable container must be marked in a 

durable and clearly visible manner with 


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a serial number or other identifying 

code that will distinguish the individual 

container from all other containers. 

Durable marking includes, but is not 

limited to, etching, embossing, ink 

jetting, stamping, heat stamping, 

mechanically attaching a plate, molding, 

and marking with durable ink. The 

serial number or other identifying code 

must be located on the outside part of 

the container except on a closure. 

Placement on the label or labeling is not 

sufficient unless the label is an integral, 

permanent part of or permanently 

stamped on the container. 

(e) What standards for openings do 

my refillable containers have to meet? If 

your refillable container is a portable 

pesticide container that is designed to 

hold liquid pesticide formulations and 

is not a cylinder that complies with the 

DOT Hazardous Materials Regulations, 

each opening of the container other than 

a vent must have a one-way valve, a 

tamper-evident device or both. A oneway valve may be located in a device or 

system separate from the container if the 

device or system is the only reasonably 

foreseeable way to withdraw pesticide 

from the container. A vent must be 

designed to minimize the amount of 

material that could be introduced into 

the container through it. 

(f) What standards do my stationary 

pesticide containers have to meet? If a 

stationary pesticide container designed 

to hold undivided quantities of 

pesticides equal to greater than 500 

gallons (1,890 liters) of liquid pesticide 

or equal to or greater than 4,000 pounds 

(1,818 kilograms) of dry pesticide is 

located at the refilling establishment of 

a refiller operating under written 

contract to you, the stationary pesticide 

container must meet the following 

standards: 

(1) Except during a civil emergency or 

any unanticipated grave natural disaster 

or other natural phenomenon of an 

exceptional, inevitable and irresistible 

character, the effects of which could not 

have been prevented or avoided by the 

exercise of due care or foresight, each 

stationary pesticide container (for liquid 

and dry pesticides) and its 

appurtenances must meet both of the 

following standards: 

(i) Each stationary pesticide container 

and its appurtenances must be resistant 

to extreme changes in temperature and 

constructed of materials that are 

adequately thick to not fail and that are 

resistant to corrosion, puncture, or 

cracking. 

(ii) Each stationary pesticide 

container must be capable of 

withstanding all operating stresses, 

taking into account static heat, pressure 

buildup from pumps and compressors, 

and any other foreseeable mechanical 

stresses to which the container may be 

subjected in the course of operations. 

(2) Each stationary liquid pesticide 

container must meet all of the following 

standards: 

(i) Each stationary liquid pesticide 

container must be equipped with a vent 

or other device designed to relieve 

excess pressure, prevent losses by 

evaporation, and exclude precipitation. 

(ii) External sight gauges, which are 

pesticide-containing hoses or tubes that 

run vertically along the exterior of the 

container from the top to the bottom, are 

prohibited on stationary liquid pesticide 

containers. 

(iii) Each stationary liquid pesticide 

container connection below the normal 

liquid level must be equipped with a 

shutoff valve which is capable of being 

locked closed. A shutoff valve must be 

located within a secondary containment 

unit if one is required by subpart E of 

this part. 

(g) Can I obtain a waiver from or a 

modification to any of the refillable 

container standards? Yes, it is possible 

for you to obtain a waiver from or a 

modification to some of the refillable 

container standards, as follows: 

(1) EPA may waive or modify the 

requirements of paragraph (a) of this 

section regarding the DOT standards for 

pesticide products that are not DOT 

hazardous materials if EPA determines 

that an alternative (partial or modified) 

set of standards or pre-existing 

requirements achieves a level of safety 

that is at least equal to that specified in 

the requirements of paragraph (a) of this 

section. 

(2) EPA may waive or modify the 

requirements of paragraph (b) of this 

section regarding the DOT standards for 

pesticide products that are DOT 

hazardous materials if EPA determines 

that an alternative (partial or modified) 

set of standards or pre-existing 

requirements achieves a level of safety 

that is at least equal to that specified in 

the requirements of paragraph (b) of this 

section. EPA will modify or waive the 

requirements of paragraph (b) of this 

section only after consulting with DOT 

to ensure consistency with DOT 

regulations and exemptions. 

(h) How do I obtain a waiver from or 

a modification to any of the refillable 

container standards? To obtain a waiver 

from or a modification to any of the 

refillable container standards, you must 

submit a written request for a waiver or 

a modification to the EPA to the 

following address: Office of Pesticide 

Programs (7504P); U.S. Environmental 

Protection Agency; Ariel Rios Building; 

1200 Pennsylvania Avenue, N.W., 

Washington, DC 20460. You cannot 

distribute or sell the pesticide product 

in a refillable container that does not 

comply with all of the refillable 

container standards unless and until 

EPA approves the request for the waiver 

or modification in writing. You must 

include two copies of the following 

information (which may be part of an 

application for registration or amended 

registration) with your written request: 

(1) The name and address of the 

registrant; the date; and the name, title, 

signature, and phone number of the 

company official making the request. 

(2) The name and EPA registration 

number of the pesticide product for 

which the waiver or modification is 

requested. 

(3) A statement specifying the 

requirement or requirements from 

which you are requesting a waiver or a 

modification. 

(4) A description of the refillable 

container or containers for which the 

waiver or modification is requested. 

(5) Documentation or justification to 

demonstrate that the applicable waiver 

or modification criteria in paragraph (g) 

of this section are satisfied. 

§ 165.47 What information must I report 

about my refillable containers? 

You are not required to report to EPA 

with information about your refillable 

containers under the regulations in this 

subpart. You should refer to the 

reporting standards in part 159 of this 

chapter to determine if information on 

container failures or other incidents 

involving pesticide containers must be 

reported to EPA under FIFRA section 

6(a)(2) (7 U.S.C. 136d(a)(2)). 

§§ 165.48–165.59 [Reserved] 

Subpart D—Standards for 

Repackaging Pesticide Products into 

Refillable Containers 

§ 165.60 General provisions. 

(a) What is the purpose of the 

regulations in this subpart? The 

regulations in this subpart establish 

requirements for repackaging some 

pesticide products into refillable 

containers for distribution or sale. 

(b) Do I have to comply with the 

regulations in this subpart? You must 

comply with the regulations in this 

subpart if you are a registrant who 

distributes or sells a pesticide product 

in refillable containers, if you are a 

registrant who distributes or sells 

pesticide products to a refiller (that is 

not part of your company) for 

repackaging into refillable containers, or 

if you are a refiller of a pesticide 

product and you are not the registrant 

of the pesticide product. Each pesticide 

product that is subject to the regulations 


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in this subpart as set out in § 165.63 and 

that is distributed or sold in a refillable 

container must be distributed or sold in 

compliance with the standards of these 

regulations. 

(c) When do I have to comply? As of 

August 16, 2011, all pesticide products 

distributed or sold by you in refillable 

containers must be distributed or sold in 

compliance with these regulations. 

§ 165.63 Scope of pesticide products 

included. 

(a) Are manufacturing use products 

subject to the regulations in this 

subpart? No, the regulations in this 

subpart do not apply to manufacturing 

use products, as defined in § 158.153(h) 

of this chapter. 

(b) Are plant-incorporated protectants 

subject to the regulations in this 

subpart? No, the regulations in this 

subpart do not apply to plantincorporated protectants, as defined in 

§ 174.3 of this chapter. 

(c) Which antimicrobial pesticide 

products are not subject to the 

regulations in this subpart? The 

regulations in this subpart do not apply 

to a pesticide product if it satisfies all 

of the following conditions: 

(1) The pesticide product meets one of 

the following two criteria: 

(i) The pesticide product is an 

antimicrobial pesticide as defined in 

FIFRA section 2(mm); or 

(ii) The pesticide product: (A) Is 

intended to: disinfect, sanitize, reduce 

or mitigate growth or development of 

microbiological organisms; or protect 

inanimate objects, industrial processes 

or systems, surfaces, water, or other 

chemical substances from 

contamination, fouling, or deterioration 

caused by bacteria, viruses, fungi, 

protozoa, algae, or slime; and 

(B) In the intended use is subject to 

a tolerance under section 408 of the 

Federal Food, Drug, and Cosmetic Act 

or a food additive regulation under 

section 409 of such Act. 

(2) The labeling of the pesticide 

product includes directions for use on a 

site in at least one of the following 

antimicrobial product use categories: 

food handling/storage establishments 

premises and equipment; commercial, 

institutional, and industrial premises 

and equipment; residential and public 

access premises; medical premises and 

equipment; human drinking water 

systems; materials preservatives; 

industrial processes and water systems; 

antifouling coatings; wood 

preservatives; or swimming pools. 

(3) The pesticide product is not a 

hazardous waste as set out in part 261 

of this chapter when the pesticide 

product is intended to be disposed. 

(4) EPA has not specifically 

determined that the pesticide product 

must be subject to the regulations in this 

subpart to prevent an unreasonable 

adverse effect on the environment 

according to the provisions of paragraph 

(e) of this section. 

(d) Which requirements must an 

antimicrobial swimming pool product 

comply with if it is not exempt from 

these regulations? (1) An antimicrobial 

swimming pool product that is not 

exempt by paragraph (a), (b), or (c) of 

this section must comply with all of the 

regulations in this subpart except for the 

following requirements: 

Requirement 

Requirement for 

registrants who 

distribute or sell 

directly in refillable 

containers 

Requirement for 

refillers who are 

not registrants 

Recordkeeping specific to each instance of repackaging § 165.65(i)(2) § 165.70(j)(2) 

Container inspection: criteria regarding a serial number or other identifying code § 165.65(e)(3) § 165.70(f)(3) 

Container inspection: criteria regarding one-way valve or tamper-evident device § 165.65(e)(4) § 165.70(f)(4) 

Cleaning requirement: criteria regarding one-way valve or tamper-evident device § 165.65(f)(1) § 165.70(g)(1) 

Cleaning if the one-way valve or tamper-evident device is not intact § 165.65(g) § 165.70(h) 

(2) For the purposes of this subpart, 

an antimicrobial swimming pool 

product is a pesticide product that 

satisfies both of the following 

conditions: 

(i) The pesticide product is intended 

to: disinfect, sanitize, reduce or mitigate 

growth or development of 

microbiological organisms; or protect 

inanimate objects, industrial processes 

or systems, surfaces, water, or other 

chemical substances from 

contamination, fouling, or deterioration 

caused by bacteria, viruses, fungi, 

protozoa, algae, or slime. 

(ii) The labeling of the pesticide 

product includes directions for use on 

only a site or sites in the antimicrobial 

product use category of swimming 

pools. 

(e) How will EPA determine if an 

antimicrobial pesticide product 

otherwise exempted must be subject to 

the regulations in this subpart to 

prevent an unreasonable adverse effect 

on the environment? (1) EPA may 

determine that an antimicrobial 

pesticide product otherwise exempted 

by paragraph (c) of this section must be 

subject to the repackaging regulations in 

this subpart to prevent an unreasonable 

adverse effect on the environment if all 

of the following conditions exist: 

(i) EPA obtains information, data or 

other evidence of a problem with the 

containers of a certain pesticide product 

or related group of products. 

(ii) The information, data or other 

evidence is reliable and factual. 

(iii) The problem causes or could 

reasonably be expected to cause an 

unreasonable adverse effect on the 

environment. 

(iv) Complying with the container 

regulations could reasonably be 

expected to eliminate the problem. 

(2) If EPA determines that an 

antimicrobial pesticide product 

otherwise exempted by paragraph (c) of 

this section must be subject to the 

repackaging regulations in this subpart 

to prevent an unreasonable adverse 

effect on the environment, EPA may 

require, by rule, that the product be 

repackaged in compliance with all or 

some of the requirements in this 

subpart. Alternatively, EPA may notify 

the applicant or registrant of its intent 

to make such a determination. After 

allowing the applicant or registrant a 

reasonable amount of time to reply, EPA 

may require, by notification and as a 

condition of registration, that the 

product be repackaged in compliance 

with all or some of the requirements in 

this subpart. For the purpose of the 

previous sentence, 60 days would be a 

reasonable amount of time to reply, 

although EPA may, in its discretion, 

provide more time. EPA may deny 

registration or initiate cancellation 

proceedings if the registrant fails to 


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comply with the repackaging 

regulations within the time frames 

established by EPA in the rule or in its 

notification. 

(f) What other pesticide products are 

subject to the regulations in this 

subpart? The regulations in this subpart 

apply to all pesticide products other 

than manufacturing use products, plantincorporated protectants, and 

antimicrobial products that are exempt 

paragraph (c) of this section. 

Antimicrobial products covered under 

paragraph (d) of this section are subject 

to the regulations indicated in that 

section. 

(g) What does ‘‘pesticide product’’ or 

‘‘pesticide’’ mean in the rest of this 

subpart? In §§ 165.63(h) through 165.70, 

the term ‘‘pesticide product’’ or 

‘‘pesticide’’ refers only to a pesticide 

product or a pesticide that is subject to 

the regulations in this subpart as 

described in paragraphs (a) through (f) 

of this section. 

(h) Are there any other exceptions? (1) 

The regulations in this subpart do not 

apply to transport vehicles that contain 

pesticide in pesticide-holding tanks that 

are an integral part of the transport 

vehicle and that are the primary 

containment for the pesticide. 

(2) Custom blending is not subject to 

the regulations in this subpart. 

(3) The regulations in this subpart do 

not apply to containers that hold 

pesticides that are gaseous at 

atmospheric temperature and pressure. 

§ 165.65 Registrants who distribute or sell 

pesticide products in refillable containers. 

(a) Must I comply with the standards 

in this section? You must comply with 

the standards in this section if you are 

a registrant who distributes or sells 

pesticide products in refillable 

containers. This means that you conduct 

all of the repackaging for a pesticide 

product and that you do not distribute 

or sell the pesticide product to a refiller 

that is not part of your company for 

repackaging into refillable containers. If 

you are a registrant that repackages a 

product directly into refillable 

containers for sale or distribution and 

you also sell or distribute other 

quantities of that product to an 

independent refiller for repackaging, 

then you must meet the requirements in 

this section for those quantities you 

distribute or sell directly and the 

requirements in § 165.67 for those 

quantities that you distribute or sell to 

an independent refiller. 

(b) Am I responsible for product 

integrity? Yes, you are responsible for 

the pesticide product that you distribute 

or sell in refillable containers not being 

adulterated or different from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

(c) What information must I develop? 

For each pesticide product distributed 

or sold in refillable containers, you must 

develop both of the following 

documents in writing. 

(1) You must develop a refilling 

residue removal procedure that 

describes how to remove pesticide 

residue from a refillable container 

(portable or stationary pesticide 

container) before it is refilled. 

(i) The refilling residue removal 

procedure must be adequate to ensure 

that the composition of the pesticide 

product does not differ at the time of its 

distribution or sale from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

(ii) If the refilling residue removal 

procedure requires the use of a solvent 

other than the diluent used for applying 

the pesticide as specified on the labeling 

under ‘‘Directions for Use,’’ or if there 

is no diluent used for application, the 

refilling residue removal procedure 

must describe how to manage any 

rinsate resulting from the procedure in 

accordance with applicable Federal and 

State regulations. 

(2) You must develop a description of 

acceptable refillable containers (portable 

or stationary pesticide containers) that 

can be used for distributing or selling 

that pesticide product. 

(i) An acceptable container is one that 

you have determined meets the 

standards in subpart C of this part and 

is compatible with the pesticide 

formulation intended to be distributed 

and sold using the refillable container. 

(ii) You must identify the containers 

by specifying the container materials of 

construction that are compatible with 

the pesticide formulation and specifying 

information necessary to confirm 

compliance with the refillable container 

requirements in subpart C of this part. 

(d) What requirements must my 

individual establishments follow 

regarding repackaging a pesticide 

product into refillable containers? A 

refiller at your individual establishment 

that repackages a pesticide product into 

refillable containers for distribution or 

sale must comply with all of the 

following provisions. 

(1) The establishment must be 

registered with EPA as a producing 

establishment as required by § 167.20 of 

this chapter. 

(2) The refiller must not change the 

pesticide formulation unless the refiller 

has a registration for the new 

formulation. 

(3) The refiller must repackage a 

pesticide product only into a refillable 

container that is identified on your 

description of acceptable containers for 

that pesticide product. 

(4) The refiller may repackage any 

quantity of a pesticide product into a 

refillable container up to the rated 

capacity of the container. In addition, 

there are no general limits on the size 

of the refillable containers that the 

refiller can use. 

(5) The refiller must have all of the 

following items at the establishment 

before repackaging a pesticide product 

into any refillable container for 

distribution or sale: 

(i) The pesticide product’s label and 

labeling. 

(ii) The written refilling residue 

removal procedure for the pesticide 

product. 

(iii) The written description of 

acceptable containers for the pesticide 

product. 

(6) Before repackaging a pesticide 

product into any refillable container for 

distribution or sale, the refiller must 

identify the pesticide product 

previously contained in the refillable 

container to determine whether a 

residue removal procedure must be 

conducted in accordance with 

paragraph (f) of this section. The refiller 

may identify the previous pesticide 

product by referring to the label or 

labeling. 

(7) The refiller must inspect each 

refillable container according to 

paragraph (e) of this section. 

(8) The refiller must clean each 

refillable container according to 

paragraph (f) or (g) of this section, if 

required by either paragraph. 

(9) The refiller must ensure that each 

refillable container is properly labeled 

according to paragraph (h) of this 

section. 

(10) The establishment must maintain 

records in accordance with paragraph (i) 

of this section. 

(11) The establishment must maintain 

records as required by part 169 of this 

chapter. 

(12) The establishment must report as 

required by part 167 of this chapter. 

(e) How must my individual 

establishments inspect refillable 

containers? Before repackaging a 

pesticide product into any refillable 

container, a refiller at your 

establishment must visually inspect the 

exterior and (if possible) the interior of 

the container and the exterior of 

appurtenances. The purpose of the 

inspection is to determine whether the 

container meets the necessary criteria 

with respect to continued container 

integrity, required markings, and 


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openings. If the condition in paragraph 

(e)(1) of this section exists, the container 

fails the inspection and must not be 

refilled unless the container is repaired, 

reconditioned, or remanufactured in 

compliance with the relevant DOT 

requirement. If the condition in 

paragraph (e)(2) or (e)(3) of this section 

exists (or both), the container fails the 

inspection and must not be refilled until 

the container meets the standards 

specified in subpart C of this part. The 

conditions are: 

(1) The integrity of the container is 

compromised in at least one of the 

following ways: 

(i) The container shows signs of 

rupture or other damage which reduces 

its structural integrity. 

(ii) The container has visible pitting, 

significant reduction in material 

thickness, metal fatigue, damaged 

threads or closures, or other significant 

defects. 

(iii) The container has cracks, 

warpage, corrosion or any other damage 

which might render it unsafe for 

transportation. 

(iv) There is damage to the fittings, 

valves, tamper-evident devices or other 

appurtenances that may cause failure of 

the container. 

(2) The container does not bear the 

markings required by § 165.45(a), (b) 

and (d), or such markings are not 

legible. 

(3) The container does not have an 

intact and functioning one-way valve or 

tamper-evident device on each opening 

other than a vent, if required. 

(f) How must my individual 

establishments clean refillable 

containers? A refiller at your 

establishment must clean each refillable 

container by conducting the pesticide 

product’s refilling residue removal 

procedure before repackaging the 

pesticide product into the refillable 

container, unless the conditions in 

paragraph (f)(1) of this section and 

either paragraph (f)(2) or (f)(3) of this 

section are satisfied: 

(1) If required, each tamper-evident 

device and one-way valve is intact. 

(2) The refillable container is being 

refilled with the same pesticide product. 

(3) Both of the following conditions 

are satisfied: 

(i) The container previously held a 

pesticide product with a single active 

ingredient and is being used to 

repackage a pesticide product with the 

same single active ingredient. 

(ii) There is no change that would 

cause the composition of the product 

being repackaged to differ from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

Examples of unallowable changes 

include the active ingredient 

concentration increasing or decreasing 

beyond the limits established by the 

confidential statement of formula or a 

reaction or interaction between the 

pesticide product being repackaged and 

the residue remaining in the container. 

(g) How must my individual 

establishments clean a refillable 

container that has a broken (non-intact) 

tamper-evident device or one-way valve? 

As required in paragraph (f) of this 

section, a refiller at your establishment 

must clean each refillable container that 

has a tamper-evident device or one-way 

valve that is not intact by conducting 

the pesticide product’s refilling residue 

removal procedure before repackaging 

the pesticide product into the refillable 

container. In addition, other procedures 

may be necessary to assure that product 

integrity is maintained in such cases. 

(h) How must my individual 

establishments label refillable 

containers? Before distributing or 

selling a pesticide product in a refillable 

container, a refiller at your 

establishment must ensure that the label 

of the pesticide product is securely 

attached to the refillable container such 

that the label can reasonably be 

expected to remain affixed during the 

foreseeable conditions and period of 

use. The label and labeling must comply 

in all respects with the requirements of 

part 156 of this chapter. In particular, 

the refiller at your establishment must 

ensure that the net contents statement 

and EPA establishment number appear 

on the label. 

(i) What recordkeeping must my 

individual establishments do? Each of 

your individual establishments that 

repackages a pesticide product into 

refillable containers for distribution or 

sale must maintain all of the records 

listed in this section in addition to the 

applicable records identified in parts 

167 and 169 of this chapter. The 

establishment must furnish these 

records for inspection and copying upon 

request by an employee of EPA or any 

entity designated by EPA, such as a 

State, another political subdivision or a 

Tribe. 

(1) For each pesticide product 

distributed or sold in refillable 

containers, both of the following records 

must be maintained for the current 

operating year and for 3 years after that: 

(i) The written refilling residue 

removal procedure for the pesticide 

product. 

(ii) The written description of 

acceptable containers for the pesticide 

product. 

(2) Each time a refiller at your 

establishment repackages a pesticide 

product into a refillable container and 

distributes or sells the product, the 

following records must be generated and 

maintained for at least 3 years after the 

date of repackaging: 

(i) The EPA registration number of the 

pesticide product distributed or sold in 

the refillable container. 

(ii) The date of the repackaging. 

(iii) The serial number of the refillable 

container. 

§ 165.67 Registrants who distribute or sell 

pesticide products to refillers for 

repackaging. 

(a) Must I comply with the standards 

in this section? You must comply with 

the standards in this section if you are 

a registrant who distributes or sells 

pesticide products to a refiller that is 

not part of your company for 

repackaging into refillable containers. 

(b) Under what conditions can I allow 

a refiller to repackage my pesticide 

product into refillable containers? You 

may allow a refiller to repackage your 

pesticide product into refillable 

containers and to distribute or sell such 

repackaged product under your existing 

registration if all of the following 

conditions are satisfied: 

(1) The repackaging results in no 

change to the pesticide formulation. 

(2) One of the following conditions 

regarding a registered refilling 

establishment is satisfied: 

(i) The pesticide product is 

repackaged at a refilling establishment 

registered with EPA as required by 

§ 167.20 of this chapter. 

(ii) The pesticide product is 

repackaged at the site of a user who 

intends to use or apply the product by 

a refilling establishment registered with 

EPA as required by § 167.20 of this 

chapter. 

(3) You have entered into a written 

contract with the refiller to repackage 

the pesticide product and to use the 

label of your pesticide product. 

(4) The pesticide product is 

repackaged only into refillable 

containers that meet the standards of 

subpart C of this part. 

(5) The pesticide product is labeled 

with the product’s label with no 

changes except the addition of an 

appropriate net contents statement and 

the refiller’s EPA establishment number. 

(c) What violations are applicable to 

illegal repackaging? Repackaging a 

pesticide product for distribution or sale 

without either obtaining a registration or 

meeting all of the conditions in 

paragraph (b) of this section is a 

violation of section 12 of the Act. Both 

you and the refiller that is repackaging 

your pesticide product under written 

contract with you may be liable for 


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47432 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

violations pertaining to the repackaged 

product. 

(d) When must I provide the written 

contract to the refiller? If you allow a 

refiller to repackage your product as 

specified in paragraph (b) of this section 

you must provide the written contract to 

the refiller before you distribute or sell 

the pesticide product to the refiller. 

(e) Am I responsible for product 

integrity? Yes, for a product that you 

distribute or sell to a refiller that is not 

part of your company for repackaging 

into refillable containers, you are 

responsible for the pesticide product not 

being adulterated or different from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

(f) What information must I develop? 

For each pesticide product distributed 

or sold in refillable containers, you must 

develop both of the following 

documents in writing. 

(1) You must develop a refilling 

residue removal procedure that 

describes how to remove pesticide 

residue from a refillable container 

(portable or stationary pesticide 

container) before it is refilled. 

(i) The refilling residue removal 

procedure must be adequate to ensure 

that the composition of the pesticide 

product does not differ at the time of its 

distribution or sale from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

(ii) If the refilling residue removal 

procedure requires the use of a solvent 

other than the diluent used for applying 

the pesticide as specified on the labeling 

under ‘‘Directions for Use,’’ or if there 

is no diluent used for application, the 

refilling residue removal procedure 

must describe how to manage any 

rinsate resulting from the procedure in 

accordance with applicable Federal and 

State regulations. 

(2) You must develop a description of 

acceptable refillable containers (portable 

or stationary pesticide containers) that 

can be used for distributing or selling 

that pesticide product. 

(i) An acceptable container is one that 

you have determined meets the 

standards in subpart C of this part and 

is compatible with the pesticide 

formulation intended to be distributed 

and sold using the refillable container. 

(ii) You must identify the containers 

by specifying the container materials of 

construction that are compatible with 

the pesticide formulation and specifying 

information necessary to confirm 

compliance with the refillable container 

requirements in subpart C of this part. 

(g) When must I provide the 

information to the refiller? You must 

provide the refiller with all of the 

following information and 

documentation before or at the time of 

distribution or sale of your pesticide 

product to the refiller: 

(1) Your written refilling residue 

removal procedure for the pesticide 

product. 

(2) Your written description of 

acceptable containers for the pesticide 

product. 

(3) The pesticide product’s label and 

labeling. 

(h) What recordkeeping must I do? 

You must maintain all of the records 

listed in this section for the current 

operating year and for 3 years after that. 

You must furnish these records for 

inspection and copying upon request by 

an employee of EPA or any entity 

designated by EPA, such as a State, 

another political subdivision or a Tribe: 

(1) Each written contract entered into 

with a refiller for repackaging your 

pesticide product into refillable 

containers. 

(2) Your written refilling residue 

removal procedure for the pesticide 

product. 

(3) Your written description of 

acceptable containers for the pesticide 

product. 

§ 165.70 Refillers who are not registrants. 

(a) Must I comply with the standards 

in this section? You must comply with 

the standards in this section if you are 

a refiller of a pesticide product and you 

are not the registrant of the pesticide 

product. 

(b) Under what conditions can I 

repackage a registrant’s pesticide 

product into refillable containers? A 

registrant may allow you to repackage 

the registrant’s pesticide product into 

refillable containers and to distribute or 

sell such repackaged product under the 

registrant’s existing registration if all of 

the following conditions are satisfied: 

(1) The repackaging results in no 

change to the pesticide formulation. 

(2) One of the following conditions 

regarding a registered refilling 

establishment is satisfied: 

(i) The pesticide product is 

repackaged at a refilling establishment 

registered with EPA as required by 

§ 167.20 of this chapter. 

(ii) The pesticide product is 

repackaged at the site of a user who 

intends to use or apply the product by 

a refilling establishment registered with 

EPA as required by § 167.20 of this 

chapter. 

(3) The registrant has entered into a 

written contract with you to repackage 

the pesticide product and to use the 

label of the registrant’s pesticide 

product. 

(4) The pesticide product is 

repackaged only into refillable 

containers that meet the standards of 

subpart C of this part. 

(5) The pesticide product is labeled 

with the product’s label with no 

changes except the addition of an 

appropriate net contents statement and 

the refillers EPA establishment number. 

(c) What violations are applicable to 

illegal repackaging? Repackaging a 

pesticide product for distribution or sale 

without either obtaining a registration or 

meeting all of the conditions in 

paragraph (b) of this section is a 

violation of section 12 of the Act. Both 

you and the pesticide product’s 

registrant may be liable for violations 

pertaining to the repackaged product. 

(d) Am I responsible for product 

integrity? Yes, you are responsible for 

the pesticide product that you distribute 

or sell in refillable containers not being 

adulterated or different from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

(e) What requirements must I follow 

regarding repackaging a pesticide 

product into refillable containers? You 

must comply with all of the following 

provisions. 

(1) Your establishment must be 

registered with EPA as a producing 

establishment as required by § 167.20 of 

this chapter. 

(2) You must not change the pesticide 

formulation unless you have a 

registration for the new formulation. 

(3) You must repackage a pesticide 

product only into a refillable container 

that is identified on the description of 

acceptable containers for that pesticide 

product provided by the registrant. 

(4) You may repackage any quantity of 

a pesticide product into a refillable 

container up to the rated capacity of the 

container. In addition, there are no 

general limits on the size of the 

refillable containers that you can use. 

(5) You must have all of the following 

items at your establishment before 

repackaging a pesticide product into any 

refillable container for distribution or 

sale: 

(i) The written contract from the 

pesticide product’s registrant. 

(ii) The pesticide product’s label and 

labeling. 

(iii) The registrant’s written refilling 

residue removal procedure for the 

pesticide product. 

(iv) The registrant’s written 

description of acceptable containers for 

the pesticide product. 

(6) Before repackaging a pesticide 

product into any refillable container for 

distribution or sale, you must identify 

the pesticide product previously 


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Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 47433 

contained in the refillable container to 

determine whether a residue removal 

procedure must be conducted in 

accordance with paragraph (g) of this 

section. You may identify the previous 

pesticide product by referring to the 

label or labeling. 

(7) You must inspect each refillable 

container according to paragraph (f) of 

this section. 

(8) You must clean each refillable 

container according to paragraph (g) or 

(h) of this section, if required by either 

paragraph. 

(9) You must ensure that each 

refillable container is properly labeled 

according to paragraph (i) of this 

section. 

(10) You must maintain records in 

accordance with paragraph (j) of this 

section. 

(11) You must maintain records as 

required by part 169 of this chapter. 

(12) You must report as required by 

part 167 of this chapter. 

(13) The stationary pesticide 

containers at your establishment must 

meet the standards in § 165.45(f). 

(14) You may be required to comply 

with the containment standards in 

subpart E of this part. 

(f) How must I inspect refillable 

containers? Before repackaging a 

pesticide product into any refillable 

container, you must visually inspect the 

exterior and (if possible) the interior of 

the container and the exterior of 

appurtenances. The purpose of the 

inspection is to determine whether the 

container meets the necessary criteria 

with respect to continued container 

integrity, required markings, and 

openings. If the condition in paragraph 

(f)(1) of this section exists, the container 

fails the inspection and must not be 

refilled unless the container is repaired, 

reconditioned, or remanufactured in 

compliance with the relevant DOT 

requirement. If the condition in 

paragraph (f)(2) or (f)(3) of this section 

exists (or both), the container fails the 

inspection and must not be refilled until 

the container meets the standards 

specified in subpart C of this part. The 

conditions are: 

(1) The integrity of the container is 

compromised in at least one of the 

following ways: 

(i) The container shows signs of 

rupture or other damage which reduces 

its structural integrity. 

(ii) The container has visible pitting, 

significant reduction in material 

thickness, metal fatigue, damaged 

threads or closures, or other significant 

defects. 

(iii) The container has cracks, 

warpage, corrosion or any other damage 

which might render it unsafe for 

transportation. 

(iv) There is damage to the fittings, 

valves, tamper-evident devices or other 

appurtenances that may cause failure of 

the container. 

(2) The container does not bear the 

markings required by § 165.45(a), (b) 

and (d), or such markings are not 

legible. 

(3) The container does not have an 

intact and functioning one-way valve or 

tamper-evident device on each opening 

other than a vent, if required. 

(g) How must I clean refillable 

containers? You must clean each 

refillable container by conducting the 

pesticide product’s refilling residue 

removal procedure before repackaging 

the pesticide product into the refillable 

container, unless the conditions in 

paragraph (g)(1) of this section and 

either paragraph (g)(2) or (g)(3) of this 

section are satisfied: 

(1) If required, each tamper-evident 

device and one-way valve is intact. 

(2) The refillable container is being 

refilled with the same pesticide product. 

(3) Both of the following conditions 

are satisfied. 

(i) The container previously held a 

pesticide product with a single active 

ingredient and is being used to 

repackage a pesticide product with the 

same single active ingredient. 

(ii) There is no change that would 

cause the composition of the product 

being repackaged to differ from the 

composition described in its 

confidential statement of formula that is 

required under FIFRA section 3. 

Examples of unallowable changes 

include the active ingredient 

concentration increasing or decreasing 

beyond the limits established by the 

confidential statement of formula or a 

reaction or interaction between the 

pesticide product being repackaged and 

the residue remaining in the container. 

(h) How must I clean a refillable 

container that has a broken (non-intact) 

tamper-evident device or one-way valve? 

As required in paragraph (g) of this 

section, you must clean each refillable 

container that has a tamper-evident 

device or one-way valve that is not 

intact by conducting the pesticide 

product’s refilling residue removal 

procedure before repackaging the 

pesticide product into the refillable 

container. In addition, other procedures 

may be necessary to assure that product 

integrity is maintained in such cases. 

(i) How must I label refillable 

containers? Before distributing or 

selling a pesticide product in a refillable 

container, you must ensure that the 

label of the pesticide product is securely 

attached to the refillable container such 

that the label can reasonably be 

expected to remain affixed during the 

foreseeable conditions and period of 

use. The label and labeling must comply 

in all respects with the requirements of 

part 156 of this chapter. In particular, 

you must ensure that the net contents 

statement and EPA establishment 

number appear on the label. 

(j) What recordkeeping must I do? You 

must maintain all of the records listed 

in this section in addition to the 

applicable records identified in parts 

167 and 169 of this chapter. You must 

furnish these records for inspection and 

copying upon request by an employee of 

EPA or any entity designated by EPA, 

such as a State, another political 

subdivision or a Tribe. 

(1) For each pesticide product 

distributed or sold in refillable 

containers, all of the following records 

must be maintained for the current 

operating year and for 3 years after that: 

(i) The written contract from the 

pesticide product’s registrant for the 

pesticide product. 

(ii) The written refilling residue 

removal procedure for the pesticide 

product. 

(iii) The written description of 

acceptable containers for the pesticide 

product. 

(2) Each time you repackage a 

pesticide product into a refillable 

container and distribute or sell the 

product, the following records must be 

generated and maintained for at least 3 

years after the date of repackaging: 

(i) The EPA registration number of the 

pesticide product distributed or sold in 

the refillable container. 

(ii) The date of the repackaging. 

(iii) The serial number of the refillable 

container. 

§§ 165.71–165.79 [Reserved] 

Subpart E—Standards for Pesticide 

Containment Structures 

§ 165.80 General provisions. 

(a) What is the purpose of the 

regulations in this subpart? The purpose 

of the containment regulations in this 

subpart is to protect human health and 

the environment from exposure to 

agricultural pesticides which may spill 

or leak from stationary pesticide 

containers. This protection is achieved 

by the construction of secondary 

containment units or pads at certain 

facilities handling agricultural 

pesticides. These regulations will also 

reduce waste generation associated 

with: 

(1) Storage and handling of large 

quantities of pesticide products. 

(2) Pesticide dispensing and 

container-refilling operations. 


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(b) Do I have to comply with the 

regulations in this subpart? You must 

comply with the regulations in this 

subpart if you are an owner or operator 

of one of the following businesses and 

if you also have a stationary pesticide 

container or a pesticide dispensing 

(including container refilling) area: 

(1) Refilling establishments who 

repackage agricultural pesticides and 

whose principal business is retail sale 

(i.e., more that 50% of total annual 

revenue comes from retail operations). 

(2) Custom blenders of agricultural 

pesticides. 

(3) Businesses which apply an 

agricultural pesticide for compensation 

(other than trading of personal services 

between agricultural producers). 

(c) When do I have to comply? You 

must comply with all applicable 

containment regulations for new and 

existing structures as of August 17, 

2009. 

§ 165.81 Scope of stationary pesticide 

containers included. 

(a) What is a stationary pesticide 

container? A stationary pesticide 

container is a refillable container that is 

fixed at a single facility or 

establishment, or, if not fixed, remains 

at the facility or establishment for at 

least 30 consecutive days, and that 

holds pesticide during the entire time. 

(b) What stationary pesticide 

containers are subject to the regulations 

in this subpart? Stationary pesticide 

containers designed to hold undivided 

quantities of agricultural pesticides 

equal to or greater than 500 gallons 

(1,890 liters) of liquid pesticide or equal 

to or greater than 4,000 pounds (1,818 

kilograms) of dry pesticide are subject to 

the regulations in this subpart and must 

have a secondary containment unit that 

complies with the provisions of this 

subpart unless any of the following 

conditions exists: 

(1) The container is empty, that is, all 

pesticide that can be removed by 

methods such as draining, pumping or 

aspirating has been removed (whether 

or not the container has been rinsed or 

washed). 

(2) The container holds only pesticide 

rinsates or wash waters, and is labeled 

accordingly. 

(3) The container holds only 

pesticides which would be gaseous 

when released at atmospheric 

temperature and pressure. 

(4) The container is dedicated to nonpesticide use, and is labeled 

accordingly. 

§ 165.82 Scope of pesticide dispensing 

areas included. 

(a) What pesticide dispensing areas 

are subject to the regulations in this 

subpart? A pesticide dispensing area is 

subject to the containment regulations 

in this subpart and must have a 

containment pad that complies with the 

requirements of this subpart if any of 

the following activities occur: 

(1) Refillable containers of 

agricultural pesticide are emptied, 

cleaned or rinsed. 

(2) Agricultural pesticides are 

dispensed from a stationary pesticide 

container designed to hold undivided 

quantities of agricultural pesticides 

equal to or greater than 500 gallons 

(1,890 liters) of liquid pesticide or equal 

to or greater than 4,000 pounds (1,818 

kilograms) of dry pesticide for any 

purpose, including refilling or emptying 

for cleaning. This applies when 

pesticide is dispensed from the 

container into any vessel, including, but 

not limited to: 

(i) Refillable containers; 

(ii) Service containers; 

(iii) Transport vehicles; 

(iv) Application equipment. 

(3) Agricultural pesticides are 

dispensed from a transport vehicle for 

purposes of filling a refillable container. 

(4) Agricultural pesticides are 

dispensed from any other container for 

the purpose of refilling a refillable 

container for sale or distribution. 

Containment requirements do not apply 

if the agricultural pesticide is dispensed 

from such a container for use, 

application or purposes other than 

refilling for sale or distribution. 

(b) What pesticide dispensing areas 

are exempt from the regulations in this 

subpart? A pesticide dispensing area is 

exempt from the regulations in this 

subpart if any of the following 

conditions exist: 

(1) The only pesticides in the 

dispensing area would be gaseous when 

released at atmospheric temperature and 

pressure. 

(2) The only pesticide containers 

refilled or emptied within the 

dispensing area are stationary pesticide 

containers which are already protected 

by a secondary containment unit that 

complies with the provisions of this 

subpart. 

(3) The pesticide dispensing area is 

used solely for dispensing pesticide 

from a rail car which does not remain 

at a facility long enough to meet the 

definition of a stationary pesticide 

container; that is, 30 days. 

§ 165.83 Definition of new and existing 

structures. 

(a) What is a new containment 

structure? A new containment structure 

is one whose installation began after 

November 16, 2006. Installation is 

considered to have begun if: 

(1) You, as the owner or operator, 

have obtained all Federal, State, and 

local approvals or permits necessary to 

begin physical construction of the 

containment structure; AND 

(2) You have either begun a 

continuous on-site physical 

construction or installation program OR 

you have entered into contractual 

obligations. The contract must be such 

that it cannot be canceled or modified 

without substantial loss, and must be for 

the physical construction or installation 

of the containment structure within a 

specific and reasonable time frame. 

(b) What is an existing containment 

structure? An existing containment 

structure is defined as one whose 

installation began on or before 

November 16, 2006. 

§ 165.85 Design and capacity 

requirements for new structures. 

(a) For all new containment 

structures, what construction materials 

must I use? These are the material 

specifications for a new containment 

structure: 

(1) The containment structure must be 

constructed of steel, reinforced concrete 

or other rigid material capable of 

withstanding the full hydrostatic head, 

load and impact of any pesticides, 

precipitation, other substances, 

equipment and appurtenances placed 

within the structure. The structure must 

be liquid-tight with cracks, seams and 

joints appropriately sealed. 

(2) The structure must not be 

constructed of natural earthen material, 

unfired clay, or asphalt. 

(3) The containment structure must be 

made of materials compatible with the 

pesticides stored. In this case, 

compatible means able to withstand 

anticipated exposure to stored or 

transferred materials and still provide 

secondary containment of those same or 

other materials within the containment 

area. 

(b) For all new containment 

structures, what are the general design 

requirements? These are the general 

design requirements for new 

containment structures: 

(1) You must protect appurtenances 

and pesticide containers against damage 

from operating personnel and moving 

equipment. Means of protection 

include, but are not limited to, supports 

to prevent sagging, flexible connections, 

the use of guard rails, barriers, and 

protective cages. 

(2) Appurtenances, discharge outlets 

or gravity drains must not be configured 

through the base or wall of the 

containment structure, except for direct 

interconnections between adjacent 

containment structures which meet the 


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requirements of this subpart. 

Appurtenances must be configured in 

such a way that spills or leaks are easy 

to see. 

(3) The containment structure must be 

constructed with sufficient freeboard to 

contain precipitation and prevent water 

and other liquids from seeping into or 

flowing onto it from adjacent land or 

structures. 

(4) Multiple stationary pesticide 

containers may be protected within a 

single secondary containment unit. 

(c) For new stationary liquid pesticide 

containment and new containment pads 

in pesticide dispensing areas, what are 

the capacity requirements? These are 

the capacity requirements: 

(1) New secondary containment units 

for stationary liquid pesticide 

containers, if protected from 

precipitation, must have a capacity of at 

least 100 percent of the volume of the 

largest stationary pesticide container 

plus the volume displaced by other 

containers and appurtenances within 

the unit. 

(2) New secondary containment units 

for stationary liquid pesticide 

containers, if exposed to or unprotected 

from precipitation, must have a capacity 

of at least 110 percent of the volume of 

the largest stationary pesticide container 

plus the volume displaced by other 

containers and appurtenances within 

the unit. 

(3) New containment pads in 

pesticide dispensing areas which have a 

pesticide container or pesticide-holding 

equipment with a volume of 750 gallons 

or greater must have a holding capacity 

of at least 750 gallons. 

(4) New containment pads in 

pesticide dispensing areas which do not 

have a pesticide container or pesticideholding equipment with a volume of at 

least 750 gallons must have a holding 

capacity of at least 100 percent of the 

volume of the largest pesticide container 

or pesticide-holding equipment used on 

the pad. 

(d) For new stationary liquid pesticide 

containment, what are the specific 

design requirements? You must either 

anchor or elevate each new stationary 

liquid pesticide container protected by 

a secondary containment unit to prevent 

flotation in the event that the secondary 

containment unit fills with liquid. 

(e) For new containment pads in 

pesticide dispensing areas, what are the 

specific design requirements? Each new 

containment pad in a pesticide 

dispensing area must: 

(1) Be designed and constructed to 

intercept leaks and spills of pesticides 

which may occur in the pesticide 

dispensing area. 

(2) Have enough surface area to 

extend completely beneath any 

container on it, with the exception of 

transport vehicles dispensing pesticide 

for sale or distribution to a stationary 

pesticide container. For such vehicles, 

the surface area of the containment pad 

must accommodate at least the portion 

of the vehicle where the delivery hose 

or device couples to the vehicle. This 

exception does not apply to transport 

vehicles that are used for prolonged 

storage or repeated on-site dispensing of 

pesticides. 

(3) Allow, in conjunction with its 

sump, for removal and recovery of 

spilled, leaked, or discharged material 

and rainfall, such as by a manually 

activated pump. Automaticallyactivated pumps which lack automatic 

overflow cutoff switches for the 

receiving container are prohibited. 

(4) Have its surface sloped toward an 

area where liquids can be collected for 

removal, such as a liquid-tight sump or 

a depression, in the case of a single-pour 

concrete pad. 

(f) For new stationary dry pesticide 

containment, what are the specific 

design requirements? These are the 

specific design requirements for new 

stationary dry pesticide containment: 

(1) The stationary dry pesticide 

containers within the containment unit 

must be protected from wind and 

precipitation. 

(2) Stationary dry pesticide containers 

must be placed on pallets or a raised 

concrete platform to prevent the 

accumulation of water in or under the 

pesticide. 

(3) The stationary dry pesticide 

container storage area must be enclosed 

by a minimum of a 6–inch high curb 

that extends at least 2 feet beyond the 

perimeter of the container. 

§ 165.87 Design and capacity 

requirements for existing structures. 

(a) For all existing containment 

structures, what construction materials 

must I use? These are the material 

specifications for an existing 

containment structure: 

(1) The containment structure must be 

constructed of steel, reinforced concrete 

or other rigid material capable of 

withstanding the full hydrostatic head, 

load and impact of any pesticides, 

precipitation, other substances, 

equipment and appurtenances placed 

within the structure. The structure must 

be liquid-tight with cracks, seams and 

joints appropriately sealed. 

(2) The structure must not be 

constructed of natural earthen material, 

unfired clay, or asphalt. 

(3) The containment structure must be 

made of materials compatible with the 

pesticides stored. In this case, 

compatible means able to withstand 

anticipated exposure to stored or 

transferred materials and still provide 

secondary containment of those same or 

other materials within the containment 

area. 

(b) For all existing containment 

structures, what are the general design 

requirements? These are the general 

design requirements for existing 

containment structures: 

(1) You must protect appurtenances 

and pesticide containers against damage 

from operating personnel and moving 

equipment. Means of protection 

include, but are not limited to, supports 

to prevent sagging, flexible connections, 

the use of guard rails, barriers, and 

protective cages. 

(2) You must seal all appurtenances, 

discharge outlets and gravity drains 

through the base or wall of the 

containment structure, except for direct 

interconnections between adjacent 

containment structures which meet the 

requirements of this subpart. 

(3) The containment structure must be 

constructed with sufficient freeboard to 

contain precipitation and prevent water 

and other liquids from seeping into or 

flowing onto it from adjacent land or 

structures. 

(4) Multiple stationary pesticide 

containers may be protected within a 

single secondary containment unit. 

(c) For existing stationary liquid 

pesticide containment and existing 

containment pads in pesticide 

dispensing areas, what are the capacity 

requirements? These are the capacity 

requirements: 

(1) Existing secondary containment 

units for stationary liquid pesticide 

containers must have a capacity of at 

least 100 percent of the volume of the 

largest stationary pesticide container 

plus the volume displaced by other 

containers and appurtenances within 

the unit. 

(2) Existing containment pads in 

pesticide dispensing areas which have a 

pesticide container or pesticide-holding 

equipment with a volume of 750 gallons 

or greater must have a holding capacity 

of at least 750 gallons. 

(3) Existing containment pads in 

pesticide dispensing areas which do not 

have a pesticide container or pesticideholding equipment with a volume of at 

least 750 gallons must have a holding 

capacity of at least 100 percent of the 

volume of the largest pesticide container 

or pesticide-holding equipment used on 

the pad. 

(d) For existing stationary liquid 

pesticide containment, what are the 

specific design requirements? You must 

either anchor or elevate each existing 


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47436 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 

stationary liquid pesticide container 

protected by a secondary containment 

unit to prevent flotation in the event 

that the secondary containment unit 

fills with liquid. 

(e) For existing containment pads in 

pesticide dispensing areas, what are the 

specific design requirements? Each 

existing containment pad in a pesticide 

dispensing area must: 

(1) Be designed and constructed to 

intercept leaks and spills of pesticides 

which may occur in the pesticide 

dispensing area. 

(2) Have enough surface area to 

extend completely beneath any 

container on it, with the exception of 

transport vehicles dispensing pesticide 

for sale or distribution to a stationary 

pesticide container. For such vehicles, 

the surface area of the containment pad 

must accommodate at least the portion 

of the vehicle where the delivery hose 

or device couples to the vehicle. This 

exception does not apply to transport 

vehicles that are used for prolonged 

storage or repeated on-site dispensing of 

pesticides. 

(3) Allow, in conjunction with its 

sump, for removal and recovery of 

spilled, leaked, or discharged material 

and rainfall, such as by a manually 

activated pump. Automaticallyactivated pumps which lack automatic 

overflow cutoff switches for the 

receiving container are prohibited. 

(f) For existing stationary dry 

pesticide containment, what are the 

specific design requirements? These are 

the specific design requirements for 

existing stationary dry pesticide 

containment: 

(1) The stationary dry pesticide 

containers within the containment unit 

must be protected from wind and 

precipitation. 

(2) Stationary dry pesticide containers 

must be placed on pallets or a raised 

concrete platform to prevent the 

accumulation of water in or under the 

pesticide. 

(3) The stationary dry pesticide 

container storage area must be enclosed 

by a minimum of a 6–inch high curb 

that extends at least 2 feet beyond the 

perimeter of the container. 

§ 165.90 Operational, inspection and 

maintenance requirements for all new and 

existing containment structures. 

(a) What are the operating procedures 

required for all new and existing 

containment structures? As the owner 

or operator of a new or existing 

pesticide containment structure, you 

must: 

(1) Manage the structure in a manner 

that prevents pesticides or materials 

containing pesticides from escaping 

from the containment structure 

(including, but not limited to, pesticide 

residues washed off the containment 

structure by rainfall or cleaning liquids 

used within the structure.) 

(2) Ensure that pesticide spills and 

leaks on or in any containment structure 

are collected and recovered in a manner 

that ensures protection of human health 

and the environment (including surface 

water and ground water) and maximum 

practicable recovery of the pesticide 

spilled or leaked. Cleanup must occur 

no later than the end of each day on 

which pesticides have been spilled or 

leaked. 

(3) Ensure that all materials resulting 

from spills and leaks and any materials 

containing pesticide residue are 

managed according to label instructions 

and applicable Federal, State and local 

laws and regulations. 

(4) Ensure that transfers of pesticides 

between containers, or between 

containers and transport vehicles are 

attended at all times. 

(5) Ensure that each lockable valve on 

a stationary pesticide container, if it is 

required by § 165.45(f), is closed and 

locked whenever the facility is 

unattended. 

(b) What are the inspection and 

maintenance requirements for all new 

and existing containment structures? As 

owner or operator of a new or existing 

pesticide containment structure, you 

must: 

(1) Inspect each stationary pesticide 

container and its appurtenances at least 

monthly during periods when pesticides 

are being stored or dispensed on the 

containment structure. Your inspection 

must look for visible signs of wetting, 

discoloration, blistering, bulging, 

corrosion, cracks or other signs of 

damage or leakage. 

(2) Immediately repair any areas 

showing visible signs of damage and 

seal any cracks and gaps in the 

containment structure or appurtenances 

with material compatible with the 

pesticide being stored or dispensed. 

(3) Not store any pesticide on a 

containment structure if the structure 

fails to meet the requirements of this 

subpart until suitable repairs have been 

made. Prompt removal of pesticides, 

including emptying of stationary 

pesticide containers, in order to effect 

repairs or recovery of spilled material is 

acceptable. 

§ 165.92 What if I need both a containment 

pad and a secondary containment unit? 

You may combine containment pads 

and secondary containment units as an 

integrated system provided the 

requirements set out in this subpart for 

containment pads and secondary 

containment units in §§ 165.85(a) and 

(b), 165.87(a) and (b) and § 165.90, and 

as applicable, §§ 165.85(c)-(f) and 

165.87(c)-(f) are satisfied separately. 

§ 165.95 What recordkeeping do I have to 

do as a facility owner or operator? 

As a facility owner or operator subject 

to the requirements of this subpart, you 

must maintain the following records, 

and you must furnish these records for 

inspection and copying upon request by 

an employee of EPA or any entity 

designated by EPA, such as a State, 

another political subdivision or a Tribe: 

(a) Records of inspection and 

maintenance for each containment 

structure and for each stationary 

pesticide container and its 

appurtenances must be kept for 3 years 

and must include the following 

information: 

(1) Name of the person conducting the 

inspection or maintenance; 

(2) Date the inspection or 

maintenance was conducted; 

(3) Conditions noted; 

(4) Specific maintenance performed. 

(b) Records for any non-stationary 

pesticide container designed to hold 

undivided quantities of agricultural 

pesticides equal to or greater than 500 

gallons (1,890 liters) of liquid pesticide 

or equal to or greater than 4,000 pounds 

(1,818 kilograms) of dry pesticide that 

holds pesticide but is not protected by 

a secondary containment unit meeting 

these regulations must be kept for 3 

years. Records on these non-stationary 

pesticide containers must include the 

time period that the container remains 

at the same location. 

(c) Records of the construction date of 

the containment structure must be kept 

for as long as the pesticide containment 

structure is in use, and for 3 years 

afterwards. 

§ 165.97 States with existing containment 

programs. 

(a) What options are available to 

States that already have containment 

regulations? States that have 

promulgated containment regulations 

effective prior to August 16, 2006, and 

which also have primary enforcement 

responsibility and/or certification 

programs, have the option of continuing 

to implement their own programs in 

lieu of these Federal regulations. 

(b) How may a State request authority 

to continue implementing its State 

containment regulations? A State with 

pesticide containment regulations may 

request the authority to continue 

implementing State containment 

regulations by August 16, 2007 in the 

following manner: 

(1) The State must submit a letter and 

any supporting documentation to EPA. 


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Supporting documentation must 

demonstrate that the States program is 

providing environmental protection 

equivalent to or more protective than 

that expected to be provided by the 

Federal regulations in this subpart. 

(2) The State must identify any 

significant changes to State regulations 

which would be necessary in order to 

provide environmental protection 

equivalent to the EPA regulations, and 

develop an estimated timetable to effect 

these changes. The letter must be signed 

by the designated State Lead Agency. 

(c) How will EPA notify the State if its 

request is granted? EPA’s Office of 

Pesticide Programs will review the 

State’s correspondence and determine 

whether the State program is adequate 

to provide environmental protection 

equivalent to or more protective than 

these Federal regulations for new and 

existing containment structures. EPA’s 

Office of Pesticide Programs will inform 

the State of its determination through a 

letter authorizing or declining to 

authorize the State to continue 

implementing its containment 

regulations and will detail any reasons 

for declining authorization. 

(d) How must a State inform EPA of 

revisions to its containment regulations? 

Any state that has received 

authorization to continue implementing 

its state containment regulations must 

inform EPA by letter signed by the 

designated State Lead Agency within 6 

months of any revision to the State’s 

containment regulations. EPA will 

inform the state by letter if it determines 

that the State’s containment regulations 

are no longer adequate based on the 

revisions. The State’s containment 

regulations will remain in effect, unless 

and until EPA sends the state a letter 

making this determination. 

[FR Doc. 06–6856 Filed 8–15–06; 8:45 am] 

BILLING CODE 6560–50–S 


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