Pesticide Management and Disposal; Standards for Pesticide Containers and Containment: Proposed Amendments, 33035-33048 [E8-12843]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 113 (Wednesday, June 11, 2008)]
[Proposed Rules]
[Pages 33035-33048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12843]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152, 156 and 165

[EPA-HQ-OPP-2005-0327; FRL-8358-1]
RIN A2070-AJ37


Pesticide Management and Disposal; Standards for Pesticide 
Containers and Containment: Proposed Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend the container and containment 
regulations to provide a 1-year extension of the labeling compliance 
date from August 17, 2009 to August 17, 2010; to change the phrase 
``sold or distributed'' to ``released for shipment'' as associated with 
all of the compliance dates; to provide for exceptions to the language 
requirements for some specific nonrefillable packages; to allow for 
waivers of certain label requirements for other refillable and 
nonrefillable containers on a case-by-case basis; and to correct 
typographical and other minor errors. In addition, the Agency is 
proposing to amend the definitions in 40 CFR part 152 to establish a 
definition of ``released for shipment.'' These changes are being 
proposed to address concerns raised by stakeholders and as a result of 
further Agency consideration.

DATES: Comments must be received on or before July 11, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2005-0327, by one of the following methods:
      Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
      Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0327. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other

[[Page 33036]]

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 https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., 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 Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Nancy Fitz, Field and External Affairs 
Division (FEAD) (7506P), Office of Pesticide Programs (OPP), 
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, or Kimberly 
Nesci, FEAD (7506P), OPP, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
703-308-8059; fax number: (703) 308-2962; e-mail address: 
nesci.kimberly@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, an independent commercial 
applicator, or a custom blender. Potentially affected entities may 
include, but are not limited to:
     Pesticide formulators (NAICS code 32532), e.g., 
establishments that formulate and prepare insecticides, fungicides, 
herbicides or other pesticides from technical chemicals or concentrates 
produced by pesticide manufacturing establishments.
     Agrichemical dealers (NAICS code 44422), e.g., retail 
dealers that distribute or sell pesticides to agricultural users.
     Independent commercial applicators (NAICS code 115112), 
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 code 44422), 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 the preamble to the final 
pesticide container and containment rule, 71 FR 47330 (August 16, 
2006). 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    On August 16, 2006, EPA promulgated a final rule titled ``Pesticide 
Management and Disposal; Standards for Pesticide Containers and 
Containment'' (71 FR 47330) (Container and Containment Rule; 
establishing 40 CFR part 165, and amending 40 CFR part 156). The 
Container and Containment Rule established regulations for the safe 
storage and disposal of pesticides, pursuant to the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), to reduce the 
likelihood of unreasonable adverse effects on human health and the 
environment. The container and containment regulations include 
requirements for pesticide container design; procedures, standards, and 
label language to facilitate removal of pesticides from containers 
prior to their being used, recycled, or discarded; and requirements for 
containment of stationary pesticide containers and procedures for 
container refilling operations. The rule required that all pesticide 
products distributed or sold by a registrant as of August 17, 2009, 
bear labels that comply with the rule's label language requirements (40 
CFR 156.159).
    EPA is proposing to amend the container and containment regulations 
to provide a 1-year extension of the labeling compliance date (from 
August 17, 2009 to August 17, 2010); to change the phrase ``sold or 
distributed'' to ``released for shipment'' as associated with all of 
the compliance dates; to provide for exceptions to the language 
requirements for some specific nonrefillable packages; to allow for 
waivers of certain label requirements for other refillable and 
nonrefillable containers on a case-by-case basis; and to correct 
typographical and other minor errors. In addition, the Agency is 
proposing to establish a definition of ``released for shipment.'' These 
changes are being proposed in response to subsequent requests from 
stakeholders and based on further Agency consideration.

B. Statutory Authority

    These proposed regulations are issued pursuant to the authority 
given the Administrator of EPA in sections 2 through 34 of FIFRA, 7 
U.S.C. 136--136y. Sections 19(e) and (f) of FIFRA, 7 U.S.C. 136a(e) and 
(f), grant EPA broad authority to establish standards and

[[Page 33037]]

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. FIFRA section 19(f) 
requires EPA to promulgate regulations prescribing procedures and 
standards for the removal of pesticides from containers prior to 
disposal.
    FIFRA section 25(a), 7 U.S.C. 136w(a), authorizes EPA to issue 
regulations to carry out provisions of FIFRA.

III. Proposed Changes to 40 CFR Part 152--Pesticide Registration and 
Classification Procedures

    The Agency is proposing to amend Sec.  152.3 to add a new 
definition for ``released for shipment.'' As discussed in subsequent 
units of this proposed rule, the Agency is proposing to use this term 
in Sec.  156.159, Sec. 165.20, Sec. 165.40, and Sec.  165.60. The 
Agency considered putting definitions for this term in both parts 156 
and 165, but notes that because the term has also been used in Sec.  
167.3 and in various guidance documents, a generally applicable 
definition may be appropriate. The Agency is asking for comments on 
both the proposed definition itself and on the placement of the 
definition in the regulations. The proposed definition is as follows:
    A product is released for shipment when the producer has 
packaged and labeled it in the manner in which it will be shipped, 
or has stored it in an area where finished products are ordinarily 
held for shipment. An individual product is only released for 
shipment once, except where subsequent events constitute production 
(e.g., relabeling, repackaging).

    The proposed definition is consistent with EPA's previously 
published definitions of ``released for shipment''; the most recent of 
these appears in PR Notice 93-11, Supplement C (August 13, 1993), and 
in a 1984 proposed rule (49 FR 37916, September 26, 1984). The first 
sentence is essentially that of the 1984 proposed rule, which focuses 
on actions manifesting the producer's intent to introduce a product 
into commerce. The second sentence would make it clear that products 
already in the channels of trade are all ``released for shipment,'' and 
that relabeled or reworked products must be released a second time.

IV. Proposed Changes to 40 CFR Part 156--Labeling Requirements for 
Pesticides and Devices

    The Container and Containment Rule added a new subpart H titled 
``Container Labeling'' to 40 CFR part 156 that requires the following 
information or statements on certain pesticide product labels:
     A statement identifying the container as nonrefillable or 
refillable.
     On nonrefillable containers, statements providing basic 
instructions for managing the container and a batch code.
     Cleaning instructions for some nonrefillable containers.
     Cleaning instructions for refillable containers at the end 
of their useful lives.
    In addition, the Container and Containment Rule modified several 
existing requirements in 40 CFR 156.10, including allowing for blank 
spaces on the labels of some refillable containers for the net contents 
and EPA establishment number and adding a reference to the container 
and containment regulations in subpart H and 40 CFR part 156.
    In this proposed rule, the Agency is proposing to amend the 
labeling requirements in 40 CFR part 156 subpart H.

A. Background

    After promulgation of the Container and Containment Rule, the 
Agency was contacted by stakeholders with concerns about the compliance 
date associated with the labeling requirements; the implications of the 
phrase ``sold or distributed'' for the handling of packaged pesticide 
products that may be returned unused to a registrant at the end of a 
use season; and the scope of pesticide products and containers for 
which some of the labeling statements are being required.
    1. Compliance date. Some registrants have asserted that they do not 
have sufficient time to change all labels for final packaging of 
pesticide products in time to meet the August 17, 2009, compliance 
date. These time constraints are due to the following factors:
    i. Almost all pesticide product registrations are involved. 
Generally, changes to product labels are done on a product by product 
basis or only for products containing one active ingredient. In the 
case of changes required by the pesticide container and containment 
regulations, essentially all product registrations are involved 
(approaching 17,000 individual products).
    ii. Often registrants sell multiple individual package sizes (often 
referred to as ``SKUs'') under one product registration number. As a 
result of multiple SKUs being associated with individual registrations, 
the changes will affect many more final printed packages than 
individual registrations.
    iii. The labels for certain types of seasonal products and consumer 
specialty products are unique and expensive to print. For example, for 
some pool chemicals, labeling is printed directly on buckets that will 
contain the pesticide product. Each label plate needed to print the 
buckets is expensive to produce, as is each individual printed bucket.
    iv. The production of many consumer specialty products (pool 
chemicals, lawn chemicals) is on an annual and seasonal basis; 
therefore, for some products, there is only one opportunity each year 
to print new product labels.
    v. Many registrants had delayed submitting revised product labels 
that include the new requirements until the Agency provided further 
guidance to explain the conditions under which registrants might submit 
revised labels under an expedited review process (that is, a 
notification process). Although this guidance has since published 
(Pesticide Registration (PR) Notice 2007-4, published on November 7, 
2007); the 15 months that passed between the publication of the August 
16, 2006, final rule and the publication of the PR Notice may have 
contributed to delays in amending labels.
    2. Labeling of returned products. Registrants have also expressed 
concerns about how the new container and containment labeling 
requirements would apply to products that are returned to the 
manufacturer. The container and containment regulations provide that 
products distributed or sold by a registrant after August 17, 2009, 
must bear the new labeling statements. According to registrants, 
contracts with many consumer retail establishments require that 
seasonal consumer products remaining on the shelves at the end of the 
use season be returned to the manufacturer. As a result, any products 
bearing old labels and originally distributed in spring 2009 and that 
did not sell might be returned to registrants in the fall of 2009 after 
the August 17, 2009, compliance date. Subsequent sale or distribution 
of the returned products would not be in compliance with the container 
and containment regulations unless the products were relabeled. 
Registrants have indicated that relabeling of the returned products 
would be especially costly and difficult and that the products may 
require repackaging that could result in unintentional exposures to the 
pesticide; therefore, registrants would be more likely to dispose of 
returned product bearing old labeling rather than relabel or repackage 
the product. While the Agency believes that the label language required 
by the

[[Page 33038]]

container and containment regulations is important, the expected 
decrease in risk from improving handling practices for the relatively 
small number of returned containers is likely not significant enough to 
justify the cost of expensive relabeling, repackaging or disposal of 
product bearing old labels, and the potential exposure from repackaging 
or disposal of product. Accordingly, EPA proposes to change the phrase 
``distributed or sold'' in Sec.  156.159 to ``released for shipment.'' 
EPA considers a product released for shipment when the producer has 
packaged and labeled it in the manner in which it will be shipped, or 
has stored it in an area where finished products are ordinarily held 
for shipment. An individual product is only released for shipment once, 
except where subsequent events constitute production (e.g., relabeling, 
repackaging). Therefore, any products returned at the end of a use 
season could be re-distributed or sold and remain in compliance with 
the container and containment regulations.
    3. Scope of products and flexibility of requirements. Some 
registrants are also concerned about the scope of products subject to 
the new container-type statements (see 40 CFR 156.140). The container 
and containment regulations require that either the statement 
``refillable container'' or ``nonrefillable container'' be placed on 
the label or container of all pesticide products except plant-
incorporated protectants. Registrants are requesting that the Agency 
exempt inherently or obviously nonrefillable packaging types from this 
requirement. These registrants believe that it is unduly burdensome and 
not appropriate to require the phrase ``Nonrefillable container. Do not 
reuse or refill'' on obviously nonrefillable packages. While the 
additional language will provide extra precautions for containers that 
physically could be reused or refilled, registrants maintain that these 
additional precautions are not necessary for containers that are 
inherently nonrefillable because existing labeling generally includes a 
phrase such as ``Do not reuse this container,'' and the container and 
containment regulations do not change this phrase. Examples of some 
types of containers that registrants consider obviously nonrefillable 
are aerosol spray cans, bait stations, and foil pouches for water 
soluble packets.
    In addition, the Agency has recognized several additional types of 
registered pesticides for which it makes sense to reconsider the 
labeling statements described above. For example, some pesticides are 
not sold in containers, such as impregnated repellent clothing 
articles. In this case, the labeling consists of a clothing tag, and it 
would serve no purpose for the tag to include the phrase 
``nonrefillable container.''
    Finally, the Agency originally intended for the waiver/modification 
statement included in the residue removal section of the container and 
containment regulations (40 CFR 156.144(d)) to apply to all of the new 
label language requirements. However, as written, the regulations do 
not allow for waivers from the ``nonrefillable container'' or 
``refillable container'' language.
    EPA is proposing several amendments to the container and 
containment regulations to address these issues and to correct 
typographical and other errors, as follows:
     EPA proposes to change the compliance date associated with 
the container and containment labeling requirements to August 17, 2010.
     EPA proposes to change the phrase ``distributed or sold'' 
to ``released for shipment'' as associated with the labeling compliance 
date. In addition, EPA proposes to make a similar change to the 
language associated with the compliance date for the container and 
repackaging requirements as well.
     EPA proposes to exempt certain container types from the 
container type labeling statements required by the container and 
containment regulations (40 CFR 156.140) and to allow the Agency to 
approve modifications to that language on a case-by-case basis. The 
specific container types that EPA proposes to exempt are described in 
detail in Unit III.C. of this proposed rule.
     EPA proposes to correct typographical and other minor 
errors in the container and containment regulations as described in 
detail in Unit V of this proposed rule.

B. Addition of Definitions Section to Subpart A

    In this proposed rule, the Agency is proposing to add a new 
definitions section (Sec.  156.3) to part 156 and to include an 
introductory paragraph in the definitions section noting that the terms 
used in part 156 have the same meaning as in the Act and 40 CFR part 
152. This paragraph simply refers readers to the definitions in the Act 
and in part 152. In addition, the Agency is proposing to add to Sec.  
156.3 a definition for the term ``dilutable,'' since this term is used 
in part 156.

C. Changes to Subpart H--Container Labeling

    1. Identification of container types. In this proposed rule, the 
Agency is proposing to exempt certain nonrefillable container types 
from the ``identification of container type'' requirements described in 
40 CFR 156.140. The container types that EPA proposes to exempt are 
listed in proposed Sec.  156.140(a)(5) and are as follows:
     Aerosol cans.
     Nonrefillable caulking tubes and other nonrefillable 
squeezable tube containers for paste, gel, or other similar formulas 
(e.g., crack and crevice application devices, unit dose application 
tubes).
     Foil packets for water soluble packaging, repellent wipes, 
and other single-use products.
     Tamper-resistant bait stations.
     Tamper-resistant cages for repellent or trapping strips.
     Packaging for pet collars.
     One-time use semiochemical dispersion devices.
     Any packaging that is destroyed by the use of the product 
contained therein.
     Any packaging that would be destroyed if reuse of the 
container were attempted (for example, bacteriostatic water filter 
cartridges, blister card packaging, etc.).
    EPA proposes to exempt these container types from the requirement 
to include a statement identifying the container as a nonrefillable 
container in Sec.  156.140(a)(1) and the requirement to include a reuse 
statement in Sec.  156.140(a)(2). These sections of the rule require 
pesticide labels to include the phrase ``Nonrefillable container. Do 
not reuse or refill this container'' or one of the other statements 
about reuse in Sec.  156.140(a)(2). Currently, many labels already 
include the statement ``Do not reuse this container.''
    EPA considers the container types listed above to be inherently 
nonrefillable because, after use of the pesticide, they do not appear 
to offer any practical use as containers. For most containers, the 
container type and reuse statements provide additional precautions and 
useful information; however, these precautions and additional 
information are not necessary for containers that are either highly 
unlikely or physically impossible to be reused or refilled. In 
addition, the majority of pesticide labels already include a phrase 
such as ``Do not reuse this container'' to prohibit any attempted 
reuse.
    Registrants also requested exemptions for bags (flexible packaging) 
and

[[Page 33039]]

syringes. EPA has not proposed an exemption for flexible packaging and 
syringes because the Agency believes it is likely that persons might 
consider these to be useful as containers or applicators for pesticides 
or other materials after initial use. The Agency believes that the 
potential for adverse effects resulting from refill and/or reuse of 
these containers is greater than the burdens associated with labeling 
these containers as nonrefillable containers and expressly prohibiting 
reuse or refill of the containers.
    EPA requests comments on the proposed approach for exempting 
certain pesticide container types from the requirement to include a 
statement identifying the container as a nonrefillable container in 
Sec.  156.140(a)(1) and the requirement to include a reuse statement in 
Sec.  156.140(a)(2). In particular, EPA requests comments regarding 
criteria that could be used to determine whether particular containers 
should be exempt; the types of containers that are included in the 
exemption; and whether other containers should also be exempted. This 
may include any additional information on flexible packaging and 
syringes that might cause the Agency to reconsider those types of 
containers for exemption.
    EPA is proposing to exempt these container designs only from the 
statement identifying the container as a nonrefillable container in 
Sec.  156.140(a)(1) and the requirement to include a reuse statement in 
Sec.  156.140(a)(2). These containers would still be required to bear a 
recycling/reconditioning statement per Sec.  156.140(a)(3). EPA is not 
proposing to automatically exempt these container types from the 
requirement to have a statement about recycling/reconditioning because 
the Agency wants to facilitate recycling wherever it is feasible. In 
addition, EPA believes that most labels already comply with that 
requirement because they include a statement about recycling. EPA 
requests comments on this approach and specifically about whether 
container types that are exempt from Sec.  156.140(a)(1) and Sec.  
156.140(a)(2) should also be exempt from Sec.  156.140(a)(3).
    The Agency is also proposing to amend Sec.  156.140 to add a new 
paragraph (c) that would allow EPA to modify or waive the label 
statements required by Sec.  156.140. The Agency originally intended 
for the waiver/modification statement included in the residue removal 
section (40 CFR 156.144(d)) to apply to all label language. However, as 
written, the regulations do not allow for exemptions from the 
``nonrefillable container'' or ``refillable container'' language. The 
Agency is proposing to allow modifications or waivers of the required 
language so that the Agency can determine on a case-by-case basis 
whether the requirements for the nonrefillable container, reuse, 
recycling/reconditioning and refillable container label statements are 
appropriate.
    There is a trade-off to exempting container types in the 
regulations and dealing with registrant-requested changes on a case-by-
case basis through the waiver/modification process. Dealing with 
registrant waiver/modification changes on a case-by-case basis is 
flexible and can account for future container developments and non-
traditional container types for which the required label statements may 
not be appropriate. However, the waiver/modification process is time- 
and labor-intensive for both the Agency and registrants. EPA requests 
comments on whether the proposed approach to specifically exempt 
certain container types and to allow waivers/modifications results in 
an appropriate balance.
    The last substantive change that the Agency is proposing to make to 
Sec.  156.140 is a change to add paragraph (d), which would exempt 
pesticide-impregnated objects that are registered as pesticides and not 
packaged in a container from all of the requirements in Sec.  156.140. 
These include such products as repellent-impregnated articles of 
clothing and other repellent-impregnated fabric articles. It would not 
be appropriate to refer to the pesticide container on the labels for 
these types of products if no container exists. This is an unusual 
situation; however, the Agency has decided to propose to include this 
exemption as a general statement to eliminate the need for the 
individual submission and review of exemption requests for these types 
of products in the future.
    In addition, EPA is proposing minor revisions to the introductory 
paragraphs in Sec.  156.140(a) and Sec.  156.140(b) to reference the 
exemptions in proposed Sec.  156.140(a)(5) and Sec.  156.140(d) and the 
proposed waiver/modification provision in Sec.  156.140(c).
    2. Changes to residue removal instructions. The Agency is proposing 
to add Sec.  156.144(e) to exempt compressed gas cylinders from the 
requirement to provide residue removal instructions. The Agency is 
proposing this exemption because it may not be safe or appropriate for 
end users to attempt to clean compressed gas cylinders. Generally, gas 
cylinders bear label language specific to the use of a compressed 
cylinder (see PR Notice 84-5), and EPA had not intended the Container 
and Containment Rule to supersede any existing precautionary language 
for gas cylinders. In the 2006 final rule, EPA exempted containers that 
hold pesticides that are gaseous at atmospheric temperature and 
pressure from the refillable container and repackaging requirements in 
40 CFR part 165. The proposed exemption in this proposed rule would 
make the label language requirements of Sec.  156.144 consistent with 
40 CFR part 165.
    In addition, the Agency is proposing to add Sec.  156.144(f) to 
exempt from the requirements of Sec.  156.144 pesticide-impregnated 
objects that are registered as pesticides and not packaged in a 
container. These include such products as repellent-impregnated 
articles of clothing and other repellent-impregnated fabric articles, 
such as tents or mosquito netting. In the absence of a container, there 
is no need for residue removal instructions. The Agency proposes to 
include this exemption to eliminate the need for the individual 
submission and review of exemption requests for these products in the 
future.
    In Sec.  156.144(g), the Agency is proposing that pesticide product 
labels do not have to bear residue removal instructions applicable to 
transport vehicles. Transport vehicles such as rail cars and other 
cargo-carrying vehicles are classified as containers in the container 
and containment regulations, but are exempt from the refillable 
container and repackaging regulations in 40 CFR part 165. The Agency is 
proposing that pesticide product labels do not have to bear residue 
removal instructions applicable to transport vehicles because the 
residue removal label language in the container and containment 
regulations is not tailored to the unique nature of transport vehicle 
containers. This change will make the residue removal label language 
requirements consistent with the refillable container and repackaging 
requirements, with regard to transport vehicles.
    Finally, EPA is proposing a minor revision to change Sec.  
156.144(a) to reference the proposed exemptions in Sec.  156.144(e), 
(f), and (g).
    3. Changes to compliance date. The Agency is proposing to extend 
the compliance date associated with the labeling requirements of part 
156, subpart H, (Sec.  156.159) from August 17, 2009, to August 17, 
2010. This change will allow additional time for registrants to change 
all labels for final packaging for all registered products and SKUs and

[[Page 33040]]

remain in compliance with the container and containment regulations. 
The Agency is maintaining August 17 as the compliance date for 
consistency with the other compliance dates in the container and 
containment regulations. EPA believes that maintaining August 16 or 17 
of varying years as a compliance date for all the different 
requirements in the container and containment regulations will 
facilitate compliance by the regulated community. EPA requests comments 
on the proposed compliance date for the part 156, subpart H, label 
requirements and specifically whether there is any advantage to 
extending the date a few additional months based on the typical 
schedule and activities involved with the production, distribution and 
sale of pesticides.
    In addition, the Agency is proposing to change the phrase 
``distributed or sold'' to ``released for shipment,'' as associated 
with the compliance date. This change will allow pesticide products 
that were initially distributed or sold to retailers before the 
compliance date, but which may be returned unused to the producer at 
the end of a use season, to be distributed or sold the following season 
without relabeling. EPA believes the number of containers which would 
be affected by this change is relatively small, and as a result, EPA 
expects relabeling would involve both high per-unit costs and low 
benefits. This change is consistent with language used by the Agency 
for other situations where it seeks label changes. In addition, this 
change is consistent with the decision in the Container and Containment 
Rule to not finalize a 5-year channels of trade provision. The Agency 
decided not to include a 5-year channels of trade provision to minimize 
the disruption and burden of implementing this rule and because the 
Agency does not believe that current products and containers pose 
enough hazard to justify the costs of recalling them from retailers or 
distributors (71 FR 47356).

V. Proposed Changes to 40 CFR Part 165--Pesticide Management and 
Disposal

A. Changes to Definitions in Subpart A

    The Agency is proposing some changes to the definitions in Sec.  
165.3. In particular, the Agency is proposing to include an 
introductory paragraph to state that the terms used in this part have 
the same meaning as the terms used in the Act and in 40 CFR part 152. 
In addition, the Agency is proposing to revise two definitions, add 
three new definitions, and delete three definitions.
    The Agency is proposing to change the definition of ``agricultural 
pesticide'' to ``...any product labeled for use in or on a farm, 
forest, nursery, or greenhouse.'' This change is being proposed in 
order to be consistent with the definition of ``agricultural 
establishment'' in the Worker Protection Standard (WPS) at 40 CFR 
170.3. EPA believes that using this definition will facilitate 
compliance with and understanding of the pesticide container and 
containment regulations because the definition of agricultural 
establishment in the WPS has a long history and is well-understood. 
Introducing a new definition of ``agricultural pesticide'' that does 
not conform exactly to the definition of ``agricultural establishment'' 
could cause unnecessary confusion. The Agency does not believe that 
changing the definition of ``agricultural pesticide'' substantially 
changes the scope of the pesticide container and containment 
regulations, but requests comment on the potential impacts of revising 
the definition of agricultural pesticide.
    The Agency is proposing to delete the definition of ``flowable 
concentrate'' and to add a new definition for the term ``suspension 
concentrate,'' as follows: ``...a stable suspension of active 
ingredients in a liquid intended for dilution with water before use.'' 
EPA is making these changes based on input from the registrants that 
``suspension concentrate'' is the term currently used in formulation 
chemistry to describe the pesticide formulations that EPA originally 
described with the term ``flowable concentrate.'' The Agency is also 
changing references to ``flowable concentrate'' to ``suspension 
concentrate'' in Sec.  165.25(f)(2) and Sec.  165.27(b)(5).
    The Agency is proposing to revise the definition of ``pesticide 
compatible'' as applied to containment to delete ``secondary'' from the 
two references to ``secondary containment'' and to change the word 
``materials'' to ``substances,'' as applied to the substances being 
contained. ``Secondary'' is misleading in this definition because the 
compatibility requirement applies to both secondary containment units 
and containment pads. The change from ``materials'' to ``substances'' 
is simply editorial since ``materials'' is also used in the phrase 
``containment construction materials.''
    The Agency is proposing to add a definition for the term 
``capacity'' since this term is used in part 165 to make clear that the 
container capacities specified refer to the rated capacity of the 
container (also known as the nominal or design capacity). In order to 
allow space for thermal expansion, containers typically hold a volume 
somewhat greater than the rated capacity. The rated capacity of a 
container is generally readily apparent, and actual capacity generally 
is not. This makes rated capacity a more useful tool for distinguishing 
containers for purposes of the regulations. While EPA did specify rated 
capacity in Sec.  165.65(d)(4) and Sec.  165.70(e)(4), it did not do so 
consistently throughout part 165. The proposed revision would confirm 
that all references to container capacity mean rated capacity.
    The Agency is proposing to add to Sec.  165.3 a definition for the 
term ``dilutable'' since this term is used in part 165. This term is 
defined in Sec.  165.25(f)(1), so the same definition should also 
appear in Sec.  165.3.
    The Agency is proposing to remove the definitions of ``pressure 
rinse'' and ``triple rinse'' because these terms are not used in part 
165.

B. Changes to Subpart B--Nonrefillable Container Standards: Container 
Design And Residue Removal

    1. General provisions. The Agency is proposing to change the 
compliance date language in Sec.  165.20(c) to be consistent with the 
proposed compliance date language in revised Sec.  156.159 by using the 
phrase ``released for shipment'' instead of ``distributed or sold.'' 
This change will allow product that was initially distributed or sold 
to retailers before the compliance date, but which may be returned 
unused to the producer at the end of a use season, to be sold or 
distributed the following season without changing the container. EPA 
believes the number of containers that would be affected by this change 
is relatively small and, as a result, EPA expects changing the 
container would involve both high per-unit costs and low benefits. This 
change is consistent with language used by the Agency for situations 
where it seeks label changes.
    In addition, the Agency is proposing an editorial change to Sec.  
165.20(c) to change ``...that complies with these regulations'' to 
``...that complies with the regulations of this subpart'' to be more 
precise.
    2. Changes to scope of pesticide products. The Agency is proposing 
to make an editorial change to the heading in Sec.  165.23(d) to remove 
quotes from the term antimicrobial.
    3. Changes to nonrefillable container standards. The Agency is 
proposing to change Sec.  165.25(a) and Sec.  165.25(b) to clarify that 
the requirement to comply with the adopted Department of Transportation 
(DOT) standards referenced therein only applies to portable containers, 
which was the

[[Page 33041]]

Agency's intent in the August 16, 2006 rule.
    The Agency is also proposing to clarify that the DOT regulations 
which are adopted in Sec.  165.25 apply to the pesticide product as it 
is packaged for transportation in commerce. This change is being 
proposed to be consistent with the DOT regulations in terms of the form 
of the packaging that is subject to the adopted DOT regulations. The 
other nonrefillable container requirements in Sec.  165.25, including 
the requirements for closures, dispensing capability and residue 
removal, apply to the container used to enclose a pesticide, i.e., the 
receptacle that comes into direct contact with the pesticide. However, 
the DOT hazardous materials regulations apply to a package as it is 
prepared for transportation in commerce. For example, 2.5-gallon jugs 
are often shipped for transportation in commerce as pairs of jugs in a 
cardboard box. When the jugs contain DOT hazardous materials, it is the 
boxed package that would have to comply with the DOT regulations. EPA 
proposes to amend Sec.  165.25 to clarify that it is the product as 
packaged for transportation in commerce that must comply with those DOT 
regulations that are adopted in Sec.  165.25 for pesticides that are 
not hazardous materials. On the other hand, the other Sec.  165.25 
requirements - for closures, dispensing capability and residue removal 
- would apply to the immediate pesticide container (e.g., the 2.5-
gallon jug itself). EPA requests comments on whether the proposed 
change accomplishes the goal of clarifying that the adopted DOT 
requirements in Sec.  165.25(a) are intended to apply to the container 
or packaging as it is transported in commerce. The Agency also requests 
suggestions for alternative revisions to Sec.  165.25(a) that would 
provide that clarification.
    In addition, the Agency is proposing to change Sec. Sec.  
165.25(a), (b)(1) and (b)(2) to add an additional citation to the list 
of DOT regulations with which non-refillable containers must comply. 
The Agency is proposing this change to include the requirements of 49 
CFR part 107, subpart B that are applicable to special permits because 
this subpart regulates exemptions from DOT requirements. The original 
intent of Sec.  165.25 was that a pesticide packaged in compliance with 
DOT's requirements would meet the requirements of Sec.  165.25(a) and 
(b). This proposed change is consistent with the original intent and 
simply clarifies that if a pesticide is in compliance with DOT 
requirements via an exemption, it is also acceptable under the 
container and containment regulations.
    The Agency is also proposing to add three additional citations to 
the list of DOT regulations in Sec.  165.25(a) with which a 
nonrefillable container must comply. Specifically, EPA is proposing to 
add 49 CFR 173.4, 173.5, and 173.6 to incorporate several additional 
DOT exceptions so they would apply to pesticides that are not hazardous 
materials. These proposed exceptions are for small retailers, 
customers, research and sales personnel (49 CFR 173.6), small 
quantities (49 CFR 173.4), and transportation of agricultural products 
over local roads between fields of the same farm (49 CFR 173.5). The 
proposal to add these exceptions to the pesticide container regulations 
is intended to identify several situations where the DOT requirements 
adopted by Sec.  165.25 would not apply. Similar to the adopted DOT 
provision in 49 CFR 173.155, which provides exceptions for Class 9 
(miscellaneous hazardous materials) chemicals, adopting these 
provisions would clarify that certain containers and packages would not 
have to comply with all of the DOT hazardous materials requirements. 
Instead, the containers and packages would only have to comply with 
conditions specified in those regulatory exceptions.
    The Agency is proposing these same changes to the corresponding 
DOT-related requirements for refillable containers in Sec.  165.45.
    Also in Sec.  165.25, the Agency is proposing to change paragraph 
(f)(2) to substitute the term ``suspension concentrate'' for ``flowable 
concentrate.'' EPA is making this change based on input from the 
registrants that ``suspension concentrate'' is the term currently used 
in formulation chemistry to describe the pesticide formulations that 
EPA originally described with the term ``flowable concentrate.''
    4. Changes to reporting and recordkeeping. The Agency is proposing 
an editorial change to the introductory paragraph in Sec.  165.27(b) to 
properly cite Sec.  165.25 - Sec.  165.27.
    The Agency is proposing to add new Sec. Sec.  165.27(b)(4)(iii) and 
(b)(5)(iii) which would provide that evidence of an EPA-approved waiver 
request shall be sufficient to demonstrate compliance with the 
container dispensing capability and container residue removal 
standards.
    Also in Sec.  165.27, the Agency is proposing to change paragraph 
(b)(5) to substitute the term ``suspension concentrate'' for ``flowable 
concentrate.'' EPA is making this change based on input from the 
registrants that ``suspension concentrate'' is the term currently used 
in formulation chemistry to describe the pesticide formulations that 
EPA originally described with the term ``flowable concentrate.''

C. Changes to Subpart C--Refillable Container Standards: Container 
Design

    1. General provisions. The Agency is proposing to add a new Sec.  
165.40(b)(3) to alert refillers to the existence of a refiller-specific 
exemption from some of the DOT-related requirements in Sec.  165.45(a).
    The Agency is proposing a change to the compliance date language in 
Sec.  165.40(c) to be consistent with the proposed compliance date 
language in Sec.  156.159 by using the phrase ``released for shipment'' 
instead of ``distributed or sold.'' See the discussion in Unit V.B.1. 
of this proposal for the rationale behind this change.
    In addition, the Agency is proposing an editorial change to Sec.  
165.40(c) to change ``...that complies with these regulations'' to 
``...that complies with the regulations of this subpart'' to be more 
precise.
    2. Changes to scope of pesticide products. The Agency is proposing 
five editorial changes to Sec.  165.43 to remove quotes from the term 
antimicrobial in the headings of paragraphs (c), (d), and (e), to 
remove an extraneous ``by'' in paragraph (f), and to add a space in 
paragraph (g).
    3. Changes to refillable container standards. The Agency is 
proposing to change Sec.  165.45 to clarify that DOT standards only 
apply to portable containers, to clarify that the DOT regulations which 
are adopted in Sec.  165.45 apply to a pesticide product as it is 
packaged for transportation in commerce, to add a citation to 49 CFR 
part 107, subpart B for completeness and to add citations to the DOT 
exceptions in 49 CFR 173.4, 173.5, and 173.6. These proposed changes 
are discussed in more detail in Unit V.B.3. about the proposed 
revisions to the nonrefillable container requirements in Sec.  165.25.

D. Changes to Subpart D--Standards For Repackaging Pesticide Products 
Into Refillable Containers

    1. General provisions. The Agency is proposing a change to the 
compliance date language in Sec.  165.60(c) to be consistent with the 
proposed compliance date language in Sec.  156.159 by using the phrase 
``released for shipment'' instead of ``distributed or sold.'' See the 
discussion in Unit V.B.1. of this proposal for the rationale behind 
this change.
    In addition, the Agency is proposing an editorial change to Sec.  
165.60(c) to change ``...that complies with these

[[Page 33042]]

regulations'' to ``...that complies with the regulations of this 
subpart'' to be more precise.
    2. Scope of pesticide products included. The Agency is proposing an 
editorial correction in Sec.  165.63 to correctly cite the appropriate 
regulations in the table under paragraph (d)(1). The citations in the 
two rows about container inspection need to be corrected.
    3. Registrants who distribute or sell pesticide products in 
refillable containers. The Agency is proposing to revise Sec.  
165.65(i)(2)(iii) to allow an identifying code other than a serial 
number as an acceptable mechanism to identify refillable containers in 
the registrant's records. This change is needed to be consistent with 
the requirement in Sec.  165.45(d), which requires refillable 
containers to be marked with a serial number or other identifying code 
that will distinguish between the individual container and all other 
containers.
    4. Registrants who distribute or sell pesticide products to 
refillers for repackaging. The Agency is proposing to revise Sec.  
165.67(b)(2)(ii) for clarity. This paragraph covers the situation where 
a pesticide product is repackaged by a refilling establishment at an 
end user's site.
    The Agency is proposing to change Sec.  165.60(d) to clarify that 
the written contract that registrants must provide to refillers is the 
contract referenced in Sec.  165.67(b)(3).
    5. Refillers who are not registrants. The Agency is proposing to 
revise Sec.  165.70(b)(2)(ii) for clarity, similar to the corresponding 
provision in Sec.  165.67 for registrants.
    The Agency is proposing to change Sec.  165.70(e)(5)(i) to clarify 
that the written contract that refillers must obtain is the contract 
referenced in Sec.  165.70(b)(3). EPA is also proposing to revise Sec.  
165.70(j)(2)(iii) to allow another identifying code other than a serial 
number as an acceptable mechanism to track refillable containers, 
similar to the corresponding requirement in Sec.  165.65 for 
registrants that sell or distribute pesticides directly in refillable 
containers.

E. Change to Subpart E--Standards For Pesticide Containment Structures

    1. General provisions. The Agency is proposing an editorial 
correction to Sec.  165.80(b)(1) to change ``that'' to ``than.''
    2. Design and capacity requirements for new structures. The Agency 
is proposing editorial changes to Sec.  165.85(a)(3) to remove 
``secondary'' in this paragraph because the Agency did not intend to 
limit the compatibility requirement to secondary containment structures 
and to change the word ``materials'' to ``substances'' where it refers 
to substances being contained.
    The Agency is proposing an editorial change to Sec.  165.85(d) to 
clarify that the word ``new'' in this paragraph applies to a new 
secondary containment unit and not the pesticide containers themselves.
    The Agency is proposing two changes to state that dry pesticide 
container storage areas must have a floor, consistent with the original 
intentions. EPA is proposing to move the existing requirement that 
stationary dry pesticide container storage areas have curbs from Sec.  
165.85(f)(3) to Sec.  165.85(f)(4) and to insert a new paragraph (f)(3) 
that would require such areas to have floors as well. The requirement 
that these areas have floors is implied in the container and 
containment regulations because it does not make sense to have a curb 
made out of concrete, steel, or other rigid material without also 
having a floor. The proposed change would make this requirement 
explicit. In addition, the Agency is proposing editorial changes to 
rephrase the new Sec.  165.85(f)(4) for clarity.
    3. Design and capacity requirements for existing structures. The 
Agency is proposing editorial changes to Sec.  165.87(a)(3) to remove 
``secondary'' in this paragraph and to change ``materials'' to 
``substances,'' similar to the proposed change in the corresponding 
regulations for new containment structures in Sec.  165.85.
    The Agency is proposing an editorial change to Sec.  165.87(d) to 
clarify that the word ``existing'' in paragraph (d) applies to an 
existing secondary containment unit and not the pesticide containers 
themselves.
    The Agency is proposing to change Sec.  165.87 to state that dry 
pesticide container storage areas must have a floor, and to make 
editorial changes for clarity, similar to the corresponding changes to 
Sec.  165.85(f) for new structures.
    4. Operational, inspection and maintenance requirements for all new 
and existing containment structures. The Agency is proposing changes to 
the timing requirements for cleanup of spills in Sec.  165.90(a)(2) and 
for repair of containment structures in Sec.  165.90(b)(2). The Agency 
is proposing to change language that currently requires cleanup or 
repair by the end of the day to allow additional time to complete 
cleanup or repair in a situation in which attempting cleanup or repair 
may result in hazards that may be avoided if cleanup or repair were 
reasonably delayed. In most cases, and for routine spills and leaks, 
the requirement for cleanup by the end of the day would still apply. 
The Agency is requesting comment on this approach and the proposed 
language.
    The Agency is proposing to change Sec.  165.90(b)(3), which 
prohibits facilities from storing pesticide on a structure that needs 
to be repaired. EPA proposes to revise this paragraph to not allow any 
additional pesticide to be stored on a containment structure in need of 
repair. This change was made for practical reasons, i.e., to allow 
product already stored on that containment structure to remain so as 
not to require movement of pesticide containers. There is potentially 
greater risk from transferring pesticide products outside of a 
containment structure (and then back after repairs have been made) than 
to repair a structure while pesticide products remain on the 
containment structure. Also, the Agency is proposing to delete the 
second sentence from Sec.  165.90(b)(3) because it would not be 
necessary after making this change.
    The Agency is also proposing to revise Sec.  165.90(b)(1) to 
clarify that the containment structures themselves must be inspected 
monthly, in addition to the containers and appurtenances. This is 
implied in the existing recordkeeping requirements (see Sec.  
165.95(a)), but EPA is proposing to modify this paragraph to make the 
requirement explicit.
    5. States with existing containment programs. The Agency is 
proposing an editorial change to Sec.  165.97(b)(1) to correct the term 
``States'' to read ``State's.''

VI. Economic Impacts

    EPA prepared two Economic Analyses (EAs) of the potential costs and 
benefits associated with the August 16, 2006, Container and Containment 
Rule, one for the container requirements and another for the 
containment requirements. The EAs, entitled ``Economic Analysis of the 
Pesticide Container Design and Residue Removal Standards'' and 
``Economic Analysis of the Bulk Pesticide Containment Structure 
Regulations,'' are available in the docket for the pesticide Container 
and Containment Rule under docket identification number EPA-HQ-OPP-
2005-0327. The Agency has prepared an addendum to these EAs to address 
the potential changes in the estimated impacts resulting from this 
proposed rule. The addendum to the EA, entitled ``Addendum to the June 
1, 2006, Economic Analysis of the Bulk Pesticide Container Design and 
Residue Removal Standards'' is briefly summarized here, and is 
available in the docket for this rulemaking.

[[Page 33043]]

    EPA estimated the total annual cost of the August 16, 2006, 
Container and Containment Rule to be $11.3 million ($8.37 million for 
containers plus $2.93 million for containment) and the total annual 
benefits from the final rule to be $17 to $23.4 million. When the 
estimated cost of the August 16, 2006, rule is adjusted to consider the 
amendments being proposed, there is an annual cost reduction of 
approximately $0.23 to $0.32 million due to a reduction in the number 
of labels that would need to be revised. There is no difference in the 
total annual benefits from the August 16, 2006, rule.

VII. FIFRA Mandated Reviews

    In accordance with FIFRA sec. 25(a), the Agency submitted a draft 
of this proposed rule to the Committee on Agriculture in the House of 
Representatives, the Committee on Agriculture, Nutrition, and Forestry 
in the United States Senate, and the FIFRA Scientific Advisory Panel 
(SAP). The Secretary of Agriculture waived review of this proposed 
rule.

VIII. 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 proposed rule is not a 
``significant regulatory action'' because these requirements will not 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order. As such, this proposed rule is not subject to review under 
Executive Order 12866.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
or activities requiring approval under the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq. The information collection activities contained in 
the existing regulations are already approved under OMB control number 
2070-0133, and are also identified under EPA ICR No. 1632. 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 in 40 CFR 
are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

     Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed 
rule does not have a significant adverse economic impact on a 
substantial number of small entities. This proposed rule is expected to 
result in a slight 2% to 3% decrease in the estimated total costs of 
the Container and Containment Rule. As such, there are not expected to 
be any adverse economic impacts of affected entities, regardless of 
their size. The factual basis for the Agency's determination is 
presented in the addendum to the EA, entitled ``Addendum to the June 1, 
2006, Economic Analysis of the Bulk Pesticide Container Design and 
Residue Removal Standards,'' prepared for this proposed rule, which is 
summarized in Unit VI., and a copy of which is available in the docket 
for this rulemaking. 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 this proposed rule on small entities, small 
entity is defined in accordance with the RFA as: (1) A small business 
as defined by the Small Business Administration's (SBA) regulations at 
13 CFR 121.201; (2) a small governmental jurisdiction that is a 
government of a city, county, town, school district, or special 
district with a population of less than 50,000; and (3) a small 
organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field.
     Based on the industry profiles that EPA prepared as part of the 
EAs for the 2006 rulemaking, EPA determined that the 2006 rulemaking 
was not expected to impact any small not-for-profit organizations or 
small governmental jurisdictions. Since this is a proposed amendment to 
that rulemaking, EPA has determined that this determination also 
applies to this proposed rule. As such, ``small entity''for purposes of 
the addendum EA prepared for this proposed rule, is synonymous with 
``small business.'' Using the size standards established by the Small 
Business Administration, ``small businesses'' potentially impacted by 
this proposed rule are expected to include the same types of businesses 
described in the EAs prepared for the 2006 rulemaking. As indicated in 
those EAs, the small business size standard varies based on the primary 
NAICS code associated with the business. Specifically, the small 
businesses size standards varies from 100 or fewer workers (e.g., NAICS 
422910, Farm Suppliers Wholesalers) to 1,000 or fewer workers (e.g., 
NAICS 325188, Inorganic Chemical Manufacturing), with the majority of 
small businesses having 500 or fewer workers (e.g., 325320, Pesticide/
Agricultural Chemical Manufacturing).
     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. EPA 
solicits comments specifically about potential small business impacts.

D. Unfunded Mandates Reform Act

    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. Since State, 
local, and tribal governments are rarely pesticide applicants or 
registrants, this rule is not expected to affect small governments and 
contains no regulatory requirements that might significantly or 
uniquely affect small governments. 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 proposed 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. Thus, Executive Order 13132 does not apply to 
this proposed 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.

[[Page 33044]]

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 VIII.A.), nor does it establish an environmental 
standard that is intended to have a negative or disproportionate effect 
on children. EPA interprets Executive Order 13045 as applying only to 
those regulatory actions that concern health or safety risks, such that 
the analysis required under section 5-501 of the Executive Order has 
the potential to influence the regulation. This action does not 
establish an environmentalstandard intended to mitigate health or 
safety risks.

H. Executive Order 13211

    This proposed rule is n