[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Proposed Rules]
[Pages 56918-56944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27397]



[[Page 56917]]

_______________________________________________________________________

Part VII





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 165



Standards for Pesticide Containers and Containment; Proposed Rule

  Federal Register / Vol. 64, No. 203 / Thursday, October 21, 1999 / 
Proposed Rules  

[[Page 56918]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 165

[OPP-190001A; FRL-5776-3]
RIN 2070-AB95


Standards for Pesticide Containers and Containment

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule; partial reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: EPA issued a proposed rule in the Federal Register proposing 
container design and residue removal requirements for refillable and 
nonrefillable pesticide containers and standards for pesticide 
containment structures. (59 FR 6712, Feb. 11, 1994). EPA is today 
reopening the comment period to obtain public comment on three issues 
brought out in the comments on the proposed rule or by recently enacted 
legislation and on one other issue. EPA is considering changes that 
would 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. EPA is also 
seeking comment on the definition for small business used to identify 
small pesticide formulators, agrichemical dealers and commercial 
pesticide applicators in the small entity impact analysis. These 
potential changes, if adopted in the final rule, would support EPA's 
goal of pollution prevention by promoting the use of refillable 
containers and would harmonize and promote consistency within the 
Federal packaging standards by adopting the DOT standards. In addition, 
the changes would decrease the estimated economic impact by reducing 
the number of pesticide products subject to the container requirements 
compared to the original proposal.
DATES: Comments, identified by the docket number OPP-190001A, must be 
received on or before December 20, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the ``SUPPLEMENTARY INFORMATION'' section of 
this notice.
FOR FURTHER INFORMATION CONTACT: Nancy Fitz, Office of Pesticide 
Programs (7506C), 401 M St., SW, Washington, DC 20460; telephone number 
(703) 305-7385; and e-mail address: [email protected].
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. However, the issues addressed in this action apply mainly 
to pesticide formulators. Potentially affected categories and entities 
may include, but are not limited to:

------------------------------------------------------------------------
                                                         Examples of
           Categories               NAICS     SIC   Potentially Affected
                                                          Entities
------------------------------------------------------------------------
Pesticide formulators...........      32532   2879  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............      44422   5191  Retail dealers that
                                                     distribute or sell
                                                     pesticides to
                                                     agricultural users.
Independent commercial               115112   0721  Businesses that
 applicators.                                        apply pesticides
                                                     for compensation
                                                     (by aerial and/or
                                                     ground application)
                                                     and that are not
                                                     affiliated with
                                                     agrichemical
                                                     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 above could also be 
affected. The Standard Industrial Classification (SIC) codes and the 
North American Industrial Classification System (NAICS) codes have been 
provided to assist you and others in determining whether or not this 
action applies to certain entities. To determine whether you or your 
business is affected by this action, you should carefully examine the 
applicability provisions in Unit VII of this document and in 
Secs. 165.100, 165.120, 165.122, 165.140, 165.141, and 165.142 of the 
original proposed rule (59 FR 6712, February 11, 1994). If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document and various support documents from the EPA internet Home Page 
at http://www.epa.gov/. On the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register - Environmental Documents.'' You can also go 
directly to the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/.
    2. Fax on Demand. You may request to receive a faxed copy of this 
document, as well as some supporting information, if available, by 
using a faxphone to call (202) 401-0527 and selecting item 6077. You 
may also follow the automated menu.
    3. In person. The EPA has established an official record for this 
action under docket control number OPP-190001A. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. A public version of this record, including printed, 
paper versions of any electronic comments submitted during the comment 
period, is available for inspection in the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The PIRIB telephone 
number is 703-305-5805.

C. How and to Whom do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To

[[Page 56919]]

ensure proper receipt by EPA, it is imperative that you identify docket 
control number OPP-190001A in the subject line on the first page of 
your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW, Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is 703-305-5805.
    3.  Electronically. You may submit your comments electronically by 
e-mail to: [email protected] or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 5.1/
6.1 or ASCII file format. All comments in electronic form must be 
identified by the docket control number OPP-190001A. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit in response to this 
document as CBI by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the comment that does 
not contain CBI must be submitted for inclusion in the public version 
of the official record. Information not marked confidential will be 
included in the public version of the official record by EPA without 
prior notice. If you have any questions about CBI or the procedures for 
claiming CBI, please consult with the person identified in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views on the various options we 
discuss in this document, new approaches we haven't considered, the 
potential impacts of the various options (including possible unintended 
consequences), and any data or information that you would like the 
Agency to consider during the development of the final action. You may 
find the following suggestions helpful for preparing your comments:
     Explain your views as clearly as possible.
     Describe any assumptions that you use.
     Provide solid technical information and/or data to support 
your views.
     If you estimate potential burden or costs, explain how you 
arrive at the estimate.
     Tell us what you support, as well as what you disagree 
with.
     Provide specific examples to illustrate your concerns.
     Offer alternative ways to improve the rule.
     Make sure to submit your comments by the deadline in this 
notice.
     To ensure proper receipt by EPA, be sure to identify the 
docket control number assigned to this action in the subject line on 
the first page of your response. You may also provide the name, date, 
and Federal Register citation.

II. Background

A. Statutory Background

    Sections 19(e) and (f) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (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 regulations may:
    (1) Specify, for each major type of pesticide container, procedures 
and standards for, at a minimum, triple rinsing or the equivalent 
degree of pesticide removal.
    (2) Specify procedures that can be implemented promptly and easily 
in various circumstances and conditions.
    (3) Provide for reusing, whenever practicable, or disposing of 
rinse water and residue.
    (4) Coordinate with requirements imposed under the Resource 
Conservation and Recovery Act (RCRA) for rinsing containers.
    Section 19(f) provides that EPA, in its discretion, may exempt 
products intended solely for household use.
    In addition, section 19(h), titled ``Relationship to Solid Waste 
Disposal Act,'' specifies that nothing in section 19 shall diminish the 
authorities or requirements of RCRA.
    The Food Quality Protection Act (FQPA) of 1996 amended section 
19(h) of FIFRA to add an exemption for certain antimicrobial 
pesticides. Since this new statutory language was not in existence at 
the time of the original proposed rule, EPA seeks comment on EPA's 
interpretation of how this statutory exemption applies to the proposed 
container regulations.
    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) 
requires an agency to prepare a regulatory flexibility analysis for any 
rule for which the agency is required to issue a notice of proposed 
rulemaking under the Administrative Procedures Act or any other 
statute, unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
For the purpose of analyzing potential impacts on small entities, 
section 601(6) of the RFA defines small entities to include small 
governments, small non-profit organizations, and small businesses, 
which are also further defined in section 601. The definition of small 
business provided in section 601(3) uses the definition of small 
business in section 3 of the Small Business Act, 15 U.S.C. 632, under 
which the Small Business Administration (SBA) establishes small 
business size standards. 13 CFR 121.201.
    In analyzing potential impacts, the RFA recognizes that it may be 
appropriate at times to use an alternate definition of small business. 
As such, section 601(3) of the RFA provides that an agency may 
establish a different definition of small business after consultation 
with the SBA Office of Advocacy and after notice and an opportunity for 
public comment. In this document, EPA seeks comments on the ``small 
business'' definitions used to identify potentially affected small 
entities in the initial regulatory

[[Page 56920]]

flexibility analysis that was prepared for the 1994 proposed rule, 
i.e., for identifying small pesticide formulators, small agrichemical 
dealers, and small commercial pesticide applicators.

B. Regulatory Background

    In a Notice of Proposed Rulemaking issued on February 11, 1994 (59 
FR 6712) (Ref. 1), EPA proposed standards for pesticide containers and 
containment structures. 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 proposed rule closed on July 11, 
1994. EPA received about 1,900 pages of comments from over 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. A 
summary of these comments is available in the docket. (Ref. 2)
    EPA received many comments during the public comment period on two 
of the issues being re-opened for comment in this document; 
specifically, the scope of the container standards and the relationship 
between the 1994 proposed rule and the Department of Transportation 
(DOT) standards for hazardous materials packaging. For each of these 
issues, a brief summary of the comments and a description of a modified 
regulatory option being considered are provided.

III. Scope of the Container Standards

A. Background on 1994 Proposal

    In the February 1994 Notice of Proposed Rule Making (NPRM), EPA 
proposed that the container standards would generally apply to all 
pesticides and all containers, regardless of the pesticide market 
sector (e.g., agricultural, industrial, institutional, household, 
etc.), the type of pesticide (e.g., insecticide, herbicide, sanitizer, 
disinfectant, etc.), or the type of container (e.g., plastic jug, steel 
drum, paper bag, minibulk tank, etc.). Where appropriate, EPA proposed 
a limited applicability for specific requirements. For example, the 
proposed nonrefillable container dispensing capability standards would 
only apply to containers holding liquid pesticides, i.e., those 
containers that have the potential to drip or ``glug'' (the common 
industry term for not pouring in a continuous, coherent stream) during 
pouring.
    During the public comment period, many commenters opposed the broad 
scope of the proposed container standards and requested EPA to exempt a 
specific subset of pesticides from the scope of the container 
requirements. The categories of pesticides that were suggested for 
exemption from the rule include: (1) Lower-risk pesticides; (2) 
nonagricultural pesticides in general; (3) antimicrobial pesticides; 
(4) swimming pool chemicals; (5) industrial biocides; and (6) 
disinfectants and/or sanitizers. To support the exemption requests, 
commenters generally argued that the pesticides suggested for exemption 
pose lower risk than agricultural pesticides (e.g., active ingredients 
that are less toxic, less persistent, more biodegradable, and/or at a 
lower concentration, and the pesticides are in smaller containers, 
etc.); that the containers suggested for exemption are handled 
differently than containers for agricultural pesticides; and/or it 
would be more burdensome for these pesticides/containers to come into 
compliance than for agricultural pesticides/containers. See the comment 
summary document (Ref. 2) for more information.

B. Regulatory Option Under Consideration

    EPA is considering exempting some pesticides and containers from 
the final container rule. However, rather than exempting products based 
on the pesticide market sector or the type of pesticide, EPA believes 
it is more appropriate to exempt pesticides based on the relative risk 
they pose.
    Under the regulatory option being considered for defining the 
general scope of the rule (i.e., for pesticides other than 
antimicrobial products that are eligible for exemption), a pesticide 
product would be subject to the container standards if the product met 
at least one of the criteria being considered: (1) The product is 
classified in Toxicity Category I or II; (2) the container capacity is 
greater than or equal to the container size criterion of 5 liters (1.3 
gallons) or 5 kilograms (11 pounds); or (3) the product is intended for 
outdoor use and the label includes at least one of the specified 
environmental hazard statements. If the product does not meet any of 
these criteria, it would not be subject to the container standards. 
(See Unit IV of this document for a discussion of which antimicrobial 
pesticides would be subject to the container standards.)

C. Discussion

    1. General principle of risk. When considering which pesticides 
should be subject to the pesticide container regulations, it is worth 
reviewing the goals of the proposed container standards, which include:
     Ensuring that pesticide containers are strong and durable 
to minimize container failures and the subsequent releases of pesticide 
to the environment
     Minimizing human exposure during container handling, e.g., 
loading and unloading the container, container cleaning, and management 
before disposal
     Facilitating container disposal and recycling
     Minimizing cross-contamination in refillable containers
     Codifying safe refilling management practices
    Failure to attain any of these goals could lead to unreasonable 
adverse effects on the environment. For example, the first item relates 
to an event that can easily be visualized as causing people or the 
environment to be directly exposed to pesticides -- a container fails 
and releases the pesticide. Regarding the second item, a pesticide user 
could be exposed if pesticide splashes or drips from a container while 
the user is handling the container. Under exposure scenarios such as 
these (or under pesticide exposures during container disposal or 
recycling, from cross-contamination or from unsafe refilling 
practices), unreasonable adverse effects would be more likely to occur 
with pesticides that are higher-risk than with pesticides that are 
lower-risk. Therefore, EPA has considered several characteristics of 
pesticides and containers to distinguish between those that are higher-
risk and those that are lower-risk in such situations.
    2. Toxicity criteria. One factor in distinguishing higher-risk 
pesticides is the toxicity of the pesticide. EPA is considering the 
following criteria to identify the higher-toxicity, higher-risk 
pesticides for general inclusion in the container rule:
    i. Toxicity Category I classification
    ii. Toxicity Category II classification
    iii. One of several environmental hazard statements (e.g. ``This 
pesticide is toxic to wildlife.'') on their labels.
    The regulations in 40 CFR 156.10(h) define four categories that 
account for human toxicity, with Toxicity Category I including the most 
toxic pesticides and Toxicity Category IV the least toxic.

[[Page 56921]]

 These categories are based on hazard information, including the oral 
LD50, inhalation LC50, dermal LD50, 
eye effects, and skin effects of the pesticide. The following table 1 
describes the hazard indicators defining each toxicity category as set 
out in Sec. 156.10(h)(1), the human hazard signal word for each as 
required by Sec. 156.10(h)(1)(i), and the precautionary statements 
regarding hazard to humans and domestic animals set forth in 
Sec. 156.10(h)(2)(i)(B).

                   Table 1.--Information on Toxicity Categories as set out in 40 CFR 156.10(h)
----------------------------------------------------------------------------------------------------------------
                                                                Toxicity Categories
                                 -------------------------------------------------------------------------------
                                           I                  II                  III                 IV
----------------------------------------------------------------------------------------------------------------
Hazard Indicators...............
   Oral LD50....................  Up to and           From 50 thru 500    From 500 thru       Greater than 5,000
                                   including 50 mg/    mg/kg.              5,000 mg/kg.        mg/kg
                                   kg.
 
   Inhalation LC50..............  Up to and           From 0.2 thru 2 mg/ From 2 thru 20 mg/  Greater than 20 mg/
                                   including 0.2 mg/   kg.                 kg.                 kg
                                   kg.
 
   Dermal LD50..................  Up to and           From 200 thru       From 2,000 thru     Greater than
                                   including 200 mg/   2,000 mg/kg.        20,000 mg/kg.       20,000 mg/kg
                                   kg.
 
   Eye effects..................  Corrosive; corneal  Corneal opacity     No corneal          No irritation.
                                   opacity not         reversible within   opacity;
                                   reversible within   7 days;             irritation
                                   7 days.             irritation          reversible within
                                                       persisting for 7    7 days.
                                                       days.
 
   Skin effects.................  Corrosive.........  Severe irritation   Moderate            Mild or slight
                                                       at 72 hours..       irritation at 72    irritation at 72
                                                                           hours.              hours.
 
Required Label Language.........
 
  Human hazard signal word......  ``Danger''; and in  ``Warning''.......  ``Caution''.......  ``Caution''
                                   some cases:
                                   ``Poison'' and
                                   the skull and
                                   crossbones.
 
  Precautionary statements        Fatal (poisonous)   May be fatal if     Harmful if          [No precautionary
   regarding hazard to humans      if swallowed        swallowed           swallowed           statements
   and domestic animals: oral,     [inhaled or         [inhaled or         [inhaled or         required.]
   inhalation, or dermal           absorbed through    absorbed through    absorbed through
   toxicity.                       skin]. Do not       skin]. Do not       skin]. Avoid
                                   breathe vapor       breathe vapor       breathing vapors
                                   [dust or spray      [dust or spray      [dust or spray
                                   mist]. Do not get   mist]. Do not get   mist]. Avoid
                                   in eyes, on skin,   in eyes, on skin,   contact with skin
                                   or on clothing.     or on clothing      [eyes or
                                   [Front panel        [Appropriate        clothing].
                                   statement of        first aid           [Appropriate
                                   practical           statement           first aid
                                   treatment           required.].         statement
                                   required.].                             required.].
 
  Precautionary statements        Corrosive, causes   Causes eye [and     Avoid contact with  [No precautionary
   regarding hazard to humans      eye and skin        skin] irritation.   skin, eyes or       statements
   and domestic animals: skin      damage [or skin     Do not get in       clothing. In case   required.]
   and eye local effects.          irritation]. Do     eyes, on skin, or   of contact
                                   not get in eyes,    on clothing.        immediately flush
                                   on skin, or on      Harmful if          eyes or skin with
                                   clothing. Wear      swallowed.          plenty of water.
                                   goggles or face     [Appropriate        Get medical
                                   shield and rubber   first aid           attention if
                                   gloves when         statement           irritation
                                   handling. Harmful   required.].         persists.
                                   or fatal if
                                   swallowed.
                                   [Appropriate
                                   first aid
                                   statement
                                   required.].
----------------------------------------------------------------------------------------------------------------

    Because these categories cover the full range of toxicities in a 
continuum, it is difficult to make a clear-cut distinction among them. 
However, EPA is considering an option that would specify the two most 
hazardous groups -- Toxicity Categories I and II -- as criteria for 
pesticides that would be subject to the container standards. EPA 
believes it is appropriate to use classification in Toxicity Categories 
I and II as criteria for inclusion in the container standards, because 
it would include, by the definitions given in table 1, the most toxic 
pesticides. In addition, the specified label language seems to indicate 
a notable difference in the hazard posed by pesticides in Toxicity 
Category II and those in Toxicity Category III.
    The United States is participating in a global effort to harmonize 
the classification and labeling of chemicals for human and 
environmental hazards, which is being lead by international agencies 
such as the Organization for Economic Cooperation and Development 
(OECD), World Health Organization, International Labor Organization and 
the United Nations Committee of Experts on the Transport of Dangerous 
Goods. OECD is the focal point for the harmonization of classification 
for health and environmental hazards, including toxicity endpoints for 
acute toxicity, reproductive toxicity, carcinogenicity, mutagenicity, 
sensitization, irritation and corrosion, and target organ effects and 
environmental endpoints for aquatic and terrestrial effects. The 
harmonized system is to be based on the intrinsic nature of all 
chemicals and mixtures regardless of their intended use (certain 
chemicals have both pesticide and non-pesticidal uses).
    The global harmonization effort is still under negotiation. A basic 
principle of the effort is that the level of protection should not be 
reduced. Hazard categories will be defined, but countries will select 
elements deemed appropriate for regulating transport, worker and 
environmental protection. However, there may be new definitions of each 
toxicity category, particularly with regard to inhalation toxicity, and 
the number of products captured by each may expand or contract. Since 
in this notice EPA is considering an approach of exempting certain 
pesticide products from the container standards based on

[[Page 56922]]

their toxicity category, any change in the toxicity classification may 
change the universe of products subject to the container rule. If the 
final criteria for toxicity categories differ significantly from those 
currently used by EPA, a clarification of the products subject to the 
container standards can be included in the final rule.
    EPA believes it is important and necessary to also account for 
environmental factors when evaluating the risk posed by pesticide 
containers. The approach EPA is currently considering is to rely on 
whether or not at least one of the environmental hazard statements is 
included on the label. Some environmental hazard statements are 
required by 40 CFR 156.10(h)(2)(ii). For the purposes of the regulatory 
option being considered here, EPA is looking at the following 
environmental hazard statements (label statements) or similar warnings 
or precautionary statements pertaining to wildlife, fish, birds, or 
groundwater:
     This pesticide is toxic (or extremely toxic) to wildlife.
     This pesticide is toxic (or extremely toxic) to fish.
     This pesticide is toxic (or extremely toxic) to birds.
     This chemical is known to leach through soil into ground 
water under certain conditions as a result of agricultural use. Use of 
this chemical in areas where soils are permeable, particularly where 
the water table is shallow, may result in ground-water contamination.
     This chemical demonstrates the properties and 
characteristics associated with chemicals detected in ground water. Use 
of this chemical in areas where soils are permeable, particularly where 
the water table is shallow, may result in ground-water contamination.
    EPA believes it is appropriate to consider only realistic 
environmental exposure scenarios. For example, it is possible that the 
label of a pesticide product for indoor use could have one of the 
environmental hazard statements, such as ``This pesticide is toxic to 
fish.'' In this case, the chance of fish in the environment being 
exposed if the container fails is very small, since the container would 
most likely be stored and the pesticide used inside. Therefore, in the 
regulatory option being considered, the environmental hazard criterion 
would apply only to pesticides intended for outdoor use.
    EPA is considering specifying several environmental hazard criteria 
in addition to the label statements listed earlier. Some pesticides are 
classified as restricted use for environmental or ecological reasons. 
EPA is considering adding this criterion (classification as restricted 
use for environmental or ecological reasons) to help distinguish the 
higher-risk pesticides in terms of environmental risk. However, EPA 
believes that pesticides that meet this criterion would most likely 
have at least one of the specified environmental hazard statements on 
their labels. EPA is also considering adding a criterion for 
``biological activity'' or phytotoxicity to include pesticides that are 
applied at low application rates. Low application rate pesticides may 
not trigger the container size criterion since only small volumes are 
used. However, a small release of a low application rate herbicide may 
still pose significant risks in the environment, because such 
pesticides are designed and intended to be effective in low doses. 
These potential criteria are not included in the draft regulatory 
language in this document, although EPA may decide to include one or 
both of them in the final rule.
    3. Container size criterion. In addition, EPA is concerned that 
even products that don't meet any of the higher-toxicity criteria may 
pose a significant risk if they are present in large enough quantities. 
Therefore, EPA is also considering container size as a criterion for 
defining the scope of the container standards. EPA is currently 
considering a size criterion of 5.0 liters (1.3 gallons) for containers 
holding liquid formulations and 5.0 kilograms (11.0 pounds) for 
containers holding solid formulations. These sizes were selected to be 
consistent with the limited quantity exceptions in the DOT Hazardous 
Materials Regulations (HMR) in 49 CFR parts 171-180. As described in 
Unit V of this document, many commenters strongly urged EPA to be 
consistent with the DOT HMR which would include adopting the DOT 
limited quantity exceptions. Therefore, EPA believes it is appropriate 
to base a container size criterion on the package sizes delineated in 
the DOT limited quantity exceptions.
    4. General discussion. The flow chart below depicts the changes 
being considered for the scope of the container standards for 
pesticides other than antimicrobial pesticides that are eligible for 
exemption. The changes to the scope and applicability provisions would 
be the same for nonrefillable containers (in proposed subpart F) and 
refillable containers (in proposed subpart G). Under the approach being 
considered for the general scope (and as shown in the flow chart), the 
container standards would not apply to manufacturing use products, as 
proposed in 1994. Regarding products other than manufacturing use 
products, if the pesticide product meets at least one of the criteria 
being considered (i.e., Toxicity Category I, Toxicity Category II, 
greater than (or equal to) the minimum container size, or outdoor use 
products with one of the label environmental hazard statements) then 
the product would be subject to the container standards. If the product 
did not meet any one of these criteria, it would not be subject to the 
container standards. Potential alternative regulatory text that is 
being considered for the final rule is provided in Unit VII of this 
document.

BILLING CODE 6560-50-F

[[Page 56923]]

[GRAPHIC] [TIFF OMITTED] TP21OC99.002



BILLING CODE 6560-50-C
    EPA believes that it has authority to reduce the scope of these 
regulations. FIFRA section 19(e) requires EPA to promulgate regulations 
that 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, but provides the EPA with much discretion in accomplishing 
this goal. In addition, FIFRA section 25(b) allows EPA to exempt (by 
regulation) any pesticide from the requirements of FIFRA if EPA 
determines that pesticide to be of a character which is unnecessary to 
be subject to FIFRA in order to carry out the purposes of FIFRA.
    Under the changes being considered to the scope of the container 
rule, the standards would not apply to small containers holding 
pesticides in Toxicity Category III or IV that don't have any of the 
environmental hazard statements on their labels or that have at least 
one of the environmental hazard statements but are not intended for 
outdoor use. EPA believes it is appropriate to exclude these groups of 
pesticides and containers from regulation because the relatively small 
risk to humans and the environment if the container fails, due to their 
low toxicity, small quantity and/or limited exposure to the 
environment, is not commensurate with the costs of imposing the 
standards on these pesticides and containers.
    These potential changes to the scope of the proposed rule are being 
considered only for the container design and residue removal standards 
in subparts F and G -- not for the proposed modifications to the 40 CFR 
part 156 label provisions. 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. EPA believes that FIFRA sections 19(e) 
and (f) provide the Agency with the authority to make this 
determination.

D. Request for Comments

    EPA solicits comments on the potential modifications to the scope 
and applicability of the container standards. In addition to any 
general comments on the approach being considered, EPA requests 
comments on the following specific issues. (1) Is it appropriate to 
apply the container standards only to the higher-risk pesticides? (2) 
Are the criteria being considered by EPA to distinguish between higher-
risk and lower-risk pesticides appropriate? (3) In particular, is 
container size a reasonable factor to consider and, if so, is the 
suggested size criterion appropriate or should EPA adopt a different 
size limit? (4) Should alternative or additional environmental hazard 
criteria, such as those described in Unit III.C.2 of this document be 
considered? (5) Are there certain container types (e.g., glass 
containers) that are sufficiently unsafe that such container types 
should be regulated for all pesticides? (6) Should the potential 
modifications to the scope be made to the container-related provisions 
only or should the changes also be made to the proposed label 
standards?

 IV. Antimicrobial Exemption

A. Statutory Background

    The Food Quality Protection Act (FQPA) of 1996, Public Law No. 104-
170, amended section 19 of FIFRA to exempt certain types of 
antimicrobial pesticides 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

[[Page 56924]]

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.


    Since this language was added after the pesticide container and 
containment rule was proposed, EPA believes it is appropriate to 
solicit public comment on the applicability of this provision to the 
proposed container regulations. In addition, EPA must interpret the 
antimicrobial exemption provision to answer two broad questions. First, 
what is the scope of ``household, industrial, or institutional 
antimicrobial product[s] that [are] not subject to regulation under the 
Solid Waste Disposal Act''? Second, which ``product[s] must be subject 
to [the container] provisions to prevent an unreasonable adverse effect 
on the environment''?

B. Scope of the Antimicrobial Exemption

    1. Regulatory option under consideration. EPA believes that a 
``household, industrial, or institutional antimicrobial product that is 
not subject to regulation under the Solid Waste Disposal Act'' is a 
pesticide product that meets all of the following criteria. (i) The 
product meets the definition of ``antimicrobial pesticide'' in section 
2(mm) of FIFRA; (ii) the product is classified in at least one of the 
following antimicrobial product use categories: (a) food handling/
storage establishments premises and equipment; (b) commercial, 
institutional, and industrial premises and equipment; (c) residential 
and public access premises; (d) medical premises and equipment; (e) 
materials preservatives; (f) industrial processes and water systems; 
(g) antifouling coatings; (h) wood preservatives; or (i) swimming 
pools; and (iii) the product is not subject to regulation under the 
Resource Conservation and Recovery Act as a hazardous waste when it 
becomes a waste.
    2. Discussion. The first criterion above requires an 
``antimicrobial product'' to be an ``antimicrobial pesticide,'' as 
defined in FIFRA. Section 2(mm) of FIFRA provides the following 
definition for an antimicrobial pesticide.
     (1) IN GENERAL.--The term `antimicrobial pesticide' means a 
pesticide that--
    (A) is intended to-- (i) disinfect, sanitize, reduce, or 
mitigate growth or development of microbiological organisms; or
    (ii) 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 exempt from, or otherwise not subject 
to, a tolerance under section 408 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 346a and 348) or a food additive regulation 
under section 409 of such Act.
    (2) EXCLUDED PRODUCTS.--The term `antimicrobial pesticide' does 
not include --
    (A) a wood preservative or antifouling paint product for which a 
claim of pesticidal activity other than or in addition to an 
activity described in paragraph (1) is made;
    (B) an agricultural fungicide product; or
    (C) an aquatic herbicide product.
    (3) INCLUDED PRODUCTS.--The term `antimicrobial pesticide' does 
include any other chemical sterilant product (other than liquid 
chemical sterilant products exempt under subsection (u)), any other 
disinfectant product, any other industrial microbiocide product, and 
any other preservative product that is not excluded by paragraph 
(2).


    Because this is a very complex definition, EPA considered using a 
more straightforward definition for ``antimicrobial product.'' 
Specifically, EPA considered defining ``antimicrobial product'' to be 
any product covered under section (1)(A) of the definition of 
``antimicrobial pesticide'' in FIFRA section 2(mm), without taking the 
remainder of that definition into account. However, EPA rejected this 
approach because the Agency is unaware of evidence that indicates 
Congress intended ``antimicrobial products'' to be different than 
``antimicrobial pesticides.'' Additionally, EPA believes that 
distinguishing between ``antimicrobial products'' and ``antimicrobial 
pesticides'' could be confusing to regulators and the regulated 
industry and could pose enforcement problems. If a pesticide product is 
not included in the definition of antimicrobial pesticide (e.g., if it 
is excluded by paragraph (2) of the definition), it is not eligible for 
the antimicrobial product exemption from the container standards and, 
thus, is subject to the general scope criteria as discussed in Unit III 
of this document.
    The second criterion for defining the scope of the antimicrobial 
exemption states that a pesticide product is a ``household, industrial, 
or institutional'' product if it is classified in at least one of nine 
specified antimicrobial product use categories.
    In response to other FQPA provisions pertaining to antimicrobial 
pesticides, EPA is developing regulations on the registration of 
antimicrobial pesticides and the associated data requirements. In its 
proposal on data requirements (that would amend 40 CFR part 158), EPA 
intends to categorize all antimicrobial uses into one of the following 
12 use categories. All currently registered antimicrobial use patterns 
are included in one of these larger use classifications for data 
requirement purposes, but EPA has not to date classified the existing 
use patterns in this organized fashion.
     Agricultural premises and equipment
     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
     Swimming pools
     Aquatic areas
The list of the 12 use categories with all of the appropriately 
classified use sites is included in the docket (Ref. 3).
    In today's document, EPA is considering the approach of identifying 
nine of these use categories to identify ``household, industrial, or 
institutional'' antimicrobial products. Specifically, EPA believes that 
the following nine use categories generally fit within the common 
understanding of household, industrial and institutional uses:
     Food handling/storage establishments premises and 
equipment
     Commercial, institutional, and industrial premises and 
equipment
     Residential and public access premises
     Medical premises and equipment
     Materials preservatives
     Industrial processes and water systems
     Antifouling coatings
     Wood preservatives
     Swimming pools
    The other three categories, which are listed below, would not be 
considered household, industrial, or institutional uses because they 
fall outside the common understanding of these uses:
     Agricultural premises and equipment
     Human drinking water systems
     Aquatic areas
    EPA considered developing definitions for household, industrial, 
and institutional use, but rejected this approach because of the 
difficulty in distinguishing among these pesticide market sectors. EPA 
believes that relying on the antimicrobial product use categories in 
the antimicrobial registration data requirements rule to distinguish 
between ``household, industrial, and institutional antimicrobial 
products'' and all others

[[Page 56925]]

for the purposes of the container rule will offer a consistent approach 
to the definitional issues involved with this criterion. There may be 
implementation issues with this approach since it is unlikely that the 
pesticide container and containment rule and the rule on antimicrobial 
pesticide registration data requirements will be finalized at the same 
time. However, EPA will coordinate between these rules to ensure 
consistency and proper notice to the public on the issue of 
antimicrobial product use categories.
    The third criterion for defining the scope of the antimicrobial 
exemption establishes that a pesticide product ``is not subject to 
regulation under the Solid Waste Disposal Act'' if it is not subject to 
regulation under the Resource Conservation and Recovery Act as a 
hazardous waste when it becomes a waste. The Solid Waste Disposal Act 
(SWDA) is the Federal waste management statute, which is commonly 
referred to as the Resource Conservation and Recovery Act (RCRA), 42 
U.S.C. 6901 to 6992k. (Technically, RCRA was the name of the law that 
extensively amended the SWDA in 1976.) The terms ``RCRA'' and ``SWDA'' 
are used synonymously in this document.
    EPA believes that the intent of the statutory language in question 
-- ``that is not subject to regulation under the SWDA'' -- is to 
include in the antimicrobial exemption household, industrial, or 
institutional antimicrobial products that are not subject to regulation 
under RCRA as hazardous wastes when they become wastes. If a household, 
industrial, or institutional antimicrobial product would be classified 
as a hazardous waste when it becomes a waste (either by being on one of 
the RCRA hazardous waste lists or by meeting one of the hazardous waste 
characteristics), then the product would not be eligible for the FIFRA 
section 19(h) exemption. An initial review showed that none of the 
``listed hazardous waste pesticides'' are antimicrobial pesticides. EPA 
believes that most household, industrial, and institutional 
antimicrobial products would not be subject to regulation under RCRA as 
hazardous wastes when they become wastes and, therefore, would be 
eligible for the FIFRA section 19(h) exemption.
    EPA considered several other interpretations of the SWDA reference, 
but rejected them because the group of pesticides that would be exempt 
did not appear to be an accurate or realistic representation of 
Congress's intent. One alternative interpretation is based on the fact 
that household, industrial, or institutional antimicrobial products are 
products and not wastes. Pesticide products are regulated by FIFRA; 
pesticide wastes are regulated by RCRA. Under this interpretation, no 
household, industrial, or institutional antimicrobial products would or 
could ever be subject to regulation under the Solid Waste Disposal Act, 
and, therefore, they all would be eligible for the FIFRA section 19(h) 
exemption. However, EPA believes that the scope of the exemption under 
this interpretation is too broad to realistically represent the 
Congressional intent.
    Another alternative would be to include in the exemption only 
household, industrial, or institutional antimicrobial products that are 
not subject to any regulation under RCRA (i.e., as solid waste or 
hazardous waste) when they become wastes. However, this interpretation 
would appear to eliminate the exemption altogether, because all 
antimicrobial product waste (including liquids) would fit into the RCRA 
regulatory definition of ``solid waste.'' Therefore, all of the 
household, industrial, or institutional antimicrobial products would be 
subject to regulation under the Solid Waste Disposal Act. Under this 
interpretation, none of these products would be eligible for the FIFRA 
section 19(h) exemption. It seems reasonable to presume that Congress 
did not intend this result, as it would clearly nullify the exception 
that Congress had crafted for antimicrobial pesticides. It would seem 
to be an absurd interpretation that Congress intended this section to 
have no effect. Further, it is reasonable to presume, given the 
structure and regulatory history of SWDA, that Congress intended its 
reference to regulation under SWDA to mean regulation as a hazardous 
waste under SWDA. Though SWDA does provide for regulation of solid 
waste (in particular, restrictions on ``open dumping''), hazardous 
waste has been subject to much more extensive regulation and has been 
to a significant degree the focus of Federal regulation under SWDA. 
(Ref. 4) It is therefore likely that the most reasonable interpretation 
of this provision is to interpret ``subject to regulation under the 
Solid Waste Disposal Act'' to mean ``subject to regulation as a 
hazardous waste under the Solid Waste Disposal Act.''
    In summary, EPA believes that the scope of ``household, industrial, 
or institutional antimicrobial products that are not subject to 
regulation under the Solid Waste Disposal Act'' includes pesticide 
products that: (1) Meet the definition of antimicrobial pesticide in 
FIFRA section 2(mm); (2) fall within one of the specified antimicrobial 
product use categories; and (3) are not subject to regulation under 
RCRA as hazardous wastes when they become wastes. Throughout the 
remainder of this document, these pesticides are referred to as 
``eligible antimicrobial pesticides,'' i.e., those pesticides that are 
eligible for the antimicrobial exemption.
    3. Request for comments. EPA requests comments on this 
interpretation of the statutory antimicrobial exemption. In addition to 
general comments, EPA solicits comments on the following specific 
questions.
    i. Is it appropriate to adopt the statutory definition for 
``antimicrobial pesticide'' to define ``antimicrobial product'' for the 
purposes of the pesticide container and containment rule? If an 
alternative definition of antimicrobial product should be adopted, 
please explain why and provide an alternative definition.
    ii. Is it appropriate to rely on antimicrobial product use 
categories developed for data requirement purposes to distinguish among 
household, industrial, and institutional antimicrobials and all others 
for container regulatory purposes or should EPA adopt another approach 
such as defining each of these pesticide use sectors?
    iii. Is EPA's interpretation of the statutory reference to the SWDA 
appropriate or should EPA adopt an alternative interpretation?
    In addition, EPA requests information about which antimicrobial 
pesticides, if any, are subject to regulation as hazardous wastes under 
RCRA when they become wastes.

C. Preventing Unreasonable Adverse Effects on the Environment

    1. Regulatory option under consideration. Under the regulatory 
option being considered, EPA has determined that eligible antimicrobial 
products classified in Toxicity Category I must be subject to a 
substantial majority of the container provisions to prevent an 
unreasonable adverse effect on the environment. As discussed in greater 
detail below, eligible Toxicity Category I antimicrobial products would 
be subject to all of the nonrefillable and refillable container 
standards with two exceptions. First, eligible Toxicity Category I 
antimicrobial products would be exempt from the nonrefillable residue 
removal standard. Second, eligible Toxicity Category I antimicrobial 
products that are used in swimming pools would be exempt from certain 
refillable container standards (including, but not limited to serial

[[Page 56926]]

number markings, one-way valves or tamper-evident devices, and some 
recordkeeping) that would greatly interfere with the current wide use 
of refillable containers in that industry segment.
    2. Description of options. EPA considered a wide range of options 
for determining which eligible antimicrobial products must be subject 
to the container provisions to prevent an unreasonable adverse effect 
on the environment. The four options that EPA preliminarily believes to 
be the most appropriate are described in Units IV.C.2.i - iv of this 
document. The options are listed in the order of how many eligible 
antimicrobial products would be exempt, where option 1 would exempt the 
most and option 4 would exempt the least. Options 2 and 3 would exempt 
the same number of products, but would apply different sets of 
standards to the products that would be included.
    This section of the document is intended to provide a brief summary 
of the options. The following unit provides a comparison, analysis, and 
more detailed explanation of the options and explains why option 3 is 
put forth as EPA's preferred option.
    i. 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. Eligible 
antimicrobials (i.e., household, industrial, or institutional 
antimicrobial products that are not subject to regulation under the 
Solid Waste Disposal Act) would be exempt from the pesticide container 
regulations, unless EPA specifically includes the antimicrobial product 
or products. EPA could make a case-by-case determination that a 
specific product or group of products must be subject to the container 
standards to prevent an unreasonable adverse effect on the environment. 
The regulations could include a provision such as the following to 
allow such case-by-case decisions to be made: ``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.''
    The overall criterion that would be used to make product-specific 
inclusion decisions is that the antimicrobial product would cause an 
unreasonable adverse effect on the environment unless it complied with 
the container standards. EPA would consider requiring a specific 
antimicrobial product to comply with the container standards in 
situations where EPA became aware of situations such as, but not 
limited to: (1) An antimicrobial product with a non-negligible number 
of containers that leaked or otherwise accidentally released pesticide 
to the environment; (2) an antimicrobial product with a non-negligible 
number of container-related documentable exposures to persons using the 
product, particularly if there are significant health effects to the 
pesticide users; or (3) the use of refillable containers to distribute 
antimicrobial products has expanded into new market segments and use 
sites, where the safeguards of the proposed regulations are necessary 
to prevent exposure and unreasonable risks to pesticide users and human 
health and the environment in general. In situations such as these, EPA 
could decide to require just the specific product in question to comply 
with the container regulations. However, EPA could also require similar 
products distributed in similar containers to comply with the container 
standards if the Agency could reasonably expect the same problems from 
these other antimicrobial products.
    A provision such as this could be added to any of the other options 
to account for new information about problems with specific products 
that might not be included by the general criteria. In order to 
simplify this discussion, EPA chose not to add such a provision to 
create a ``suboption'' for each of the following options. In the final 
rule, however, EPA may decide to add a ``case-by-case provision'' to 
one of the following options.
    ii. Option 2. Subject eligible antimicrobials classified in 
Toxicity Category I to all of the container regulations. Eligible 
antimicrobials classified in Toxicity Category I would be included in 
the pesticide container regulations. Other eligible antimicrobials 
(i.e., those in Toxicity Categories II, III, and IV) would be exempt 
from the container regulations. Under this option, EPA would make a 
determination that eligible antimicrobials classified in Toxicity 
Category I must be subject to all of the container regulations to 
prevent an unreasonable adverse effect on the environment.
    iii. Option 3. Subject eligible antimicrobials classified in 
Toxicity Category I to a subset of the container regulations. This 
option is similar to option 2 in that eligible antimicrobials 
classified in Toxicity Category I would be included in the pesticide 
container regulations and other eligible antimicrobials (i.e., those in 
Toxicity Categories II, III, and IV) would be exempt from the container 
standards. EPA would make an unreasonable adverse effects determination 
similar to that in option 2. Under this option, however, only a subset 
of the container standards would apply to eligible antimicrobial 
pesticides in Toxicity Category I.
    Specifically, eligible Toxicity Category I antimicrobial products 
would be subject to all of the nonrefillable container standards except 
for the residue removal standard (which was proposed as Sec. 165.104). 
Also, eligible Toxicity Category I antimicrobial products that are used 
in swimming pools would be exempt from certain refillable container 
standards (including, but not limited to serial number markings, one-
way valves or tamper-evident devices, and some recordkeeping). All 
other eligible Toxicity Category I antimicrobial products would have to 
comply with all of the refillable container standards. The full list of 
requirements that would apply under this approach is provided in the 
potential alternative regulatory text in Unit VII of this document. The 
exemptions from specific requirements are discussed in more detail in 
Unit IV.C.3 of this document.
    iv. Option 4. Apply the scope criteria being considered for other 
pesticides (as discussed in Unit III of this document) to eligible 
antimicrobials. Eligible antimicrobials would be subject to the same 
exclusion/inclusion criteria as other pesticides, according to the 
modifications being considered for the scope of the container 
regulations. As discussed in Unit III of this document, EPA is 
considering criteria based on: (a) Classification in Toxicity 
Categories I or II; (b) container size; and (c) environmental hazard 
statements on the labels of outdoor pesticides to distinguish between 
higher-risk and lower-risk pesticides. Under this approach, EPA would 
make a determination that eligible antimicrobials that meet any of the 
criteria must be subject to the container regulations to prevent an 
unreasonable adverse effect on the environment.
    3. Discussion. One issue regarding these options is whether EPA can 
set general criteria for making an unreasonable adverse effect 
determination or if such a determination must be made on a case-by-case 
basis. EPA believes that the statutory language ``unless the 
Administrator determines that [an eligible antimicrobial] product must 
be subject to [the container]

[[Page 56927]]

provisions to prevent an unreasonable adverse effect on the 
environment'' does not preclude the adoption of either approach 
(general criteria or a case-by-case decision). Section 19(h) provides 
the Agency with considerable flexibility to make a reasonable 
interpretation of the statutory language. EPA believes that the Agency 
can set general criteria and/or make case-by-case decisions in making 
unreasonable adverse effect determinations.
    Another issue regarding these options is estimating how many 
products would be included in the regulations by each of the options. 
(Ref. 5) EPA estimates that there are about 5,000 registered 
antimicrobial end-use products being marketed in the United States. 
While not all of these products would be household, industrial, or 
institutional antimicrobial products that are not subject to regulation 
under the SWDA, this analysis will use 5,000 products as a reasonable 
upper limit. To estimate the percentage of eligible antimicrobial 
pesticides classified in Toxicity Categories I and II, EPA analyzed 
information in an Office of Pesticide Programs data base. Based on this 
analysis, EPA estimates that about 70% of eligible antimicrobial 
products are classified in Toxicity Category I and an additional 15% 
are classified in Toxicity Category II. The number and percent of 
eligible antimicrobial products that would have to comply with the 
container standards under the four options is summarized in the 
following table 2.

                   Table 2.--  Summary of Options for Exempting Certain Antimicrobial Products
----------------------------------------------------------------------------------------------------------------
                                                           Products Included             Products Exempted
          Option Number               Description     ----------------------------------------------------------
                                                           Number       Percent         Number         Percent
----------------------------------------------------------------------------------------------------------------
Option 1........................  Exempt all except              some        > 0     most (< 5,000)        < 100
                                   case-by-case.
Option 2........................  Include Toxicity              3,500         70              1,500           30
                                   Category I.
Option 3........................  Include Toxicity              3,500         70              1,500           30
                                   Category I.
Option 4........................  Include Toxicity      4,250 - 4,500    85 - 90          500 - 750      10 - 15
                                   Category I & II,
                                   container size,
                                   environmental
                                   criteria.
----------------------------------------------------------------------------------------------------------------

    Under option 1, eligible antimicrobials would be exempt from the 
pesticide container regulations, unless EPA made a case-by-case 
determination that a specific product or group of products must be 
subject to the container standards to prevent an unreasonable adverse 
effect on the environment. This option would exempt nearly all eligible 
antimicrobials from the container rule. Therefore, this option would 
have the lowest economic costs since the economic costs of the rule are 
directly related to the number of products that would be regulated.
    EPA rejected option 1 because the Agency believes that the risk of 
exempting nearly all eligible antimicrobial products is too high. Under 
this approach, few, if any, antimicrobial pesticides would initially be 
subject to these regulations, even those antimicrobial pesticides that 
are in Toxicity Category I. A high percentage, about 70%, of eligible 
antimicrobials are classified in Toxicity Category I (mostly because 
they meet the criteria for eye and/or skin effects). This is a 
significantly larger percentage than for other segments of the 
pesticide industry. Based on an analysis of information in an Office of 
Pesticide Programs data base (Ref. 5), EPA estimates that about 20% of 
agricultural pesticides are classified in Toxicity Category I (with an 
additional 15% in Toxicity Category II) and about 10% of pesticides for 
forestry and ornamental turf and plants are classified in Toxicity 
Category I (with an additional 15% in Toxicity Category II). This 
information is summarized in the following table 3.

 Table 3.--  Comparison of Highly Toxic Products in Different Pesticide
                             Market Segments
------------------------------------------------------------------------
                                              Percentage of Products
                                        --------------------------------
       Pesticide Industry Segment         Toxicity   Toxicity   Toxicity
                                          Category   Category   Category
                                             I          II      I or II
------------------------------------------------------------------------
Forestry and ornamental turf and plants      10         15         25
Agricultural crops.....................      20         15         35
Eligible antimicrobials................      70         15         85
------------------------------------------------------------------------

    In addition, the large quantity of antimicrobial products used each 
year supports including some of these products within the scope of the 
container requirements. The following table 4 summarizes the U.S. usage 
of different types of pesticides in 1995. (Ref. 6) According to this 
information, eligible antimicrobial pesticides account for over 40% of 
all pesticides used in 1995 (on a weight basis).

                            Table 4.--  Pesticide Usage in the United States in 1995
----------------------------------------------------------------------------------------------------------------
                                                                           Quantity of Pesticide Used
                                                               -------------------------------------------------
                       Type of Pesticide                           Millions of pounds
                                                                   active ingredient             Percent
----------------------------------------------------------------------------------------------------------------
                                          Non-antimicrobial pesticides
Conventional pesticides.......................................            973                       21

[[Page 56928]]

 
Sulfur, petroleum (oil, distillates, etc.), sulfuric acid and             249                       6
 other miscellaneous chemicals used as pesticides.............
                                                               =================================================
  Subtotal....................................................            1222                      27
 
                                        Eligible antimicrobial pesticides
Wood preservatives 1..........................................            718                       16
Specialty biocides by end use.................................
  Swimming pools, spas, individual water treatment 2..........            175                       4
  Disinfectants and sanitizers 3..............................             32                       1
  Other 4.....................................................             50                       1
Chlorine/hypochlorites........................................
  Bleaching disinfectant and pools............................            925                       20
                                                               =================================================
  Subtotal....................................................           1,900                      42
 
                                     Non-eligible antimicrobial pesticides 5
Chlorine/hypochlorites........................................
   Disinfection of potable and waste water....................           1,390                      31
                                                               =================================================
  Subtotal....................................................           1,390                      31
                                                               -------------------------------------------------
    TOTAL 6...................................................           4,512                     100
----------------------------------------------------------------------------------------------------------------
\1\ Includes water and air borne preservatives and creosote/coal tar/petroleum preservatives. The original
  report (Ref. 6) also included 7 million pounds of fire retardants in the category of wood preservatives. The 7
  million pounds of fire retardants are not included as wood preservatives in this table.
\2\ Specialty biocides only. Does not include hypochlorite or chlorine consumption, which is reported
  separately.
\3\ Includes industrial/institutional applications and household cleaning products. Specialty biocides only.
  Does not include hypochlorite or chlorine consumption, which is reported separately.
\4\ Includes biocides for adhesives and sealants, leather, synthetic latex polymers, metalworking fluids, paints
  and coatings, petroleum products, plastics, and textiles. Does not include: hospital and medical antiseptics,
  food and feed preservatives, and cosmetics/toiletries. These latter types of usage are not included (in Ref.
  6), as they are regulated largely by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic
  Act rather than FIFRA. The FDA and EPA share regulatory responsibilities over some of the specialty biocide
  usage reported in the table.
\5\ This category of chlorine/hypochlorites usage is not considered a ``household, industrial, or institutional
  use.'' See the discussion of antimicrobial use product use categories in Unit IV.B.2 of this document.
\6\ The total is 7 millions pounds less than in Ref. 6 because 7 million pounds of fire retardants were removed
  from the original estimate of wood preservatives. See footnote 1.

    Because most eligible antimicrobial products pose a high (Toxicity 
Category I) or relatively high (Toxicity Category II) hazard to humans 
and the large quantity of eligible antimicrobials used annually (over 
40% of pesticides used in 1995, based on pounds of active ingredient), 
EPA believes that it is appropriate and necessary to require certain 
eligible antimicrobial products to comply with the container standards 
to prevent unreasonable adverse effects on the environment.
    In option 2, EPA would require eligible antimicrobial products in 
Toxicity Category I to comply with the container standards. EPA 
believes it is appropriate to include these products because they 
present the highest hazards to humans. Subjecting these highest-risk 
pesticides to the container standards that are intended to ensure the 
safe storage, use, refill/reuse and disposal of pesticides would 
provide benefits, by lowering the overall risk to man and the 
environment, that would not be obtained by option 1.
    However, EPA prefers option 3, a variation of option 2, because it 
offers some cost and environmental benefits over option 2. Option 3 
would exempt eligible antimicrobial products in Toxicity Category I 
from certain container requirements.
    To ease the economic impact on registrants of antimicrobial 
pesticides, option 3 would exempt eligible antimicrobial products from 
the nonrefillable residue removal standard, which was proposed as 
Sec. 165.104. While representatives from all sectors of the pesticide 
industry commented that the proposed nonrefillable residue removal 
standard would be a burdensome and costly requirement, the 
antimicrobial industry pointed out some characteristics of their 
containers and products that pose particular difficulties with respect 
to residue removal. Commenters stated that antimicrobial products tend 
to have extremely low active ingredient concentrations, which makes it 
difficult to make the measurements needed to determine compliance with 
the proposed standard. In addition, commenters said that antimicrobial 
formulations often contain ingredients that create foam when containers 
are shaken during the triple rinsing procedure, making it more 
difficult to comply with the proposed residue removal standard. (Ref. 
2) Based on the comments, EPA believes these problems are more 
prevalent with antimicrobials than with other pesticides. EPA also 
believes that the ``unreasonable adverse effect'' language of section 
19(h), which requires review of costs and benefits, allows EPA more 
flexibility to exempt antimicrobial pesticides from these requirements 
than does the language in section 19(e) and (f) which is more directed 
at risk. Therefore, under the regulatory approach under consideration, 
eligible antimicrobial products would not have to comply with the 
nonrefillable residue removal standard. Please note that EPA is 
considering a range of modifications to the residue removal standard in 
the final rule that take into account all of the comments on the 
proposed standard. This document is not soliciting additional comments 
on the proposed nonrefillable residue removal standard.

[[Page 56929]]

    Another significant concern with the proposed rule that was raised 
in the public comments was that the refillable container standards 
posed many impediments to the extensive and successful use of 
refillable containers that are currently used to distribute swimming 
pool chemicals. The swimming pool chemical industry commented that the 
following proposed requirements would require significant and costly 
changes to the many refillable containers currently used: the serial 
number marking; one-way valves or tamper-evident devices; relabeling 
the container; and recordkeeping. (Ref. 2) EPA agrees that applying 
these requirements to swimming pool pesticides would disrupt the 
current refillable container system for swimming pool chemicals and 
would probably cause the refillables to be replaced by millions of 
single-use, nonrefillable containers. EPA believes that adding millions 
of pounds of these nonrefillable containers to the waste stream is 
inconsistent with the goals of section 19(e) of FIFRA, particularly 
that the regulations facilitate the safe refill and reuse of 
containers.
    In addition, many of the proposed refillable container standards in 
question are intended to minimize the possibility of cross-
contamination in refillable containers. Cross-contamination is less of 
a concern for swimming pool pesticides than for agricultural pesticides 
for several reasons. First, several commenters indicated that the 
refillable containers in the swimming pool market are only used to 
distribute sodium hypochlorite and not other kinds of antimicrobial 
pesticides. (Ref. 2) Second, these antimicrobial pesticides are used on 
the same site, i.e., swimming pools. EPA evaluates the risks posed by 
swimming pool pesticides at the concentrations at which they are used. 
Therefore, low levels of contamination from other swimming pool 
chemicals would pose little additional risk to humans or the 
environment because of the low concentrations and because the 
contaminant is intended to be used in swimming pools. In other words, 
the contaminant would not be applied to a site, pest, or crop for which 
it wasn't intended, which could easily happen in an agricultural 
setting. [Note: this does not exempt swimming pool chemicals from 
complying with the product chemistry registration requirements and 
related policies, including PR Notice 96-8 ``Toxicologically 
Significant Levels of Pesticide Active Ingredients'' (Ref. 7)].
    Therefore, this option would exempt swimming pool antimicrobial 
pesticides from certain refillable container standards.
    As described above in the discussion of options 2 and 3, EPA 
believes it is appropriate to require eligible antimicrobial products 
that are in Toxicity Category I to comply with most of the container 
standards. About 70% of eligible antimicrobials would therefore have to 
comply with most of the container standards. This might be considered 
too large a percentage of antimicrobial products to be subject to the 
regulation. Therefore, EPA is requesting comments on possible ways to 
divide the eligible antimicrobial products in Toxicity Category I into 
subcategories, for the purposes of regulating the products that pose 
the highest risk and exempting the others. For example, the formulation 
of the product may be related to the exposure of the handler when 
dispensing a product from a container. For example, liquid formulations 
may cause higher exposures than solid formulations due to dripping, 
glugging, and leaking. In this example, EPA could choose to require 
only liquid eligible antimicrobial products in Toxicity Category I to 
comply with most of the container standards. EPA requests comments on 
whether it is appropriate to divide eligible antimicrobial products in 
Toxicity Category I into subcategories and, if so, EPA requests 
suggestions on reasonable criteria for making such a distinction.
    Option 4 would apply the same exclusion/inclusion criteria being 
considered for other pesticides to eligible antimicrobials. As 
discussed in Unit III of this document, EPA is considering criteria 
based on (1) classification in Toxicity Categories I or II; (2) 
container size; and (3) environmental hazards to distinguish between 
higher-risk and lower-risk pesticides. Subjecting a larger group of 
higher-risk pesticides to the container standards would provide more 
benefits -- by further lowering the overall risk to man and the 
environment -- than for options 2 and 3. However, EPA rejected option 4 
mainly because the Agency believes that the FQPA amendment to FIFRA 
section 19(h) indicates a Congressional intent for EPA to regulate 
eligible antimicrobial products differently than all other pesticide 
products. In particular, the standard set for subjecting antimicrobial 
products to the container standards by FIFRA section 19(h) is ``to 
prevent an unreasonable adverse effect on the environment.'' On the 
other hand, the mandates in FIFRA sections 19(e) and (f) establish a 
level of ``safety,'' e.g., ``safe storage and disposal'' and ``safe 
use.'' In addition, Congress's revision to section 19(h) indicates that 
Congress was particularly concerned about the economic impacts of 
section 19(e) and (f) on the manufacture and use of antimicrobial 
pesticides. Therefore, EPA believes that Congress intended that 
eligible antimicrobial products should not be regulated unless there is 
an extremely serious risk to humans or the environment if exposed 
during a container incident, as there would be for Toxicity Category I 
products. EPA believes a Toxicity Category I product would pose a 
serious risk in such a situation regardless of whether it is classified 
in Toxicity Category I because of its systemic toxicity, e.g., oral or 
dermal LD50 or inhalation LC50, or because of its 
eye and/or skin effects.
    Because of the many questions raised by the statutory antimicrobial 
exemption, it is instructive to review the approach EPA is considering 
to implement this exemption. The following flow chart depicts EPA's 
potential approach for implementing the antimicrobial exemption as 
discussed above.

BILLING CODE 6560-50-F

[[Page 56930]]

[GRAPHIC] [TIFF OMITTED] TP21OC99.003



BILLING CODE 6560-50-C
    EPA is interpreting the antimicrobial pesticide exemption to be an 
exemption from the container design and residue removal standards in 
proposed subpart F for nonrefillable containers and proposed subpart G 
for refillable containers. On the other hand, EPA does not intend to 
exempt eligible antimicrobials from the proposed container-related 
labeling requirements. EPA believes that container cleaning and 
disposal instructions should be included on the labels of all 
pesticides. As described in Unit III.C.4 of this document, 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 containers from all segments of the pesticide industry, 
including eligible antimicrobial products, are currently being 
recycled, container cleaning and disposal instructions are needed on 
the labels of all pesticides. EPA believes that section 3 of FIFRA 
provides the Agency with the authority to require cleaning and disposal 
instructions on the labels of eligible antimicrobial pesticides. 
Cleaning and disposal instructions were required on the labels of 
eligible antimicrobial products as part of the directions for use 
before FIFRA section 19(a) was added in 1988.
    Decisions on the label requirements to be included in the final 
rule will be made separately from the issues discussed in this 
document. When making these decisions, EPA will consider all the 
comments received during the initial public comment period, including 
suggestions for alternative label instructions for household and 
institutional pesticides. EPA is not soliciting further comments on the 
specific label statements and standards proposed in 1994.
    4. Request for comments. EPA requests comments on the approach 
under consideration for determining that an eligible antimicrobial 
product must be subject to the container standards to prevent an 
unreasonable adverse effect on the environment, specifically, setting 
classification in Toxicity Category 1 as a general criterion and 
requiring these eligible antimicrobial pesticides to comply with a 
subset of the container standards, as well as the other possible 
approaches. EPA also solicits comments on the following specific 
questions.
    i. Should EPA establish general criteria for making this 
determination (such as classification in Toxicity Category I) or should 
such a

[[Page 56931]]

determination be made only on a case-by-case basis?
    ii. If general criteria should be included, is the criterion being 
considered appropriate or should EPA establish alternative or 
additional general criteria, such as classification in Toxicity 
Category II, a provision that accounts for environmental risk, and/or a 
container size limit?
    iii. Should EPA establish a detailed procedure for making a case-
by-case determination if there is a serious hazard problem related to 
the containers of a specific antimicrobial product or group of 
products? Are the examples of situations where EPA might make such a 
determination, as discussed in Unit IV.C.2.i of this document, 
reasonable? What other situations or criteria should EPA use in making 
a decision to require a specific product to comply with the container 
regulations?
    iv. Is it appropriate to subject eligible antimicrobial products to 
only a subset of the container requirements as set out in option 3?
    v. Is it appropriate for EPA to divide eligible antimicrobial 
products in Toxicity Category I into subcategories? If so, what would 
be reasonable criteria for making such a distinction?
    vi. Should eligible antimicrobial pesticides in Toxicity Categories 
II, III, and IV be exempt from the container-related standards only, 
i.e., should they be required to comply with the label standards? If 
eligible antimicrobial pesticides in Toxicity Categories II, III, and 
IV should be exempt from the label standards, please explain why these 
containers do not need to be properly cleaned prior to being disposed 
of or recycled.

D. Summary of Scope Modifications and the Antimicrobial Exemption 

    As described in Unit IV.C.3 of this document, EPA is considering 
different criteria for antimicrobial pesticides than for all other 
pesticides in terms of determining whether they would be subject to the 
container standards. For antimicrobials that are ``eligible'' for 
exemption, i.e., household, industrial, and institutional antimicrobial 
pesticides that are not subject to RCRA, EPA is considering requiring 
those that are classified in Toxicity Category I to comply with most of 
the container standards. EPA has determined that eligible antimicrobial 
pesticides that are classified in Toxicity Category I must be subject 
to the container standards (other than the nonrefillable residue 
removal standard and, for antimicrobial products used in swimming 
pools, some of the refillable container standards) to prevent an 
unreasonable adverse effect on the environment.
    For all pesticides other than eligible antimicrobials, EPA is 
considering applying the full set of container standards to those that 
meet at least one of the following criteria: Toxicity Category I 
classification, Toxicity Category II classification, container size 
greater than or equal to 5.0 liters for liquids or 5.0 kilograms for 
solids, or outdoor use pesticides that have one of the specified 
environmental hazard statements on their label. EPA has determined that 
pesticides that meet one of these criteria are higher-risk from a 
container-release point of view and should be subject to the container 
standards.
    Because of the overlap in criteria being considered to delineate 
the antimicrobial exemption and to define the general scope of the 
container standards, it is useful to consider how these approaches 
would mesh in the final rule. The following table 5 sets out which 
pesticides would be included in the container regulations (for both 
nonrefillable and refillable containers) and which would be exempt, 
considering both the possible modifications to the scope and the 
exemption for certain antimicrobial pesticides. Potential alternative 
regulatory text that is being considered for the final rule is provided 
in Unit VII of this document.

   Table 5.--Summary of the Scope Modifications and the Antimicrobial
                                Exemption
------------------------------------------------------------------------
                                    Conditions for
       General Category         Inclusion or Exemption     Included or
                                           1                Exempt? 2
------------------------------------------------------------------------
Manufacturing use products....  Any manufacturing use   Exempt
                                 product is exempt
                                 from the regulations.
------------------------------------------------------------------------
Antimicrobial products that     A product is included   Included
 are eligible for exemption      in the regulations if
 and that are end use products.  it satisfies all of
                                 the following
                                 conditions:
                                 It is an end
                                 use product..
                                 It is a
                                 household,
                                 industrial, or
                                 institutional
                                 antimicrobial product
                                 that is not a
                                 hazardous waste when
                                 disposed..
                                 It is in
                                 Toxicity Category I..
                                [Note: Although these
                                 products are included
                                 in the regulations,
                                 they are exempt from
                                 certain specific
                                 requirements, such as
                                 the residue removal
                                 standard for
                                 nonrefillable
                                 containers. Also,
                                 swimming pool
                                 pesticides in this
                                 category are exempt
                                 from some of the
                                 refillable container
                                 standards.].
                               -----------------------------------------
                                A product is exempt     Exempt
                                 from the regulations
                                 if it satisfies all
                                 of the following
                                 conditions:
                                 It is an end
                                 use product..
                                 It is a
                                 household,
                                 industrial, or
                                 institutional
                                 antimicrobial product
                                 that is not a
                                 hazardous waste when
                                 disposed..
                                 It is in
                                 Toxicity Category II,
                                 III, or IV..
------------------------------------------------------------------------
All other end use products,     A product is included   Included
 which includes the following    in the regulations if
 three categories: (1)           it satisfies both of
 products that are not           the following
 antimicrobial products; (2)     conditions:
 antimicrobial products that     It is in the
 are not eligible for            ``all other end use
 exemption because they are      products'' general
 hazardous wastes when           category..
 disposed; and (3)               It is in
 antimicrobial products that     Toxicity Category I
 are not eligible for            or II..
 exemption because they are
 not household, industrial, or
 institutional antimicrobial
 products.
------------------------------------------------------------------------

[[Page 56932]]

 
                                A product is included   Included
                                 in the regulations if
                                 it satisfies all of
                                 the following
                                 conditions:
                                 It is in the
                                 ``all other end use
                                 products'' general
                                 category..
                                 It is in
                                 Toxicity Category III
                                 or IV..
                                 It is in a
                                 container whose
                                 capacity is equal to
                                 or greater than 5
                                 liters (1.3 gallons)
                                 or 5 kilograms (11
                                 pounds)..
                               -----------------------------------------
                                A product is included   Included
                                 in the regulations if
                                 it satisfies all of
                                 the following
                                 conditions:
                                 It is in the
                                 ``all other end use
                                 products'' general
                                 category..
                                 It is in
                                 Toxicity Category III
                                 or IV..
                                 It is in a
                                 container whose
                                 capacity is less than
                                 5 liters or 5
                                 kilograms..
                                 It has a
                                 label with at least
                                 one of the
                                 environmental hazard
                                 statements..
                                 It has a
                                 label that permits
                                 outdoor use..
                               -----------------------------------------
                                A product is exempt     Exempt
                                 from the regulations
                                 if it satisfies all
                                 of the following
                                 conditions:
                                 It is in the
                                 ``all other end use
                                 products'' general
                                 category..
                                 It is in
                                 Toxicity Category III
                                 or IV..
                                 It is in a
                                 container whose
                                 capacity is less than
                                 5 liters or 5
                                 kilograms..
                                 It has a
                                 label with at least
                                 one of the
                                 environmental hazard
                                 statements..
                                 It has a
                                 label that does not
                                 permit outdoor use..
                               -----------------------------------------
                                A product is exempt     Exempt
                                 from the regulations
                                 if it satisfies all
                                 of the following
                                 conditions:
                                 It is in the
                                 ``all other end use
                                 products'' general
                                 category..
                                 It is in
                                 Toxicity Category III
                                 or IV..
                                 It is in a
                                 container whose
                                 capacity is less than
                                 5 liters or 5
                                 kilograms..
                                 It has a
                                 label without any of
                                 the environmental
                                 hazard statements..
------------------------------------------------------------------------
\1\ This column lists the conditions that determine whether a product is
  included in the regulations or is exempt from the regulations.
\2\ This column provides a quick indication of whether the products
  described in the previous column are included in the regulations or
  are exempt from the regulations.

E. Request for Comments

    EPA requests comments on the overall approach being considered for 
implementing the antimicrobial exemption and for modifying the scope of 
the container standards. EPA solicits comments on the complexity, 
clarity, and appropriateness of the approach and on potential 
alternatives. Also, EPA requests input on the potential impacts of the 
approach being considered, i.e., how many pesticides would be excluded 
and how many would be included.

V. Department of Transportation (DOT) Packaging Standards

A. Background on 1994 Proposal

    The third issue being opened for comment in this document is a 
regulatory approach being considered by EPA to adopt and refer to the 
relevant portions of the DOT Hazardous Materials Regulations (HMR).
    During the public comment period, EPA received many comments that 
urged EPA to be consistent with the DOT regulations. Over 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 (U.N.) Recommendations 
on the Transport of Dangerous Goods. All of the commenters agreed that 
EPA should be consistent with the DOT HMR and the U.N. 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 U.N. 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 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. (Ref. 
2)
    EPA is considering incorporating this suggestion to change the 
container regulations by adopting and referring to the DOT packing 
group III criteria. While EPA discussed the DOT standards in some 
detail in the preamble of the 1994 proposal, EPA did not specifically 
discuss the approach of adopting and referring to the DOT HMR in the 
final rule. Therefore, EPA is describing the approach under 
consideration and soliciting comments in this document.

B. Regulatory Option Under Consideration

    Pesticides that are classified as DOT hazardous materials would 
continue to be packaged in accordance with the DOT HMR. Under the 
regulatory approach being considered for the final rule, EPA would 
cross-reference the HMR, so EPA could enforce these standards. 
Pesticides that are not classified as DOT hazardous materials would be 
required to be packaged in accordance with the specified packaging 
design, construction, and marking standards that would apply to a DOT 
packing group III material. All pesticides, regardless of DOT hazardous 
material classification, would have to comply with additional 
requirements for pesticides (``pesticide-specific requirements'') that 
have no equivalents in the DOT HMR, e.g., a standard for minimizing 
dripping. In addition, EPA

[[Page 56933]]

is considering incorporating a provision to provide exceptions for 
pesticides not classified as DOT hazardous materials that would be 
similar to the limited quantity exceptions in the DOT HMR.
    Potential regulatory language that is being considered for the 
approach of referring to and adopting the DOT standards is provided in 
Unit VII of this document.

C. Discussion

    1. Adoption of the DOT standards. The 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 
classification of materials, packaging (including manufacture, 
continuing qualification, and maintenance), hazard communication (i.e., 
package marking, labeling, placarding, and shipping documentation), 
transportation and handling, and incident reporting. For the purposes 
of applying DOT standards to pesticides that are not classified as 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 standards. EPA is not 
considering incorporating the HMR standards for labeling, placarding, 
shipping documentation, transportation and handling, and incident 
reporting for pesticides that are not classified as DOT hazardous 
materials. In general, these standards are outside the scope of the 
original proposed rule for pesticide containers and containment. In 
other words, EPA is considering referring to and adopting only a subset 
of the DOT HMR for pesticides that are not classified as DOT hazardous 
materials.
    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 for packaging, 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.
    Under the revisions to the pesticide container rule being 
considered, pesticides that are classified as DOT hazardous materials 
would continue to be packaged in accordance with the DOT HMR. Most 
pesticides that are classified as DOT hazardous materials are in 
Packing Group III, although some are in PG II and a few are in Packing 
Group I. (Ref. 8) Nothing in the pesticide container rule would change 
any of the incorporated DOT requirements -- if a pesticide is 
categorized as a PG II material, it would continue to have to meet the 
PG II standards and likewise for pesticides in PG I or PG III.
    Under the regulatory approach being considered, pesticides that are 
not classified as DOT hazardous materials would be required to be 
packaged in accordance with the specified packaging design, 
construction, and marking standards that would apply to a DOT PG III 
material. Such pesticides would not have to meet the DOT standards for 
labeling, placarding, or shipping papers which, as discussed above, are 
outside the scope of the original proposed container regulations. 
Specifically, pesticides that are not classified as DOT hazardous 
materials would have to comply with the packaging standards in 49 CFR 
173.24, 173.24a, 173.24b, 173.28, 173.203, 173.213, 173.240, and 
173.241, the packaging standards and testing requirements in 49 CFR 
part 178; and the continuing qualification and maintenance requirements 
in 49 CFR part 180. EPA would retain its independent authority to 
enforce compliance with these regulations as with any other regulations 
promulgated under FIFRA.
    2. Include pesticide-specific standards. One issue involved with 
the regulatory approach under consideration is whether the DOT package 
design and marking standards should be the only requirements for 
pesticide containers or whether EPA should promulgate additional 
standards that apply only to pesticide containers. Some of the 
commenters on the proposed rule implied that the only standards 
necessary are the DOT standards and that EPA should not add any 
additional requirements. EPA disagrees with this assessment and 
believes that it is appropriate to promulgate additional pesticide-
specific requirements because the purposes of the two sets of 
regulations are different.
    The Hazardous Materials Transportation Act provides DOT with the 
authority to ``issue regulations for the safe transportation of 
hazardous materials in intrastate, interstate, and foreign commerce ... 
[that] shall govern any aspect of hazardous materials transportation 
safety which the Secretary of Transportation deems necessary or 
appropriate.'' An overall goal of this law is ``to improve the 
regulatory and enforcement authority of the Secretary of transportation 
to protect the Nation adequately against the risks to life and property 
which are inherent in the transportation of hazardous materials in 
commerce.''
    Section 19 of FIFRA gives EPA a much broader mandate for addressing 
pesticide containers. Section 19(e) requires EPA to promulgate 
``regulations for the design of pesticide containers that will promote 
the safe storage and disposal of pesticides.'' This section further 
specifies that the regulations ensure that containers accommodate 
procedures used for the removal of pesticides and facilitate the safe 
use, safe disposal, safe refill, and safe reuse of the containers. In 
addition, section 19(f) requires EPA to ``promulgate regulations 
prescribing procedures and standards for the removal of pesticides from 
containers prior to disposal.''
    EPA believes the broader mandate in FIFRA justifies the approach of 
requiring that pesticides meet certain pesticide-specific requirements 
in addition to the DOT standards. In the regulatory option under 
consideration, EPA would not include in the final regulations a 
proposed FIFRA-specific container standard if there was an equivalent 
DOT standard (e.g., the drop test for minibulks). EPA would merely 
incorporate the equivalent DOT standard. However, EPA would retain 
other proposed standards (e.g., the container dispensing standards to 
minimize dripping and to require pouring in a continuous, coherent 
stream) that did not have equivalent DOT standards.
    Therefore, all pesticides that would be subject to the pesticide 
container regulations -- regardless of whether or not they are 
classified as DOT hazardous materials -- would have to comply with both 
the DOT HMR requirements incorporated into EPA's regulations and the 
pesticide-specific requirements in the final pesticide container rule.
    Table 6 categorizes the proposed pesticide container ``design'' and 
marking requirements according to whether or not the DOT HMR have an 
equivalent standard. The table is included only to provide a general 
idea of the proposed requirements that EPA may replace in the final 
rule with DOT standards and those proposed standards that EPA would 
retain as pesticide-specific requirements. EPA is not soliciting 
further comments on the

[[Page 56934]]

proposed pesticide container standards listed in the table, except 
regarding the extent to which DOT standards are appropriate equivalents 
to such standards. EPA has considered the comments previously submitted 
on these proposed requirements and will continue to do so as the final 
rule is developed.

 Table 6.-- Comparison of the Proposed Container Standards with the DOT
                              Requirements
------------------------------------------------------------------------
   Proposed Pesticide Container      Proposed 40 CFR   Equivalent 49 CFR
            Requirement                    Cite               Cite
------------------------------------------------------------------------
   Proposed Pesticide Container
  Standards with DOT Equivalents
 
  Nonrefillables: Container                165.102(b)          173.24(b)
   integrity/compatibility........                             173.24(e)
  Nonrefillables: Marking -             165.102(c)(2)           178.3(a)
   container material.............                            178.503(a)
 
  Nonrefillables: Dispensing -          165.102(d)(3)          173.24(f)
   reclose securely...............
 
  Nonrefillables: Certification\1\            165.111        178.2(a)(2)
 
  Nonrefillables: Recordkeeping\1\            165.114         178.601(l)
 
  Refillables: Marking other than          165.124(b)           178.3(a)
   serial number and EPA statement                            178.503(a)
                                                                 178.703
 
  Refillables: Minibulk container          165.124(c)          173.24(b)
   integrity......................                             173.24(e)
                                                                 178.704
 
  Refillables: Drop test for               165.124(d)            178.603
   minibulk containers............                               178.803
                                                                 178.810
 
  Refillables: Drop test                      165.125            178.602
   methodology....................                               178.603
 
  Refillables: Certification\1\...            165.126        178.2(a)(2)
 
  Refillables: Recordkeeping\1\...            165.128         178.601(l)
                                                              178.801(l)
 
  Refillables: Inspection prior to         165.134(e)             173.28
   refill.........................                               180.352
 
  Refillables: Age of plastic              165.134(f)      no time limit
   liquid minibulk................
 
   Proposed Pesticide Container
 Standards without DOT Equivalents
 
  Nonrefillables: Marking - EPA         165.102(c)(1)               none
   registration no................
 
  Nonrefillables: Dispensing -          165.102(d)(1)               none
   minimize glugging..............
 
  Nonrefillables: Dispensing - no       165.102(d)(2)               none
   dripping.......................
 
  Nonrefillables: Standardized             165.102(e)               none
   closures.......................
 
  Nonrefillables: Residue removal             165.104               none
   standard.......................
 
  Refillables: Marking - serial            165.124(b)               none
   number and EPA statement.......
 
  Refillables: Apertures..........         165.125(e)               none
 
  Refillables: Bulk container              165.124(f)               none
   standards......................
------------------------------------------------------------------------
\1\ The DOT HMR include provisions for certification and recordkeeping
  for the standards in the HMR. However, EPA may choose to retain the
  proposed certification and recordkeeping requirements for the
  pesticide-specific requirements.

    The proposed ``procedural'' requirements for registrants and 
refillers in proposed 40 CFR 165.130, 165.132, 165.134, and 165.136 are 
not included in the table because they are not container design or 
marking requirements. These four sections would establish requirements 
for registrants to develop and provide certain documents to refillers, 
for refillers to obtain these documents and follow specified container 
handling procedures, and for both registrants and refillers to maintain 
records. Under the approach being considered for the final rule, EPA 
would generally retain these procedural standards in the final rule. 
However, some of the requirements, such as the registrants providing 
refillers a list of acceptable containers which would be identified by 
the container manufacturer and model number, may need to be modified to 
mesh with the revisions.
    3. Limited quantity exception. The HMR include exceptions from 
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 - 173.156 set out limited quantity and consumer commodity 
exceptions for different hazard classes and divisions. The limited 
quantity exceptions provide relief from some of the HMR requirements, 
specifically the labeling requirements (unless the package is 
transported by aircraft), the packaging standards and testing 
requirements in 49 CFR part 178, and the placarding provisions. Also, 
if a limited quantity meets the definition of ``consumer commodity,'' 
relief from the shipping paper requirements is provided in many cases.
    In the HMR, the size of packages that are eligible for limited 
quantity exceptions varies according to the

[[Page 56935]]

hazard class (e.g., Class 8), hazard division (e.g., Division 6.1), 
and, in some cases, the packing group of the material. The DOT limited 
quantity exceptions generally provide regulatory relief from the HMR, 
although they do add some requirements. First, the exceptions only 
apply to combination packaging (e.g., four plastic jugs in a cardboard 
box). Second, the packaging must comply with the general packaging 
standards in 49 CFR 173.24. Third, the package cannot exceed 30 
kilograms (66 pounds) gross weight.
    Pesticides already regulated under DOT's hazardous materials 
regulations as Packing Group I, II or III materials shall be subject, 
under EPA's FIFRA regulations, to the same limited quantity exception 
to which they are subject under DOT's regulations. For pesticides not 
already regulated under DOT's regulations, EPA is considering 
incorporating the relevant parts of the limited quantity exception in 
49 CFR 173.155 for Class 9 hazardous materials (miscellaneous hazardous 
materials) into the final pesticide container rule. Based on amendments 
made by DOT in 1996, the package sizes eligible for the Class 9 limited 
quantity exceptions are those that are less than 5.0 liters (1.3 
gallons) for liquids and less than 5.0 kilograms (11 pounds) for 
solids. The purposes of incorporating a DOT limited quantity exception 
are to maintain consistency with the HMR and to provide regulatory 
relief for relatively small quantities of pesticides.
     EPA is considering using the Class 9 limited quantity exception 
for pesticides not previously covered by DOT regulations for several 
reasons. First, Class 9 includes miscellaneous hazardous materials, 
which are defined in 49 CFR 173.140 to be materials that pose a hazard 
during transportation but don't meet the definition of any other hazard 
class. Pesticides that have not previously been covered by DOT's 
hazardous materials regulations (i.e., that are not classified as DOT 
hazardous materials) logically fit into such a grouping. Second, DOT 
has generally placed hazardous materials that are defined as DOT 
hazardous materials as a result of EPA regulation (e.g. hazardous 
substances under the Comprehensive Environmental Response, 
Compensation, and Liability Act and hazardous wastes under RCRA) into 
Class 9. Therefore, EPA would be following DOT precedent by regulating 
these pesticides consistently with many other Class 9 hazardous 
materials.
    Under the regulatory approach being considered, EPA would be 
applying only the DOT packaging and marking standards to pesticide 
containers -- not the DOT labeling, placarding, and shipping paper 
requirements. Therefore, only the ``relevant parts'' of the limited 
quantity exception would need to be incorporated -- not the provisions 
that relate to DOT labeling, placarding, and shipping paper standards. 
Also, EPA believes it is unnecessary to incorporate the consumer 
commodity exception (as opposed to the limited quantity exception) 
because the only additional relief provided by a consumer commodity 
exception is from the shipping paper requirements.
    4. EPA modification. The regulatory text under consideration (in 
Unit VII of this document) includes a provision that would allow EPA to 
modify or waive the requirements of the regulatory section that refers 
to and adopts the DOT requirements if a person provides an application 
for exemption to the Director of the Office Pesticide Programs that 
contains data showing that the alternative, i.e., the partial or 
modified, set of standards achieves a level of safety that is at least 
equal to that specified in the requirements of this section. This 
provision is included to provide flexibility in cases where, for some 
reason, a container could not meet all of the DOT packing group III 
standards, but would still function safely and adequately during the 
use, handling, cleaning, and disposal of the pesticide container.
    The DOT standards provide the regulated industry with a similar 
opportunity to obtain administrative relief from the Hazardous 
Materials Regulations through an exemption process described in 49 CFR 
part 107. DOT receives applications for exemptions and grants 
exceptions if the situations meet the criterion of equivalent levels of 
safety or levels of safety consistent with the public interest and the 
policy of the Hazardous Materials Transportation Act. For example, in a 
Federal Register notice (Ref. 9), DOT announced the actions taken on 
exemptions from July 1997 through December 1997, which included 
granting 32 modification exemptions, 48 new exemptions and 39 emergency 
exemptions, denying seven exemption applications, and having seven 
exemption applications withdrawn.
    It is essential for EPA to incorporate a modification process into 
its regulations to prevent EPA regulations from being less flexible 
than the DOT requirements, which would happen if DOT granted an 
exemption for a pesticide and EPA did not have a mechanism to provide 
the same relief. EPA anticipates that the modification process would be 
used predominantly to maintain consistency with exemptions granted by 
DOT that affect pesticides, although EPA would maintain its authority 
to deny an exemption, even where DOT has granted an exemption, if EPA 
could not find that an exemption was appropriate under FIFRA and its 
regulations. On the other hand, EPA could choose to implement the 
modification provision for technical reasons, if a registrant can show 
that the modified or more limited set of standards achieves a level of 
safety that is at least equal to the full set of incorporated DOT 
requirements.
    EPA believes the draft modification provision is sufficient because 
of the interaction between the Agency and pesticide registrants, 
despite the fact it is significantly less detailed than the DOT 
exemption process. However, EPA is considering the option of adopting a 
more detailed exclusion process in the final rule if the Agency 
concludes that a general provision would not be adequate, based on 
comments or information received during the comment period.
    5. Providing notice to the public. The regulatory text under 
consideration (in Unit VII of this document) also includes a provision 
that says EPA will provide notice to the public in the Federal Register 
if DOT proposes to change any of the regulations that are incorporated 
in EPA's pesticide container regulations. The intent of this provision 
is to ensure that the pesticide-related regulated community is notified 
of regulatory modifications being considered by DOT, since the 
pesticide industry may not regularly monitor DOT's regulatory activity.
    6. Alternative approach. Under the regulatory approach being 
considered for the final rule, EPA would refer to and adopt the full 
HMR for pesticides that are classified as DOT hazardous materials. 
Specifically, Sec. 165.102(b)(1) of the potential alternative 
regulatory language includes the following statement: ``Pesticide 
products that meet the definition of a hazardous material in 49 CFR 
171.8 shall be packaged as required by 49 CFR parts 171-180.'' EPA 
believes this approach is advantageous because EPA could enforce the 
DOT standards for pesticides that are DOT hazardous materials.
    However, EPA is considering not explicitly stating in its 
regulations that pesticides that are DOT hazardous materials must 
comply with the DOT HMR. EPA requests comments on whether the Agency 
should simply include a reference to the DOT HMR, such as ``Pesticide 
products that meet the definition of a hazardous material in 49 CFR 
171.8 are subject to the

[[Page 56936]]

requirements of 49 CFR parts 171-180.'' Another alternative would be to 
cite only the portions of the HMR that pesticides that are not 
classified as DOT hazardous materials would have to comply with.
    Under the regulatory approach being considered for the final rule, 
pesticides that are not classified as DOT hazardous materials would be 
required to be packaged in accordance with the specified packaging 
design, construction, and marking standards that would apply to a DOT 
packing group III material. EPA believes this approach would be the 
most straightforward in terms of compliance by the regulated industry 
and enforcement by the appropriate governmental agencies. The pesticide 
registrants and enforcement officials could rely on the marking 
indicating compliance with the packing group III standards.
    EPA considered but rejected an alternative approach specifying that 
pesticides that are not classified as DOT hazardous materials would be 
required to be packaged in containers that are capable of meeting the 
specified packaging design, construction, and some of the marking 
standards that would apply to a DOT packing group III material. Under 
this approach, the containers would not actually have to be marked to 
indicate compliance with the PG III standards. This would eliminate the 
need to comply with some of the continued maintenance and production 
testing. However, to make this approach work logistically, EPA would 
have to specify some recordkeeping so the Agency could determine that 
the containers were capable of meeting the PG III standards and require 
some marking, such as ``Meets EPA standards for refillable containers'' 
to provide an indicator of compliance to enforcement officials. 
Standards similar to these two provisions were included in the proposal 
and were strongly criticized by commenters, who opposed standards that 
would create a different framework and set of packaging standards for 
accomplishing the same goals as the existing DOT standards.

D. Request for Comments

    EPA requests comments on the regulatory approach discussed above 
for revising the pesticide container regulations to refer to and adopt 
the DOT HMR packaging and marking standards. In addition to general 
comments, EPA solicits comments on the following questions and issues:
    (1) Is it clear which portions of the DOT HMR would be referred to 
and adopted?
    (2) Does the sample regulatory text in Unit VII of this document 
accomplish EPA's intent?
    (3) Is the approach of incorporating the Class 9 limited quantity 
exception appropriate?
    (4) The regulatory option under consideration would expand the 
number of tests containers are required to meet. Under the original 
1994 proposal, nonrefillable containers weren't subject to any of the 
DOT performance tests and minibulks were subject to a drop test only. 
Despite the large increase in potentially applicable testing 
requirements, EPA believes referring to and adopting the DOT HMR PG III 
standards would not greatly increase the economic burden of the 
regulations because: (i) Many pesticide products, including an 
estimated one-third of all agricultural products, are classified as DOT 
hazardous materials (Ref. 8); (ii) many other pesticides are packaged 
in containers that meet the DOT PG III standards, even though it isn't 
required; and (iii) the container and pesticide manufacturing 
industries are familiar with the DOT regulations. Is EPA's assessment 
that there would only be a relatively minor cost increase attributed to 
the regulatory approach being considered accurate? EPA also requests 
specific information about the potential economic impacts of referring 
to and adopting the DOT PG III standards, such as the costs of 
conducting the leakproofness, hydrostatic pressure, stacking, and drop 
testing.
    (5) In general, the proposed regulations would apply to all types 
of packaging, including but not limited to rigid (plastic and steel) 
containers, paper and plastic bags, and water-soluble packaging, 
although specific requirements would apply to appropriate subsets of 
these container types. Under the regulatory approach discussed in this 
document, EPA would require all types of pesticide containers to meet 
the DOT PG III standards. EPA believes that it may be easier for some 
kinds of packaging, e.g., rigid plastic or steel containers, to comply 
with the DOT PG III standards than for other types of containers, e.g., 
bags or water-soluble film. EPA requests comments about whether the 
ease of complying with the DOT PG III standards varies according to the 
container type and whether certain kinds of packaging may be 
disproportionately impacted.
    (6) Is the provision that would allow EPA to modify or waive the 
requirements referring to and adopting the DOT requirements sufficient 
or should EPA include a more detailed exemption provision?
    (7) Should EPA adopt any of the alternative approaches discussed in 
Unit V.C.6 of this document instead of the preferred approach discussed 
in Units V.B and V.C.1 - V.C.5 of this document?

VI. Proposed Definition of Small Business Used in Impact Analysis

    As discussed in Unit II.A. of this document, section 601(3) of the 
RFA establishes as the default definition of small business the SBA 
size standards, which are primarily intended to define whether a 
business entity is eligible for government programs and preferences 
reserved for small businesses (13 CFR 121.101). Section 601(3) of the 
RFA also allows an agency to establish an alternate definition of small 
business after consultation with the SBA Office of Advocacy and after 
notice and an opportunity for public comment.
    In the regulatory impact analyses (RIA) and the initial regulatory 
flexibility analyses for the 1994 proposed rule (Ref. 10 and 11), EPA 
used alternate definitions of small business for identifying the 
potentially affected small entities. The alternate definitions were 
presented in these analyses, but EPA did not specifically solicit 
comment on these alternate definitions in conjunction with the 1994 
proposed rule. EPA is, therefore, specifically seeking comment on the 
establishment of these alternate definitions for use in identifying 
small pesticide formulators, small agrichemical dealers, and small 
independent custom (aerial and ground) applicators for analytical 
purposes related to this rulemaking. These alternate definitions are 
only used for analytical purposes and do not in any way affect the 
scope or any other provision of the proposed rule.
    The following discussion provides additional information about the 
alternate definitions that EPA used in the regulatory flexibility 
analysis for the 1994 proposed rule.

A. Overview of the Alternate Definitions for Use in the Analysis 

    As described in Unit I.A. of this document, the three major 
industry sectors that would be affected by the pesticide container and 
containment rule are pesticide formulators, agrichemical dealers, and 
independent custom (aerial and ground) applicators. The SBA, at 13 CFR 
part 121, defines a small business as having:
     500 or fewer employees for pesticide formulators (SIC 
2879)
     100 or fewer employees for agrichemical dealers (SIC 5191)

[[Page 56937]]

     Maximum revenues of $5.0 million for independent 
applicators (SIC 0721)
    In analyzing the potential impacts of the 1994 proposed rule, EPA 
determined that it was appropriate to use alternate definitions to 
assess the potential impacts on small pesticide formulators, small 
agrichemical dealers, and small independent custom (aerial and ground) 
applicators. EPA's alternative definitions of small businesses for 
pesticide formulators, agrichemical dealers, and independent commercial 
pesticide applicators are given in the following table 7. SBA's 
definitions are also provided in the table for the purposes of 
comparison.

  Table 7.--Comparison of the Definitions of Small Businesses to Use in
                            Analyzing Impacts
------------------------------------------------------------------------
                                       Definition of Small Business
                                 ---------------------------------------
         Industry Sector          SBA definition (13     Proposed EPA
                                     CFR part 121)        definition
------------------------------------------------------------------------
Pesticide formulators...........  500 or fewer        1 to 19 employees
                                   employees.
Agrichemical dealers............  100 or fewer        1 to 9 employees
                                   employees.
Independent commercial            Maximum revenues    One plane and
 applicators\1\.                   of $5.0 million.    $93,750 in sales
------------------------------------------------------------------------
\1\ Profiles of small, medium, and large facilities were developed for
  aerial applicators but not for ground applicators, because not enough
  information was available to profile ground applicators.

B. Discussion

    After careful consideration of the SBA small business definitions 
for the three industry sectors, EPA determined that it was appropriate 
to use alternate definitions of small business. As indicated 
previously, the SBA size standards are primarily intended to define 
whether a business entity is eligible for government programs and 
preferences reserved for small businesses (13 CFR 121.101), with the 
objective ``to ensure that a concern that meets a specific size 
standard is not dominant in its field of operation.'' (13 CFR 
121.102(b)). See section 632(a)(1) of the Small Business Act. Under 
SBA's definitions, all agrichemical dealers, all independent commercial 
applicators, and nearly all pesticide formulators would be considered 
small businesses. When assessing the potential impacts on small 
entities, however, EPA believes that it is important to ensure that the 
definition of small business is not as broad. EPA is concerned that 
using an overly broad definition of small business in the analysis may 
cause potentially significant economic impacts on smaller facilities to 
be camouflaged when combined with information about potential impacts 
on those facilities that meet the SBA size standard for small business, 
but which are not typical of a small business in that industrial 
sector. For example, a small pesticide formulator with 1 to 19 
employees is going to have significantly different sales and profits 
than a formulating facility with over 100 employees. To account for 
such differences, facilities in the pesticide formulating, agrichemical 
dealer, and independent applicator industries were profiled as small, 
medium or large, as summarized in the following table 8.

 Table 8.-- Profile of Small, Medium, and Large Business Categories Used
                         in the Impact Analysis
------------------------------------------------------------------------
                                Definition of    Number of    Percent of
     Industry sector/size          category      facilities   facilities
------------------------------------------------------------------------
Pesticide formulators
 Small.......................  1 to 19                  172           62
                                employees.
 Medium......................  20 to 99                  81           29
                                employees.
Large........................  100 to 2,499              24            9
                                employees.
Agrichemical dealers
 Small.......................  1 to 9                12,991           77
                                employees.
 Medium......................  10 to 49               3,623           22
                                employees.
Large........................  50 to 99                 181            1
                                employees.
Independent applicators\1\
Small........................  1 plane and              780           39
                                $93,750 in
                                sales.
Medium.......................  2 to 4 planes          1,120           56
                                and $375,000
                                in sales.
Large........................  5 or more                100           5
                                planes and
                                $750,000 in
                                sales.
------------------------------------------------------------------------
\1\ Profiles of small, medium, and large facilities were developed for
  aerial applicators but not for ground applicators, because not enough
  information was available to profile ground applicators.

    In considering the analysis of the 1994 proposed rule on pesticide 
formulators, the RIA defined a number of ``representative'' facilities, 
with different financial characteristics (e.g., sales, net profit 
before tax, and tax rate) and varying operating characteristics (number 
of employees, filling lines, and formulations). The RIA then evaluated 
the impacts of three different regulatory options on a small and 
medium-sized representative facility in each of the four different 
pesticide markets (agricultural, industrial, institutional, and 
household) and on four different kinds of large representative 
facilities in the agricultural market. For each regulatory option, the 
RIA also considered two different implementation scenarios for the 
nonrefilable residue removal standard. Based on the regulatory 
flexibility analysis prepared for the 1994 proposed rule, Table 9 
provides a summary illustration of the representative facilities that 
might be significantly impacted under the different regulatory options 
and implementation scenarios presented in the 1994 proposed rule.
    Table 9 below shows that, for the options/scenarios identified in 
the analysis with a potential for significant impacts, the small 
representative facilities are more likely to have these

[[Page 56938]]

impacts than the medium or large facilities. If EPA had evaluated the 
impact of the proposed regulations on only medium or large facilities 
(based on an ``average'' small business under SBA's definition), the 
potential impacts on these small companies might not have been 
identified as clearly in the analysis.
    The initial regulatory flexibility analysis identified residue 
removal testing as the most critical variable affecting EPA's small 
formulators. The proposed regulations addressed this issue in several 
ways. First, the proposal made allowances for using residue removal 
test data from similar products and containers as documentation that 
another container/formulation combination meets the residue removal 
standard (i.e., implementation scenario 1). Second, the regulations 
include a provision for obtaining a waiver from the residue removal 
standard. The regulatory flexibility analysis also describes an 
alternative to increase the compliance period for residue removal 
testing, although this alternative was not included in the proposed 
rule.

               Table 9.--Representative Facilities that would be Significantly Impacted by the Proposed Pesticide Container Regulations\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    \2\ Option 1                          \2\ Option 2                          \2\ Option 3
 Representative Facility by Market and -----------------------------------------------------------------------------------------------------------------
                 Size                     \3\ Scenario 1     \3\ Scenario 2     \3\ Scenario 1     \3\ Scenario 2     \3\ Scenario 1     \3\ Scenario 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small agricultural facility...........                                                                   x                  x                  x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small industrial facility.............                                                                   x                  x                  x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small institutional facility..........                                                                   x                  x                  x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small household facility..............                                                                   x                                     x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium agricultural facility..........                                                                                                         x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium industrial facility............                                                                   x                  x                  x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium institutional facility.........                                                                                      x                  x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium household facility.............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 1.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 2.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 3.........                                                                   x                                     x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 4.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In the analysis, a representative facility was determined to be significantly impacted if the ratio of its annualized cost of compliance (ARR) over
  its sales was greater than one percent and the ratio of its ARR over its profits before tax was greater than 20%.
\2\ EPA considered three regulatory options. Option 1 included the least stringent standards, option 2 was the EPA proposed rule, and option 3 included
  the most stringent requirements.
\3\ For each regulatory option, EPA considered two implementation scenarios for the nonrefillable residue removal requirement. Under scenario 1, 50% of
  container/formulation combinations would have to be tested to determine compliance with the residue removal standard. Under scenario 2, all container/
  formulation combinations would have to be tested.

    This example of the economic impact analysis and regulatory 
flexibility analysis for pesticide formulators supports the use of 
EPA's alternative definitions for small businesses, by showing that 
EPA's alternative definitions:
     Are more reflective of the small facilities in the 
relevant industry sectors
     Provide a more meaningful analysis of the facilities 
likely to have the most significant economic impact
     Distinguish facilities that have the stronger technical 
expertise and larger revenue sources (and, therefore, can more easily 
comply with the regulations) from those that do not.

C. Consultation with the SBA Office of Advocacy

    EPA recently contacted the SBA Office of Advocacy for the purpose 
of consulting on the use and establishment of the alternate definitions 
of small business for analytical purposes related to this rulemaking. 
(Ref. 12) After a discussion of the potential changes presented in this 
action, the regulatory flexibility analysis prepared for the 1994 
proposed rule, and the alternate definitions EPA used in that analysis, 
the SBA suggested that EPA consider combining the small and medium 
categories for the purpose of analyzing the potential impacts on small 
entities. SBA indicated that it generally

[[Page 56939]]

recommends using a broader definition of small business to ensure a 
broader assessment of the potential impacts on small entities. 
Additional information is available in the public version of the 
official record described in Unit I.B.3 of this document.

D. Request for Comments

    EPA solicits comments on the alternate definitions used in the 
impact analyses to identify small pesticide formulators, small 
agrichemical dealers, and small independent commercial applicators. EPA 
will consider SBA's recommendations, along with any public comments 
received, when preparing the final rule. Comments regarding the 
alternate definitions should be submitted to EPA according to the 
process established in Unit I.C. of this document.

VII. Potential Alternative Regulatory Text

    If the changes discussed in this document are adopted, the 
potential alternative regulatory text in this section, or a variation 
of it, may be incorporated into the final rule. However, EPA may choose 
to retain the regulatory text from the original 1994 proposal or 
incorporate language implementing one of the alternative approaches 
discussed in this section.
    EPA is considering the following two modifications to the 
regulatory text for the final rule for Subpart F ``Nonrefillable 
Container Standards: Container Design and Residue Removal.'' First, EPA 
is considering replacing the proposed regulatory text for 40 CFR 
165.100 with the following.
    Sec. 165.100 Applicability and scope.
    (a) Scope. This subpart establishes design and construction 
standards and requirements for nonrefillable containers used for the 
sale or distribution of pesticide products. This subpart applies to 
pesticide registrants.
    (b)  Manufacturing use products. This subpart does not apply to 
containers that contain manufacturing use products, as defined in 
Sec. 158.153(h) of this chapter.
    (c) Antimicrobial pesticide products. (1) Except as provided in 
paragraph (c)(2) of this section, this subpart does not apply to 
containers that contain a pesticide product that meets all of the 
following criteria:
    (i) The pesticide product meets the definition of 
``antimicrobial pesticide'' in FIFRA section 2(mm).
    (ii) The label of the pesticide product includes directions for 
use on sites in at least one of the following antimicrobial product 
use categories:
    (A) Food handling/storage establishments premises and equipment.
    (B) Commercial, institutional, and industrial premises and 
equipment.
    (C) Residential and public access premises.
    (D) Medical premises and equipment.
    (E) Materials preservatives.
    (F) Industrial processes and water systems.
    (G) Antifouling coatings.
    (H) Wood preservatives.
    (I) Swimming pools.
    (iii) The pesticide product does not meet the criteria for 
hazardous waste as set out in part 261 of this chapter when the 
pesticide product is intended to be disposed.
    (2) A pesticide product that meets the criteria in paragraphs 
(c)(1)(i) through (1)(iii) of this section is subject to the 
following requirements if the pesticide meets the criteria of 
Toxicity Category I as set out in Sec. 156.10(h)(1) of this chapter:
    (i) 40 CFR 165.102(b) regarding DOT standards for nonrefillable 
containers.
    (ii) 40 CFR 165.102(c) regarding permanent marking for 
nonrefillable containers.
    (iii) 40 CFR 165.102(d) regarding container dispensing for 
nonrefillable containers.
    (iv) 40 CFR 165.111 regarding certification for nonrefillable 
containers.
    (v) 40 CFR 165.114 regarding recordkeeping and inspections for 
nonrefillable containers.
    (vi) 40 CFR 165.117 regarding compliance dates for nonrefillable 
containers.
    (d) General applicability. Except for pesticide products that 
are excluded by paragraph (b) of this section or addressed by 
paragraph (c) of this section, a pesticide product distributed or 
sold in a nonrefillable container shall meet all of the standards of 
this subpart if at least one of the conditions in paragraphs (d)(1) 
through (4) of this section is met:
    (1) The product meets the criteria of Toxicity Category I as set 
out in Sec.  156.10(h)(1) of this chapter.
    (2) The product meets the criteria of Toxicity Category II as 
set out in Sec.  156.10(h)(1) of this chapter.
    (3) The container size is equal to or larger than 5.0 liters 
(1.3 gallons) for liquid formulations or 5.0 kilograms (11.0 pounds) 
for solid formulations.
    (4) The product label meets the standards in paragraphs 
(d)(4)(i) and (ii) of this section.
    (i) The product label includes at least one of the following 
environmental hazard statements:
    (A) This pesticide is toxic (or extremely toxic) to wildlife.
    (B) This pesticide is toxic (or extremely toxic) to fish.
    (C) This pesticide is toxic (or extremely toxic) to birds.
    (D) This chemical is known to leach through soil into ground 
water under certain conditions as a result of agricultural use. Use 
of this chemical in areas where soils are permeable, particularly 
where the water table is shallow, may result in ground-water 
contamination.
    (E) This chemical demonstrates the properties and 
characteristics associated with chemicals detected in ground water. 
Use of this chemical in areas where soils are permeable, 
particularly where the water table is shallow, may result in ground-
water contamination.
    (F) Any environmental hazard statement pertaining to wildlife, 
fish, birds, or groundwater.
    (ii) The product label permits outdoor use.


    Second, EPA is considering deleting proposed Secs. 165.102(a)(3) 
and 165.102(b) and incorporating the following regulatory text as 
Sec. 165.102(b). Proposed Secs. 165.102(a)(1) and 165.102(a)(2) would 
not be changed under the regulatory approaches being considered in this 
document. The proposed standard for container integrity in proposed 
Sec. 165.102(b) could be deleted because there is an equivalent 
standard in the incorporated DOT standards.
    Sec. 165.102(b) DOT standards. (1) Pesticide products that meet 
the definition of a hazardous material in 49 CFR 171.8 shall be 
packaged as required by 49 CFR parts 171-180. In addition, such 
pesticide products shall comply with the requirements of this 
subpart.
    (2) Pesticide products that do not meet the definition of a 
hazardous material in 49 CFR 171.8 shall be packaged in containers 
that are designed, constructed, and marked to comply with the 
requirements of 49 CFR 173.24, 173.24a, 173.24b, 173.28, 173.203, 
173.213, 173.240, 173.241, Part 178, and Part 180 as applicable to a 
Packing Group III material, liquid or solid, as appropriate. In 
addition, such pesticide products shall comply with the requirements 
of this subpart.
    (3) Limited quantities of pesticide products that do not meet 
the definition of a hazardous material in 49 CFR 171.8 are excepted 
from the requirements set out in paragraph (b)(2) of this section 
when packaged in combination packagings according to this paragraph. 
Each package shall conform to the general requirements for 
packagings and packages in 49 CFR 173.24 and may not exceed 30 
kilograms (66 pounds) gross weight. The following combination 
packagings are authorized:
    (i) For liquids, inner packagings not over 5.0 liters (1.3 
gallons) net capacity each, packed in strong outer packagings.
    (ii) For solids, inner packagings not over 5.0 kilograms (11.0 
pounds) net capacity each, packed in strong outer packagings.
    (4) The Agency may modify or waive the requirements of this 
section if a person provides an application for exemption to the 
Director of the Office of Pesticide Programs that contains data 
showing that the alternative (partial or modified) set of standards 
achieves a level of safety that is at least equal to that specified 
in the requirements of this section.
    (5) If the Department of Transportation proposes to change any 
of the regulations that are incorporated in paragraph (b)(1), 
(b)(2), or (b)(3) of this section, the Agency will provide notice to 
the public in the Federal Register.


    EPA is considering the following two modifications to the 
regulatory text for the final rule for Subpart G ``Refillable Container 
Standards: Container Design and Residue Removal.'' First, EPA is 
considering replacing the proposed regulatory text for 40 CFR 165.120 
with the following potential alternative regulatory text. [This 
language is very

[[Page 56940]]

similar to the above regulatory text for nonrefillable containers. The 
main differences are the lists of regulatory sections that eligible 
antimicrobial products in Toxicity Category I would have to comply 
with.]
    Sec. 165.120 Applicability and scope.
    (a) Scope. This subpart establishes design and construction 
standards and requirements for refillable containers used for the 
sale or distribution of pesticide products. This subpart also 
establishes the standards and requirements for repackaging pesticide 
products into refillable containers.
    (b) Manufacturing use products. This subpart does not apply to 
containers that contain manufacturing use products, as defined in 
Sec. 158.153(h) of this chapter.
    (c) Antimicrobial pesticide products. (1) Except as provided in 
paragraphs (c)(2) and (3) of this section, this subpart does not 
apply to containers that contain a pesticide product that meets all 
of the following criteria:
    (i) The pesticide product meets the definition of 
``antimicrobial pesticide'' in FIFRA section 2(mm).
    (ii) The label of the pesticide product includes directions for 
use on sites in at least one of the following antimicrobial product 
use categories:
    (A) Food handling/storage establishments premises and equipment.
    (B) Commercial, institutional, and industrial premises and 
equipment.
    (C) Residential and public access premises.
    (D) Medical premises and equipment.
    (E) Materials preservatives.
    (F) Industrial processes and water systems.
    (G) Antifouling coatings.
    (H) Wood preservatives.
    (I) Swimming pools.
    (iii) The pesticide product does not meet the criteria for 
hazardous waste as set out in part 261 of this chapter when the 
pesticide product is intended to be disposed.
    (2) A pesticide product that meets the criteria in paragraphs 
(c)(1)(i), (c)(1)(ii)(A) through (ii)(H), and (c)(1)(iii) of this 
section is subject to the following requirements if the pesticide 
meets the criteria of Toxicity Category I as set out in 40 CFR 
156.10(h)(1):
    (i) 40 CFR 165.124(a) regarding DOT standards for refillable 
containers.
    (ii) 40 CFR 165.124(b) regarding permanent marking for 
refillable containers.
    (iii) 40 CFR 165.124(e) regarding apertures for refillable 
containers.
    (iv) 40 CFR 165.124(f) regarding standards for bulk refillable 
containers.
    (v) 40 CFR 165.126 regarding certification for refillable 
containers.
    (vi) 40 CFR 165.128 regarding recordkeeping and inspection for 
refillable containers.
    (vii) 40 CFR 165.129 - 165.136 regarding procedural standards 
for registrants and refillers who repackage pesticide into 
refillable containers.
    (viii) 40 CFR 165.139 regarding compliance date for refillable 
containers.
    (3) A pesticide product that meets the criteria in paragraphs 
(c)(1)(i), (c)(1)(ii)(I), and (c)(1)(iii) of this section is subject 
to the following standards if the pesticide meets the criteria of 
Toxicity Category I as set out in Sec. 156.10(h)(1) of this chapter:
    (i) 40 CFR 165.124(a) regarding DOT standards for refillable 
containers;
    (ii) 40 CFR 165.124(f) regarding standards for bulk refillable 
containers;
    (iii) 40 CFR 165.126 regarding certification for refillable 
containers;
    (iv) 40 CFR 165.128 regarding recordkeeping and inspection for 
refillable containers;
    (v) 40 CFR 165.129 regarding the transfer of registered 
pesticide products into refillable containers;
    (vi) 40 CFR 165.130 - 165.132 regarding procedural standards for 
registrants who repackage pesticide into refillable containers;
    (vii) 40 CFR 165.134(a) - 165.134(h) regarding procedural 
standards for refillers who repackage pesticide into refillable 
containers;
    (viii) 40 CFR 165.136(a) regarding recordkeeping for each 
pesticide product that is repackaged by a refiller; and
    (ix) 40 CFR 165.139 regarding compliance date for refillable 
containers.
    (d) General applicability. Except for pesticide products that 
are excluded by paragraph (b) of this section or addressed by 
paragraph (c) of this section, a pesticide product distributed or 
sold in a nonrefillable container shall meet all of the standards of 
this subpart if at least one of the conditions in paragraphs (d)(1) 
through (4) below is met:
    (1) The product meets the criteria of Toxicity Category I as set 
out in Sec.  156.10(h)(1) of this chapter.
    (2) The product meets the criteria of Toxicity Category II as 
set out in Sec.  156.10(h)(1) of this chapter.
    (3) The container size is equal to or larger than 5.0 liters 
(1.3 gallons) for liquid formulations or 5.0 kilograms (11.0 pounds) 
for solid formulations.
    (4) The product label meets the standards in paragraphs 
(d)(4)(i) and (ii) of this section:
    (i) The product label includes at least one of the following 
environmental hazard statements:
    (A) This pesticide is toxic (or extremely toxic) to wildlife.
    (B) This pesticide is toxic (or extremely toxic) to fish.
    (C) This pesticide is toxic (or extremely toxic) to birds.
    (D) This chemical is known to leach through soil into ground 
water under certain conditions as a result of agricultural use. Use 
of this chemical in areas where soils are permeable, particularly 
where the water table is shallow, may result in ground-water 
contamination.
    (E) This chemical demonstrates the properties and 
characteristics associated with chemicals detected in ground water. 
Use of this chemical in areas where soils are permeable, 
particularly where the water table is shallow, may result in ground-
water contamination.
    (F) Any environmental hazard statement pertaining to wildlife, 
fish, birds, or groundwater.
    (ii) The product label permits outdoor use.


    Second, EPA is considering deleting proposed Secs. 165.124(a)(3) 
and 165.124(c) and incorporating the following regulatory text as 
Sec. 165.124(c). Proposed Secs. 165.124(a)(1) and 165.124(a)(2) would 
not be changed under the regulatory approaches being considered in this 
document. The proposed standard for minibulk container integrity in 
proposed Sec. 165.124(c) could be deleted because there is an 
equivalent standard in the incorporated DOT standards.
    Sec. 165.124(c) DOT standards. (1) Pesticide products that meet 
the definition of a hazardous material in 49 CFR 171.8 shall be 
packaged as required by 49 CFR parts 171-180. In addition, such 
pesticide products shall comply with the requirements of this 
subpart.
    (2) Pesticide products that do not meet the definition of a 
hazardous material in 49 CFR 171.8 shall be packaged in containers 
that are designed, constructed, and marked to comply with the 
requirements of 49 CFR 173.24, 173.24a, 173.24b, 173.28, 173.203, 
173.213, 173.240, 173.241, Part 178, and Part 180 as applicable to a 
Packing Group III material, liquid or solid, as appropriate. In 
addition, such pesticide products shall comply with the requirements 
of this subpart.
    (3) Limited quantities of pesticide products that do not meet 
the definition of a hazardous material in 49 CFR 171.8 are excepted 
from the requirements set out in paragraph (b)(2) of this section 
when packaged in combination packagings according to this paragraph. 
Each package shall conform to the general requirements for 
packagings and packages in 49 CFR 173.24 and may not exceed 30 
kilograms (66 pounds) gross weight. The following combination 
packagings are authorized:
    (i) For liquids, inner packagings not over 5.0 liters (1.3 
gallons) net capacity each, packed in strong outer packagings.
    (ii) For solids, inner packagings not over 5.0 kilograms (11.0 
pounds) net capacity each, packed in strong outer packagings.
    (4) The Agency may modify or waive the requirements of this 
section if a person provides an application for exemption to the 
Director of the Office of Pesticide Programs that contains data 
showing that the alternative (partial or modified) set of standards 
achieves a level of safety that is at least equal to that specified 
in the requirements of this section.
    (5) If the Department of Transportation proposes to change any 
of the regulations that are incorporated in section (b)(1), (b)(2), 
or (b)(3) of this section, the Agency will provide notice to the 
public in the Federal Register.

VIII. Statutory Review Requirements

    As required by FIFRA 25(a), this document was submitted to the U.S. 
Department of Agriculture (USDA) for review and comment. USDA elected 
not to comment officially on it. This document was submitted to the 
Committee on Agriculture of the U.S. House of Representatives and the 
Committee on Agriculture, Nutrition, and Forestry of the U.S. Senate. 
EPA did not receive comments on this document. The FIFRA Scientific 
Advisory Panel

[[Page 56941]]

(SAP) waived its review of this document.

IX. References

    1. U.S. EPA, ``Proposed Rule: Standards for Pesticide Containers 
and Containment'' 59 FR 6712 (February 11, 1994).
    2. U.S. EPA, ``Summary of Comments on the Proposed Rule on 
Standards for Pesticide Containers and Containment,'' (October 28, 
1996).
    3. U.S. EPA, ``Appendix of Antimicrobial Product Use Sites and 
Categories,'' (January 14, 1997).
    4. Rogers, William H. ``Environmental Law: Hazardous Wastes and 
Substances,'' West Publishing, St. Paul, Minnesota, pp. 40-59, 
(1992).
    5. U.S. EPA, ``Characterization of Antimicrobial Pesticides,'' 
(July 16, 1998).
    6. U.S. EPA, ``Pesticide Industry Sales and Usage: 1994 and 1995 
Market Estimates,'' number 733-R-002, (August 1997).
    7. U.S. EPA, ``Pesticide Regulation (PR) Notice 96-8: 
Toxicologically Significant Levels of Pesticide Active 
Ingredients,'' (October 31, 1996).
    8. U.S. EPA, ``Characterization of Pesticides as Department of 
Transportation Hazardous Materials,'' (July 15, 1998).
    9. U.S. DOT, ``Notice of Actions on Exemption Applications,'' 63 
FR 14990 (March 27, 1998).
    10. U.S. EPA, ``Regulatory Impact Analysis: Proposed Container 
Design and Residue Removal Regulations Under the Federal 
Insecticide, Fungicide, and Rodenticide Act as Amended, 1988,'' 
(1993).
    11. U.S. EPA, ``Regulatory Impact Analysis: Standards for 
Pesticide Containment Structures Under the Federal Insecticide, 
Fungicide, and Rodenticide Act as Amended, 1988,'' (1993).
    12. U.S. EPA, ``Use of an Alternate Definition for `Small 
Business' in the Small Entity Economic Impact Analysis Conducted for 
the 1994 Proposed Standards for Pesticide Container and Containment 
[RIN 2070-AB95],'' (1999).
    13. U.S. EPA, ``Economic Analysis for the Potential Changes 
Discussed in the Supplemental Federal Register Notice,'' (July 28, 
1998).
    14. U.S. EPA, ``Supporting Statement for SF-83; Container Design 
and Residue Removal Regulations (40 CFR part 165),'' prepared for 
EPA by Mitchell Systems Corporation (1993).

X. Regulatory Assessment Requirements

    The regulatory assessment requirements applicable to the original 
proposed rule are discussed in the preamble for that proposal. (See 59 
FR 6774, February 11, 1994) The following discussion is intended to 
supplement that original discussion by describing the regulatory 
assessment requirements applicable to this action.

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), it has been determined that this 
action is not a ``significant regulatory action'' subject to review by 
the Office of Management and Budget (OMB). The Agency's estimated 
impacts of the proposed rule are contained in a document entitled 
``Regulatory Impact Analysis: Proposed Container Design and Residue 
Removal Regulations under the Federal Insecticide, Fungicide, and 
Rodenticide Act as Amended, 1988'' (Ref. 10) The Agency's estimates 
with regard to the potential changes discussed in this document are 
contained in a document entitled ``Economic Analysis for the Potential 
Changes Discussed in the Supplemental Federal Register Notice'' (Ref. 
13). Both of these documents are available as a part of the public 
version of the official record for this rulemaking (see Unit I.B.3 of 
this document). The impacts related to the potential changes discussed 
in this document are briefly summarized here.
    1. Summary of potential economic impacts. EPA estimates that the 
potential changes presented in this document would decrease the overall 
estimated cost of the rule by 13 to 27%.
    As set out in the Regulatory Impact Analysis (RIA) of the 1994 
proposed rule (Ref. 10), the annualized cost of the proposed rule was 
estimated to be between $38.7 million and $49.9 million, which would be 
split between the pesticide formulating industry (about $20 million to 
$27.2 million), the pesticide refilling industry ($11.2 million), 
independent (for-hire) pesticide applicators ($1.6 million) and 
pesticide end users ($6 million to nearly $10 million).
    The potential regulatory changes discussed in this document would 
primarily affect the pesticide formulating industry. The proposed 
regulations that would apply to the pesticide refilling industry (i.e., 
mainly the ``procedural'' container-related standards and the 
containment regulations), independent pesticide applicators (the 
containment standards), and pesticide end users (the label 
requirements) would not be modified significantly by the changes 
discussed in this document.
    EPA estimates that the potential changes discussed in this document 
would decrease the overall cost of the rule by 13 to 27%. The 
regulatory options discussed in Units III and IV of this document would 
lower the costs by decreasing the number of pesticide products and 
containers that would be subject to the pesticide container standards 
and by excluding certain antimicrobial products from the nonrefillable 
residue removal standard. (See Ref. 13 for a more detailed discussion 
of the economic analysis.)
    2. Antimicrobial exemption. EPA estimates that about 25% of the 
20,000 currently registered pesticide products are eligible 
antimicrobial pesticides. As discussed in Unit IV.C.3 of this document, 
an estimated 70% of eligible antimicrobial pesticides are classified in 
Toxicity Category I and, therefore, would be subjected to the container 
standards. Also, the nonrefillable residue removal standard accounts 
for about 50% of the annualized cost for the pesticide formulating 
industry, as estimated in the economic analysis of the proposed rule.
    If EPA implemented the exemption for certain antimicrobial products 
as discussed in this document, 30% of the eligible antimicrobial 
products would be exempt from the rule and the remaining products would 
not have to comply with the nonrefillable residue removal standard. In 
this scenario, the cost to the pesticide formulating industry for 
eligible antimicrobials to comply with the rule would be $1.8 million 
to $2.4 million (compared to a range of $5.0 million to $6.8 million 
for the same products to comply with the proposed rule).
    3. Modifications to the scope. For the purpose of analyzing how 
many products, other than eligible antimicrobials, would be included by 
the scope modifications under consideration, EPA estimates that 50 to 
90% of pesticides other than eligible antimicrobial pesticides would 
meet one of the scope criteria, as shown in the following table 10.

      Table 10.--Analysis of the Scope Criteria Under Consideration
------------------------------------------------------------------------
                                                         Percentage of
                      Criterion                        products included
                                                        in criterion (%)
------------------------------------------------------------------------
Toxicity Category I..................................       10 - 25
Toxicity Category II.................................       15 - 20
Environmental Hazard Statement.......................       10 - 20
Container Size.......................................       15 - 25
                                                      ==================
  Total..............................................       50 - 90
------------------------------------------------------------------------

    According to this estimate, 10 to 50% of products other than 
eligible antimicrobials would be categorized as ``lower-risk'' and 
would be exempt from the container standards. If EPA implemented the 
modifications to the scope as discussed in this document, the cost to 
the formulating industry for products other than eligible 
antimicrobials to comply with the rule would be $7.5 million to $18.4 
million

[[Page 56942]]

(compared to a range of $15.0 million to $20.4 million for the proposed 
rule).
    4. Combined cost decrease. Therefore, the estimated annual cost to 
the pesticide formulating industry of the container standards 
(considering the antimicrobial exemption and the modifications to the 
scope) would be $9.3 million to $20.8 million. The following table 11 
compares the costs of the container standards estimated for the 
proposed rule and the changes being considered in this document. EPA 
estimates that the changes considered in this document would lead to a 
$6.4 million to $10.6 million cost decrease compared to the proposed 
rule -- a 13 to 27% decrease.

                                     Table 11.--Comparison of Cost Estimates
----------------------------------------------------------------------------------------------------------------
                                                            Annualized Cost (millions of $)
                                                        --------------------------------------  Percent Decrease
                    Industry Segment                     1994 Proposal (59   Changes in this          (%)
                                                              FR 6712)           Document
----------------------------------------------------------------------------------------------------------------
Pesticide formulating industry.........................        19.9 - 27.2         9.3 - 20.8            31 - 53
Pesticide refilling industry...........................               11.2               11.2                  0
Independent (for-hire) pesticide applicators...........                1.6                1.6                  0
Pesticide end users....................................          6.0 - 9.9          6.0 - 9.9                  0
                                                        ========================================================
  Total................................................        38.7 - 49.9        28.1 - 43.5             13 -27
----------------------------------------------------------------------------------------------------------------

    5. DOT packaging standards. The third major regulatory change 
considered in this document would require all pesticide containers 
(that are subject to the container regulations) to comply with at least 
the DOT packing group III standards in addition to pesticide-specific 
requirements which were previously proposed. Unlike the other two 
issues that have already been discussed, the change to refer to and 
adopt the DOT PG III standards would increase the costs to the 
pesticide formulating industry.
    However, EPA believes that the magnitude of the cost increase from 
referring to and adopting the DOT PG III standards will be relatively 
minor, particularly compared to the $6.4 million to $10.6 million 
decrease from the other changes. As discussed in Unit V.D of this 
document, despite the increase in potentially applicable testing 
requirements, EPA believes referring to and adopting the DOT standards 
would not greatly increase the economic burden of the regulations 
because: (i) Many pesticide products are classified as DOT hazardous 
materials; (ii) many other pesticides are voluntarily packaged in 
containers that meet the DOT standards; and (iii) the container and 
pesticide manufacturing industries are familiar with the DOT 
regulations.
    6. Request for comments. EPA is interested in comments on its 
assessment of the potential impacts associated with the changes 
presented in this document. EPA is particularly interested in any 
information or data specific to the number of products and containers 
that would be excluded by these potential changes, and any information 
or data related to the costs or cost savings attributable to each of 
these potential changes.

B. Paperwork Reduction Act

    This action does not contain any new information collection 
requirements that need additional approval or review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq (PRA). In conjunction with the proposed rule that 
was published in 1994, EPA prepared an Information Collection Request 
(ICR) document for the paperwork burden imposed by the proposed 
container and labeling standards (EPA ICR No. 1631.01) (Ref. 14). 
Although EPA specifically sought comment on the ICR document in the 
proposed rule, EPA is hereby seeking additional comment on the original 
estimated burden presented in that ICR document, specifically with 
regard to the anticipated decrease in the burden resulting from this 
action. The ICR document is available in the public version of the 
official record for the proposed rule (Ref. 14), and a copy may be 
obtained in person from the PIRIB as described in Unit I.B.3. of this 
document, by mail from Sandy Farmer, OP Regulatory Information 
Division; U.S. Environmental Protection Agency (2137); 401 M St., SW.; 
Washington, DC 20460, by calling (202) 260-2740, or electronically by 
sending an e-mail message to ``[email protected].'' An electronic 
copy of the ICR document has also been posted with this Federal 
Register notice on EPA's home page.
     An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information subject to OMB approval under 
the PRA unless it displays a currently valid OMB control number. The 
OMB control numbers for EPA's regulations, after initial publication in 
the Federal Register as part of the final rule, are maintained in a 
list at 40 CFR part 9. The information requirements contained in EPA's 
1994 proposal, as potentially amended by the changes discussed in this 
document, are not effective until EPA issues a final rule and has 
obtained OMB approval for the information collection requirements 
contained in the final rule.
    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or 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.
    EPA anticipates that the changes being considered in this document 
should decrease the estimated total annual reporting and recordkeeping 
burden of 573,425 hours by about 13 to 27%. This decrease results 
mainly from decreasing the number of products and containers subject to 
the regulations. Not requiring eligible antimicrobial products to 
comply with the nonrefillable residue removal standard should further 
decrease the original burden estimates. In addition, referring to and 
adopting the DOT standards as a minimum should streamline the reporting 
and recordkeeping process by allowing companies to use the processes 
and systems they currently have in place for complying with the DOT 
HMR. Many companies cited this as a significant reason for supporting 
the

[[Page 56943]]

DOT regulatory option. On the other hand, the potential additional step 
of EPA providing a separate notice in the Federal Register whenever DOT 
issued a Federal Register notice that proposes to change any of the 
incorporated DOT standards may increase the burden on EPA and industry. 
However, EPA believes that any such increase would be insignificant 
compared to the decreases described above.
    Please note that OMB has not approved the ICR associated with the 
container and labeling provisions in the 1994 proposed rule. Instead, 
OMB provided comments about the proposed residue removal standard and 
the potential burden that the standard may have on registrants of 
products with active ingredients that have low toxicities or that are 
present at small concentrations. Specifically, OMB stated that ``EPA 
should consider less burdensome testing requirements to meet the 
objective that disposal of containers pose no unreasonable risk to 
health or the environment.'' As stated in Unit IV.C.3 of this document, 
EPA is considering changes to the residue removal standard in the 
context of preparing a final rule, but is not specifically addressing 
this issue in this document. However, EPA's preferred approach for 
implementing the FQPA antimicrobial provision -- excluding eligible 
antimicrobial products in Toxicity Category I from the nonrefillable 
residue removal standard and exempting all other eligible antimicrobial 
products from the entire rule -- would greatly decrease the potential 
burden that would be imposed by the final rule and would address OMB's 
comment.
    EPA is specifically interested in your comments on EPA's need for 
this information, the accuracy of the provided burden estimates, and 
any suggested methods for minimizing respondent burden, including the 
use of automated collection techniques. Send comments on the ICR to the 
EPA at the address provided in Unit I.C of this document. In addition, 
send a copy of your comments on the ICR to OMB at the following 
address: Office of Information and Regulatory Affairs, Office of 
Management and Budget, 725 17th St., NW., Washington, DC 20503, marked 
``Attention: Desk Officer for EPA.'' Please remember to include the ICR 
number in any correspondence. The final rule will respond to comments 
that EPA receives on the information collection requirements.

C. 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 regulatory action is 
not subject to the requirements of sections 202 and 205, because this 
action does not contain a ``Federal mandate'' that would result in 
expenditures of $100 million or more for State, local, or Tribal 
governments, in the aggregate, or for the private sector in any one 
year. This regulatory action would not impose an enforceable duty on 
any State, local or Tribal governments or on anyone in the private 
sector. In addition, this document contains no regulatory requirements 
that might significantly or uniquely affect small governments. 
Therefore, no action is needed under section 203 of the Unfunded 
Mandates Reform Act.

D. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments, or EPA consults with those governments. 
If EPA complies by consulting, Executive Order 12875 requires EPA to 
provide to the Office of Management and Budget a description of the 
extent of EPA's prior consultation with representatives of affected 
State, local and tribal governments, the nature of their concerns, 
copies of any written communications from the governments, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 12875 requires EPA to develop an effective process 
permitting elected officials and other representatives of State, local 
and tribal governments ``to provide meaningful and timely input in the 
development of regulatory proposals containing significant unfunded 
mandates.''
    Today's document does not create an unfunded Federal mandate on 
State, local or tribal governments. This document does not impose any 
enforceable duties on these entities. Accordingly, the requirements of 
section 1(a) of Executive Order 12875 do not apply to this document.

E. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments, or EPA 
consults with those governments. If EPA complies by consulting, 
Executive Order 13084 requires EPA to provide to the Office of 
Management and Budget, in a separately identified section of the 
preamble to the rule, a description of the extent of EPA's prior 
consultation with representatives of affected tribal governments, a 
summary of the nature of their concerns, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 13084 
requires EPA to develop an effective process permitting elected 
officials and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's document does not significantly or uniquely affect the 
communities of Indian tribal governments. This document does not 
involve or impose any requirements that affect Indian Tribes. 
Accordingly, the requirements of section 3(b) of Executive Order 13084 
do not apply to this document.

F. Executive Order 12898 

    Pursuant to 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 considered 
environmental justice related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income and minority communities and has determined that this 
document will not adversely affect environmental justice.

G. Executive Order 13045

    This document is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866 (see 
Unit X.A above), nor do the environmental health or safety risks 
addressed by this action have an affect on children.

H. Regulatory Flexibility Act

    Pursuant to section 605(b) of the RFA, EPA hereby certifies that 
this action will not have a significant economic impact on a 
substantial number of small

[[Page 56944]]

entities. The RFA requires an agency to prepare a regulatory 
flexibility analysis for any rule for which the agency is required to 
issue a notice of proposed rulemaking under the Administrative 
Procedures Act or any other statute, unless the agency certifies that 
the rule will not have a significant economic impact on a substantial 
number of small entities. This action does not impose any new 
requirements that would result in any adverse impacts on the 
potentially affected entities. Instead, the changes considered in this 
document would decrease the potential impacts of the 1994 proposed 
rule. EPA prepared an initial regulatory flexibility analysis for the 
1994 proposed rule. Although EPA did not specifically certify under 
section 605(b) of the RFA, EPA stated that the regulatory flexibility 
analysis showed that there would not be significant impact on 
potentially affected small facilities and that there would not be a 
substantial number of small aerial applicators adversely impacted (see 
59 FR 6712, at 6776). This action does not affect that conclusion and 
the potential changes would only decrease the estimated total impact 
presented in that analysis.
     The initial regulatory flexibility analysis that EPA prepared as 
part of the 1994 proposed rule made the following conclusions. First, 
whether or not small formulating facilities would be significantly 
impacted depended on how many container/formulation combinations would 
need to be tested to confirm compliance with the proposed residue 
removal standard. Second, representative refillers/refilling 
establishments would not be adversely affected by compliance with the 
1994 proposed regulations. Third, some small for-hire applicators, 
primarily aerial application businesses, could be adversely affected by 
the proposed containment requirements.
    The potential changes discussed in this document would not affect 
pesticide refillers and for-hire applicators significantly, so the 
relevant conclusions presented in the initial regulatory flexibility 
analysis that EPA prepared as part of the 1994 proposed rule would not 
change. The rest of this discussion focuses on EPA's assessment of the 
potential impact of the changes considered in this document on small 
formulating facilities, including the nonrefillable residue removal 
standard.
    EPA anticipates that the changes being considered in this document 
would decrease the costs for small formulators. As discussed 
previously, EPA estimates that the changes in this document would lead 
to a 13 to 27% lower cost than the cost of the proposed rule. EPA 
believes that all formulators would experience similar cost decreases, 
since formulators in each of the size categories -- small, medium, and 
large -- would have products exempt from the container regulations by 
either the antimicrobial exemption or the scope criteria.
    In addition, EPA believes that the antimicrobial exemption would 
make it unlikely that small formulating facilities in the household, 
industrial, and institutional pesticide markets would be significantly 
impacted. The crucial factor determining the significance of the impact 
on these facilities was the implementation of the residue removal 
standard. Under the approach being considered, antimicrobial products 
that would be subject to the container standards (eligible 
antimicrobial pesticides in Toxicity Category I) would not have to 
comply with the nonrefillable residue removal standard. While small 
household, institutional, and industrial formulators produce pesticides 
other than antimicrobials, exempting antimicrobial products from the 
nonrefillable residue removal standard should greatly decrease the 
potential economic impact on these facilities. Also, it is worth noting 
that changes to the residue removal standard are being considered 
separately from this document.
    As discussed previously, the change to refer to and adopt the DOT 
PG III standards would increase the costs to the pesticide formulating 
industry. However, EPA believes that the magnitude of the cost increase 
from referring to and adopting the DOT PG III standards will be 
relatively minor, particularly compared to the significant cost 
decrease due to the other changes being considered. EPA therefore 
certifies that the regulatory changes considered in this notice will 
not have a significant economic impact on a substantial number of small 
entities.
    As discussed in Unit VI. of this document, EPA believes it is 
appropriate to use alternate definitions of small business for the sole 
purpose of assessing the potential impacts of the proposed rule on the 
potentially impacted small businesses. With this document, EPA is 
providing the public with an opportunity to comment on these 
definitions and has consulted with the SBA Office of Advocacy as 
required by section 601(3). Seeking comment on the use of the alternate 
definitions does not impact EPA's ability to certify that this action, 
which is likely to decrease the potential burden of the 1994 proposed 
rule, will not result in a significant impact on a substantial number 
of small entities. Comments regarding the potential impacts of these 
changes, including any comments on the definitions, should be submitted 
to EPA according to the process established in Unit I.C. of this 
document.

I. National Technology Transfer and Advancement Act 

    This document does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Section 12(d) 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. The NTTAA requires EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. EPA 
invites public comment on this conclusion.

J. Federalism Review

    On August 4, 1999, President Clinton issued a new executive order 
on federalism, Executive Order 13132 (64 FR 43255, August 10, 1999), 
which will go into effect on November 2, 1999. In the interim, the 
current Executive Order 12612 (52 FR 41685, October 30, 1987) on 
federalism still applies. Under this order, this rule will not have a 
substantial direct effect upon States, upon the relationship between 
the national government and the States, or upon the distribution of 
power and responsibilities among the various levels of government. This 
rule does not apply to States; it applies to pesticide registrants, 
manufacturers and agricultural chemical dealers.

 List of Subjects in 40 CFR Part 165

     Environmental protection, Antimicrobial pesticides, Packaging and 
containers, Pesticides and pests.

    Dated: October 12, 1999.

Carol M. Browner,
Administrator.

[FR Doc. 99-27397 Filed 10-20-99; 8:45 am]
BILLING CODE 6560-50-F