Data Requirements for Antimicrobial Pesticides, 59382-59446 [E8-23127]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Proposed Rules]
[Pages 59382-59446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23127]



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Part III





Environmental Protection Agency





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40 CFR Parts 158 and 161



Data Requirements for Antimicrobial Pesticides; Proposed Rule

Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / 
Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 158 and 161

RIN 2070-AD30


Data Requirements for Antimicrobial Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to revise and update the existing data 
requirements for antimicrobial pesticides. The proposed revisions are 
needed to reflect current scientific knowledge and current Agency 
regulatory practices, and to improve protection of the general 
population as well as sensitive subpopulations. The proposed 
requirements are intended to further enhance the Agency's ability to 
make regulatory decisions about the human health and environmental fate 
and effects of antimicrobial pesticide products.

DATES: Comments must be received on or before January 6, 2009.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0110, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0110. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA 22202. The hours of operation of 
this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The Docket Facility telephone number 
is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Field and External 
Affairs Division, Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; mail code 7506P; telephone number: 703-305-6304; fax number: 703-
305-5884; e-mail address: boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are a producer of 
pesticide products (NAICS 32532), antifoulants (NAICS 32551), 
antimicrobial pesticides (NAICS 32561) or wood preservatives (NAICS 
32519), importers of such products, or any person or company who seeks 
to register an antimicrobial, antifoulant coating, ballast water 
treatment, or wood preservative pesticide or to obtain a tolerance for 
such a pesticide. 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 North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, please contact Norm Cook, Chief of the Risk 
Assessment and Science Support Branch in the Antimicrobials Division of 
the Office of Pesticide Programs at 703-308-8253 or via email, 
cook.norm@epa.gov.

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

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2008-0110. Publicly 
available docket materials are available either in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA 22202. The hours of operation of this Docket 
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The Docket Facility telephone number is (703) 305-5805.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.

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    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    The Environmental Protection Agency (EPA or the Agency) is 
proposing to establish a separate listing of the data requirements for 
antimicrobial pesticides in Title 40 of the Code of Federal Regulations 
(CFR) in subpart W of part 158. This proposal sets out use patterns 
that are designed to make it easier to determine which requirements 
apply to antimicrobial products. In addition to retaining most current 
data requirements for antimicrobials, this proposal incorporates nine 
new data requirements and revises other existing data requirements. 
This rule, once final, is intended to further enhance the Agency's 
ability to make regulatory decisions about the human health, and 
environmental fate and effects of antimicrobial pesticide products.
    The Agency has previously issued updated data requirements for 
conventional pesticides, and biochemical and microbial pesticides in 
part 158. This proposal is part of a larger effort to update and 
improve all of the data requirements for pesticide regulatory purposes. 
Data requirements for antimicrobial pesticides, currently contained in 
part 161, are proposed to be revised and included in part 158 upon 
promulgation.
    Generally, antimicrobials are considered to be those chemicals that 
disinfect and sanitize. However, within this proposal EPA is using the 
term antimicrobials to collectively refer to antimicrobial pesticides, 
antifoulant coatings and paints, and wood preservatives.
    As discussed in Unit XVIII.A., EPA has prepared a white paper 
entitled ``Use of Structure-Activity Relationship (SAR) Information and 
Quantitative SAR (QSAR) Modeling For Fulfilling Data Requirements for 
Antimicrobial Pesticide Chemicals and Informing EPA's Risk Management 
Process,'' a copy of which is contained in the docket for this proposed 
rule (Ref. 43). The white paper discusses the current level of 
information and usage of structure-activity-relationship (SAR) 
assessments and Quantitative SAR (QSAR) modeling to fulfill data 
requirements in the Pesticide Program. The Agency specifically seeks 
comment on this support document.
    Since many antimicrobial pesticides are typically rinsed down the 
drain, EPA has considered the potential impacts of pesticides that are 
discharged into wastewater treatment plants (WWTPs). This proposed rule 
addresses the issue of down-the-drain antimicrobials by proposing four 
new data requirements for use in a screening-level assessment on the 
fate of antimicrobials that reach a WWTP. To assess the impacts of this 
screening assessment and utility of the new data requirements for 
decision-making, EPA prepared four case studies (Ref. 42). The case 
studies, copies of which are contained in the docket for this proposed 
rule, are discussed in more detail in Unit XII.D. The Agency 
specifically seeks comment on the proposed approach for evaluating the 
potential impact of antimicrobial pesticide chemicals on WWTPs and 
nontarget organisms in receiving water bodies, and on the case studies, 
including the assumptions used in those studies, that were used to 
develop the proposed approach. EPA will consider comments specific to 
the case studies along with comments on the proposed approach, as the 
Agency evaluates the use of the proposed approach for down-the-drain 
antimicrobials in the final rule for antimicrobial data requirements.
    On October 26, 2007, EPA promulgated final rules establishing data 
requirements for conventional pesticides (72 FR 60934), and biochemical 
pesticides and microbial pesticides (72 FR 60988). These final rules 
were effective on December 24, 2007, and are therefore the current part 
158. As part of those actions, on October 24, 2007, (72 FR 60251) EPA 
preserved the original part 158 data requirements to provide continued 
regulatory coverage for antimicrobial pesticides until the Agency could 
promulgate a final regulation. To accomplish this, EPA transferred 
intact the original 1984 data requirements of part 158 into a new part 
161, entitled ``Data Requirements for Antimicrobial Pesticides.'' Part 
161, which applies only to antimicrobial pesticides, contains the 
current data requirements for antimicrobial pesticide chemicals.
    As explained in the preamble to the conventional pesticide final 
rule, EPA intended to preserve the existing data requirements for 
antimicrobial pesticides until a new rule tailored specifically to 
antimicrobial pesticides could be promulgated. Part 161 is intended to 
be transitional. Once subpart W of part 158 is promulgated, there will 
be no need for part 161. Accordingly, EPA proposes to revoke part 161 
upon the effective date of a final rule arising from today's proposal.

B. Reasons for Today's Action

    Since the promulgation of part 158 in 1984, the Agency has 
recognized that the tables and test notes promulgated in 1984 failed to 
adequately address the unique applications, use patterns, and other 
factors germane to antimicrobial pesticides. Part 158 specifies the 
types of data and information generally required for making sound 
regulatory judgments under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). The types of actions for which these data are 
needed include experimental use, registration, amended registration, 
reregistration, or registration review (collectively referred to in 
this proposal as ``registration''). The information required under 
FIFRA for registration of food-use pesticides is also information the 
Agency needs in order to grant tolerances or exemptions from the 
requirement of tolerances under section 408 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA).
    Required data are intended to provide information about the 
potential adverse effects of uses of pesticides, and to define what is 
generally expected from applicants for registration in support of their 
products. However, it must be emphasized that each applicant has the 
continuing obligation under FIFRA to demonstrate that an individual 
product meets the standard for registration under section 3 of FIFRA or 
section 408 of FFDCA. Accordingly, as indicated in current Sec.  158.75 
and Sec.  161.75, additional data may be needed to reflect the 
characteristics and use of specific pesticide products under review.
    Since the data requirements now set out in part 161 (formerly part 
158) were first published in 1984, every disciplinary area and 
requirement has been reconsidered and many have been revised in 
practice. These changes have been needed because the state of the 
science underlying the data requirements has advanced, and because the 
Agency has learned in specific registration actions that additional or 
different data are necessary to make sound regulatory decisions. These 
case-by-case decisions have been made in accordance with Sec.  158.75, 
which allows the Agency to impose additional data requirements

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beyond those specified in part 158 and now part 161.
    Use patterns specific to antimicrobial pesticides are not specified 
in part 161, as they were not set out separately when originally 
promulgated in 1984. As a result, applicants have needed to interpret 
the data requirements often via extensive consultation with and 
interpretation from the Agency to determine the antimicrobial data 
requirements for a particular product. Today, EPA is proposing that the 
antimicrobial pesticide requirements be codified in a separate subpart 
W to part 158 with use patterns (see Unit IV.I. of this preamble) and 
groups of use patterns specific to antimicrobials.
    Today's proposed rule is part of a series of rules to update all of 
the data requirements for pesticide products. On October 26, 2007, EPA 
published in the Federal Register two final rules to promulgate the 
data requirements for conventional (72 FR 60934), and biochemical and 
microbial (72 FR 60988) pesticide chemicals. These rules and their 
proposals (conventional (March 11, 2005) (70 FR 12276) and biochemical 
and microbial (March 8, 2006) (71 FR12072)) state the rationales for 
requiring and/or revising particular data requirements. With few 
exceptions, these rationales are also applicable to antimicrobial 
pesticide chemicals, and as such have not been repeated in today's 
proposed rule. Today's proposal discusses in detail only those 
revisions that are singularly applicable to antimicrobial pesticides, 
including antifoulants and wood preservatives.

C. Benefits of this Proposal

    Greater detail on the benefits of this proposal is provided in the 
document entitled ``Economic Analysis of the Proposed Change in Data 
Requirements for Antimicrobial Pesticides'' which is available in the 
docket for this rulemaking (Ref. 44). The following briefly highlights 
the anticipated benefits:
    1. More refined assessments mean less uncertainty and clearer 
understanding of actual risks. EPA's current applicator/user exposure 
data base is not comprehensive, especially regarding exposures to 
antimicrobials in industrial and residential settings. The new data 
that would be collected once this proposal becomes final would allow 
the Agency to conduct improved pre- and post-application exposure 
assessments for applicators/users, and the general public. This will 
benefit not only workers (including applicators) and consumers by 
helping EPA to make better informed regulatory decisions that are 
neither too stringent nor too lenient, but also benefit the regulated 
industry by reducing the uncertainty in Agency risk assessments. Thus, 
today's proposal will reduce, but not eliminate, uncertainty related to 
the risks posed by antimicrobial pesticides.
    2. Clarity and transparency to regulated community means savings. 
The enhanced clarity and transparency of the information presented in 
part 158, subpart W should enhance the ability of industry to 
efficiently manage their antimicrobial registration submissions. 
Applicants may save time and money by understanding when studies are 
needed. Having all required studies available to EPA at the time of 
application should halt potential delays in the registration process, 
thereby enabling registration of antimicrobial pesticides sooner. 
Products would enter the market faster.
    3. EPA information assists other communities in assessing pesticide 
risks. Scientific, environmental, and health communities find 
antimicrobial pesticide toxicity information useful to respond to a 
variety of needs. For example, medical professionals are concerned 
about the health of patients exposed to antimicrobials; poison control 
centers use and distribute information on toxicity and treatment 
associated with poisoning; and scientists use toxicity information to 
characterize the effects of antimicrobial pesticides and to assess 
risks of pesticide exposure. Similarly, those responsible for 
protection of nontarget wildlife need reliable information about 
antimicrobial pesticides and assurance that pesticides do not pose an 
unreasonable threat. The proposed changes will help the scientific, 
environmental, and health communities by increasing the breadth, 
quality, and reliability of Agency regulatory decisions by improving 
their scientific underpinnings.
    4. Better informed users mean informed risk-reduction choices. 
Better regulatory decisions resulting from the proposed changes should 
also mean that the label will provide better information on the use of 
the antimicrobial pesticide. A pesticide label is the user's direction 
for using pesticides safely and effectively. It contains important 
information about where to use (or not use) the product, health and 
safety information to be read and understood before using a pesticide 
product, and how to dispose of that product. This benefits users by 
enhancing their ability to obtain antimicrobial pesticide products 
appropriate to their needs, and to use and dispose of products in a 
manner that is safe and environmentally sound. Applicators/users may 
benefit from label information based on the data submitted to the 
extent it helps inform their decisions about whether or how to use 
particular pesticides to avoid potential exposure.

D. What is the Agency's Authority for Taking this Action?

    This action is issued under the authority of sections 3, 4, 5, 10, 
12, and 25 of FIFRA as amended and section 408 of FFDCA. The data 
required for a registration, reregistration, experimental use permit, 
or tolerance are listed in 40 CFR part 158.

III. Statutory and Historical Framework

A. FIFRA

    Under FIFRA section 3, every pesticide product must be registered 
with EPA or specifically exempted under FIFRA section 25(b) before 
being sold or distributed in the United States. Under FIFRA, an 
applicant for a new registration or an existing registrant 
(collectively referred to as applicant in this proposal) must 
demonstrate to the Agency's satisfaction that, among other things, the 
pesticide product, when used in accordance with widespread and commonly 
recognized practice, will not cause ``unreasonable adverse effects'' to 
humans or the environment. This safety determination requires the 
Agency to weigh the risks of the use of the pesticide against any 
benefits. EPA must determine that the standard for registration 
contained in FIFRA is met before granting a registration.
    1. Registration. Section 3 of FIFRA contains the requirements for 
registration. Specifically, FIFRA section 3(c)(2) provides EPA broad 
authority, before and after registration, to require scientific testing 
and submission of the resulting data to the Agency by applicants for 
registration of pesticide products. An applicant must furnish EPA with 
substantial amounts of data on the pesticide, its composition, 
toxicity, potential human exposure, environmental properties, and 
ecological effects, as well as information on its product performance 
(efficacy) in certain cases. Although the data requirements are imposed 
primarily as a part of initial registration, EPA is authorized under 
FIFRA section 3(c)(2)(B) to require a registrant to develop and submit 
additional data to maintain a registration.
    2. Reregistration. FIFRA section 4 requires that EPA reregister 
each pesticide product first registered before November 1984. This date 
was chosen because pesticides registered after 1984 were subject to the 
part 158 requirements of the 1984 regulation.

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EPA has completed the reregistration/tolerance reassessment process for 
food-use pesticides and expects to complete all reregistration 
activities by the statutory deadline of August 2008.
    3. Registration review. FIFRA section 3(g) mandates that the 
registrations of all pesticides are to be periodically reviewed. 
Changes in science, public policy, and pesticide use practices occur 
over time. Through the new registration review program implemented via 
a regulation promulgated on August 9, 2006 (71 FR 45719) (40 CFR part 
155, subpart C), the Agency is periodically reevaluating all registered 
pesticides to assure that they continue to meet the statutory standard 
of no unreasonable adverse effects. Starting in 2006, registration 
review began to replace EPA's reregistration program as the mechanism 
for systematic review of existing pesticides. The registration review 
process begins by reviewing the available information in the possession 
of the Agency and then determining the specific data needed for 
assessing a particular pesticide. Thus, the data needed, and the scope 
and depth of the Agency's review will be tailored to the specific 
circumstances of a particular pesticide. This means that reviews will 
be commensurate with the complexity of the issues associated with each 
pesticide.
    4. Experimental Use Permits (EUPs). Subject to some exceptions, 
FIFRA section 5 requires persons seeking permission for experimental 
use of a pesticide under controlled condition to obtain an experimental 
use permit. A EUP allows limited use of a pesticide for specified 
experimental and data collection purposes intended to support future 
registration of the pesticide. Because a EUP is for limited use under 
controlled conditions, the data needed to support issuance of the 
permit are correspondingly less than those required for full 
registration. The regulations governing the issuance of EUPs are found 
in 40 CFR part 172. In its final rule ``Data Requirements for 
Conventional Pesticides'' EPA promulgated subpart C of part 158 to 
contain the data requirements for EUPs, which will be applied on a 
case-by-case basis to any EUP applications for an antimicrobial 
pesticide.
    5. Registration requirements for antimicrobials. FIFRA section 3(h) 
requires that EPA evaluate its registration process to identify 
improvements and reforms that will reduce historical review times for 
antimicrobial applications. This includes defining the classes of 
antimicrobial use patterns and the types of application review, 
conforming reviews to risks and benefits, ensuring efficacy, and 
meeting review time goals. EPA believes that this rule assists in 
meeting the section 3(h) mandate. By defining the 12 use patterns for 
antimicrobials in relation to the data required for a registration 
under FIFRA, EPA is providing clearer and more transparent information 
to applicants. This should result in submissions to EPA that contain 
the required data and therefore can be reviewed and evaluated more 
expeditiously.

B. FFDCA

    FFDCA requires EPA to determine that the level of pesticide 
chemical residues in food and feed will be safe for human consumption. 
The safety standard set under FFDCA section 408(b) and (c) defines safe 
as ``a reasonable certainty that no harm'' will result from exposures 
to pesticide chemical residues. The combination of aggregate and 
cumulative exposure assessments required by FFDCA section 408 increases 
the nature and scope of EPA's risk assessment, and potentially 
increases the types and amounts of data needed to determine that the 
FFDCA safety standard is met.
    Under FFDCA section 408, EPA is authorized to establish tolerances 
for pesticide residues in food and feed, or to exempt a pesticide from 
the requirement of a tolerance, if warranted. In this preamble, 
references to tolerances include exemptions from tolerance since the 
standards and procedures for both are the same. The safety standard 
applies to tolerances in a number of regulatory situations, including:
     Tolerances that support registration under FIFRA;
     Tolerances for imported products which are established to 
allow importation of pesticide-treated commodities, but for which no 
U.S. registration is sought;
     Time-limited tolerances which are established for FIFRA 
section 18 emergency exemptions; and
     Temporary tolerances established for experimental use 
permits under FIFRA section 5.

C. Linking FIFRA and FFDCA Safety Standards

    Under FIFRA section 2(bb), a pesticide that is inconsistent with, 
or does not meet, the FFDCA section 408 safety standard poses an 
unreasonable adverse effect that precludes new or continued 
registration. Given this linkage between registration and tolerances, 
it makes sense for EPA to define data requirements for both purposes: 
The data required to support a determination of ``reasonable certainty 
of no harm'' under FFDCA are an integral part of the data needed for an 
``unreasonable adverse effects'' determination under FIFRA. 
Consequently, when promulgated, these proposed data requirements would 
encompass the basic data requirements for both registration and 
tolerance-setting determinations. EPA has authority to require 
additional data on a case-by-case basis.

D. Scope of Proposed Subpart W

    FIFRA contains a number of provisions specific to ``antimicrobial 
pesticides'' as defined in FIFRA section 2(mm). The statutory 
definition contains a complex construction of functionality, types of 
organisms, and intended use to describe what is encompassed by the term 
``antimicrobial pesticide.'' EPA believes that the definition was 
primarily intended to be used in conjunction with the provisions of 
section 3(h), which contains requirements for process improvements, 
timeframes for review purposes, and other regulatory matters, but, 
significantly, does not include provisions pertaining to data 
requirements. The definition in section 2(mm) as it relates to section 
3(h) was discussed fully in a proposed rule issued in the Federal 
Register of September 17, 1999 (64 FR 50672).
    The statutory definition, however, does not mesh with the Agency's 
needs in developing this proposed rule concerning data requirements. 
Data requirements depend upon the use pattern, taking into account the 
pesticide's hazard and exposure profiles. How well the pesticide kills 
or repels particular pests are relevant factors in the determination of 
product performance data requirements.
    Neither FIFRA section 3(c)(2) nor section 3(h) requires the Agency 
to develop data requirements for an ``antimicrobial pesticide'' as 
defined specifically in section 2(mm). Therefore, the scope of this 
proposal has been expanded beyond ``antimicrobial pesticide'' as 
defined by FIFRA section 2(mm) to include related pesticides that are 
excluded from the 2(mm) definition. The broader applicability of this 
40 CFR part 158, subpart W is intended to ensure that all pesticides 
currently considered as antimicrobial products for purposes of FIFRA 
section 33 fees and review periods are covered.
    Accordingly, this proposal applies to:
     Antimicrobial pesticides, as defined in FIFRA section 
2(mm).
     Pesticide products for antimicrobial uses in/on food or 
feed.
     Antifoulant paints and coatings.

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     Wood preservatives.
     Pesticide products intended to be manufactured into any of 
the above.

IV. Introduction to Subpart W

A. Data Requirements for Registration

    First promulgated in 1984, EPA's pesticide data requirements 
outline the kinds of data and related information typically needed to 
register a pesticide. In this proposal, the data requirements are 
organized by scientific discipline (e.g., toxicology), just as the 
existing data requirements in part 158 for conventional, and 
biochemical and microbial pesticides and those in part 161 for 
antimicrobials. A significant change in this proposal from the existing 
data requirements in part 161 is the introduction of 12 use patterns 
specific to antimicrobials. Since there is much variety in pesticide 
chemistry, exposure, and hazard, the requirements are designed to be 
flexible. Test notes to the data requirements tables explain the 
conditions under which data are typically needed. Essentially, the data 
requirements identify the questions that the applicant will need to 
answer regarding a pesticide product before the Agency can register it. 
Data requirements address both components of a risk assessment, i.e., 
the hazards that the pesticide presents, and the estimated level of 
exposure to humans or nontarget species. Having the appropriate 
information enables the Agency to understand when those hazards pose 
risks. The answer to one question may inform the kind of information 
needed to answer other questions. For example, a pesticide that is 
persistent and toxicologically potent may require more extensive 
exposure data to help establish a safe level of exposure. In addition, 
because a number of antimicrobials are used for public health purposes 
(for example, disinfectants, sterilants, or sanitizers), there are 
product performance data requirements to assure that the antimicrobial 
product works as intended.

B. Structure of Part 158

    At this time data requirements for conventional, biochemical, and 
microbial pesticides are established in 40 CFR part 158. Data 
requirements for antimicrobial pesticides are established in 40 CFR 
part 161.
    Part 158 contains general provisions concerning all pesticide data 
(subpart A), instructions on how to use the data tables that follow 
(subpart B), and a series of disciplinary data tables that are focused 
on conventional pesticides (subparts C - O). Individual subparts are 
devoted to biochemical (subpart U) and microbial (subpart V) 
pesticides. The revised data requirements for antimicrobial pesticides 
would be incorporated into part 158 as subpart W.

C. Subpart W of Part 158

    Subpart W is proposed to be a freestanding series of tables and 
regulatory text establishing specific data requirements for each 
scientific discipline for antimicrobial pesticides. EPA recognizes that 
antimicrobial uses are generally different from the uses more typically 
associated with conventional pesticides (e.g., agricultural outdoor 
uses) and therefore can have different combinations of exposure 
considerations. The use patterns and expected exposures typically 
determine the data requirements for any pesticide. Antimicrobial 
pesticides are no different in this regard from conventional, 
biochemical, and microbial pesticides.
    The order of proposed subpart W mirrors that of the larger part 
158: from product chemistry, to efficacy, to hazard/toxicity 
requirements (both human health and ecological toxicity), to exposure 
data requirements (application and post-application human exposures, 
and exposure to residues in food), and environmental fate requirements, 
which overlap human exposure through drinking water. Units V-XIV of 
this preamble describe the revisions to the current requirements. The 
proposed data requirement tables are comprehensive. Generally, the data 
requirements for each discipline are discussed separately, but the 
applicator and post-application exposure disciplines are discussed 
together in a single unit.

D. Clarifying How to Use the Data Tables

    Part 158 subpart B contains a step-wise process to assist the 
applicant in determining the data needed to support its particular 
product. At this time subpart B is specific to the needs of 
conventional, and biochemical and microbial pesticides. The process 
needed for antimicrobials is no different. EPA is proposing certain 
clarifying changes to subpart B to specify the needs of antimicrobial 
pesticides. Specifically, EPA proposes to include antimicrobial use 
patterns in Sec.  158.100 and a reference to the antimicrobial use site 
index that will be available on the EPA website.
    While EPA is attempting to assist the applicant in subpart B, it is 
important to emphasize that it is the applicant's obligation under 
FIFRA to demonstrate that an individual product meets the standard 
under FIFRA and that of FFDCA. Accordingly, applicants are encouraged 
to consult with the Agency on the appropriate data requirements, as 
proposed here, as related to their specific product prior to and during 
the registration process.
    EPA is continuing its current system of identifying the 
applicability of data requirements in the data tables. In essence, the 
data requirements illustrate the questions the registrant will need to 
answer about the safety of the pesticide product before the Agency can 
register it. Because of the variety of chemicals and use patterns, and 
because EPA must retain flexibility to tailor data requirements as 
appropriate, only qualitative descriptors are in the tables. Test notes 
provide more specific information on the applicability of specific data 
requirements.
    The table descriptors NR (not required), R (required), and CR 
(conditionally required) should be viewed as a general presentation, 
indicating the likelihood that the data requirement applies. The use of 
R does not necessarily indicate that a study is always required, but 
that it is more likely to be required than not. For example, if the 
applicant wanted to apply his pesticide to apples, then crop field 
trials would be required almost always on apples. However, if the 
physical/chemical properties of the chemical did not lend themselves to 
the test, such as performing an inhalation test with a chemical that is 
a solid and has an extremely low vapor pressure, then a waiver might be 
granted. Generally test notes for R studies discuss any particular 
circumstances when the testing might not be required.
    The use of CR means a study is less likely to be required. Triggers 
in the test notes indicate the circumstances under which the Agency has 
learned through experience that the information is needed. Although 
only an approximation, if percentages were to be assigned to indicate 
the need for a particular study, then R could be viewed as representing 
the submission of a study 50% to 100% of the time and CR would be up to 
50%.
    Thus, NR, R, and CR are used for convenience to make the table 
format feasible, but serve only as a general indication of the 
applicability of a data requirement. In all cases, the test notes 
referred to in the table must be consulted to determine the actual need 
for the data. Applicants are also encouraged to visit the Agency's 
website, entitled ``Data Requirements for Pesticide Registration'' (see 
https://www.epa.gov/pesticides/regulating/data_requirements.htm). Since 
it is not

[[Page 59387]]

possible to sufficiently delineate all circumstances in test notes, 
consultation with EPA is encouraged.
    The table format includes a column heading entitled ``Guideline,'' 
which refers to the OPPTS (Office of Pollution Prevention and Toxic 
Substances) Harmonized Test Guidelines. Guideline numbers are provided 
as information/guidance to applicants. These Guidelines set forth 
recommended instructions and test methods for performing a study to 
generate the required data. Since these are guidance documents, the 
applicant is not required to use these Guidelines, but may instead seek 
to fulfill the data requirement by other appropriate means such as 
alternative test methods, submission of an article from open 
literature, or use of modeling. The applicant may submit a protocol of 
his own devising for the Agency to review. However, the OPPTS 
Harmonized Guidelines have been developed through a rigorous scientific 
process, including extensive peer review by the FIFRA Scientific 
Advisory Panel. Additionally, many of the Guidelines have been 
harmonized internationally. As such, they represent the recommended 
approach to developing high-quality data that should satisfy EPA's data 
needs for risk assessment.

E. The Nature of Changes to Requirements

    Proposed subpart W does not differ greatly from the data 
requirements for conventional pesticides promulgated in October 2007. 
Where this proposal differs is in the explicit adaptation of those data 
requirements to antimicrobials. As previously discussed, antimicrobial 
uses were covered in the original (1984) part 158. However part 158 
(now transitioned for antimicrobials as part 161) was developed 
primarily for agricultural pesticides. Since the use patterns which now 
appear in tables in part 161 are not specific to antimicrobials, often 
it has been difficult to discern directly from such tables the data 
requirements for certain antimicrobials. Without extensive consultation 
with and interpretation from the Agency, frequently it has been 
difficult for applicants to effectively use the tables to determine 
which data requirements apply to antimicrobials.
    Today's proposal reflects the Agency's current needs for risk 
assessment of antimicrobials. Describing the antimicrobial data 
requirements in terms of use patterns specific to antimicrobial uses 
provides a clarity that should reduce the need for extensive 
consultations.
    There are nine new data requirements for antimicrobials set out in 
this proposal. Two (developmental neurotoxicity and immunotoxicity) are 
the same new data requirements as promulgated in the final rule for 
conventional chemicals (72 FR 60934) (see Unit VIII). While 
photodegradation in soil studies have been routinely required for 
conventional chemicals, this study would be a new data requirement for 
wood preservatives (see Unit XII). Similarly, two new exposure data 
requirements (soil residue dissipation and non-dietary ingestion 
exposure) are today proposed for antimicrobials (see Unit IX.D).
    Four new data requirements (activated sludge sorption isotherm 
study; ready biodegradability study; porous pot study; and modified 
activated sludge, respiration inhibition test) are proposed today for 
antimicrobials that are not included in the final rule for conventional 
pesticides. This is due to the nature of antimicrobial pesticides, 
which includes many down-the-drain uses, i.e. those discharged to 
public treatment systems, and is discussed in Units XII.B. and C.
    Most screening-level environmental fate assessments would be 
performed using the hydrolysis, photodegradation in water, activated 
sludge sorption isotherm, ready biodegradability, and modified 
activated sludge, respiration inhibition tests. For wood preservatives, 
the results of the photodegradation in soil study may also be 
considered in the screening-level assessment. If the porous pot study 
is triggered based on the results of the ready biodegradability study, 
then those results would also be considered.
    EPA notes that its proposed approach for performing a screening-
level fate assessment could potentially result in the submission of 
higher-tiered studies. There are seven higher-tiered environmental fate 
studies, that could be triggered based on a weight-of-evidence 
evaluation of the results of the screening-level studies. For example, 
if the screening-level assessment were to indicate that a down-the-
drain chemical would partition to sludge, soil, or sediment, then 
higher-tiered environmental fate studies such as the aerobic and 
anaerobic soil metabolism studies may be required. If the chemical 
would partition to water then higher-tiered ecotoxicity studies such as 
the fish early life stage may be required. Thus, the higher-tiered 
studies that could be triggered include both the environmental fate and 
ecotoxicity scientific disciplines.
    While not a new data requirement, subchronic dermal testing of end-
use products has not been routinely required and therefore would be 
considered a new testing requirement. The circumstances for requiring 
the testing is the same as for conventional chemicals. (See Unit VIII).
    Each data requirement proposed in Units, VIII, IX, X, XII, XIII, 
and XIV is described as ``new,'' ``current practices,'' or 
``existing.'' ``New'' means that the data requirement has never been 
required or has rarely been required on a case-by-case basis, and has 
not been routinely considered during the Agency's evaluation of the 
data needed for the purpose of risk assessment.
    ``Current practices'' encompasses the data that is typically 
required to register an antimicrobial pesticide product. This would 
include existing data requirements that are codified in part 161 as 
well as those that are not codified in part 161 and are now being 
proposed for codification in part 158, subpart W. It would also include 
any study that has been routinely required on a case-by-case basis, or 
any study that is routinely considered during the Agency's evaluation 
of the data needed for the purpose of risk assessment but is 
infrequently required because the triggers for that study are 
infrequently met.
    ``Existing'' requirements are a subset of ``current practices.'' 
This particular subset means that the data requirement is codified in 
part 161 and being transferred to part 158, subpart W either ``as is'' 
or with specified changes to the test notes, to the Rs, CRs, and NRs, 
or to the use patterns for which required. If there are proposed 
revisions to an existing data requirement, then clarifications on these 
proposed revisions are included in the preamble. Such revisions include 
proposing changes such as a change from conditionally-required to 
required, a change in the number of test species, or expanding the 
number of use patterns for which the test is required.
    As previously discussed, there are frequently consultations to 
discern data requirements for certain of the antimicrobial use 
patterns. These consultations have led to general understandings as to 
the data required for a particular use pattern. For certain use 
patterns, all of the studies are considered to be the Agency's current 
practices. As an example, for the wood preservative use patterns, there 
is not a good fit to any of the part 161 use patterns in the tables and 
therefore the data needed to register a wood preservative is difficult 
to interpret from those tables. Given these circumstances,

[[Page 59388]]

EPA developed a series of requirements developed specifically for wood 
preservatives. These requirements are not codified in CFR, but the 
applicants understand that these are the data needed for wood 
preservatives and they routinely provide these studies to EPA.

F. Tiered Data Requirements

    The Agency has organized the proposed requirements for 
antimicrobial pesticide products to support a tiered testing approach. 
Under such an approach the Agency prescribes a specific subset of 
``lower tier'' studies that are conducted first. The results of this 
first- or lower-tiered testing are then used in conjunction with 
exposure data or other information to determine the need for more 
complex ``higher tier'' studies. The risk assessment must provide 
sufficient information to make the risk management decisions needed to 
register the product or establish a tolerance. This is a significant 
factor in the tiering process.
    Data requirements have been tiered when EPA believes it can 
adequately conduct a risk assessment using a tiered approach. The 
conditions for ``triggering'' these higher tiered studies are specified 
in the test notes to the tables in proposed subpart W. A tiered data 
submission process is intended to allow the Agency to assess a 
pesticide's risk without requiring the applicant to conduct and submit 
studies that may not be needed for the regulatory decision. For certain 
chemicals, data from lower tiered requirements may be sufficient in and 
of themselves or in combination with other data to address the Agency's 
risk concerns without submission of higher tiered data requirements. In 
other cases, data from lower tiered requirements may indicate that 
higher tiered data need to be provided. The Agency expects applicants 
to consult with the Agency, as needed, to determine when submission of 
higher tiered data may be required.
    The Agency has tiered the data requirements based on an 
understanding of the potential exposure for a specific use pattern. As 
an example, for toxicology studies used to support human health risk 
assessments, the high human exposure grouping specifies 19 toxicology 
studies as required at the lower tier. The low human exposure grouping 
specifies 13 toxicology studies as required. The Agency considered the 
frequency, duration, and/or magnitude of the exposure to determine the 
lower tier of toxicology testing requirements for both the high and low 
human exposure groupings.
    For ecotoxicity data requirements, the Agency requires a first tier 
of required data for all antimicrobials regardless of the use pattern. 
The need for higher tiered data depends not only on the frequency, 
duration, or magnitude of the exposure, but also on the results of the 
first tier of the data.
    Such a flexible approach allows EPA to require enough data, but not 
more than enough, to make the required safety finding. Such an approach 
is the same as that used for other pesticides; however, for 
antimicrobials the progression from lower to higher tier requirements 
may differ from that of conventional pesticides because the uses and 
expected exposures are different.

G. Impact of this Proposal on Future and Existing Registrations

    This proposal concerns prospective data requirements for future 
registrations of antimicrobial pesticides. That is, these proposed data 
requirements, once final, would apply to all new applications for 
registration of antimicrobial pesticides submitted after the effective 
date of the rule. The new data requirements would also apply to 
applications of antimicrobial pesticides that are undergoing Agency 
review when the new regulation goes into effect. EPA believes that 
there may be a need for some type of a limited transition ``window'' 
for certain antimicrobial registration applications. EPA anticipates 
applicants of applications that were submitted, but not yet approved 
when the new regulations go into effect, may need to discuss with EPA 
the specifics of their application and whether additional time may be 
needed to complete generation of certain studies that may then be 
required to fulfill new data requirements. The Agency specifically 
requests comment on implementing the effective date of the final rule 
for antimicrobials with regards to future registrations of 
antimicrobials.
    The Agency does not intend to apply these requirements 
automatically or routinely to all existing pesticide registrations. 
While EPA intends a flexible approach to imposing the new requirements 
upon existing products, the Agency may find it necessary to call-in 
data on certain existing registrations, for example, as warranted by 
emerging risks of concern for particular pesticides or as a result of 
possible future programmatic changes and priorities on existing 
pesticides, or during registration review.
    However, EPA notes that issuance of this proposed rule provides 
notice to applicants of potential new data requirements and of 
potential expansion of existing data requirements to additional 
antimicrobial use patterns. Applicants and potential applicants for new 
registrations as well as registrants of existing products may wish to 
evaluate their products in light of the proposed requirements. As 
always, the Agency encourages applicants to consult with EPA, if they 
have any questions regarding data requirements.

H. Weight-of-Evidence Approach

    The weight-of-evidence (WOE) approach is referenced in several 
subpart W test notes. Such an approach requires a critical analysis of 
the entire body of available data for consistency and biological 
plausibility. Some considerations in this approach are listed below:
     Sufficiency of data. Studies that completely characterize 
both the effects and exposure of the agent have more credibility and 
support than studies that contain data gaps.
     Quality of the data. Potentially relevant studies are 
judged for quality and studies of higher quality are given more weight 
than those of lower quality.
     Evidence of causality. The degree of correlation between 
the presence of an agent and some adverse effect is an important 
consideration.
     Corroborative information. Supplementary information 
relevant to the conclusions reached in the assessment is incorporated, 
e.g., studies demonstrating agreement between model predictions and 
observed effects.
    WOE considers the kinds of evidence available, how that evidence 
fits together in drawing conclusions, and significant issues/strengths/
limitations of the data and conclusions. WOE is not simply tallying the 
number of positive or negative studies.

I. Use Patterns in Subpart W

    The general use pattern groups described in subpart B of part 158 
are not used as the bases for describing antimicrobial data 
requirements. Those general use patterns were developed for and are 
appropriate to conventional pesticide chemicals.
    Some years ago, 12 use categories were developed specifically for 
antimicrobials. At that time the Agency's data requirements for all 
pesticide chemicals were specified by use patterns developed for and 
appropriate to conventional pesticide chemicals. To fit antimicrobial 
uses into this agricultural scheme, the antimicrobial use categories 
referred back to the then-existing use patterns. With the Agency's 
intention to establish specific data requirements for

[[Page 59389]]

antimicrobials in subpart W, this referral is no longer needed.
    Therefore, the Agency is proposing that the use categories employed 
in recent years to generalize the range of uses for individual 
antimicrobial pesticide chemicals, now constitute the use patterns for 
specifying the antimicrobials data requirements in the tables in 
proposed subpart W. Additionally, EPA is proposing to codify in Sec.  
158.2201 the specific use patterns for antimicrobials.
    FIFRA section 3(h)(3)(A)(ii)(I) requires that EPA ``define the 
various classes of antimicrobial use patterns.'' For antimicrobial 
pesticides, the Agency proposes to structure its requirements by using 
a system of 12 use patterns based on similarity of use, purpose, 
pesticidal function, the nature of the exposure, and, in some cases, 
application methods. Today's proposal meshes with the statutory mandate 
to identify classes of antimicrobial use patterns by defining for each 
use pattern the data requirements that apply. EPA requests comment not 
only on the 12 antimicrobial use patterns described in this Unit, but 
also on the usefulness of these use patterns. EPA also requests comment 
on whether or not any different/additional use patterns should be 
codified by splitting or recombining the existing use patterns to make 
separate and distinct use patterns.
    Antimicrobial use patterns also reflect environmental concerns for 
indoor versus outdoor use, as well as food versus nonfood-use, and high 
versus low human exposure. The 12 general use patterns for 
antimicrobial pesticides are described below. Examples within each use 
pattern are provided:
    1. Agricultural premises and equipment. This use pattern includes 
many indirect food uses with mostly indoor use sites.
     Farm and farm animal premises such as animal houses and 
pens (including milk houses), parlors, stalls, and barns.
     Transportation vehicles used to transport animals.
     Equipment such as forks, shovels, scrapers; halters, 
ropes, other restraining equipment; racks, mangers, feeders, waterers, 
troughs, and fountains.
     Food-handling equipment such as milking equipment.
    2. Food-handling/storage establishments, premises, and equipment. 
This use pattern also includes many indirect food uses due to the 
treatment of food contact surfaces and the resultant human exposures. 
All use sites are indoor.
     Food or feed processing plants.
     Eating establishments such as restaurants and cafeterias.
     Food storage or distribution facilities.
     Commercial transportation vehicles, shipping, and storage 
containers.
     Food or feed stores and markets.
     Vending machines.
    3. Commercial, institutional and industrial premises and equipment. 
This use pattern includes nonfood contact areas of commercial sites. 
Typically, antimicrobial pesticides would be applied to ceilings, 
doors, doorknobs, fixtures, floors, light switches, stairs, walls, 
windows, and woodwork as part of routine cleaning practices. Included 
within this use pattern are residential school and daycare 
institutions.
    This use pattern includes both indoor and outdoor uses. Some of the 
uses have the potential for significant exposure due to the repetitive 
nature of certain exposures and therefore may be considered as high 
human exposure.
    4. Residential and public access premises. This use pattern 
includes mostly nonfood areas, although it includes food-handling areas 
in homes. Some of the uses have the potential for significant exposure 
due to the repetitive nature of certain exposures and therefore may be 
considered as high human exposure. Most uses are indoor.
     Premises, contents, and equipment of homes, apartments, 
mobile homes and shelters, including home-based daycare.
     Public areas, public buildings, and public rooms.
     Commercial kennels, or living quarters of pets, zoo 
animals, race horses, or laboratory animals.
    5. Medical premises and equipment. Medical waste is defined as any 
solid waste that is generated in the diagnosis, treatment, or 
immunization of human beings or animals, in research pertaining 
thereto, or in the production of biologicals including, but not limited 
to, culture and stocks, pathological wastes, human blood and blood 
products, and sharps. This use pattern is considered to be indoor 
nonfood. Some of the uses have the potential for repeated exposure and 
therefore may be considered as high human exposure.
     Hospital or medical environments such as clinics, dental 
offices, nursing homes, sick rooms, morgues, and veterinary clinics.
     Non-critical medical equipment such as bedpans, basins, 
and furniture.
    6. Human drinking water systems. Human drinking water systems 
include any methods used to provide potable water from raw water 
supplies. This use pattern is considered to be high human exposure due 
to the potential for human exposures via drinking water, as well as 
dermal exposures to the treated water.
     Public water systems.
     Individual water systems.
     Emergency water systems.
     Water purifier units.
     Private water systems of individual homes, farms, 
institutions, camps, resorts, and industrial plants.
     Emergency water systems for the public, campers, 
travelers, military, and fishermen.
    7. Materials preservatives. Materials preservatives are 
antimicrobial chemicals added during industrial processes to prevent 
the growth of microorganisms. Examples of such uses include paints, 
coatings, adhesives, textiles, and paper. This use pattern includes 
food and nonfood, and mostly indoor uses.
    8. Industrial processes and water systems. Certain antimicrobial 
chemicals, known as microbiocides, are used to control the growth of 
bacteria, fungi, and algae in circulating water systems. There are two 
types of systems: ``once-through'' and ``recirculating.''
    For ``once-through'' systems, the water is not re-used and is 
therefore released into the aquatic environment or a wastewater 
treatment plant after a single cycle through the system. Once-through 
uses have the potential for significant environmental exposure when the 
treated water is released to the environment. Large volumes of water 
(as much as millions of gallons per minute) may be released directly to 
a river, estuary, or marine environment within minutes or hours of 
adding the antimicrobial to the system. In addition to the potential 
for environmental exposure after release, there is the potential for 
high human exposure via drinking water if the intake pipe for a 
drinking water treatment plant is downstream. Also, the water could be 
used in crop and/or livestock production thus providing for additional 
human exposure.
    However, for many uses of water in industrial plants the treated 
water is re-used repeatedly within the system, ``recirculating'' in the 
system multiple times until released into the aquatic environment or a 
wastewater treatment plant. EPA has assumed that the releases are 
scheduled as the antimicrobial has been ``used-up.'' Given the lower 
frequency of release, resulting in lower volumes released to the 
environment, recirculating uses are likely to have less environmental 
exposure than that of once-through systems.
    As will be explained later in Unit XI, for the purposes of 
determining data requirements for environmental fate and

[[Page 59390]]

ecological effects, the industrial processes and water systems use 
pattern will be subdivided. Because of the distinct differences between 
the once-through and recirculating water systems, the once-through 
water system will be grouped with those use patterns with potential for 
higher environmental exposures and the recirculating water system with 
those use patterns with the potential for lower environmental 
exposures.
    9. Antifoulant paints and coatings. Antifoulants are coatings and 
paints applied to boat hulls and bottoms, crab and lobster pots, and 
underwater structures or equipment to control the growth of freshwater 
or marine fouling organisms. Antifoulant coatings have the potential 
for high environmental exposure most particularly for marine (both 
freshwater and saltwater) environments.
    Also included within this use pattern is ballast water, that is, 
the water that is pumped in and out of ballast tanks as a ship's weight 
changes due to loading and unloading of cargo. Ballast water provides 
needed stability for safe operation of marine vessels. In recent years 
there have been significant concerns about transport of marine species 
from one marine environment to another in ballast water. When 
discharged into a new environment, the new species may become invasive 
and disrupt the native ecology. Ballast water treatments (such as 
adding an antimicrobial to the ballast water before discharge) are 
intended to prevent this. The Agency has reviewed few applications for 
ballast water treatments, presumably because treatment of ballast water 
to prevent the transfer of microorganisms from one marine environment 
to another is relatively new. Since ballast water treatments also have 
the potential for high exposure to the aquatic (both freshwater and 
seawater) environment, EPA has grouped the ballast water treatment 
pesticide chemicals with the antifoulant coating pesticide chemicals.
    10. Wood preservatives. Wood preservative products are those which 
claim to control wood degradation problems due to fungal rot or decay, 
sapstain, molds, or wood-destroying insects. This use pattern has the 
potential for high exposure for both humans and the environment with 
mostly outdoor use sites. Certain uses can be food-uses. The types of 
wood and the products that can be manufactured with this treated wood 
are:
     Freshly cut logs or lumber.
     Seasoned building materials.
     Utility poles, fence posts and rails.
     Structural members.
     Structures and dwellings.
     Transportation vehicles (truck beds and support 
structures).
     Crop containers.
     Lawn furniture and decks.
     Playground equipment.
     Garden/landscape timbers.
     Log homes.
    11. Swimming pools. Products in this use pattern are used to 
prevent/control the growth of bacteria or algae in the water systems of 
swimming pools, Jacuzzis, and hot tubs. This use pattern is considered 
to be high human exposure. Under routine use little or no environmental 
exposure is expected, as the water in swimming pools, Jacuzzis, or hot 
tubs is considered to be separated from the natural environment. 
However, when draining is needed, depending on the volume of water and 
the location of the pool or hot tub, it is most likely that discharge 
would be down-the-drain to a wastewater treatment plant, to a storm 
drain that discharges to a stream, or directly to soil.
    12. Aquatic areas. Products in this use pattern are designed to 
control or kill slime-forming bacteria, fungi, or algae in lakes, 
ponds, streams, drainage ditches, and other bodies of water. In 
addition to the potential for environmental exposure, there is the 
potential for high human exposure via drinking water if the intake pipe 
for a drinking water treatment plant is in a lake or downstream, or 
through recreational activities such as swimming. Also, the water could 
be used in crop and/or livestock production thus providing for 
additional human exposure.

J. Use Site Index

    As part of this action, the Agency is proposing to place on its 
website an Antimicrobial Use Site Index similar to the existing 
Pesticide Use Site Index at https://www.epa.gov/pesticides/regulating/
usesite/index.htm. Information similar to that which would be included 
on the Antimicrobial Use Site Index is included in the docket for this 
action (Ref. 41). The existing Pesticide Use Site Index will be re-
titled, the Pesticide Use Si