[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Rules and Regulations]
[Pages 26935-26993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10162]



[[Page 26935]]

Vol. 78

Wednesday,

No. 89

May 8, 2013

Part III





 Environmental Protection Agency





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40 CFR Parts 158 and 161





 Data Requirements for Antimicrobial Pesticides; Final Rule

Federal Register / Vol. 78 , No. 89 / Wednesday, May 8, 2013 / Rules 
and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 158 and 161

[EPA-HQ-OPP-2008-0110; FRL-8886-5]
RIN 2070-AD30


Data Requirements for Antimicrobial Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revising the data requirements for antimicrobial 
pesticide products to reflect current scientific and regulatory 
practice, and to provide the regulated community with clearer and 
transparent information about the data needed to support pesticide 
registration decisions for antimicrobial products. The updated data 
requirements also serve to further enhance EPA's ability to make 
regulatory decisions about the human health, and environmental fate and 
effects of antimicrobial pesticide products. These revisions are also 
expected to help protect human health and the environment by providing 
an up-to-date scientific framework for identifying and assessing the 
risks of antimicrobial pesticides sold or distributed in the United 
States.

DATES: This final rule is effective July 8, 2013.

ADDRESSES: The docket for this action, identified under docket 
identification (ID) number EPA-HQ-OPP-2008-0110, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in the EPA West 
Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. 
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
OPP Docket is (703) 305-5805. Please review the visitor instructions 
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-6304; email address: 
boyle.kathryn@epa.gov, or contact Scott Drewes, same address: telephone 
number (703) 347-0107; email address: drewes.scott@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

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. 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. 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 could also be affected.

B. What is the agency's authority for taking this action?

    This action is issued under the authority of sections 2, 3, 4, 5, 
10, 12, and 25 of the Federal Insecticide, Fungicide and Rodenticide 
Act (FIFRA), 7 U.S.C. 136 et seq., and section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. The data required for 
antimicrobials (e.g., for registration, reregistration or registration 
review, experimental use permit (EUP), or tolerance/tolerance 
exemption) are currently listed in 40 CFR part 161 and, with this final 
rule, will be listed in 40 CFR part 158.

C. What action is the agency taking?

    The Agency is revising and updating the data requirements for 
antimicrobial pesticides that are currently found in Title 40 of the 
Code of Federal Regulations (CFR) in part 161, and which are being 
relocated as revised by this rule to subpart W of part 158. Subpart W 
sets out data requirements specific to antimicrobial products that are 
described by the antimicrobial use patterns and use exposure 
considerations particular to antimicrobials. With the promulgation of 
part 158, subpart W, EPA is removing part 161, entitled ``Data 
Requirements for Registration of Antimicrobial Pesticides'' as it is no 
longer needed.
    Antimicrobial pesticides are used to control microbiological 
contamination in healthcare applications, and deterioration in 
industrial, commercial, and consumer products. Nearly 60 percent of 
antimicrobial products are registered as public health products (as 
defined at FIFRA 2(gg)) to control infectious microorganisms in 
hospitals and other health care environments. Public health products 
are intended to control microorganisms infectious to humans in any 
inanimate environment. The common public health antimicrobial products 
include sterilants, disinfectants, and sanitizers. Nonpublic health 
products are sold and distributed for use to control growth of algae, 
odor-causing bacteria, bacteria which cause spoilage, deterioration or 
fouling of materials and microorganisms infectious only to animals. 
Other examples of nonpublic health products include products used in 
cooling towers, jet fuel, paints, and treatments for textile and paper 
products. Within this final rule EPA is using the term antimicrobials 
to collectively refer to antimicrobial pesticides, antifoulant coatings 
and paints, and wood preservatives. The amendments contained in this 
final rule, which are discussed in detail in Units IV. through XXII. of 
this document, change the existing data requirements for antimicrobial 
pesticides in the following substantive respects:
     By changing some of the existing data requirements, 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.
     By adding newly codified data requirements, i.e., data 
requirements that are not currently identified in 40 CFR part 161, but 
are considered in current practice on a case-by-case basis.
     By adding new data requirements, i.e., data requirements 
that have not been required or have rarely been required in current 
practice on a case-by-case basis, and have not been routinely 
considered during the Agency's evaluation of the data needed for the 
purpose of risk assessment.
     By eliminating the requirement for the chronic non-rodent 
study currently required in 40 CFR part 161.
     By codifying the antimicrobial data requirements as 
finalized in this rule in 40 CFR part 158, subpart W, and removing the 
current requirements that appear in 40 CFR part 161.

D. What are the incremental costs and benefits of this action?

    The Economic Analysis (EA) of the potential costs and benefits 
associated with this action, as revised to address comments received on 
the proposed rule, is contained in a document entitled ``Final Economic 
Analysis of Changes in Data Requirements for Antimicrobial Pesticides'' 
(Ref. 1), a copy of which is in the docket, discussed in Unit XXII., 
and are briefly summarized here.

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    1. Estimated costs. In its analysis, the Agency considered the 
potential, additional costs for the registration of new antimicrobial 
pesticides or new uses of currently registered antimicrobial 
pesticides, as well as the potential, additional costs incurred during 
the registration review of existing antimicrobial pesticides.
    The estimated total annual industry costs of the final rule is 
expected to be about $19.3 million. The difference between the baseline 
costs (the existing data requirements that were codified in 1984) and 
the cost of the Agency's current practices is about $1 million 
annually. The difference between the baseline costs and the final rule 
costs, i.e., the incremental costs, is approximately $8.2 million 
annually assuming an estimated 15 new registrations.
    Under the final rule, the average cost per registration action of a 
new antimicrobial active ingredient is approximately $1 million to $5 
million. For existing chemicals, data requirements in part 158, subpart 
W are relevant to the registration review program, and the average 
additional cost is estimated to be about $588,000 for wood 
preservatives, $284,000 for food and indirect food uses, and $260,000 
for all other uses. For registration review, the total annual cost is 
$6.8 million.
    EPA also conducted an analysis of the potential impact of this 
final rule on small entities, which is included in the EA and discussed 
in Unit XXV.C. In brief, EPA estimates that 500, or approximately 67 
percent, of the unique parent companies that constitute the total 
universe of pesticide antimicrobial registrants, qualify as a small 
business. When considering both registration review and new 
registrations, on average each year about 30 small businesses are 
estimated to incur additional costs under this final rule. EPA 
estimates that about 23 small firms (almost 5 percent of the 500 small 
antimicrobial firms) may experience an economic impact of 3 percent or 
more of gross sales. As discussed later in this document, EPA has 
concluded, based on this analysis, that this potential impact is not a 
significant impact on a substantial number of small entities.
    2. Estimated benefits. In its analysis, EPA provides a qualitative 
discussion of the benefits, which are not quantifiable in the same 
monetary terms as the costs. In general, before manufacturers can sell 
pesticides in the United States, EPA must evaluate the pesticides 
thoroughly to ensure that they meet Federal safety standards in FIFRA 
and FFDCA that were established to protect human health and the 
environment. EPA grants a ``registration'' or license that permits a 
pesticide's distribution, sale, and use only after the company meets 
the scientific and regulatory requirements. In evaluating a pesticide 
registration application, EPA assesses a wide variety of potential 
human health and environmental effects associated with use of the 
product. Applicants, or potential registrants, must generate or provide 
the scientific data necessary to address the identity, composition, 
potential adverse effects, and environmental fate of each pesticide. 
The information provided by the data requirements in this final rule 
allow EPA to evaluate whether an antimicrobial pesticide meets the 
applicable statutory standards.
    Antimicrobials play an important role in public health and safety. 
While intended to provide health benefits of pathogen control or 
removal and, in some cases, safety benefits of materials preservation, 
they also involve risks of potential efficacy failure and exposure of 
hazards to humans and the environment. Therefore, the effectiveness and 
proper use of an antimicrobial pesticide is determined by EPA based on 
its evaluation of specific data that is provided as part of 
registration and registration review activities.
    This final rule will enhance EPA's ability to make sound regulatory 
decisions and help prevent the registration of pesticide products that 
may have unreasonable adverse effects on human health and the 
environment. The Agency believes that having the appropriate data 
ultimately leads to better risk management decisions, as well as 
provides the following other benefits:
    i. More refined assessments mean less uncertainty and clearer 
understanding of actual risks. For example, EPA's current applicator/
user exposure data base is not comprehensive, especially regarding 
exposures to pesticides in industrial and residential settings. 
Codifying these data requirements, many of which are currently applied 
on a case-by-case basis, would allow the Agency to conduct improved 
exposure assessments for applicators/users. This will benefit workers 
and consumers by allowing EPA to make better informed regulatory 
decisions that are neither too stringent nor too lenient.
    ii. Clarity and transparency to regulated community means savings. 
The enhanced clarity and transparency of the information presented in 
part 158, subpart W will reduce uncertainty for applicants in 
generating and submitting data that is necessary for EPA to be able to 
make registration decisions based on data-driven risk estimates that 
use fewer conservative assumptions. Applicants may save time and money 
by understanding which studies are needed to support the use of their 
product. Thus, the antimicrobial industry will, along with other 
partners in the regulated community, attain a better understanding of 
and can more efficiently participate in the pesticide registration 
process. This should allow products to enter the market earlier, 
thereby enabling registration of safer pesticides sooner and 
potentially reducing risks, as well as increasing profits. The clarity 
derived from having data requirements specific to antimicrobials may be 
especially important to small firms and new firms entering the industry 
who may have less experience than those firms that routinely work with 
the Agency.
    iii. EPA information assists other communities in assessing 
pesticide risks. Scientific, environmental, and health communities find 
pesticide toxicity information useful to respond to a variety of needs. 
For example, medical professionals are concerned about the health of 
patients exposed to pesticides; poison control centers make use of and 
distribute information on toxicity and treatment associated with 
poisoning; and scientists use toxicity information to characterize the 
effects of pesticides and to assess risks of pesticide exposure. 
Similarly those responsible for protection of nontarget wildlife need 
reliable information about pesticides and assurance that pesticides do 
not pose an unreasonable threat. These data requirements will help the 
scientific, environmental, and health communities by increasing the 
breadth, quality, and reliability of Agency regulatory decisions by 
improving their scientific underpinnings.
    iv. Better informed users mean informed risk-reduction choices. 
Better regulatory decisions resulting from these data requirements also 
mean that the label will provide better information on the use of the 
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 that should 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 pesticide products appropriate to 
their needs, and to use and dispose of products in a manner that is 
safe and environmentally sound.
    v. Recognizes the unique down-the-drain uses associated with 
antimicrobials. For antimicrobial

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chemicals that go down the drain and eventually reach a waste water 
treatment plant (WWTP), EPA intends to conduct an assessment of the 
potential impact of the antimicrobial chemical on the microorganisms in 
the biological treatment processes of a WWTP and the potential for the 
antimicrobial chemical to pass through the WWTP in the effluent. The 
final rule will minimize costs to States and municipalities by ensuring 
that antimicrobial pesticide products registered under FIFRA don't 
cause water quality problems or harm treatment facilities.
    vi. A milestone towards the Agency's vision for 21st Century 
toxicology and new integrated testing strategies. The Agency's goal is 
to use 21st Century science to increase the efficiency and 
effectiveness of our assessment process. This rule is a launching pad 
for that vision.

II. Background

A. Brief History of Pesticide Data Requirements

    EPA's data requirements for pesticides were first published in 
1984. Those data requirements were primarily influenced by agricultural 
uses. Since then, new risk concerns have been identified, and EPA's 
statutory mandates for pesticide registration under FIFRA and 
tolerance-setting under the FFDCA were amended in 1996 to require EPA 
to update the scientific underpinnings of risk assessments. The Agency 
must now perform more in-depth risk analyses, such as aggregate and 
cumulative risk assessments.
    On October 26, 2007, EPA promulgated final rules updating the data 
requirements for conventional pesticides (72 FR 60934), and biochemical 
pesticides and microbial pesticides (72 FR 60988). The rule development 
process for part 158, subpart W used the updated conventional 
pesticides data requirements as the starting point while considering 
the case-by-case data requirement decisions made over the years of 
registering antimicrobial pesticide products. The following four 
subparts in part 158, promulgated in 2007, also apply to antimicrobial 
pesticides (see 40 CFR 158.1):

 Subpart A: General Provisions
 Subpart B: How to Use Data Tables
 Subpart C: Experimental Use Permits
 Subpart D: Product Chemistry

    To provide continued regulatory coverage for antimicrobial 
pesticides until the Agency could promulgate a final regulation for 
antimicrobial pesticides, the 2007 final rule (72 FR 60251, October 24, 
2007) (FRL-8116-2) preserved the original part 158 data requirements 
(promulgated in 1984) to apply to antimicrobial pesticides by 
redesignating them as part 161. This final rule finishes the 
promulgation of a final regulation for antimicrobial pesticides. 
Accordingly, EPA is also revoking 40 CFR part 161.

B. How To Use the Data Tables

    In establishing the data requirements in 1984, EPA adopted a step-
wise approach to assist the applicant in determining the data needed to 
support the registration of a particular product. This approach, which 
is described in 40 CFR part 158, subpart B, involves the use of ``data 
tables'' to facilitate the identification of the applicability of the 
data requirements. 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 percent of the time and CR would be 
up to 50 percent
    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.
    The table format includes a column heading entitled ``Guideline,'' 
which refers to the OCSPP 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 
OCSPP Harmonized Guidelines have been developed through a rigorous 
scientific process, including extensive peer review by the Advisory 
Panel (SAP). 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.
    In addition, since it is not possible to sufficiently delineate all 
circumstances in test notes, consultation with EPA is encouraged. 
Applicants are also encouraged to visit the Agency's Web site at http://www.epa.gov/pesticides/regulating/data_requirements.htm.

C. Efforts to Incorporate 21st Century Science into Pesticide Decision 
Making

    Over the next several years, EPA's Office of Pesticide Programs 
(OPP) is committed to improving and transforming the Agency's approach 
to pesticide risk management by enhancing the Agency's ability to use 
integrated approaches to testing and assessment. The Pesticide Program 
plans to maximize use of existing data from similar compounds, 
including information from new in silico and in vitro predictive models 
and exposure modeling to target in vivo toxicity testing that is needed 
to assess and manage chemical risks appropriately.
    Over the next decade, as experience is gained and as the Agency's 
understanding of toxicity pathways increases, an enhanced integrated 
testing and assessment approach will be implemented for all pesticides. 
The approach will fully integrate hazard and

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exposure information using advanced computer modeling of new in vitro 
data and an understanding of toxicity pathways to better predict risks 
and to determine what additional data are necessary to provide a sound 
basis to manage risks of concern. Data from improved biomarkers of 
exposure and biological outcomes from population-based studies will be 
used to evaluate the effectiveness of this new risk assessment 
paradigm, to readily identify early effects in exposed populations, and 
to improve the approach.
    Current Agency scientific and regulatory practice provides the 
foundation for this final rule. While current practice is still largely 
dependent on animal (in vivo) testing, this rule is one milestone 
towards the Agency's longer term vision for 21st Century Toxicology and 
new integrated testing strategies. OPP believes that certain classes of 
chemicals, such as antimicrobial pesticides, provide an appropriate 
starting point for OPP's planned transformation. Many antimicrobials 
have both pesticidal and non-pesticidal uses. In addition, many 
antimicrobial products are regulated under multiple jurisdictions. 
Thus, many antimicrobial chemicals have been assessed by other 
regulatory programs and agencies. The ready availability of published 
literature and publicly-available assessments offer a unique 
opportunity for the applicant to use the available information as a 
starting point for fulfilling data requirements, and, when appropriate, 
to use computer modeling and/or in vitro data to supplement or fulfill 
data requirements. For example, OPP established a voluntary pilot 
program for eye irritation testing of certain antimicrobial pesticides 
using non-animal test methods. OPP will continue to evaluate use of new 
in vitro and computer-based approaches in OPP's hazard and risk 
assessment processes as the technologies are sufficiently developed and 
peer-reviewed. Certain tools are already available or anticipated to 
become available in the near term including, (Quantitative) Structure-
Activity-Relationship (Q)SAR/expert systems and in vitro high through-
put screening technologies. Furthermore, in conjunction with the 
International Life Sciences Institute (ILSI), OPP is currently pursuing 
the development of an application of the thresholds of toxicological 
concern (TTC) concept to evaluate antimicrobial pesticides. In 
collaboration with OPP, EPA's Office of Research and Development (ORD) 
is providing momentum for achieving the vision of 21st Century 
Toxicology by developing and evaluating new technologies in molecular, 
cellular, and computational sciences to supplement or replace more 
traditional methods of data development. OPP believes that its goal of 
using 21st Century science in integrated approaches to testing and 
assessment is achievable with strong scientific and stakeholder support 
through a transparent process. As the enhanced integrated testing and 
assessment approach matures, based on these scientific advances, EPA 
may determine to update its data requirements to reflect evolving 
program needs as specified in Sec.  158.30(c). See Unit XVIII. of the 
proposed rule for further discussion of EPA's use of integrated 
approaches to testing and assessment.

III. Public Comments on the Notice of Proposed Rulemaking (NPRM)

A. Comments Submitted to EPA

    This unit discusses, in general terms, the public comments received 
on the NPRM that appeared in the Federal Register of October 8, 2008 
(73 FR 59382), and EPA's responses to those comments. The comment 
period for the NPRM was extended from January 6, 2009 to April 6, 2009, 
to allow stakeholders additional time to submit their comments. In 
addition, EPA convened a public workshop in Arlington, Virginia, to 
explain the provisions of the NPRM on November 6, 2008. The proposed 
rule, the notice of the extension of the comment period, the notice of 
the public meeting, the presentations used at the public meeting, the 
comments submitted, and EPA's Response to Comments Document are 
available in the docket for this rule.
    During the public comment period, EPA received comments on the 
proposed part 158, subpart W regulations from 29 entities. There were 
also late comments received at meetings held at EPA in Arlington, VA on 
December 2, 2009, and June 14, 2010, as well as at a meeting on May 17, 
2011, and in a letter dated June 17, 2011. The presentation materials 
and EPA's summary of the meetings, and the letter with attachments are 
included in the docket. These late comments were not new comments, but 
rather restatements of issues presented in their original comments 
submitted to EPA, and are also available in the docket. Another late 
comment, received on September 1, 2010, was addressed by adding 
additional comments and responses to the toxicology section of the 
Response to Comments Document.
    EPA carefully reviewed all comments submitted, and provides 
responses in the Response to Comments Document, a copy of which is 
available in the docket. The Response to Comments Document also 
contains the rationale for the changes that were made from the proposed 
rule to the final rule, in response to submitted comments. Similar 
comments are grouped together. Comments that had a substantive impact 
on changes from the proposed rule to the final rule are also discussed 
in Units IV. to XXII. of this document.

B. Overview of This Final Rule

    1. In general. This final rule reflects updates and revisions to 
the data requirements currently contained in 40 CFR part 161, in many 
cases by codifying the case-by-case data requirements decisions made 
over the years to help apply the agriculturally-based 1984 data 
requirements to antimicrobial pesticide products. The antimicrobial 
data requirements are being relocated to 40 CFR part 158, subpart W, 
and 40 CFR part 161 is being removed.
    Based on comments received, EPA revised the proposed data tables. 
EPA's Response to Comments Document contains the rationale for the 
changes that were made from the proposed rule to the final rule in 
response to submitted comments.
    Eleven new data requirements for antimicrobial pesticides are being 
codified in this final rule. As discussed in the preamble to the 
proposed rule, a ``new'' data requirement ``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'' (73 FR 59387). Eight new data requirements that were 
proposed in 2008 and are now being codified are: Developmental 
neurotoxicity; immunotoxicity; photodegradation in soil; soil residue 
dissipation; ready biodegradability study; porous pot study; activated 
sludge sorption isotherm study; and modified activated sludge, 
respiration inhibition test. The developmental neurotoxicity and 
immunotoxicity tests are new compared to part 161, but were added for 
conventional pesticides in the 2007 amendments to part 158. The 
photodegradation in soil study was not previously required for wood 
preservatives. The other four studies are unique to antimicrobials.
    Based on comments received, two other ``new'' data requirements are 
being added that serve as alternatives to tests that were proposed (and 
are now being finalized): Simulation tests to assess the 
biodegradability of chemicals

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in discharged wastewater, and simulation test--aerobic sewage 
treatment: Activated sludge units. Similarly, also based on comments, 
one ``new'' data requirement, the nature of the residue on surfaces, is 
being added as a more definitive trigger or screen for determining 
whether one of the studies that was proposed--the migration study--must 
be conducted.
    Additionally, this final rule:
     Codifies data requirements/use pattern combinations that 
were not codified in part 161, but have typically been required to 
register an antimicrobial pesticide product.
     Provides improved definitions for antimicrobial pesticides 
used for public health and nonpublic health purposes.
     Codifies data requirements to determine risks to WWTPs and 
the potential for movement of antimicrobials and their degradates from 
the indoor environment to the outdoor environment via effluent 
discharge from a publically owned treatment work (POTW).
    The data requirements promulgated in this final rule identify the 
types of information that EPA needs to determine whether an 
antimicrobial pesticide product should be registered and to make 
decisions regarding tolerances or tolerance exemptions for pesticide 
residues in food. Subpart W to part 158 includes a series of tables and 
regulatory text that mirrors the structure of the data requirements for 
conventional pesticides. However, subpart W establishes specific data 
requirements for each scientific discipline (except product chemistry) 
for antimicrobial pesticides. As explained in Unit II.A. of this 
document, subpart D to part 158, which contains the product chemistry 
data requirements for conventional pesticides, also applies to 
antimicrobials. The order of subpart W also mirrors that of the larger 
part 158. As such, the following data requirements categories are 
included in detail in part 158, subpart W: Product performance, hazard/
toxicity (both human health and ecological toxicity), exposure (both 
application and post-application human exposures), residue chemistry, 
and environmental fate requirements.
    EPA is also codifying 12 antimicrobial use patterns, as described 
in the proposed rule (73 FR 59389, October 8, 2008). As part of this 
final rule, EPA has developed an Antimicrobial Use Site Index to 
provide additional information about these use patterns. This index is 
included in the docket and is posted on the Agency's Web site.
    2. Changes from what was proposed. In response to comments, EPA has 
made numerous changes to the proposed requirements in crafting the 
final rule. The most significant changes are summarized as follows.
    i. Alternatives to the porous pot study. With regard to the porous 
pot study in the final environmental fate data requirements table in 
Sec.  158.2280, EPA is adding two simulation studies that can serve as 
an alternative to the porous pot study. This change was based on a 
comment that requested consideration of whether ``studies that simulate 
wastewater treatment plants (WWTPs) [could] substitute for [the porous 
pot study].'' (ACC Comment identified in the docket by document ID 
number EPA-HQ-OPP-2008-0110-0088.9; Appendix H, entitled ``Comments on 
Proposed Data Requirements for Environmental Fate'' p. 5). 
Additionally, in the commenter's suggested environmental fate data 
requirements table (p. 11), instead of giving the title of the study as 
``Porous Pot,'' the commenter wrote ``Simulated WWTP; e.g., Porous Pot 
Study.''
    EPA agreed with the commenter and identified two other studies: The 
biodegradation in activated sludge study as described in the OPPTS 
guideline entitled ``Simulation Tests to Assess the Biodegradability of 
Chemicals Discharged in Wastewater'' and simulation test--aerobic 
sewage treatment: Activated sludge units. This change provides 
applicants with more flexibility in meeting this data requirement. 
EPA's rationale is described in Unit XV.A., and for greater detail see 
response to comment 134.1 in the Response to Comments Document in the 
docket. Test note 3 to the final environmental fate data requirements 
table in Sec.  158.2280 clearly specifies that only one biodegradation 
study is to be submitted.
    In creating a tiered structure for the antimicrobial environmental 
fate data requirements table, the table and accompanying test notes are 
intended to be used to determine which antimicrobials would be expected 
to reach a WWTP. Test notes 18, 19, 20, and 21 to the environmental 
fate data requirements table discuss specific criteria for determining 
whether data from a biodegradation study, the activated sludge sorption 
isotherm study, and the activated sludge respiration inhibition test 
are required for a particular product based on its intended uses.
    ii. Trigger for migration study. EPA made changes to the trigger 
for the migration study in the final Residue Chemistry Data 
Requirements in Sec.  158.2290. In its proposed rule, EPA ``triggered'' 
the migration study based on anticipated instances such as theoretical 
(modeled) estimates yielding a risk of concern. One commenter submitted 
a suggested residue chemistry data requirements table with a line-item 
entitled ``Nature of residue of surface.'' (ACC Comment, identified in 
the docket by document ID number EPA-HQ-OPP-2008-0110-0088.10; Appendix 
I, entitled ``Comments on Proposed Data Requirements for Residue 
Chemistry'' p. 7). A different commenter also submitted a different 
residue chemistry data requirements table, which also included the same 
line-item entitled ``Nature of residue on surface.'' (CSPA Comment, 
identified in the docket by document ID number EPA-HQ-OPP-2008-0110-
0086.2).
    The commenters' suggestion of requiring a nature of the residue 
study on surfaces provides a more definitive trigger for the migration 
study. EPA is adding a nature of the residue on surfaces study. As 
specified in test note 5 to the final Residue Chemistry Data 
Requirements Table, the results of the nature of the residue on 
surfaces study will serve as a trigger for determining whether the 
migration study will need to be performed. EPA considers the 
commenters' suggestions to be a valuable addition to the final residue 
chemistry data requirements table in Sec.  158.2290 that provides more 
definitive triggers to help define and narrow the instances of higher-
tiered testing.
    iii. Changes to data requirements for wood preservatives. As 
discussed in Unit VI.B., EPA's current practice of determining the data 
required for a wood preservative product is dependent upon where the 
product is intended to be used (land-only versus land and aquatic). 
This approach also assumes that diversion does not occur and that wood 
that is treated for land-only uses does not end up in the water and 
vice versa. In practice, it is difficult to assure that diversion does 
not occur. Accordingly, in response to comments, the Agency determined 
that all treated wood needs to be considered as having the potential to 
come into contact with surface water. Therefore, for the final 
Environmental Fate Table, for the wood preservatives column, the data 
requirements for anaerobic soil metabolism, aerobic aquatic metabolism, 
and anaerobic aquatic metabolism were changed from ``CR'' to ``R.'' For 
the final Nontarget Organism Table, for the wood preservatives column, 
the data requirements for chronic toxicity testing with fish (fish 
early-life stage) and aquatic invertebrate (aquatic invertebrate life-
cycle) are

[[Page 26941]]

being changed from ``CR'' to ``R'' to provide chronic data when chronic 
exposure is expected. With regards to the three acute toxicity tests 
conducted with the TEP, the ``NR'' in the wood preservatives column is 
changed to ``CR.'' Additionally, EPA will perform a down-the-drain 
analysis for every product with an applicable use or exposure scenario, 
including wood preservatives, that has the potential for waters 
containing antimicrobials to reach a WWTP. Therefore, to perform this 
analysis, the Agency is requiring data on the biodegradation of a wood 
preservative and its potential toxicity to WWTP microorganisms in an 
activated sludge basin.
    iv. Changes to data requirements for antifoulants. Antifoulants are 
released/applied directly to the aquatic environment. These products 
are often manufactured to be persistent, and because of the continuous 
release process, some of the active ingredient is likely to be 
transferred to the bottom of the water column, and then be adsorbed to 
the sediment. Therefore, EPA is changing, in the final Environmental 
Fate Data Requirements Table, the ``CR'' for the aquatic sediment study 
for the antifoulant paint and coatings column to ``R.'' With regards to 
the three acute toxicity tests conducted with the TEP, the ``NR'' in 
the antifoulant paint and coatings column is changed to ``CR.'' Also, 
to perform a down-the-drain analysis, the Agency is requiring data on 
the biodegradation of an antifoulant and its potential toxicity to WWTP 
microorganisms in an activated sludge basin.
    v. Non-dietary ingestion. EPA proposed to require this post-
application exposure study. However, EPA agrees that instead of 
requiring this study, it is more likely that EPA would model this route 
and pathway of exposure using inputs from available and reliable 
published research. Therefore, EPA has removed this data requirement 
from the final Post-Application Exposure Table.
    vi. Re-structuring of proposed toxicology and residue chemistry 
data requirement tables. In the proposed rule, for the toxicology data 
requirements table, EPA separated those use patterns needing more 
toxicology data from those needing less toxicology data using a 
terminology described as high or low. Based on comments received, in 
this final rule, EPA is now using a food/nonfood approach with some 
similarities to that of the toxicology data requirements table for 
conventional pesticides to distinguish the use patterns that need more 
toxicity data from those that need less. The food-use column and the 
nonfood-use column are split into subcolumns to explain which food-uses 
or nonfood-uses require more data, and which require less. This 
modification of the food/nonfood approach delineates the specific data 
requirement needs for antimicrobial pesticides.
    For the final residue chemistry data requirements table, EPA has 
adopted the commenters' suggestion for a tiered format. After review of 
the commenter's suggested tables, EPA believes the commenters' 
suggested tiered approach is more suitable to antimicrobials than that 
proposed by EPA.
    vii. Change in terminology. The commenters' asserted that the use 
of terms such as ``high'' or ``low'' as a means of tiering was 
insupportable, and an ``unsubstantiated assignment of exposure 
categories'' (ACC Comment, identified in the docket by document ID 
number EPA-HQ-OPP-2008-0110-0088.1, p. 21 and 22). EPA continues to 
believe that the use of ``high'' and ``low'' categories of exposure 
defined by the antimicrobial use patterns are a valid method for 
identifying those exposures that have greater exposure and those that 
have less. Based on its experience, EPA understands which use patterns 
require more data. However, EPA can achieve the same result without the 
use of the terms ``high'' or ``low.'' Therefore, based on comments 
received, EPA notes that it is no longer using the terms ``high human 
exposure'' and ``low human exposure'' as table headers for the final 
Antimicrobial Toxicology Data Requirements Table. Similarly, EPA is no 
longer using the terms ``high environmental exposure'' and ``low 
environmental exposure'' as table headers for the final Antimicrobial 
Nontarget Organism, the Nontarget Plant Protection, or the 
Environmental Fate Data Requirements Tables. However, EPA also notes 
that terms such as ``high human exposure,'' ``low human exposure,'' 
``high environmental exposure,'' and ``low environmental exposure,'' 
can be appropriate when discussing a particular antimicrobial use. A 
statement that a particular use results in, for example, ``high 
environmental exposure'' provides information and alerts the reader 
that more data are likely to be needed, rather than less data.

IV. Scope of the Rule

    This rule establishes a separate listing in Title 40 of the CFR for 
EPA's data requirements under FIFRA and FFDCA section 408 for 
antimicrobial pesticide uses. Although the rule is tailored to the 
unique characteristics of antimicrobial pesticides, it builds upon the 
existing data requirements imposed in 1984 on all pesticides and the 
2007 amendments to those requirements pertaining to conventional 
pesticides. Both sets of data requirements--conventional and 
antimicrobial--are designed to provide EPA with the information needed 
to make the required regulatory determinations under FIFRA and FFDCA 
section 408. FIFRA provides that a pesticide may not be registered for 
sale, distribution, and use unless ``it will perform its intended 
function without unreasonable adverse effects on the environment. . . 
.'' [7 U.S.C. 136a(c)(5)(C)]. FIFRA defines ``unreasonable adverse 
effects on the environment'' as both ``any unreasonable risk to man or 
the environment'' and ``a human dietary risk . . . inconsistent with 
the standard under section 408 of the [FFDCA]'' [7 U.S.C. 136(bb)]. 
FFDCA section 408 directs that EPA shall not establish a tolerance 
permitting pesticide residues in food unless EPA determines that the 
tolerance is ``safe'' [21 U.S.C. 346a(b)(2)(A)(i)]. ``Safe,'' under 
FFDCA section 408, is defined as ``a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information'' [21 U.S.C. 346a(b)(2)(A)(ii)]. In 
making safety determinations, EPA is required to consider aggregate and 
cumulative exposures from pesticides and other related substances and 
multiple factors specifically related to the protection of children [21 
U.S.C. 346a(b)(2)(C) and (D)].
    Under FIFRA, EPA has required ``[s]ubstantial 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'' 
(73 FR 59384, October 8, 2008). Since 1984, EPA has had codified FIFRA 
data requirements mandating data on, among other things, the toxicity 
hazards from ingestion of pesticides and exposure levels of pesticide 
residues in food (Ref. 2). With the passage in 1996 of the Food Quality 
Protection Act, [Pub. L. 104-170, 110 Stat. 1489 (1996)], which added 
the expanded safety standard in FFDCA section 408 described previously, 
EPA's data needs have expanded. As noted in the preamble to the 
proposed rule, ``[t]he combination of aggregate and cumulative exposure 
assessments required by FFDCA section 408 increases the nature and 
scope of EPA's

[[Page 26942]]

risk assessment, and potentially increases the types and amounts of 
data needed to determine that the FFDCA safety standard is met'' (73 FR 
59385, October 8, 2008). Moreover, with the explicit linkage in FIFRA 
between the FIFRA and FFDCA section 408 safety standards (also added by 
FQPA), ``[t]he 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'' [Id.; see 72 FR 60934, October 26, 2007 (FRL-8106-5), 
recodifying part 158 data requirements under the authority of both 
FIFRA and FFDCA section 408]. This rule, establishing specific data 
requirements for antimicrobial pesticides, is designed to capture the 
broad range of data needed to assess the safety of pesticides under the 
standards of both FIFRA and FFDCA section 408.
    The ACC Biocides Panel and other commenters, however, have claimed 
that the scope of the proposed rule exceeds the EPA's statutory 
authority because EPA is asserting ``jurisdiction under FIFRA over some 
antimicrobial food uses where, in the Panel's view, the statutory 
scheme provides exclusive jurisdiction to FDA'' (Food and Drug 
Administration). (ACC Comment identified in the docket by document ID 
number EPA-HQ-OPP-2008-0110-0088.1, p. 31). Although the ACC Biocides 
Panel acknowledges that these uses are properly regulated by EPA as 
``pesticides'' under FIFRA, the Panel argues that ``EPA's 
responsibility for such use[s] is to evaluate whether the antimicrobial 
meets the standard for registration under FIFRA, taking into account 
FDA's existing regulatory finding [under FFDCA section 409]. . . . EPA 
does not have the authority under either FIFRA or FFDCA to review or 
change the terms of the FDA approval.'' (ACC Comment, identified in the 
docket by document ID number EPA-HQ-OPP-2008-0110-0088.1, p.33). In 
essence, the Panel is asserting that for these antimicrobial uses, EPA 
is without authority or jurisdiction under FIFRA to evaluate, or 
require data on, the level of risk from dietary exposure to the 
antimicrobial--where FDA has evaluated the safety of the use of the 
substance under section 409. As a basis for this argument, the ACC 
Biocides Panel points to the Antimicrobial Regulation Technical 
Corrections Act (ARTCA), [Pub. L. 105-324, in 1998], which divided 
FFDCA jurisdiction between EPA and FDA with respect to antimicrobials. 
The Panel further argues that EPA is wrong to rely on FIFRA section 
2(bb)'s inclusion of the FFDCA section 408 safety standard in the 
definition of ``unreasonable adverse effects'' as authority for 
requiring data on antimicrobial uses falling under FDA's FFDCA section 
409 jurisdiction. Labeling EPA's interpretation of FIFRA section 2(bb) 
in the proposed rule as ``new,'' the ACC Biocides Panel claims that EPA 
has contradicted its ``long-standing'' interpretation of this 
provision.
    The ACC Biocides Panel fundamentally misunderstands EPA's statutory 
authority under FIFRA to require data pertaining to dietary risk from 
pesticides. EPA's authority to regulate pesticides under FIFRA with 
regard to their dietary risk is derived from FIFRA not the FFDCA. Under 
FIFRA, EPA is charged with protecting the public from ``unreasonable 
adverse effects on the environment.'' As noted previously, FIFRA in 
section 2(bb) defines ``unreasonable adverse effects'' in the first 
instance as ``any unreasonable risk to man. . . .'' [7 U.S.C. 346(bb)]. 
This broad standard clearly encompasses any unreasonable dietary risk. 
EPA's authority to regulate pesticides under FIFRA on the basis of 
dietary risk is explicitly reinforced by the second part of the 
unreasonable adverse effects standard which directs EPA to evaluate 
``human dietary risks'' from ``pesticides'' under the safety standard 
in FFDCA section 408. [Id.]
    Nothing in FIFRA or the FFDCA limits or constrains EPA's authority 
or jurisdiction to regulate pesticides based on dietary risk under 
FIFRA section 2(bb). The FIFRA section 2(bb) standard is independent 
from the safety standard under FFDCA section 409. Further, any finding 
by EPA under FIFRA that considers dietary risk would not ``change the 
terms of a FDA approval;'' rather, it would simply be a determination 
as to whether the separate FIFRA regulatory standard had been met. 
Finally, contrary to the ACC Biocides Panel's contention, the 
adjustment by the ARTCA of EPA's and FDA's jurisdiction under FFDCA 
sections 408 and 409 over antimicrobials does not affect EPA's 
jurisdiction or authority with regard to dietary risks of pesticides 
under FIFRA. In fact, as explained further in this unit, not only did 
the ARTCA not amend FIFRA section 2(bb) but Congress in the ARTCA took 
the unusual step of expressly disavowing any intent to narrow the scope 
of EPA's authority under FIFRA.
    The ARTCA was follow-on legislation to the major 1996 FFDCA 
amendments which, among other things, changed EPA and FDA jurisdiction 
under FFDCA sections 408 and 409. Prior to 1996, section 408 of the 
FFDCA, which is administered by EPA, only applied to ``pesticide 
chemicals'' that were defined as FIFRA ``pesticides'' ``used in the 
production, storage, and transportation of raw agricultural 
commodities'' [21 U.S.C. 321(q) (1994)]. FIFRA pesticide residues in 
food not falling within this provision (i.e., FIFRA pesticides used 
later in the food production process than the growth of raw 
agricultural commodities) came under section 409 of the FFDCA as food 
additives [See 21 U.S.C. 321(s), 348 (1994)]. FDA administers the 
establishment of food additive regulations under FFDCA section 409. 
Many antimicrobial pesticides used in conjunction with the 
manufacturing and processing of foods, at that time, were regulated as 
food additives. This division of legislative authority was changed by 
the FQPA in 1996. The FQPA amended the definition of ``pesticide 
chemical'' in the FFDCA to make it co-terminous with the definition of 
a ``pesticide'' in FIFRA by deleting the language restricting pesticide 
chemicals to those pesticides used in the production of raw 
agricultural commodities. Correspondingly, the FQPA also excluded 
``pesticide chemicals'' from the definition of a ``food additive'' 
[Pub. L. 104-170 sec. 402, 110 Stat. 1489, 1513 (1996)]. This change 
had the effect for FFDCA purposes of bringing all FIFRA pesticides 
under FFDCA section 408. Not only did Congress consolidate regulation 
of all pesticide residues in FFDCA section 408 but it also amended 
FIFRA to insure that the new safety standard in FFDCA section 408 was 
part and parcel of the FIFRA registration standard for pesticides 
resulting in residues in food [7 U.S.C. 136(bb)(2)]. Specifically, in 
section 2(bb)(2), Congress defined an ``unreasonable adverse effect on 
the environment'' under FIFRA as ``a human dietary risk from residues 
that result from a use of a pesticide in or on any food inconsistent 
with the standard under FFDCA section 408 [21 U.S.C. 346a].''
    In 1998 in the ARTCA, Congress modified slightly its FFDCA decision 
to consolidate all pesticide chemical residues in foods under FFDCA 
section 408. ARTCA amended the definition of ``pesticide chemical'' in 
FFDCA section 201 to exclude certain antimicrobial substances from the 
coverage of the definition [See 21 U.S.C. 321(q)]. More specifically, 
with certain qualifications, the ARTCA excepted, from the definition of 
pesticide chemical, substances that are FIFRA pesticides and are 
``applied for [an antimicrobial]

[[Page 26943]]

use on food, or the substance is included for such use in water that 
comes into contact with food, in the preparing, packing, or holding of 
the food for commercial purposes.'' [21 U.S.C. 321(q)(1)(B)(i)]. In 
addition, ARTCA excepted substances from the definition of pesticide 
chemical that are food contact substances, as defined in section 
409(h)(6) of the FFDCA, based on certain circumstances related to their 
use. These antimicrobial substances were now no longer considered 
``pesticide chemicals'' under the FFDCA but fell under the definition 
of ``food additive.'' That had the effect of shifting the residues 
resulting from these antimicrobial substances from FFDCA section 408 to 
FFDCA section 409 and shifting agency jurisdiction under the FFDCA over 
the same from EPA to FDA. Importantly, Congress, in ARTCA, did not 
amend FIFRA to remove these uses of antimicrobial substances from the 
definition of ``pesticide'' under FIFRA and left unchanged FIFRA 
section 2(bb)(2) which mandates that the section 408 safety standard is 
part of FIFRA's unreasonable adverse effects standard as to FIFRA 
``pesticide'' residues on food. Thus, EPA retained FIFRA jurisdiction 
over these antimicrobial substances (because they remained FIFRA 
``pesticides'') while FDA reacquired FFDCA jurisdiction over them under 
FFDCA section 409 (because they were removed from the definition of 
``pesticide chemical''). To make clear its intent on EPA's FIFRA 
jurisdiction, the ARTCA included the following express disavowal which 
was inserted into the FFDCA definition of ``pesticide chemical'':

    With respect to the definition of the term `pesticide' that is 
applicable to the Federal Insecticide, Fungicide, and Rodenticide 
Act, this clause [excluding certain antimicrobial substances from 
the FFDCA definition of ``pesticide chemical''] does not exclude any 
substance from such definition'' [21 U.S.C. 321(q)(1)(B)].

    Since its passage, EPA has interpreted the ARTCA according to its 
plain language, excluding the designated antimicrobial substances from 
the coverage of FFDCA section 408 but continuing to regulate those 
antimicrobial substances that qualify as FIFRA ``pesticides'' under 
FIFRA and requiring that, when those antimicrobial pesticides result in 
residues in food, the risks from such residues be consistent with the 
safety standard in FFDCA section 408. After all, FIFRA section 
2(bb)(2), on its face, applies to FIFRA ``pesticides'' and not FFDCA 
``pesticide chemicals.'' Any other result would be directly contrary to 
Congress' dictate that it was not excluding any substances from the 
FIFRA definition of ``pesticide.'' Accordingly, it is well within EPA's 
FIFRA authority to require that data be submitted on pesticides to 
determine if those pesticides meet the FFDCA section 408 safety 
standard, whether or not those pesticides come within the definition of 
a FFDCA ``pesticide chemical,'' so long as the use of those pesticides 
results in residues in food. On the other hand, the ACC Biocides 
Panel's approach would involve amending the language of section 
2(bb)(2) in a manner specifically rejected by the Congress when it 
passed ARTCA.
    There is no basis for the ACC Biocide Panel's claim that EPA's 
interpretation of FIFRA section 2(bb)(2) is ``new.'' The best evidence 
of the consistent and long-held nature of EPA's interpretation are the 
numerous submissions to the Agency from the Panel (and others) over the 
last 10 years disputing EPA's plain language approach to FIFRA section 
2(bb)(2). (Refs. 3, 4, 5, 6, 7, 8, 9, 10 and 11)

V. Issues Repeated Throughout Most Comments

    In evaluating the comments received on proposed part 158, subpart 
W, EPA noted that four specific comments were routinely repeated 
throughout most of the entire set of comments. Additional discussion 
can be found in the Response to Comments Document available in the 
docket to this rule.

A. Differentiating the Review of Antimicrobials

    1. Comment. EPA received several comments noting that FIFRA section 
3(h)(3)(A)(ii) specifies that EPA must differentiate the review of 
antimicrobial pesticides from that of other pesticides.
    2. EPA's response. FIFRA section 3(h)(3)(A)(ii) specifies, among 
other things, that, in proposed regulations to accelerate and improve 
the review of antimicrobial pesticide products, EPA shall define the 
various classes of antimicrobial use patterns, differentiate the types 
of review undertaken for antimicrobial pesticides, conform the degree 
and type of review to the risks and benefits presented by antimicrobial 
pesticides, and ensure that the registration process is sufficient to 
maintain antimicrobial product efficacy. While those elements apply to 
a proposed rulemaking that the Agency published on September 17, 1999 
(64 FR 50671) (FRL-5770-6), the Agency has been mindful of those same 
elements in its development of part 158, subpart W. As applied to 
antimicrobial product registration actions, differentiation refers to 
the tailoring of data requirements so that they are responsive to 
considerations about the antimicrobial products to which they relate. 
In practice, differentiation means that the data requirements applied 
to antimicrobials are designed to respond to the special or unique 
needs of antimicrobials such as the nature of the products, their 
ingredients, their uses, etc. Differentiation or tailoring does not 
mean that the resulting data requirements for antimicrobials will 
necessarily be comprised of more, less, or the same number and type of 
data requirements as required for other types of pesticides such as 
conventional pesticides.
    For example, the residue chemistry data requirements for 
conventional pesticides focus on the application of agricultural 
pesticides to crops growing in the fields. However, the residue 
chemistry data requirements for antimicrobials, codified in this final 
rule, have been tiered to account for applications that focus not on 
crops growing in the fields (where antimicrobials are rarely used), but 
instead account for antimicrobial uses, including those that result in 
residues on food more indirectly, such as from use as sanitizers in 
food processing plants. The overall impact is to require fewer studies 
since the tiering used for the antimicrobial residue chemistry data 
requirements table is structured differently, and there are fewer ``R'' 
studies and most studies are ``CR.'' However, there are two residue 
chemistry data requirements (migration and nature of the residue on 
surfaces) for antimicrobials that are not included in the conventional 
residue chemistry data requirements table because they reflect the 
unique use sites for antimicrobials; see Unit XVI. for additional 
discussion. Ecotoxicity and environmental fate data requirements 
provide another example of the differentiation of data requirements 
between antimicrobials and conventional pesticides. While conventional 
or biochemical/microbial pesticides are often used outdoors, and are 
deliberately placed/spread in the environment, most antimicrobials are 
used indoors. As discussed in the preamble (73 FR 59406), previously 
EPA had assumed that many of the indoor uses went down the drain to a 
WWTP, where the WWTP processes would mitigate environmental concerns. 
Therefore, in 1984, EPA required basic ecotoxicity and environmental 
fate data for conventional pesticides but made these types of data 
conditional for indoor uses such as antimicrobials based on whether 
antimicrobial-specific

[[Page 26944]]

data indicated that environmental exposure may occur. However, as 
discussed in the proposed rule (73 FR 59407), in recent years there 
have been detections of antimicrobial chemicals (with indoor uses) in 
waterbodies. These antimicrobials are moving into the environment via 
treated effluent. Therefore, EPA is requiring for antimicrobials a 
specific tiered-set of data to evaluate the likelihood of environmental 
exposure to antimicrobials that may reach a WWTP, as a result of being 
washed down the drain via leachates, rinsates, and flushes. These data 
evaluate whether antimicrobials are likely to survive the treatment 
processes at a typical WWTP, and thus would be present in the WWTP 
effluent. Antimicrobials that do survive the treatment processes have 
the potential to end up in the terrestrial or aquatic environments and 
higher-tiered ecotoxicity and environmental fate data are only 
triggered for these antimicrobials.
    Thus, differences in data requirements stem directly from the 
inherent differences in the nature of the particular type of pesticide 
used. Even with such differentiation or tailoring, there is a general 
core of data requirements which may be expected to be applicable to any 
kind of pesticide product, such as product chemistry data requirements. 
EPA's ultimate goal with its antimicrobial data requirements is to 
create a body of data requirements which produce sufficient information 
for the Agency to consider and use in making its statutorily-required 
determinations regarding the risks and benefits, where applicable, of 
antimicrobial pesticides. The differentiation or tailoring of the 
antimicrobial data requirements is instrumental in accomplishing that 
goal.

B. Rewrite and Repropose the Rule

    Several commenters requested that EPA rewrite and then repropose 
this rule. Commenters raised three arguments as to why EPA should 
repropose. First, the proposed regulation does not contain 
scientifically-based criteria for determining data requirements but 
instead requires that data requirements be determined in case-by-case 
consultations in which EPA retains ``sole discretion'' as to the data 
required. Second, EPA has not disclosed how it plans to use the 
proposed data in EPA risk assessments. Third, affected parties cannot 
properly evaluate the data requirements without final guidelines on how 
such studies should be conducted. Each of these three arguments are 
addressed in detail in the following responses.
    1. Comment on scientifically-based criteria. Several commenters 
focused on the test notes to the data requirements tables, and claimed 
that the proposed rule ``leaves too many standards and decisions to the 
sole discretion of EPA, creating uncertainty and, inevitability, 
inconsistency in regulatory decision making.'' Too many determinations, 
the commenter asserted, are at ``EPA's discretion'' because the 
proposal is vague, without clear-cut criteria. Additionally, they 
argued that there are too many places in the test notes where 
consultation with the Agency is required or the phrase ``as determined 
by the Agency'' is used. (One commenter listed 37 instances in which 
the proposal allegedly substituted a mandatory consultation process for 
regulatory criteria.) According to the commenters, EPA should eliminate 
most of the consultation requirements and instead, repropose the rule 
providing a clear set of requirements.
    2. EPA's response to comment on scientifically-based criteria. Test 
notes often contain qualitative or quantitative measures for use in 
determining whether a study is triggered or not. Most frequently this 
occurs when there is an initial study that relates to whether 
subsequent testing would be needed or not. Not all triggers are easily 
reduceable to quantitative measures and EPA believes that qualitative 
descriptors such as ``expected to enter the environment in significant 
concentrations,'' or ``if repeated dermal exposure is likely to occur 
under conditions of use,'' and ``the use of the pesticide is likely to 
result in repeated human exposure over a considerable portion of the 
human lifespan'' provide meaningful criteria for determining when a 
study is triggered. EPA has carefully reviewed each of the 37 test 
notes cited by one commenter and has identified several instances in 
which clarification of the criteria was appropriate. EPA's analysis of 
these 37 test notes and resultant changes are included in response to 
comment 3 in the Response to Comments Document in the docket.
    In numerous places the test notes contain language stating that the 
criteria would be applied ``as determined by the Agency.'' Commenters 
have misinterpreted this as giving EPA the authority to make decisions 
on factors other than the regulatory criteria included or in its ``sole 
discretion.'' This was not EPA's intent and, accordingly, EPA has 
removed all of the phrases ``as determined by the Agency'' from all 
test notes for the final antimicrobials rule so there can be no chance 
of a misunderstanding of how the criteria are to be applied.
    Commenters also asserted that the EPA's alleged mandatory 
consultation requirements rendered the test notes meaningless, as EPA 
would determine whether studies were required in private based on 
unspecified factors. EPA disagrees. The commenters have misread the 
proposed rule language and misunderstood the purpose for consultation. 
The consultation references were not intended to impose a mandatory 
consultation requirement. To the contrary, references to consultation 
were an attempt by EPA to signal its willingness to meet with 
applicants to adapt studies, if necessary, to the specifics of 
individual antimicrobials.
    Consultation is a longstanding, commonly used and valuable process 
in EPA's Pesticide Program. Applicants often meet with OPP staff on a 
pre-submission basis to review and discuss the adequacy of the 
available data. OPP believes that such meetings are beneficial to both 
EPA and the applicants. In practice, such meetings are very often 
sought by registrants and applicants. By encouraging communication and 
exchange of ideas, such discussions can help in the development of 
clearer expectations of what must be submitted in instances where data 
requirements involve complexities. Consultation can result in data that 
better meets EPA's needs and saves resources for both EPA and the 
applicant. Depending upon what is intended to be addressed, such 
meetings do not necessarily need to be held in person, but can be 
frequently accomplished via teleconferencing.
    EPA did not intend its references to consultations in the test 
notes to impose mandatory consultation requirements; neither did EPA 
intend the consultation references as a means of establishing a 
different standard for determining if a study is triggered. EPA has 
carefully reviewed all test notes in the antimicrobials final rule and 
removed all references to consultation from all test notes for the 
antimicrobials rule so there can be no chance of misunderstanding the 
voluntary nature of consultation.
    3. Comment on use of data in risk assessment. The commenters also 
argued that reproposal was necessary because they could not 
meaningfully comment on the proposal without understanding how the data 
would be used by EPA. Specifically, one commenter wrote: ``It is not 
plausible for [the commenter] or others to meaningfully comment on the 
Proposal

[[Page 26945]]

without the benefit of understanding the risk assessment approaches EPA 
plans to use, (e.g., human and ecological), the ways in which the data 
requirements will provide information to conduct those assessments and 
the ways EPA will use those risk assessments in making regulatory 
decisions.''
    4. EPA's response on use of data in risk assessment. EPA disagrees 
with this comment for several reasons. First, how EPA conducts risk 
assessments and how it uses toxicological, ecological, and exposure 
data in those risk assessments is well known. Risk assessment is not 
unique to OPP. The principles used by OPP and, in fact, by EPA are 
those used by the scientific community in general. OPP follows the 
processes and procedures in the many risk assessment guidance documents 
that have been issued by EPA (see http://www.epa.gov/riskassessment/guidance.htm). The Agency's exposure and risk assessment procedures 
have been presented in numerous exposure and risk assessments for 
antimicrobial pesticides. EPA's assessments reflect the best available 
data, and the state of the science of exposure and risk assessment 
models, methods, and procedures.
    Moreover, OPP's risk assessment procedures for pesticides are well-
documented. EPA has concluded the process of completing Reregistration 
Eligibility Decision Documents for all pesticides under FIFRA and 
reassessing all FFDCA pesticide tolerances. This was a very open 
process involving multiple public comment opportunities as to each 
pesticide. Further, all regulatory decision documents as well as the 
underlying risk assessments have been made available to the public. EPA 
has now begun new pesticide reviews under the Registration Review 
program, and that process is equally open and transparent.
    A second reason why EPA believes this comment to be misdirected is 
that the proposed rule does not represent a change to EPA's existing 
and transparent risk assessment procedures. Rather, the proposal is 
merely designed to tailor the existing data requirements that apply to 
all pesticides in a way that is more specific to antimicrobial 
pesticides, as well as including some new requirements applicable to 
antimicrobials.
    Finally, the comment is without foundation because EPA has 
explained the need for each study and provided background information 
on the purpose for which each study would be required. Part 158, 
subpart B contains an extensive description of the need for and use of 
submitted studies (40 CFR 158.130). Additionally, as explained in the 
preamble to the antimicrobials proposed rule, EPA relied on the 
proposed and final rules for establishing data requirements for 
conventional pesticides. As stated in the proposed rule for 
antimicrobials, the rationales for requiring and/or revising particular 
data requirements were in those rules.

    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.'' (73 FR 59384).

    Examples of studies applicable to antimicrobial pesticides and for 
which a description of the need for the requirement was included in the 
preamble to the proposed rule for antimicrobials include the need for:
     The 90-day dermal and 90-day inhalation studies for 
heating, ventilation, air conditioning, and refrigeration uses (73 FR 
59395),
     A food migration study (73 FR 59404), and
     Environmental fate studies to support a down-the-drain 
assessment (73 FR 59408).
    One commenter presented several examples of what the commenter 
labeled as EPA's ``ad hoc risk assessment processes.'' An examination 
of those examples shows that the commenter is concerned with what it 
labels as ``inconsistency in EPA's current practice'' as to when a 
dietary risk assessment is needed for antimicrobial pesticides. The 
commenter argued that this alleged inconsistent practice shows the 
``need for stable, transparent guidance on risk assessment to support 
data requirements regulation.'' EPA does not believe that it has been 
inconsistent in its risk assessments. Furthermore, EPA does not believe 
that such ``inconsistencies,'' if they exist, would mean that affected 
parties could not comment meaningfully on the proposed data 
requirements. Ultimately, the issue with the data requirements rule is 
whether EPA has asked for data needed for determining whether 
pesticides meet the relevant statutory safety standards. The fact that 
EPA might have been inconsistent in the past in its determinations with 
regard to the safety standard or how it went about assessing whether a 
pesticide met the safety standards (e.g., did EPA need to do a dietary 
risk assessment), does not handicap an affected party in determining 
whether a proposed data requirement is consistent with the statutory 
safety standards. To reiterate, the relevant question is not whether 
EPA has guidance on when dietary risk assessment is needed but whether 
the proposed data requirements pertaining to dietary risk would require 
information that are appropriate to EPA's determination under the 
applicable statutory safety standards. To the extent, the commenter is 
concerned with any particular Agency decision regarding when a dietary 
risk assessment is needed for antimicrobials, EPA encourages the 
commenter to raise that concern directly with the Agency in the context 
of the specific matter causing the commenter concern.
    This commenter later filed additional comments that further 
developed the argument that reproposal is necessary because EPA 
allegedly has not clearly defined when a dietary risk assessment is 
needed. The commenter wrote: ``[T]he Proposal does not clearly 
articulate any standards for determining what uses trigger a food 
analysis. It has become apparent since the Proposal was issued that the 
Agency will interpret this regulation to vastly increase the number of 
antimicrobials regulated as food use.'' (ACC/CSPA letter, identified in 
the docket by document ID number EPA-HQ-OPP-2008-0110-0107, p. 2). 
Further, the commenter then asserts that ``EPA's economic analysis does 
not even attempt to address the increase in the burden on registrants 
and applicants that this [alleged] expansion of the need for `food 
contact' approvals will cause.'' (Id.) These additional comments 
suggest that this commenter is concerned with EPA decisions issued 
prior to this final rule (and, in most cases, prior to issuance of the 
proposed rule) and fears how the final rule may be interpreted in the 
future. However, it is difficult to determine from these comments 
whether the commenter is claiming that this alleged ``expansion'' of 
food use antimicrobials is effected by any particular language in the 
proposed rule. To the extent the commenter is arguing that the 
expansion is caused by EPA's application of the FFDCA section 408 
standard to all antimicrobial food uses under FIFRA section 2(bb) 
(whether the use requires clearance under FFDCA section 408 or 409), 
the commenter, as explained in Unit XVI.A., misunderstands EPA's 
authority under FIFRA and EPA's practice as to antimicrobials since the 
passage of ARTCA. In another place in its subsequent comments, the 
commenter argues that the use of the categories of ``direct food use'' 
and ``indirect food use'' ``creates the potential for almost all 
antimicrobials to be considered as possibly leaving residues on food.''

[[Page 26946]]

(ACC attachment 1, identified in the docket by document ID number EPA-
HQ-OPP.2008-0110-0108, p. 4). However, EPA adopted the categories of 
direct and indirect food use as a way to tier data requirements for 
residue chemistry and toxicology, not to expand the category of food 
uses. For a use to qualify as an indirect food use it must result in 
residues in food and EPA clearly has the authority under FIFRA and the 
FFDCA to request data on and assess the risk of pesticide residues in 
food. Despite the commenter's claims to the contrary, it is not EPA's 
intent to use this data requirements rule as a basis for expanding what 
antimicrobial uses qualify as direct or indirect food uses. 
Accordingly, EPA's economic analysis has accurately captured the costs 
imposed by this rule.
    5. Comment on lack of final guidelines. Finally, commenters argued 
that reproposal was needed because affected parties cannot properly 
evaluate the data requirements without final guidelines on how such 
studies should be conducted.
    6. EPA's response on lack of final guidelines. EPA disagrees with 
this comment: EPA can require submission of a particular study even if 
no guideline has been provided. The types of data needed for EPA to 
make a registration decision are clearly identified in its proposed 
rule. Testing laboratories routinely conduct these studies, as 
evidenced by the test cost data which was available for use in both 
EPA's and the commenter's economic analyses. Final guidelines are 
available for the majority of tests required, and draft guidelines 
provide information for the applicant to consider. Since there was an 
understanding of the types of data EPA proposed to require, the 
commenter had sufficient information to comment on whether EPA had 
asked for the data needed for determining whether pesticides meet the 
relevant statutory safety standards.
    It is important to keep in mind that, as noted in the proposed 
rule, new part 158, subpart W is ``retaining most current data 
requirements for antimicrobials . . . and revises other existing data 
requirements.'' (73 FR 59383) The guidelines that the commenter asserts 
as not providing sufficient information to permit meaningful comment 
pertain, for the most part, to these existing data requirements that 
are not being modified by this rulemaking. As to the ``new'' data 
requirements that are imposed by this rule, the commenter has not 
specifically explained why interested parties cannot meaningfully 
comment on these requirements or why a final guideline is needed to 
provide meaningful comments on these studies. In fact, as to these 
``new'' studies, OCSPP guidelines (formerly OPPTS) are available for 
all except the nature of the residue on surfaces study. For that study, 
due to the many site- and chemical-specific variations, a protocol 
review is required.
    This commenter later filed additional comments stating that ``FIFRA 
requires EPA to issue test guidelines.'' (ACC/CSPA letter, identified 
in the docket by document ID number EPA-HQ-OPP-2008-0110-0107, p. 4). 
In accordance with FIFRA section 3(c)(2)(A), EPA has promulgated data 
requirement rules ``specifying the kinds of information which will be 
required to support the registration of a pesticide.'' EPA is not 
required to issue guidance explaining how studies that are addressing 
the data required under the regulations should be performed. Additional 
information on EPA's development of guidelines is in Unit XVIII.

C. Alternative Testing Paradigms

    1. Comment. A commenter asked how OPP plans to implement the 
National Academy of Sciences (NAS)/EPA Vision of Toxicity Testing in 
the 21st Century or the Strategic Plan for Evaluating the Toxicity of 
Chemicals. The commenter noted that the rule should be specific in 
identifying alternative approaches that EPA will consider.
    2. EPA's response. In the proposed rule, in Unit XVIII., entitled 
``Alternative Testing Paradigms,'' EPA discussed its commitment to 
moving towards a more efficient and refined testing/risk assessment 
paradigm for antimicrobial pesticide chemicals. That discussion 
included the following:
     OPP's current thinking on how Structure-Activity-
Relationships (SAR) and Quantitative SAR (QSAR or (Q)SAR) modeling 
could be used as part of an integrated approach to hazard and risk 
assessment to support a regulatory decision-making process for 
antimicrobial pesticides.
     The evolution of the current paradigm of animal (in vivo) 
toxicity testing toward a more integrated tiered testing approach for 
antimicrobial pesticides.
     Development of computational tools for interpreting data 
from computational chemistry, high-throughput screening (HTS) and 
genomic technologies.
     The EPA-funded reports by the NAS entitled ``Toxicity 
Testing for Assessment of Environmental Agents'' (2006) and ``Toxicity 
Testing in the 21st Century: A Vision and a Strategy'' (2007).
    The NAS recommendations are truly visionary and involve a 
transformative paradigm shift in toxicology based largely on the 
increased use of in vitro molecular and cellular assays, and 
computational modeling that make testing faster and less costly, and 
reduces animal testing significantly. The new technologies are expected 
to help EPA better understand how chemicals perturb normal biological 
function(s), and thus identify toxicity pathways. Potential toxic 
effects of chemicals could then be predicted based on in vitro 
bioactivity profiles derived from a chemical's effects on cellular 
molecules and processes. Thus, the scientific foundation for this new 
paradigm is based on linking in vitro effects with adverse outcomes in 
vivo, and on computer modeling that extrapolates to predicted responses 
in whole tissues, organisms and populations based on realistic human or 
environmental exposures.
    EPA is working to develop and evaluate new technologies in 
molecular, cellular, and computational sciences to supplement or 
replace the more traditional methods of toxicity testing and risk 
assessment (see http://www.epa.gov/pesticides/science/testing-assessment.html). Such an approach begins with consideration of 
exposure information along with hazard-based hypotheses about the 
plausible toxicological potential of a chemical or group of chemicals 
based on their physical-chemical properties and their effects on 
biological targets in vitro. This information is then combined with 
computer modeling to target animal testing to the specific data needed 
for human health and ecological risk assessments.
    No single new technology will be able to address all situations. 
However, by using a suite of tools and approaches in combination, EPA 
believes it is possible to improve the hazard and exposure assessments 
that form the basis for understanding pesticide chemical risks. It will 
take time and substantial research to build this new approach. OPP will 
incorporate the new technologies into EPA's hazard and risk assessment 
processes as the technologies are sufficiently developed and peer 
reviewed. Development and vetting of this new approach to chemical 
management must be accomplished while continuing to make pesticide 
registration decisions. Eventually, the new technologies should:
     Create a broader suite of computer-aided methods to better 
predict potential hazards and exposures, and to focus testing on likely 
risks of concern.

[[Page 26947]]

     Improve the approaches to more traditional toxicity tests 
to minimize the number of animals used while expanding the amount of 
information obtained.
     Improve OPP's understanding of toxicity pathways to allow 
development of non-animal tests that better predict how exposures 
relate to adverse effects.
     Improve the diagnostic biomonitoring and surveillance 
methods to detect chemical exposures and identify causes of toxic 
effects.
    Since the publication of the proposed rule in October 2008, OPP 
announced its strategic direction to move toward an improved testing 
and assessment paradigm where in vivo (animal) testing would be 
targeted to the most likely hazards of concern. OPP envisions an 
enhanced testing/assessment paradigm that is a progressive, tiered-
testing approach. This paradigm shift should accrue the following 
benefits to OPP:
     Ability to evaluate more chemicals across a broader range 
of potential effects in a shorter time frame.
     Potential to increase the feasibility of assessing the 
risks posed by mixtures.
     Enhanced predictive ability to determine whether animal 
testing is needed to refine a risk assessment and to inform management 
decisions.
     Refine and reduce animal testing by maximizing information 
obtained from animal studies, and focusing on effects of concern.
     Opportunities for improved diagnostic biomonitoring and 
surveillance methods to detect chemical exposures and identify causes 
of toxic effects.
     Enhance the quality and efficiency of risk assessment and 
risk management decisions.
    Over the next several years, OPP intends to improve and transform 
its approach to pesticide risk management by enhancing its ability to 
use integrated approaches to testing and assessment. The Agency's work 
on an integrated approach means the development of increasingly 
effective laboratory animal tests that are designed to maximize the 
information generated about the nature of the effects being studied. 
OPP intends to expand its toolbox of predictive models. The new 
toxicity and exposure approaches will enhance priority-setting and 
screening approaches and therefore focus Agency and societal resources 
on those chemicals with the greatest risk potential.
    These advances will be incorporated within a risk assessment 
framework of problem formulation, hazard, dose response, exposure 
assessment, and risk characterization to support pesticide registration 
decisions. As this framework evolves, EPA will create pilot programs 
and develop guidance documents to inform applicants and others of the 
alternative approaches being used.
    It will require many years to realize the NAS vision of a new 
toxicity paradigm based on evaluating perturbations in cellular 
pathways by reliance on an array of computational and in vitro methods. 
However, the development and expansion of certain tools used to guide 
more intelligent in vivo testing is anticipated to become available in 
the nearer term (<=5 years) which includes (Q)SAR/expert systems, TTCs, 
and in vitro technologies. As EPA transitions to the use of these 
components of intelligent testing or alternative methods, communication 
will be essential. Through its Pesticide Program Dialog Committee, OPP 
has created a 21st Century Toxicology/New Integrated Testing Strategies 
Workgroup. For information, see http://www.epa.gov/pesticides/ppdc/testing/index.html.
    Additionally, OPP has and will continue to publicly vet this new 
approach. On May 24-26, 2011, OPP requested that the FIFRA SAP consider 
and revise a set of scientific issues related to Integrated Approaches 
to Testing and Assessment (IATA) Strategies: Use of new computational 
and molecular tools. OPP plans to build on an established foundation of 
using a variety of tools in a tiered testing and assessment framework 
by systematically adding new tools and methodologies, as well as an 
advancing understanding of key events in toxicity pathways. OPP 
requested the SAP's input on EPA's plans to maximize use of existing 
data from similar compounds, including information from new toxicity 
hazard computational and in vitro predictive models, and exposure 
modeling to target in vivo toxicity testing that is necessary to assess 
and manage chemical risks, appropriately. Two case studies illustrated 
the use of these approaches. The SAP Report is available at http://www.epa.gov/scipoly/sap/meetings/2011/052411meeting.html#frn.

VI. Antimicrobial Use Patterns

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.

 A. Definitions of Use Patterns

    1. Comment. The commenter suggested different use patterns for EPA 
to consider. The commenter believes that the use patterns proposed by 
EPA are not use patterns but descriptions of product types. The 
commenter suggested six general use patterns for EPA to consider. These 
include:
     Indoor industrial (all nonfood);
     Indoor residential/commercial/institutional nonfood;
     Indoor commercial/institutional food;
     Aquatic areas nonfood;
     Aquatic areas food;
     Material preservative for exempt treated article uses.
    2. EPA's response. The Agency disagrees that these suggested use 
patterns are adequate substitutes for the proposed use patterns. The 
use patterns that EPA proposed provide a reasonable approach for 
allowing the Agency to more clearly identify and tailor the data 
requirements for the different types of antimicrobial pesticides. In 
some cases, that is best accomplished by using the product type to 
define the use pattern.
    EPA has reviewed the commenters' descriptions of their six 
suggested general use patterns and has determined that they do not 
acknowledge all potential exposure pathways of antimicrobial 
pesticides, particularly those discharged to wastewater as a result of 
processing and end-use. Although three of the proposed general use 
patterns include ``indoor'' in the name, the exposure potential for 
these use patterns is not limited to the indoor environment. This is 
because these patterns include processes and end-uses of antimicrobial 
pesticides that are discharged to wastewater, thereby leading to the 
potential for microorganisms in WWTPs to be exposed to antimicrobial 
pesticides and for aquatic organisms to be exposed to antimicrobial 
pesticides in surface water downstream of WWTPs. If the antimicrobial 
is not completely removed during treatment, exposures of humans to 
antimicrobials may also be associated with antimicrobials discharged to 
wastewater that enters WWTPs and subsequently enters surface water via 
WWTP effluents. Furthermore, there may also be the potential for 
terrestrial organisms and humans to be exposed to antimicrobial 
pesticides if the antimicrobial that is discharged to wastewater 
partitions to biosolids.
    Since the processing or end-use of an antimicrobial pesticide in an 
indoor setting does not preclude the potential for its release to 
ambient environmental media, particularly under circumstances in which 
there is potential for discharges of antimicrobial pesticides to 
wastewater, EPA believes that the designation of an antimicrobial use 
pattern as ``indoor'' is misleading. Based on the conclusion that 
processing or

[[Page 26948]]

end-use of an antimicrobial pesticide in an indoor setting does not 
preclude its release to the ambient environment, EPA believes that a 
down-the-drain analysis is needed for all use patterns with the 
exception of the aquatic areas use pattern.
    The commenter's suggested use patterns are also inconsistent with 
EPA's reevaluation of the data required for wood preservatives. In 
response to comments, the Agency determined that all treated wood needs 
to be considered as having the potential to come into contact with 
surface water. Therefore, for wood preservatives, EPA has changed 
several data requirements in both the environmental fate table and the 
non-target organisms table from ``CR'' to ``R.'' However, under the 
commenter's six suggested use patterns, wood preservatives would be 
considered to be the same as material preservatives. The commenter did 
not differentiate the data needed between the two use patterns. EPA 
believes that the data needed for a wood preservative is distinctly 
different from that needed for a materials preservative. Wood 
preservatives have a high potential for environmental exposure, as 
evidenced by both environmental fate and nontarget organisms data 
requirements that are ``R.'' Material preservatives have a lower 
potential for environmental exposure and consequently are ``CR.'' Thus, 
the data requirements codified in this final rule acknowledge the 
differences in the data needed by having two distinctly different use 
patterns: Wood preservatives and material preservatives.
    Given the inclusion of the term ``indoor'' as part of the title of 
three of the suggested use patterns, and the combining of wood 
preservatives and materials preservatives into a single use pattern, 
EPA believes that the six general use patterns suggested by the 
commenter would not adequately serve EPA's or the public's needs. 
Additionally, the 1997 review by the FIFRA SAP of EPA's 12 
antimicrobial use patterns indicated the SAP's agreement that the 
Agency's proposed designation of 12 use patterns was a reasonable 
approach to organizing data requirements, and was, in fact, similar to 
the approaches used by Canada's Pest Management Regulatory Agency 
(PMRA), and the California Environmental Protection Agency. Therefore, 
EPA is codifying the 12 use patterns that were proposed.

B. Wood Preservative Use Pattern

    1. Comment. Several commenters questioned how wood preservatives 
were treated in the proposed rule. One commenter thought that all wood 
preservatives should be considered as having contact with water. 
Another commenter argued that the industrial, commercial and do-it-
yourself uses of wood preservatives are different and should be 
assessed differently.
    2. EPA's response. Wood preservatives are pesticides for 
incorporation into wood products to control wood degradation problems 
due to fungal rot or decay, sapstain, molds, or wood-destroying 
insects.
    As explained in the proposed rule, (73 FR 59405) EPA's current 
practice of determining the data required for a wood preservative 
product is dependent upon where the product is intended to be used 
(land-only versus land and aquatic). Under this approach, fewer 
environmental fate and ecological effects studies are required for 
products that limit their use patterns to land-only uses. This approach 
also assumes that diversion does not occur and that wood that is 
treated for land-only uses does not end up in the water and vice versa. 
EPA specifically requested comments on the regulation of wood 
preservative products, and indicated that based on the comments 
received could determine to continue with the current practice of 
considering land-only applications, or change to a land and aquatic 
usage. Based on comments indicating that the data required to register 
a wood preservative should not differentiate between land only and 
aquatic only applications of treated wood, EPA has reevaluated this 
approach. As discussed in the proposed rule, it is difficult to assure 
that diversion does not occur. EPA considered three possibilities:
     Assume all treated wood could have the potential to come 
into contact with surface water.
     Use an approach similar to that advocated by the American 
Wood Protection Association (AWPA) approach which differentiates 
between marine/freshwater and ground contact use/above ground contact 
use.
     Maintain status-quo.
    Wood preservatives used to protect wood structures placed directly 
in or over water (e.g., marine pilings, docks) will leach active 
ingredient into the water, resulting in potential exposure of aquatic 
organisms. Wood preservatives used in the terrestrial environment for 
uses such as fences, siding, and decks will leach active ingredient 
into soil where it may be transported into the aquatic environment and 
expose aquatic organisms.
    The Emission Scenario Document (ESD) for Wood Preservatives 
prepared by the Organisation for Economic Co-operation and Development 
(OECD) as part of its Series on Emissions Scenario Documents provides 
guidance on how to estimate emissions of chemical substances in wood 
preservative products to air, water, and soil as a result both of 
product application and storage of treated wood prior to shipment and 
treated wood-in-service. This OECD ESD documents the occurrence of 
pathways of release of chemical substances during wood preservative 
application to facility drains that subsequently convey wastewater to 
WWTPs; entry of chemical substances to adjacent surface water bodies by 
way of run-off water from unpaved storage of wood preservative-treated 
products following a rain event; and leaching of chemical substances 
from in-service uses of treated exterior wood out of ground (i.e., 
fences, noise barriers), wood in-ground (transmission poles, fence 
posts), and wood in direct contact with fresh and sea water (poles and 
planks/decking of jetties and wharfs). Additional information on 
indirect releases to surface water of antimicrobial pesticides used as 
wood preservatives can be found in response to comment 134.1 in the 
Response to Comments Document in the docket.
    Given the number of pathways identified that result in potential 
exposure from treated wood, the Agency determined that all treated wood 
should be considered as having the potential to come into contact with 
surface water. All wood preservative risk assessments will now be 
performed considering that the treated wood could end-up either on the 
land or in the aquatic environment. As previously discussed, there are 
multiple pathways for wood preservative degradates and/or leachates to 
reach surface water. The AWPA approach would have continued the 
practice of determining the data requirements based on the intended use 
site of the treated product.
    Given this decision, that all treated wood could have the potential 
to come into contact with surface water, the wood preservative columns 
of the final Environmental Fate and the Nontarget Organisms Tables were 
revised.
    For the final Environmental Fate Table, for the wood preservatives 
column, the data requirements for anaerobic soil metabolism, aerobic 
aquatic metabolism, and anaerobic aquatic metabolism were changed from 
``CR'' to ``R.'' Because treated wood products have outdoor usages, the 
Agency believes that these products have the potential to come into 
contact with surface water as well as soils which can become flooded or

[[Page 26949]]

waterlogged and then be released to surface water.
    For the final Nontarget Organism Table, for the wood preservatives 
column, the data requirements for chronic toxicity testing with fish 
(fish early-life stage) and aquatic invertebrate (aquatic invertebrate 
life-cycle) are being changed from ``CR'' to ``R'' to provide chronic 
data when chronic exposure is expected.
    The Agency agrees that the industrial, commercial, and do-it-
yourself uses of wood preservatives are different in terms of human 
exposure. Industrial wood preservative uses are assessed for those 
workers involved in the actual treatment of the wood with the 
preservative. This includes operations at a pressure treatment facility 
where workers add the preservative to treatment cylinders, remove 
treated wood charges from the cylinders, check the treated wood to 
verify retention rates, and move the freshly treated wood around the 
facility (from cylinder to drip pad to storage to shipping). Industrial 
sapstain wood preservatives are also assessed at the treatment facility 
for the application of the pesticide. Worker tasks for the non-pressure 
treatment (non-PT) are slightly different than those at pressure 
treatment (PT) facilities. Separate exposure measurements unique to 
each type of treatment (PT vs non-PT) are used in the assessments.
    Exposures to commercial and do-it-yourself uses of treated wood are 
assessed for those installing the treated wood and for those exposed to 
the treated structures (e.g., play sets and decks).

VII. General and Administrative Issues

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.

A. Scientific Advisory Panel (SAP) Waivers

    1. Comment. A commenter noted that in the preamble to proposed part 
158, subpart W, EPA cites multiple SAP reports that did not 
specifically mention antimicrobial pesticides. Therefore, the commenter 
believes these SAP reviews were insufficient. Another commenter noted 
that it has been 9 years since the last SAP review and that EPA should 
request another SAP review prior to implementation of proposed part 
158, subpart W. Still another commenter believes that EPA's request 
that the SAP waive its review of proposed part 158, subpart W based on 
the SAP's 1997 review was improper, and that the SAP cannot waive its 
statutory review obligation.
    2. EPA's response. EPA disagrees with the comments. On June 3, 
1997, EPA presented an early version of the part 158, subpart W 
proposal in an open meeting to the SAP. At that time, the SAP provided 
extensive comments in five areas: Toxicology, residue chemistry, 
ecological effects and environmental fate, human exposure, and 
efficacy. Since then, the SAP has considered many specific studies and 
scientific issues included in proposed part 158, subpart W as part of 
their reviews of guidelines and of data requirements for conventional 
agricultural pesticides (see the documents identified in the docket by 
document ID numbers EPA-HQ-OPP-2008-0110-0032, -0033, -0034, -0035, and 
-0036). In 1997, the SAP also noted its concern about the possible 
effects of antimicrobials on WWTPs. Partially in response to the SAP 
comments, EPA proposed a tiered set of environmental fate data 
requirements that will allow the Agency to better characterize 
potential incidences of antimicrobials in surface waters, as a result 
of down-the-drain uses of antimicrobials.
    When the Agency prepared to propose 40 CFR part 158, subpart W, EPA 
requested that the SAP waive its review of the about-to-be-proposed 
part 158, subpart W because there were no new scientific issues. The 
SAP waived its review of the about-to-be proposed part 158, subpart W 
on February 19, 2008. The Agency continues to believe that there are no 
new scientific issues that warrant additional review by the SAP. EPA's 
request for a SAP waiver for the final antimicrobial data requirements 
rule is discussed in Unit XXIV. FIFRA section 25 requires EPA to give 
the SAP at least 60 days to review proposed regulations and 30 days to 
review final regulations. However, the SAP can determine to waive its 
review during the statutory time periods.

B. Risk Assessments for Wood Preservatives

    1. Comment. A commenter noted that Canada's PMRA and USEPA conduct 
risk assessment for wood preservatives differently. EPA's risk 
assessment is based on the treated wood when used at the final use 
site, while the PMRA's risk assessment is based at the site where the 
wood is treated. The PMRA also does not distinguish between 
terrestrial-only or aquatic-only use for anti-sapstains and heavy-duty 
wood preservatives.
    2. EPA's response. The Agency acknowledges differences between its 
risk assessment of wood preservatives and that of Canada's PMRA. As 
previously discussed in Unit VI.A. and B., EPA has reevaluated its 
approach for determining the data required for a wood preservative 
product. As part of the reevaluation, EPA considered the human and 
ecological risks based on exposure pathways identified in OECD's ESD 
for Wood Preservatives. This ESD identifies potential human and 
ecological exposures from both treatment of wood at processing 
facilities and in-service uses on land and in water. The Agency 
determined that all treated wood should be considered as having the 
potential to come into contact with surface water. This determination 
reflects EPA's concern about the potential for the indirect release to 
surface waters of wood preservatives. As a result, EPA is changing its 
approach to requiring environmental and ecological effects studies for 
wood preservatives. All wood preservative risk assessments will now be 
performed considering that the treated wood could end-up either on the 
land or in the aquatic environment, thus increasing harmonization 
between PMRA and EPA with regard to wood preservatives.

C. Clarity on How and When CR Data is Required

    1. Comment. A commenter asked EPA to specify criteria to determine 
whether a data requirement is ``R'' (Required) or ``CR'' (Conditionally 
Required). According to the commenter, the discussion of ``R'' and 
``CR'' suggests that a data requirement labeled ``CR'' may not be 
required to be addressed by the applicant. A second commenter stated 
that it is unclear how and when conditionally required data are 
triggered. Another commenter asserted that data requirements should be 
waived only under extraordinary circumstances, and that the use of 
waivers can effectively preclude appropriate regulation of the 
pesticide under FIFRA.
    2. EPA's response. In its proposed data requirement tables, EPA 
specified whether a data requirement is ``Required'', ``Conditionally 
Required'', or ``Not Required'' based on how likely the study is needed 
to complete an assessment of an antimicrobial pesticide. As a rule of 
thumb, a ``Required'' study is likely to be needed 50 percent of the 
time or more and a ``Conditionally Required'' study is likely to be 
needed less than 50 percent of the time. Typically, a ``Conditionally 
Required'' study is triggered based on the results of a study that has 
already been conducted. Triggers in the test notes indicate the 
circumstances under

[[Page 26950]]

which the Agency has learned through experience that the information is 
needed. In many instances, the applicant would be able to make the 
determination that the trigger has been met and should include the data 
in their original submission. In other cases, EPA will make the 
determination based on its review of submitted data and would then 
request additional data from the applicant. EPA encourages applicants 
to consult with the Agency to determine the actual need for the data.
    All data requirements must be addressed by the applicant by either 
conducting the study or submitting information that could fulfill the 
data requirement, such as citing open literature or other data sources, 
or by requesting and receiving a data waiver. EPA grants data waiver 
requests only on a case-by-case basis and only when the available 
evidence indicates a particular study is not needed or that there are 
particular reasons for not conducting the study. For example, if the 
physical/chemical properties of the chemical did not lend themselves to 
the testing procedure, such as performing an inhalation study with a 
chemical that is a solid and has an extremely low vapor pressure, then 
a waiver might be granted. EPA also grants waivers in exceptional 
circumstances, for instance, if a test substance is so corrosive that 
animal studies would cause undue pain and suffering.

VIII. Product Chemistry

    The following represent the significant comments received on the 
need for and evaluation of product chemistry studies as proposed by 
EPA. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Application of Subpart D Product Chemistry Data Requirements to 
Antimicrobials

    1. Comment. A commenter requested that EPA provide adequate 
justification for applying the existing product chemistry data 
requirements for conventional pesticides to antimicrobials without 
consideration of the highly dissimilar chemistries and inapplicability 
of many of the requirements.
    2. EPA's response. It has been EPA's longstanding practice to 
require product chemistry data. Product chemistry data are required to 
identify the chemicals used to manufacture a product and to understand 
the physical and chemical properties of the ingredient or product. Such 
information is generally independent of the intended use pattern. 
Product chemistry data are used during label development to identify 
information to be included on the label, such as the flammability 
statement, and directions for disposal of the product. Hence, despite 
any differences between conventional and antimicrobial pesticides, the 
Agency believes it is appropriate to apply the same product chemistry 
data requirements to antimicrobials as required for conventional 
pesticides. The guidelines for conducting product chemistry studies 
offer flexibility to account for differences between chemical classes.

B. Lack of Adequate Opportunity for Review of Product Chemistry Data 
Requirements

    1. Comment. One commenter asserted that registrants of 
antimicrobial pesticides were not given the opportunity to review and 
comment on conventional pesticide data requirements that are now being 
proposed for antimicrobial pesticides.
    2. EPA's response. In the preamble to proposed part 158, subpart W, 
EPA proposed to apply the product chemistry data requirements for 
conventionals in 40 CFR part 158 subpart D to antimicrobial pesticides. 
Therefore, during the public comment period for proposed part 158, 
subpart W, from October 8, 2008, to April 6, 2009, any interested party 
could have commented on the product chemistry data requirements in 
subpart D (which have been in place since October 2007) and their 
potential applicability to antimicrobials.

IX. Product Performance Data Requirements

    The following represent the significant comments received on the 
need for and evaluation of product performance studies as proposed by 
EPA. Changes from the proposed rule to the final rule are also 
described. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Product Performance Guidelines

    1. Comment. Several commenters shared their belief that EPA was 
seeking to avoid comment on the product performance data requirements 
in the proposed rule by stating that the Agency ``is not proposing to 
revise product performance data requirements'' at this time. Another 
commenter asked how the product performance section of the proposed 
rule could be finalized without the 810 guidelines?
    2. EPA's response. The proposed product performance data 
requirements table referenced the older 91 series guidelines. As stated 
in the proposed rule, the requirements being proposed were ``nearly 
identical'' to the existing data requirements in Sec.  158.400 and 
161.640, and the table was ``transferred essentially unchanged'' (73 FR 
59391). Since the 2008 proposed rule, EPA published four of the 810 
series guidelines (810.2000, 810.2100, 810.2200, and 810.2300 for 
sterilants, disinfectants and sanitizers) for comment in the Federal 
Register of January 27, 2010 (75 FR 4380) (FRL-8437-2), indicating that 
these guidelines would be incorporated into the final rule for 
antimicrobial data requirements. Three additional product performance 
guidelines (810.2400, 810.2500, and 810.2600) were published for public 
comment on September 15, 2011 (76 FR 57031) (FRL-8879-1). Thus, in 
addition to commenting on the draft guidelines themselves, commenters 
had an opportunity to comment on the inclusion of the 810 series in the 
Product Performance Data Requirements table.
    The availability of the final guidelines for sterilants, 
disinfectants and sanitizers (810.2000, 810.2100, 810.2200, and 
810.2300) was announced in the Federal Register of March 16, 2012 (77 
FR 15750) (FRL-9332-4), and for the three additional product 
performance guidelines (810.2400, 810.2500, and 810.2600) in the 
Federal Register of June 27, 2012 (77 FR 38280) (FRL-9349-5).
    In this final rule, EPA is replacing the 91 series designations 
proposed in the part 158, subpart W product performance table with the 
appropriate 810 series guideline numbers and names. The 810 series 
guidelines represent the Agency's current recommendations for 
conducting product performance studies to support antimicrobial 
pesticide label claims. See Unit XVIII for a discussion on guidelines.

B. Emerging Pathogens

    1. Comment. A commenter asked why there is no formal regulatory 
practice for registering products to address public health emergencies 
or emerging pathogens promptly and effectively?
    2. EPA's response. EPA does not believe that the promulgation of a 
rule dealing with data requirements is the appropriate place to address 
emerging pathogens. A major consideration in the Agency's process for 
addressing public health emergencies and emerging pathogens is to work 
closely with the Centers for Disease Control and Prevention (CDC), 
USDA, and FDA, as appropriate, to provide a timely and accurate 
response to these situations.

[[Page 26951]]

Under FIFRA section 18, the Agency also has authority to grant certain 
exemptions from the provisions of FIFRA and also to approve the use of 
unregistered pesticides when emergency conditions exist. Additionally, 
in April 2008, the Agency implemented a disinfection hierarchy policy 
for addressing emerging viral pathogens. Information on this policy is 
available on the EPA Web site at http://www.epa.gov/oppad001/disinfection_hier.htm. EPA believes that emerging pathogens require 
flexibility and speed in disseminating information and seeks to address 
such situations in a prompt and effective manner.

C. Definitions of Sanitizer and Disinfectant

    1. Comment. Several commenters claimed that the proposed 
definitions do not reflect the work done by the regulated community in 
cooperation with EPA since 1999. In particular, these commenters did 
not agree with the proposed definitions of sanitizer and disinfectant.
    2. EPA's response. Since the publication of the proposed rule, the 
definitions, including those for sanitizer and disinfectant, were 
published in the Federal Register for public comment on January 27, 
2010, as part of requesting comment on draft guideline 810.2000. After 
further review of the comments submitted on the proposed definition for 
disinfectant and sanitizer, the Agency has revised the definitions that 
had been proposed for both part 158, subpart W and the 810 Guidelines. 
EPA believes that the definitions being codified in part 158, subpart W 
reflect the input received from the regulated community in multiple 
submissions.
    The definition for disinfectant is being revised from, 
``Disinfectant means a substance, or mixture of substances that 
destroys or eliminates a specific species of infectious or public 
health microorganism, but not necessarily bacterial spores, in the 
inanimate environment'' to read, ``Disinfectant means a substance, or 
mixture of substances, that destroys or irreversibly inactivates 
bacteria, fungi and viruses, but not necessarily bacterial spores, in 
the inanimate environment.''
    The definition for sanitizer is being revised from, ``Sanitizer 
means a substance, or mixture of substances that reduces the bacterial 
population in the inanimate environment by significant numbers, but 
does not destroy or eliminate all bacteria or other microorganisms'' to 
read, ``Sanitizer means a substance, or mixture of substances that 
reduces the bacterial population in the inanimate environment by 
significant numbers, but does not destroy or eliminate all bacteria. 
Sanitizers meeting Public Health Ordinances are generally used on food 
contact surfaces and are termed sanitizing rinses.'' A 3 
log10 reduction is the minimum log reduction needed to make 
a non-food contact surface sanitizing label claim, and is considered a 
significant reduction.
    The definitions for fungicide, sterilant, tuberculocide and 
virucide are being revised to include the following phrase: ``or 
mixture of substances.'' Inclusion of this phrase in all of the 
definitions in Sec.  158.2203 for types of products that bear public 
health claims (excepting microbiological water purifier) means 
consistency in the definitions and an acknowledgement that the 
destroying, reducing, or inactivating may be accomplished via more than 
a single substance. Also, this makes these definitions similar to the 
FIFRA section 2(u) definition of pesticide which also contains the 
phrase ``or mixture of substances.''
    Additionally, the definition for virucide is being revised to 
include the word irreversibly, as follows: ``Virucide means a 
substance, or mixture of substances, that destroys or irreversibly 
inactivates viruses in the inanimate environment,'' thus reading 
similar to the definition for tuberculocide. Additionally, the 
definition for sterilant will be revised to remove the second sentence 
of the proposed definition: ``For purposes of this subpart, `sporicide' 
and `sterilant' are synonymous.'' EPA no longer requires that products 
that make sporicidal claims also make sterilant claims.

D. Nonpublic Health Data and Claims

    1. Comment. A commenter asked that the issue of when to generate 
efficacy data for nonpublic health products be discussed, since 
registrants are required to develop data to substantiate label claims. 
2. EPA's response. The Agency believes this issue has been addressed in 
Sec.  158.2220 ``Product Performance,'' which clearly states, ``Each 
applicant must ensure through testing that his product is efficacious 
when used in accordance with label directions and commonly accepted 
pest control practices.'' However, to clarify the issue further, the 
Agency is adding a definition for nonpublic health claims that will 
appear as 40 CFR 158.2204(b). Additionally, EPA is revising 40 CFR 
158.2220(a)(3) to describe that products bearing a nonpublic health 
claim are to be supported by product performance data.
    Also, EPA has posted on the Antimicrobials Division Web site the 
parts of the 91 Guideline series that apply to testing of nonpublic 
health products. Although these guidelines are from 1982, they are 
still relied on to develop data to support label claims for nonpublic 
health products. EPA acknowledges that some of the references in the 
1982 guidelines are to the older 91 series guidelines, which is being 
replaced by the 810 series guidelines. To assist readers, EPA has also 
posted a cross-walk table so readers can locate the applicable section 
of the 810 Guidelines. For information, see http://www.epa.gov/oppad001/non-public-health.html.

X. Toxicology Data Requirements

    The following represent the significant comments received on the 
need for and evaluation of toxicology studies as proposed by EPA. 
Changes from the proposed rule to the final rule are also described. A 
more detailed discussion can be found in the Response to Comments 
Document available in the docket to this rule.

A. Threshold of Toxicological Concern Approach

    1. Comment. There should be a threshold of toxicological concern 
(TTC) type of approach for antimicrobials.
    2. EPA's response. OPP's Antimicrobials Division is aware of the 
TTC concept. ILSI is currently pursuing the development of an 
application of the TTC concept to evaluate antimicrobial pesticides. 
Development and peer review of a TTC approach for antimicrobials is 
expected to occur over the next 1 to 2 years. Based on expert peer 
review and public comment, the Agency will make decisions regarding 
implementation.

B. Test Note to Neurotoxicity Studies

    1. Comment. A commenter stated that proposed test note 6 to the 
proposed toxicology table in Sec.  158.2230 triggering the 
neurotoxicity studies is contradictory and unclear. The commenter asked 
how the absence of a neurotoxicity screen in the 90-day oral rodent 
study would impact proposed test note 6?
    2. EPA's response. Proposed test note 6 specifies that if the 
neurotoxicity screen that occurs in the 90-day oral rodent study or any 
other data demonstrate neurotoxic effects, then both the acute 
neurotoxicity study and the 90-day neurotoxicity study are triggered. 
For certain use patterns with the potential for larger exposures (most 
notably food exposures), all three of these studies are initially 
required. According to proposed test note 8 to the proposed toxicology 
table in Sec.  158.2230,

[[Page 26952]]

the applicant may combine the 90-day oral toxicity study and the 90-day 
neurotoxicity study by adding a separate group of test animals.
    However, for some use patterns, the 90-day oral study is required, 
and the other two studies are conditionally required, being triggered 
by proposed test note 6. EPA acknowledges that when only the 90-day 
oral study is required, an applicant is at a disadvantage in terms of 
any chance for combining the 90-day neurotoxicity study with the oral 
study: Once the 90-day oral study with its neurotoxicity screen has 
been performed, and neurotoxic effects are identified, then it is not 
possible to add a separate group of test animals to the already 
conducted study.
    As a point of clarification, EPA is adding a new test note to the 
final toxicology table in Sec.  158.2230(g) to clarify that the 
neurotoxicity screen that is part of the 90-day oral study is not 
equivalent to a 90-day neurotoxicity study. If the 90-day oral toxicity 
study does not have a neurotoxicity screen, then the acute 
neurotoxicity study in the rat would be required. The new test note 
also includes: ``if the 90-day oral rodent study does not include a 
neurotoxicity screen, then the acute neurotoxicity study will be 
required.'' As part of renumbering, this new test note is now test note 
11 to the toxicology table in Sec.  158.2230(g) in this final rule.

C. End-Product Use-Dilution Toxicity Testing

    1. Comment. Several commenters stated their belief that acute end 
product use-dilution toxicity testing should be optional and requested 
greater clarification on when to test a diluted product. The commenters 
asked whether extrapolation from the active ingredient or as-sold acute 
toxicity testing is acceptable? Another commenter claimed that 
requiring end-product six-pack testing of one or more dilutions is 
duplicative.
    2. EPA's response. Proposed test note 2 to the proposed toxicology 
table in Sec.  158.2230, specifies how to conduct acute toxicity 
testing for end-use products (EP). EP testing is conducted on the 
product as formulated for sale and distribution. From the EP acute 
toxicity studies, EPA derives toxicity categories which are then used 
to determine the precautionary labeling statements on the product. 
However, it is common for some products to be diluted before being 
used. The use-dilution testing is in addition to the as-formulated-for-
sale testing since there are exposures to both. Acute toxicity testing 
on the product that has been diluted-for-use supplies the information 
needed to derive precautionary statements for the user of the product. 
EPA is revising proposed test note 2 to make this clearer.

D. The Phrasing ``Limited Portion of the Human Lifespan''

    1. Comment. Several commenters asked EPA to identify the criteria 
to determine ``repeated human exposure over a limited portion of the 
human life span.'' They asked EPA to specifically describe what the 
phrase ``human exposure is not purposeful'' means?
    2. EPA's response. Proposed test note 11 to the proposed toxicology 
table in Sec.  158.2230, specifies the triggers that would require the 
performance of a 90-day oral study in the non-rodent. EPA has 
reevaluated this test note and decided not to codify test note 11, as 
proposed, Proposed test note 11, subparagraph i. contained the phrase 
``repeated human exposure over a limited portion of the human life 
span.'' EPA agrees that this phrase is not useful. Proposed test note 
11, subparagraph ii. contained a trigger for any indirect food use that 
would have been considered to be a ``low exposure.'' Given the 
restructuring of the final toxicity data requirements table, i.e., the 
shift away from using high and low exposure as the table headers to a 
food/nonfood approach, test notes 11, subparagraphs i. and ii. are no 
longer needed. In the final toxicity table in Sec.  158.2230(g), the 
data required for an indirect food-use is specified directly (in the 
table header) and a trigger is not needed.
    Test note 12 to the proposed toxicology table in Sec.  158.2230, 
specifies three triggers that would require the performance of a 21/28-
day dermal study. EPA has also reevaluated proposed test note 12 and 
agrees that the phrases ``repeated human exposure over a limited 
portion of the human life span'' and ``human exposure is not 
purposeful'' are not useful. Accordingly, EPA has revised the 21/28 day 
dermal study trigger. The 21/28 day dermal study is now triggered if 
all of the following criteria are met:
    i. The intended use of the antimicrobial pesticide product is 
expected to result in repeated dermal human exposure to the product;
    ii. Data from a 90-day dermal toxicity study are not available;
    iii. The 90-day dermal toxicity study has not been triggered (the 
third proposed trigger).

E. Mouse Carcinogenicity Study

    1. Comment. According to several commenters, the mouse 
carcinogenicity study does not provide useful information, and is, in 
fact, not suited for determining/extrapolating human carcinogenicity. 
They contended that EPA should no longer require the mouse 
carcinogenicity study. This would also mean that there is no need for 
the mouse range-finding study.
    2. EPA's response. The issue regarding the usefulness of the mouse 
for carcinogenicity testing is one that is currently under debate by 
the OPP. Currently, carcinogenicity testing, whether for conventional 
pesticides under Sec.  158.500 or for antimicrobials under part 158, 
subpart W requires testing in two rodent species. However, OPP is 
currently conducting a comprehensive analysis of its rodent chronic 
bioassay database to document the utility of the mouse bioassay for 
both cancer risk assessment and Reference Dose (RfD) derivation for 
non-cancer endpoints. When this analysis is completed, a recommendation 
will be made regarding the testing needed for cancer hazard 
identification. Once OPP's internal review process is complete, then it 
is likely that EPA would solicit review and comment by the FIFRA SAP. 
If at a later date, the determination is made to alter the 
carcinogenicity data requirements, then appropriate changes would be 
proposed to be made to data requirements and regulations pertaining to 
conventionals, biochemicals and microbials, and antimicrobials through 
rulemaking.

F. Ames Assay

    1. Comment. A commenter argued that the Ames assay should not be 
required, because it is inappropriate for antimicrobials that kill 
bacteria.
    2. EPA's response. It is recognized that the Ames assay may not be 
useful for assessment of mutagenic potential of antimicrobial 
pesticides, as this test uses strains of bacteria as the primary test 
material, and antimicrobials are designed to kill, among other things, 
bacteria. So, the bacteria may be killed before mutagenic effects are 
demonstrated. However, for some antimicrobial pesticides, the Ames 
assay has already been conducted and if the Ames assay was conducted at 
levels that do not cause toxicity to the bacterial strains tested, then 
the study may be acceptable to fulfill the reverse mutation assay 
requirement. However, if an Ames assay has not yet been conducted for a 
particular antimicrobial, then, the Ames assay should not be conducted. 
In this final rule, test note 32 for the reverse

[[Page 26953]]

mutation assay requirement in the final toxicology table in Sec.  
158.2230(g), is revised to allow reliance on previously-conducted Ames 
tests when the bacteria strain was not killed, but to state a 
preference for assays such as an in vitro mammalian cell assay, (e.g., 
the mouse lymphoma TK +/- assay).

G. Dermal Absorption Studies

    1. Comment. A commenter argued that EPA should accept in vitro skin 
penetration data. According to the commenter, accepting such data would 
harmonize with requirements in the European Union (EU) and elsewhere. 
The commenter pointed to well-established OECD guidelines for these 
studies. The commenter also asserted that proposed test note 37 to the 
proposed toxicology table in Sec.  158.2230, addressing the requirement 
for a dermal absorption study, should not apply to corrosive/irritant 
products.
    2. EPA's response. The Agency has, on a case-by-case basis, used in 
vitro dermal absorption studies to determine the magnitude of dermal 
absorption of pesticide chemicals. However, the Agency has not adopted 
an official policy of using only in vitro data to support these 
decisions. OECD guideline 428, while describing an in vitro method for 
dermal absorption, does not rule out the use of in vivo data along with 
in vitro data to determine dermal absorption. Further, the test 
guideline notes that formal validation studies of the in vitro method 
have not been performed.
    The Agency is working on developing a more formal policy that would 
use both in vivo and in vitro dermal penetration data in a weight-of-
evidence (WOE) determination in appropriate cases. The Agency would 
always consider QSAR or other models, submitted in support of the 
determination of dermal absorption. The decision to accept such 
information is the Agency's, based on its review and evaluation of the 
submission.
    Test note 37 to the proposed toxicology table in Sec.  158.2230, 
specifies that the trigger for requiring a dermal penetration study are 
the results from a risk assessment ``assuming that dermal absorption is 
equal to oral absorption.'' This means that EPA assumes 100 percent 
dermal absorption. If a subchronic dermal study and/or dermal 
absorption data are not available, then a risk assessment could be 
conducted using the default assumption of equivalent absorption by the 
dermal and oral routes of exposure. If unacceptable risks are found, 
then either the subchronic dermal study or a dermal absorption study 
would be required. EPA recognizes that the assumption of 100 percent 
dermal absorption is conservative; however, this assumption would only 
be used in the absence of an acceptable dermal subchronic study or 
dermal absorption data. In this final rule, test note 37 to the 
toxicology table in Sec.  158.2230(g), is revised to clarify this 
process. EPA also agrees that corrosive/irritant products should not be 
tested in dermal absorption studies. Therefore, test note 3 to the 
toxicology table in Sec.  158.2230(g), which specifies that testing is 
not needed for corrosive materials, is added as a trigger for not 
requiring the dermal absorption study.

H. Tiering

    1. Comment. One commenter argued that EPA has not provided 
meaningful tiering for its toxicology requirements for antimicrobials. 
Another commenter claimed that exposure alone is not an appropriate 
criterion to use for a tiered testing scheme, that both exposure and 
risk should be considered. A third commenter asserted that the high and 
low human exposure categories for toxicity are not appropriate and 
suggested that a tiered scheme such as that used for environmental fate 
data requirements would be more appropriate.
    2. EPA's response. In its proposed rule EPA proposed a tiered 
testing scheme for toxicology testing that was based on the amount of 
exposure as defined by use patterns. Based on its experience in 
conducting risk assessments, EPA understands which use patterns have 
exposures of higher duration and magnitude, and therefore could have 
greater risks. Use patterns with higher exposures require submission of 
more data than use patterns with lower exposures.

I. Guideline Numbers in the Code of Federal Regulations

    1. Comment. A commenter stated that the final rule should not 
specify a guideline number. Instead, the data requirement tables should 
describe the endpoint in question, and the information needed for EPA's 
risk assessment. OPP could develop guidance that could be placed on the 
web.
    2. EPA's response. The guideline number column could be removed 
from the table. Instead, EPA could have an internet page that describes 
multiple methods of fulfilling the data requirements. An internet table 
could be updated faster to reflect newer techniques than rulemaking to 
revise a regulation in the CFR. However, there is also value in having 
the guideline number in the CFR, which then shows the available 
guidelines relevant to the particular study that should be considered 
in addressing the requirement. EPA has made no decision on whether or 
not to initiate a rulemaking to remove all the guideline numbers from 
the data requirement tables in 40 CFR part 158. The tables finalized in 
subpart W in this rule include guideline numbers.

J. Animal Testing

    1. Comment. A commenter requested that EPA specifically state in 
its regulations that non-animal methods are acceptable for fulfilling a 
data requirement. The commenter argued that the Draize study (the acute 
eye irritation study) in rabbits should be eliminated.
    2. EPA's response. Non-animal test methods are continually being 
examined for use in fulfilling the toxicology data requirements that 
are used to assess the hazard of pesticide chemicals. However, in order 
for non-animal approaches to be used for fulfilling toxicology data 
requirements, these approaches must first be scientifically validated 
to ensure that they are as good as the existing test method for 
predicting hazard and also assessed to determine whether they meet the 
Agency's ``3 R'' goals of reduce, refine, and replace the use of 
animals in testing. With respect to antimicrobial pesticides, the 
Agency has started to explore such approaches. One example of this is 
the voluntary pilot program for eye irritation testing of antimicrobial 
pesticides using non-animal test methods, found at http://www.epa.gov/oppad001/eye-irritation.pdf.

K. Derivation of 200 Parts per Billion Criterion

    1. Comment. A commenter asked whether the 200 parts per billion 
(ppb) level used as the dividing line between high and low human 
exposures is the concentration of a substance in an adult's daily food 
consumption?
    2. EPA's response. The derivation of the 200 ppb level was 
previously established by FDA for indirect food use biocides 
(identified in the docket by document ID number EPA-HQ-OPP-2008-0110-
0010). FDA derived the 200 ppb level by dividing the cumulative 
exposure upper limit of 1,000 ppb for food contact substances by 5 to 
account for the fact that antimicrobial pesticides (e.g., biocides) are 
a class of pesticide that are generally toxic by design. The 200 ppb 
level is the concentration of the antimicrobial residues in or on the 
food item. EPA is using 200 ppb as a delineation consistent with the 
FDA's

[[Page 26954]]

toxicology recommendations for food contact substances. Therefore, 
those indirect food uses that have residues that are less than or equal 
to 200 ppb in or on the food item usually have fewer data requirements 
than those that have residues that are greater than 200 ppb in or on 
the food item. For clarity, information concerning the 200 ppb level 
and its derivation from FDA levels has been added to Sec.  158.2230(d).

L. Use of OECD Guidelines for EPA Registrations

    1. Comment. A commenter asked EPA to consider incorporating the 
following OECD guidelines into the new part 158, subpart W to reduce 
the number of animals killed in LD50 tests: OECD guidelines 
436; Acute Inhalation Toxicity--Acute Toxic Class Method, and revised 
223; Avian Acute Oral Toxicity Test, and Short Guidance on the 
Threshold Approach for Acute Fish Toxicity.
    2. EPA's response. OPP does not have a policy for use of OECD 436 
for acute inhalation toxicity. If a study conducted according to OECD 
436 were submitted for the purpose of assessing acute inhalation 
toxicity, EPA would review and accept the results if the study were 
conducted in an acceptable manner and provided sufficient information 
to fulfill the data requirement. Similarly, if a study conducted 
according to OECD 223 or the Threshold Approach, were submitted, then 
EPA would review the study and then make a determination on whether the 
study was conducted in an acceptable manner and provided sufficient 
information to fulfill the data requirement.

M. Alternative Formats for Toxicology Data Requirements Table

    1. Comment. In the comments submitted to EPA, the commenters 
suggested two alternative toxicity data requirement approaches for EPA 
to consider. Alternative approach 1 was organized in paragraphs and 
alternative approach 2 was in a table format similar to that proposed 
by EPA.
    2. EPA's response. The commenters provided two alternative 
approaches for toxicology data requirements for antimicrobials. As 
stated by the commenter, alternative approach 1 was ``intended to 
provide clearer instructions to registrants,'' attempted ``to fully 
incorporate the new science'' of integrative approaches to testing, and 
included ``a threshold concept for toxicological concerns.'' (ACC 
Comment, identified in the docket by document ID number EPA-HQ-OPP-
2008-0110-0088.6; Appendix E, entitled ``Comments on Proposed Data 
Requirements for Toxicology'' p. 24). The commenter did not provide to 
EPA the same or similar table-type of format used for part 158 data 
requirements. There were no test notes to define the triggers for 
moving from tier to tier. The commenter acknowledged that their 
suggested alternative approach 1 would require ``expert scientific 
judgment'' (p. 25), and also discussed that EPA in the proposed rule 
(73 FR 59423) had indicated the need to develop scientific position 
papers, and recommendations for internal and external review of 
integrative approaches. EPA considers alternative approach 1 to be a 
dramatic departure from EPA's proposal, and agrees with the commenter 
that certain scientific issues may not be ready for codification. EPA 
does not believe, at this time, that this approach meets the needs of 
the Agency, or has any advantages over the table format. EPA found the 
paragraph explanations unclear. As acknowledged by the commenter, the 
paragraph format would result in a more complex decision tree that 
would require a significantly greater amount of interpretation and 
consultation when compared to the existing table formats. There would 
be a significant learning curve for both EPA and those members of the 
public that have become accustomed to data requirement tables such as 
in part 158. Within this response, EPA has responded to alternative 
approach 1 in totality. EPA notes that the individual scientific issues 
raised within the paragraphs are addressed separately, as they were 
separated into the various disciplinary areas of the toxicology 
comments.
    EPA has also evaluated alternative approach 2. This alternative 
approach is in a table-type of format with a strict split between food 
and nonfood uses. The test notes developed by the commenters are 
extremely detailed and contain information that EPA believes is more 
appropriate in guidance. However EPA has used the suggested test notes 
to revise the test notes in this final rule as appropriate. For 
example, the commenters' suggested test note 32 to the in vivo 
cytogenetics study is clearer than EPA's proposed test note 34. 
Therefore EPA is revising test note 34 to the final toxicology table in 
Sec.  158.2230(g), accordingly.
    As discussed previously, as a result of comments received, EPA is 
no longer using the terms ``high human exposure'' and ``low human 
exposure'' as proposed for the antimicrobial toxicology data 
requirements table. Instead, in the final rule, EPA is now using a 
food/nonfood approach with some similarities to that of the toxicology 
data requirements table for conventional pesticides to distinguish the 
use patterns with higher exposure that need more toxicity data from 
those that need less. Accordingly, the table headers for the toxicology 
data requirements table in the final rule are: ``Direct Food Uses;'' 
``Indirect Food Uses (>200 ppb);'' ``Indirect Food Uses (<=200 ppb);'' 
``Swimming Pools, Aquatic Areas, Wood Preservatives, Metal Working 
Fluids;'' and ``All Other Nonfood Uses.''
    Unlike conventional pesticide chemicals, a strict food/nonfood use 
``split'' for delineating data requirements is not appropriate for 
antimicrobial chemicals. Such an approach does not fully address the 
unique use patterns for antimicrobials, most specifically, those 
involving indirect food uses. As a result of comments received, EPA 
decided to employ a modification of the food/nonfood approach to 
delineate the specific data requirement needs for antimicrobial 
pesticides.
    The commenter has also asked that EPA include within subpart W a 
new Sec.  158.2235 which would be analogous to 40 CFR 158.510 for 
conventional chemicals (Tiered Testing Options for Nonfood Use 
Pesticides). EPA does not believe this is needed for antimicrobials. 
Once it has been determined that the use is nonfood, then certain of 
the nonfood use scenarios require the submission of more data, and 
certain require the submission of less data. As specified in the column 
headings for Nonfood Uses, swimming pools, aquatic areas, wood 
preservatives, and metal working fluids require a particular set of 
data. All other nonfood uses require less data. Thus, the tiering is 
already built into the approach used for antimicrobials.

XI. Nontarget Organism Data Requirements

    The following represent the significant comments received on the 
need for and evaluation of nontarget organism studies as proposed by 
EPA. Changes from the proposed rule to the final rule are also 
described. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Need for Ecotoxicity Data for Indoor Uses

    1. Comment. Several commenters argued that there are few 
antimicrobial use patterns where ecological effects information would 
be relevant to an assessment under FIFRA because there is no 
expectation of environmental exposure.

[[Page 26955]]

    2. EPA's response. As explained in the proposed rule, there is now 
a greater concern regarding indoor uses of antimicrobials because those 
uses can lead to environmental exposure when they go down the drain. 
The Agency and the scientific community have become concerned with 
pharmaceuticals and personal care products (PPCPs), which are now 
recognized as environmental contaminants. A subset of these PPCPs 
includes antimicrobial pesticide products, some of which are being 
detected in various environmental compartments/media [e.g., surface 
water and WWTP biosolids]. As discussed in the proposed rule (73 FR 
59407), these findings are notable, because many of the antimicrobial 
pesticides detected are registered for only indoor use patterns.
    There are many uses for which a high potential for environmental 
exposure exists, especially outdoor uses such as wood preservatives, 
ballast water treatments, antifoulant paints and coatings, aquatic 
areas, and others. These uses may require a more extensive data set 
that could include acute and chronic tests in both freshwater and 
saltwater, and possibly in the sediment as well as the water column. If 
the effluent from a WWTP is likely to contain an antimicrobial 
pesticide, or if the antimicrobial is likely to partition to the sludge 
that is derived during the treatment process, then indoor uses could 
require additional testing to further characterize the hazard and the 
risk.

B. Transformation Products

    1. Comment. Several commenters questioned, how a registrant would 
determine if ``transformation products'' would need to be tested. With 
regard to the criteria for when testing is required on transformation 
products, another commenter stated the belief that any data developed 
to assess the potential risk to nontarget organisms should be developed 
with the appropriate residue of concern (ROC) (i.e., degradation 
product, metabolite, or TGAI) rather than always testing with the TGAI. 
Still another commenter asked how would EPA determine that the 
transformation products are ``more toxic, persistent, bioaccumulative 
or have been shown to cause adverse effects in mammalian or aquatic 
reproductive studies.'' Finally, a commenter requested that EPA explain 
what is considered ``stable'' in the environment in proposed test note 
3 to the proposed nontarget organism table in Sec.  158.2240.
    2. EPA's response. The Agency evaluates the need for nontarget 
organism testing of transformation products on a case-by-case basis, 
using several sources of information, which includes, most importantly, 
environmental fate data. EPA proposed to require nontarget organism 
testing of transformation/degradation products or leachate residues in 
proposed Sec.  158.2240(a)(3) and (4). To respond to this comment, EPA 
also considered a similar comment on transformation/degradation 
products or leachate residues for environmental fate testing (see Unit 
XIV.B.). In response to these comments, EPA determined to clarify and 
revise the criteria for testing of transformation/degradation products 
and leachate residues for nontarget organisms in Sec.  158.2240(a)(3), 
for environmental fate in Sec.  158.2280(a)(2) and for nontarget plant 
protection in Sec.  158.2250(b).
    As explained in Unit XIV.B., environmental fate studies provide 
information on the stability and persistence of the active ingredient 
and degradation products in the various environmental media. If the 
environmental fate studies on the parent indicate the transformation/
degradation product(s) is, for example, more persistent in soils, then 
it is possible that nontarget plants or animals could be exposed to the 
degradate. Once the transformation products and the environmental 
compartment in which they occur are identified, then the available 
toxicology data (e.g., reproduction tests, developmental tests, non-
rodent chronic studies) are reviewed to determine toxicity.
    After reviewing all available information, then EPA would use these 
criteria to determine if ecological effects data on the transformation/
degradation products or leachate residues are required for either 
nontarget organisms or nontarget plants. EPA believes that nontarget 
plant protection data may sometimes be needed when the Agency begins 
conducting species-specific endangered species assessments for 
antimicrobial pesticides.
    EPA does not use the term ``residue of concern (ROC)'' in the final 
Nontarget Organisms Data Requirements Table. Instead, the appropriate 
test material(s), such as TGAI, degradate, or TEP, is specified in the 
data requirements table in Sec.  158.2240. This approach is also used 
for the conventional nontarget organism table in part 158. Generally, 
for ecological testing, the TGAI testing is performed first, and then 
additional testing on a transformation product may be required based on 
the process described previously. Depending on how fast a substance 
decays, a nontarget organism or plant could actually be exposed to a 
mixture of the parent and one or more degradation/transformation 
products.

C. Test Note 7 to the Nontarget Organism Table and Wood Preservatives

    1. Comment. Test note 7 to the proposed nontarget organism data 
requirements table in Sec.  158.2240 specifies the triggers for 
requiring typical end-use product (TEP) testing for the acute 
freshwater invertebrate study and acute freshwater fish study. A 
commenter asked whether, even though, the wood preservatives use 
pattern is specified as ``NR,'' could the TEP testing be required 
because of the triggers in test note 7.
    2. EPA's response. Proposed test note 7 also triggered the testing 
for the TEP acute estuarine and marine organisms toxicity testing. EPA 
agrees that the combination of ``R''s, ``CR''s, ``NR''s and the current 
structure of proposed test note 7, is confusing and that clarification 
is needed.
    The data requirements for TEP testing and proposed test note 7 were 
also considered in light of the Agency's determination based on 
comments received (see Unit VI.B.) on EPA's current practice of 
conducting risk assessments for wood preservatives based on land-only 
versus a land and aquatic predetermined use pattern. All wood 
preservative risk assessments will now be performed considering that 
the treated wood could end-up on both the land or in the aquatic 
environment. As previously discussed, there are multiple pathways for 
wood preservative degradates and/or leachates to reach surface water. 
EPA has also determined to conduct a down-the-drain assessment for all 
appropriate use patterns which would include wood preservatives, and 
antifoulant paints and coatings (see Unit XV.A.). For wood 
preservatives, these determinations mean that additional ecological 
testing is required to conduct an ecological risk assessment, and the 
following changes are made to the wood preservative testing column:
     Acute freshwater invertebrates toxicity (TEP testing): 
change from ``NR'' to ``CR'';
     Acute freshwater fish toxicity (TEP testing): change from 
``NR'' to ``CR'';
     Acute estuarine and marine organisms toxicity (TEP 
testing): change from ``NR'' to ``CR''.
    For antifoulant paints and coatings, the determination to conduct 
assessment also means that additional data could be needed for the 
down-the-drain assessment, and the following changes have been made to 
the antifoulant paints and coatings testing column:

[[Page 26956]]

     Acute freshwater invertebrates toxicity (TEP testing): 
change from ``NR'' to ``CR'';
     Acute freshwater fish toxicity (TEP testing): change from 
``NR'' to ``CR'';
     Acute estuarine and marine organisms toxicity (TEP 
testing): change from ``NR'' to ``CR''.
    EPA believes that simplifying the data requirements that reference 
test note 7 to the final nontarget organism table in Sec.  158.2240(c) 
so that these requirements are CR for all use patterns is clearer, and 
also closer to the suggestions made by the commenters in their 
suggested nontarget organism data requirements table. Their suggested 
table was predominantly ``CR'' for aquatic uses. Therefore, in this 
final rule, test note 7 triggers the ``CR'' studies.
    However, changing all the use patterns to ``CR'' for the TEP 
studies means changing the ``R'' proposed for the aquatic use, and 
industrial processes and water systems use patterns for the acute 
freshwater invertebrates toxicity study and the acute freshwater fish 
toxicity study, to ``CR.'' To account for this change proposed test 
note 7 to the proposed nontarget organism table in Sec.  158.2240 has 
been revised in the final rule to include an additional trigger (see 
Sec.  158.2240(d) test note 7.iv). Data are required when ``the end-use 
antimicrobial product will be applied directly into an aquatic 
environment.'' EPA believes that the implications of this trigger are 
equivalent to the ``R'' and essentially this is a non-change. These 
changes are summarized here for both the aquatic areas and industrial 
processes and water systems testing column:
     Acute freshwater invertebrates toxicity (TEP testing): 
change from ``R'' to ``CR'';
     Acute freshwater fish toxicity (TEP testing): change from 
``R'' to ``CR'';
     Acute estuarine and marine organisms toxicity (TEP 
testing): no change.
    Nontarget organism toxicity testing of the TEP should be 
infrequently required for the antifoulant paints and coatings use 
pattern because for this use pattern, the TEP could be the paint. 
Because the testing for aquatic organisms is done in water, the test 
material must be soluble in water, or made soluble by addition of an 
appropriate solvent, if one exists, or other appropriate mechanical 
methods. Paint is not soluble and there may not be a way to make it 
soluble. Since these studies are often run in glass aquaria, the paint 
could coat the sides of the glass and the test animals themselves. The 
paint could ruin test equipment by clogging lines and injection 
nozzles. Therefore EPA has added a new test note 5, which is replacing 
proposed test note 5 to the proposed nontarget organism in Sec.  
158.2240. New test note 5 to the final nontarget organism table in 
Sec.  158.2240(c) states that an applicant should request a waiver if 
the TEP cannot be tested.
    EPA also notes that a test note specifying the number of species to 
be tested was omitted in the proposed rule for the TEP testing for 
acute freshwater fish toxicity. This test note is needed for clarity. 
Test note 3 to the final nontarget organism table in Sec.  158.2240(c) 
has been added to the line for acute freshwater fish toxicity. Instead 
of ``greater than 1 ppm or 1 mg/L'' as indicated in the proposed rule, 
the toxicity trigger has been corrected to read ``less than or equal to 
1 ppm or 1 mg/L.'' If the LC50 is greater than 1 ppm this 
means that the chemical tested was moderately to practically non-toxic 
on an acute basis. If the LC50 is less than 1 ppm this means 
that the chemical tested was highly to very highly toxic on an acute 
basis and would have a serious adverse affect(s) on the organism tested 
at low concentrations. For clarity, in test note 3 to the nontarget 
organism table, EPA has specified the appropriate trigger (less than or 
equal to) to indicate that testing is needed for chemicals that 
demonstrate high to very high toxicity on an acute basis.

D. Acute and Chronic Toxicity Data

    1. Comment. A commenter argued that it is essential to have both 
acute and chronic toxicity test results for at least one freshwater 
invertebrate, vertebrate, and plant species, and at least one marine/
estuarine invertebrate, vertebrate, and plant species.
    2. EPA's response. EPA proposed to require acute tests for both a 
cold water and warm water freshwater fish, an invertebrate, and one or 
more aquatic plants. For marine/estuarine species, for most use 
patterns, EPA proposed to conditionally require acute testing with a 
fish and two aquatic invertebrate species, including a bivalve, when 
the Agency believes there is a potential for the active ingredient or a 
potentially toxic degradate to reach the estuarine/marine environment 
through transport (e.g., leaching, runoff) from the treatment site. In 
such a situation, chronic testing with one or more marine/estuarine 
species also may be required if the Agency believes that chronic 
exposure is likely. These studies also are required for those uses 
where the pesticide product is applied directly into the marine/
estuarine environment.
    As to chronic testing, EPA proposed to require the fish early life 
stage and the aquatic invertebrate life-cycle studies for the 
industrial processes and water systems (once-through), antifoulant 
coatings and paints, and aquatic areas use patterns. At that time, EPA 
also proposed to conditionally require the same two studies for the low 
environmental grouping (now called the all other use patterns category) 
and wood preservatives.
    However, based on this and other comments, EPA has reevaluated the 
nontarget organism data needed for a registration decision and 
concluded that additional acute and chronic data are needed. Plant 
species encompass many different life spans. Phytoplankton reproduce 
quickly and have extremely short life spans. Annuals live for 1 year. 
Many perennials do not actually live for multiple years, but reproduce 
from seeds year after year. The plant species that live the longest 
would be woody species, such as trees. EPA does not believe that 
antimicrobial use patterns impact terrestrial areas such that chronic 
exposures occur. To EPA's knowledge, no adverse chronic effects to 
terrestrial plants caused by pesticides have been documented on plants. 
Any effect on terrestrial plant species has been categorized as an 
acute effect and would be covered by current testing procedures. 
Chronic effects of aquatic plants are covered by the aquatic testing 
guidelines. Algae are used as the primary test species for evaluating 
effects to the aquatic plants. The testing is based on growth 
parameters and the tests normally run for periods of time that would 
include several generations of the algae. The results from these algal 
studies, while only conducted over a few days, would be similar to 
those obtained from chronic testing in other species, and would be used 
to assess any chronic effects to aquatic plant species.

E. Avian Studies

    1. Comment. In proposed test note 4 to the proposed nontarget 
organism table in Sec.  158.2240, which triggers the avian dietary 
study, EPA specified a trigger of 100 mg a.i./kg (milligrams active 
ingredient/kilogram) for additional testing. A commenter requested 
information on why this trigger was selected. The commenter also 
claimed that EPA could use exposure tools to conduct an initial 
assessment based on Tier I data, and then trigger additional testing 
based on risk.
    2. EPA's response. OPP has long used this value as an indication of 
toxicity to birds. As specified in 40 CFR 156.85(b)(3), any pesticide 
(including conventional pesticides) that is

[[Page 26957]]

intended for outdoor use with an avian acute oral LD50 of 
100 mg a.i./kg or less requires a precautionary label statement that 
the pesticide is toxic to birds. EPA believes that if 100 mg a.i./kg is 
appropriate to trigger a precautionary label statement, then it is also 
appropriate to use as a trigger for testing. Therefore, if the avian 
oral acute toxicity study indicates an oral LD50 of 100 mg 
a.i./kg or less, then an avian dietary study is required.
    In the proposed rule, for the avian dietary toxicity study, EPA 
proposed to require testing on two species for the aquatic areas and to 
conditionally require testing on one avian species for all of the other 
use patterns. The comments reviewed and evaluated by EPA on avian 
toxicity testing included the commenter's suggested data requirements 
table for nontarget organisms, which specified ``CR'' for all avian 
testing. EPA agrees with the commenter that ``CR'' is appropriate for 
the avian dietary toxicity and avian reproduction studies for all use 
patterns. This simplifies the test notes and with the appropriate 
triggers EPA would be able to require the needed testing.
    The following changes have been made to the aquatic areas column:
     Avian dietary toxicity: change from ``R'' to ``CR'';
     Avian reproduction: change from ``R'' to ``CR''.
    Test note 4 to the final nontarget organism table in Sec.  
158.2240(c) triggers the avian dietary toxicity study based on the 
results of the avian acute toxicity study. For the avian dietary study, 
testing in a second species would be triggered based on the results of 
the avian dietary testing in the first species. Since the second test 
species will be required, based on the results of the first species, 
proposed test note 5 is no longer needed and is being removed. Test 
note 6 to the final nontarget organism table in Sec.  158.2240(c) would 
trigger the avian reproductive study based on one or more of four 
specific criteria. There were no revisions to these criteria from the 
proposed rule to the final rule.

F. Water Quality Criterion

    1. Comment. A commenter argued that the registrants of any 
antimicrobial pesticide that has the potential to be discharged either 
directly or indirectly to surface water should be required to supply 
any additional data needed to derive a water quality criterion for the 
pesticide in question.
    2. EPA's response. As discussed in the conventionals' Response to 
Comments Document in docket EPA-HQ-OPP-2004-0387 (p. 104), the Agency's 
pesticide registration process, including its data requirement 
regulations, adequately considers the endpoints that are protected 
under the Clean Water Act (CWA) as administered by the Office of Water 
(OW). When acceptable data are available, OPP uses these data in its 
risk assessment process.
    The purpose of a water quality criterion under the CWA is to 
determine the level at which a water body may be at risk for 
environmental damage. The purpose of certain data requirements for 
pesticide registration is to allow the Agency to determine the 
ecological risk of using a pesticide. Thus, these program offices 
within EPA have similar goals. While EPA has developed guidelines for 
developing Water Quality Criteria (WQC), the Agency has also recognized 
that WQC can be developed with a more limited data set.
    Pesticide registration data are valuable in assessing water quality 
risks. As noted in EPA's 2005 Response to Comments Document on the 
conventional pesticides, EPA's OW and OPP together developed aquatic 
life benchmarks for 71 pesticides or pesticide degradation products for 
States to use to establish targets for safe levels of pesticides for 
aquatic plants and animals. The benchmarks are derived from data 
submitted to EPA for pesticide registration. As of April 18, 2011, 
there are 242 pesticide chemicals with aquatic benchmarks on EPA's Web 
site (http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm).

G. Sediment Testing

    1. Comment. The commenter asserted that EPA did not consider the 
environmental fate of a compound (such as the tendency of a chemical to 
absorb/desorb) when considering the need for sediment testing.
    2. EPA's response. EPA disagrees with this comment. Test notes 17 
and 18 to the final nontarget organism table in Sec.  158.2240(c) 
trigger the sediment studies based on the results of the aerobic soil 
or aquatic metabolism studies and knowledge of the physical/chemical 
properties which express the environmental fate of the antimicrobial 
pesticide chemical. The soil partition coefficient (Kd) is 
used as an expression of the binding capability of the chemical to 
sediments. The Agency's justification for using Kd [gteqt] 
50 as a criterion for requiring sediment testing is that this value 
would capture those chemicals with about 80 percent adsorption to 
sediments (relative to organic carbon).
    The octanol-water partition coefficient (Kow) and the 
soil organic carbon-water partition coefficient (Koc) also 
are used by EPA as part of its decision process. Both values are 
frequently more available than either the Kd or half-life 
values. Test note 17, the trigger for requiring an acute sediment 
study, considers all four of these values.
    Next, as explained in test note 18, the chronic sediment study is 
triggered based on the results of the acute sediment study as well as a 
reexamination of the Kow, Koc, and Kd.

XII. Nontarget Plant Protection Data Requirements

    The following represent the significant comments on the need for 
and evaluation of nontarget plant protection studies as proposed by 
EPA. The changes from the proposed rule to final rule are also 
described. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Triggers for Higher-Tiered Plant Studies

    1. Comment. One commenter asked EPA to explain the criteria used to 
trigger higher-tiered plant studies based on the results of the algal 
studies.
    2. EPA's response. The criteria to trigger higher-tiered plant 
studies are specified in test notes 2 and 5 to the proposed nontarget 
plant protection table in Sec.  158.2250. A toxicity level 
(EC50 < 1 ppm) indicates that the antimicrobial pesticide 
would have serious adverse affect(s) on algae at low concentrations. 
This could have serious consequences to nontarget algae species. 
Therefore, at this toxicity level, additional higher-tiered testing is 
required to further characterize the potential adverse affects to 
aquatic plants. EPA is retaining the toxicity trigger of <1 ppm in test 
note 5 to the final nontarget plant protection table in Sec.  158.2250.
    In evaluating test note 2 to the proposed nontarget plant 
protection table in Sec.  158.2250, EPA has considered the commenter's 
suggested table for nontarget plants. For the seedling emergence study, 
the commenter used ``CR'' for most use patterns and suggested that the 
seedling emergence study should only be required ``when environmental 
exposure is likely to result under normal usage conditions as 
determined by appropriate assessment methods.'' Another comment (see 
response to comment 140.27 in the Response to Comments Document in the 
docket) advocated for the use of a Risk Quotient (RQ) approach for 
assessing plants.
    Based on this evaluation, EPA believes using ``CR'' for the 
seedling

[[Page 26958]]

emergence study when triggered by a level of concern approach (RQ 
approach) would provide EPA with the required data when needed. Test 
note 2 to the final nontarget plant protection table in Sec.  158.2250 
now reads as: Data are required if the risk quotient from any aquatic 
plant growth Tier II study exceeds a level of concern for aquatic 
plants.
    However, test note 2 also triggers the aquatic plant growth 
(aquatic vascular plant) study, and is still the appropriate trigger 
for that study. With this final rule, EPA is adding a new test note 10 
to the final nontarget plant protection table in Sec.  158.2250, which 
will read the same as the original, proposed test note 2 to the 
proposed nontarget plant protection table in proposed Sec.  158.2250.

B. Alternative Format for Plant Protection Data Requirements Table

    1. Comment. In the comments submitted to EPA, the commenters 
suggested an alternate antimicrobial plant protection data requirements 
table.
    2. EPA's response. The table suggested by the commenter is not 
adequate to evaluate the hazards and risks to nontarget plants from 
antimicrobial pesticides. The suggested table did not include test 
guideline numbers, changed and reduced the number of use patterns, and 
proposed that all ecotoxicity plant studies are either not required or 
only conditionally required. The commenter contends that there are no 
circumstances where ecological effects plant data are relevant for 
antimicrobial pesticides, and that indoor uses should not be subject to 
environmental exposure or nontarget plant species risk assessments. EPA 
disagrees with many aspects of these comments and the suggested 
ecotoxicity data requirements table for plant species.
    As previously discussed, in the preamble to the proposed rule (73 
FR 59406-7) and in Units III. and V. of this rule, EPA disagrees that 
exposure for nontarget plants should be presumed to be minimal or 
nonexistent for antimicrobials applied indoors, or that tests are not 
required if the test organism is the target species for the pesticide 
(see ACC comment, identified in the docket by document ID No. EPA-HQ-
OPP-2008-0110-0088.7, p. 12, test notes 1 and 2 to the commenter's 
suggested table). Moreover, there are many outdoor uses of 
antimicrobials that are not addressed in the commenter's suggested 
table. FIFRA mandates that EPA conduct a risk assessment for any uses 
for which exposure may occur in the various environmental compartments/
media. Those risks are assessed separately for the various taxa, 
including plants, categories (e.g., freshwater, saltwater), and short-
term (i.e., acute) and longer-term (i.e., chronic) exposures. Assessing 
these potential risks necessitates having an appropriate ecotoxicity 
data base for plant exposure and toxicity. This can only be 
accomplished by requiring plant studies for the initial assessment. A 
tiered approach cannot be driven solely by risk quotients derived from 
a Tier I study. The fact that an acute risk quotient for a plant 
species does not exceed a level of concern for acute risk does not 
imply that a chronic risk does not exist or that data are not needed to 
assess that risk. The trigger for a chronic test is more likely driven 
by the frequency, duration, or magnitude of the chronic exposure and 
the environmental properties of the pesticide. For example, plants 
might be subjected to repeated low-level exposure that is not acutely 
lethal but which may impact reproductive success and plant growth.
    EPA disagrees that the test substance for plant studies (in the 
commenter's table) should be identified simply as the ``residue of 
concern (ROC).'' In its proposed nontarget plant data requirements 
table, EPA specified the test material (TGAI, TEP) to be used for each 
study. The test substance determination is made after reviewing the 
required environmental fate and physical/chemical properties data and 
any other available information (e.g., open literature, closely related 
chemicals) to determine the substance of concern for exposure of non-
target plants and organisms. For example, if an applicant can 
adequately demonstrate that the TGAI dissipates so rapidly that there 
would be no acute or chronic exposure, TGAI testing may be waived, and 
instead degradate testing may be required.
    The commenter also omitted all guideline numbers from its suggested 
data table. At this time, all data requirement tables in 40 CFR part 
158 have guideline numbers since this is a method of providing 
information to applicants. Applicants are not required to use these 
guidelines, but are encouraged to use these test guidelines when 
developing data. Since these guidelines have been developed via a 
rigorous process, as discussed in the preamble to the proposed rule [73 
FR 59387], ``they represent the recommended approach to developing 
high-quality data that should satisfy EPA's data needs for risk 
assessment.''

XIII. Applicator and Post-Application Exposure Data Requirements

    The following represent the significant comments received on the 
need for and evaluation of applicator and post-application exposure 
studies as proposed by EPA. Changes from the proposed rule to the final 
rule are also described. A more detailed discussion can be found in the 
Response to Comments Document available in the docket to this rule.

A. Consistency With OSHA and Other Standards

    1. Comment. A commenter asserted that EPA should be consistent with 
OSHA and other standards with regard to exposure limits and handling 
practices, and incorporate the OSHA standards into risk assessment 
evaluations. The commenter also asked that when EPA believes that an 
OSHA or American Conference of Governmental and Industrial Hygienists 
(ACGIH) standard is not adequately protective for an antimicrobial, 
that the finding should be substantiated.
    2. EPA's response. The OSHA workplace standard is the permissible 
exposure limit (PEL). When developing a PEL, OSHA considers the 
toxicity of the chemical, often using data from the open literature as 
well as the feasibility that exposures could be reduced to the PEL 
using process modifications, engineering controls and personal 
protective equipment (PPE). Approximately 500 PELs have been 
established.
    The ACGIH establishes health-based Threshold Limit Values (TLVs), 
which are non-governmental guidelines used by professional industrial 
hygienists in making decisions about safe levels of exposure to a 
chemical substance in the workplace. The TLVs were established for some 
chemicals as early as 1946 and they are updated on a regular basis as 
new health effects information becomes available. Like the OSHA PELs, 
the TLVs are based on health effects data from the open literature. 
However, unlike the OSHA PELs, feasibility issues are not considered in 
establishing TLVs. TLVs are not available for most pesticide chemicals.
    However, for those pesticide chemicals with both TLVs and RfCs 
(Reference Concentrations are established by OPP based on studies 
submitted by the registrants), the RfCs are often lower than the TLVs. 
There could be several reasons for such differences. The data used by 
OPP is submitted by the pesticide registrants and the toxicity data 
base is composed of animal studies. So, uncertainty

[[Page 26959]]

factors are used to derive the RfCs (exposure limits). Instead of 
animal studies, ACGIH prefers to rely on epidemiology studies/case 
reports of human, particularly worker, exposures from the literature 
and on professional judgment.
    For example, ACGIH and OPP established different inhalation limits 
for formaldehyde based on slightly different interpretations of the 
same literature studies. The TLV for formaldehyde is 300 ppb and the 
OPP ``RfC'' for occupational uses is 100 ppb. Although the TLV is 
greater than the ``RfC,'' ACGIH does acknowledge in their TLV 
documentation that irritation can occur in some workers at levels of 
100 to 300 ppb.
    EPA believes that an existing OSHA or ACGIH standard should be 
considered as part of EPA's hazard evaluation. However, before using an 
OSHA or ACGIH standard, EPA would review the standard and the health 
effects (toxicology) documents supporting the standard's development to 
determine if EPA believes that the standard provides adequate 
protection. EPA agrees with the commenter that EPA's evaluation of an 
existing OSHA or ACGIH standard should be part of its hazard evaluation 
documentation.
    In its proposed rule, EPA proposed in the applicator exposure table 
(40 CFR 158.2260(a)(1)) and the post-application exposure table (40 CFR 
158.2270(a)(1)) to use established workplace standards, such as OSHA's. 
The proposed language was:

If EPA determines that industrial standards, such as the workplace 
standards set by the Occupational Safety and Health Administration, 
provide adequate protection for a particular pesticide or a 
particular use pattern, applicator exposure data may not be required 
for that pesticide or the use pattern. Applicants should consult 
with the Agency on appropriate testing before the initiation of 
studies.

    In addressing this comment, EPA realized that this proposed 
language is misplaced and also needs some textual modification. As 
discussed previously, an OSHA PEL or ACGIH TLV standard is part of 
hazard evaluation. If the PEL or TLV is determined to be adequate to 
fulfill EPA's selection of a toxicity endpoint, then the types and 
number of toxicity studies that may be required is impacted, not the 
need for exposure data. Therefore, EPA has removed the language 
originally proposed for Sec.  158.2260(a)(1) and Sec.  158.2270(a)(1) 
concerning use of OSHA standards. With modifications, the language 
appears in the final toxicity rule in Sec.  158.2230(e).

B. Poisoning Incident Data

    1. Comment. ``Poisoning incident data'' should not be incorporated 
into this regulation unless the EPA can provide criteria to trigger the 
need for exposure data based on poisoning incidents. Regulating based 
upon anecdotal reports of ``poisoning'' is not appropriate.
    2. EPA's response. Both proposed Sec.  158.2260(b) and Sec.  
158.2270(b) contained the following trigger for requiring exposure 
data: ``Scientifically sound epidemiological or poisoning incident data 
indicate that adverse health effects may have resulted from handling of 
the pesticide.'' EPA understands that anecdotal reports may or may not 
indicate a cause-effect relationship, i.e., that adverse health effects 
may or may not have resulted from exposure to the pesticide. EPA agrees 
that anecdotal reports may not substantiate a clear dose response 
relationship of ``poisoning,'' and therefore, when not substantiated, 
are not appropriate for regulatory endpoints. In-depth information on 
the dose response is the critical information needed for regulatory 
endpoints, and poisoning incident data rarely include this information. 
However, EPA's intention was to use scientifically credible information 
as a trigger for requiring exposure data. Based on this comment, EPA 
has revised the toxicity triggers in Sec.  158.2260 and Sec.  158.2270 
to clarify that poisoning incident data must have a clear cause-effect 
relationship to indicate that adverse health effects have resulted from 
exposure to the pesticide.

C. Use of Existing Post-Application Exposure Data

    1. Comment. A commenter argued that there is a significant amount 
of post-application exposure data available that should be considered/
used before requiring data under FIFRA.
    2. EPA's response. EPA acknowledges that there are existing 
exposure data either in the literature, or via other governmental 
organizations such as OSHA, or academia, etc. When available and 
appropriate, EPA uses such exposure data and/or information in its risk 
assessments. For example, the risk assessments for both chlorine 
dioxide and ethylene oxide relied heavily on the workplace air 
concentration monitoring data available in OSHA's Chemical Exposure 
Health Database (CEHD), formerly known as, Integrated Management 
Information System (IMIS). To access CEHD, users navigate on the OSHA 
homepage (http://osha.gov/) to Chemical Exposure Health Data under the 
Data and Statistics section towards the bottom right of the page. Users 
can search CEHD by Establishment Name, State, Zip Code, Year Range, 
Standard Industrial Classification (SIC), North American Industrial 
Classification System Code (NAICS), Chemical Abstracts Service Number 
(CAS), Chemical Name, or Result Range.
    Applicants who are aware of existing data that could fulfill a data 
requirement should submit the data to EPA. EPA will consider the 
appropriateness and robustness of the data, and, if appropriate, will 
use the data in the Agency's risk assessment.

D. Soil Residue and Indoor Surface Residue Dissipation Studies

    1. Comment. A commenter claimed that there is little justification 
for requiring the soil residue dissipation and indoor surface residue 
dissipation studies.
    2. EPA's response. In the proposed rule, EPA conditionally required 
the soil residue dissipation study for both occupational and 
residential scenarios. EPA agrees that the likelihood of requiring soil 
residue dissipation data is low for the majority of antimicrobial use 
patterns. The low likelihood is reflected in the ``CR'' designation in 
the proposed post-application exposure data requirements table for the 
soil residue dissipation study for both occupational and residential 
use patterns. No changes are needed.
    In the proposed rule, EPA required the indoor surface residue 
dissipation study for both occupational and residential scenarios. 
However, the likelihood of requiring indoor surface residue dissipation 
data is high for residential products such as antimicrobial-treated 
clothing and plastic consumer items/toys, as well as direct 
applications such as carpet shampoos, laundry detergents, and floor 
cleaners that are antimicrobial products. Therefore, the indoor surface 
residue dissipation study for the residential use sites will remain 
``R'' as proposed.
    However, EPA has reevaluated the ``R'' proposed for occupational 
use sites. When compared to residential use sites, occupational use 
sites are less likely to result in the need for indoor surface residue 
dissipation data. Therefore, the data requirement for indoor surface 
residue data has been revised from ``R'' to ``CR'' for occupational 
uses.
    In most manufacturing settings, there is less contact with surfaces 
than in most residential scenarios. For example, under most 
circumstances workers do not crawl around the floors of manufacturing 
plants. The need for indoor surface residue dissipation data

[[Page 26960]]

for workers is limited by the residue distribution where contact may 
occur. EPA now agrees that the occupational use sites are less likely 
to result in the need for indoor surface residue dissipation data, and 
therefore, the ``R'' has been revised to ``CR.''

E. Non-Dietary Ingestion Study

    1. Comment. A commenter asserted that the proposed requirement for 
non-dietary ingestion is impractical and unnecessary, and, in fact, 
could be replaced by modeling.
    2. EPA's response. EPA agrees that the non-dietary ingestion study 
is impractical, as a stand-alone direct measurement study. Non-dietary 
ingestion exposure (i.e., incidental oral ingestion by children) is of 
potential concern for treated articles or surfaces that may be accessed 
by children. For example, uses such as carpet shampoo, hardwood floor 
treatments, pressure-treated wood, and impregnated materials (including 
but not limited to plastic toys or treated clothing) are assessed for 
non-dietary exposures when toxicity criteria are triggered. In all of 
these instances, non-dietary ingestion exposures are estimated using 
residue data from the treated surface combined with activity factors 
for children's behaviors (e.g., frequency of hand-to-mouth contact). 
Often, EPA models this route and pathway of exposure using inputs from 
the available and reliable published research. If EPA were to require 
data to estimate this exposure pathway, EPA would require surface 
residue data, rather than the actual monitoring of children or having 
individual registrants collecting data on frequency of hand-to-mouth 
activities, as these are not chemical-specific. Given the unlikelihood 
of requiring non-dietary ingestion exposure studies, EPA has determined 
to not finalize this proposed data requirement and its accompanying 
test note 12 in the final post-application exposure table in Sec.  
158.2270(e).

XIV. Environmental Fate Data Requirements

    The following represent the significant comments received on the 
need for and evaluation of environmental fate studies as proposed by 
EPA. Changes from the proposed rule to the final rule are also 
described. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Need for Environmental Fate Data for Indoor Uses

    1. Comment. Several commenters argued that the proposed 
environmental fate data requirements for indoor uses of antimicrobials 
should not exceed those in part 158 for conventional pesticide 
chemicals, since antimicrobials are not directly broadcast into the 
environment.
    2. EPA's response. As explained in the proposed rule, there is now 
a greater concern regarding indoor uses of antimicrobials because those 
antimicrobial uses can lead to environmental exposure when they go down 
the drain. The rationale for requiring environmental fate data for 
antimicrobials mirrors that of Unit XI.A. for requiring nontarget 
organism data for antimicrobials.
    There are many uses for which a high potential for exposure exists, 
and these uses may require a more extensive environmental fate data set 
that could also include aerobic and anaerobic metabolism studies. 
However, such uses will typically require a much reduced first tier 
data set with additional testing triggered if the results of the 
required data indicate a potential risk that needs further 
characterization.

B. Transformation Products

    1. Comment. A commenter argued that the Agency has not clearly 
stated when environmental fate data on the transformation products 
would be required. Additionally, the commenter also wanted to 
understand the data that would be required if the substance degrades 
quickly?
    2. EPA's response. For environmental fate data, the Agency 
evaluates transformation products on a case-by-case basis, using 
several sources of information. First, the transformation products need 
to be identified. While product chemistry data can provide some 
information on degradates, environmental fate data provide data 
specific to a particular environmental compartment. Environmental fate 
studies provide information on the stability and persistence of the 
active ingredient and its degradation products in the various 
environmental media. For example, in the hydrolysis study, a half-life 
>30 days indicates that the substance is stable to hydrolytic 
processes, i.e., the substance did not degrade. Similar determinations 
are made based on the results of the photodegradation in soil and water 
studies, and the aerobic and anaerobic metabolism in soil and water 
studies after review of the required fate data. Monitoring and incident 
data, if available, also may indicate stability and persistence. There 
could also be environmental fate data conducted on a related chemical 
or information from the open literature. This analysis is critical to 
determining not only the need for environmental fate data for 
transformation products, but also is the first step for determining the 
need for nontarget organism or nontarget plant data for transformation 
products.
    EPA proposed criteria to require testing of transformation/
degradation products or leachate residues in proposed Sec.  
158.2280(a)(2) and (3). To respond to this comment, EPA also considered 
a similar comment on transformation/degradation products or leachate 
residues for nontarget plant and organism testing (see Unit XI.B.). In 
response to these comments, EPA determined to clarify and revise the 
criteria for testing of transformation/degradation products and 
leachate residues for nontarget organisms in Sec.  158.2240(a)(3), for 
environmental fate in Sec.  158.2280(a)(2), and for nontarget plant 
protection in Sec.  158.2250(b).
    EPA would use these criteria to determine if environmental fate 
data on the transformation/degradation products or leachate residues 
are required. Therefore, if the environmental fate studies on the 
parent indicate the transformation product(s) is, for example, more 
persistent in soils, then the same environmental fate data required for 
the parent are required for the transformation product(s). If concerns 
are identified, then higher-tiered environmental fate and/or ecological 
effects data on the transformation/degradation product(s) would be 
required.
    It should be noted that the criteria for determining whether to 
assess risks from a chemical substance and/or its degradation products 
when conducting a down-the-drain analysis are different from those 
discussed previously. Those criteria are discussed in response to 
comment 130.4 in the Response to Comments Document in the docket.

C. Photodegradation in Soil Study

    1. Comment. A commenter claimed that EPA has not sufficiently 
explained why a photodegradation in soil study would be required if a 
substance hydrolyzes and its behavior is known from its soil profile.
    2. EPA's response. EPA proposed to require the photodegradation in 
soil study for only one use pattern: Wood preservatives. Wood products 
that have been treated with wood preservatives are often in contact 
with soil, and therefore it is possible for the wood preservative 
chemical, as well as its transformation and degradation products, to 
leach out from the treated wood product. To understand the fate of wood 
preservative chemicals in soil, first requires an understanding of the 
soils properties. Soil profiles are

[[Page 26961]]

descriptions of soil properties, both physical and chemical. Examples 
of physical characteristics would include: color, bulk density, and 
texture. Examples of chemical characteristics would include: pH of the 
soil, organic matter content, and Cation Exchange Capacity (CEC). 
Depending on the soil profile, an antimicrobial pesticide can undergo 
chemical and/or biochemical (biodegradation) processes. For example, if 
the pH of the soil is less than 7, the antimicrobial can undergo 
hydrolysis and become nonpersistent, or if the pH of the soil is basic, 
the antimicrobial could remain stable and become persistent. If the 
organic carbon content of a soil is high, then the soil has a high 
microbial population which facilitates the biodegradation process. 
Hence the nature of a soil (soil profile) is an important indicator of 
how a pesticide may behave in a soil.
    Many applicants are well aware of soil profiles, since EPA asks for 
the soil profile to be submitted along with the results of the studies 
in soils. A number of soil profile data bases are available. Two of the 
data bases used by OPP are one from the United States Department of 
Agriculture (USDA) and one called CLARION.
    In this final rule, EPA has retained the requirement for a 
photodegradation in soil study for the wood preservatives use pattern. 
The photodegradation in soil study is required for all wood 
preservatives, except for two circumstances. First, if the 
antimicrobial is an inorganic substance or a metal salt, then a 
photodegradation study does not provide applicable information for 
inorganics and metal salts that do not degrade (chemically or 
biochemically). Second, if data from standardized soil profiles show 
that the chemical is likely to readily degrade microbially or undergo 
redox reactions (degrade chemically) to such a degree that there is no 
formation of degradation/transformation/leachate products of concern 
(as defined in Sec.  158.2280(a)(2)), then the photodegradation in 
soils study would not be needed. EPA has revised the proposed test note 
10 to the environmental fate table, so that test note 10 to the final 
environmental fate table in Sec.  158.2280(c) explains the conditions 
for not requiring the photodegradation in soil study.

D. Aquatic Sediment Study

    1. Comment. A commenter claimed that EPA is unclear about the 
triggers that would lead to the requirement for an aquatic sediment 
study, and how down-the-drain modeling could affect the need for this 
study.
    2. EPA's response. Test notes 5 and 13 to the proposed 
environmental fate table in Sec.  158.2280 trigger the aquatic sediment 
study for all use patterns except the aquatic areas use pattern. EPA 
has reevaluated the need for the aquatic sediment study and the 
appropriate triggers. EPA agrees that having two triggers, both of 
which use a weight-of-evidence evaluation process, is confusing, and 
believes that one trigger (proposed test note 13) would be sufficient 
for triggering the aquatic sediment study. In this final rule, EPA is 
removing test note 5 from the test note column for the aquatic sediment 
study data requirement. Based on this reevaluation, EPA also believes 
that the aquatic sediment study should be required for the antifoulant 
coatings and paints use pattern since an antifoulant use would meet the 
criteria of the trigger in test note 13, which is: ``* * * data are 
required based on the potential for aquatic exposure and if the weight-
of-evidence indicates that the active ingredient or principal 
transformation products are likely to have the potential for 
persistence, mobility, nontarget aquatic toxicity, or 
bioaccumulation.'' Antifoulants are released/applied directly to the 
aquatic environment. These products are often manufactured to be 
persistent, and because of the continuous release process, some of the 
active ingredient is likely to be transferred to the bottom of the 
water column and then be adsorbed to the sediment. This is likely to 
result in adverse effects on nontarget benthic organisms. Since this 
meets the triggers for requiring the study, in this final rule EPA is 
changing the ``CR'' for the aquatic sediment study for the antifoulant 
coatings and paints use pattern to ``R.''
    The aquatic sediment study provides information about the 
degradation/dissipation processes under field conditions. The results 
of down-the-drain modeling are unlikely to provide appropriate 
information to determine the need for the aquatic sediment study. The 
current version of the down-the-drain model estimates concentrations of 
chemical substances in the water column downstream of wastewater 
treatment facilities, but does not estimate concentrations in the 
sediment.

E. Monitoring of Representative U.S. Waters Study

    1. Comment. The commenter noted that there is no guidance on how to 
conduct a ``monitoring of representative U.S. waters'' study, and that 
EPA has not provided the criteria for triggering a ``monitoring of 
representative U.S. waters'' study.
    2. EPA's response. The commenter is correct. EPA does not have a 
guideline for conducting this study. For all pesticides, such 
monitoring (studies) of representative U.S. waters is a very rare 
occurrence. If EPA were to require such a monitoring study, protocols 
would have to be developed to specify a great deal of information:
     At which locations would the monitoring occur, and how 
often would the monitoring occur?
     Is the sampling for ground water, surface water, or the 
estuarine/marine environment?
     Which chemical substances would be monitored? Is just the 
antimicrobial (parent) to be analyzed, or would the transformation/
degradation products also be analyzed?
    Such a protocol would be specific to a particular pesticide, where 
that pesticide is used, and where the pesticide has been detected, and 
could not necessarily be used for a different pesticide.
    For the monitoring of representative U.S. waters data requirement, 
the term ``residue of concern'' (ROC) is currently specified in the 
environmental fate data requirements table in the test substance to 
support column. Since the ROC would be determined during protocol 
development, EPA is adding this information as part of a new test note 
17 to the final environmental fate table in Sec.  158.2280.
    As stated in the preamble to the proposed rule, a WOE approach 
would be used to determine if a monitoring of representative U.S. 
waters study should be required. The preamble to the proposed rule 
discusses this aspect in more detail (73 FR 59413). EPA expects this 
study to be rarely required.

F. American Wood Protection Association (AWPA) and American Society for 
Testing and Materials (ASTM) Methods

    1. Comment. A commenter argued that AWPA method E11-97 or E20-04, 
and ASTM Method D5108-90 ``are of limited or no relevance to estimating 
environmental exposures'' for wood preservatives, or antifoulants, 
respectively. According to the commenter, the results of the ASTM 
method are not suitable for ``estimating release rates for regulation 
purposes.'' The commenter believes that both methods ``overestimate 
leach rates and are not intended for use in risk assessments.'' The 
commenter also provided information to indicate that ASTM Method D5108-
90 has been replaced by ASTM D6442-06.
    2. EPA's response. Test note 15 to the proposed environmental fate 
table in

[[Page 26962]]

Sec.  158.2280 triggers the special leaching data requirement for the 
wood preservative use pattern. EPA's intent in specifying that it would 
accept an ASTM or AWPA method was to allow applicants to use these 
readily available protocols. However, as noted in the proposed test 
note, protocol review was still required for some of these methods. 
Since the commenters believe that these AWPA methods are inappropriate, 
but have not offered alternative methods, test note 15 to the final 
environmental fate table in Sec.  158.2280(c) is revised to remove the 
AWPA methods. Test note 12 to the final environmental fate table in 
Sec.  158.2280(c) is added to require protocol review.
    Test note 16 to the proposed environmental fate table in Sec.  
158.2280 triggers the special leaching data requirement for the 
antifoulant coatings and paints. Since the commenter indicated that the 
ASTM method has been replaced, EPA believes that specifying an ASTM 
method number in regulatory text may provide insufficient clarity, at 
some point in the future. Therefore, test note 16 to the final 
environmental fate table in Sec.  158.2280 is revised to remove the 
ASTM methods. Test note 12 to the final environmental fate table in 
Sec.  158.2280(c) is added to require protocol review.

XV. Down-the-Drain Analysis

    The following represent the significant comments received on the 
need for and performance of a down-the-drain analysis as proposed by 
EPA. Changes from the proposed rule to the final rule are also 
described. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Changes to Down-the-Drain Analysis Based on Comments Received

    1. Comment. Some commenters expressed concern regarding EPA's 
proposal to exclude antifoulants and wood preservatives from testing 
designed to protect POTWs and the aquatic environment. These commenters 
contend that these compounds may reach POTWs through sources such as 
hull blast water, landfill leachate, and centralized waste treatment 
facilities. They think EPA should revisit this assumption to verify its 
accuracy.
    2. EPA's response. Based on this comment, EPA did reevaluate its 
original determination to exclude antifoulant coating and paints, wood 
preservatives, and aquatic areas from down-the-drain analysis. EPA 
still believes that it is appropriate to exclude aquatic areas from a 
down-the-drain analysis. As discussed in the preamble to the proposed 
rule (73 FR 59390) aquatic areas include lakes, ponds, streams, 
drainage ditches, and other bodies of water. These would not be 
expected to result in down-the-drain releases and are therefore 
unlikely to be discharged to a WWTP.
    Based on its reevaluation, EPA believes that a down-the-drain 
analysis is needed for the wood preservative, and antifoulant paints 
and coatings use patterns, as well as the all other use patterns 
category. There are a number of sources of indirect releases of 
antifoulants and wood preservatives to surface water via WWTPs. The 
Emission Scenario Document (ESD) for Wood Preservatives, which is part 
of the OECD Series on Emission Scenario Documents, documents numerous 
sources of environmental releases directly to surface water. The ESD 
also describes various types of wood preservative facilities where 
there may be environmental releases to the facility drain that 
subsequently drains to a WWTP. Some of the types of wood preservative 
facilities identified in the OECD ESD for wood preservatives include 
automated spraying plants, dipping/immersion plants, and plants that 
employ vacuum-pressure and double vacuum processes. According to this 
OECD ESD for wood preservatives, it is also possible for releases to 
sewage treatment plants to occur from some treated wood products, such 
as noise barriers.
    According to the OECD ESD for Antifouling Products, in addition to 
the numerous sources of direct environmental releases to surface water 
resulting from the use of antifoulant paints and coatings, there is the 
potential for antifoulants to enter sewage treatment plants as a result 
of application and removal of antifoulant paints at boatyards and 
marinas.
    Thus, OPP's Antimicrobial Division (AD) will perform a down-the-
drain assessment for every product with an applicable use or exposure 
scenario that has the potential for waters containing antimicrobials to 
reach a WWTP. To perform this assessment, the Agency is requiring data 
on the biodegradation of an antimicrobial pesticide and its potential 
toxicity to WWTP microorganisms in an activated sludge basin. For some 
antimicrobial pesticides, the Agency will also require the activated 
sludge sorption isotherm test to determine removal from wastewater via 
partitioning to activated sludge. For additional information on the 
changes made to the proposed environmental fate data requirements table 
see response to comment 134.1 in the Response to Comments Document in 
the docket.

B. Use of E-FAST Model

    1. Comment. According to one commenter, EPA staff indicated at the 
part 158, subpart W Antimicrobials Data Requirements Workshop held on 
November 6, 2008 that the E-FAST model may have been based on municipal 
WWTPs that received only ``residential'' discharges. The commenter 
suggested that is very unlikely and stated that according to the E-FAST 
manual, the model was based on data from actual U.S. municipal WWTPs. 
Nearly every municipal WWTP receives discharges from many types of non-
residential sources, like commercial facilities, medical facilities, 
institutions, and cooling water systems (which are common in commercial 
buildings). Even in smaller communities, POTWs receive wastewater from 
residential and commercial (e.g., schools, stores, restaurants, hotels/
motels, and/or medical facilities) sources. Most municipal WWTPs also 
receive both process and non-process discharges from industrial 
facilities. Some commenters contend that the E-FAST model is applicable 
as a screening-level model for all antimicrobial use patterns with 
discharges that are typically rinsed down the drain including 
agricultural premises and equipment, food handling/storage 
establishments, residential and public access premises, medical 
premises and equipment, industrial processes and water systems, 
swimming pools, and others.
    2. EPA's response. The E-FAST documentation manual indicates that 
the down-the-drain module was developed as a screening-level model for 
estimating concentrations of chemicals in surface water that may result 
from the disposal of consumer products into household wastewater. The 
model developers have confirmed, however, that the data base of WWTPs 
that is accessed by this module consists of domestic WWTPs that receive 
wastewaters predominantly from residential, commercial, and 
institutional sources, and not solely from residential sources. In 
modeling releases of antimicrobial pesticides to environmental media, 
the appropriate data inputs, methods, and tools are dependent upon the 
source of the environmental releases. To assess exposures and risks to 
releases of antimicrobial pesticides to surface water from residential, 
commercial, and institutional sources, the down-the-drain module of E-
FAST is the most appropriate tool.

[[Page 26963]]

    To assess exposures and risks to antimicrobial pesticides from 
manufacturing, processing, and industrial use facilities, the general 
population and ecological exposures from the industrial releases module 
of E-FAST is the most appropriate tool. The decision to use the general 
population and ecological exposures from the industrial releases module 
is made on a case-by-case basis considering the availability of data 
required as inputs to the module, and the potential for significant 
exposure. For example, a low volume use may not require use of this 
module.
    EPA agrees that the E-FAST model is applicable as a screening-level 
model for all antimicrobial use patterns with discharges that are 
typically rinsed down the drain, including agricultural premises and 
equipment, food handling/storage establishments, residential and public 
access premises, medical premises and equipment, industrial processes 
and water systems, swimming pools, and others.

C. Exceedance Levels

    1. Comment. Some commenters questioned the justification for the 
following exceedance levels that were used by EPA to evaluate potential 
risks to aquatic organisms:
    i. Potential risks from effects to aquatic invertebrates and fish: 
Exceedance of the chronic concentration of concern (COC) for 20 or more 
days triggers a potential for concern;
    ii. Potential risks from effects to aquatic invertebrates and fish: 
Exceedance of the acute COC for 4 or more days triggers a potential for 
concern; and
    iii. Potential risks from effects to algae: Exceedance of the COC 
for algae for 4 days or less may trigger a concern and is evaluated on 
a case-by-case basis.
    2. EPA's response. Exceedance levels and corresponding number of 
days of exceedance that trigger potential for concern are those cited 
in EPA/OPPTS/OPPT's ``Interpretive Assistance for Sustainable Futures 
Summary Assessment'', last updated August, 2011. The justification that 
the potential for chronic risk to aquatic organisms may exist if the 
predicted environmental concentration (PEC) exceeds the chronic COC and 
the exceedance occurs for 20 days or more per year is documented on 
page 11:

    The potential for chronic risk to aquatic organisms may exist 
ONLY if the PEC exceeds the chronic COC for 20 days or more per 
year. If exposure occurs for 20 days of more per year, the 
concentration of the chemical in surface water may reach levels 
associated with chronic effects (Lynch et al., 1994). The 20-day 
criterion is derived from partial life-cycle tests (Daphnid chronic 
and fish early life-stage tests) that typically range from 21 to 29 
days in duration. Low concentration for chronic risk exists if the 
COC is exceeded on fewer than 20 days per year.

    The justification for the potential for acute risks to aquatic 
organisms appears on page 12:

    The potential for acute risk to aquatic organisms exists if the 
predicted environmental concentration (PEC) is greater than the 
acute concentration of concern (COC).
    If Acute COC > PEC: Low concern for risk
    If Acute COC < PEC: Potential for risk

    EPA notes that risk is influenced by both the duration of exposure 
and the likelihood of that exposure occurring. Often mathematical 
models are used to estimate exposures and risks. There are two types of 
models: Deterministic or probabilistic. Probabilistic modeling is a 
technique that utilizes the entire range of input data to develop a 
probability distribution of risk or exposure rather than a single point 
value. The analysis identifies the probability that the exposure 
exceeds the COC and for what timeframe. Deterministic modeling is based 
on select input data that result in a single point estimate. The 
estimate either exceeds or does not exceed the COC. Models such as E-
FAST have the capability of providing either deterministic or 
probabilistic results. Consequently, criteria for determining whether 
or not testing on aquatic organisms is required need to take into 
account the possibility that the estimated exposure could be modeled 
using either deterministic or probabilistic modeling. Therefore, two 
test notes to the final nontarget organism table in Sec.  158.2240 have 
been revised to include a probabilistic trigger for down-the-drain 
analyses, while retaining the existing deterministic trigger for 
releases of antimicrobials that are expected to enter WWTPs. Test note 
7 to the final nontarget organism table in Sec.  158.2240(c) triggers 
the acute freshwater invertebrate toxicity study (TEP testing) and the 
acute freshwater fish toxicity study (TEP testing). Test note 12 to the 
final nontarget organism table in Sec.  158.2240(c) triggers the fish 
life-cycle study.

D. Evaluation of Discharges to Still Water and to Salt Water

    1. Comment. During the Antimicrobial Data Requirements Workshop 
held on November 6, 2008, EPA staff indicated that evaluation of 
discharges to still water and to salt water would be challenging. The 
commenter argued that the E-FAST model manual suggests that these 
discharges can be readily evaluated with appropriate input data and 
elimination of the PDM (Probabilistic Dilution Model) option.
    2. EPA's response. EPA believes that the commenter misunderstood 
the context of the Information provided by EPA staff both in the 
proposed rule and at the presentation on November 6, 2008. E-FAST has 
two modules for estimating releases to surface water: The down-the-
drain module, and the general population and ecological exposure from 
industrial releases module.
    When the down-the-drain module of E-FAST is run without the PDM 
option, the results are limited to estimates of concentrations in 
surface water downstream of domestic wastewater treatment facilities. 
The down-the-drain module has no option for estimating concentrations 
in non-flowing waterbodies such as lakes, bays, estuaries, and oceans. 
The discussion at the November 6, 2008, Workshop focused solely on the 
down-the-drain module.
    E-FAST, however, has the capability for evaluating discharges to 
still water and to salt water from discharges to WWTPs that receive 
manufacturing, processing, and industrial use releases, but not from 
discharges to surface water via domestic WWTPs. The general population 
and ecological exposure from industrial releases module is designed to 
estimate releases to air, water, and land from manufacturing, 
processing, and industrial use of chemical substances. The data base 
for estimating releases to WWTPs that primarily receive wastewater from 
manufacturing, processing, and industrial uses requires estimates of 
releases to environmental media from models such as ChemSTEER (Chemical 
Screening Tool for Exposures and Environmental Releases), a model 
developed by EPA's OPPT or from data and calculations included in 
standard scenarios, also developed by OPPT (www.epa.gov/oppt/exposure/pubs/chemsteerdl.htm). The general population and ecological exposure 
from industrial releases module includes an option for estimating 
concentrations in lakes, bays, estuaries, and oceans.

E. Parameters for Down-the-Drain Analysis

    1. Comment. Several commenter's argued that EPA's approach for 
down-the-drain chemicals separates the exposure and the effects of the 
assessment and subjects chemicals to similar testing requirements 
regardless of the mass of chemicals disposed of in

[[Page 26964]]

the environment. According to these commenters, the fact that EPA does 
not guide testing by the extent of environmental exposure is wasteful 
for ingredients which will reach the environment at low levels. Even 
for chemicals which are used at greater volume, the commenters claimed 
that there is no proof that EPA's program will achieve its goal without 
being wasteful and some commenters believe that EPA's approach will 
likely result in significant unwarranted costs in animals, time, and 
dollars. The commenters asserted that this will result in unnecessary 
loss of animals, increased costs to the consumer and will negatively 
affect product innovation as new product development will be slowed due 
to the extra regulatory burden. The benefit to the environment of the 
EPA approach, according to the commenters, is likely to be small and 
not commensurate with its costs.
    2. EPA's response. EPA disagrees with this comment. Three key input 
parameters for the down-the-drain model are:
    i. Percent removal of antimicrobial pesticide during wastewater 
treatment;
    ii. Concentrations of concern for antimicrobial pesticides based on 
acute and chronic end-points for freshwater fish, freshwater 
invertebrates, and freshwater plants; and
    iii. Wastewater treatment plant influent volume of antimicrobial 
pesticide.
    As demonstrated in the sensitivity analysis of the down-the-drain 
model in the document, ``Four Case Studies of Antimicrobial Pesticides 
in the Down-the-Drain Screening Model, Using the Proposed Approach for 
a Screening-Level Environmental Fate Assessment'' (identified in the 
docket by document ID number EPA-HQ-OPP-2008-0110-0044), the amount of 
chemical disposed in the environment strongly influences the results of 
the down-the-drain model. It is possible that if the amount of chemical 
disposed is small (i.e., WWTP influent volume is low and/or high 
percent removal during wastewater treatment), the predicted surface 
water concentration of the antimicrobial, even for a chemical of high 
toxicity, would not exceed the Agency's level of concern. Under such 
circumstances, higher-tier testing (environmental fate, ecotoxicity, 
and plant protection) is unlikely to be triggered. Since higher-tier 
testing is triggered only if the down-the-drain model indicates that 
the predicted concentration of the antimicrobial may adversely affect 
aquatic organisms this reduces the number of tests required, and 
therefore the animals, time, and dollars.
    EPA also notes that two of the three key input parameters needed to 
run the down-the-drain model, percent removal during wastewater 
treatment and wastewater treatment plant influent volume do not involve 
animal testing and would not lead to loss of animals. Fate tests 
required to determine removal during wastewater treatment via 
biodegradation and adsorption are inexpensive. No costs are associated 
with WWTP influent volume.

F. Acute and Chronic Toxicity Endpoints

    1. Comment. At the Antimicrobial Data Requirements Workshop held on 
November 6, 2008, EPA staff indicated that chronic aquatic toxicity 
endpoints might not be used to evaluate antimicrobial discharges from 
municipal WWTPs. A commenter argued that since EPA/OW requires 
municipal WWTPs to conduct both acute and chronic toxicity tests 
regularly as conditions of CWA-regulated National Pollution Discharge 
Elimination System (NPDES) permits, both acute and chronic endpoints 
should be evaluated by EPA/OPP to ensure that antimicrobial discharges 
will not cause toxicity in municipal WWTP effluent.
    2. EPA's response. To assess whether the proposed screening level 
assessment and tiered system of data requirements provides the data 
needed to assess exposure and risk of antimicrobial pesticides released 
to the environment via down-the-drain use patterns, the Agency 
conducted four case studies (73 FR 59408-9). Based on this comment, EPA 
has reevaluated the approach used for the case studies, in which the 
higher-tiered data was triggered based on the results of the available 
data. To ensure that antimicrobial discharges will not cause toxicity 
to aquatic organisms downstream of WWTP effluents requires an 
evaluation of both acute and chronic toxicity endpoints. This means 
that the chronic ecotoxicity data needs to be submitted at the same 
time as the acute ecotoxicity data, so both types of studies are 
available for EPA to use for the ecological risk assessment. Also see 
Units XV.A. and B.
    Consequently, in the final nontarget organism table in Sec.  
158.2240(c), the table descriptors for the fish early-life stage and 
aquatic invertebrate life-cycle tests have been changed from ``CR'' to 
``R'' for the wood preservatives use pattern and the all other use 
patterns category. Test note 10 to the final nontarget organism table 
in Sec.  158.2240(c) has been modified to remove the trigger since it 
is no longer needed.

XVI. Residue Chemistry Data Requirements

    The following represent the significant comments received on the 
need for and evaluation of residue chemistry studies as proposed by 
EPA. Changes from the proposed rule to the final rule are also 
described. A more detailed discussion can be found in the Response to 
Comments Document available in the docket to this rule.

A. Scope of the Residue Chemistry Data Requirements

    1. Comment. Several commenters found the scope of coverage of the 
residue chemistry data requirements in Sec.  158.2290(b) to be vague 
and confusing. Further, the ACC Biocides Panel asserted that this 
section required data for uses for which a FFDCA section 408 tolerance 
is not required and over which, therefore, EPA allegedly has no 
jurisdiction.
    2. EPA's response. EPA is clarifying Sec.  158.2290(b) which 
pertains to the scope of the residue chemistry data requirements. That 
section can be read as limiting the residue chemistry data requirements 
to pesticide products requiring a tolerance or tolerance exemption. 
This apparent limitation is inconsistent with both the preamble's 
general description of the scope of subpart W and the preamble's 
description of the scope of the residue chemisty data requirements 
section, and is internally inconsistent with the terms of Sec.  
158.2290(b). Various commentators noted the lack of clarity in this 
portion of the rule.
    The preamble's general discussion of the scope of subpart W made 
clear that this subpart was not limited to ``antimicrobial pesticides'' 
as defined by FIFRA section 2(mm)--which excluded antimicrobial 
pesticide uses subject to either FFDCA section 408 or section 409--but 
extended to among other things, ``[p]esticide products for 
antimicrobial use in/on food'' (73 FR 59385). In no way, however, did 
this discussion suggest or imply that the subpart is limited to 
antimicrobial uses requiring FFDCA section 408 tolerances or exemptions 
from tolerances. To the contrary, the preamble's discussion of toxicity 
data requirements expressly notes that data are needed under subpart W 
to assess dietary risk whether or not a section 408 tolerance is 
required. The preamble specifically states that, although certain 
antimicrobial food uses are regulated under the FFDCA by FDA under 
section 409 and not section 408, EPA still needs

[[Page 26965]]

data on these uses to assess dietary risk to fulfill its statutory 
obligations under FIFRA section 2(bb)(2), which establishes the FFDCA 
section 408 safety standard as a component of the FIFRA standard for 
registration/cancellation for FIFRA pesticide uses that result in 
residues on food (73 FR 59394). Further, the preamble's discussion of 
residue chemistry data requirements states that these data are needed 
for ``direct and indirect food uses'' including application to ``food 
or water'' both to assess risk and for tolerance-setting purposes (73 
FR 59401: ``In addition to dietary risk assessments, residue chemistry 
data are used to establish pesticide tolerance. . . .''). Finally, both 
the preamble's discussion of residue data requirements and the relevant 
rule text mention antimicrobial uses that would be excluded by a 
limitation of the rule to antimicrobial uses requiring tolerances. For 
example, both the preamble and rule text refer to ``fruit and vegetable 
rinses,'' antimicrobials ``incorporated into a material that may 
contact food or feed,'' and ``[a]quatic uses that have the potential to 
result in residues in potable water'' and the fact that all of these 
uses may not need section 408 tolerances (73 FR 59401 and 59444).
    Accordingly, EPA is revising Sec.  158.2290(b) to make clear it is 
not limited to antimicrobial uses which need FFDCA section 408 
tolerances. With some modifications, EPA is retaining in Sec.  
158.2290(b) a non-exclusive list identifying examples of antimicrobial 
products covered by this section. The revision to the introductory text 
of Sec.  158.2290(b)(1) makes clear that the residue data requirements 
apply to antimicrobial products that may result in residues in food or 
water whether or not a FFDCA section 408 tolerance is needed.
    The first item in the list of covered uses now reads ``Products 
that require a tolerance, tolerance exemption, or food additive 
regulation or clearance.'' The insertion of the reference to food 
additive regulations and clearances is consistent with the rule's scope 
which is not limited to pesticide uses regulated under FFDCA section 
408. Additionally, each of the subparagraphs listing examples of 
covered uses has been revised to refer to ``products'' rather than 
``uses'' for consistency and clarity. Although the subparagraphs are 
overlapping (i.e., a product may fall in more than one paragraph), the 
revised subsection now clarifies the overall scope of the section. 
These revisions make Sec.  158.2290(b) consistent with the scope of the 
rule described in the preamble and the scope of the toxicology data 
requirements.
    Not only are these changes consistent with the scope of the rule as 
discussed in the preamble (i.e., data requirements are not limited to 
uses needing section 408 tolerances) but the revised language's focus 
on whether use of a pesticide may result in residues in or on food 
follows directly from the intent of the residue chemistry requirements 
as discussed in the preamble. There, EPA explained that the proposed 
requirements will provide information ``to better estimate human 
dietary exposure to antimicrobial residues in or on food or feed,'' 
``to determine the composition of the pesticide residue and how much of 
the residue is present in food or animal feed,'' and to ``measure how 
much of the residue of concern is present in food, feed, and water'' 
(73 FR 59401). Further, the revised language is consistent with the 
scope of FFDCA section 408 (applies to ``pesticide chemical residue[s] 
in or on food'') and FIFRA (requires consideration of ``residues that 
result from the use of a pesticide in or on food''). It also follows 
directly from the existing data requirements applying to antimicrobials 
in part 161. Those regulations provide that ``Residue Chemistry Data 
are used by the Agency to estimate the exposure of the general 
population to pesticide residues in food and for setting and enforcing 
tolerances for pesticide residues in food or feed.'' 40 CFR 
161.202(c)(1); see also 40 CFR 161.202(c)(2) (``results of tests on the 
amount of residues remaining on or in the treated food or feed are 
needed to support a finding as to the magnitude and identity of 
residues which result in food or animal feed as a consequence of a 
proposed pesticide usage''); 40 CFR 161.240(b)(14) (Residue data on 
indoor use of pesticide ``if such a use could result in residues in 
food or feed''). Finally, the revised language also tracks EPA's 
requirements for residue chemistry data under the current data 
requirements for conventional pesticides in 40 CFR part 158, subpart O. 
In the preamble to the proposed rule, EPA explained that the residue 
data requirements for antimicrobials were adapted from the conventional 
data requirements in subpart O (73 FR 59401). For uses of conventional 
pesticides, other than uses in agriculture, part 158 states that 
``[residue chemistry] [d]ata may be required . . . if residues may 
occur in food or feed as a result of the use.'' (40 CFR 
158.1410(b)(2)). The regulation also makes clear that this requirement 
applies whether or not a tolerance is needed under FFDCA section 408. 
The regulation specifies that ``most products used in or near kitchens 
require residue data for risk assessment purposes even though 
tolerances may not be necessary in all cases.'' (Id.)
    The commenters' concern that the residue chemistry requirements 
exceeded EPA's jurisdiction under the FFDCA is addressed in Unit IV.

B. Complete Transference of the Antimicrobial into Food

    1. Comment. The commenter believes that additional clarification is 
needed concerning EPA's statement, ``in the absence of data [the Agency 
will] evaluate the need for a tolerance or tolerance exemption by 
assuming complete transference of the chemical into food over the 
lifetime of the treated product.''
    2. EPA's response. Complete transference refers to an assumption 
that the Agency would initially make regarding the migration of 
antimicrobial residues from an impregnated food contact material to the 
food contacting that material over the typical use life of the 
antimicrobial-impregnated material. The worst-case assumption is that 
100 percent of the antimicrobial residues resulting from use at the 
maximum registered rate transfers into the food, which is then used to 
estimate a conservative dietary exposure. If the aggregate risk 
calculated using this conservative assumption, from use of the 
antimicrobial in question, is less than EPA's level of concern, then no 
measured data are needed. If the aggregate risk meets or exceeds EPA's 
level of concern, then chemical-specific data quantifying residue 
migration to refine this dietary exposure component may be required. To 
refine the exposure, the applicant may choose to perform one or more of 
the FDA protocols to estimate migration rate into food stimulants (see 
document ID number EPA-HQ-OPP-2008-0110-0013). Alternatively, or 
subsequently, the applicant may choose to conduct a chemical-specific 
nature of the residue on surfaces study and a migration study 
investigating actual impregnated materials using representative foods.

C. Alternative Formats for Residue Chemistry Data Requirements Table

    1. Comment. Two different commenters suggested two different 
options as alternative approaches to the antimicrobial residue 
chemistry data requirement table proposed by EPA. One of the commenters 
separated the residue chemistry data requirements into two tables, 
referred to as Part 1 and 2 (ACC comment, identified in the

[[Page 26966]]

docket by document ID number EPA-HQ-OPP-2008-0110-0088.10, p. 7). The 
other commenter suggested a single table format (CSPA Comment, 
identified in the docket by document ID number EPA-HQ-OPP-2008-0110-
0086.2).
    2. EPA's response. All three of the commenter-suggested tables had 
the same five ``Supporting Information'' studies as the first section 
of the table proposed by EPA, but with various mixtures of ``R,'' 
``CR,'' and ``NR.'' In the final rule, EPA has retained the same 
Supporting Information of the first section of the residue chemistry 
table as proposed. However, EPA has adopted the commenters' suggestion 
for a tiered format in the last two sections of the residue chemistry 
table. After review, EPA believes the commenters' suggested tiered 
approach is more suitable to antimicrobials than that proposed by EPA. 
All three of the commenters' tables suggested that Tier I consist of a 
``Screening-level dietary exposure assessment.'' Although an applicant 
may opt to conduct a dietary exposure assessment, EPA does not consider 
this to be a data requirement. Applicants often conduct a dietary 
exposure assessment to understand the dietary risks before submitting 
an application to EPA. If submitted, EPA would review the assumptions 
used by the applicant and compare them to EPA's modeling. If the 
applicant's modeling indicates that dietary risk is likely to meet or 
exceed the Agency's level(s) of concern, the applicant may decide to 
continue on to Tier II or III. Therefore, EPA has not added a 
requirement to conduct a dietary exposure assessment.
    Both the Part 1 Table and the single table suggested that Tier II 
consist of a ``Refined dietary exposure assessment.'' As is the case 
for the commenter's suggested Tier I ``Screening-level dietary exposure 
assessment,'' this is optional for the applicant; therefore, EPA has 
not added a requirement to conduct a refined dietary exposure 
assessment.
    Both the Part 1 Table and the single table suggested that Tier 3 
consist of nature of residue on surface, bioaccumulation, magnitude of 
residue, residue analytical method, and storage stability. These are 
each addressed individually as follows:
    i. Nature of residue on surface. The Agency agrees that this study 
is applicable and a valuable addition to the data set necessary to 
support registration and risk assessment of antimicrobial uses on/in 
food-contact surfaces and impregnated materials (treated articles). EPA 
has added this study to the final residue chemistry data requirements 
table in part 158, subpart W.
    ii. Bioaccumulation. EPA believes that the commenters intended that 
this study apply only to fish and that the bioaccumulation study 
required for ecological effects should substitute for the nature of the 
residue on surface study for aquatic uses or indoor/outdoor raw 
agricultural commodity uses. EPA has found that the fish 
bioaccumulation study is often not useful for residue chemistry 
purposes because characterization of fish residues is only required if 
the bioconcentration (of total residues) factor is > 1,000. The fish 
bioaccumulation study has not been adopted by EPA for residue 
chemistry. Of much more use to residue chemistry and retained in this 
final rule, are the fish metabolism and magnitude of the residue 
studies in fish described in OPPTS Guideline 860.1400.
    iii. Magnitude of residue (MOR). Commenters proposed this study by 
the very general title ``Magnitude of residue.'' EPA considers MOR to 
be any study designed to quantify ``how much'' of the residues of 
concern will result in food, on surfaces, in water, etc., following use 
of an antimicrobial according to label directions. The commenters 
stated in a footnote to this study that, in the case of food-contact 
sanitizers and treated articles, MOR would consist of a migration 
study. Because food-contact sanitizer and treated article uses comprise 
at least 80 percent of all antimicrobial food uses, EPA has retained 
the migration study and the food-handling study by name but has moved 
them to a different tier. All the remaining proposed types of MOR 
studies are much more rarely required due to characteristics such as 
the use pattern and/or physicochemical properties of the antimicrobial 
in question. For that reason, the following have been grouped as 
``Higher tiered'' studies in the final rule: Nature of the residue in 
plants, nature of the residue in livestock, residue analytical methods 
for tolerance enforcement, multiresidue method testing, potable water, 
fish, irrigated crops, meat/milk/poultry/eggs, crop field trials, 
processed food or feed, and anticipated residues.
    iv. Residue analytical method. EPA agrees with the commenters that 
an analytical method for data collection is required whenever magnitude 
of the residue studies are required. The Agency has retained this study 
in the final Residue Chemistry Table.
    v. Storage stability. EPA agrees with the commenters that storage 
stability data are required whenever magnitude of the residue studies 
are required. The Agency has retained this study in the final Residue 
Chemistry Table.
    The Part 2 Table did not recommend requiring a Refined Dietary 
Exposure Assessment. Rather, its Tier 2 consists of studies entitled 
nature of the residue in commodity, nature of the residue in livestock, 
residue analytical methods for enforcement of tolerances, multiresidue 
analytical method, magnitude of the residue: In commodities, in water, 
and in meat/milk/poultry/eggs, storage stability, and anticipated 
residues. EPA agrees that all of these studies should be required and 
has retained all of them in the highest tier in the final Residue 
Chemistry Table. Note that two of the commenter-suggested studies 
(nature of the residue in commodity and magnitude of the residue in 
commodities) were considered applicable only to raw agricultural 
commodities (RACs) treated via a fruit and vegetable rinse; whereas, 
the analogous EPA data requirements apply to both crop plants and 
metabolically-active RACs. The data requirements in EPA's final rule 
easily subsume the studies suggested by a commenter in Part 2. The 
commenters feel that EPA only has authority to require residue data for 
RACs of plants treated by a fruit or vegetable rinse whereas EPA 
interprets FIFRA and FFDCA, as amended by FQPA, to mean that data may 
be required for any use if necessary to support registration of any use 
under FIFRA (see Units XVI.A. and IV.).
    As evidenced by the recommendation to divide EPA's single proposed 
data requirement table into two tables (Parts 1 and 2), the commenters 
believe the data requirements are distinctly different depending on the 
use pattern of interest. While this is sometimes the case, the Agency 
has found that there is much overlap between which studies are 
necessary to characterize the dietary exposure potentially resulting 
from a given use. This is why the test notes provide the conditions 
under which each study is required, likely to be required, or not 
required. EPA has historically used and currently uses a single data 
requirement table for each scientific discipline; doing so permits the 
interrelationships between use pattern, tiering, and data needs to be 
fully evident.
    The commenters did not account for data needed to estimate dietary 
exposure associated with uses that do not require a FFDCA section 408 
tolerance or exemption (see Unit XVI.A. and Unit IV.). The commenters 
also did not account for data needed to estimate dietary exposure from 
food residues inadvertently resulting from, but not limited to, 
discharges of antimicrobial-treated water from indoor industries, 
leaching from preserved lumber, or

[[Page 26967]]

treatment of food crops when a public health claim is made on the 
label.

XVII. SAR and QSAR, and the OCSPP (formerly OPPTS) Integrated Testing 
Vision

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.

A. Guidance on Policies, Procedures, and Processes

    1. Comment. A commenter asked EPA to provide clear guidance on its 
policies, procedures, and processes on the use of alternative 
technologies such as SAR and QSAR, and the WOE approach. In addition, 
the commenter stated that EPA should also provide education and 
training on these approaches.
    2. EPA's response. The Agency encourages applicants to create 
submissions that include predictive techniques such as SAR and QSAR to 
fulfill data requirements. As described in the white paper to the 
proposed rule, 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'' (see document ID number EPA-HQ-OPP-2008-0110-
0045), an important part of the applicant's submission is the 
rationale. The rationale, or WOE evaluation, is the part of the 
submission that explains the applicant's belief as to why and how the 
predictive data would fulfill the data requirement. The WOE approach 
requires a critical analysis of the entire body of available data for 
consistency and biological plausibility. In support of a request that 
predictive data be considered, the applicant would need to explain why 
it believes the surrogate data or the modeling are appropriate for the 
intended use and are of sufficient completeness and quality, and 
therefore would fulfill the data requirement. The Agency would evaluate 
each submission with a WOE rationale on a case-by-case basis.
    The general types of information that are considered appropriate 
for a WOE approach would include:
     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 high 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.
    Regarding SAR/QSAR, the white paper to the proposed rule (p. 30) 
discusses the five criteria set by the OECD for evaluating a model. EPA 
encourages submitters to follow the established criteria set by OECD, 
and show how the model is validated for that particular pesticide 
chemical structure as a measure of the model's applicability.
    Different computer software programs are used to estimate/predict 
different hazards (see: http://www.epa.gov/oppt/sf/tools/methods.htm). 
This means that predictive software models for different scientific 
disciplines are not at the same level of development. The Agency has 
long standing experience in predicting (modeling) physical-chemical 
properties, environmental fate, ecotoxicity, and experience in 
predicting carcinogenesis for certain classes of chemicals. However, 
the Agency is still gaining experience to become familiar with 
predictive approaches that look at other human health endpoints (e.g., 
reproductive, developmental), which have not been widely used at EPA. 
Given the different stages of predictive software development, EPA 
would expect to undertake a case-by-case evaluation of submitted WOEs. 
EPA encourages the use of integrated approaches that combine the 
knowledge from existing data bases about the chemical of interest with 
data from appropriate surrogate chemicals.
    EPA agrees that guidance on the policies, procedures, and processes 
for using alternative approaches such as SAR/QSAR is needed. In 
developing such a guidance document for pesticides, EPA sought to 
harmonize its approach with that of Canada's PMRA . The guidance 
document was issued as a North American Free Trade Agreement guidance 
document in 2012. This guidance document adheres to the five OECD 
principles that were discussed in the white paper and is now considered 
to be the definitive source of information for applicants seeking to 
use SAR and QSAR approaches for fulfilling data requirements for 
pesticide registration. For information, see http://www.epa.gov/oppfead1/international/naftatwg/guidance/guidance.htm.

B. Integrating SAR/QSAR Within the Data Requirements Rule

    1. Comments. One commenter argued that there should be an explicit 
statement that SAR and QSAR can be considered to fulfill data 
requirements. Another commenter had concerns on codifying the use of 
SAR in 40 CFR part 158, subpart A since that would mean that ``SAR/QSAR 
Techniques would be applicable to conventional, biochemical and 
microbial, and antimicrobials pesticide chemicals.'' Another commenter 
requested that SAR/QSAR be fully integrated within the rule.
    2. EPA's response. EPA has and will continue to consider accepting 
SAR/QSAR to fulfill its data requirements on a case-by-case basis. 
Acceptance would be based on the information provided and most 
especially on the supporting rationale submitted to EPA. The Agency 
would evaluate the information submitted to determine if the applicant 
has provided information that is of sufficient quality and 
completeness. The Agency notes that validation of QSAR models is 
necessary before the predictions from those models can be fully 
integrated into the testing requirements. To that end, QSAR models must 
be inclusive of pesticide toxicology data and chemical structures. 
Until these models become customized with pesticide information, full 
incorporation of predictive tools likely will be limited to a case-by-
case basis.
    EPA agrees that if use of SAR/QSAR were to be codified in subpart 
A, that it would be applicable to all pesticide chemicals. At this 
time, EPA is not codifying the use of SAR and QSAR in subpart A.

XVIII. Guidelines

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.

A. Commenters' Concerns with Guidelines

    1. Comment. Several commenters indicated their belief that the 
current Harmonized Guidelines have significant problems, which include:
     Lack of guidelines could create an unevenness from one 
company to another in how the data requirements are applied.
     Data requirements for which guidelines are not available.
     Older, outdated guidelines that need revision.
     Draft guidelines that need to be finalized.
     Older exposure guidelines that do not include information 
about the Human Studies Review Board.
     Guidelines that were adopted without the opportunity for 
public comment.

[[Page 26968]]

    According to the commenters, lack of current guidelines could 
create an unevenness from one company to another in how the data 
requirements are applied. The commenter argued that the Agency needs to 
provide current, consistent, and reliable guidance and standards for 
each data requirement. The commenters recommended that EPA finalize all 
of its guidelines before the final rule is published per the 
recommendation from OMB.
    2. EPA's response. EPA's Harmonized Test Guidelines are publicly-
available at http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm. The 
Harmonized Guidelines contain recommendations on how to conduct a study 
that is most likely to provide the information needed by EPA for making 
a registration decision.
    The Harmonized Guidelines are guidance. The guidelines themselves 
do not impose mandatory requirements. Applicants are not required to 
submit studies developed according to the guidelines to fulfill a data 
requirement. However, EPA encourages applicants to use the guidelines. 
These guidelines were developed to provide applicants, who would be 
conducting the studies, with recognized approaches for developing high 
quality data, guidance on evaluating and reporting data, definition of 
terms, and suggested study protocols. It would not be possible to 
address every conceivable circumstance that could occur when conducting 
a particular study. Instead the guidelines provide a framework that 
provides recommended approaches for conducting studies while offering 
flexibility and accommodation for individual circumstances where 
appropriate. EPA has reviewed and accepted many studies, on a case-by-
case basis, that were not conducted in accordance with current 
guidelines, but which provided suitable information for risk assessment 
purposes.
    Since guidelines cannot account for every conceivable circumstance, 
EPA, for certain studies, proposed a ``required'' or ``highly 
suggested'' protocol submission and review step in the test notes to 
the tables in the proposed rule. Generally, these pertain to those 
studies that are ``newer'' or have not been routinely conducted. Given 
that the applicant community and contracting laboratories would have 
less experience in conducting these kinds of ``newer'' studies, 
protocol submission, review, and meetings about proposed protocols are 
beneficial to both the applicant and EPA, and help assure that the 
study submitted for review should provide the information needed by EPA 
for its registration decision.
    EPA acknowledges that in some instances there are: Data 
requirements for which guidelines are not available; outdated 
guidelines that need revision; and draft guidelines that need to be 
finalized. Ideally, up-to-date final guidelines would be available for 
every data requirement. Up-to-date guidelines increase the possibility 
that EPA will receive useful data and that applicants can produce such 
data in the most cost-efficient and consistent manner. However, given 
the rapidly evolving scientific methods for conducting toxicity, 
exposure, and ecological studies with pesticides, study guidelines 
often need frequent updating to include the latest techniques and 
methods. Moreover, the need for openness and transparency means that 
developing a guideline or updating an existing one can be a lengthy 
process. In a letter to CropLife America (June 26, 2009), (Ref. 12) the 
Agency discussed the timeframe for developing the Terrestrial Field 
Dissipation Guideline (835.6100), which spanned 15 years. During that 
time period, there were presentations to the SAP, at various symposia, 
including ones conducted by the American Chemical Society and the 
American Society of Agronomy, and to a workshop in Washington, DC co-
hosted by EPA and Canada's Pest Management Regulatory Agency.
    Thus, the reality is that test guidelines will always be a work in 
progress. At the same time, EPA is implementing a regulatory program 
under FIFRA and FFDCA section 408 under which it must make timely 
decisions on the safety of pesticide products based on toxicity and 
exposure testing. Guidance on optimal testing procedures remains an 
Agency goal but the absence of testing guidelines is not a barrier to 
the imposition of testing requirements necessary to make the required 
statutory findings.
    In 2008, OMB, during its Executive Order 12866 review of the 
proposed rule, recommended that certain draft guidelines be finalized 
before publishing the Antimicrobial Data Requirements final rule. These 
guidelines were:
     Applicator product use information (OPPTS 875.1700).
     Post application product use information (OPPTS 875.2700).
     Indoor surface residue dissipation (OPPTS 875.2300).
     Non-dietary ingestion (OPPTS 875.3000).
    In the proposed rule (73 FR 59382, October 8, 2008), EPA discussed 
that the publicly-available versions of these draft guidelines were 
available on the SAP portion of EPA's Web site http://www.epa.gov/scipoly/sap/meetings/1998/march/contents.htm. Since the two product use 
information related guidelines (875.1700 and 875.2700) are expected to 
provide similar guidance for the narrative descriptions that the 
related data requirements call for, EPA intends to update them 
together.
    The indoor surface residue dissipation draft guideline (875.2300) 
will be updated before issued in final form to account for new advances 
in how exposure is measured and modeled and to provide more information 
on additional methods. EPA intends to revise the draft guideline to 
expand the methods for antimicrobial uses, and has begun to work with 
EPA's ORD to develop additional methods (e.g., one current project is 
to develop guidance for testing in small scale air chambers). EPA is 
also consulting with the Consumer Product Safety Commission (CPSC) to 
review their sampling methods for similar products (e.g., chemicals 
leaching from fabrics).
    Also, as previously discussed, the proposed data requirement 
referencing the non-dietary ingestion guideline (identified as 
875.3000) is not included in the final post-applicator exposure table 
in Sec.  158.2270. As a result, that draft guideline is no longer 
referenced in part 158. (See Unit XIII.D.).
    In addition, as noted in the proposed rule, EPA notes that it has 
reviewed and accepted many studies, on a case-by-case basis, that were 
not conducted in accordance with current final guidelines, but which 
serve its needs and provide suitable information for risk assessment 
purposes. The guidelines themselves do not impose mandatory 
requirements. Instead, they present recognized standards for conducting 
acceptable tests, guidance on evaluating and reporting data, definition 
of terms, and suggested study protocols. The draft guidelines, 
therefore, serve as a starting point for developing study protocols. 
The Agency's scientists can also provide guidance to applicants, 
registrants, or task forces on aspects of study design that is often 
discussed at pre-protocol submission meetings. The Agency's scientists 
are always willing to work with individual applicants or registrants to 
develop study designs to fulfill data requirements.
    EPA acknowledges that the guidelines for dermal and inhalation 
exposure studies need revisions to account for new advances in how 
exposure is measured and modeled. To provide needed information to the 
public and applicants, EPA will change the way these guidelines are 
referenced on the Harmonized Guidelines Web site by

[[Page 26969]]

adding links to the SAP and Human Studies Review Board (HSRB) meetings 
at which the changes needed to conduct one of these studies were 
publicly discussed.
    Since the publication of the proposed rule on October 8, 2008, EPA 
has worked to update and finalize a number of guidelines. In the 
Federal Register of April 15, 2009 (74 FR 17479) (FRL-8352-8), EPA 
issued a Notice of Availability describing updates to 16 environmental 
fate guidelines.
    In the Federal Register of January 27, 2010 (75 FR 4380) (FRL-8437-
2), EPA published four draft product performance guidelines for comment 
(i.e., 810.2000, 810.2100, 810.2200, and 810.2300). These four 
guidelines were developed over an extended period of time with multiple 
levels of review across divisions and program offices in EPA, expert 
external peer review by the FIFRA SAP, and discussions with and 
comments from the regulated community. After soliciting public comment 
in 2010, EPA announced the availability of the final guidelines in the 
Federal Register of March 16, 2012 (77 FR 15750) (FRL-9332-4). Many of 
the technical changes described in these four guidelines have been in 
use by the Agency for several years.
    Three additional Product Performance Guidelines (i.e., 810.2400, 
810.2500, and 810.2600) published for public comment on September 15, 
2011 (76 FR 57031) (FRL-8879-1), and in the Federal Register of June 
27, 2012 (77 FR 38280) (FRL-9349-5), EPA announced the availability of 
the final guidelines.
    Also in the Federal Register of June 27, 2012 (77 FR 38282) (FRL-
9333-1), EPA announced the availability of 26 Ecological Effects Test 
Guidelines in Series 850, and Groups B, C, D and F. In finalizing the 
guidelines, EPA changed the numbering and/or titles of certain 
guidelines, and split or merged other guidelines. EPA continues to work 
to revise the remaining Ecological Effects Test Guidelines, Group A, 
and anticipates finalizing many of these guidelines in 2013.
    Before finalizing a guideline, EPA provides many opportunities for 
public comment. EPA's commitment to transparency is not new. 
Transparency allows all stakeholders to know what, how, and why EPA is 
adopting a guideline. EPA's procedures for developing a guideline is 
described in a Notice of Availability that published on August 28, 1996 
(61 FR 44308) (FRL-5390-7):
     Guidelines under development (whether new or being 
substantially revised) are made available for public comment.
     Guidelines under development (whether new or being 
substantially revised) undergo an external peer review process. Most 
commonly, the peer review process would be a review by the FIFRA SAP.
     Reformatted guidelines (no substantial revisions) are not 
subject to review and comment.
     Public review and comment is also used when EPA guidelines 
are being harmonized with OECD guidelines.

B. Harmonization of Guidelines With OECD

    1. Comment. EPA should harmonize its guidelines with those of OECD.
    2. EPA's response. EPA agrees with this comment and is continuing 
to harmonize guidelines, to the extent practicable, as they are 
revised. As noted on its Web site http://www.epa.gov/pesticides/science/guidelines.htm, EPA has several harmonization activities 
underway with the OECD. The Master List of Harmonized Test Guidelines 
includes a reference to an OECD guideline, once harmonized. All 
harmonized OECD test guidelines (http://www.epa.gov/epahome/exitepa.htm) fall under the OECD Mutual Acceptance of Data decision, 
which calls for acceptance for regulatory use by all OECD member 
nations. Additionally, under 40 CFR 158.70(d)(2), acceptance of testing 
conducted in accordance with OECD protocols is described.
    Harmonized test guidelines reduce the burden on chemical producers 
and conserve scientific resources, including the minimal use of 
laboratory test animals. They also form a basis for work sharing and 
cooperation among all OECD countries. U.S. experts are engaged in 
harmonization activities through OECD to revise toxicology and 
ecotoxicology test guidelines. These revisions will emphasize 
reduction, refinement, or replacement of animal testing, while 
incorporating the latest advances in science. Animal welfare concerns 
and international regulatory needs are being considered in the course 
of these revisions of the test guidelines. In addition, EPA is actively 
engaged in OECD's development and harmonization efforts for guidelines 
to address environmental fate, endocrine disruptor screening, and 
efficacy of antimicrobial pesticides.
    Tests conducted in accordance with the requirements and 
recommendations of the applicable OECD protocols can be used to develop 
data necessary to fulfill the data requirements. However, some of the 
OECD recommended test standards, such as test duration and selection of 
test species, are less restrictive than those recommended by EPA. When 
using OECD protocols, applicants should be careful to observe the test 
standards so that the data generated will satisfy the EPA data 
requirements.

C. Guidelines Specific to Antimicrobials

    1. Comment. The commenter claimed that guidelines specific to 
antimicrobials are needed.
    2. EPA's response. EPA agrees that for certain scientific 
disciplines or certain studies antimicrobial-specific guidance may be 
needed. The data required to demonstrate product performance would be 
very different for an insect repellent or a termiticide versus that 
needed for sanitizers and disinfectants. Exposure studies could be 
conducted differently for an antimicrobial used in a food-processing 
plant versus a conventional pesticide sprayed on an agricultural field. 
Exposure studies could also be conducted via the same method: A spray 
can with an insecticide is assessed using the same techniques as a 
spray can with a disinfectant, with any differences in the assessment 
being attributed to actual use conditions, such as, indoors versus 
outdoors or surfaces sprayed. For other scientific disciplines such as 
toxicology or product chemistry, generally, with a few exceptions, the 
guidance would be the same. A carcinogenicity, developmental, or 
reproductive toxicity study would be conducted similarly for an 
antimicrobial or a conventional pesticide. However, as noted in Unit 
X.F., the Ames assay may not be useful for assessment of mutagenic 
potential of antimicrobial pesticides.

XIX. Endangered Species Assessments

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.

A. Endangered Species Assessment for Antimicrobials

    1. Comment. The commenter argued that EPA needs to recognize the 
manner in which antimicrobials may result in environmental exposure and 
the regulations under statutes other than FIFRA in order to promote an 
effective and efficient approach to regulating antimicrobial pesticides 
with regard to endangered and threatened species. According to the 
commenter, antimicrobials are not applied directly to the environment, 
but environmental exposures from antimicrobial pesticides result from 
point-source discharges or

[[Page 26970]]

slow release from pesticide-containing materials.
    2. EPA's response. EPA agrees that there are differences between 
antimicrobial pesticides and agricultural pesticides. As discussed in 
the proposed rule (October 8, 2008, 73 FR 59425), for agricultural 
pesticides, there is generally greater specificity relative to where a 
pesticide may be used compared to antimicrobial pesticides. 
Agricultural pesticides are typically used on crops. As part of its 
endangered and threatened species assessment, EPA extracts information 
on county-level crop occurrence and acreage within counties of 
particular crops from the most recent USDA National Agricultural 
Statistics Services' Census of Agriculture. Because antimicrobial 
pesticides are typically not applied directly to the environment, it is 
easier to delineate and overlay agricultural pesticide use with 
endangered or threatened species locations than to delineate and 
overlay antimicrobial pesticides use. Nevertheless, wood preservatives, 
antifoulant paints and coatings, and other antimicrobial uses, 
including uses in swimming pool water, industrial slimicides used in 
recirculating water cooling towers, and paper mills, have the potential 
for environmental exposures. The Agency is working to refine its 
endangered species assessment for antimicrobial pesticides to account 
for the unique mechanisms involved in application and use of 
antimicrobial pesticides, and the different routes through which 
antimicrobial pesticides enter the environment.
    EPA recognizes that antimicrobials, like any other pesticide 
product, may be subject to other Federal, State and local laws. FIFRA 
requires that, before a pesticide may be lawfully sold or distributed 
in the United States, the product must be registered by EPA, unless the 
product is exempt from registration requirements. Prior to registering 
a pesticide product, EPA must first ensure that the pesticide, when 
used according to label directions, can be used without posing 
unreasonable risks to humans and the environment. The registration of a 
pesticide product, whether it is an antimicrobial or other type of 
pesticide product, is considered an ``action'' subject to the 
Endangered Species Act (ESA). The ESA requires all Federal agencies to 
ensure that any action they permit or authorize will not result in 
likely jeopardy to the continued existence of endangered or threatened 
species, or destroy or adversely modify habitat designated as critical 
by the U.S. Fish and Wildlife Service (FWS) or National Marine 
Fisheries Service (NMFS).
    In order to ensure EPA's actions are consistent with the ESA, the 
Agency must assess the potential for both direct and indirect effects 
to any potentially exposed threatened or endangered species and 
critical habitat, independent of whether exposure results from a point-
source discharge or the slow release of a pesticide containing 
material. If effects may occur, EPA consults with the FWS or NMFS to 
determine whether there may be jeopardy to the species or destruction 
or adverse modification to habitat designated as critical.

B. Method for Conducting Endangered Species Assessments

    1. Comment. A commenter claimed that EPA/OPP does not have a mature 
program currently in place for antimicrobial environmental risk 
assessment generally. More specifically, the commenter contended that 
EPA does not have a program in place for assessing potential impacts on 
endangered and threatened species relevant to antimicrobials and their 
uses. The commenter argued that until EPA scientifically substantiates 
data requirements to use in estimating antimicrobial environmental 
exposures and modeling and the potential for risks from such exposures, 
it will not be feasible to make any meaningful determinations on 
potential impacts to endangered species. The commenter concluded that 
it is thus premature for the EPA to determine how it should approach 
antimicrobials with regard to endangered species.
    2. EPA's response. EPA disagrees with the commenter. EPA has a 
robust program for completing antimicrobial environmental risk 
assessments, as outlined in the preamble to the proposed rule (73 FR 
59405). Environmental fate studies evaluate the mobility, distribution 
and dissipation of a pesticide in various compartments of the 
environment, such as water, soil, air, and sediment. Ecological effects 
data are used by the Agency to determine the toxicological hazards of 
pesticides to various nontarget organisms, such as birds, mammals, 
fish, bees, terrestrial and aquatic invertebrates, and plants. The 
required environmental fate studies and ecological effects (both plant 
and animal) data provide the foundation for an environmental risk 
assessment. EPA's environmental risk assessment for antimicrobials 
combines environmental fate studies with ecological effects data to 
determine the potential of the pesticide to cause harmful effects to 
nontarget organisms and plants. The data requirements that will be 
codified in the final rule will provide sufficient information for EPA 
to perform an ecological risk assessment.
    EPA/OPP's process for assessing the potential risks of a pesticide 
to federally-listed threatened or endangered species and their 
designated critical habitat is described in the document titled 
``Overview of the Ecological Risk Assessment Process in the Office of 
Pesticide Programs, U.S. Environmental Protection Agency--Endangered 
and Threatened Species Effects Determinations'' (Ref. 13). Appendix A 
to that document--``Overview of OPP's Screening-Level Ecological Risk 
Assessment Process for Antimicrobial Pesticides''--explains both the 
data needed and the process that would be used by EPA to assess 
potential risks to endangered and threatened species from antimicrobial 
pesticides.
    EPA's assessment of potential impacts on endangered and threatened 
species begins with a screening level assessment to determine if there 
is a potential concern. When the screening-level ecological risk 
assessment raises potential concerns related to a listed species, EPA 
then conducts a species-specific evaluation to refine the assessment. 
The more refined assessment should involve clear delineation of the 
action area associated with the proposed use of the pesticide and best 
available information on the temporal and spatial co-location of the 
listed species with respect to the action area. EPA notes that with the 
publication of the proposed rule, the discussion in Appendix A is out 
of date. In response to comments received on the proposed antimicrobial 
data requirements, EPA indicated it is no longer relying on its 
proposed approach classifying use patterns as high/low or minimal/
significant exposure uses with regard to ecological effects testing. 
However, the Agency's basic approach to endangered species risk 
assessments, which combine environmental fate studies with ecological 
effects data to determine the potential of the pesticide to cause 
harmful effects to endangered species, has not changed. In addition, 
the Agency will conduct an assessment for antimicrobial pesticides with 
down-the-drain uses, as described in response to comment 134.1 in the 
Response to Comments Document in the docket. The codified data 
requirements and the down-the-drain assessment will extend EPA's 
Antimicrobial Division's ability to understand the potential impacts of 
antimicrobial pesticides on endangered species.

[[Page 26971]]

    EPA cannot wait to comply with the ESA until newer, more advanced, 
models are available or additional data needs are determined. Federal 
agencies must comply with the ESA by performing their assessments and 
analyses using the best scientific and commercial data available. As a 
part of Registration Review, EPA is conducting species-specific 
environmental risk assessments that will allow EPA to determine whether 
the antimicrobial pesticide product has ``no effect'' or ``may affect'' 
federally-listed threatened or endangered species (listed species) or 
their designated critical habitats. When an assessment concludes that a 
pesticide product's use ``may effect'' a listed species or its 
designated critical habitat, the Agency will consult with the FWS and/
or NMFS, as appropriate.

XX. Endocrine Disruption

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.
    1. Comment. The commenters noted that EPA did not include any 
studies to assess endocrine disruption effects.
    2. EPA's response. The commenter is correct that EPA did not 
include, within proposed part 158, subpart W, studies whose sole 
purpose is to assess endocrine disruption effects in avian and aquatic 
species. The Agency is also not including such studies in this final 
rule.
    With regards to toxicology data requirements, as required by FIFRA 
and FFDCA, EPA reviews a toxicological data base of numerous studies to 
assess potential adverse outcomes from exposure to chemicals. 
Collectively, these studies include acute, subchronic and chronic 
toxicity, including assessments of carcinogenicity, neurotoxicity, 
developmental, reproductive, and general or systemic toxicity. These 
studies include endpoints which may be susceptible to endocrine 
influence, including effects on endocrine target organ histopathology, 
organ weights, estrus cyclicity, sexual maturation, fertility, 
pregnancy rates, reproductive loss, and sex ratios in offspring. EPA 
reviews these data and selects the most sensitive endpoints for 
relevant risk assessment scenarios from the existing toxicological data 
base.
    With regards to ecotoxicity data requirements, as required by FIFRA 
and FFDCA, EPA reviews a nontarget organism data base of numerous 
studies to assess potential adverse outcomes from exposure to 
chemicals. For ecological hazard assessments, EPA evaluates acute tests 
and chronic studies that assess growth, developmental and reproductive 
effects in different taxonomic groups. EPA reviews these data and 
selects the most sensitive endpoints for relevant risk assessment 
scenarios from the existing nontarget organism database.
    Through a separate effort, the Agency has also developed a 
screening battery to identify chemicals that may have effects on the 
hormone systems of humans and wildlife. As required under FFDCA section 
408(p), the Agency developed the Endocrine Disruptor Screening Program 
(EDSP) to determine whether certain substances (including pesticide 
active and other ingredients) may have an effect in humans or wildlife 
similar to an effect produced by a ``naturally occurring estrogen, or 
other such endocrine effects as the Administrator may designate.'' The 
EDSP employs a two-tiered approach to making the statutorily required 
determinations. Tier I consists of a battery of 11 screening assays to 
identify the potential of a chemical substance to interact with the 
estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals 
that go through Tier I screening and are found to have the potential to 
interact with E, A, or T hormonal systems will proceed to the next 
stage of the EDSP where EPA will determine which, if any, of the Tier 2 
tests are necessary based on the available data. Tier 2 testing is 
designed to identify any adverse endocrine-related effects caused by 
the substance, and establish a dose-response relationship between the 
dose and the E, A, or T effect.
    Between October 2009 and February 2010, EPA issued test orders/data 
call-ins for 58 pesticide active ingredients and 9 inert ingredients. 
This list of chemicals was selected based on the potential for human 
exposure through pathways such as food and water, residential activity, 
and certain post-application agricultural scenarios. This list should 
not be construed as a list of known or likely endocrine disruptors.
    Under FFDCA section 408(p) the Agency must screen all pesticide 
chemicals, including antimicrobials. Accordingly, EPA anticipates 
issuing future EDSP test orders/data call-ins for all pesticide active 
ingredients.
    For further information on the EDSP including the status and test 
guidelines, please visit the Web site: http://www.epa.gov/endo/.

XXI. Effective Date of Final Antimicrobial Data Requirements

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.
    1. Comment. Several commenters have expressed concern over when the 
final rule would take effect. One commenter stated that compliance with 
the Administrative Procedures Act requires EPA to apply any final 
rulemaking on data requirements for antimicrobials only to applications 
submitted after the effective date; otherwise, EPA would be 
promulgating the final rule retroactively. The commenter also asserted 
that EPA should be consistent in its implementation of effective dates, 
noting that EPA did not impose new data requirements on pending 
conventional pesticide registrants when the conventional pesticide 
rules were revised. A second commenter suggested that registrations 
pending at the time of the final rule publication be given conditional 
registration under section 3(c)(7) of FIFRA or under section 3(c)(5) if 
the requirements of part 161 have been met, and that implementation of 
the part 158, subpart W data requirements occur at the time of periodic 
registration review. Another commenter noted that EPA has provided 
reasonable notice to registrants and recommends that EPA implement the 
rule as soon as technically feasible. A different commenter questioned 
whether additional Pesticide Registration Improvement Act (PRIA) 
registration fees would be required for pending applications if the 
registrant did not meet new data requirements and withdrew the 
application, or if the Agency issued a determination that it cannot 
grant the application.
    2. EPA's response. EPA will follow an approach similar to that used 
for conventional pesticides following the promulgation of that portion 
of 40 CFR part 158.
    As previously discussed, the final rule for antimicrobials contains 
11 ``new'' data requirements. ``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. The 
new data requirements being codified include eight that were proposed 
and three that have been added based on public comments received about 
the proposed rule.

[[Page 26972]]

    EPA recognizes that during early implementation of 40 CFR part 158, 
subpart W not all application packages may have all of the newly-
required data. Therefore during early implementation of 40 CFR part 
158, subpart W, EPA will accept for review and evaluation application 
packages that may not have all of the newly required data in 
appropriate cases supported by adequate justification. This early 
implementation period could extend up to 2 years post-promulgation for 
situations in which a more time-intensive new study is missing but 
could be less for other situations, such as for less time-intensive new 
studies. The applicant should address the issue of timing (i.e., why 
the data are not yet submitted and when the data can be submitted) with 
respect to any missing newly-required data, in their justification.
    EPA is statutorily required to evaluate the proposed pesticide 
thoroughly to ensure that it will not unreasonably harm human health or 
the environment. For pesticides needing FFDCA section 408 tolerances, 
EPA is statutorily required to make a safety finding that the pesticide 
can be used with ``reasonable certainty of no harm.'' In cases where 
the application may not have all the required data, EPA would evaluate 
whether a registration determination or a safety finding can be made 
based on the available data or on the results of other studies in the 
pesticide's data base. If there is insufficient information, and if the 
data base does not provide information on the endpoints that would be 
tested, or data provided by the applicant or information in the data 
base shows evidence of effects, EPA may not be able to make a 
registration decision or safety finding. In such cases, the application 
may be denied or the applicant may choose to withdraw the application 
pending completion of the needed data. In some cases, conditional 
registrations may be appropriate for consideration. Among other things, 
a determination that the proposed use will not significantly increase 
the risk of unreasonable adverse effects on the environment will need 
to be made. If EPA can make that determination and the other elements 
for a conditional registration are met, then a conditional registration 
may be appropriate and the new data required as a condition of 
registration. If there is a basis for granting a conditional 
registration, then the timeframe for conditioning the registration 
would be determined based on factors such as the required studies 
involved and the length of time required to conduct those studies.
    Importantly, it should be noted that acceptance of an application 
for processing during early implementation of 40 CFR part 158, subpart 
W, that does not result in a conditional registration, does not 
permanently relieve the applicant from providing the newly required 
data. Based on the particular case involved, the Agency will employ 
appropriate mechanisms, for example, through a data call-in or through 
the registration review process, to ensure the generation and 
submission of any missing newly-required data.
    With respect to pending applications that are withdrawn, additional 
Pesticide Registration Improvement Act (PRIA) registration fees will 
generally only be required if the applicant seeks to pursue the action 
again by submitting a new application (and addressing the deficiencies 
in the original application). In withdrawal situations, the Agency 
provides a refund for any work that the Agency did not perform on the 
application following a withdrawal. Similarly, a determination that the 
application cannot be granted does not require additional PRIA 
registration fees. In that case, additional fees will only be incurred 
if the application is subsequently withdrawn or denied, and the 
applicant seeks to pursue the action again and submits a new 
application.

XXII. Economic Analysis

    This unit summarizes the significant public comments and EPA's 
response to those comments. A more detailed discussion can be found in 
the Response to Comments Document available in the docket to this rule.

A. Comparing Estimates of Cost of the Proposed Rule

    1. Comment. A commenter performed an independent economic analysis 
(EA) for the proposed rule. According to the commenter's analysis, the 
cost of proposed part 158, subpart W is greater than that estimated by 
the EPA. In addition, the unit test costs and frequency of tests used 
in the commenter's analysis are different than EPA's.
    2. EPA's response. EPA reviewed the commenter's analysis and based 
on that review revised the EA for the final rule. EPA's evaluation of 
the commenter's EA indicated there were the following differences 
between the two EAs:
     The cost estimates used for the studies,
     Overhead costs were included by the commenter, but not by 
EPA,
     Costs for Registration Review (see Unit XXII.C.).

The differences between the cost of the proposed rule as estimated by 
the commenter and the cost as assessed by the Agency for new 
registrations are explained in the following subunits.
    i. How data requirement costs are calculated. The annual cost of a 
data requirement is the product of three factors: Unit test cost, 
probability of the test being required, and the number of registrations 
in the industry per year for the registration type and use. That is: 
``Industry cost of a data requirement = Unit test cost x test 
probability x number of registrations.'' These costs are summed for all 
data requirements, uses, and registration types to get the total annual 
cost of the data requirements for the industry.
    ii. Differences in unit test costs. EPA acknowledges that there are 
significant differences between the Agency's analysis and the 
commenter's analysis regarding the unit test costs. According to the 
commenter's EA, the costs were provided to them by their client's 
technical consultants, and are ``based on quotes from laboratories, 
actual experience, and professional judgment.'' The commenter did not 
provide sufficient information with which to evaluate the commenter's 
test cost estimates. Additionally, EPA notes that having all test cost 
estimates ending in zero could be indicative of estimation.
    EPA's unit test costs for each data requirement were obtained by 
contacting established contract research organizations (CROs) to assess 
what the labs would charge to conduct studies according to specific 
designs provided by EPA, or as specified in OPPTS guidelines (now OCSPP 
guidelines). Upper and lower cost estimates were requested. For each 
test, the upper cost estimates from each CRO were averaged to obtain a 
high average estimate. A similar calculation was done for the lower 
cost estimate. EPA's estimate is the average of the high and low 
average estimates.
    iii. Test costs and overhead costs. The commenter added 30 percent 
to their test cost estimates to account for the overhead of the 
registrants managing and overseeing the tests they contract to the 
labs. EPA acknowledges that there are costs other than test costs 
associated with registering and maintaining the registrations of 
pesticide products. Overhead is not a new cost, attributable to the 
rule, and EPA does not believe that overhead costs will change 
significantly as a result of codifying data requirements for 
antimicrobials. EPA does not include overhead costs in its economic 
analyses of data requirements rules because the Agency accounts for 
other registration costs such as overhead

[[Page 26973]]

in the Information Collection Request (ICR) for FIFRA Section 3 
Registration under the Paperwork Reduction Act.
    iv. Test probabilities. EPA's test probabilities (the probabilities 
of tests being required for a registration action) were based on a 
sample of 70 actual antimicrobial registration actions out of 90 
relevant new registration actions during the 6 year period beginning 
2000 and ending 2005, supplemented with EPA's scientific judgment. The 
time period (2000-2005) was chosen for EPA's EA because the analysis in 
the EA was started in 2006. The commenter claims to have based the test 
probabilities used to make their estimates on a sample of 29 
registration review cases (not new registrations) occurring between 
2008 and 2010.
    v. Factors which drive costs for new registrations. To determine 
the influence of the previously-discussed factors on the difference 
between the commenter's and EPA's estimates, EPA performed the 
following analysis on the data requirements costs and incremental costs 
using the same unit test costs and test probabilities used in the 
proposed rule:
     To account for the effect of the unit test costs on the 
data requirements costs and incremental costs, EPA substituted the 
commenter's unit test costs without overhead into EPA's analysis of the 
proposed rule using EPA's test probabilities and number of 
registrations. If there were no changes, this would indicate that the 
test costs were not driving the differences in estimates.
     To account for the effect of test probabilities and number 
of registrations, EPA substituted the commenter's unit test costs with 
overhead into EPA's analysis. In this case, the difference between the 
EPA's and the commenter's analysis is contained in the test 
probabilities and number of registrations. If there were no changes, 
this would indicate that the test probabilities and number of 
registrations were not driving the differences between the two 
analyses. Since the commenter includes overhead in their analysis, 
overhead was included in this comparison to make other things equal so 
that the differences in test probabilities and number of registrations 
could be isolated.
    vi. Results. The results of the factor analysis are presented in 
the following Table 1.

                 Table 1--Comparison of Data Requirement Costs and Factors for New Registrations
----------------------------------------------------------------------------------------------------------------
             Factors                       A                   B                   C                   D
----------------------------------------------------------------------------------------------------------------
Unit Test Costs according to:...  EPA Proposed Rule.  Commenter without   Commenter with 30   Commenter with 30
                                                       overhead.           percent overhead.   percent overhead.
Test Probabilities according to:  EPA...............  EPA...............  EPA...............  Commenter.
Number of Registrations           EPA...............  EPA...............  EPA...............  Commenter.
 according to:
Data Requirement Cost according   $15.0.............  $19.9.............  $25.5.............  $25.9.
 to Proposed Rule ($ millions).
Cost of Proposed Rule             $3.9..............  $7.6..............  $9.8..............  $9.2.
 (Incremental Costs) ($
 millions).
----------------------------------------------------------------------------------------------------------------

    Column A exhibits the data requirements and incremental costs from 
EPA's EA of the proposed rule. In column B, the data requirements and 
incremental costs are calculated using the commenter's unit test costs 
without overhead costs, but EPA's test probabilities and number of 
registrations. Column C is the same as column B, but with overhead 
costs included. Finally, column D exhibits the data requirements and 
incremental costs with overhead as calculated by the commenter.
    The result of the first factor analysis is demonstrated by 
comparing column A to column B. In this case, the difference between 
the two columns is the unit test costs. Inserting the commenter's unit 
test costs, without overhead, into the cost estimates with EPA's test 
probabilities and number of registrations leads to over a 30 percent 
increase in data requirements cost and a nearly 100 percent increase in 
incremental costs.
    The result of the second factor analysis is demonstrated by 
comparing columns C and D. In this case, the difference between the two 
columns is in the test probabilities and number of registrations. While 
individual test probabilities may be different in EPA's and the 
commenter's analyses, the overall effect of the products of test 
probabilities and number of registrations, when summed with the unit 
test costs, including overhead, are similar in both of these analyses. 
The resulting differences in data requirements cost and incremental 
costs are less than 2 percent and about 6 percent, respectively. 
Therefore, EPA concludes that any differences in test probabilities and 
number of registrations used as input parameters in the calculations do 
not have a significant effect on the total data requirement cost of new 
registrations.
    Comparisons across columns A, B, and C also provide information on 
the portion of the cost difference accounted for by overhead costs. 
Columns A, B, and C compare the cost of data requirements using the 
unit test cost estimates of EPA and those of the commenter with and 
without overhead. The overhead costs account for more than one-half of 
the difference in the total cost of the data requirements, but less 
than 40 percent of the difference in incremental costs (the incremental 
cost is the increase in costs between the baseline (the existing data 
requirements in part 161) and proposed part 158, subpart W).
    From this comparison, EPA makes the following conclusions. First, 
differences in test probabilities and number of registrations do not 
have a significant impact on the cost of the rule. Second, even if EPA 
and the commenter used the same probabilities and test costs, inclusion 
of overhead costs by the commenter would result in a 30 percent 
difference in costs. Finally, when the overhead costs are removed from 
the commenter's analysis, differences in unit test costs between EPA 
and the commenter account for most of the differences in the estimates 
of the cost of the rule for new registrations.
    vii. Revised test costs. In light of the results of the comparison 
between EPA's and the commenter's EA, EPA sought to verify its unit 
test cost estimates. To examine the costs submitted by ACC, EPA 
resurveyed the cost of conducting studies for 30 data requirements: The 
criteria for selecting which test's cost to update included how the 
difference in estimates would impact on the cost of the rule, the 
magnitude of the differences in estimates, and the age and source of 
EPA's estimates. EPA's data gathering

[[Page 26974]]

methodology is reproducible, and based on actual data. EPA does not 
adjust the lab's cost estimates, i.e., the costs are used as obtained 
from the laboratory. Under the Information Quality Act (IQA), EPA must 
ensure and maximize the quality, objectivity, utility, and integrity of 
the data used in its analyses.
    The resurveyed test costs are used in the EA for the final rule. 
EPA is using its cost estimates because it has revised its most 
relevant and oldest unit test cost estimates. In addition, the 
commenter did not provide a basis or sufficient explanation that would 
meet the standards of the IQA to justify EPA's accepting the 
commenter's costs. For additional information see response to comment 
40.1 in the Response to Comments Document and the final economic 
analysis, both in the docket.

B. Impact on Small Businesses

    1. Comment. A commenter claimed that EPA underestimated costs, is 
not fully complying with the Regulatory Flexibility Act (RFA) and the 
Small Business Regulatory Enforcement Fairness Act (SBREFA), and must 
prepare an Initial Regulatory Flexibility Assessment (IRFA). In 
addition, the commenter argued that small businesses will be adversely 
affected, that there will be an ``increased disparity between 
registrants and a more uneven playing field,'' and finally, that a 
SBREFA analysis should have been conducted.
    2. EPA's response. EPA acknowledges that the cost of the data 
requirements would likely be a larger percentage of a small business's 
revenues, but did not find that the rule would have a significant 
adverse economic impact on a substantial number of small firms.
    A regulatory flexibility analysis examines the type and number of 
small entities potentially subject to the rule, recordkeeping and 
compliance requirements, and significant regulatory alternatives, among 
other things. RFA, as amended by SBREFA, requires EPA to consider the 
economic impact of proposed rules on small entities. RFA requires EPA 
to prepare an IRFA for each proposed rule, when the rule will have a 
significant economic impact on a substantial number of small entities.
    To comply with RFA, EPA did a retrospective analysis of what the 
additional costs would have been on actual new registrations if the 
proposed rule had been in effect during 2000-2005. This analysis did 
not indicate a significant impact on a substantial number of small 
entities; instead, the analysis indicated that 5 percent of small firms 
(25 out of 500) are likely to experience some impact and only 2.8 
percent of small firms (14 out of 500) are likely to experience an 
economic impact of 3 percent or more of gross sales. Based on this 
analysis, EPA certified that the proposed rule would not have a 
significant adverse economic impact on a substantial number of small 
firms. As a result, EPA did not have to conduct an IRFA nor convene a 
SBREFA Panel for the proposed part 158, subpart W rule.
    In the EA for the final rule, EPA reestimated the SBREFA analysis 
with revised unit test costs and changes in data requirements.
     About 23 small firms (almost 5 percent) are likely to 
experience an economic impact of 3 percent or more of gross sales, and
     About 26 small firms, (over 5 percent) are likely to 
experience an economic impact of 1 percent or more of gross sales.
    Hence, had these results been estimated at the proposal stage, EPA 
would still have concluded that there would not be a significant impact 
on a substantial number of small entities.

C. Cost of New Data Requirements on Registration Review

    1. Comment. A commenter stated that EPA has not accurately stated 
the potential costs and benefits, as required by Executive Order (EO) 
12866. In particular, EPA has not included the impact of incremental 
costs of new data requirements on registration review, or the cost of 
consultations. The commenter also claims that under the Paperwork 
Reduction Act (PRA), EPA should include the paperwork burden costs of 
registration review for existing registrants.
    2. EPA's response. EO 12866 requires the Agency to submit to OMB 
for review significant regulatory actions. EPA complied with EO 12866 
during 2008 by submitting drafts of both the economic analysis and the 
proposed rule to OMB. The changes that were made to the proposed rule 
as the result of OMB's review were included in the docket for the 
proposed rule. The Agency notes that one purpose of soliciting comments 
on the economic analysis at the proposal stage is to get input on where 
the Agency might improve the economic analysis.
    The commenter is not correct in asserting that EPA did not include 
the impact of incremental costs. The Agency has captured the 
anticipated costs necessary for complying with the regulations. See the 
final Economic Analysis (Ref. 1) in the docket for a more detailed 
discussion, particularly sections 5.3 and 5.5.
    The commenter is correct in that the costs of fulfilling the 11 
``new'' data requirements during registration review were not 
considered in the Agency's economic analysis of the proposed part 158, 
subpart W data requirements. EPA agrees with the commenter that 
registrants of existing antimicrobial products will incur costs during 
registration review. In fact, EPA relied on the 2005 EA conducted for 
the Registration Review Rule. When registration review was proposed, 
EPA prepared an economic analysis of that program, which estimated the 
cost of data requirements and paperwork burden according to what would 
likely be required in registration review for existing registrants. The 
2005 registration review EA estimate of data requirement costs for 
existing antimicrobial pesticides was based on what would likely be 
required for a sample of antimicrobial active ingredients. This would 
have included all tests that would have been required at that time, 
i.e., those in current practice whether or not in part 158.
    However, proposed part 158, subpart W included ``new'' tests, which 
were not anticipated when the economic analysis of the registration 
review process was completed. In a final economic analysis for part 
158, subpart W, EPA addresses the additional registration review costs 
for these 11 ``new'' studies, as well as other changes from the 
proposed rule to the final rule, including changes made as a result of 
the comments received. The incremental impact for Registration Review 
is $ 6.8 million.
    The commenter is also correct that EPA did not include the cost of 
consultation in its economic analysis. Consultations are longstanding, 
commonly used, and valuable processes in EPA's Pesticide Program and 
are beneficial to both EPA and the applicants. However, consultations 
are not mandatory, and based on comments received EPA has removed all 
references to consultations from the final data requirements tables. 
See Unit V.C. for additional information on the use and purpose of 
consultations.

XXIII. References

    As indicated under ADDRESSES, a docket has been established for 
this rulemaking under docket ID number EPA-HQ-OPP-2008-0110. The 
following is a listing of the documents that are specifically 
referenced in this proposed rule. The docket includes these documents 
and other information considered by EPA in developing this rule, 
including documents that are referenced within the documents that are 
included in the docket, even if the referenced document is not 
physically

[[Page 26975]]

located in the docket. For assistance in locating documents, please 
consult the technical contact listed under FOR FURTHER INFORMATION 
CONTACT.

    1. USEPA, Final Economic Analysis of Changes in Data 
Requirements for Antimicrobial Pesticides, (March 13, 2013).
    2. USEPA, ``Data Requirements for Pesticide Registration; Final 
Rule'' (49 FR 42856, October 26, 2007)(FRL-8106-5).
    3. ACC Biocides Panel; ``Regulation of Antimicrobials that are 
Indirect or Secondary Direct Food Additives;'' (February 2, 2006).
    4. CMA Biocides Panel; ``Comments on EPA's September 17, 1999 
Proposed Rule on Registration Requirements for Antimicrobial 
Pesticide Products and Other Pesticide Regulatory Changes for 
Codification; (January 18, 2000).
    5. ACC Biocides Panel; Memorandum to Frank Sanders, ``EPA's 
Current Interpretation of the Antimicrobial Reform Technical 
Corrections Act and Section 2(bb) of FIFRA is Inconsistent with the 
Statutes;'' (November 3, 2000).
    6. ACC Biocides Panel; ``EPA/FDA Jurisdiction for Food Contact 
Antimicrobials;'' (July 17, 2003).
    7. Grizzle, Charles L.; representative of Albright & Wilson 
Americas, Inc., letter to Lynn R. Goldman; (September 11, 1997).
    8. ChemReg International, L.L.C.; Tiered Testing for Risk 
Assessment of Antimicrobial Pesticides; (September 12, 2002).
    9. Goldberg, Seth; ``Section 2(bb) of FIFRA; Dual Jurisdiction 
Over Food Contact Antimicrobials; (April 27, 2001).
    10. ACC Biocides Panel; ``Comments on The Preliminary Risk 
Assessment for 1,4-Bis(bromoacetoxy)-2-butene (BBAB);'' (August 6, 
2001).
    11. ACC Biocides; Hasmukh C. Shah letter to Frank T. Sanders; 
(August 3, 2000).
    12. Edwards, Deborah; OPP Response to CropLife letter of May 29, 
2009; (June 26, 2009).
    13. Overview of the Ecological Risk Assessment Process in the 
Office of Pesticide Programs, U.S. Environmental Protection Agency--
Endangered and Threatened Species Effects Determinations (January 
2004) (see www.epa.gov/espp/consultation/ecorisk-overview.pdf).
    14. Portier; SAP Waiver; (April 4, 2011).

XXIV. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), a draft of this final rule 
was submitted to the FIFRA SAP. EPA requested the FIFRA SAP to waive 
its review of the final rule based on the fact that the SAP, in 2008, 
had waived review of the proposed rule. The final rule does not contain 
any new scientific issues warranting additional review by the SAP. The 
SAP waived its review on April 4, 2011, stating that ``[t]he final rule 
does not contain scientific issues that the Panel has not previously 
considered'' (Ref. 14).
    In accordance with FIFRA section 25(a), EPA has submitted a draft 
of the final rule to the appropriate Congressional Committees and the 
Secretary of the Department of Agriculture. There were no comments in 
response to these submissions.
    In accordance with FIFRA section 21(b), EPA submitted a draft of 
the final rule to the Secretary of Health and Human Services (HHS), and 
their comments were reviewed and addressed in this final rule.

XXV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is a ``significant regulatory action'' because the Office of 
Management and Budget (OMB) determined that this action might raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order.
    Accordingly, EPA submitted this action to OMB for review under 
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Any 
changes made in response to OMB recommendations have been documented in 
the docket for this action as required by Executive Order 12866.
    EPA has prepared an EA of the potential costs associated with this 
action, entitled ``Final Economic Analysis of Changes in Data 
Requirements for Antimicrobial Pesticides'' (Ref. 1), a copy of which 
is in the docket. This final EA evaluates the potential benefits and 
costs expected as a result of registrations and registration reviews. 
The EA is briefly summarized here.
    In its analysis, the Agency considered the potential, additional 
costs for the registration of new antimicrobial pesticides or new uses 
of currently registered antimicrobial pesticides, as well as the 
potential, additional costs incurred during the registration review of 
existing antimicrobial pesticides.
    Based on comments received during the public comment period, the 
following changes were made to the rulemaking, and are therefore 
reflected in the final EA:
     One proposed data requirement will not be codified: Non-
dietary ingestion exposure. The test cost is $75,000. In the proposed 
rule, EPA expected to receive the test 0.8 times per year, representing 
an annual industry savings of $63,125.
     EPA revised certain of the data requirements from ``NR'' 
or ``CR'' to ``R,'' or vice-versa.
    Based on comments received, three new data requirements were added: 
Simulation test to assess the biodegradability of chemicals discharged 
in wastewater, simulation test--aerobic sewage treatment: Activated 
sludge units, and nature of the residue on surfaces. The rationale for 
these three new studies is described in Unit III.B.
    The estimated costs for both registration review and for a 
registration action for the three newly-required data requirements are:
    1. Simulation tests to assess the biodegradability of chemicals in 
discharged wastewater and simulation test--aerobic sewage treatment: 
activated sludge units. Both of these studies are used as part of the 
down-the-drain analysis for antimicrobials. The studies are 
conditionally required for all use patterns, except for the aquatic 
areas use pattern, for which the study is not required. EPA does not 
have an estimate for the cost of either of these studies; instead, for 
the EA, EPA used the value $33,000, which is the cost of the porous pot 
test. The Agency expects, however, that the cost of the simulation 
tests will be less than this amount. For registration review, EPA 
expects to receive the porous pot test or one of the simulation tests 
up to 8.5 times per year, for an annual industry cost of $280,500. For 
new registrations, EPA expects to receive either of the studies up to 
7.5 times per year, for an annual industry cost of $247,500. The total 
annual cost is $528,000.
    2. Nature of residue on surfaces. This test is part of the residue 
chemistry data requirements, and is conditionally required for all use 
pattern categories. The test cost is $95,000. For registration review, 
EPA expects to receive this test 1.3 times per year, for an annual 
industry cost of $118,750. For new registrations, EPA expects to 
receive this test up to 0.5 times per year, for an annual industry cost 
of $44,333. The total annual cost is $163,083.
    Many test notes for data requirements were revised based on 
comments received. Data requirements for certain use patterns were 
changed from ``NR'' or ``CR'' to ``R,'' while others were changed from 
``R'' to ``CR.'' Because the cost of the rule depends, in part, on the 
probabilities of the tests being required, these revisions have 
resulted in a modification of the cost of the rule. Instead of 
estimating the cost of each change individually, the Agency reestimated 
the potential cost of the regulation as a whole, taking into account 
the changes discussed previously.
    Based on comments received, EPA has updated the unit test costs for 
30

[[Page 26976]]

selected tests. The criteria for selecting which test's cost to update 
included:
     How changing the cost estimates would impact on the cost 
of the rule,
     The magnitude of the difference between EPA's cost 
estimate and the commenters' cost estimate, and
     The length of time since EPA's cost estimate was last 
updated.
    EPA estimated the annual cost of registering a new antimicrobial 
pesticide or new use of currently-registered antimicrobial pesticides, 
taking into account both the changes in data requirements and in unit 
test costs. Both the total annual industry costs and the newly-imposed 
costs were estimated. The updated test costs plus exposure and other 
test costs revisions since the proposed rule increased the cost of the 
rule by about 23 percent compared to the proposed rule. The estimated 
total annual industry costs of the final rule is expected to be about 
$19.3 million, which is approximately 29 percent higher than the cost 
of the proposed rule. The difference between the baseline costs (the 
existing data requirements that were codified in 1984) and the cost of 
the Agency's current practices is about $1 million annually. The 
difference between the baseline costs and the final rule costs, i.e., 
the incremental costs, is approximately $8.2 million annually. Under 
the final rule, the average cost per registration action of a new 
antimicrobial active ingredient is approximately $1 million to $5 
million.
    For existing chemicals, data requirements in part 158, subpart W 
are relevant to the registration review program which began to replace 
the reregistration program in 2006 as a means of systematically 
reevaluating existing registrations against the standards of FIFRA.
    EPA has evaluated the impact of the data requirements being 
codified in this final rule on registrants of existing chemicals 
undergoing registration review whose active ingredient data bases do 
not contain all of the new data requirements. The average additional 
cost of registration review as a result of the new data requirements is 
estimated to be about $588,000 for wood preservatives, $284,000 for 
food and indirect food uses, and $260,000 for all other uses. For 
registration review, the total annual cost is $6.8 million.
    As required, EPA conducted an analysis of the impact of this final 
rule on small businesses, as discussed in the Unit XXV.C.

B. Paperwork Reduction Act (PRA)

    The information collection requirements contained in this rule have 
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et 
seq. At the time of the proposed rule, EPA prepared a supporting 
statement for amending an ICR, entitled ``Data Requirements for 
Antimicrobial Pesticides (Proposed Rule)'' and identified by EPA ICR 
No. 2318.01, a copy of which is in the docket.
    Under 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.
    The information collection activities related to the submission of 
data to EPA in order to register, amend or retain a new or existing 
pesticide product or obtain a tolerance for that product are already 
approved by OMB under PRA. As such, the supporting statement only 
addresses the proposed changes to the data requirements that impact the 
information collection activities related to antimicrobial pesticides. 
The procedures for submitting data to EPA under FIFRA and FFDCA are not 
changed in this proposal, and are already approved by OMB in the 
following ICRs:
    1. Tolerance ICR. Data Submission Activities Associated with 
Tolerance Actions (currently approved under OMB Control No. 2070-0024 
(EPA ICR No. 0597));
    2. Registration ICR. Data Submission Activities Associated with the 
Application for a New or Amended Registration of a Pesticide (currently 
approved under OMB Control No. 2070-0060 (EPA ICR No. 0277)); and
    3. Reregistration, Special and Registration Review ICR. Data 
Submission Activities Associated with the Generation of Data for 
Special Review or Registration Review (currently approved under OMB 
Control No. 2070-0174 (EPA ICR No. 2288)).
    These three program activities are an integral part of the Agency's 
pesticide program, including antimicrobial pesticides, and the 
corresponding ICRs are regularly renewed every 3 years as required by 
PRA. The total estimated average annual public reporting burden 
currently approved by OMB for these various activities range from 8 
hours to approximately 3,000 hours per respondent, depending on the 
activity and other factors surrounding the particular pesticide 
product.
    In the supporting statement the Agency estimates that the typical, 
current annual paperwork burden for registrants per antimicrobial 
pesticide registration is 194 burden hours and $12,631. The total 
annual registrant paperwork burden and costs for data submission 
activities for antimicrobial pesticides applicants and registrants will 
be updated accordingly in the ICRs specified in this discussion during 
the next, appropriate ICR renewal cycle.
    An agency may not conduct or sponsor, and a person is not required 
to respond to an information collection request unless it displays a 
currently valid OMB control number, or is otherwise required to submit 
the specific information by a statute. The OMB control numbers for 
EPA's regulations codified in Title 40 of the Code of Federal 
Regulations, after appearing in the preamble of the final rule, are 
further displayed either by publication in the Federal Register or by 
other appropriate means, such as on the related collection instrument 
or form, if applicable. The display of OMB control numbers for certain 
EPA regulations is consolidated in a list at 40 CFR 9.1.

C. Regulatory Flexibility Act (RFA)

    The RFA, 5 U.S.C. 601 et seq., generally requires an Agency to 
prepare a regulatory flexibility analysis of any rule subject to notice 
and comment rulemaking requirements under the Administrative Procedure 
Act, 5 U.S.C. 551-553, 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. Small entities include small 
businesses, small organizations and small governmental jurisdictions.
    For purposes of assessing the impacts of this final rule on small 
entities, small entity is defined as:
    1. A small business as defined by the Small Business 
Administration's (SBA) regulations at 13 CFR 121.201, which is based on 
either the maximum number of employees or on the sales for small 
businesses in each industry sector, as defined by a 6-digit NAICS code, 
and for this rule is 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;
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district or special district with a 
population of less than 50,000; or
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this final rule on small

[[Page 26977]]

entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The factual 
basis for the Agency's determination is presented in the small entity 
impact analysis prepared as part of the Economic Analysis for this 
final rule (Ref. 1), and is summarized in this unit.
    EPA has determined that this rulemaking does not impact any small 
governmental jurisdictions or any small not-for-profit enterprise 
because these entities are rarely pesticide applicants or registrants. 
As such, EPA has assessed the impacts on small businesses. Some of the 
small entities directly regulated by this rulemaking are in the 
pesticide and other agricultural chemical manufacturing industry sector 
(NAICS code 325320). Firms in this sector are considered small under 
the SBA definition if they employ 500 or fewer people. The economic 
analysis for the final rule specifies the NAICS code used for each of 
the firms analyzed.
    EPA estimates that 750 unique parent companies constitute the total 
universe of pesticide antimicrobial registrants. Of these, based on the 
SBA definition of a small business and the available sales data for 
these firms, EPA estimates that 500, or approximately 67 percent, 
qualify as a small business. When considering both registration review 
and new registrations, on average each year about 30 small businesses 
would have incurred additional costs under this rule. EPA estimates 
that:
     About 23 small firms (almost 5 percent of the 500 small 
antimicrobial firms) subject to this regulation are likely to 
experience an economic impact of 3 percent or more of gross sales,
     About 3 small firms (0.6 percent of the 500 small 
antimicrobial firms) subject to this regulation are likely to 
experience an economic impact of greater than 1 percent but less than 3 
percent of sales revenues, and
     About 3 small firms (0.6 percent of the 500 small 
antimicrobial firms) subject to this regulation are likely to 
experience an economic impact of greater than 0 percent, but less than 
1 percent of sales revenues.
    In addition, there are also opportunities for small entities to 
lower their potential costs. The proposed data requirements in many 
instances are tiered, with higher-tiered testing triggered on the 
results of lower-tiered testing. EPA encourages registrants to consult 
with the Agency to ensure that only the required data is submitted. If 
available, open literature or the same tests on similar products, or 
alternative means to meet data requirements, such as QSAR, can be 
submitted for Agency consideration. Some firms may have surrogate data 
or they may share the cost of generating data. These may present 
opportunities for cost savings by small entities, and all other 
applicants as well, while allowing the Agency to fulfill its role of 
making pesticide regulatory decisions that protect the general 
population, sensitive sub-populations, and the environment.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for 
Federal agencies to assess the effects of their regulatory actions on 
State, local, and tribal governments and the private sector. EPA has 
determined that this final rule does not contain a Federal mandate that 
may result in expenditures of $100 million or more for State, local, 
and tribal governments, in the aggregate, or the private sector in any 
one year. As described in Unit XXV.A., the incremental costs for this 
final rule is estimated at approximately $8.3 million (for registration 
actions) and $6.8 million (for registration review) per year for the 
private sector, which is below the $100 million threshold. Since State, 
local, and tribal governments are rarely pesticide applicants, this 
rule is not expected to significantly or uniquely affect small 
governments, nor does this rule contain any regulatory requirements 
that might significantly or uniquely affect small governments. 
Accordingly, this rule is not subject to the requirements of sections 
202 and 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of 
UMRA because it contains no regulatory requirements that might 
significantly or uniquely affect small governments. As stated 
previously, State, local, and tribal governments are rarely pesticide 
applicants.

E. Executive Order 13132: Federalism

    This action does not have federalism implications, because it will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). 
Since States or local governments are rarely pesticide applicants or 
registrants, this final rule would seldom affect a State or local 
government. Thus, Executive Order 13132 does not apply to this rule.
    In the spirit of Executive Order 13132 and consistent with EPA 
policy to promote communication between EPA, and State and local 
governments, EPA specifically solicited comment on the proposed rule 
from State and local officials. EPA did receive comments on substantive 
parts from local sanitation districts and associations representing 
their interests. Their comments are addressed in the Response to 
Comments Document in the docket, and, as appropriate, revisions were 
made for the final rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Government Implications

    This action does not have tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). At present, no 
tribal government holds, or has applied for, a pesticide registration. 
Thus, Executive Order 13175 does not apply to this action. In the 
spirit of the Order, and consistent with EPA policy to promote 
communications between the Agency and Indian tribes, EPA specifically 
solicited comment on the proposed rule from tribal officials. No 
comments were received.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern health or 
safety risks, such that the analysis required under section 5-501 of 
the Executive Order has the potential to influence the regulation. This 
final rule is not subject to Executive Order 13045 because it is not 
economically significant as defined by Executive Order 12866, and 
because the Agency does not have reason to believe the environmental 
health or safety risks addressed by this action present a 
disproportionate risk to children. This rule does not propose an 
environmental standard that is intended to have a negatively 
disproportionate effect on children. To the contrary, this rule is 
intended to provide added protection to children from antimicrobial 
pesticide risk. EPA will use the data and information obtained by this 
action to carry out its mandate under FFDCA to give special attention 
to the risks of pesticides to sensitive groups in early lifestages, 
especially infants and children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This final rule is not subject to Executive Order 13211 (66 FR 
28355, May 22, 2001) because it is not likely to

[[Page 26978]]

have any adverse effect on the supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. NTTAA directs EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards. This action does not involve 
technical standards. Therefore, EPA did not consider the use of any 
voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes 
Federal executive policy on environmental justice. Its main provision 
directs Federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse human health or environmental effects of their programs, 
policies, and activities on minority populations and low-income 
populations in the United States.
    EPA has determined that this final rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it increases the 
level of environmental protection for all affected populations without 
having any disproportionately high and adverse human health or 
environmental effects on any population, including any minority or low-
income population.

XXVI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 158

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

40 CFR Part 161

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 19, 2013.
Bob Perciasepe,
Acting Administrator.

    Therefore, under the authority of 7 U.S.C. 136-136y and 21 U.S.C. 
346a, 40 CFR Chapter I is amended as follows:

PART 158--[AMENDED]

0
1. The authority citation for part 158 continues to read as follows:

    Authority:  7 U.S.C. 136-136y and 21 U.S.C. 346a.


0
2. Revise Sec.  158.1(c)(4) to read as follows:


Sec.  158.1  Purpose and scope.

* * * * *
    (c) * * *
    (4) Antimicrobial pesticides. Subparts A, B, C, D, and W of this 
part apply to antimicrobial pesticides.


0
3. In Sec.  158.100 revise the heading of paragraph (a); revise 
paragraph (b); redesignate paragraph (c) as paragraph (e); revise newly 
redesignated paragraph (e) and add new paragraphs (c) and (d), to read 
as follows:


Sec.  158.100  Pesticide use patterns.

    (a) General use patterns for conventional, biochemical, and 
microbial pesticides. * * *
    (b) Pesticide use site index for conventional, biochemical, and 
microbial pesticides. The Pesticide Use Site Index for Conventional, 
Biochemical, and Microbial Pesticides is a comprehensive list of 
specific pesticide use sites. The index is alphabetized separately by 
site for all agricultural and all nonagricultural uses. The Pesticide 
Use Site Index associates each pesticide use site with one or more of 
the 12 general use patterns. It may be used in conjunction with the 
data tables to determine the applicability of data requirements to 
specific uses. The Pesticide Use Site Index for Conventional, 
Biochemical, and Microbial Pesticides will be updated periodically, and 
is available from the Agency or may be obtained from the Agency's Web 
site at http://www.epa.gov/pesticides.
    (c) Antimicrobial pesticide use patterns. The general use patterns 
for antimicrobial pesticides are described in Sec.  158.2201.
    (d) Pesticide use site index for antimicrobial pesticides. The 
Pesticide Use Site Index for Antimicrobial Pesticides is a 
comprehensive list of specific antimicrobial use sites. The index is 
alphabetized by antimicrobial use sites, and associates each 
antimicrobial use site with one or more of the antimicrobial use 
patterns. It may be used in conjunction with the data tables to 
determine the applicability of data requirements to specific uses. The 
Pesticide Use Site Index for Antimicrobial Pesticides will be updated 
periodically, and is available from the Agency or may be obtained from 
the Agency's Web site at http://www.epa.gov/pesticides.
    (e) Determination of use pattern. Applicants unsure of the correct 
use pattern for their particular product should consult the Agency.

Sec.  158.400  [Amended]

0
4. In the table in Sec.  158.400(d) remove the heading ``Efficacy of 
Antimicrobial Agents,'' and the entries 91-2 through 91-8 under that 
category.
0
5. Add subpart W to read as follows:
Subpart W--Antimicrobial Pesticide Data Requirements
Sec.
158.2200 Applicability.
158.2201 Antimicrobial use patterns.
158.2203 Definitions.
158.2204 Public health and nonpublic health claims.
158.2210 Product chemistry.
158.2220 Product performance.
158.2230 Toxicology.
158.2240 Nontarget organisms.
158.2250 Nontarget plant protection.
158.2260 Applicator exposure.
158.2270 Post-application exposure.
158.2280 Environmental fate.
158.2290 Residue chemistry.

Subpart W--Antimicrobial Pesticide Data Requirements


Sec.  158.2200  Applicability.

    Part 158, subpart W establishes data requirements for any pesticide 
product that is:
    (a) A pesticide that is intended for use as an ``antimicrobial 
pesticide'' within the meaning of FIFRA sec. 2(mm)(1)(A), regardless of 
whether it also meets the criterion of FIFRA sec. 2(mm)(1)(B).

[[Page 26979]]

That criterion excludes from the definition any antimicrobial product 
that is intended for a food-use requiring a tolerance or exemption 
under FFDCA sec. 408 or a food additive regulation or clearance under 
FFDCA sec. 409. EPA will apply this subpart to all products intended 
for an antimicrobial use, purpose or function; the exclusion in FIFRA 
sec. 2(mm)(1)(B) does not exclude products from the data requirements 
of this subpart.
    (b) A product that bears both antimicrobial and non-antimicrobial 
uses or claims. Such a product is subject to the data requirements for 
pesticides in subparts C through O, and U or V of this part with 
respect to its non-antimicrobial uses and claims, and to the 
requirements of this subpart with respect to its antimicrobial uses and 
claims.
    (c) A wood preservative, including a product that is intended to 
prevent wood degradation problems due to fungal rot or decay, sapstain, 
or molds.
    (d) An antifoulant, including a product that is intended to kill or 
repel organisms that can attach to underwater surfaces, such as boat 
bottoms.


Sec.  158.2201  Antimicrobial use patterns.

    (a) Antimicrobial use patterns. The 12 general use patterns used in 
the data tables in this subpart are:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises and equipment.
    (3) Commercial, institutional and industrial premises and 
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Industrial processes and water systems.
    (9) Antifoulant paints and coatings.
    (10) Wood preservatives.
    (11) Swimming pools.
    (12) Aquatic areas.
    (b) Use site index. The Pesticide Use Site Index for Antimicrobial 
Pesticides is a comprehensive list of specific antimicrobial use sites. 
The Index associates antimicrobial use sites with one or more of the 12 
antimicrobial use patterns. It is to be used in conjunction with the 
data tables in this subpart to determine the applicability of data 
requirements to specific uses. The Antimicrobial Pesticide Use Site 
Index, which will be updated periodically, is available from the Agency 
or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides.


Sec.  158.2203  Definitions.

    The following terms are defined for the purposes of this subpart:
    Disinfectant means a substance, or mixture of substances, that 
destroys or irreversibly inactivates bacteria, fungi and viruses, but 
not necessarily bacterial spores, in the inanimate environment.
    Fungicide means a substance, or mixture of substances, that 
destroys fungi (including yeasts) and fungal spores pathogenic to man 
or other animals in the inanimate environment.
    Microbiological water purifier means any unit, water treatment 
product or system that removes, kills or inactivates all types of 
disease-causing microorganisms from the water, including bacteria, 
viruses and protozoan cysts, so as to render the treated water safe for 
drinking.
    Sanitizer means a substance, or mixture of substances, that reduces 
the bacteria population in the inanimate environment by significant 
numbers, but does not destroy or eliminate all bacteria. Sanitizers 
meeting Public Health Ordinances are generally used on food contact 
surfaces and are termed sanitizing rinses.
    Sterilant means a substance, or mixture of substances, that 
destroys or eliminates all forms of microbial life in the inanimate 
environment, including all forms of vegetative bacteria, bacterial 
spores, fungi, fungal spores, and viruses.
    Tuberculocide means a substance, or mixture of substances, that 
destroys or irreversibly inactivates tubercle bacilli in the inanimate 
environment.
    Virucide means a substance, or mixture of substances, that destroys 
or irreversibly inactivates viruses in the inanimate environment.


Sec.  158.2204  Public health and nonpublic health claims.

    (a) Public health claim. An antimicrobial pesticide is considered 
to make a public health claim if the pesticide product bears a claim to 
control pest microorganisms that pose a threat to human health, and 
whose presence cannot readily be observed by the user, including but 
not limited to, microorganisms infectious to man in any area of the 
inanimate environment. A product makes a public health claim if one or 
more of the following apply:
    (1) A claim is made for control of specific microorganisms that are 
directly or indirectly infectious or pathogenic to man (or both man and 
animals). Examples of specific microorganisms include, but are not 
limited to: Mycobacterium tuberculosis, Pseudomonas aeruginosa, 
Escherichia coli (E. coli), human immunodeficiency virus (HIV), 
Streptococcus, and Staphylococcus aureus. Claims for control of 
microorganisms infectious or pathogenic only to animals (such as canine 
distemper virus or hog cholera virus) are not considered public health 
claims.
    (2) A claim is made for the pesticide product as a sterilant, 
disinfectant, virucide, sanitizer, or tuberculocide against 
microorganisms that are infectious or pathogenic to man.
    (3) A claim is made for the pesticide product as a fungicide 
against fungi infectious or pathogenic to man, or the product does not 
clearly state that it is intended for use only against nonpublic health 
fungi.
    (4) A claim is made for the pesticide product as a microbiological 
water purifier or microbial purification system.
    (5) A non-specific claim is made that the pesticide product will 
beneficially impact or affect public health at the site of use or in 
the environment in which it is applied, and:
    (i) The pesticide product contains one or more ingredients that, 
under the criteria in 40 CFR 153.125(a), is an active ingredient with 
respect to a public health microorganism and there is no other 
functional purpose for the ingredient in the product; or
    (ii) The pesticide product is similar in composition to a 
registered pesticide product that makes antimicrobial public health 
claims.
    (b) Nonpublic health claim. An antimicrobial pesticide is 
considered to make a nonpublic health claim if the pesticide product 
bears a claim to control microorganisms of economic or aesthetic 
significance, where the presence of the microorganism would not 
normally lead to infection or disease in humans. Examples of nonpublic 
health claims include, but are not limited to: Algaecides, slimicides, 
preservatives and products for which a pesticidal claim with respect to 
odor sources is made.


Sec.  158.2210  Product chemistry.

    The product chemistry data requirements of subpart D of this part 
apply to antimicrobial products covered by this subpart.


Sec.  158.2220  Product performance.

    (a) General--(1) Product performance requirement for all 
antimicrobial pesticides. Each applicant must ensure through testing 
that his product is efficacious when used in accordance with label 
directions and commonly accepted pest control practices. The Agency may 
require, on a case-by-case basis, submission of product

[[Page 26980]]

performance data for any pesticide product registered or proposed for 
registration or amendment.
    (2) Product performance data for each product that bears a public 
health claim. Each product that bears a public health claim, as 
described in Sec.  158.2204(a), must be supported by product 
performance data, as listed in the table in paragraph (c) of this 
section. Product performance data must be submitted with any 
application for registration or amended registration.
    (3) Product performance data for each product that bears a 
nonpublic health claim. Each product that bears a nonpublic health 
claim, as described in Sec.  158.2204(b), must be supported by product 
performance data. Each registrant must ensure through testing that his 
product is efficacious when used in accordance with label directions 
and commonly accepted practices. The Agency reserves the right to 
require, on a case-by-case basis, submission of product performance 
data for any pesticide product registered or proposed for registration 
or amendment.
    (4) Determination of data requirements. Subpart B of this part and 
Sec.  158.2201 describe how to use the table in paragraph (c) of this 
section to determine the product performance data requirements for 
antimicrobial pesticide products.
    (b) Key. R = Required; EP = End-use product.
    (c) Antimicrobial product performance data requirements table. The 
following table shows the data requirements for antimicrobial product 
performance.

                           Table--Antimicrobial Product Performance Data Requirements
----------------------------------------------------------------------------------------------------------------
         Guideline No.               Data requirement          All use patterns             Test substance
----------------------------------------------------------------------------------------------------------------
810.2100.......................  Sterilants--Efficacy     R.........................  EP
                                  Data Recommendations.
810.2200.......................  Disinfectants for Use    R.........................  EP
                                  on Hard Surfaces--
                                  Efficacy Data
                                  Recommendations.
810.2300.......................  Sanitizers for Use on    R.........................  EP
                                  Hard Surfaces--
                                  Efficacy Data
                                  Recommendations.
810.2400.......................  Disinfectants and        R.........................  EP
                                  Sanitizers for Use on
                                  Fabrics and Textiles--
                                  Efficacy Data
                                  Recommendations.
810.2500.......................  Air Sanitizers--         R.........................  EP
                                  Efficacy Data
                                  Recommendations.
810.2600.......................  Disinfectants for Use    R.........................  EP
                                  in Water--Efficacy
                                  Data Recommendations.
----------------------------------------------------------------------------------------------------------------

Sec.  158.2230  Toxicology.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how 
to use the table in paragraph (g) of this section to determine the 
toxicology data requirements for an antimicrobial pesticide product. 
Notes that apply to an individual test, including specific conditions, 
qualifications, or exceptions are listed in paragraph (h) of this 
section.
    (b) Uses. The applicant for registration must first determine 
whether the use is likely to result in pesticide residues in food or 
water and therefore consult the ``Food Use'' columns of the table in 
paragraph (g) of this section. Generally, if the residues of the 
antimicrobial result from an application to a surface or if 
incorporated into a material that may come into contact with food or 
feed, and residues may be expected to transfer to such food or feed, 
then the ``Indirect Food Uses'' columns is to be consulted.
    (c) Tiering of data requirements. Applicants for registration of 
antimicrobials may perform tests in a tiered fashion. After the 
initially required tests are conducted, additional testing may be 
required if results of the initial tests trigger the need for 
additional data. Conditions that trigger the need for additional data 
are given in the test notes in paragraph (h) of this section.
    (d) 200 parts per billion (ppb). The 200 ppb level was originally 
used by the Food and Drug Administration with respect to the 
concentration of residues in or on food for tiering of data 
requirements for indirect food use biocides. The Agency has also 
adopted this same residue level for determining toxicology data 
requirements for indirect food uses of antimicrobial pesticides. The 
200 ppb level is the concentration of antimicrobial residues in or on 
the food item.
    (e) Use of OSHA standards. If EPA determines that industrial 
standards, such as the workplace standards set by the Occupational 
Safety and Health Administration (OSHA standards), provide adequate 
protection for a particular pesticide or a particular use pattern, 
additional toxicity data may not be required for that pesticide or the 
use pattern.
    (f) Key. R = Required; CR = Conditionally required; NR = Not 
required; MP = Manufacturing-use product; EP = End-use product; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use 
product; PAI = Pure active ingredient; PAIRA = Pure active ingredient, 
radiolabeled; Choice = choice of several test substances depending on 
studies required.
    (g) Antimicrobial toxicology data requirements table. The following 
table shows the data requirements for toxicology. The test notes 
applicable to the data requirements in this table appear in paragraph 
(h) of this section.

                                                                        Table--Antimicrobial Toxicology Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Food uses                                          Nonfood uses                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Swimming pools,
  Guideline No.     Data  requirement                                                                 aquatic areas, wood                                                          Test note No.
                                         Direct food uses    Indirect food uses   Indirect food uses     preservatives,     All other nonfood          MP               EP
                                                                 (>200 ppb)          (<=200 ppb)         metal working             uses
                                                                                                             fluids
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Acute Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100.........  Acute oral          R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....            1, 2
                    toxicity--rat.

[[Page 26981]]

 
870.1200.........  Acute dermal        R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    toxicity.
870.1300.........  Acute inhalation    R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....            2, 4
                    toxicity--rat.
870.2400.........  Primary eye         R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    irritation--rabbi
                    t.
870.2500.........  Primary dermal      R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    irritation.
870.2600.........  Dermal              R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....      1, 2, 3, 5
                    sensitization.
870.2600.........  Acute               R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........           6, 11
                    neurotoxicity--ra
                    t.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Subchronic Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100.........  90-Day oral         R..................  R..................  R..................  R..................  CR.................  TGAI...........  TGAI...........    8, 9, 15, 38
                    toxicity--rodent.
870.3150.........  90-Day oral         R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........          10, 15
                    toxicity--nonrode
                    nt.
870.3200.........  21/28-Day dermal    CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  EP and TGAI....          12, 13
                    toxicity.
870.3250.........  90-Day dermal       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  EP and TGAI....   7, 13, 14, 15
                    toxicity.
870.3465.........  90-Day inhalation   CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........   7, 15, 16, 17
                    toxicity--rat.
870.6200.........  90-Day              R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........            6, 8
                    neurotoxicity--ra
                    t.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Chronic Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100.........  Chronic oral        R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........      18, 19, 20
                    toxicity--rodent.
870.4200.........  Carcinogenicity--t  R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........      19, 21, 22
                    wo rodent
                    species--rat and
                    mouse preferred.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Developmental Toxicity and Reproduction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700.........  Prenatal            R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........  23, 24, 25, 26
                    developmental
                    toxicity--rat and
                    rabbit preferred.
870.3800.........  Reproduction and    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........  26, 27, 28, 29
                    fertility effects.
870.6300.........  Developmental       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      28, 29, 30
                    neurotoxicity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Mutagenicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100.........  Reverse mutation    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 32
                    assay.
870.5300.........  In vitro mammalian  R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 33
870.5375.........   gene mutation.
870.5385.........  In vivo             R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 34
870.5395.........   cytogenetics.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Special Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.7485.........  Metabolism and      R..................  R..................  CR.................  R..................  CR.................  PAI or PAIRA...  PAI or PAIRA...          35, 39
                    pharmacokinetics.
870.7200.........  Companion animal    CR.................  CR.................  CR.................  CR.................  CR.................  NR.............  Choice.........              36
                    safety.
870.7600.........  Dermal penetration  CR.................  CR.................  CR.................  CR.................  CR.................  Choice.........  Choice.........           3, 37

[[Page 26982]]

 
870.7800.........  Immunotoxicity....  R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               8
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (h) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (g) of this section:
    1. Not required if test material is a gas or highly volatile 
liquid.
    2. The six end-use product (EP) acute toxicity studies are required 
using the product as formulated for sale and distribution. In addition, 
if the EP label has directions for diluting the product, then, the 
applicant may also need to conduct certain of the acute toxicity 
studies using the highest concentration labeled for dilution (i.e., the 
least diluted product). The end-use dilution testing is in addition to 
the testing conducted on the EP.
    3. Not required if test material is corrosive to skin or has pH 
less than 2 or greater than 11.5.
    4. Data are required when the product consists of, or under 
conditions of use will result in, a respirable material (e.g., gas, 
vapor, aerosol or particulates).
    5. Data are required if repeated dermal exposure is likely to occur 
under conditions of use.
    6. For indirect food uses <= 200 ppb, and all other nonfood uses, 
data are required if the neurotoxicity screen in the 90-day oral rodent 
study or other data indicate neurotoxicity.
    7. The 90-day dermal toxicity study and/or 90-day inhalation 
toxicity study are required if the Agency determines that dermal and/or 
inhalation exposure is the primary route of exposure.
    8. All 90-day subchronic studies in the rodent can be designed to 
simultaneously fulfill the requirements of the 90-day neurotoxicity 
and/or immunotoxicity studies by adding separate groups of animals for 
testing of neurotoxicity and/or immunotoxicity parameters.
    9. The 90-day study is required in the rodent for hazard 
characterization (possibly endpoint selection) and dose-setting for the 
chronic/carcinogenicity study. It is not required in the mouse, but the 
Agency would encourage the applicant to conduct a 90-day range finding 
study for the purposes of dose selection for the mouse carcinogenicity 
study to achieve adequate dosing and an acceptable study.
    10. A 1-year non-rodent study (i.e., 1-year dog study) may be 
required if the Agency finds that a pesticide chemical is highly 
bioaccumulative and slowly eliminated. EPA may also require the 
appropriate metabolism and pharmacokinetic studies to evaluate more 
precisely bioavailability, half life, and steady state to determine if 
a longer duration dog toxicity study is needed.
    11. Although the subchronic toxicity testing guidelines include 
measurement of neurological endpoints, such screens do not meet the 
requirement of the 90-day neurotoxicity study. For nonfood uses, if the 
90-day study does not include a neurotoxicity screen, then the acute 
neurotoxicity study will be required.
    12. Data are required if all of the following criteria are met:
    i. The intended use of the antimicrobial pesticide product is 
expected to result in repeated dermal human exposure to the product.
    ii. Data from a 90-day dermal toxicity study are not available.
    iii. The 90-day dermal toxicity study has not been triggered.
    13. EP testing is required if the product or any component of the 
product may increase dermal absorption of the active ingredient(s) or 
increases its toxic or pharmacologic effects, as determined by testing 
using the TGAI or based on available information about the toxic 
effects of the product or its components.
    14. Data are required if the active ingredient in the product is 
known or expected to be metabolized differently by the dermal route of 
exposure than by the oral route, and a metabolite of the active 
ingredient is the toxic moiety.
    15. A 90-day oral toxicity test is not required for heating, 
ventilation, air conditioning, and refrigeration systems (collectively 
referred to as HVAC&R). Instead, two 90-day toxicity tests, one by the 
dermal route and one by the inhalation route are required.
    16. Data are required if there is the likelihood of significant 
repeated inhalation exposure to the pesticide as a gas, vapor, or 
aerosol.
    17. Based on estimates of the magnitude and duration of human 
exposure, studies of shorter duration, e.g., 21- or 28-days, may be 
sufficient to satisfy this requirement. The prime consideration in 
determining the appropriateness of a shorter duration study is the 
likely period of time for which humans will be exposed.
    18. Based on the positive results of the acute or 90-day 
neurotoxicity studies, or on other data indicating neurotoxicity, a 
chronic neurotoxicity study (i.e., a chronic study with additional 
neurotoxicity evaluations) may be required to provide information about 
potential neurotoxic effects from long-term exposures.
    19. Studies which are designed to simultaneously fulfill the 
requirements of both the chronic oral and carcinogenicity studies 
(i.e., a combined study) may be conducted.
    20. For indirect food uses <= 200 ppb, and all other nonfood uses, 
data are required if either of the following criteria are met:
    i. The use of the pesticide is likely to result in repeated human 
exposure over a considerable portion of the human lifespan; or
    ii. The use requires that a tolerance, tolerance exemption, or food 
additive regulation or clearance be established.
    21. For indirect food uses <= 200 ppb, and all other nonfood uses, 
data are required if any of the following criteria, are met:
    i. The use of the pesticide is likely to result in significant 
human exposure over a considerable portion of the human life span which 
is significant in terms of frequency, time, duration, and/or magnitude 
of exposure.
    ii. The use requires that a tolerance, tolerance exemption, or food 
additive regulation or clearance be established.
    iii. The active ingredient, metabolite, degradate, or impurity:
    A. Is structurally related to a recognized carcinogen;
    B. Causes mutagenic effects as demonstrated by in vitro or in vivo 
testing; or
    C. Produces a morphologic effect in any organ (e.g., hyperplasia, 
metaplasia) in subchronic studies that may lead to a neoplastic change.
    22. If the requirement for a carcinogenicity study in any species 
is modified or waived for any reason, then

[[Page 26983]]

a subchronic 90-day oral study in the same species may be required.
    23. Testing in two species is required for all uses.
    24. The oral route, by oral intubation, is preferred, unless the 
chemical or physical properties of the test substance, or the pattern 
of human exposure, suggest a more appropriate route of exposure.
    25. Additional testing by other routes of exposure may be required 
if the pesticide is determined to be a prenatal developmental toxicant 
after oral dosing.
    26. The developmental toxicity study in rodents may be combined 
with the two-generation reproduction study in rodents by using a second 
mating of the parental animals in either generation. Protocols must be 
approved by the Agency prior to the initiation of the study.
    27. A two-generation reproduction study is required.
    28. An information-based approach to testing is preferred, which 
utilizes the best available knowledge on the chemical (hazard, 
pharmacokinetic, or mechanistic data) to determine whether a standard 
guideline study, an enhanced guideline study, or an alternative study 
should be conducted to assess potential hazard to the developing 
animal. Applicants must submit any alternative proposed testing 
protocols and supporting scientific rationale to the Agency. Protocols 
must be approved by the Agency prior to the initiation of the study.
    29. The use of a combined two-generation reproduction/developmental 
neurotoxicity study that utilizes the two-generation reproduction study 
in rodents as a basic protocol for the addition of other endpoints or 
functional assessments in the immature animal is encouraged.
    30. A DNT study is required using a weight-of-evidence approach 
when:
    i. The pesticide causes treatment-related neurological effects in 
adult animal studies (i.e., clinical signs of neurotoxicity, 
neuropathology, functional or behavioral effects).
    ii. The pesticide causes treatment-related neurological effects in 
developing animals, following pre- or post-natal exposure (i.e., 
nervous system malformations or neuropathy, brain weight changes in 
offspring, functional or behavioral changes in the offspring).
    iii. The pesticide elicits a causative association between 
exposures and adverse neurological effects in human epidemiological 
studies.
    iv. The pesticide evokes a mechanism that is associated with 
adverse effects on the development of the nervous system (i.e., 
structure-activity-relationship (SAR) to known neurotoxicants, altered 
neuroreceptor or neurotransmitter responses).
    31. To facilitate the weight-of-evidence determination for the 
pesticide's mutagenicity, in addition to those specifically listed in 
this table, the Agency requires submission of other mutagenicity test 
results that may have been performed. A reference list of all studies 
and papers known to the applicant concerning the mutagenicity of the 
test chemical must be submitted with the required studies.
    32. Due to the nature of antimicrobials, if testing with bacterial 
strains has not been conducted, then testing using a mammalian cell 
assay such as the mouse lymphoma TK +/- assay is preferred. If reverse 
mutation assay testing with bacterial strains has already been 
conducted, and the testing was conducted at levels that did not cause 
toxicity to the bacterial strains tested, then the applicant may submit 
the study to fulfill this data requirement.
    33. For the in vitro mammalian gene mutation study, there is a 
choice of assays using either mouse lymphoma L5178Y cell thymidine 
kinase (tk) gene locus, maximizing assay conditions for small colony 
expression and detection; Chinese hamster ovary (CHO) or Chinese 
hamster lung fibroblast (v79) cells, hypoxanthine-guanine 
phosphoribosyl transferase (hgprt) gene locus, accompanied by an 
appropriate in vitro test for clastogenicity; or CHO cells strains 
AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
    34. There is a choice of assays, but the micronucleus rodent bone 
marrow assay is preferred; the rodent bone marrow assays using 
metaphase analysis (aberrations) are acceptable.
    35. Data are required when chronic toxicity or carcinogenicity 
studies are also required.
    36. Data is required if the product label directs that it be 
applied to domestic animals, such as cats, dogs, cattle, pigs, and 
horses.
    37. In the absence of dermal absorption data or a repeated dose 
dermal toxicity study, the assumption of 100 percent dermal absorption 
would be used in a risk assessment to determine if a dermal penetration 
study is required, and to identify the doses and duration of exposure 
for which dermal absorption is to be quantified.
    38. Required for nonfood uses, if oral exposure could occur.
    39. Data may be required if significant adverse effects are seen in 
available toxicology studies and these effects can be further 
elucidated by metabolism and pharmacokinetics studies.


Sec.  158.2240  Nontarget organisms.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how 
to use the table in paragraph (c) of this section to determine the 
terrestrial and aquatic nontarget organisms data requirements for a 
particular antimicrobial pesticide product. Notes that apply to an 
individual test, including specific conditions, qualifications, or 
exceptions are listed in paragraph (d) of this section.
    (1) Terrestrial and aquatic nontarget organism data are required to 
support the registration of most end-use and manufacturing-use 
antimicrobial products.
    (2) Data are generally not required to support end-use products of 
a gas, highly volatile liquid, highly reactive solid, or a highly 
corrosive material.
    (3) Data on transformation/degradation products or leachate 
residues of the parent compound are also required to support 
registration, if the transformation/degradation/degradation products or 
leachate residues meet one of the following criteria:
    (i) More toxic, persistent, or bioaccumulative than the parent;
    (ii) Have been shown to cause adverse effects in mammalian or 
aquatic reproductive studies; or
    (iii) The moiety of concern (i.e., functional group in the parent 
chemical molecule that imparts adverse effects) remains intact.
    (4) If an antimicrobial may be applied to a field crop, 
horticultural crop, or turf, then the data requirements in Sec.  
158.630 apply.
    (5) For the purpose of determining data requirements, the all other 
use patterns category includes the following use patterns:
    (i) Agricultural premises and equipment.
    (ii) Food-handling/storage establishments, premises, and equipment.
    (iii) Commercial, institutional and industrial premises and 
equipment.
    (iv) Residential and public access premises.
    (v) Medical premises and equipment.
    (vi) Human drinking water systems.
    (vii) Materials preservatives.
    (viii) Swimming pools.
    (b) Key. MP = Manufacturing use product; EP = End-use product; R = 
Required; CR = Conditionally required; NR = Not required; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use 
product; PAIRA = Pure active ingredient radiolabeled; a.i. = active 
ingredient.

[[Page 26984]]

    (c) Antimicrobial nontarget organism data requirements table. The 
following table shows the data requirements for nontarget organisms. 
The test notes appear in paragraph (d) of this section.

                                                                    Table--Antimicrobial Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Use pattern                                                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement       Industrial                                                                                                                             Test note No.
                                       processes and water      Antifoulant      Wood  preservatives     Aquatic areas        All other use            MP               EP
                                             systems        coatings and paints                                             patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Tier One Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100.........  Acute avian oral    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               1
                    toxicity.
850.1010.........  Acute freshwater    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               2
                    invertebrates
                    toxicity.
850.1075.........  Acute freshwater    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               3
                    fish toxicity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Higher Tier Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian Testing...................................................................................................................................................................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200.........  Avian dietary       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........               4
                    toxicity.
850.2300.........  Avian reproduction  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........            1, 6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010.........  Acute freshwater    CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         2, 5, 7
                    invertebrates
                    toxicity.
850.1075.........  Acute freshwater    CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         3, 5, 7
                    fish toxicity.
850.1025.........  Acute estuarine     CR.................  R..................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........            8, 9
                    and marine
                    organisms
                    toxicity.
850.1035
850.1045
850.1055.........  Acute estuarine     CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         5, 7, 8
                    and marine
                    organisms
                    toxicity.
850.1075
850.1400.........  Fish early-life     R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........              10
                    stage.
850.1300.........  Aquatic             R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........              10
                    invertebrate life-
                    cycle.
850.1350
850.1500.........  Fish life-cycle...  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........          11, 12
850.1710.........  Aquatic organisms,  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI, PAI,       TGAI, PAI,                   13
                    bioavailability,                                                                                                             degradate.       degradate.
                    biomagnification,
                    toxicity tests.
850.1730
850.1850
850.1950.........  Simulated or        CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............      14, 15, 16
                    actual field
                    testing for
                    aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1735.........  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........          15, 17
                    acute freshwater
                    invertebrates.
850.1740.........  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      15, 17, 19
                    acute marine
                    invertebrates.
None.............  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      15, 18, 19
                    chronic
                    invertebrates
                    fresh-water and
                    marine.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 26985]]

 
                                                                                    Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3020.........  Honeybee acute      NR.................  NR.................  R..................  NR.................  CR.................  TGAI...........  TGAI...........              20
                    contact.
850.3030.........  Toxicity of         NR.................  NR.................  R..................  NR.................  CR.................  TGAI...........  TEP or treated           20, 21
                    residues to                                                                                                                                   wood.
                    honeybees.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

     (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section:
    1. For industrial processes and water systems, antifoulant paints 
and coatings, wood preservatives, and aquatic areas, data are required 
for two avian species: one waterfowl species and one upland game bird 
species. For the all other use patterns category (as specified in Sec.  
158.2240(a)(5)), data are required for one avian species.
    2. Data are required on one freshwater aquatic invertebrate 
species.
    3. For the industrial processes and water systems, antifoulant 
paints and coatings, wood preservatives, and aquatic use pattern areas, 
data are required on two species of fish, one cold water species and 
one warm water species. For the all other use patterns category (as 
specified in Sec.  158.2240(a)(5)), data are required on one species of 
fish, either one cold water species or one warm water species. Testing 
on a second species is required if the active ingredient or principal 
transformation products are stable in the environment and the 
LC50 in the first species is less than or equal to 1 ppm or 
1 mg/L.
    4. Data are required on one avian species, either one waterfowl 
species or one upland game bird species, if the avian acute oral 
LD50 (TGAI testing) is less than or equal to 100 mg/a.i./kg 
and a.i. residues or its principal transformation products are likely 
to occur in avian feed items. Data on the second species are required 
if the avian dietary LC50 in the first species tested is 
less than or equal to 500 ppm a.i. in the diet.
    5. If TEP testing cannot be conducted due to the physical 
characteristics of the test substance (for example, a paint), then the 
applicant should request a waiver.
    6. Data are required if one or more of the following criteria are 
met:
    i. Birds may be subjected to repeated or continued exposure to the 
pesticide or any of its transformation products, especially preceding 
or during the breeding season.
    ii. The pesticide or any of its major metabolites or degradation 
products are stable in the environment to the extent that a potentially 
toxic amount may persist in avian feed.
    iii. The pesticide or any of its major metabolites or degradation 
products are stored or accumulated in plant or animal tissues, as 
indicated by the octanol/water partition coefficient (Kow is 
greater than or equal to 1,000), accumulation studies, metabolic 
release and retention studies, or as indicated by structural similarity 
to known bioaccumulative chemicals.
    iv. Any other information, such as that derived from mammalian 
reproduction studies, indicates that reproduction in terrestrial 
vertebrates may be adversely affected by the anticipated use of the 
pesticide product.
    7. TEP testing is required for any product which meets one or more 
of the following conditions:
    i. When based on deterministic modeling results: If the Estimated 
Environmental Concentration (EEC) in the aquatic environment is equal 
to or greater than one-half the LC50/EC50 of the 
TGAI.
    ii. When based on probabilistic modeling results: If the estimated 
10th percentile 7Q10 Surface Water Concentration exceeds the acute 
concentration of concern (i.e., one-half the LC50/
EC50).
    iii. If an ingredient in the end-use product other than the active 
ingredient is expected to enhance the toxicity of the active ingredient 
or to cause toxicity to aquatic organisms.
    iv. The end-use antimicrobial product will be applied directly into 
an aquatic environment.
    8. Data are required on one estuarine/marine mollusk, one other 
estuarine/marine invertebrate, and one estuarine/marine fish species.
    9. For the all other use patterns category (as specified in Sec.  
158.2240(a)(5)), industrial processes and water systems, wood 
preservatives, and aquatic areas, data are required if the pesticide 
residues from the parent compound and/or transformation products are 
likely to enter the estuarine/marine environment.
    10. Testing must be conducted with the most sensitive organism 
(either freshwater or estuarine/marine vertebrates, or freshwater or 
estuarine/marine invertebrates), as determined from the results of the 
acute toxicity tests (acute EC50 freshwater invertebrates; 
acute LC50/EC50 estuarine and marine organisms; 
acute freshwater fish LC50).
    11. Data are required on estuarine/marine species if the product is 
intended for direct application to the estuarine or marine environment, 
or the product is expected to enter this environment in significant 
concentrations because of its expected use or mobility patterns.
    12. Data are required on freshwater species if the end-use product 
is intended to be applied directly to water, or is expected to be 
transported to water from the intended use site, and when one or more 
of the following conditions apply:
    i. When based on deterministic modeling results: If the Estimated 
Environmental Concentration (EEC) in water is equal to or greater than 
0.1 of the no-observed-adverse-effect concentration or no-observed-
adverse-effect level (NOAEC/NOAEL) in the fish early-life stage or 
invertebrate life cycle tests.
    ii. When based on probabilistic modeling results: If the estimated 
10th percentile 7Q10 Surface Water Concentration based on probabilistic 
modeling exceeds for 20 days or more the chronic concentration of 
concern (i.e., one-tenth the NOAEC or NOAEL) determined in the fish 
early-life stage or invertebrate life cycle tests.
    iii. If studies of other organisms indicate that the reproductive 
physiology of fish may be affected.
    13. Not required when:
    i. The octanol/water partition coefficients of the pesticide and 
its major degradates are less than 1,000;
    ii. There are no potential exposures to fish and other nontarget 
aquatic organisms; or

[[Page 26986]]

    iii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 
9.
    14. Environmental chemistry methods used to generate data 
associated with this study must include results of a successful 
confirmatory method trial by an independent laboratory. Test standards 
and procedures for independent laboratory validation are available as 
addenda to the guideline for this test requirement.
    15. Protocols must be approved by the Agency prior to the 
initiation of the study.
    16. Data are required if the intended use pattern, and the 
physical/chemical properties and environmental fate characteristics of 
the antimicrobial indicate significant potential exposure, and, based 
on the results of the acute and chronic aquatic organism testing, 
significant impairment of nontarget aquatic organisms could result.
    17. Data are required if the half-life of the pesticide in the 
sediment is equal to or less than 10 days in either the aerobic soil or 
aquatic metabolism studies, and if one or more of the following 
conditions are met:
    i. The soil partition coefficient (Kd) is equal to or 
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    18. Data are required if the EEC in sediment is greater than 0.1 of 
the acute LC50/EC50 values and if one or more of 
the following conditions are met:
    i. The soil partition coefficient (Kd) is equal to or 
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    19. Sediment testing with estuarine/marine test species is required 
if the product is intended for direct application to the estuarine or 
marine environment or the product is expected to enter this environment 
in significant concentrations either by runoff or erosion, because of 
its expected use or mobility pattern.
    20. For the all other use patterns category (as specified in Sec.  
158.2240(a)(5)), data are required only for beehive applications when 
the beehive (empty or occupied) may be treated.
    21. A study similar to ``Honey Bee Toxicity of Residues on 
Foliage'' is required using treated wood instead of the foliage. 
Protocols must be approved by the Agency prior to the initiation of the 
study.


Sec.  158.2250  Nontarget plant protection.

    (a) Subpart B of this part and Sec.  158.2201 describe how to use 
the table in paragraph (f) of this section to determine the nontarget 
plant protection data requirements for a particular antimicrobial 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions are listed in 
paragraph (g) of this section.
    (b) Data on transformation/degradation products or leachate 
residues of the parent compound are also required to support 
registration, if the transformation/degradation products or leachate 
residues meet one of the following criteria:
    (1) More toxic, persistent, or bioaccumulative than the parent;
    (2) Have been shown to cause adverse effects in mammalian or 
aquatic reproductive studies; or
    (3) The moiety of concern (i.e., functional group in the parent 
chemical molecule that imparts adverse effects) remains intact.
    (c) For the purpose of determining data requirements, the all other 
use patterns category includes the following use patterns:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises, and equipment.
    (3) Commercial, institutional and industrial premises and 
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Swimming pools.
    (d) If an antimicrobial may be applied to a field crop, 
horticultural crop, or turf, then the data requirements in Sec.  
158.660 apply.
    (e) Key. MP = Manufacturing use product; EP = End-use product; R = 
Required; CR = Conditionally required; NR = Not required; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use 
product.
    (f) Nontarget plant protection data requirements table. The 
following table shows the data requirements for nontarget plant 
protection. The test notes appear in paragraph (g) of this section.

                                                                       Table--Nontarget Plant Protection Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Use pattern                                                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement       Industrial                                                                                                                             Test note No.
                                       processes and water      Antifoulant       Wood preservatives     Aquatic areas        All other use            MP               EP
                                             systems        coatings and paints                                             patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225.........  Seedling            CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............            1, 2
                    emergence, Tier
                    II--dose response.
850.4250.........  Vegetative vigor,   CR.................  NR.................  CR.................  CR.................  CR.................  TEP............  TEP............            1, 3
                    Tier II--dose
                    response.
850.4400.........  Aquatic plant       R..................  R..................  R..................  R..................  CR.................  TGAI, TEP......  TGAI, TEP......           4, 10
                    growth (aquatic
                    vascular plant)
                    Tier II--dose
                    response.
850.5400.........  Aquatic plant       R..................  R..................  R..................  R..................  R..................  TGAI, TEP......  TGAI, TEP......         4, 5, 6
                    growth (algal)
                    Tier II (dose
                    response).
850.4300.........  Terrestrial field.  CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............         7, 8, 9
850.4450.........  Aquatic field.....  CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............         7, 8, 9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 26987]]

    (g) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (f) of this section:
    1. Data on only one plant species (rice, Oryza sativa) are 
required.
    2. Data are required if the risk quotient from any aquatic plant 
growth Tier II study exceeds a level of concern for aquatic plants.
    3. Not required when:
    i. There are no potential exposures to plants;
    ii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9; 
or
    iii. The results of a biodegradation study indicate that the active 
ingredient or principal degradation products are not biodegradable in 
28 days, i.e., the biodegradation curve has not reached a plateau for 
at least three determinations within the 28 days.
    4. For TEP testing, data are required for the applicant's end-use 
product if an ingredient in the end-use product, other than the active 
ingredient, is expected to enhance the toxicity of the active 
ingredient.
    5. One Tier II (dose response) study, conducted with Selenastrum 
capricornutum, is required for the all other use patterns category (as 
specified in Sec.  158.2250(c)). If the results of this study exhibit 
detrimental effects (EC50 less than 1.0 ppm or mg/L), then 
additional Tier II (dose response) studies are required on three 
species (Anabaena flos-aquae, Navicula pelliculosa, and Skeletonema 
costatum).
    6. For industrial processes and water systems, antifoulant coatings 
and paints, wood preservatives, and aquatic areas, Tier II (dose 
response) studies are required on four species (Anabaena flos-aquae, 
Navicula pelliculosa, Skeletonema costatum, and Selenastrum 
capricornutum).
    7. Environmental chemistry methods used to generate data must 
include the results of a successful confirmatory method trial by an 
independent laboratory.
    8. Tests are required on a case-by-case basis based on the results 
of lower tier plant protection studies, adverse incident reports, 
intended use pattern, and environmental fate characteristics that 
indicate potential exposure.
    9. Protocols must be approved by the Agency prior to the initiation 
of the study.
    10. For the all other use patterns category (as specified in Sec.  
158.2250(c)), data are required if the aquatic (algal) plant growth 
Tier II study demonstrates detrimental effects at less than 1.0 ppm or 
mg/L.


Sec.  158.2260  Applicator exposure.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how 
to use the table in paragraph (d) of this section to determine the 
applicator exposure data requirements for antimicrobial pesticide 
products. Notes that apply to an individual test including specific 
conditions, qualifications, or exceptions are listed in paragraph (e) 
of this section.
    (1) The Agency may accept surrogate exposure data estimations and/
or modeling estimations from other sources to satisfy exposure data 
requirements. The surrogate data must meet the basic quality assurance, 
quality control, good laboratory practice, and other scientific 
requirements set by EPA. To be acceptable, the Agency must find that 
the surrogate exposure data estimations have adequate information to 
address the applicable exposure data requirements and contain adequate 
monitoring events of acceptable quality. The data must reflect the 
specific use prescribed on the label and the activity of concern, 
including formulation type, application methods and rates, type of 
activity, and other pertinent information.
    (2) Occupational uses include not only handlers, mixers, loaders, 
and applicators, but also commercial applications to residential sites. 
Residential uses are limited to non-occupational, i.e., non-
professional, antimicrobial applications. Both occupational and 
residential applicator data may be required for the same product.
    (b) Criteria for testing. Applicator exposure data described in the 
table to paragraph (d) of this section are required based on toxicity 
and exposure criteria. Data are required if at least one of the 
toxicity criteria in paragraph (b)(1) of this section, and at least one 
of the exposure criteria in paragraph (b)(2) of this section are met.
    (1) Toxicity criteria. (i) Evidence of potentially significant 
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident 
data with a clear cause-effect relationship indicating that adverse 
health effects may have resulted from exposure to the pesticide.
    (2) Exposure criteria. (i) Dermal exposure may occur during product 
use.
    (ii) Respiratory exposure may occur during product use.
    (c) Key. R = Required; CR = Conditionally required; TEP = Typical 
end-use product.
    (d) Antimicrobial applicator exposure data requirements table. The 
following table shows the data requirements for applicator exposure. 
The test notes appear in paragraph (e) of this section.

                                               Table--Antimicrobial Applicator Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Use sites
           Guideline No.                  Data requirements      --------------------------------------------------     Test  substance       Test note
                                                                        Occupational             Residential                                     No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100...........................  Dermal exposure............  R......................  R......................  TEP....................   1, 2, 3, 4
875.1200
875.1300...........................  Inhalation exposure........  R......................  R......................  TEP....................   1, 2, 3, 4
875.1400
875.1500...........................  Biological monitoring......  CR.....................  CR.....................  TEP....................      1, 2, 3
875.1600...........................  Data reporting and           R......................  R......................  TEP....................            5
                                      calculations.
875.1700...........................  Product use information....  R......................  R......................  TEP....................  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section:
    1. Prior to initiation of the study, protocols involving 
intentional exposure of human subjects must be submitted for review by 
EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 
26.1125. Examples of proposed human study research can be found in 
various reviews provided by the Human Studies Review Board (http://www.epa.gov/osa/hsrb/index.htm).
    2. Biological monitoring data may be submitted in addition to, or 
in lieu of, dermal and inhalation passive dosimetry exposure data, 
provided the human pharmacokinetics of the pesticide or metabolite/
analog compounds (i.e., whichever method is

[[Page 26988]]

selected as an indicator of body burden or internal dose) allow for the 
back calculation to the total internal dose.
    3. For products with both indoor and outdoor uses, and similar 
conditions of use, data are generally required for the indoor 
applications only. However, data for outdoor uses are required if the 
Agency expects outdoor uses to result in greater exposure than indoor 
uses (e.g., higher use rates and application frequency, or longer 
exposure duration, or application methods/equipment create potential 
for increased dermal or inhalation exposure in outdoor versus indoor 
use sites). In certain cases, when a pesticide may be used both indoors 
and outdoors under dissimilar conditions of use, the Agency may require 
submission of applicator exposure data for both use patterns.
    4. EPA will consider waiving this data requirement for 
antimicrobials applied via closed loading systems if the antimicrobial 
has a low vapor pressure.
    5. Data reporting and calculations are required only if handler 
exposure data are required.


Sec.  158.2270  Post-application exposure.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how 
to use the table in paragraph (d) of this section to determine the 
post-application exposure data requirements for antimicrobial pesticide 
products. The data generated during these studies are used to determine 
the quantity of pesticide to which people may be exposed after 
application. Notes that apply to an individual test, including specific 
conditions, qualifications, or exceptions to the designated test, are 
listed in paragraph (e) of this section.
    (1) Post-application exposure data are required when certain 
toxicity criteria are met and the human activities associated with the 
pesticide's use pattern can lead to potential adverse exposures.
    (2) The Agency may accept surrogate exposure data estimations and/
or modeling estimations from other sources to satisfy exposure data 
requirements. The surrogate data must meet the basic quality assurance, 
quality control, good laboratory practice, and other scientific 
requirements set by EPA. To be acceptable, the Agency must find that 
the surrogate exposure data estimations have adequate information to 
address the applicable exposure data requirements and contain adequate 
monitoring events of acceptable quality. The data must reflect the 
specific use prescribed on the label and the activity of concern, 
including formulation type, application methods and rates, type of 
activity, and other pertinent information.
    (b) Criteria for testing. Post-application exposure data described 
in the table to paragraph (d) of this section are required based on 
toxicity and exposure criteria. Data are required if at least one of 
the toxicity criteria in paragraph (b)(1) of this section, and at least 
one of the exposure criteria in paragraph (b)(2) of this section are 
met.
    (1) Toxicity criteria. (i) Evidence of potentially significant 
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident 
data with a clear cause-effect relationship indicating that adverse 
health effects may have resulted from exposure to the pesticide.
    (2) Exposure criteria--(i) Outdoor uses. (A) Occupational human 
post-application or bystander exposure to residues of antimicrobial 
pesticides could occur as the result of, but is not limited to, worker 
reentry into treatment sites, clean-up and equipment maintenance tasks, 
handling wood preservative-treated wood, or other work-related 
activity.
    (B) Residential human post-application or bystander exposure to 
residues of antimicrobial pesticides could occur following the 
application of antimicrobial pesticides to outdoor areas and spaces at 
residential sites, such as, but not limited to homes, daycare centers, 
and other public buildings.
    (ii) Indoor uses. (A) Occupational human post-application or 
bystander exposure to pesticide residues could occur following the 
application of the antimicrobial pesticide to indoor spaces or 
surfaces.
    (B) Residential human post-application or bystander exposure to 
pesticide residues could occur following the application of the 
antimicrobial pesticide to indoor spaces or surfaces at residential 
sites, such as, but not limited to homes, daycare centers, hospitals, 
schools, and other public buildings.
    (c) Key. R = Required; CR = Conditionally required; NR = Not 
required; TEP = Typical end-use product.
    (d) Antimicrobial post-application exposure data requirements 
table. The following table shows the data requirements for post-
application exposure. The test notes appear in paragraph (e) of this 
section.

                                            Table--Antimicrobial Post-Application Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Use sites
           Guideline No.                   Data requirement      --------------------------------------------------     Test  substance       Test note
                                                                        Occupational             Residential                                     No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2200...........................  Soil residue dissipation...  CR.....................  CR.....................  TEP....................         2, 3
875.2300...........................  Indoor surface residue       CR.....................  R......................  TEP....................   3, 4, 5, 6
                                      dissipation.
875.2400...........................  Dermal exposure............  CR.....................  CR.....................  TEP....................      1, 7, 8
875.2500...........................  Inhalation exposure........  CR.....................  CR.....................  TEP....................    1,7, 8, 9
875.2600...........................  Biological monitoring......  CR.....................  CR.....................  TEP....................         1, 8
875.2700...........................  Product use information....  R......................  R......................  TEP....................  ...........
875.2800...........................  Description of human         R......................  R......................  TEP....................  ...........
                                      activity.
875.2900...........................  Data reporting and           R......................  R......................  TEP....................           10
                                      calculations.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section:
    1. Prior to initiation of the study, protocols involving 
intentional exposure of human subjects must be submitted for review by 
EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 
26.1125. Examples of proposed human study research can be found in 
various reviews provided by the Human Studies Review Board (HSRB) 
(http://www.epa.gov/osa/hsrb/index.htm).
    2. For residential wood preservative uses, data may be required if 
soil has the potential to be an important exposure pathway, and soil is 
in contact with or adjacent to treated wood, including but not limited 
to decks, play sets, and gazebos,
    3. Protocols must be approved by the Agency prior to the initiation 
of the study.

[[Page 26989]]

    4. For wood preservatives, data are required for treated wood 
surfaces where post-application contact with treated wood is 
anticipated.
    5. For occupational uses, data are required if the pesticide may be 
applied to or around surfaces, and if the human activity data indicate 
that workers are likely to have post-application dermal contact with 
treated surfaces while participating in typical activities.
    6. Data are required for residential use sites, schools, and 
daycare institutions. This includes but is not limited to the 
following: Residential and public access premises; material 
preservatives (including those used in residential products, including 
but not limited to clothing and plastic toys) and wood preservatives 
(when contact with treated wood is likely to occur).
    7. Data are required for occupational and residential uses if the 
human activity data indicate the potential for post-application dermal 
and/or inhalation exposures while participating in typical activities 
and no acceptable modeling options are available.
    8. Biological monitoring data may be submitted in addition to, or 
in lieu of, dermal and inhalation passive dosimetry exposure data 
provided the human pharmacokinetics of the pesticide or metabolite/
analog compounds (i.e., whichever method is selected as an indicator of 
body burden or internal dose) allow for a back-calculation to the total 
internal dose.
    9. Data are required for occupational and residential uses if there 
is the potential for bystander exposure and the pesticide use could 
result in respirable and/or inhalable material (e.g., gas, vapor, 
aerosol, or particulates).
    10. Data reporting and calculations are required only if post-
application exposure data are required.


Sec.  158.2280  Environmental fate.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how 
to use the table in paragraph (c) of this section to determine the 
environmental fate data requirements for antimicrobial pesticide 
products. Notes that apply to an individual test including specific 
conditions, qualifications, or exceptions are listed in paragraph (d) 
of this section.
    (1) Environmental fate data are required to support the 
registrations of all end-use and manufacturing-use antimicrobial 
products.
    (2) Data on transformation/degradation products or leachate 
residues of the parent compound are also required to support 
registration, if the transformation/degradation products or leachate 
residues meet one of the following criteria:
    (i) More toxic, persistent, or bioaccumulative than the parent;
    (ii) Have been shown to cause adverse effects in mammalian or 
aquatic reproductive studies; or
    (iii) The moiety of concern (i.e., functional group in the parent 
chemical molecule that imparts adverse effects) remains intact.
    (3) For the purpose of determining data requirements, the all other 
use patterns category includes the following use patterns:
    (i) Agricultural premises and equipment.
    (ii) Food-handling/storage establishments, premises, and equipment.
    (iii) Commercial, institutional and industrial premises and 
equipment.
    (iv) Residential and public access premises.
    (v) Medical premises and equipment.
    (vi) Human drinking water systems.
    (vii) Materials preservatives.
    (viii) Swimming pools.
    (b) Key. MP = Manufacturing use product; EP = End-use product; R = 
Required; CR = Conditionally required; NR = Not required; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use 
product; PAIRA = Pure active ingredient radiolabeled; ROC = residue of 
concern.
    (c) Antimicrobial environmental fate data requirements table. The 
following table shows the data requirements for environmental fate. The 
test notes appear in paragraph (d) of this section.

                                                                    Table--Antimicrobial Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Use pattern                                                        Test substance
                                       ------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement        Industrial                                                                                                                            Test note No.
                                        processes and  water  Antifoulant coatings         Wood            Aquatic areas       All other use           MP               EP
                                               systems             and paints          preservatives                        patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Degradation Studies--Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.2120.........  Hydrolysis.........  R...................  R...................  R.................  R.................  R.................  TGAI or PAIRA..  TGAI or PAIRA..               1
835.2240.........  Photodegradation in  R...................  R...................  R.................  R.................  R.................  TGAI or PAIRA..  TGAI or PAIRA..               2
                    water.
835.2410.........  Photodegradation in  NR..................  NR..................  R.................  NR................  NR................  TGAI or PAIRA..  TGAI or PAIRA..              10
                    soil.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Toxicity and Fate in Wastewater Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.6800.........  Activated Sludge,    R...................  R...................  R.................  NR................  R.................  TGAI...........  TGAI...........              21
                    Respiration
                    Inhibition Test.
                   OECD 209...........
835.1110.........  Activated Sludge     CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........          19, 20
                    Sorption Isotherm.
835.3110.........  Ready                CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........        3, 4, 18
                    Biodegradability.
835.3220.........  Porous Pot Study...  CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
835.3280.........  Simulation Tests to  CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
                    Assess the
                    Biodegradability
                    of Chemicals
                    Discharged in
                    Wastewater.

[[Page 26990]]

 
835.3240.........  Simulation Test--    CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
                    Aerobic Sewage
                    Treatment: A.
                    Activated Sludge
                    Units.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Mobility Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1230.........  Leaching and         R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 6
                    adsorption/de-
                    sorption.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1240
                                                                                 Metabolism Studies--Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4100.........  Aerobic soil         CR..................  NR..................  R.................  CR................  CR................  TGAI or PAIRA..  TGAI or PAIRA..         7, 8, 9
                    metabolism.
835.4200.........  Anaerobic soil       NR..................  NR..................  R.................  NR................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
835.4300.........  Aerobic aquatic      R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
835.4400.........  Anaerobic aquatic    R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Dissipation Studies--Field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6200.........  Aquatic (sediment).  CR..................  R...................  CR................  R.................  CR................  TEP............  TEP............      11, 12, 13
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Ground and Surface Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None.............  Monitoring of        CR..................  CR..................  CR................  CR................  CR................  ROC............  ROC............      11, 14, 17
                    representative
                    U.S. waters.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Special Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None.............  Special leaching...  NR..................  R...................  R.................  NR................  NR................  TGAI...........  TEP............          15, 16
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table in paragraph (c) of this section:
    1. For testing antifoulant paints and coatings, testing is to be 
performed separately with both sterile buffered distilled water and 
sterile synthetic seawater at pHs 5, 7, and 9.
    2. Not required if:
    i. The electronic absorption spectra, measured at pHs 5, 7 and 9, 
of the chemical and its hydrolytic products, if any, show no absorption 
or tailing between 290 and 800 nm, inclusive; or
    ii. The results of the hydrolysis study at all three pHs (5, 7, and 
9) demonstrates a half-life of less than 30 days.
    3. The results of the activated sludge, respiration inhibition 
(ASRI) test determine which of the following tests are required: Ready 
biodegradability, porous pot, the biodegradation in activated sludge 
study as described in the ``Simulation Tests to Assess the 
Biodegradability of Chemicals Discharged in Wastewater,'' or simulation 
test--aerobic sewage treatment: A. activated sludge units.
    i. If the ASRI test EC50 is equal to or less than 20 mg/
L, then the applicant must choose either to:
    A. Conduct the biodegradation in activated sludge study as 
described in the ``Simulation Tests to Assess the Biodegradability of 
Chemicals Discharged in Wastewater'';
    B. Conduct the porous pot test; or
    C. Conduct the simulation test--aerobic sewage treatment: A. 
activated sludge units.
    ii. If the ASRI test EC50 is greater than 20 mg/L, then 
the applicant must choose either to:
    A. Conduct a ready biodegradability study; or
    B. Conduct one of the following studies: The biodegradation in 
activated sludge study as described in the ``Simulation Tests to Assess 
the Biodegradability of Chemicals Discharged in Wastewater,'' the 
porous pot test, or the simulation test--aerobic sewage treatment: A. 
activated sludge units.
    4. Pass criteria for the ready biodegradability study are: 70 
percent removal of dissolved organic carbon (DOC) and 60 percent 
removal of theoretical oxygen demand (ThOD) or theoretical carbon 
dioxide (ThCO2) production for respirometric methods. These 
pass levels must be reached in a 10-day window within the 28-day period 
of the test. If the antimicrobial passes the ready biodegradability 
study, then no further testing is required. If the antimicrobial fails 
the ready biodegradability study, then the applicant must conduct one 
of the following studies: The biodegradation in activated sludge study 
as described in the ``Simulation Tests to Assess the Biodegradability 
of Chemicals Discharged in Wastewater,'' the porous pot test, or the 
simulation test--aerobic sewage treatment: A. activated sludge units.
    5. For the all other use patterns category (as specified in Sec.  
158.2280(a)(3)), data are required based on a weight-of-evidence 
evaluation of the results of the hydrolysis, photodegradation in water, 
activated sludge sorption isotherm, biodegradability, and activated 
sludge, respiration inhibition tests.
    6. Adsorption and desorption using a batch equilibrium method is 
preferred.

[[Page 26991]]

In some cases, as when the antimicrobial pesticide degrades rapidly, 
soil column leaching with unaged or aged columns may be more 
appropriate to fully characterize the potential mobility of the parent 
compound and major transformation products.
    7. For industrial processes and water systems, aquatic areas, and 
the all other use patterns category (as specified in Sec.  
158.2280(a)(3)), data are required based on a weight-of-evidence 
evaluation of the results of the hydrolysis, photodegradation in water, 
activated sludge sorption isotherm, biodegradability, and activated 
sludge, respiration inhibition tests.
    8. The environmental media (soil, water, hydrosoil, and biota) to 
be utilized in these studies must be collected from areas 
representative of potential use sites.
    9. For industrial processes and water systems, and aquatic areas, 
data are required for use sites that are intermittently dry.
    10. Data are not required if the antimicrobial is an inorganic 
substance or a metal salt; or if the standardized soil profiles 
demonstrate that the antimicrobial is likely to readily degrade either 
microbially or via redox reactions (chemically) and no transformation/
degradate/leachate products of concern (as described under Sec.  
158.2280(a)(2)) are produced.
    11. Analytical methods used to generate data associated with this 
study must include results of a successful confirmatory method trial by 
an independent laboratory.
    12. Protocols must be approved by the Agency prior to the 
initiation of the study.
    13. For industrial processes and water systems, wood preservatives, 
and the all other use patterns category (as specified in Sec.  
158.2280(a)(3)), data are required based on the potential for aquatic 
exposure and if the weight-of-evidence indicates that the active 
ingredient or principal transformation products are likely to have the 
potential for persistence, mobility, nontarget aquatic toxicity, or 
bioaccumulation.
    14. Data are required if the weight-of-evidence indicates that the 
active ingredient or principal transformation products are likely to 
occur in nontarget freshwater, estuarine, or marine waters such that 
human or environmental exposures are likely to occur. In making that 
determination, the Agency takes into account other factors such as the 
toxicity of the chemical(s), available monitoring data and the 
vulnerability of the freshwater, estuarine, or marine water resources 
in the antimicrobial use area.
    15. For wood preservatives, an aquatic leaching study is required. 
A soil leaching study is required if human or environmental exposures 
are likely to occur from leachates that contain the active ingredient 
or principal transformation products from wood treated with a 
preservative product. Protocols must be approved by the Agency prior to 
the initiation of the study.
    16. For antifoulant paints and coatings, a leaching study is 
required. Protocols must be approved by the Agency prior to the 
initiation of the study.
    17. Protocols, which include the residues of concern (such as 
parent, degradate/transformation product, and/or leachate residues) 
that would be monitored, must be approved by the Agency prior to the 
initiation of the study.
    18. A biodegradation study is not required if the antimicrobial 
meets one or more of the following criteria:
    i. Classified as a metal,
    ii. Relatively volatile, but not hydrophobic,
    iii. Highly reactive,
    iv. Both the parent and all transformation/degradate products (as 
described under Sec.  158.2280(a)(2)) have half-lives of less than 3 
hours,
    v. None of the registered or proposed product uses would result in 
transport of the parent and its transformation/degradate products (as 
described under Sec.  158.2280(a)(2)) to a wastewater treatment plant.
    19. The activated sludge sorption isotherm test is not required if 
the antimicrobial is:
    i. Relatively volatile, but not hydrophobic;
    ii. Highly reactive; or
    iii. The log Kow is less than 3.0.
    20. If the criteria of test note 19 of this paragraph are not met, 
then the activated sludge sorption isotherm test is required if one or 
more of the following criteria are also met:
    i. The antimicrobial is a metal,
    ii. The log Kow is greater than or equal to 3.0,
    iii. The antimicrobial is positively charged or polycationic,
    iv. The EC50 in the activated sludge, respiration 
inhibition test is less than or equal to 20 mg/L,
    v. The EC50 in the activated sludge, respiration 
inhibition test is greater than 20 mg/L, and the antimicrobial fails 
the ready biodegradability study.
    21. The activated sludge respiration inhibition study is not 
required if none of the registered or proposed product uses would 
result in transport of the parent and its transformation/degradate 
products (as described under Sec.  158.2280(a)(2)) to a wastewater 
treatment plant.


Sec.  158.2290  Residue chemistry.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how 
to use the table in paragraph (h) of this section to determine the 
residue chemistry data requirements for antimicrobial pesticide 
products. Notes that apply to an individual test including specific 
conditions, qualifications, or exceptions are listed in paragraph (i) 
of this section.
    (b) Residue chemistry data are required for:
    (1) Antimicrobial end-use products with uses that may result in 
residues in or on food, including but not limited to:
    (i) Products that require a tolerance, tolerance exemption, or food 
additive regulation or clearance.
    (ii) Products that may be used to treat livestock or poultry 
drinking water, for food egg washing, or for fruit and vegetable 
rinses.
    (iii) Products that may be applied to a surface or incorporated 
into a material that may contact food or feed. Data are required 
regardless of whether the antimicrobial is applied or impregnated for 
the purpose of imparting antimicrobial protection to external surfaces 
of the substance or article, or for the purpose of protecting the 
substance or article itself.
    (iv) Products that may be applied to water that have the potential 
to result in residues in potable water, or in water used for livestock 
and poultry drinking water, irrigation of crops, or water containing 
fish that may be used for human food.
    (v) Wood preservative or antifoulant products intended for treating 
submerged materials that may result in food contact (e.g., lobster 
pots, fish cages on fish farms).
    (2) Each manufacturing-use product bearing directions for 
formulation into an end-use product bearing uses described in paragraph 
(b)(1) of this section.
    (c) Residue chemistry data are not required under paragraph (b) of 
this section if no adverse effects (no toxicity endpoints) are 
associated with dietary exposure to the active ingredient or if 
theoretical (high-end) dietary exposure estimates combined with the 
applicable toxicity endpoint result in acute and chronic dietary risks 
that are below the Agency levels of concern.
    (d) For purposes of this section, Magnitude of the Residue Studies 
include the following: Food-handling, migration studies, potable water, 
fish,

[[Page 26992]]

irrigated crops, meat/milk/poultry/eggs, crop field trails, processed 
food or feed, and anticipated residues.
    (e) If the antimicrobial chemical may be applied to a field crop, 
then the residue chemistry data requirements of Sec.  158.1410 apply.
    (f) The following term is defined for the purposes of this section: 
Residue of concern means the parent pesticidal compound and its 
metabolites, degradates, and impurities of toxicological concern.
    (g) Key. R = Required; CR = Conditionally required; NR = Not 
required; TGAI = Technical grade of the active ingredient; TEP = 
Typical end-use product; PAI = Pure active ingredient; PAIRA = Pure 
active ingredient radiolabeled; ROC = Residue of concern.
    (h) Antimicrobial residue chemistry data requirements table. The 
following table shows the data requirements for residue chemistry. The 
test notes appear in paragraph (i) of this section.

                                                Table--Antimicrobial Residue Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Uses
                                     ------------------------------------------------------------------------------------                     Test note
  Guideline No.    Data requirement       Agricultural                                                                     Test  substance       No.
                                            premise           Indirect food         Direct food            Aquatic
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1100........  Chemical identity.  R..................  R..................  R..................  R..................  TGAI.............  ...........
860.1200........  Directions for use  R..................  R..................  R..................  R..................  .................  ...........
860.1550........  Proposed tolerance/ R..................  R..................  R..................  R..................  .................            1
                   tolerance
                   exemption.
860.1560........  Reasonable grounds  R..................  R..................  R..................  R..................  .................            1
                   in support of
                   petition.
860.1650........  Submittal of        R..................  R..................  R..................  R..................  PAI/ROC..........            2
                   analytical
                   reference
                   standards.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Food-Contact Surfaces or Impregnated Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1460........  Food-handling.....  CR.................  CR.................  CR.................  CR.................  TEP..............            3
None............  Nature of residue   CR.................  CR.................  CR.................  CR.................  PAIRA or TGAI....            4
                   on surfaces.
None............  Migration studies.  CR.................  CR.................  CR.................  CR.................  TEP..............            5
860.1340........  Residue analytical  CR.................  CR.................  CR.................  CR.................  ROC..............            6
                   method for data
                   collection.
860.1380........  Storage stability.  R..................  R..................  R..................  R..................  TEP or ROC.......            7
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Higher tiered
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300........  Nature of the       CR.................  CR.................  CR.................  CR.................  PAIRA............            8
                   residue in plants.
860.1300........  Nature of the       CR.................  CR.................  CR.................  CR.................  PAIRA............            9
                   residue in
                   livestock.
860.1340........  Residue analytical  CR.................  CR.................  CR.................  CR.................  ROC..............           10
                   methods for
                   tolerance/
                   tolerance
                   exemption
                   enforcement.
860.1360........  Multiresidue        CR.................  CR.................  CR.................  CR.................  ROC..............           11
                   method testing.
860.1400........  Potable water.....  CR.................  CR.................  CR.................  CR.................  TEP..............           12
860.1400........  Fish..............  CR.................  CR.................  CR.................  CR.................  TEP..............           13
860.1400........  Irrigated crops...  CR.................  CR.................  CR.................  CR.................  TEP..............           14
860.1480........  Meat/milk/poultry/  CR.................  CR.................  CR.................  CR.................  TGAI or ROC......           15
                   eggs.
860.1500........  Crop field trials.  CR.................  CR.................  CR.................  CR.................  TEP..............           16
860.1520........  Processed food or   CR.................  CR.................  CR.................  CR.................  TEP..............           17
                   feed.
None............  Anticipated         CR.................  CR.................  CR.................  CR.................  ROC..............           18
                   residues.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (i) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (h) of this section:
    1. A petition proposing a numerical tolerance or a tolerance 
exemption is required for any food or feed use subject to section 408 
of FFDCA if the use is not covered by an existing tolerance or 
tolerance exemption. If the use is subject to FFDCA section 409, the 
applicant must identify to EPA an applicable section 409 food additive 
regulation or clearance, or submit a copy of a petition to FDA 
requesting a section 409 food additive regulation or clearance for the 
food or feed use.
    2. An analytical reference standard is required for any food or 
feed use requiring a numeric tolerance or exemption. Material safety 
data sheets as specified by the Occupational Safety and Health 
Administration in 29 CFR 1910.1200 must accompany analytical standards.
    3. Data are required if a pesticide may be used in a food-handling 
establishment unless data including, but not limited to, theoretical 
(high-end) estimates, radiolabeled laboratory data, or the nature of 
the residue on surfaces study show that residues will not occur in food 
or feed.
    4. If an antimicrobial pesticide may be applied to a food-contact 
surface or impregnated into a food-contact material and if theoretical 
(high-end) estimates of exposure exceed EPA's risk level of concern, 
then the nature of the residue on surfaces study is required. Protocols 
must be approved by the Agency prior to the initiation of the study.
    5. Based on the results of the nature of the residue on surfaces 
study, if residues of concern are identified, then the migration study 
will be required. Protocols must be approved by the Agency prior to the 
initiation of the study.

[[Page 26993]]

    6. If a magnitude of the residue study, as specified in Sec.  
158.2290(d), is required, then a residue analytical method suitable for 
collecting data is also required. The method must be capable of 
determining all residues of concern, to permit calculation of dietary 
risk or to establish a tolerance or tolerance exemption.
    7. If a magnitude of the residue study, as specified in Sec.  
158.2290(d), is required, then storage stability data are also 
required, unless analytical samples are stored for 30 days or less. If, 
during hazard characterization, a residue has been identified as ``of 
concern'' and is known to be volatile or labile, then storage stability 
data are required regardless of sample storage time.
    8. If crop plants or metabolically active raw agricultural 
commodities of food crops may be directly or indirectly exposed to an 
antimicrobial, plant metabolism studies are required to determine the 
transformation products that may enter the human diet. Such exposure 
could include, but is not limited to:
    i. Treatment of storage or shipping containers,
    ii. Postharvest fruit and vegetable treatment prior to shipping or 
storage,
    iii. Use of antimicrobial-treated water for irrigation, and
    iv. Any direct food contact use.
    9. If livestock may be exposed to an antimicrobial, then hen and 
ruminant metabolism studies are required to determine the identities of 
residues of concern that may enter the human diet from consumption of 
livestock commodities. Livestock may be exposed via the oral, dermal, 
or inhalation route following treatment or contamination of sites 
including, but not limited to, livestock premises, feed, and drinking 
water. Shell eggs and other metabolically active livestock products may 
also be treated. If livestock may be exposed to one or more residues of 
concern differing from those found in animals, then one or more 
additional livestock metabolism studies involving dosing with these 
residues may be required.
    10. If there is a numerical tolerance or tolerance exemption level 
to enforce, then a residue analytical method suitable for enforcement 
purposes is required. The method must be supported by an independent 
laboratory validation.
    11. If there is a numerical tolerance or tolerance exemption level 
to enforce, then testing is required to determine whether the Food and 
Drug Administration/United States Department of Agriculture 
multiresidue methodology would detect and identify the antimicrobial 
and its residues of concern, as part of programs to monitor pesticides 
in the U.S. food supply.
    12. Data are required if an antimicrobial may be applied directly 
to water or if there is the potential that the antimicrobial-treated 
water could be used directly for drinking water purposes by humans or 
animals or that contaminated water could run-off, leach, or be 
discharged from treated sites or materials and make its way into 
potable water.
    13. Data are required if an antimicrobial may be applied directly 
to water inhabited by fish or that will be inhabited by fish or if 
contaminated water could run-off, leach, or be discharged from treated 
sites or materials and make its way into bodies of water containing 
fish that may be used for human consumption.
    14. Data are required if an antimicrobial may be applied directly 
to water used for irrigation of food crops or such that contaminated 
water could run-off, leach, or be discharged from treated sites or 
materials to make its way into water used for irrigation of food crops.
    15. If the antimicrobial may be applied directly to livestock, 
metabolically-active livestock commodities (e.g., eggs), livestock feed 
or drinking water, or livestock premises, or a livestock metabolism 
study indicates that residues of the antimicrobial may result in 
livestock commodities, studies are required to determine the magnitude 
of the residues of concern in fat, meat, meat by-products, milk, 
poultry, and eggs that may be consumed by humans. These studies, 
however, may not be required in cases where the livestock metabolism 
studies indicate that transfer of pesticide residues of concern to 
tissues, milk, and eggs is not expected to occur at the maximum 
expected exposure level for the animals.
    16. If food crops or raw agricultural commodities of food crops may 
be exposed to an antimicrobial, then residue studies are required to 
determine the magnitude of the residues of concern that may enter the 
human diet. Such exposures include, but are not limited to, postharvest 
fruit and vegetable treatments and application of antimicrobial 
chemicals to field crops, mushroom houses, empty or occupied beehives, 
or wood used to construct beehives.
    17. Data on the nature and magnitude of residues in processed food 
or feed are required if antimicrobial residues could potentially 
concentrate on processing. If so, the establishment of a separate 
tolerance higher than that in the raw agricultural commodity may be 
required.
    18. Data are required when dietary exposure values at the tolerance 
level or screening-level (high-end) result in estimates of dietary or 
aggregate risk that meet or exceed the Agency's level of concern. These 
data may include, but are not limited to, washing, cooking, processing, 
or degradation studies as well as market basket surveys for a more 
realistic residue determination. Protocols must be approved by the 
Agency prior to the initiation of the study.

PART 161--[REMOVED]

0
6. Remove part 161.

[FR Doc. 2013-10162 Filed 5-7-13; 8:45 am]
BILLING CODE P