Vol. 78 Wednesday, 

No. 89 May 8, 2013 

Part III 

Environmental Protection Agency 

40 CFR Parts 158 and 161 

Data Requirements for Antimicrobial Pesticides; Final Rule 

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26936 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

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. 

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 caseby-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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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 26937 

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-thedrain 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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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 26939 

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 populationbased 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 nonanimal 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) StructureActivity-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 

§ 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 agriculturallybased 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 postapplication 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 § 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 § 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 

§ 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 

§ 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 

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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 postapplication 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 PostApplication 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 fooduse column and the nonfood-use 

column are split into subcolumns to 

explain which food-uses or nonfooduses 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 

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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 ‘‘longstanding’’ 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] 

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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 longheld 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 

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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 presubmission 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 

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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 welldocumented. 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.’’ 

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(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, highthroughput 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/testingassessment.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 computeraided methods to better predict 

potential hazards and exposures, and to 

focus testing on likely risks of concern. 

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• 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 

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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 Cooperation 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 

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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-ityourself 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-thedrain 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 

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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 § 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. 

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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 § 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 § 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/nonpublic-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 § 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 § 158.2230, 

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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 § 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 § 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 endproduct six-pack testing of one or more 

dilutions is duplicative. 

2. EPA’s response. Proposed test note 

2 to the proposed toxicology table in 

§ 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 usedilution testing is in addition to the asformulated-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 

§ 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 

§ 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 § 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 § 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 noncancer 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 

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mutation assay requirement in the final 

toxicology table in § 158.2230(g), is 

revised to allow reliance on previouslyconducted 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 wellestablished OECD guidelines for these 

studies. The commenter also asserted 

that proposed test note 37 to the 

proposed toxicology table in § 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 § 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 § 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 

§ 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 nonanimal 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 nonanimal test methods, found at http:// 

www.epa.gov/oppad001/eyeirritation.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 

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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 § 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 

§ 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 

§ 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. 

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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 § 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 

§ 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 § 158.2240(a)(3), for 

environmental fate in § 158.2280(a)(2) 

and for nontarget plant protection in 

§ 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 § 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 § 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-thedrain assessment, and the following 

changes have been made to the 

antifoulant paints and coatings testing 

column: 

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• 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 

§ 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 

§ 158.2240 has been revised in the final 

rule to include an additional trigger (see 

§ 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 § 158.2240. New test note 5 

to the final nontarget organism table in 

§ 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 § 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 § 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 

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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 § 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 § 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 

§ 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 ≥ 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 § 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 

§ 158.2250. 

In evaluating test note 2 to the 

proposed nontarget plant protection 

table in § 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 

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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 § 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 § 158.2250, which will read the 

same as the original, proposed test note 

2 to the proposed nontarget plant 

protection table in proposed § 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 longerterm (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 

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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 

§ 158.2260(a)(1) and § 158.2270(a)(1) 

concerning use of OSHA standards. 

With modifications, the language 

appears in the final toxicity rule in 

§ 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 

§ 158.2260(b) and § 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 § 158.2260 and § 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 

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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 nondietary 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, pressuretreated 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-tomouth 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 § 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-bycase 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 halflife >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 § 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 

§ 158.2240(a)(3), for environmental fate 

in § 158.2280(a)(2), and for nontarget 

plant protection in § 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 highertiered 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 

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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 § 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 § 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 § 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-ofevidence 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-thedrain modeling are unlikely to provide 

appropriate information to determine 

the need for the aquatic sediment study. 

The current version of the down-thedrain 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 

§ 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 

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§ 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 § 158.2280(c) is revised to 

remove the AWPA methods. Test note 

12 to the final environmental fate table 

in § 158.2280(c) is added to require 

protocol review. 

Test note 16 to the proposed 

environmental fate table in § 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 § 158.2280 is 

revised to remove the ASTM methods. 

Test note 12 to the final environmental 

fate table in § 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 downthe-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-thedrain module of E–FAST is the most 

appropriate tool. 

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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 § 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 § 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 § 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 downthe-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 

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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 Downthe-Drain Screening Model, Using the 

Proposed Approach for a ScreeningLevel 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 highertier testing is triggered only if the downthe-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 CWAregulated 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 § 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 

§ 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 

§ 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 

§ 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 § 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 

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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 

§ 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 § 158.2290(b) a nonexclusive list identifying examples of 

antimicrobial products covered by this 

section. The revision to the introductory 

text of § 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 § 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 

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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 metabolicallyactive 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 antimicrobialtreated water from indoor industries, 

leaching from preserved lumber, or 

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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. 

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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-bycase 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 costefficient 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 cohosted 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 § 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-bycase 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 

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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 

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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 speciesspecific 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 downthe-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. 

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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 endocrinerelated 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 callins 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 postapplication 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. 

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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 timeintensive 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 

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

overhead.

Commenter with 30 

percent overhead.

Commenter with 30 

percent overhead. 

Test Probabilities according to: EPA ............................ EPA ............................ EPA ............................ Commenter. 

Number of Registrations according to: EPA ............................ EPA ............................ EPA ............................ Commenter. 

Data Requirement Cost according to Proposed Rule ($ millions).$15.0 .......................... $19.9 .......................... $25.5 .......................... $25.9. 

Cost of Proposed Rule (Incremental Costs) 

($ millions).

$3.9 ............................ $7.6 ............................ $9.8 ............................ $9.2. 

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 

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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 

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

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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 currentlyregistered 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 

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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 subpopulations, 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 

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26978 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

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] 

■ 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. 

■ 2. Revise § 158.1(c)(4) to read as 

follows: 

§ 158.1 Purpose and scope. 

* * * * * 

(c) * * * 

(4) Antimicrobial pesticides. Subparts 

A, B, C, D, and W of this part apply to 

antimicrobial pesticides. 

■ 3. In § 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: 

§ 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 

§ 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. 

§ 158.400 [Amended] 

■ 4. In the table in § 158.400(d) remove 

the heading ‘‘Efficacy of Antimicrobial 

Agents,’’ and the entries 91–2 through 

91–8 under that category. 

■ 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 

§ 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). 

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

§ 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. 

§ 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. 

§ 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. 

§ 158.2210 Product chemistry. 

The product chemistry data 

requirements of subpart D of this part 

apply to antimicrobial products covered 

by this subpart. 

§ 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 

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26980 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

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 

§ 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 

§ 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 

§ 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 Data Recommendations ......................................... R ........................... EP 

810.2200 .............................. Disinfectants for Use on Hard Surfaces—Efficacy Data Recommendations.R ........................... EP 

810.2300 .............................. Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations.R ........................... EP 

810.2400 .............................. Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy 

Data Recommendations.

R ........................... EP 

810.2500 .............................. Air Sanitizers—Efficacy Data Recommendations .................................. R ........................... EP 

810.2600 .............................. Disinfectants for Use in Water—Efficacy Data Recommendations ....... R ........................... EP 

§ 158.2230 Toxicology. 

(a) General. Subpart B of this part and 

§ 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

Guideline 

No. 

Data 

requirement 

Food uses Nonfood uses Test substance 

Test note No. Direct food 

uses 

Indirect food 

uses (>200 

ppb) 

Indirect food 

uses (≤200 

ppb) 

Swimming 

pools, 

aquatic areas, 

wood preservatives, metal 

working fluids 

All other 

nonfood uses MP EP 

Acute Testing 

870.1100 .... Acute oral toxicity—rat.R ..................... R ..................... R ..................... R ..................... R ..................... MP and 

TGAI.

EP and 

TGAI.

1, 2 

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TABLE—ANTIMICROBIAL TOXICOLOGY DATA REQUIREMENTS—Continued 

Guideline 

No. 

Data 

requirement 

Food uses Nonfood uses Test substance 

Test note No. Direct food uses Indirect food 

uses (>200 

ppb) 

Indirect food 

uses (≤200 

ppb) 

Swimming 

pools, 

aquatic areas, 

wood preservatives, metal 

working fluids 

All other 

nonfood uses MP EP 

870.1200 .... Acute dermal 

toxicity.

R ..................... R ..................... R ..................... R ..................... R ..................... MP and 

TGAI.

EP and 

TGAI.

1, 2, 3 

870.1300 .... Acute inhalation 

toxicity—rat.

R ..................... R ..................... R ..................... R ..................... R ..................... MP and 

TGAI.

EP and 

TGAI.

2, 4 

870.2400 .... Primary eye irritation—rabbit.R ..................... R ..................... R ..................... R ..................... R ..................... MP and 

TGAI.

EP and 

TGAI.

1, 2, 3 

870.2500 .... Primary dermal 

irritation.

R ..................... R ..................... R ..................... R ..................... R ..................... MP and 

TGAI.

EP and 

TGAI.

1, 2, 3 

870.2600 .... Dermal sensitization.R ..................... R ..................... R ..................... R ..................... R ..................... MP and 

TGAI.

EP and 

TGAI.

1, 2, 3, 5 

870.2600 .... Acute 

neurotoxicity—rat.

R ..................... R ..................... CR .................. R ..................... CR .................. TGAI ......... TGAI ......... 6, 11 

Subchronic Testing 

870.3100 .... 90-Day oral toxicity—rodent.R ..................... R ..................... R ..................... R ..................... CR .................. TGAI ......... TGAI ......... 8, 9, 15, 38 

870.3150 .... 90-Day oral toxicity—nonrodent.R ..................... R ..................... CR .................. R ..................... CR .................. TGAI ......... TGAI ......... 10, 15 

870.3200 .... 21/28-Day dermal toxicity.CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... EP and 

TGAI.

12, 13 

870.3250 .... 90-Day dermal 

toxicity.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... EP and 

TGAI.

7, 13, 14, 15 

870.3465 .... 90-Day inhalation toxicity— 

rat.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 7, 15, 16, 17 

870.6200 .... 90-Day 

neurotoxicity—rat.

R ..................... R ..................... CR .................. R ..................... CR .................. TGAI ......... TGAI ......... 6, 8 

Chronic Testing 

870.4100 .... Chronic oral toxicity—rodent.R ..................... R ..................... CR .................. R ..................... CR .................. TGAI ......... TGAI ......... 18, 19, 20 

870.4200 .... Carcinogenicity—two 

rodent species—rat and 

mouse preferred.

R ..................... R ..................... CR .................. R ..................... CR .................. TGAI ......... TGAI ......... 19, 21, 22 

Developmental Toxicity and Reproduction 

870.3700 .... Prenatal developmental toxicity—rat and 

rabbit preferred.

R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 23, 24, 25, 26 

870.3800 .... Reproduction 

and fertility effects.

R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 26, 27, 28, 29 

870.6300 .... Developmental 

neurotoxicity.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 28, 29, 30 

Mutagenicity 

870.5100 .... Reverse mutation assay.R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 31, 32 

870.5300 ....

870.5375 ....

In vitro mammalian gene mutation.R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 31, 33 

870.5385 ....

870.5395 ....

In vivo cytogenetics.R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 31, 34 

Special Testing 

870.7485 .... Metabolism and 

pharmacokinetics.

R ..................... R ..................... CR .................. R ..................... CR .................. PAI or 

PAIRA.

PAI or 

PAIRA.

35, 39 

870.7200 .... Companion animal safety.CR .................. CR .................. CR .................. CR .................. CR .................. NR ............ Choice ...... 36 

870.7600 .... Dermal penetration.CR .................. CR .................. CR .................. CR .................. CR .................. Choice ...... Choice ...... 3, 37 

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TABLE—ANTIMICROBIAL TOXICOLOGY DATA REQUIREMENTS—Continued 

Guideline 

No. 

Data 

requirement 

Food uses Nonfood uses Test substance 

Test note No. Direct food uses Indirect food 

uses (>200 

ppb) 

Indirect food 

uses (≤200 

ppb) 

Swimming 

pools, 

aquatic areas, 

wood preservatives, metal 

working fluids 

All other 

nonfood uses MP EP 

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 dosesetting 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 

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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 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 twogeneration 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 treatmentrelated neurological effects in adult 

animal studies (i.e., clinical signs of 

neurotoxicity, neuropathology, 

functional or behavioral effects). 

ii. The pesticide causes treatmentrelated 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-ofevidence 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. 

§ 158.2240 Nontarget organisms. 

(a) General. Subpart B of this part and 

§ 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 

§ 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. 

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26984 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

(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

Guideline 

No. 

Data 

requirement 

Use pattern Test substance 

Industrial Test note No. 

processes and 

water systems 

Antifoulant 

coatings and 

paints 

Wood 

preservatives Aquatic areas 

All other use 

patterns 

category 

MP EP 

Tier One Testing 

850.2100 .... Acute avian oral 

toxicity.

R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 1 

850.1010 .... Acute freshwater invertebrates toxicity.R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 2 

850.1075 .... Acute freshwater fish toxicity.R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 3 

Higher Tier Testing 

Avian Testing 

850.2200 .... Avian dietary 

toxicity.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 4 

850.2300 .... Avian reproduction.CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 1, 6 

Aquatic Organisms Testing 

850.1010 .... Acute freshwater invertebrates toxicity.CR .................. CR .................. CR .................. CR .................. CR .................. .................. TEP .......... 2, 5, 7 

850.1075 .... Acute freshwater fish toxicity.CR .................. CR .................. CR .................. CR .................. CR .................. .................. TEP .......... 3, 5, 7 

850.1025 .... Acute estuarine 

and marine 

organisms 

toxicity.

CR .................. R ..................... CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 8, 9 

850.1035 

850.1045 

850.1055 .... Acute estuarine 

and marine 

organisms 

toxicity.

CR .................. CR .................. CR .................. CR .................. CR .................. .................. TEP .......... 5, 7, 8 

850.1075 

850.1400 .... Fish early-life 

stage.

R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 10 

850.1300 .... Aquatic invertebrate life-cycle.R ..................... R ..................... R ..................... R ..................... R ..................... TGAI ......... TGAI ......... 10 

850.1350 

850.1500 .... Fish life-cycle ... CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 11, 12 

850.1710 .... Aquatic organisms, bioavailability, 

biomagnification, toxicity 

tests.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI, PAI, 

degradate.

TGAI, PAI, 

degradate.

13 

850.1730 

850.1850 

850.1950 .... Simulated or actual field testing for aquatic 

organisms.

CR .................. CR .................. CR .................. CR .................. CR .................. TEP .......... TEP .......... 14, 15, 16 

Sediment Testing 

850.1735 .... Whole sediment; 

acute freshwater invertebrates.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 15, 17 

850.1740 .... Whole sediment; 

acute marine 

invertebrates.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 15, 17, 19 

None ........... Whole sediment; 

chronic invertebrates freshwater and marine.

CR .................. CR .................. CR .................. CR .................. CR .................. TGAI ......... TGAI ......... 15, 18, 19 

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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 26985 

TABLE—ANTIMICROBIAL NONTARGET ORGANISM DATA REQUIREMENTS—Continued 

Guideline 

No. 

Data 

requirement 

Use pattern Test substance 

Industrial Test note No. 

processes and 

water systems 

Antifoulant 

coatings and 

paints 

Wood 

preservatives Aquatic areas 

All other use 

patterns 

category 

MP EP 

Insect Pollinator Testing 

850.3020 .... Honeybee acute 

contact.

NR .................. NR .................. R ..................... NR .................. CR .................. TGAI ......... TGAI ......... 20 

850.3030 .... Toxicity of residues to honeybees.NR .................. NR .................. R ..................... NR .................. CR .................. TGAI ......... TEP or 

treated 

wood.

20, 21 

(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 

§ 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 

§ 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 

§ 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-adverseeffect 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 

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26986 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

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 

§ 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. 

§ 158.2250 Nontarget plant protection. 

(a) Subpart B of this part and 

§ 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 

§ 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

Guideline 

No. 

Data 

requirement 

Use pattern Test substance 

Industrial proc- Test note No. 

esses and 

water systems 

Antifoulant 

coatings and 

paints 

Wood preservatives Aquatic areas 

All other use 

patterns 

category 

MP EP 

850.4225 .... Seedling emergence, Tier 

II—dose response.

CR .................. CR .................. CR .................. CR .................. CR .................. TEP .......... TEP .......... 1, 2 

850.4250 .... Vegetative vigor, 

Tier II—dose 

response.

CR .................. NR .................. CR .................. CR .................. CR .................. TEP .......... TEP .......... 1, 3 

850.4400 .... Aquatic plant 

growth (aquatic vascular 

plant) Tier II— 

dose response.

R ..................... R ..................... R ..................... R ..................... CR .................. TGAI, TEP TGAI, TEP 4, 10 

850.5400 .... Aquatic plant 

growth (algal) 

Tier II (dose 

response).

R ..................... R ..................... R ..................... R ..................... R ..................... TGAI, TEP TGAI, TEP 4, 5, 6 

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 

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(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 § 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 flosaquae, 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 § 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. 

§ 158.2260 Applicator exposure. 

(a) General. Subpart B of this part and 

§ 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 nonoccupational, 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

Guideline No. Data requirements 

Use sites Test 

substance 

Test note 

No. Occupational Residential 

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 calculations .................................................... R ................. R ................. TEP ............. 5 

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 

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26988 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

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. 

§ 158.2270 Post-application exposure. 

(a) General. Subpart B of this part and 

§ 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. Postapplication 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 postapplication 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 postapplication 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 postapplication 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

Guideline No. Data requirement 

Use sites Test 

substance 

Test note 

No. Occupational Residential 

875.2200 .......... Soil residue dissipation ................................................................. CR ............... CR ............... TEP ............. 2, 3 

875.2300 .......... Indoor surface residue dissipation ................................................ CR ............... R .................. TEP ............. 3, 4, 5, 6 

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 activity ....................................................... R ................. R ................. TEP ............. ....................

875.2900 .......... Data reporting and calculations .................................................... R ................. R ................. TEP ............. 10 

(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. 

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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 backcalculation 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. 

§ 158.2280 Environmental fate. 

(a) General. Subpart B of this part and 

§ 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

Guideline 

No. 

Data 

requirement 

Use pattern Test substance 

Industrial Test note No. 

processes and 

water systems 

Antifoulant 

coatings and 

paints 

Wood 

preservatives Aquatic areas 

All other use 

patterns 

category 

MP EP 

Degradation Studies—Laboratory 

835.2120 .... Hydrolysis ............ R ..................... R ..................... R .................... R .................... R .................... TGAI or 

PAIRA.

TGAI or 

PAIRA.

1 

835.2240 .... Photodegradation 

in water.

R ..................... R ..................... R .................... R .................... R .................... TGAI or 

PAIRA.

TGAI or 

PAIRA.

2 

835.2410 .... Photodegradation 

in soil.

NR .................. NR .................. R .................... NR ................. NR ................. TGAI or 

PAIRA.

TGAI or 

PAIRA.

10 

Toxicity and Fate in Wastewater Systems 

850.6800 .... Activated Sludge, 

Respiration Inhibition Test.

R ..................... R ..................... R .................... NR ................. R .................... TGAI ......... TGAI ......... 21 

OECD 209.

835.1110 .... Activated Sludge 

Sorption Isotherm.

CR .................. CR .................. CR ................. NR ................. CR ................. TGAI ......... TGAI ......... 19, 20 

835.3110 .... Ready 

Biodegradability.

CR .................. CR .................. CR ................. NR ................. CR ................. TGAI ......... TGAI ......... 3, 4, 18 

835.3220 .... Porous Pot Study CR .................. CR .................. CR ................. NR ................. CR ................. TGAI ......... TGAI ......... 3, 18 

835.3280 .... Simulation Tests 

to Assess the 

Biodegradability 

of Chemicals 

Discharged in 

Wastewater.

CR .................. CR .................. CR ................. NR ................. CR ................. TGAI ......... TGAI ......... 3, 18 

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26990 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

TABLE—ANTIMICROBIAL ENVIRONMENTAL FATE DATA REQUIREMENTS—Continued 

Guideline 

No. 

Data 

requirement 

Use pattern Test substance 

Industrial Test note No. 

processes and 

water systems 

Antifoulant 

coatings and 

paints 

Wood 

preservatives Aquatic areas 

All other use 

patterns 

category 

MP EP 

835.3240 .... Simulation Test— 

Aerobic Sewage 

Treatment: A. 

Activated 

Sludge Units.

CR .................. CR .................. CR ................. NR ................. CR ................. TGAI ......... TGAI ......... 3, 18 

Mobility Studies 

835.1230 .... Leaching and adsorption/desorption.R ..................... R ..................... R .................... R .................... CR ................. TGAI or 

PAIRA.

TGAI or 

PAIRA.

5, 6 

835.1240 

Metabolism Studies—Laboratory 

835.4100 .... Aerobic soil metabolism.CR .................. NR .................. R .................... CR ................. CR ................. TGAI or 

PAIRA.

TGAI or 

PAIRA.

7, 8, 9 

835.4200 .... Anaerobic soil 

metabolism.

NR .................. NR .................. R .................... NR ................. CR ................. TGAI or 

PAIRA.

TGAI or 

PAIRA.

5, 8 

835.4300 .... Aerobic aquatic 

metabolism.

R ..................... R ..................... R .................... R .................... CR ................. TGAI or 

PAIRA.

TGAI or 

PAIRA.

5, 8 

835.4400 .... Anaerobic aquatic 

metabolism.

R ..................... R ..................... R .................... R .................... CR ................. TGAI or 

PAIRA.

TGAI or 

PAIRA.

5, 8 

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 representative U.S. 

waters.

CR .................. CR .................. CR ................. CR ................. CR ................. ROC ......... ROC ......... 11, 14, 17 

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 

§ 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. 

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

§ 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 § 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 § 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-ofevidence 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 § 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 

§ 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 

§ 158.2280(a)(2)) to a wastewater 

treatment plant. 

§ 158.2290 Residue chemistry. 

(a) General. Subpart B of this part and 

§ 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, 

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26992 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

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 

§ 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 enduse 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

Guideline 

No. Data requirement 

Uses 

Test 

substance 

Test note 

Agricultural 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/tolerance exemption.R ................. R ................. R ................. R .................. .................... 1 

860.1560 .. Reasonable grounds in support of petition.R ................. R ................. R .................. R ................. .................... 1 

860.1650 .. Submittal of analytical reference 

standards.

R ................. R ................. R ................. R ................. PAI/ROC .... 2 

Food-Contact Surfaces or Impregnated Materials 

860.1460 .. Food-handling ..................................... CR ............... CR ............... CR ............... CR ............... TEP ............ 3 

None ........ Nature of residue on surfaces ............ CR ............... CR ............... CR ............... CR ............... PAIRA or 

TGAI.

4 

None ........ Migration studies ................................. CR ............... CR ............... CR ............... CR ............... TEP ............ 5 

860.1340 .. Residue analytical method for data 

collection.

CR ............... CR ............... CR ............... CR ............... ROC ........... 6 

860.1380 .. Storage stability .................................. R ................. R ................. R ................. R .................. TEP or ROC 7 

Higher tiered 

860.1300 .. Nature of the residue in plants ........... CR ............... CR ............... CR ............... CR ............... PAIRA ........ 8 

860.1300 .. Nature of the residue in livestock ....... CR ............... CR ............... CR ............... CR ............... PAIRA ........ 9 

860.1340 .. Residue analytical methods for tolerance/tolerance exemption enforcement.CR ............... CR ............... CR ............... CR ............... ROC ........... 10 

860.1360 .. Multiresidue method testing ................ CR ............... CR ............... CR ............... CR ............... ROC ........... 11 

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/eggs ........................ CR ............... CR ............... CR ............... CR ............... TGAI or 

ROC.

15 

860.1500 .. Crop field trials .................................... CR ............... CR ............... CR ............... CR ............... TEP ............ 16 

860.1520 .. Processed food or feed ...................... CR ............... CR ............... CR ............... CR ............... TEP ............ 17 

None ........ Anticipated residues ........................... CR ............... CR ............... CR ............... CR ............... ROC ........... 18 

(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. 

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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 26993 

6. If a magnitude of the residue study, 

as specified in § 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 § 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 byproducts, 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] 

■ 6. Remove part 161. 

[FR Doc. 2013–10162 Filed 5–7–13; 8:45 am] 

BILLING CODE P 

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