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EO12866_Rin2070-AD30_Part158W-FRM_EA_2012-05-24clean

EO 12866_Antimicrobial Data Requirements_RIN 2070-AD30_FRM_EA_2011-08-08.docX

FINAL ECONOMIC ANALYSIS OF CHANGES INfor the FINAL RULE: DATA 

REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES 

(RIN 2070-AD30)

Prepared by: 

Economic Analysis Branch 

Biological and Economic Analysis Division 

Office of Pesticide Programs 

U.S. EPA 

Prepared for: 

Antimicrobial Division and 

Field and External Affairs Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave, NW 

Washington, DC 20460 

August 8, 2011

May 24, 2012

 
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Table of Contents 

1 Executive Summary ................................................................................................................ 4

2 Problem Statement .................................................................................................................. 6

2.1 Overview of Antimicrobial Pesticide Usage, Exposure, and Effects ............................... 6

2.2 Nature of Market Failures Inherent from Pesticide Producer and User Behavior ........... 7

2.3 Overview of the Rule ....................................................................................................... 8

2.4 Statutory Authority for the rule ........................................................................................ 9

2.5 Current Regulation ......................................................................................................... 10

2.6 Description of the Part 158 W Rule ............................................................................... 11

2.7 Types of Data Requirement Changes in the Rule .......................................................... 16

3 Regulatory Options ............................................................................................................... 17

3.1 Selected Option—Final Rule ......................................................................................... 17

3.2 Codification of Current Practices ................................................................................... 18

3.3 Conventional Data Requirement for Antimicrobial Pesticides ...................................... 19

4 Profile of the Regulated Community .................................................................................... 20

4.1 Size of the Antimicrobial Industry ................................................................................. 20

4.2 Firms with Registration Actions (2000-2005) ............................................................... 20

4.3 Estimation of the Number Firms Impacted by the Rule................................................. 22

5 Economic Impacts on Pesticide Registrants Due to Change in Data Requirements ............ 23

5.1 Step 1. Expected Cost of each Data Requirement (CX

Dur) ............................................ 25

5.2 Step 2. Expected Cost per Registration Action (RX

ur) .................................................. 29

5.3 Step 3. Incremental (ΔR) and Newly Imposed Costs per Registration Action ............. 31

5.4 Step 4. Expected Industry-Wide Impacts (∆A) ............................................................. 33

5.5 Step 5. Incremental Cost per Firm ................................................................................ 35

5.6 Applicator Exposure Test Costs ..................................................................................... 36

6 Registration Review .............................................................................................................. 39

6.1 Step 1. Expected Cost of each Data Requirement ......................................................... 40

6.2 Step 2. Costs per Registration Review .......................................................................... 42

6.3 Step 3. Incremental Costs .............................................................................................. 42

6.4 Step 4. Industry Wide Cost ........................................................................................... 42

6.5 Step 5. Cost per Firm ..................................................................................................... 42

7 Small Business Impacts ........................................................................................................ 43

7.1 Regulatory Overview ..................................................................................................... 43

7.2 Categorization of Small Businesses ............................................................................... 43

7.3 Estimation of the Number of Small Businesses ............................................................. 43

7.4 Small Business Impacts for New and Existing Registrations ........................................ 44

8 Benefits Due to Changes in Data Requirements ................................................................... 46

9 Limitations and Uncertainties of the Economic Analysis ..................................................... 48

10 Consideration of Paperwork Burden ..................................................................................... 50
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References 

Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations. 

Appendix B. Data Requirement Probabilities for Antimicrobial Pesticides 

Appendix C. Data Requirement Costs for Antimicrobial Pesticides 

Appendix D. Changes in Data Requirements and Costs 

Appendix E. Glossary

LIST OF TABLES AND CHARTS

Table 2-1: Data Disciplines 

Table 2-2: Types of Registration Actions and Descriptions 

Table 4-1: Distribution of Antimicrobial Registrants According to the NAICS Code 

Table 4-2: Antimicrobial Product Registrants: Number of Firms and Revenues in the Large and

 Small Categories 

Table 5-1: Revised Unit Test Costs 

Table 5-2.: Example of Estimating Cost of Five Data Requirements 

Table 5-3: Six Use-Site GroupsGroupings for the Economic Analysis

Table 5-4. : Expected Cost of Data Requirements (CR) and Registration Actions (RR) by 

Registration Type and Use Grouping According to the Rule Table 5-5. Expected Incremental 

Cost of Registration Actions 

Table 5-6. Calculation of Industry Cost 

Table 5-7: Total Industry Cost per Year 

Table 5-8: Applicator Exposure Data Requirements Cost 

Table 5-9: Applicator Exposure Testing Cost by AEATF 

Table 6-1: Estimation of Data Requirement Costs of New Tests in Registration Review of New 

Tests not Anticipated When the Economic Analysis of the Registration Review Process Was 

Completed

Table 7-1: Estimated Small Business Impacts for New Registrations 

Table 7-2: Small Firm Impact of Newly Imposed Tests in Registration Review 

Table 7-3: Estimated Small Business Impacts—New Registrations plus Registration Review 

Table 9-1: Antimicrobial Registrant Paperwork Burden and Costs per Registration Action

Table 9-2: Agency Antimicrobial Paperwork Burden and Costs
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1 Executive Summary 

 The U.S. Environmental Protection Agency (EPA) is updating and revising its data 

requirements for the registration of antimicrobial pesticides. In this rule, the Agency collectively 

refers to antimicrobial pesticides, antifoulant coatings and paints, and wood preservative 

pesticides, as antimicrobials. 

 The revisions to the data requirements are needed to more adequately protect the general 

population as well as sensitive subpopulations, to increase the Agency's knowledge of the human 

health and environmental fate and effects of antimicrobial pesticide products, and to help ensure 

that antimicrobial regulatory decisions reflect current scientific knowledge and current Agency 

regulatory practices. This Final Economic Analysis evaluates the potential benefits and costs 

expected as a result of registrations and registration reviews occurring after the final rule’s 

effective date. 

 This rule establishes a separate listing of the data requirements for antimicrobial 

pesticides in subpart W of part 158. The subpart W format does not differ greatly from the 

format of the data requirements for conventional pesticides promulgated in 2007 but does differ 

in the substance of the data requirements applicable to antimicrobials. Antimicrobial uses were 

covered in the original part 158 (now part 161), which was promulgated in 1984 and developed 

primarily for agricultural pesticides. Use patterns specific to antimicrobials were not specified in 

the original part 158. As a result, it has been difficult at times for applicants to determine which 

data requirements apply to antimicrobials without extensive consultation with and interpretation 

from the Agency. Additionally, the current regulations for antimicrobials (part 161) no longer 

reflect the state of the science of risk assessment, thus leading to frequent consultations and 

incomplete submissions, which lead to increased transaction costs for industry and the Agency to 

identify the appropriate data required. Clearer, more transparent information to applicants 

should help to clarify the data required for a regulatory decision. 

 Therefore, after the promulgation of the data requirements in 158W, specific to 

antimicrobials, data submissions to EPA are more likely to contain the data needed for EPA to 

make regulatory decisions. Future consultations will be better focused, for example, on how to 

fulfill a particular data requirement, or how to conduct a specific study rather than on what 

studies to conduct. Focused consultations will help reduce the burden on the regulated 

community associated with understanding and submitting complete submission packages to 

EPA. 

 In this final rule for part 158W, EPA is: 

 Adding newly codified data requirements, which are not currently established in part 161, 

but are considered in current practice on a case-by-case basis. 

 Changing some of the existing data requirements, such as a change from conditionallyrequired to required, a change in the number of test species, or expanding the number of 

use patterns for which the test is required. 

 Adding new data requirements, which have never been required or have rarely been 

required in current practice, on a case-by-case basis, and have not been routinely 
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considered during the Agency’s evaluation of the data needed for the purpose of risk 

assessment. 

 Eliminating the requirement for the chronic non-rodent study currently established in part 

161. 

These changes in data requirements affect the cost of data requirements for both existing 

registrations going through registration review as well as new registrations.

 EPA estimates the incremental costs of the changes above for new registrations under this 

rule in chapter 5 of this document. Incremental costs are the additional costs of the rule 

compared to the baseline, which is defined as costs of the data requirements under part 161. The 

newly imposed cost, which is the difference between the rule and the current practice1, is 

estimated at $7.2 million per year. The total annual industry incremental cost from the baseline 

to the rule, is estimated to be $8.2 million per year for 15 new registrations. The average 

incremental cost per registration action of all types applicable to this EA is about $549,000. The 

average incremental cost per firm under this rule having a registration action during 2000 – 2005 

would have been about $722,000 over this six-year period. 

 Based on comments received during the public comment period on the proposed rule, 

changes were made to the final rule since the proposed rule and are reflected in this final 

economic analysis (EA). These changes include: 

 Three new data requirements were added: simulation tests to assess the biodegradability 

of chemicals discharged in wastewater, simulation test – aerobic sewage treatment: 

activated sludge units, and nature of the residue on surfaces. 

 One proposed new data requirement will not be codified: non-dietary ingestion exposure. 

 Some data requirements for certain use patterns were changed from not required (NR) or 

conditionally required (CR) to required (R), while others were changed from R to CR. 

 The changes described in the three bullets above were made in response to comments and 

therefore the incremental cost from the proposed rule (with the revised test costs) to the final rule 

(with the same test costs) is an increase of about 25%. In response to comments on the EA for 

the proposed rule, the Agency updated some of the test costs. EPA also revised its cost estimates 

for generating applicator exposure data for antimicrobial pesticides: See section 5.6. These cost 

revisions have the largest impact on the cost of the rule. 

 

 The cost of the data requirements of antimicrobials going through registration review 

were not estimated in the EA for the proposed rule because EPA considered these costs to be 

covered in the registration review EA. However, eleven new tests have been added in the part 

158W rule that were not considered in the registration review rule EA. EPA estimates the cost of 

these new data requirements as part of registration review to be about $6.8 million per year for 

the industry. The total incremental cost of the rule including registration review and new 

registrations is about $15 million per year. 

 

 

1

 Current practice is the baseline (CFR part 161) plus data requirements that have been imposed on a case-by-case 

basis, 2000-2005. 
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 As required, EPA conducted an analysis of the impact of this final rule on small 

businesses. EPA’s analysis showed that only about 26 small firms (or a little over 5% of the 

total number of potentially impacted small firms) are expected to experience a cost increase 

representing 1% or more of gross sales. Thus, EPA concludes that the final rule will not have a 

significant impact on a substantial number of small entities (businesses). 

 In this 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.

2 Problem Statement 

2.1 Overview of Antimicrobial Pesticide Usage, Exposure, and Effects 

 Antimicrobial pesticides are used to control microbiological contamination and 

deterioration in industrial, commercial, and health care applications and consumer products. 

Antimicrobial products contain about 275 different active ingredients and are marketed in several 

types of formulations, including sprays, liquids, concentrated powders, and gases. Each year, 

about $1 billion are spent on a variety of different types of antimicrobial products. More than 

5,000 antimicrobial products are currently registered with the EPA and sold in the marketplace. 

Nearly 60% 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 (EPA, 2010a4). 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. Non-public 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 non-public health products include those products used in cooling towers, jet 

fuel, paints, and treatments for textile and paper products (EPA 2010a4). 

 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 hazards 

to humans and the environment. Therefore, the effectiveness and proper use of antimicrobial 

pesticides are of widespread concern (EPA 2010ba). 
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2.2 Nature of Market Failures Inherent from Pesticide Producer and 

User Behavior 

 It is generally accepted by economists that regulatory intervention is justified in the 

presence of market failure, that is, when the market fails to function efficiently. In the case of 

antimicrobial pesticides, the most salient source of market failure is externalities. An externality 

is a cost or benefit resulting from an economic transaction that is borne or received by parties not 

directly involved in the transaction. When the individuals involved in the transaction do not 

consider external costs and benefits, the market fails to function efficiently. 

 In the case of antimicrobial pesticides, externalities arise because some of the costs (e.g. 

post-application exposure and ecological effects) associated with antimicrobial use are not borne 

by those involved in the production, sale and use of the antimicrobial pesticides. For example, 

after an antimicrobial product is used, and then disposed of down-the drain, the antimicrobial can 

get into wastewater and destroy the beneficial microbes in wastewater treatment plants that are 

used to treat wastewater. Such damages are external to the market, because they are not borne 

by those using and therefore benefiting from the antimicrobials, but instead are borne by those 

paying for wastewater treatment. Similarly, antifoulants and wood preservatives can leach into 

the water and the environment, and have the potential to produce ecological effects on non-target 

organisms. Statutory authority allows the Agency to correct these market failures by imposing 

pesticide regulatory standards that ensure their safe use. 

 The final rule helps the Agency to correct the market failure by requiring that registrants 

of antimicrobial pesticides provide the Agency with adequate information to make pesticide 

regulatory decisions that mitigate externalities by protecting the general population, sensitive 

subpopulations, and the environment. The data requirements in the final rule reflect current 

scientific knowledge and Agency practices. 

 Antimicrobial uses were covered in the original part 158, which was promulgated in 1984 

and developed primarily for agricultural pesticides. Use patterns specific to antimicrobials were 

not specified in the original part 158. As a result, it has been difficult at times for applicants to 

determine which data requirements apply to antimicrobials without extensive consultation with 

and interpretation from the Agency. Additionally, the current regulations (part 161) for 

antimicrobials no longer reflect the state of the science of risk assessment, thus leading to 

frequent consultations and incomplete submissions, which lead to increased transaction costs for 

industry and the Agency to identify the appropriate data required. Clearer, more transparent 

information to applicants should help to clarify the data required for a regulatory decision. 

 Therefore, after the promulgation of the data requirements in 158W, specific to 

antimicrobials, data submissions to EPA are more likely to contain the data needed for EPA to 

make regulatory decisions. Future consultations will be better focused, for example, on how to 

fulfill a particular data requirement, or how to conduct a specific study rather than on what 

studies to conduct. Focused consultations will help reduce the burden on the regulated 

community associated with understanding and submitting complete submission packages to 

EPA. 
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2.3 Overview of the Rule

Although this rule concerns only data requirements for antimicrobials, it is part of a 

larger effort to update and improve all of the data requirements in 40 CFR part 158. Since the 

data requirements set out in the original part 158 (now part 161) were first published in 1984, 

every disciplinary area and requirement has been reconsidered and revised by EPA in practice. 

These changes have been needed because the state of the science underlying the data 

requirements has advanced, and because the Agency has learned in many specific registration 

actions that additional or different data are necessary to make sound regulatory decisions. These 

case-by-case decisions to impose additional data requirements have been made in accordance 

with current §161.75, which allows the Agency to impose additional data requirements beyond 

EPA’s codified data requirements to insure that the pesticide meets the standard for registration; 

this standard is discussed in the rule preamble. The Agency has discussed its need to update the 

data requirements for antimicrobial pesticides in many public forums, such as meetings of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), a 

scientific peer review mechanism required by section 25(d) of FIFRA. Also, EPA made 

presentations at the Antimicrobial Workshops sponsored by the Biocides Panel of the American 

Chemistry Council. However, these additional data requirements, while frequently imposed on a 

case-by-case basis, have not been codified through the rulemaking process. 

 Subpart W, which covers data requirements for antimicrobial pesticides, does not differ 

greatly in format from the data requirements promulgated for conventional pesticides in 2007, 

but does differ in the substance of the data requirements applicable to antimicrobials. 

Antimicrobial uses were covered in the original part 158 (now part 161), which was developed 

primarily for agricultural pesticides. Since use patterns specific to antimicrobials were not 

specified in the original 1984 data requirements, part 161 often does not fully describe the data 

requirements a registrant or applicant must potentially fulfill to maintain or obtain an 

antimicrobial registration. Determining which data requirements apply to antimicrobials has at 

times required registrants and applicants for registration to engage in extensive consultation with 

and to seek interpretation from the Agency. 

EPA recognizes that during early implementation of 40 CFR Part 158W not all 

application packages may have all of the newly-required data. Therefore, during early 40 CFR 

Part 158W implementation, 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 two years post-promulgation 

for situations in which a more time-intensive new study is missing but could be less for other 

situations. The registrant 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. 

Products Covered by This Rule

 This rule is intended to apply to: 

 Antimicrobial pesticides, as defined in FIFRA sec. 2(mm) 

 Pesticide products for antimicrobial uses in or on food or feed 
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 Antifoulant coatings and paints 

 Wood preservatives 

 Pesticide products intended to be manufactured into the above. 

Although wood preservatives, and antifoulant paints and coatings bearing nonantimicrobial claims are excluded from the definition of “antimicrobial” in section 2(mm), the 

environmental and health concerns raised by the use of these pesticides are the same, whether or 

not a wood preservative or antifoulant is intended to control organisms other than 

microbiological organisms. In this rule, the Agency is collectively referring to antimicrobial, 

antifoulant coatings and paints, and wood preservative pesticides, as antimicrobials. 

2.4 Statutory Authority for the rule 

 This action is issued under the authority of sections 3, 4, 5, 10, 12, and 25 of The Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (U.S.C. 136-136y) and section 

408 of The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a). 

A. FIFRA 

 Under FIFRA, every pesticide product must be registered with EPA or specifically 

exempted from registration before being sold or distributed in the United States. Under FIFRA, 

an applicant for registration or registrant must demonstrate that, among other things, the 

pesticide product will not cause “unreasonable adverse effects” to humans or the environment. 

This safety determination requires the Agency to consider any risks of the use of the pesticide 

and weigh this against any benefits. EPA must determine that the standard for registration 

contained in FIFRA is met before granting a registration. 

1. Registration. Section 3 of FIFRA contains the requirements for registration. 

Specifically, FIFRA sec. 3(c)(2) provides EPA broad authority, before and after registration, to 

require scientific testing and submission of the resulting data to the Agency by registrants and 

applicants for registration of pesticide products. An applicant for registration must furnish EPA 

with substantial amounts of data on the pesticide, its composition, toxicity, potential human 

exposure, environmental properties and ecological effects, as well as information on its efficacy 

in certain cases. Although the data requirements are imposed primarily as a part of initial 

registration, EPA is authorized under FIFRA sec. 3(c)(2)(B) to require a registrant to develop 

and submit additional data to maintain a registration. 

2. Reregistration. FIFRA sec. 4 requires that EPA reregister each pesticide product first 

registered before November 1984. This date was chosen based upon the fact that pesticides 

registered since 1984 were subject to the part 158 requirements of the 1984 regulation. 

Reregistration is considered complete for active ingredients since all of the Registration 

Eligibility Decision Documents have been signed. However, both confirmatory Data Call-Ins 

(DCIs) for active ingredients and product specific DCIs for product level data continue to be 

issued. 

3. Registration Review. The Food Quality Protection Act mandated a new program: 

registration review. Changes in science, public policy, and pesticide use practices occur over 
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time. Through the new registration review program, the Agency will periodically reevaluate all 

registered pesticides to assure that they continue to meet the statutory standard of no 

unreasonable adverse effects. In 2006, registration review began to replace EPA’s reregistration 

program. The scope and depth of the Agency's reviews will be tailored to the circumstances, so 

reviews will be commensurate with the complexity of the issues associated with each pesticide. 

B. FFDCA 

 FFDCA mandates that EPA determine the level of pesticide chemical residues in food 

and feed that will be safe for human consumption. The safety standard set under FFDCA sec. 

408(b) and (c) defines safe as “a reasonable certainty that no harm” will result from exposures to 

pesticide chemical residues. The aggregate and cumulative exposure assessment requirements in 

FFDCA sec. 408 dictate the broad nature and scope of EPA risk assessments under this provision 

and the types and amounts of data needed to determine that the FFDCA safety standard is met. 

 Under FFDCA sec. 408, EPA is authorized to establish tolerances for pesticide residues 

in food and feed, or to exempt a pesticide from the requirement of a tolerance, if warranted. 

References to tolerances include tolerance exemptions since the standards and procedures for 

both are the same. The new safety standard applies to tolerances in a number of regulatory 

situations, including: 

 • Tolerances that support registration under FIFRA; 

• Tolerances for imported products which are established to allow importation of 

pesticide-treated commodities, but for which no U.S. registration is sought; 

• Time-limited tolerances which are established for FIFRA sec. 18 emergency 

exemptions; and 

• Temporary tolerances established for experimental use permits under FIFRA sec. 5. 

C. Linking FIFRA and FFDCA safety standards 

Under FIFRA sec. 2(bb), a pesticide use that results in residues in food that is 

inconsistent with, or does not meet, the FFDCA sec. 408 safety standard poses an "unreasonable 

adverse effect" under FIFRA that precludes new or continued registration. Given this linkage 

between registration and tolerances, it makes sense for EPA to define data requirements for both 

purposes: the data required to support a determination of “reasonable certainty of no harm” 

under FFDCA are, as to pesticide uses that result in residues in food, an integral part of the data 

needed for an “unreasonable adverse effects” determination under FIFRA. Consequently, when 

promulgated, these data requirements would encompass the basic data requirements for both 

registration and tolerance-setting determinations. EPA will retain its authority to require 

additional data on a case-by-case basis. 

2.5 Current Regulation 

 The requirements for antimicrobials were formerly listed in part 158 of Title 40 of the 

Code of Federal Regulation (CFR). In 2007, EPA promulgated final rules establishing new data 

requirements for conventional pesticides, biochemical pesticides and microbial pesticides. As 

part of those actions, EPA preserved the original (1984) part 158 data requirements to provide 

regulatory coverage for antimicrobial pesticides until the Agency could promulgate a final 
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regulation. To accomplish this, EPA transferred intact the original 1984 data requirements of 

part 158 into a new part 161, entitled “Data Requirements for Antimicrobial Pesticides.” Part 

161, which applies only to antimicrobial pesticides, contains the existing data requirements for 

antimicrobial pesticide chemicals, and will be removed as part of codifying part 158W. 

2.6 Description of the Part 158 W Rule 

In 40 CFR part 161 data requirements for antimicrobials are specified. The final rule 

codifies current practices, expands some data requirements beyond current practices, and adds 

some new requirements. The data requirements are organized by scientific discipline. The 

specific data required within each data category depends on various factors, including the use 

pattern and type of registration action as described below. 

A. Data Requirements by Discipline

When registering an antimicrobial product, the applicant must submit data to support the 

registration, as specified in 40 CFR part 161. Table 2-1 lists the eight disciplines of data that 

may be required, depending on the type of product being registered. 
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Table 2-1: Data Disciplines 

DATA DISCIPLINE DESCRIPTION 

Nontarget Organism Tests of the effects of the product on mammalian, avian, and 

aquatic animal species are required to determine whether the 

product poses an ecological hazard to animals that may come in 

contact with the product. 

Nontarget Plant 

Protection 

Tests of the effects of the product on plant species are required to 

determine whether the product poses an ecological hazard to plants 

that may come in contact with the product. 

Environmental Fate Information on the transport and dissipation of the chemical in 

water, air, and soil is required to determine whether the product 

persists in the environment and where it is likely to concentrate. 

Toxicology Tests of acute, subchronic, and chronic toxicity and carcinogenicity 

are required to determine whether the product may pose a hazard to 

humans. Information on metabolism of products in the body may 

also be required. 

Human Exposure Because individuals may be exposed to the product both during 

application of the product and after application, information about 

possible dermal and inhalation exposure as well as information on 

how the product is used is required for registration. 

Product Chemistry Tests of product identity and composition, delineation of methods 

of analysis, and tests of physical and chemical properties are 

required to identify the product. 

Residue Chemistry To determine whether the chemical may be found in plants, 

livestock, and fish that may be used for food, a variety of 

information may be required, including a proposed safe level in 

food. 

Product Performance Products must maintain a specified level of performance or efficacy 

associated with the claims made on the product label, which is 

generally defined as a specified percentage of organisms that the 

product must kill. Tests to determine whether the product meets the 

specified level of performance are required. 

B. Data Requirements for Antimicrobials by Use Pattern 

A significant change in this rule from the existing data requirements in part 161 is the 

introduction of 12 use patterns specific to antimicrobials. In the proposed rule the Agency 

discussed that these 12 use patterns have been in use for some years. Having use patterns 

specific to antimicrobials makes it easier to determine which requirements apply to which 

antimicrobial products. The 12 use patterns are based on similarity of use, purpose, pesticidal 

function, the nature of the exposure, and/or, in some cases, application methods. Since there is 

much variety in pesticide chemistry, exposure, and hazard, the requirements are designed to be 

flexible. Test notes to the data requirements tables explain the conditions under which data are 

typically needed. Essentially, the data requirements identify the questions that the applicant will 
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need to answer regarding a pesticide product before the Agency can make its registration 

decision. The 12 use patterns are as follows: 

 1. Agricultural premises and equipment. This use pattern includes many indirect food 

uses with mostly indoor use sites. 

 farm and farm animal premises such as animal houses and pens (including milk 

houses), parlors, stalls, and barns 

 equipment such as forks, shovels, scrapers; halters, ropes, other restraining 

equipment; racks, mangers, feeders, waterers, troughs, and fountains 

 food handling equipment such as milking equipment. 

 2. Food handling/storage establishments, premises, and equipment. This use pattern also 

includes many indirect food uses due to the treatment of food contact surfaces, and the resultant 

human exposures. All use sites are indoor. 

 food or feed processing plants 

 eating establishments such as restaurants and cafeterias 

 food storage or distribution facilities 

 commercial transportation vehicles, shipping and storage containers 

 food or feed stores and markets 

 vending machines. 

 3. Commercial, institutional and industrial premises and equipment. This use pattern 

includes non-food contact areas of commercial sites. Typically antimicrobial pesticides would 

be applied to ceilings, doors, doorknobs, fixtures, floors, light switches, stairs, walls, windows, 

and woodwork as part of routine cleaning practices. This use pattern includes both indoor and 

outdoor uses. Some of the uses have the potential for significant exposure due to the repetitive 

nature of certain exposures, and therefore may be considered as high human exposure. 

 4. Residential and public access premises. This use pattern includes mostly nonfood 

areas, although it includes food handling areas in homes. Some of the uses have the potential for 

significant exposure due to the repetitive nature of certain exposures, and therefore may be 

considered as high human exposure. Most uses are indoor. 

 premises, contents, and equipment of homes, apartments, mobile homes and shelters 

 public areas, public buildings, or public rooms. 

 commercial kennels, or living quarters of pets, zoo animals, race horses, or laboratory 

animals. 

 5. Medical premises and equipment. This use pattern is considered to be indoor nonfood. Some of the uses have the potential for repeated exposure and therefore may be considered 

as high human exposure. This includes medical waste, which is defined as any solid waste that 

is generated in the diagnosis, treatment, or immunization of human beings or animals, in research 

pertaining thereto, or in the production of biologicals including but not limited to culture and 

stocks, pathological wastes, human blood and blood products, and sharps. 
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 hospital or medical environments such as clinics, dental offices, nursing homes, sick 

rooms, morgues, and veterinary clinics 

 non-critical medical equipment such as bedpans, basins or furniture. 

 6. Human drinking water systems. Human drinking water systems include any methods 

used to provide potable water from raw water supplies. This use pattern is considered to be high 

exposure due to the potential for human exposures via drinking water, as well as dermal 

exposures to the treated water. 

 public water systems 

 individual water systems 

 emergency water systems 

 water purifier units 

 individual water systems (private water systems of individual homes, farms, 

institutions, camps, resorts, and industrial plants). 

 emergency water systems for the public, campers, travelers, military and fishermen. 

 7. Materials preservatives. Materials preservatives are antimicrobial chemicals added 

during industrial processes to prevent the growth of micro-organisms. This use pattern includes 

food and non-food, and indoor and outdoor uses. 

8. Industrial processes and water systems. Certain antimicrobial chemicals, known as 

microbiocides, are used to control the growth of bacteria, fungi, and algae in water systems. For 

“once-through” systems, the water is not re-used, and is therefore released into the aquatic 

environment or a wastewater treatment plant after a single cycle through the system. However, 

for many uses of water in industrial plants, the treated water is re-used repeatedly within the 

system, recirculating in the system multiple times until released into the aquatic environment or a 

wastewater treatment plant. Both “once-through” and recirculating water systems have the 

potential for environmental exposure when the treated water is released to the environment. 

 

 9. Antifoulant Paints and Coatings. Antifoulants are coatings and paints applied to boat 

hulls and bottoms, crab and lobster pots, and underwater structures or equipment to control the 

growth of freshwater or marine fouling organisms. Antifoulant coatings have the potential for 

high environmental exposure most particularly for marine environments. Included within this 

use pattern is ballast water, that is, the water that is pumped in and out of the ballast tanks as the 

ship’s weight changes due to loading and unloading of cargo. 

 10. Wood preservatives. Wood preservative products are those which claim to control 

wood degradation problems due to fungal rot or decay, sapstain, molds, or wood-destroying 

insects. This use pattern has the potential for high exposure for both humans and the environment 

with mostly outdoor use sites. Certain uses can be food uses. The types of wood, and the 

products that can be manufactured with this treated wood include: 

 freshly cut logs or lumber 

 seasoned building materials 
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 utility poles, fence posts and rails 

 structural members 

 structures and dwellings 

 transportation vehicles (truck beds and support structures) 

 crop containers 

 lawn furniture and decks 

 playground equipment 

 garden/landscape timbers 

 log homes. 

 11. Swimming pools. Products in this use pattern treat the water systems of swimming 

pools, jacuzzis and hot tubs for control of bacteria or algae. This use pattern is considered to be 

high human exposure. Under routine use little or no environmental exposure is expected, as the 

water in these pools, jacuzzis or hot tubs is considered to be separated from the natural 

environment. However, if draining is needed, depending on the volume of water and the location 

of the pool or hot tub, it is possible that the waters could drain into a storm-drain or directly into 

soil. 

 12. Aquatic areas. Products in this use pattern are designed to control or kill slimeforming bacteria, fungi, or algae in lakes, ponds, streams, drainage ditches and other bodies of 

water. In addition to the potential for environmental exposure, there is the potential for human 

exposure via drinking water if the intake pipe for a drinking water treatment plant is in a treated 

body of water or downstream from that body of water, or through recreational activities such as 

swimming. Treated water could also be used in crop and/or livestock production. 

 In response to comments, EPA notes that it is no longer using the terms “high human 

exposure” and “low human exposure” as table headers for the Antimicrobial Toxicology Data 

Requirements Table. Nor is EPA using the terms “high environmental exposure” and “low 

environmental exposure” as table headers for the Antimicrobial Nontarget Organism Data 

Requirements Table, the Nontarget Plant Protection Data Requirements Table, or the 

Environmental Fate Data Requirements Table. 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 is likely to be needed, rather than less data. 

C. Data Requirements by Type of Registration Action 

 In addition to differences in the site where an antimicrobial pesticide is used, a second 

reason that data requirements may differ depends on the type of registration being sought. Table 

2-2 shows how registrations are grouped in those categories that are relevant to this EA. 
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Table 2-2: Types of Registration Actions and Descriptions 

TYPE OF 

REGISTRATION 

DESCRIPTION 

New Active Ingredient An application for registration of a new product that contains 

an active ingredient that is not included in any currently 

registered product. 

Major New Use An application for registration of a new product that includes a 

proposed or additional use pattern that is not currently 

registered for one or more active ingredient(s) contained in the 

product. “New use” is defined in 40 CFR 152.3. 

Major New Use Amendment An amendment of an existing product registration that includes 

a proposed or additional use pattern that is not currently 

registered for one or more active ingredient(s) contained in the 

product. “New use” is defined in 40 CFR 152.3. 

 There are other categories, which are not expected to incur costs under this rule, such as 

me-too registrations. Me-too registrations are products that are very similar to products that are 

already registered and can cite the data of those existing products. 

D. Registration Review 

The economic analysis that supported the proposed rule for 158W data requirements 

focused on new pesticide registrations. However, based on comments received, EPA has now 

estimated the additional data costs in registration review, which is the process of periodically 

reviewing currently registered pesticides to assure that they continue to meet the statutory 

standard of no unreasonable adverse effects. 

 When registration review was proposed, EPA prepared an economic analysis of that 

program. The 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 including all tests that have been required in current practice 

whether or not in 40 CFR 158. However, part 158W includes new tests, which were not 

anticipated when the economic analysis of the registration review process was completed. This 

final economic analysis for part 158W addresses the additional data costs associated with these 

new tests in Chapter 6 of this economic analysis. 

2.7 Types of Data Requirement Changes in the Rule 

 Since 1984, when 40 CFR part 158 (current 40 CFR part 161) was first promulgated, 

EPA’s data requirements have evolved along with the general scientific understanding of the 

potential hazards posed by pesticides. In the final rule, EPA is:

1. Adding newly codified data requirements, which are not currently established in part 161, 

but are considered in current practice on a case-by-case basis. 

2. Changing some of the existing data requirements such as a change from conditionallyrequired to required, a change in the number of test species, or expanding the number of 

use patterns for which the test is required. 
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3. Adding new data requirements, which have never been required or have rarely been 

required in current practice, on a case-by-case basis, and have not been routinely 

considered during the Agency’s evaluation of the data needed for the purpose of risk 

assessment. 

4. Eliminating the requirement for the chronic non-rodent study currently established in part 

161. 

3 Regulatory Options 

 The Agency compared the costs and benefits of the three options in order to determine 

the most appropriate approach. The goal is to arrive at a structure and process for data 

requirements so that the Agency receives sufficient data to inform the decision for any 

registration action, while not imposing unnecessary impacts on pesticide registrants. These 

impacts include the direct cost of generating the data as well as less tangible costs brought about 

by uncertainty in registration requirements. The three options are as follows. 

3.1 Selected Option—Final Rule 

The Agency is updating its regulations by: 

 Adding newly codified data requirements, which are not currently established in part 161, 

but are considered in current practice on a case-by-case basis. 

 Changing some of the existing data requirements such as a change from conditionallyrequired to required, a change in the number of test species, or expanding the number of 

use patterns for which the test is required. 

 Adding new data requirements, which have never been required or have rarely been 

required in current practice, on a case-by-case basis, and have not been routinely 

considered during the Agency’s evaluation of the data needed for the purpose of risk 

assessment. 

 Eliminating the requirement for the chronic non-rodent study currently established in part 

161. 

A. Benefits 

 The 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 due to more realistic risk estimates that use 

fewer conservative assumptions. This option would be more efficient than the current 40 CFR 

part 161, because the data requirements, specific to antimicrobials, would be known in advance, 

specifically as they apply to antimicrobial pesticides, thereby reducing uncertainty and possible 

delay in generating and submitting required data. By codifying these data requirements, many of 

which are currently applied on a case-by-case basis, the antimicrobial industry can, along with 

other partners in the regulated community, attain a better understanding of and can more 

efficiently participate in the pesticide registration process. 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 dealing with EPA than the larger firms or 

those firms that routinely work with the Agency. 
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 Data provided under the new requirements are intended to lead to increased 

understanding of the potential for exposure as well as the chemical and toxicological properties 

of pesticides. By adding new requirements, the Agency can evaluate risks that had not been 

previously identified, and use the registration process to mitigate these risks. EPA is using a 

tiered approach. If the lower-tiered data indicate a need of further data to resolve the issues 

raised by the results of the lower-tiered study(ies), the Agency will require higher-tiered data 

(indicated in the tables as CR – conditionally required) when appropriately triggered. Such an 

approach works to provide EPA with the data needed to add significant information and value to 

the decision, while ensuring that the registration meets statutory safety standards, and without 

automatically requiring the generation of higher-tiered data without consideration of factors 

which may negate the need for a study.

B. Costs 

 Under the option (the final rule) the incremental cost for the part 158 subpart W data 

requirement changes for an average of 15 antimicrobial registration actions per year is estimated 

at $8.2 million2

 per year as explained in Chapter 5. The average incremental cost per registration 

action is about $549,0003. The average incremental cost per firm having a registration action 

during 2000 – 2005 would have been about $722,0004

 over this six-year period. 

3.2 Codification of Current Practices 

This option codifies the Agency’s current practices, and is similar to the selected option 

except it does not include new requirements and changes in existing requirements, which the 

Agency does not currently impose. 

A. Benefits 

Like the selected option, this option would be more efficient in terms of process than no 

new rule at all, because most of the data requirements would be known in advance, thus avoiding 

delays in generating and submitting data. However, this option would not provide EPA with all 

data that the Agency has found to be necessary to understand and measure the potential risks to 

human health and the environment from exposure to antimicrobial pesticides. Since EPA would 

not have codified data requirements for all data needed, there would be fewer benefits as 

compared to the selected option. 

 

2

 The incremental cost is the cost of the data requirements under the final rule, $19.3 million, minus what they were 

under the baseline (part 161), $11.1 million. 

3

 The annual incremental cost of the rule divided by an average of 15 registration actions per year. 4

 The incremental cost of the rule divided by 64 firms that had registration actions, 2000-2005. 
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B. Costs 

 The incremental cost, which is the difference between the baseline (part 161) and current 

practice, for this option is estimated in Chapter 5 to be about $1 million per year for the industry 

(Table 5.87). This cost is small, relative to the selected option, because many of the newly 

codified studies required under the selected option have not been required in current practices.

3.3 Conventional Data Requirement for Antimicrobial Pesticides 

The other option the Agency analyzed is to require that conventional pesticide data 

requirements be extended to antimicrobial pesticides. 

A. Benefits

To simply adopt the conventional requirements would impose a situation much like the 

status quo. Data requirements would not be well adapted to the antimicrobial use patterns, and 

applicants would continue to have difficulty in interpreting the requirements. The Agency would 

continue to consider the differences between conventional use patterns and antimicrobial use 

patterns, and specify how the data requirements apply to antimicrobial pesticides on a case-bycase basis. This option would be less efficient than the selected option and the low cost option 

because the data requirements would have to be interpreted for the applicability to 

antimicrobials. 

B. Costs 

 This option is evaluated for the average cost of a single registration action of a new active 

ingredient for the groupings defined in Table 5-3. EPA does not have information on the total 

costs for registration actions for major new uses and amendments for conventional pesticides, 

because the economic analysis for the rule on the data requirements for conventional pesticides, 

part 158, (EPA, 2007) only estimated the incremental costs, not the total costs. The costs of data 

requirements for conventional pesticides are typically much higher than those for antimicrobial 

pesticides because conventional pesticides typically have outdoor uses and food uses which 

require a much more extensive set of data requirements at higher test costs. For instance, the 

cost per registration action of a new antimicrobial pesticide active ingredient would average 

under the rule about $1.5 million for lower exposure uses, and about $4.8 million for higher 

exposure uses, while for a conventional pesticide the cost for a new active ingredient registration 

ranges from about $4.4 million to $12 million (EPA, 2007). 
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4 Profile of the Regulated Community 

The objective of this profile of the regulated community is to provide data for analyzing 

the economic impacts of the rule on the industry. Data on revenues, both by firm and by 

product, are reported in this profile. To be consistent with the guidelines for the Small Business 

Regulatory Enforcement Fairness Act (SBREFA) analysis, this profile reports data at the highest 

level of multi-layered corporate organizations, called the parent or “ultimate” firm.

 Data from EPA’s Office of Pesticide Programs Information Network (OPPIN) and 

financial data from Dun & Bradstreet (2006) were used in this analysis. EPA used the Dun & 

Bradstreet (D&B) Market Spectrum database to obtain firm size and financial data for our 

analysis of the impacts of the rule on individual firms (Dun & Bradstreet, 2006). D&B is a 

comprehensive source of financial information on entities, including firm locations, sales, and 

primary business classifications under North American Industrial Classification System code 

(NAICS). Antimicrobial firms fall under a wide variety of industrial activities, as currently 

indicated by the NAICS codes. 

4.1 Size of the Antimicrobial Industry 

 EPA identified 846 companies having one or more FIFRA Section 3 or FIFRA Section 

24(c) antimicrobial pesticide registrations in EPA’s OPPIN database in 2007. Companies with 

the same parent companies were consolidated and treated as one. EPA estimates that there are 

about 750 unique parent antimicrobial firms. The Small Business Administration (SBA) 

definition of company size is based on annual sales and the number of employees. This 

definition of size varies with a company’s NAICS code. Based on the SBA definition of a small 

business and the Dun & Bradstreet company data, EPA estimates that approximately 67% (500 

out of 750) of the firms are small businesses. 

4.2 Firms with Registration Actions (2000-2005)

From 2000 through 2005, EPA estimates that 72 parent companies submitted registration 

actions, of all types, for antimicrobial pesticides. Of the 72 registrants, sales and employment 

data were available from the D&B database for 57 parent companies. The distribution of the 57 

antimicrobial registrants according to the NAICS codes is presented in Table 4-1. 
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Table 4-1: Distribution of Antimicrobial Registrants According to the NAICS Code

NAICS Code Sector Description Number of Parent 

Companies 

325 Chemical Manufacturing 29 

424 Merchant Wholesalers, Nondurable Goods 7 

423 Merchant Wholesalers, Durable Goods 4 

333 Machinery Manufacturing 2 

326 Plastics and Rubber Products Manufacturing 2 

 Other Sectors * 11 

 None given 2 

Total 57 

Source: Calculated from 2006 Dun & Bradstreet data and EPA OPPIN database. 

*These eleven sectors include a variety of manufacturing sectors such as wood products, and of support sectors such 

as building material and fuel suppliers. 
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4.3 Estimation of the Number Firms Impacted by the Rule 

While the above sample of 57 antimicrobial parent firms was used to characterize the 

antimicrobial industry that has had registration actions from 2000 to 2005, it does not indicate 

how many firms are likely to be impacted by the rule. Some types of registration actions do not 

incur data costs or can involve citation of data from other registration actions. 

In the time period for which EPA has available registration data (2000 to 2005), there 

were 72 firms that had registration actions of all types. Of these 72 firms, EPA estimates that 64 

parent firms had antimicrobial registrations that would have incurred additional costs under the 

rule because these were registrations of new active ingredients, major new uses, and major new 

use amendments. (The other eight registration actions were the type that would not incur 

additional data costs.) Of the 64 firms, EPA could determine the size of 41 firms, of which 16 or 

39% are small. Projecting this proportion to all 64 firms, EPA estimates that 25 firms incurring 

registration costs due to the rule meet the SBA definition of a small business. 

Table 4-2 breaks down for those 41 antimicrobial firms that could be sized by large and 

small categories, and reports their average and total annual revenue, and their average number of 

employees. 

Table 4-2: Antimicrobial Product Registrants: Number of Firms and Revenues in the 

Large and Small Categories

Entity Size 

Category 

SBA-Defined 

Sizes* 

Total 

Companies 

(number) 

Total 

Revenue for 

All 

Companies 

(millions) 

Average 

Revenue 

per 

Company 

(millions) 

Average 

Number of 

Employees per 

Company 

(number) 

Large 25 $514.6 $20.6 31,567

Small 16 $0.5 $0.03 45

 All firms 41 $515.1 $12.6 19,266

Source: Calculated from 2006 Dun & Bradstreet data and EPA OPPIN database. 

*The definition of the size categories is determined by each company’s NAICS code. See Table 4.1.
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5 Economic Impacts on Pesticide Registrants Due to Change in 

Data Requirements 

 This chapter describes the data requirements and method used to assess the incremental 

cost of compliance with the rule for new registrations. This analysis was done in the following 

six steps: 

Step 1 Determine the expected cost of each data requirement 

Step 1a. Determine the unit tests costs of each data requirement 

Step 1b. Determine the probability (percent of registration actions that tests are 

likely to be required) of the data requirements per registration action 

Step 2. Determine the expected costs per registration action 

Step 3. Determine the expected incremental costs per registration action 

Step 4. Determine the incremental industry-wide impacts 

Step 5. Determine the average incremental impact per firm 

Step 6. Determine the incremental impact per small firm as a percent of sales 

 

The unit test costs (Step 1a) are multiplied by the probability of the data requirements 

(Step 1a) to estimate the expected cost of each data requirement (Step 1). The expected costs of 

all the data requirements are summed to estimate the expected costs of registration actions (Step 

2) for each type of action and use pattern. The expected costs of registration actions for the 

baseline are subtracted from these costs as required by the rule to estimate the incremental costs 

per registration action (Step 3). The incremental costs per registration action are multiplied by 

the number of registration actions per year for the industry to get the industry-wide incremental 

impacts (Step 4), which is divided by the number of firms to get the average incremental impact 

per firm (Step 5). The incremental costs per small firm are divided by the firms’ sales revenue to 

estimate the distribution of incremental impacts per small firm as a percent of sales revenue 

(Step 6), which is discussed in chapter 7. 

Greater detail on the methodology is in the rest of this section, as well as Sections 5.1 

through 5.5 for Steps 1 – 5. Section 5.6 presents the analysis of the applicator exposure data 

costs, which are estimated using two different methods. 

Further Explanation On How Data Requirement Costs Are Calculated

The expected annual cost of a data requirement to the industry for a use and registration 

type (new active ingredient or major new use) is the product of three factors: unit test cost, test 

probability, 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 
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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. The terms used here are explained as 

follows: 

Data requirement—specific information, typically the results of a specified test, that is 

required under specified conditions. 

Unit test cost—the cost of performing a test to fulfill a data requirement. 

Test probability—the probability of the test being required for a registration. This 

probability varies by the type of registration and by the pesticide use. 

Use—the use to which an antimicrobial is applied, such as food, nonfood, industrial, 

antifoulant, and wood preservative. See Table 5-3. 

Registration type—new active ingredient, major new use registration or amendment. See 

Table 2-2. 

Number of registrations in the industry per year for the registration type and use. 

The method of cost calculation is explained more precisely in the following steps: 

Step 1. Expected cost of a data requirement = unit test cost × test probability.

CX

Dur = TD × PXDur 

where 

CDur = the expected cost of data requirement D on use pattern u for registration type r. 

TD = the unit test cost of data requirement D. 

PDur = the test probability of data requirement D for use pattern u and registration type r. 

Superscript X refers to: R for rule; C for current practice; B for baseline. 

Step 2. Expected cost of a registration action = the sum of the expected cost of data 

requirements. 

RX

ur = ∑CXDur

where 

Rur = the expected cost of a registration action for use pattern u and registration type r. 

∑CDur = the sum of the expected costs of all data requirements for use pattern u and registration 

type r. 

Step 3. Incremental cost of a registration action = the cost of the registration action according to 

the rule minus the baseline cost of the registration action. 

ΔRur = RR

ur − RBur 

where 

The prefix Δ refers to incremental: ΔRur = the expected incremental cost of Rur. 

RR

ur = the expected cost of Rur according to the rule. 

RB

ur = the expected cost of Rur according to the baseline, CFR part 161. 

Step 4. Incremental industry-wide cost of the data requirements = the sum of the data 

requirements for all registration types and use patterns. 
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ΔA = ∑(ΔRur× Nur) 

where 

ΔA = Incremental antimicrobial industry-wide cost of the data requirements 

Nur = the number of registrations for the industry on use pattern u for registration type r. 

∑(ΔRur× Nur) = the sum of the expected incremental costs of all registration actions for all use 

patterns and registration types. 

The following alternative way to calculate the industry-wide cost provides the number of tests 

and cost of each data requirement for the industry per year while providing a check on the above 

calculation: 

θD= ∑( PDur × Nur) 

AR

 = ∑( θD × TD) 

where 

θD = number of tests required for data requirement D in the industry 

∑( PDur × Nur) = the sum of the expected number of tests for all use patterns and registration 

types for data requirement D. 

AR = Antimicrobial industry-wide cost of the data requirements 

∑( θD × TD) = the sum of the expected cost of all the tests required in the industry for all data 

requirements. 

This calculation can also be done for the baseline in order to calculate the industry-wide 

incremental cost of the data requirements 

ΔA = AR – AB 

Step 5. Average incremental impact per firm = incremental industry-wide cost of the data 

requirements divided by the number of impacted firms = ΔR/F, where F = the number of firms 

impacted. 

 Because of the unique nature of applicator exposure studies, which are scenario specific 

rather than chemical specific, the method of cost calculation for these studies, explained in 

section 5.6, does not follow these steps. 

5.1 Step 1. Expected Cost of each Data Requirement (CX

Dur) 

The expected cost of a data requirement is the unit test cost times the probability that the 

test would be required. 

A. Unit Test Costs (TD) 

In order to demonstrate that a pesticide meets the statutory standard for a registration, 

registrants must submit or cite test results or other information so that EPA can conduct 

appropriate risk assessments. The unit test costs represent the costs of complying with the 

specific data requirements, which depend on the type of product and use pattern. 

EPA has, over a period of years, surveyed testing laboratories to obtain estimates of the 

cost of conducting specific studies that would be required for antimicrobial, conventional, and 
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other pesticides. To do this, EPA contacts fewer than 10 laboratories to obtain or update cost 

data for different test requirements conducted by testing labs. Laboratories were asked to 

identify the minimum and maximum cost for each guideline based on a set of predetermined 

protocols. Understanding that the lab costs could vary considerably based on the study protocol 

chosen by the lab, EPA often established two protocols, a high cost protocol and a low cost 

protocol, for each guideline in order to bracket the costs. To establish the protocols, EPA 

initially identified the various study design options for each study based on the Office of 

Chemical Safety and Pollution Prevention (OCSPP) guidelines. In-house labs of the registrant 

were not surveyed, although many of the larger companies may have them. For-profit 

laboratories have significant similarities in how they cost the testing they sell. In-house 

laboratory costs might be lower or higher than an independent testing lab. 

 

The Agency collected low and high cost estimates from actual testing labs for each 

guideline. For each data requirement, the Agency averaged the low cost estimates and high cost 

estimates provided by the various laboratories. The average unit test cost used in this EA is the 

average of the low and high average cost estimates. The estimated costs of complying with 

individual tests range from $233 (product identity and composition) to $1.5 million 

(carcinogenicity). Estimated average antimicrobial data requirement test costs are provided in 

Appendix C. 

The estimates vary within a lab, between labs, and the year the estimate was made. 

During the public comment period estimates were provided that differed from EPA’s estimates. 

To verify the validity of EPA’s cost estimates, EPA resurveyed labs for 30 selected data 

requirements. The criteria for selecting which test costs to update include how changes in 

estimates would impact on the cost of the rule, the magnitude of the differences between EPA’s 

and the estimates provided during the comment period, and the age and source of EPA’s 

estimates. Table 5-1 lists the 30 tests for which costs were updated, and compares the new 

revised estimates to the estimates used in the economic analysis supporting the proposed rule. 

While some of these revisions decreased the cost of the tests, most were increased. The largest 

increase was nearly $300,000 while the largest decrease was almost $200,000. How these 

revisions affect the cost of the rule depends on how frequently these tests are required. In this 

analysis, these new unit test cost estimates, other test cost updates since the proposed rule5

, plus 

exposure test cost revisions increased the incremental cost of the rule by about 87% compared to 

the proposed rule. See Table 5-7 for more details on the effect of the revised unit test costs on 

the rule. 

 

5

 The Office of Pesticides Programs maintains a database of unit test costs. Individual test costs are updated as 

needed. 
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Table 5-1: Revised Unit Test Costs 

Test 

Guideline Test Name 

Average Unit Test Cost 

Proposed 

Rule 

Revised by 

EPA in 2010 

835 Environmental Fate 

835.1110 Activated Sludge Sorption Isotherm $10,051 $19,733 

835.1230 Adsorption/desorption $23,750 $42,741 

835.2120 Hydrolysis $25,230 $41,938 

835.2410 Photodegradation on soil (soil photolysis) $42,350 $73,979 

835.3110 Ready Biodegradability $10,364 $8,667 

835.3220 Porous Pot Test $41,413 $33,000 

835.4200 Anaerobic soil metabolism $71,250 $150,167 

835.4300 Aerobic aquatic metabolism $44,475 $102,200 

835.4400 Anaerobic aquatic metabolism $80,900 $107,224 

850 Ecological Effects Tests 

850.1735 Whole sediment acute invertebrates - freshwater $20,250 $21,903 

850.4250 Vegetative vigor, Tier II - dose response $24,500 $36,963 

850.4300 Terrestrial field $111,863 $44,000 

850.4450 Aquatic field $220,000 $28,500 

850.5400 Aquatic plant growth (algal) Tier II - dose response $35,155 $14,426 

850.6800 Modified Activated Sludge, Respiration Inhibition Test $5,126 $4,292 

none Whole sediment chronic invertebrates freshwater & marine $51,350 $64,757 

860 Residue Chemistry 

860.1400 Irrigated crops $18,000 $87,500 

860.1500 Crop field trials $163,667 $83,650 

860.1520 Processed food/feed $35,000 $89,925 

870 Health Effects 

870.3250 90-day dermal toxicity $137,094 $132,130 

870.3700 Prenatal developmental toxicity study - rat $76,844 $117,053 

871.3700 Prenatal developmental toxicity study - rabbit $76,844 $166,653 

870.3800 Reproduction and fertility effects $378,469 $393,307 

870.4100 Chronic toxicity -– nonrodent $950,000 $757,910 

870.6200 Acute neurotoxicity -– rat $89,596 $155,600 

870.6300 Developmental neurotoxicity $406,904 $702,500 

875 Occupational and Residential Exposure 

875.1300 Inhalation outdoor exposure $164,286 $450,000 

875.2200 Soil residue dissipation $83,125 $253,733 

875.2300 Indoor surface residue dissipation $35,000 $75,427 

875.2600 Biological monitoring $166,875 $375,000 
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28

B. Test Probabilities (PX

Dur)

 The probabilities or percent of actions that tests are likely to be required were determined 

as follows: 

1. Current Practices. These probabilities were based on a sample of 70 actual 

registration actions out of 90 registration actions that are relevant to this EA 

during the six year period of 2000 through 2005. The time period (2000 – 2005) 

was chosen since the analysis for this EA was started in 2006. Data indicating 

which tests were required were not available for the other 20 actions. Appendix 

A shows these requirements for a sample of new active ingredient registrations 

from 2000 through 2005. 

2. Baseline. These probabilities are the same as current practices for tests that are 

in the current CFR part 161 and were intended to apply to antimicrobials to all or 

specific use patterns. If the test is not in part 161, then it is not in the baseline. 

3. Final Rule. These probabilities are calculated from data on current EPA 

registration practices, and adjusted according to EPA’s scientific judgment. To 

avoid underestimating the costs of the rule, the probabilities estimated by this 

scientific judgment tended to be higher than those estimated in current practice. 

However, if the probability for a registration action type and use site grouping is 

higher for current practices, then the higher probability from current practices is 

used.6 In addition, some tests were not required during our sample of 

registration actions from 2000 through 2005 according to the registration data, 

but are expected to be required under the rule.7 Appendix B shows the 

percentage of actions for which the tests are likely to be required by the final rule 

for new active ingredients and major new use registrations and amendments 

under the six use-site groupings in Table 5-3. 

C. Calculation of Expected Data Requirement Costs (CX

Dur) 

Table 5-2 below illustrates how expected data requirement costs are calculated for a new 

active ingredient. Since there are many data requirements for a new registration, only a few 

select data requirements are shown for this example. The unit test cost, TD, is multiplied by the 

test probability, PD, to estimate the expected cost of a data requirement, CD. These calculations 

are done for both the test probabilities expected with the rule and for the baseline to estimate the 

expected cost of the data requirements for the rule, for the baseline, and the difference between 

the two, i.e. the incremental cost. 

 

6

 For example, the 3 tests required for acute testing of avian, and freshwater fish and invertebrates are expected to 

be required 25% of the time for major new use registrations and amendments under the rule. However, the data 

indicate that such tests were required in current practice 37.5% of the time for indirect food as a major new use. 

This 37.5% was used for indirect food use to estimate the cost of the proposed rule. 

7

 For example, biological monitoring for applicator exposure and post application exposure, and dermal and 

inhalation post application exposure were not required in current practice, but are expected to be required a small 

percent of the time (5-10% for most uses depending on the type of registration action) under the rule. 
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29

Table 5-2. Example of Estimating Cost of Five Data Requirements

Step 1. Cost of Data Requirements

New active ingredient 

Test probability PD

Data requirement cost CD

CD = TD × PD 

Guideline Data Requirement 

Test 

Costs TD

Rule 

PR

D

Baseline 

PB

D

Rule

CR

Baseline 

CB

Incremental

ΔC=CR−CB

870.4100 Chronic toxicity - rodent $757,910 50% 50% $378,955 $378,955 $0 

875.1500 Biological monitoring $375,000 10% 0% $37,500 $0 $37,500 

850.2100 Avian acute oral toxicity $10,100 100% 50% $10,100 $5,050 $5,050 

835.2120 Hydrolysis $41,938 100% 50% $41,938 $20,969 $20,969 

860.1340 

Residue analytical method 

for data collection $65,500 60% 0% $39,300 $0 $39,300 

Source: Appendix B 

Note: Only a few data requirements are shown as an example. Much more data are required for a new registration. 

5.2 Step 2. Expected Cost per Registration Action (RX

ur) 

 A registration action, applicable to this EA, is an application from a registrant to: 

1. register a product containing a new active ingredient (AI), 

2. register a new product with an existing registered AI, but with a major new use, or 

3. amend an existing registration of an existing registered product to add a major new use. 

 To estimate the expected cost of a registration action, the expected cost of all data 

required for the type of registration action and use-site grouping specific to the registration action 

are summed. 

 The data required for a registration action depend on several factors; including the end 

use and type of registration action. The division of end uses into 12 use patterns more precisely 

defines the data that will be required (see Section 2.6). In the data requirement tables, each data 

requirement for each use pattern is specified as R (required), CR (conditionally required), and 

NR (not required). Test notes further specify when data are required. Although a product may 

eventually be registered for several use patterns, this generally occurs as a result of multiple 

registration actions. During any individual registration action, this analysis assumes that the 

product is registered for only one use pattern as determined by EPA staff. 

 For the purposes of this economic assessment, the 12 use patterns are organized into the 

six groupings as described in Table 5-3. This is because data requirements are similar within 

each of the six groupings and also the probability that a test is required can be estimated with a 

higher degree of confidence when the estimates are based on a larger sample in each of the six 

groupings. Many of the use patterns are split between two or more groupings depending on 

exposure and other characteristics. Because this analysis considers individual registration 

actions submitted to the Agency, this EA assumes that each registration action is associated with 

only one grouping. 
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30

Table 5-3: Six Use-Site Groupings for the Economic Analysis 

USE SITE GROUPINGS USE PATTERNS 

Higher Exposure Uses

Direct Food Uses and Indirect 

Food Uses (≥200 ppb) 

Includes Use Patterns 1, 2, 4, 6, 7, and 12 

Food uses include a) fruit and vegetable rinses, b) egg 

washes, c) indirect food uses with residues greater than 200 

parts per billion (ppb), and d) any other uses not already 

specified which require a tolerance or exemption from the 

requirement for a tolerance. 

Indirect Food Uses (< 200 ppb) Includes Use Patterns 1, 2, 4, 7, and 10 

This grouping includes indirect food uses with residues less 

than 200 ppb. 

Higher Exposure Industrial and 

Other Uses 

Includes Use Patterns 7 and 11 

High exposure uses include metal cutting (metalworking) 

fluids and swimming pools. 

Wood Preservatives Includes Use Pattern 10 

Uses in Use Pattern 10 include but are not limited to: 

1) freshly cut logs or lumber seasoned building materials, 

2) utility poles and fence posts and rails, 3) structural 

members, 4) structures, and 5) dwellings. 

Lower Exposure Uses

Lower Exposure Industrial and 

Other Uses; 

Includes Use Patterns 1, 2, 3, 4, 5, 7, and 8 

Antifoulants Includes Use Pattern 9 

 Table 5.4 illustrates how the expected cost of data requirements are summed to get the 

expected cost of registration actions. The cost of data requirements in Table 5-4 are summarized 

by scientific discipline (rows) and registration type and use grouping (columns). Each discipline 

consists of a number of individual data requirements, where the expected cost of each is 

calculated as illustrated in Table 5-2, except applicator exposure as explained in section 5.6. 
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31

Table 5-4. Expected Cost of Data Requirements (CR) and Registration Actions (RR) by 

Registration Type and Use Grouping According to the Rule,

Source: Appendix B 

There were no new active ingredient registration actions for food and high exposure during the study period (2000-

2005) 

5.3 Step 3. Incremental (ΔR) and Newly Imposed Costs per 

Registration Action 

 The incremental cost of a registration action is the difference between the cost of a 

registration action according to this rule and the cost according to the baseline (CFR part 

161). Similarly, the newly imposed cost of a registration action is the difference between the 

cost of a registration action according to this rule and the actual cost of the registration action 

in current practice (2000-2005). 

 The changes in data required and in the probabilities of the data required between the 

baseline and final rule and current practice and final rule are used to estimate the incremental 

and newly imposed costs. These changes include: 

1. Newly Codified Data Requirements: Data not required for antimicrobials under 

part 161, even though most of these data have been currently required in practice 

on a case-by-case basis. 

2. Newly Codified Expanded Use Pattern: In some cases, the rule increases the 

probability of data required in the tests currently in part 161. Examples include: 

a. Data not required in part 161 for certain use patterns will be required in the 

rule for these use patterns. 

b. Data conditionally required in part 161 would be routinely required by the rule 

for certain use patterns. The requirements for some use patterns of some data 

have changed from the proposed rule affecting the test probabilities. 

Registration Type: new active ingredient major new use/amendment 

Use-site Grouping: Indirect 

Food 

Wood 

Pres 

AntiFoul Lo 

Exp Food 

Indirect 

Food 

Hi 

Exp 

Wood 

Pres 

AntiFoul Lo 

Exp 

Expected Cost of Data Requirements ($1000) CR

Product Chemistry $119 $44 $21 $57 $23 $34 $36 $1 $69 $32 

Toxicology $3,169 $2,462 $277 $897 $134 $1,364 $426 $97 $144 $439 

Applicator Exposure $187 $187 $187 $187 $169 $169 $169 $169 $169 $169 

Post Application 

Exposure $155 $409 $99 $99 $80 $80 $80 $334 $54 $54 

Ecological Effects $592 $686 $503 $83 $29 $99 $171 $124 $679 $66 

Plant Protection $78 $79 $79 $19 $5 $5 $27 $27 $53 $8 

Environmental Fate $501 $812 $761 $109 $58 $69 $206 $320 $613 $87 

Residue Chemistry $218 $0 $0 $0 $117 $115 $5 $0 $0 $0 

Efficacy $0 $0 $0 $0 $2 $0 $9 $0 $0 $1 

Expected Cost of Registration Actions ($1000) Step 2. Sum of the above data requirements

Rule RR $5,021 $4,679 $1,927 $1,451 $615 $1,934 $1,128 $1,071 $1,780 $856 
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32

c. Some current test notes specifying when data are required have been changed 

in a manner that expands the application of the data requirement. 

3. Newly imposed data requirements: These requirements and increased 

probability of data requirements are a subset (albeit a large majority) of the 

newly codified data and newly codified expanded use pattern data requirements 

that are not currently being imposed on a case-by-case basis. The new data 

requirements that were proposed and are now being codified are: 

a. developmental neurotoxicity, 

b. immunotoxicity, 

c. photodegradation in soil, 

d. soil residue dissipation, 

e. ready biodegradability study, 

f. porous pot study, 

g. activated sludge sorption isotherm study, and 

h. modified activated sludge respiration inhibition test. 

Since the proposed rule, based on comments received, three new data requirements 

have been added 

i. simulation tests to assess the biodegradability of chemicals in discharged 

wastewater, 

j. simulation test – aerobic sewage treatment: activated sludge units. and 

k. nature of the residue on surfaces. 

4. Eliminated: Chronic oral toxicity data requirement for non-rodent, which was 

required in part 161, is no longer required. Therefore, there will be a cost saving 

from eliminating this data requirement. Also, non-dietary ingestion exposure, 

which was part of the proposed 158W data requirements, has been deleted from 

the final rule. 

5. Differences in Estimated Probabilities. The probability of the data requirements 

for current practice was determined by data that was actually required during 

2000-2005. EPA reviewed this information and updated the probabilities for the 

final rule based on EPA’s scientific judgment. Some of these differences could 

be caused by differences in the method of estimation between current practice 

and the final rule, rather than newly imposed expanded data requirements. 

 Table 5-5 below illustrates how expected incremental costs of registration actions are 

calculated by subtracting the cost of registration actions according to the rule from their baseline 

according to CFR part 161. The baseline and current practice costs of registration actions are 

calculated the same way as the costs of registration actions according to the rule as illustrated in 

Table 5-4 above. 
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33

 The bottom two rows of Table 5-5 also illustrate how newly imposed costs are calculated 

by subtracting the cost of registration actions according to the rule from their cost in current 

practice.

Table 5-5. Expected Incremental Cost of Registration Actions 

Source: Appendix B 

* According to the rule 

 As shown in Table 5-5, the average incremental cost per registration action for new AI 

higher exposure uses (indirect food and wood preservatives) are less than lower exposure uses. 

Even though data required by the rule for new AI registration actions cost more for higher 

exposure than lower exposure uses, the incremental costs for higher exposure are less because 

most of the data that is required by the rule was also required in the baseline for these higher 

exposure uses. Since fewer data were required for lower exposure uses in the baseline (part 

161), their incremental costs are higher. Furthermore, the chronic non-rodent study, which costs 

about $758,000, was required in the baseline for these higher exposure uses only, but is no 

longer required under the rule, which further reduces the additional or incremental data 

requirement costs imposed by this rule on higher exposure uses. 

5.4 Step 4. Expected Industry-Wide Impacts (∆A) 

The industry-wide impacts were calculated by multiplying the incremental costs of the 

registration actions of each type and use site grouping (Step 3) by the average number of 

registration actions of each type and use site grouping per year for the industry, then summing 

these costs for all registration action types and use groupings. This calculation is illustrated in 

Table 5-6. 

 

Registration Type: new active ingredient major new use/amendment 

Use-site Grouping: Indirect 

Food 

Wood 

Pres 

AntiFoul Lo 

Exp Food 

Indirect 

Food 

Hi 

Exp 

Wood 

Pres 

AntiFoul Lo 

Exp 

Cost of Registration Actions ($1000) 

Rule* RR $5,021 $4,679 $1,927 $1,451 $615 $1,934 $1,128 $1,071 $1,780 $856 

Baseline RB $4,415 $4,379 $21 $759 $66 $1,437 $386 $0 $1,174 $432 

Incremental: Step 3 

ΔR= RR − RB $606 $301 $1,907 $692 $549 $497 $742 $1,071 $606 $424 

Current Practice RC $4,466 $4,473 $21 $759 $71 $1,437 $469 $0 $1,760 $535 

Newly Imposed Costs 

= RR − RC $555 $207 $1,907 $692 $544 $497 $659 $1,071 $21 $321 
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34

Table 5-6. Calculation of Industry Cost 

Source: Appendix B 

* Based on the actual number of registration actions of those types from 2000 through 2005. 

 The above calculation was also done in the following alternative way to calculate the 

industry-wide number of tests and cost of each data requirement while providing a check. To 

estimate the number of times each test is likely to be required for all registration actions per year, 

the percentage of time each registration action (by type and use site grouping) is likely to be 

required is multiplied by the average annual number (of that type and use grouping) of 

registration actions, then summed for all registration action types and use groups. These 

numbers are multiplied by the unit test costs to get the industry-wide cost of each data 

requirement per year,,, and then summed over all data requirements to get the industry-wide cost 

of the data requirements. 

The number (N) of registration and amendment submissions by action code was obtained 

from EPA’s OPPIN database, where registration actions are tracked. This analysis estimates the 

average annual number of registration submissions based on registration data for antimicrobial 

pesticides for the years 2000 through 2005. 

The OPPIN database provides registration actions by action code, so the number of each 

type is known. The use site groupings relevant to each registration action were identified by 

staff in the Antimicrobial Division. In making these estimates we are assuming that the 

registration actions in the future under the rule will be similar to the period from 2000 through 

2005. 

The total annual industry incremental impact per year from baseline ($11.1 million) to 

rule ($19.3 million) is estimated to be $8.2 million per year. Newly imposed data requirements 

cost, which is the difference between the final rule ($19.3 million) and current practice ($12.1 

million), is estimated at $7.2 million per year. (Table 5-7) 

Table 5-7 shows total estimated industry cost per year, and compares these costs as 

estimated in the EA for the proposed rule, as revised with the new unit test cost estimates, and as 

estimated in this EA for the final rule. If the revised unit test costs (Table 5-1) plus exposure and 

other test cost revisions since the proposed rule were used to re-estimate the cost of the proposed 

Registration Type: new active ingredient major new use/amendment 

Use Grouping: Indirect 

Food 

Wood 

Pres 

AntiFoul Lo 

Exp Food 

Indirect 

Food 

Hi 

Exp 

Wood 

Pres 

AntiFoul Lo 

Exp 

Incremental Cost of 

Registration Actions 

= ΔR $606 $301 $1,907 $692 $549 $497 $742 $1,071 $606 $424 

Average Number of 

Registration Actions 

per year* = N 0.33 0.50 0.17 1.17 2.00 1.83 2.17 0.33 0.17 6.33 

Average Annual 

Incremental Industry 

Cost per year ($1000) $202 $150 $318 $808 $1,098 $911 $1,607 $357 $101 $2,685 

Total Incremental Industry Cost ($1000) per Year = ΔA = Sum of the above row. Step 4 $8,237 
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35

rule, then the estimated cost of data requirements under the proposed rule increases by about 

23%. Since these revised test costs had almost no effect on the baseline, nearly all this increase 

is in the incremental cost of these data requirements, which increased by about 87%. The rest of 

the changes in cost estimates from the proposed rule to the final rule are a result of changes in 

test probability estimates, the addition of three new tests, and the decision to not codify a data 

requirement that was proposed. Since these changes increased the cost of the data requirements 

by another 6.6% and the incremental costs by another 25%, most of the changes in cost estimates 

from the proposed to the final rule are a result of the revised unit test cost estimates (See Table 5-

1). The total change from the proposed to the final rule is 29% or 112% for the incremental 

costs. 

Table 5-7: Total Industry Cost per Year 

 Total Industry Cost per Year ($1,000s) 

 Proposed 

Rule EA 

Proposed Rule 

EA with Revised 

Test Costs 

Final Rule EA

Baseline = BL $11,080 $11,085 $11,085

Current Practices = CP $11,726 $12,087 $12,087 

Rule = R 

 (% increase from Proposed Rule) 

$14,961 $18,341 

 (23%) 

$19,322

 (29%)

Incremental Costs = R – BL 

 (% increase from Proposed Rule) 

$3,882 $7,257 

 (87%) 

$8,327237

 (112%)

Newly Imposed Costs = .R – CP $3,236 $6,255 $7,235 

Incremental Costs of Codification of 

 Current Practice = CP – BL $646 $1,002 $1,002 

* These costs are calculated fromin Table 5-6 by multiplying the average cost per registration action by the average 

number of actions per year of each type and use grouping and summing for all types and use groupings. 

5.5 Step 5. Incremental Cost per Firm 

According to the EPA’s OPPIN database, 64 firms involved in the 90 registration actions 

would have experienced incremental impacts under the rule during the six-year period, 2000-

2005, and would have experienced incremental impacts under the rule. A total annual impact of 

$8.2 million implies a six-year total of $59.249.4 million, suggesting an average impact per firm 

of about $772,000 over the six-year period. The actual impacts for each firm would vary widely 

depending on the registration actions for each firm. 

 While the six year period (2000 – 2005) is a reasonable period of time to obtain average 

numbers of registration actions per year, it may over estimate the average annual impacts per 

firm. Since a longer period of time would likely capture more firms and registration actions with 

impacts spread over more years, a longer period would likely result in less average annual 

impacts for some firms. This lower annual average impact would be true for all firms that have 

registration actions less frequently than every six years 
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36

5.6 Applicator Exposure Test Costs 

EPA has re-evaluated the costs associated with generating applicator exposure data for 

antimicrobial pesticides. The costs were estimated for two different ways of generating data. 

The first subsection (5.6A below) estimates the costs according to the data requirements in the 

rule. This is the same methodology as used in the proposed rule and is explained in detail in 

sections 5.1-5.5 of this final EA. Note that different test cost estimates and test probabilities 

were used from those of the proposed rule. Also, this re-evaluation is only for applicator 

exposure, not for post-application exposures. 

The second subsection (5.6B) uses a different methodology that relies on the unique 

nature of applicator exposure studies, and the development of such data through a task force. 

A. Based on Test Cost and Probabilities 

The baseline in this EA is based on 40 CFR part 161. Since there are no applicator 

exposure tests in part 161 applicable to antimicrobials, the baseline is zero. 

Under this approach, EPA assumes that each applicant would be required to generate a 

dermal and an inhalation study, either for indoor or outdoor, to support a registration action for a 

new active ingredient or major new use (as described in Table 5-8). 
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37

Table 5-8: Applicator Exposure Data Requirements Cost 

Guideline Data Requirement 

Test 

Costs* 

New 

Active 

Ingredie

nt 

Major 

New 

Use 

Average 

number 

of tests / 

year** 

Annual Cost 

to Industry 

($1000) 

875.1100 or 

875.1200 

Dermal outdoor exposure or

Dermal indoor exposure $450,000 100% 100% 15 $6750 

875.1300 or 

875.1400 

Inhalation outdoor exposure or

Inhalation indoor exposure $450,000 100% 100% 15 $6750 

875.1600 Data reporting & calculations $7,500 100% 100% 15.0 $113 

 Subtotal (These tests would be covered by AEATF exposure testing) $13,613 

 

875.1500 Biological monitoring $375,000 10% 5% 0.9 $322 

875.1700 Product use information $3,000 100% 100% 15.0 $45 

 Total $13,980 

* The cost for any dermal or inhalation applicator exposure study is considered to be $450,000, based on the resurvey of the test cost for the outdoor inhalation study (Table 5-1). 

**Based on 15 registration actions per year (2000-2005). 

The probabilities of actually generating data are likely to be much less, since registrants 

may be able to cite submitted tests generated for previous registration actions. One way to do 

that is to form a task force to share data as is described in the next subsection. 

B. Based on the Task Force Costs 

Particularly for exposure data, registrants often use task forces to generate data that are 

then cost-shared by all the task force members. The reason cost-sharing works for exposure 

studies is that many of these exposure studies are scenario-specific, not chemical-specific. For 

example, the exposure resulting from a spray can application could then be used for other 

antimicrobial registration actions that are also spray can applications. Rather than each registrant 

generating data for a particular registration action, under the task force concept, an exposure 

study is a one-time cost. Data and costs will be shared by all task force members. Task force 

membership allows that member to access all taskforce-conducted studies. Additionally, 

taskforce exposure studies found to be adequate may simultaneously fulfill three data 

requirements: dermal exposure, inhalation exposure, and data reporting and calculations, thus 

further reducing costs. Historically, pesticide registrants have used task forces to generate 

exposure data. Most registrants choose to join the task force for such studies since costs are 

lower. However, whether a task force is organized and whether a registrant participates in a task 

force can depend on case-by-case considerations. Among the potential considerations that could 

cause a registrant to generate their own data could be certain chemical classes (such as volatile 

chemicals) or scenarios that fall outside the range of task force data. At this time, EPA is of the 

understanding that the majority of registrants will rely on task force data. 

The antimicrobial industry has a history of using task forces to generate exposure data, 

which is why the number of applicator exposure tests in current practice (2000-2005) was very 

low. The Chemical Manufacturers Association (CMA) Task Force provided the first exposure 

data for antimicrobials. These data were generated from 1988 to 1992 and are now 

acknowledged to have many limitations. 
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38

As part of its re-evaluation of several antimicrobials, in Reregistration Eligibility 

Decision Documents, EPA required additional exposure data, citing deficiencies in the CMA 

data. The need for additional exposure data was confirmed by EPA’s SAP in January 2007. 

Thus, the Antimicrobial Exposure Assessment Task Force (AEATF), sponsored by the American 

Chemistry Council’s (ACC) Biocides Panel, was formed to generate exposure data to support 

EPA’s development of improved exposure assessments for antimicrobials risk analyses and 

associated regulatory decision-making. The AEATF has broad industry participation (more than 

40 companies) and is conducting 19 scenarios. 

In this section, EPA assumes that only the AEATF will bear the burden of cost for 

generating exposure data. Once these exposure data are generated, registrants participating in 

the task force arrangement will not have to develop their own applicator exposure data to fulfill 

the applicator dermal and inhalation exposure data requirements. Instead task force members 

can cite to the AEATF exposure data, thus fulfilling the dermal exposure, inhalation exposure, 

and data reporting and calculations requirements. Registrants would still need to submit data to 

satisfy post-application exposure, biological monitoring, and product use information data 

requirements. 

The cost of AEATF applicator exposure testing is estimated in Table 5-9 in the following 

steps: 

1. Determine expenditures per scenario: The total cost to AEATF per exposure scenario 

is about $1.8 million, based on a June 17, 2011, letter to EPA (Shah (ACC) and Klein 

(CSPA)). 

2. Account for overhead: Based on information in the task force governing documents, 

EPA understands that support/overhead costs are included in the stated costs. EPA 

assumes that at least 30% was added for overhead8

; therefore, we divide this cost by 

1.3 to get an estimate of about $1.4 million for each scenario for testing cost only. 

3. Multiply by number of exposure scenarios: Since AEATF is testing 19 different 

exposure scenarios, the total cost to the industry will be about $26 million. 

4. Annualize costs: The $26 million is a one-time cost, since the AEATF database 

should replace the need for individual applicator exposure tests for registrants 

participating in the task force for at least 15 years, maybe longer, based on the life of 

the CMA data. We assume that eventually science will advance and more advanced 

exposure testing will replace this testing. 

a. The average annual industry cost is the total industry cost divided by 15 years, 

which is about $1.8 million. 

b. This annual cost does not take into consideration the time cost of money. The 

$26 million cost occurs early and is good for at least 15 years. The annualized 

costs are what the annual payments would have to be ($2.2 and $2.9 million) 

to pay off a loan of about $26 million at interest rates of 3% and 7%9

, 

respectively. 

 

8

 Because the American Chemistry Council added 30% in their estimates of unit test cost, we assume the same 

proportion was added for overhead costs here. 

9

 The Office of Management and Budget (OMB) suggests using discount rates of both 3% and 7% to estimate 

present values and annualized values to represent the social and private discount or interest rates. 
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39

5. Estimate the average annualized cost per registration action: We estimate about 15 

new registration actions (new active ingredients and major uses/amendments) per 

year based on past history (2000-2005) to estimate the average cost per registration 

action. The annualized cost of about $147,000 at the 3% interest rate is most of the 

applicator exposure cost in Table 5-4. The difference is due to the biological 

monitoring test and product use information not covered by the AEATF exposure 

studies. 

Table 5-9: Applicator Exposure Testing Cost by AEATF

Step $1000s

1 1-time cost per exposure scenario $1,800

2 1-time cost per exposure scenario without overhead $1,385

3 Number of exposure scenarios 19 

3 Industry cost $26,308

4 Time horizon – years 15 

4a Industry cost per year over 15 years $1,754

4b Annualized cost @ interest rate: 

4b 3% $2,204

4b 7% $2,888

5 Average number of new registration actions per year 15 

5 Average annualized cost per registration action @ interest rate: 

5 3% $147

5 7% $193

C. Conclusion 

These two methods of estimating applicator exposure costs illustrate that there are two 

different ways of meeting data requirements—either individually or through a task force. 

Since the task force is a more cost effective way of meeting the applicator exposure data 

requirements and since the AEATF is generating the applicator exposure data that will be used in 

the Agency’s risk assessments, the task force costs are used in estimating the cost of the rule. 

6 Registration Review 

 The economic analysis thus far has focused on new pesticide registrations and 

amendments to existing registrations. However, existing registered antimicrobial pesticides will 

incur data costs in registration review, which is the process of periodically reviewing currently 

registered pesticides and assuring that they continue to meet the statutory standards for 

registration. 
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When registration review was proposed, EPA prepared an economic analysis of that 

program (EPA, 2005). The registration review EA estimate of data requirement costs for 

existing antimicrobial pesticides was based on what would likely be required for a random 

sample of antimicrobial active ingredients that would be subject to review in the first years of the 

program. For each pesticide active ingredient in the sample, all tests that could be needed to 

conduct a risk assessments consistent with current practice were identified, whether or not the 

requirement was listed in part 161. The Registration Review EA estimated the average cost of 

registration review to be over $1.7 million per chemical case, about $1 million per firm, and 

about $24 million for the industry per year (EPA, 2005). The Registration Review EA represents 

the baseline for the current analysis. 

 The new part 158W includes 11 new tests, which were not anticipated when the 

economic analysis of the registration review process was completed. The data requirement costs 

of these new tests in registration review are estimated in this section following the same steps as 

estimating the costs for new registration actions. The analysis is shown in Table 6-1. 

6.1 Step 1. Expected Cost of each Data Requirement 

A. Unit Test Costs 

EPA used the same unit test cost estimates for the 11 new tests as was used in the new 

registration analysis. These costs are shown in Column C of Table 6-1. 

B. Data Requirements per Registration (Test Probabilities). 

Since these 11 tests were considered to be newly–required for the proposed rule, and 

were not considered as part of developing the 2005 economic analysis, the requirements for these 

tests in the first registration review cycle will be the same as they are for a new registration of a 

new active ingredient. The probabilities of these new tests being required are the same for all 

use site groupings except wood preservatives, food and indirect food uses10. As these tests will 

be required for new active ingredients, they will not be required again when the new AI goes 

through Registration Review in the future if data requirements remain the same. That is, for each 

chemical, these are likely to be one-time costs. The probabilities, defined as the percentage of 

registration reviews for which the test is likely to be required in the near future, are shown in 

Columns D – F of Table 6-1. 

 

10 We were able to reduce the six use site groupings to wood preservatives, food/indirect food, and other, because 

the probabilities as estimated by EPA staff for these new tests being required are the same for all use site groupings, 

except: 

 the soil residue dissipation and photodegradation in soil tests are required 100% of the time for wood 

preservatives only, and 

 the nature of residue on surfaces is expected to be required 25% of registration reviews for food and 

indirect food uses only. 
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Table 6-1: Estimation of Data Requirement Costs in Registration Review of New Tests not 

Anticipated When the Economic Analysis of the Registration Review Process Was 

Completed 

A B C D E F G H 

 

Probability = % of registration 

reviews test is likely to be required

Test 

Guideline Test Name

Average 

Unit 

Test 

Cost

Wood 

Preservatives 

Food and 

Indirect 

Food* 

All 

Other 

Average 

Number 

of Tests 

per Year

Average 

Industry 

Cost per 

Year

870.6300 

Developmental 

neurotoxicity study $702,500 3% 3% 3% 0.5 $358,275

870.7800 Immunotoxicity $204,400 100% 100% 100% 17.0 $3,474,800

875.2200 Soil residue dissipation $253,733 100% 0% 0% 7.0 $1,776,133

835.2410 

Photodegradation in soil 

(soil photolysis) $73,979 100% 0% 0% 7.0 $517,853

850.6800 

Modified Activated 

Sludge, Respiration 

Inhibition Test $4,292 100% 100% 100% 17.0 $72,968

835.1110 

Activated Sludge Sorption 

Isotherm $19,733 50% 50% 50% 8.5 $167,726

835.3110 Ready Biodegradability $8,667 50% 50% 50% 8.5 $73,673

835.3220 

or 

835.3280 

or 

835.3240 

Porous Pot Test 

or 

Simulation Tests to assess 

the biodegradability of 

chemicals in discharged 

wastewater 

or 

Simulation Test – Aerobic 

Sewage Treatment: 

Activated Sludge Units 

$33,000 50% 50% 50% 8.5 $280,500

None 

Nature of residue on 

surfaces $95,000 0% 25% 0% 1.3 $118,750

Number of Registration Reviews per Year ==> 7 5 5 17 

Average Cost per Registration Review Case $588,180 $284,217 $260,467 

Total number of New Tests per Year 75

Total Annual Cost of Registration Review for these New Tests $6,840,679

* The number of food and indirect food use registration reviews is based on 28% of the sample of 90 new 

registration actions being for food and indirect food uses.
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6.2 Step 2. Costs per Registration Review 

The average additional cost of Registration Review as a result of the new data 

requirements in Table 6.1 is estimated to be about $588,000 for a wood preservative, $284,000 

for food and indirect food uses, and $260,000 for all other uses. These costs are shown near the 

bottom of Columns D – F of Table 6-1. 

6.3 Step 3. Incremental Costs 

The baseline is the Registration Review EA. Since the 11 new tests were not considered 

in that EA, the cost of these new tests as estimated in this chapter are the incremental costs of 

this rule for registration review. 

6.4 Step 4. Industry Wide Cost 

Average annual industry registration review cost of these new tests can be calculated by 

multiplying the average cost per registration review of each use (wood preservatives, food and 

indirect food, and all other) by the average number of registration reviews of each use per year, 

then summing these costs for all uses. EPA’s Antimicrobial Division estimates that about 17 

active ingredients, of which about 7 include wood preservatives as a use, (EPA, 2010cb) would 

go through registration review each year. 

Σ (Average cost per registration review × Average number of registration reviews per year) 

(summed over the uses—wood preservatives, food & indirect food, & all other) 

As a check and as a method to estimate the industry-wide number and costs of the 11 new 

tests, the industry cost was also calculated by multiplying the average unit test costs (Column C) 

by the number of times each test is likely to be required per year, (Column G), then summing for 

all new tests. The number of tests per year is obtained by multiplying the number of registration 

reviews for each use by their test probability and summing over all uses. 

Σ (unit test cost × Average number of tests required per year) 

(summed over all the new tests—Column H, Average Industry Cost per Year) 

The total industry cost of about $6.8 million is shown in the bottom right corner of Table 6-1. 

6.5 Step 5. Cost per Firm 

 The average cost for a firm for each chemical in registration review is estimated as the 

cost per registration review divided by the number of firms with registrations of the same active 

ingredient. For a single firm holding a registration for an AI, the new data requirement cost 

would be about $260,000 ─ $588,000 for a registration review. If more than one firm held a 

registration for an AI, we assumed that the firms would share the data costs of that registration 

review. Although they are not required to share these costs, most do. Chapter 7 will examine 

the impacts on small firms. 
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43

7 Small Business Impacts 

 EPA concludes that the rule will not have a significant impact on a substantial number of 

small antimicrobial pesticide registrants. This conclusion is based on our finding that the 

following criteria are met: Fewer than 100 small businesses are likely to experience an 

economic impact of 3% or more of gross sales, and less than 20% are likely to experience an 

economic impact of 1% or more of gross sales. Our analytical method and conclusions are 

discussed below. 

7.1 Regulatory Overview 

 The Regulatory Flexibility Act (RFA) of 1980 and its 1996 amendment, the Small 

Business Regulatory Enforcement Fairness Act (SBREFA), require that special consideration be 

given to the effects of federal regulations on small business entities. The RFA and SBREFA 

require that a determination be made as to whether a regulation will have a significant impact on 

a substantial number of small entities. 

7.2 Categorization of Small Businesses 

 The Small Business Administration (SBA), under statute, establishes the definition of a 

small business. The SBA has set size standards under the North American Industrial 

Classification System (NAICS), using various thresholds on employee number and revenue 

amount, which vary by NAICS code. In determining the size of a company, the SBA applies its 

standards to the parent level of a business entity. Specifically, the SBA treats a firm that has a 

substantial portion of its assets and/or liabilities shared with a predecessor entity as part of that 

predecessor entity. The SBA also makes determinations based on the primary industry of the 

firm. In this analysis, the firm’s primary NAICS code is assumed to be its primary industry, and 

the definition of small business is determined by the SBA based on maximum number of 

employees or sales for small businesses in each industry sector, as defined by a 6-digit NAICS 

code. Most of the firms in this analysis are in the Pesticide and Other Agricultural Chemical 

Manufacturing (NAICS code 325320) industry sector. Firms in this sector are considered small 

if they employ 500 people or fewer. 

7.3 Estimation of the Number of Small Businesses 

EPA estimates that 750 unique parent companies constitute the total universe of pesticide 

antimicrobial registrants. See section 4.1. Of these, based on the SBA definition of a small 

business and the D&B data, EPA estimates that 500, or approximately 67%, are small 

businesses. 

 All of the 500 small antimicrobial pesticide registrants are potentially subject to the 

regulations. However, based on the available antimicrobial pesticide registration data for 2000-

2005, only a small portion of these registrants are likely to be impacted by the regulation. There 

are many types of registrations, which are not expected to incur costs under this rule, such as metoo registrations. Me-too registrations are products that are very similar to products that are 

already registered and can cite the data of those existing products. Other registrants are 

formulating a registered pesticide product into a different product. In these cases, EPA provides 
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a “formulator’s exemption” for certain data to registrants that qualify for the exemption. They 

may need to provide some product information, but most of the “generic” data are generated by 

the manufacturer of the AI. Any data required by those qualifying for the exemption are not 

likely to be changed by this rule. In the time period for which EPA has available registration 

data (2000 through 2005), 64 firms with antimicrobial registrations would have incurred 

additional costs under the rule. Of the 64 firms, EPA estimates that a total of 25 small

antimicrobial pesticide registrants would have incurred additional costs under the rule. See 

section 4.3. 

7.4 Small Business Impacts for New and Existing Registrations 

The incremental costs to antimicrobial registrants are measured as the increase in test 

costs per firm between the current application of CFR part 161 (the baseline) and the rule. The 

impact of this rule is expressed as the proportion of the average annual incremental costs per firm 

to the average annual firm sales. These impacts apply to both existing registrations going 

through registration review and new registrations.

A. New Registrations

 As stated above, EPA estimates 25 small businessesantimicrobial registrants with new 

registrations would have been impacted by the regulation during the six-year period of study 

(2000-2005). We assume that these impacts are representative of the future, although in any sixyear period of time, different firms would be impacted. For these small firms, the average 

incremental cost was estimated based on the number of registration actions by action code, 

which identifies the type of registration action for each firm, and the average estimated cost 

associated with each action. The data requirement costs were annualized by dividing by six the 

total costs of the registration actions for each firm during the six-year period, 2000 through 2005. 

Of these 25 firms, 16 firms have sales data. For each of these 16 firms, the average annual 

incremental cost was divided by the firm’s annual sales revenue to estimate the impact of the test 

costs as a percent of sales revenue. The distribution of the impacts of these 16 firms is projected 

to 25 firms11. The results of the analysis are shown in Table 7-1. 

Table 7-1: Estimated Small Business Impacts for New Registrations 

Incremental Costs as % of Sales 

Revenue 

Number of Small 

Firms* 

Percent of 

Small Firms* 

0% 475 95.0% 

> 0% 25 5.0% 

>1% 23 4.7% 

>3% 22 4.4% 

* EPA estimates that there are a total of 500 small pesticide registrants in the antimicrobial industry. 

 

11 For example, 15 of the 16 firms had an impact (incremental cost of data requirements, 2000-2005, as a result of 

the rule) of over 1% of their sales revenue. Keeping the same proportion, we estimate that about 23 out of 25 firms 

would have an impact of over 1% of sales revenue. 
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45

 Table 7.1 shows that 25 small antimicrobial firms (5% of the 500 small antimicrobial 

pesticide registrants that are subject to the rule) are likely to experience an impact greater than 

zero percent of their sales revenue for new registrations. While only 5% of small firms are 

impacted at all, almost 90% (22 firms) of these impacted small firms are likely to have impacts 

greater than 3%, because the incremental cost of most registration actions are costly and these 

small firms have small sales revenue. The incremental data requirement costs for new 

registrations for small firms ranges from about $424,000 to $1 million over the six-year period 

(2000-2006). However registration review data costs for existing registrations were not 

considered in the above analysis, but are estimated in the next section.

A.B. Small Business Impacts forExisting Registrations in Registration Review 

The Agency did a screening level estimate of small business impacts based on the same 

sample of 11 antimicrobial chemical cases that was used in the Registration Review EA (EPA, 

2005). As discussed in the Registration Review EA, there were a total of 24 firms that would be 

subject to the data requirements. Of these 24 firms, two were small by the SBA definition, and 

data were not available for one firm, which was assumed to be small. Sales revenue for the latter 

was assumed to be the average of the two small firms as shown in Table 7-2. 

 Since the assessment is screening level, we assumed the higher average cost per 

registration review from Table 6-1 of $588,180, associated with a wood preservative chemical. 

If more than one firm held a registration for a chemical case, we assumed that the firms shared 

the data costs. 

Table 7-2: Small Firm Impact of Newly Imposed Tests in Registration Review 

Sales Revenue of 

Small Firms 

Data Cost Number of 

Firms with same 

chemical case 

Share of 

Data Costs 

% of Sales 

Revenue 

$ 4 million $588,180 1 $588,180 14.7% 

$55 million $588,180 3 $196,060 0.4% 

$29.5 million* $588,180 1 $588,180 2.0% 

*Since sales revenue is not available for this firm, it was assumed to be the average of the above 2 firms. 

Table 7-3 is the small business impacts for new registrations from Table 7-1 plus the impacts for 

registration review from Table 7-2.There are a total of about 250 antimicrobial active ingredients, 

which would need to go through registration review in 15 years, or almost 17 per year. Most 

antimicrobial cases have one active ingredient. The sample of 11 cases, as explained above, and 

the number of firms impacted are scaled up by 50% to approximate the number of cases in one 

year. We estimate the average number of small firmsantimicrobial registrants impacted by 

registration review each year to be 4.5 (3 x 1.5), and the number of firms impacted by more than 

1% to be 3 (1.5 x 2). 

C. Total of New and Existing Registrations

Table 7-3 is the small business impacts for new registrations from Table 7-1 plus the 

impacts for registration review from Table 7-2. 
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46

Table 7-3: Estimated Small Business Impacts – New Registrations plus Registration Review 

Compliance 

Costs as % of 

Revenue 

Average per Year 

 New 

registrations 

Registration 

Review 

New registrations plus 

Registration Review 

# small 

firms* 

# small 

firms 

# small 

firms* 

% small 

firms* 

0% 475.0 470.5 94.1% 

> 0% 25.0 4.5 29.5 5.9% 

>1% 23.4 3.0 26.4 5.3% 

>3% 21.9 1.5 23.4 4.7% 

* There are 500 small pesticide antimicrobial registrants. 

Because the numbers of small firms with any impact were scaled up from samples, (16 scaled up to 25 for new 

registrations and 3 scaled up by 50% for registration review) the numbers of small firms impacted are not whole 

numbers. 

EPA conclusions in terms of the SBREFA conditions (beginning of Chapter 7) are: 

 About 23 small firms antimicrobial registrants (almost 5%)%, consisting of about 22 firms 

with new registrations and 1 firm with existing registrations(s) in registration review) are 

likely to experience an economic impact of 3% or more of gross sales, and 

 About 26 small firms, (over 5%)About 26 small antimicrobial registrants (over 5%, 

consisting of about 23 firms with new registrations and 3 firms with existing registration 

in registration review) are likely to experience an economic impact of 1% or more of gross 

sales.

 EPA concludes that there would not be a substantial number of small entities that would 

incur a significant impact under the rule. 

8 Benefits Due to Changes in Data Requirements

In this chapter, 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. 

As promulgated, subpart W is intended to improve the scientific basis for antimicrobial 
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47

pesticide decisions. These efforts are 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. 

 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:

 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.

 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.

 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 
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48

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.

 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. 

 New data requirements recognize the unique down-the-drain uses associated with 

antimicrobials. For antimicrobial chemicals that go down-the-drain and eventually reach 

a WWTP (waste water treatment plant), EPA intends to conduct an assessment of the 

potential impact of the antimicrobial chemical on the micro-organisms 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.

 This rule is 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.

89 Limitations and Uncertainties of the Economic Analysis 

There are a number of uncertainties and limitations that potentially affect the results of 

this analysis including, but not limited to, the following: 

 Unit Test Costs: Costs for guideline studies were gathered from a limited survey of labs, 

and for a number of studies there is a range of cost estimates. The years when labs were 

surveyed also varies. The costs for some data requirements, also applicable to 

conventional pesticides, were surveyed in 2003 and 2005, while others were surveyed 

more recently, including 30 tests in 2010. In-house labs were not surveyed, although 

many companies use them. Their costs might be lower or higher than an independent lab. 

In addition, some of the data requirements have multiple guidelines. Since EPA did not 

always know which test would be appropriate, given the wide variation in use patterns, 

EPA used the highest cost to insure the costs would not be underestimated. 

 

 Probability of a Test Being Required: In this EA, the percentage of registration actions 

for which a test is required in current practices was estimated with the registration data 

from 2000 through 2005. For the rule, the Agency has also relied upon the scientific 
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49

judgment of EPA staff to produce estimates of how frequently newly generated guideline 

studies will be required to satisfy the data requirements. The percentages from the 

baseline were assumed to be the same as current practices if the test was in the current 

CFR part 161 and intended to apply to antimicrobials. If the test is not in the current 

CFR part 161, the baseline is zero. In addition, many of the tests in the rule have not 

been requested in current practice. Many of these tests are in CFR part 161, and many 

are not, but in either case these tests were not requested during our registration action 

sample period of 2000 through 2005. EPA assumed that since these tests are in the rule, 

the intention was that these tests would occasionally be required. EPA relied on the 

scientific judgment of EPA staff to provide a reasonable estimated percentage for these 

tests. However, if the probability that a test is required was greater for current practices, 

than what was estimated for the rule, the larger probability was used. 

 Number of Future Requested Registration Actions: Actual future requested registration 

actions may not closely reflect registration data from the past six years that the Agency 

used as a baseline for its estimate to predict future actions. This uncertainty is a result of 

a number of factors including unforeseen changes in markets or scientific knowledge. 

Registration data from 2000 through 2005 did not show any trend that could be used to 

forecast future requested registration actions. 

 Sales data: Since sales data were not available for all firms with registrations (2000-

2005), this analysis was based on a sample and projected to the industry. However, EPA 

cannot determine whether or how much the sample represents the total population of 

antimicrobial firms. 

 Structure Activity Relationship (SAR) Assessments: The Agency has begun to accept on 

a case-by-case basis the use of SAR techniques to fulfill certain pesticide data 

requirements. Because OPP has limited experience with these SAR techniques, EPA was 

not able to estimate the potential industry cost savings, but savings are expected to 

increase over time as EPA gains experience. Therefore, the cost estimates in this 

document may be over-estimated. 

 Cost Incidence: Because data limitations made it difficult to determine precisely when 

and who bears the costs of data requirements, several assumptions were made. EPA was 

not able to determine whether the net effect of these assumptions results in cost estimates 

that are overly concentrated in fewer firms or under concentrated in more firms than the 

actual number of firms. 

1. Data Cost Sharing. The analysis assumed that the registrants initiating 

registration actions would pay the full costs of the data required by these actions. 

Since other registrants may compensate them in order to cite this data, the costs 

of data may be distributed more widely resulting in a larger number of firms 

incurring smaller costs than estimated. 

2. Expected Test Costs. Many of the tests are not required for all registration 

actions. EPA estimated expected test costs per registration action by multiplying 
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50

the test costs times the percent of time the tests are likely to be required. In 

reality, specific registration actions which require most of the tests will be more 

expensive, while others requiring few tests will be less expensive than the 

estimated expected costs. Thus, there is a range of costs a firm may incur for the 

same type of registration action. 

3. Annual Average Costs. EPA averaged the costs over six years (2000-2005). 

However, average annual impacts will be overestimated for firms that average 

less than one registration action every six years. A longer time period would 

likely capture more firms thus spreading the annual impacts over more firms. 

910 Consideration of Paperwork Burden 

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 the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 

seq. The procedures for submitting data to EPA under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) are not 

changed in this final rule, and are already approved by OMB in the following ICRs (Information 

Collection Requests): 

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)). 

 

 For the proposed rule, EPA prepared a supporting statement for amending an Information 

Collection Request (ICR), titled “Data Requirements for Antimicrobial Pesticides (Proposed 

Rule)” and identified by EPA ICR No. 2318.01, a copy of which is in the docket for this rule. 

This amended ICR addressed those changes to the data requirements in the proposed rule that 

impact the information collection activities related to antimicrobial pesticides covered by these 

existing ICRs, and documents the changes in burden. 

 These activities already occur as part of existing program activities, and are not being 

changed by this rule. These program activities are an integral part of the Agency pesticide 

program and the corresponding ICRs are regularly renewed every three years as required by the 

PRA. The total estimated average annual public reporting burden currently approved by OMB 

for these various activities ranges from 8 hours to approximately 3,000 hours per respondent, 

depending on the activity and other factors surrounding the particular pesticide product. 

Reregistration is considered complete for active ingredients since all of the Registration 

Eligibility Decision Documents have been signed. However, both confirmatory Data Call-Ins 
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51

(DCIs) for active ingredients and product specific DCIs for product level data continue to be 

issued. 

 Since the rule adds new data requirements, additional DCIs are expected during 

registration review. We estimate that 75 new tests not anticipated when the economic analysis of 

the registration review process was completed will be required in Registration Review each year 

as estimated in Table 6-1. 

 Once the new data requirements are finalized, the total annual registrant paperwork 

burden and costs for data submission activities for antimicrobial pesticides applicants and 

registrants will be updated accordingly in the existing ICRs during the next, appropriate ICR 

renewal cycle. 

References

ACC presentation; Antimicrobials Exposure Assessment Task force (AEATF) II, Introduction 

and Background (October 2007) (accessed July 8, 2011) 

http://www.epa.gov/hsrb/files/meeting-materials/jun-24-25-2008-publicmeeting/aeatf_introduction_and_background(10-17-07).pdf 

AEATF; Governing Document for a Multi-Year Antimicrobial Chemical Exposure Monitoring 

Program; page 13 (February 13, 2008) (accessed July 8, 2011) 

http://www.epa.gov/hsrb/files/meeting-materials/apr-9-10-2008-public-meeting/volume-5-

AEATF-governing-doc.pdf 

Dun & Bradstreet. 2006. Market Spectrum Analysis Portal. Downloaded November 2006. 

Office of Management and Budget (OMB). 2003. Circular A-4. 

Shah and Klein; Letter to Bradbury and Harrigan-Farrelly; ACC Biocides Panel/CSPA Followup Regarding Issues with Proposed 158W; page 3 (June 17, 2011) (ACC/CSPA letter in the 

docket at http://www.regulations.gov; document EPA-HQ-OPP.2008-0110-0107 ). 

U.S. EPA. 2010a4. Antimicrobial Pesticide Products. 

http://www.epa.gov/pesticides/factsheets/antimic.htm#info. Last accessed, May 11, 2012.

U.S. EPA. 2010ba. Regulating Antimicrobial Pesticide. http://www.epa.gov/oppad001. 

U.S. EPA. 2010cb. OPPIN database. 

U.S. EPA. 2007. Economic Analysis of the Change in Data Requirements Rule for Conventional 

Pesticides. Office of Pesticide Programs

U.S. EPA. 2006a. Memorandum, Part 158W Economic Analysis (EA) Methodology.
*** Deliberative Document for E.O. 12866 Review – Do NOT Cite, Quote, or Release *** 

52

U.S. EPA. 2005. Economic Analysis of Proposed Procedural Regulations for The Registration 

Review Of Pesticides (May 2005). 

U.S. EPA. 2000. Guidelines for Preparing Economic Analyses. 

U.S. EPA. 1994. Economic Impact Analysis of Proposed Effluent Limitations Guidelines and 

Standards for the Pesticide Formulating, Packaging, and Repackaging Industry. Office of Water. 

EPA 821-R-94-003. 

Code of Federal Regulations. Parts 158 and 161. 

U.S. EPA Proprietary Data 

Appendices. See Word file W.EA.Apx A, and Excel file W.EA.Apx BCD. 

Appendix A. Data Required for New Active Ingredient Antimicrobial Registrations. 

Appendix B. Data Requirement Probabilities for Antimicrobial Pesticides 

Appendix C. Data Requirement Costs for Antimicrobial Pesticides 

Appendix D. Changes in Data Requirements and Costs 

Appendix E. Glossary