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RIN 2070-AJ26

ECONOMIC ANALYSIS OF THE NOTICE OF PROPOSED 

RULEMAKING CONCERNING THE STATUS OF A PRION AS 

A PEST UNDER THE FEDERAL, INSECTICIDE, FUNGICIDE, 

AND RODENTICIDE ACT (FIFRA) 

Prepared by: 

Economic Analysis Branch 

Biological and Economic Analysis Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

Prepared for: 

Antimicrobials Division and 

Field and External Affairs Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave, NW 

Washington, DC 20460 

April 1, 2010 DRAFT 
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TABLE OF CONTENTS 

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

2 Introduction........................................................................................................................................................6

2.1 Background ................................................................................................................................................6

2.2 Problem Statement......................................................................................................................................7

2.2.1 Three Problems......................................................................................................................................8

2.2.2 Agency Goals.......................................................................................................................................10

2.3 Overview of Proposed Rule......................................................................................................................11

2.3.1 Appropriateness of Regulation at the National Level..........................................................................11

2.4 Statutory Authority for the Proposed Rule ...............................................................................................12

2.4.1 Statutory Authority for Considering Prions to be Pests under FIFRA.................................................12

2.4.2 Statutory Authority for Registration Data Requirements.....................................................................12

2.5 Affected Persons.......................................................................................................................................13

Category #1........................................................................................................................................................13

Category #2........................................................................................................................................................14

Category #3........................................................................................................................................................15

3 Regulatory and Data Requirement Options and Benefits ............................................................................17

3.1 Option #1: Determine Prions are Pests.....................................................................................................18

3.1.1 General Data Requirements .................................................................................................................19

3.1.2 Product Performance Data Requirements ............................................................................................22

3.2 Option #2: Determine That Prions are not Pests.......................................................................................23

4 Economic Impacts on Pesticide Registrants due to Changes in Data Requirements .................................24

4.1 The Baseline .............................................................................................................................................24

4.2 Description of Data and Sources ..............................................................................................................25

4.2.1 Data Requirements / Test Costs...........................................................................................................25

4.2.2 Frequency of Data Requirements.........................................................................................................26

4.3 Cost Estimation ........................................................................................................................................27

4.3.1 Incremental Costs per Registration Action ..........................................................................................27

4.3.2 Industry-Wide Impacts ........................................................................................................................30

5 Small Business Analysis...................................................................................................................................34

5.1 Methodology.............................................................................................................................................34

5.2 Industry Profile.........................................................................................................................................34

5.2.1 Number of Firms in the Industry .........................................................................................................34

5.2.2 Characterization of Firms Identified as Potential Prion Product Registrants.......................................35

5.3 Incremental Impact per Small Firm..........................................................................................................37

5.4 Conclusions ..............................................................................................................................................37

6 ICR Analysis.....................................................................................................................................................39

6.1 Registrant Paperwork Burden...................................................................................................................39

6.2 Agency Paperwork Burden.......................................................................................................................43

REFERENCES ..........................................................................................................................................................44

Appendix A: Descriptions of NAICS Codes ............................................................................................................45

Appendix B: Expected Costs of Data Requirements ..............................................................................................46
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TABLE OF TABLES 

Table 2-1. Comparison of Applications Rates Recommended by WHO to inactivate prions versus EPA-Registered 

Disinfectant Label Rates ......................................................................................................................................8

Table 3-1. Summary of Option Components and Utility for Achieving Agency Goals..............................................18

Table 3-2. Purpose of Data Requirements by Discipline.............................................................................................20

Table 3-3. Types of Registration Actions....................................................................................................................21

Table 3-4. Exposure Categories and Examples ...........................................................................................................22

Table 4-1. Possible Registration Scenarios..................................................................................................................29

Table 4-2. Incremental Cost Per Prion Product Registration Action ($000s)..............................................................30

Table 4-3. Total Industry Cost in First Year After Rule Takes Effect ($000s)*..........................................................33

Table 5-1. Potential Prion Product Registrants Classified by NAICS Code................................................................35

Table 5-2. Bleach (NaOCl) and Lye (NaOH) Registrants, Number of Firms and Sales .............................................36

Table 6-1. Estimated Cost of Paperwork Burden per Registration of New Active Ingredient or Major New Use 

Product for an Antimicrobial Pesticide ..............................................................................................................41

Table 6-2. Estimated Cost of Paperwork Burden per Tolerance Petition ....................................................................42
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1 EXECUTIVE SUMMARY

The U.S. Environmental Protection Agency (EPA or “the Agency”) is proposing to add “prions” 

to the definition of a “pest” in regulations promulgated under the Federal, Insecticide, Fungicide, 

and Rodenticide Act (FIFRA). The Agency currently regulates products intended to reduce 

infectivity of prions (hereafter called “prion products”) as pesticides under FIFRA pursuant to 

the Agency’s September 10, 2003 determination that prions should be considered a pest under 

FIFRA. 

The Agency has identified hazards to human health and the environment that could stem from 

using prion products without FIFRA regulation and has regulated prion products as pesticides 

since 2003. The proposed regulatory definition addition will provide more clear notice to the 

regulated community and general public that prion products are subject to regulation under 

FIFRA, including all data and labeling requirements. This Economic Analysis (EA) presents the 

Agency’s assessment of the potential costs and benefits expected to result from the proposed 

rule. Although the proposed rule will not alter the regulatory status of prion products, in order to 

take into account the full economic impact of the decision to regulate these products under 

FIFRA, EPA has chosen to compare the economic impact of the proposed rule to what it would 

be if prions were not considered pests and prion products were not subject to FIFRA. 

This EA begins with a discussion of the problems that could stem from the use of prion products 

without FIFRA registration; they include potential negative externalities to human health and the 

environment, potential exposure to prions due to imperfect information, and regulatory 

uncertainty. A brief synopsis of the proposed rule is presented as well as the Agency’s statutory 

authority for issuing the rule. 

The EA also outlines two options for addressing the problems described in Section 2, which are: 

1) to amend 40 CFR §152.5 to explicitly include prions, consistent with the Agency’s September 

10, 2003, decision that prions are considered to be pests under FIFRA (EPA, 2004), or 2) to 

reverse that decision and determine that prions are not considered to be pests under FIFRA. The 

first option (to declare prions to be a pest under FIFRA) is the basis for the proposed rule. Its 

description includes an outline of the types of data that would be required by the Agency and 

how it would be used to mitigate externalities (unintended negative effects). 

The EA further discusses the costs of various types of registrations that are likely to occur 

initially under the proposed rule and presents expected incremental costs for eight potential types 

of prion product registration scenarios. Of these eight, three are considered likely to occur: new 

active ingredient, new use product, and new use amendment. Using the pre-2003 scenario as the 

baseline, the incremental costs of the proposed rule per registration action range from $424 

thousand to $4.72 million. 

The Agency estimates that three firms may seek registrations for major new use products in the 

first year. If all uses were high exposure (e.g., indirect food uses), the maximum potential total 

cost to industry in the first year would be approximately $7.05 million, and costs per firm would 

be approximately $2.35 million. Given the uncertainty that characterizes the market for prions at 

this time, the Agency does not wish to speculate further on the expected number of registrations 
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in subsequent years. However, registrations that occur after the initial major new use product 

registrations would probably be major new use amendments. Data requirements would entail 

only product-specific efficacy data for major new use amendments at a cost of approximately 

$431 thousand per registration action. 

Approximately 80% of the firms in the pesticide manufacturing industry are small firms with 

revenues of $22 million, on average. A cost of $7.05 million suggests that the incremental cost 

per firm of $2.35 million dollars would equal nearly 11% of annual revenues. However, after the 

initial three registrations, a major new use amendment at a cost of $431,000 would represent 

fewer than 2% of average annual revenues. 

Using the estimate of three high exposure, major new use product registrations in the first year, 

the additional registration of three antimicrobial products making prion related claims will result 

in an increase in new registration applications for the Agency from 140 to 143 and an increase in 

tolerance petitions of from 64 to 67. The increase in paperwork burden for the registrant will be 

nearly $38,000 (600 hours for three registrations) for registration activities and a little more than 

$423,000 (5,200 hours for three registrations) for tolerance petitions’ documentation. 
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2 INTRODUCTION 

Prion (“proteinaceous infectious particle”) is a term used to describe an infectious agent that 

causes progressive neurodegenerative diseases of the central nervous system (CNS). These 

neurodegenerative prion diseases are known collectively as transmissible spongiform 

encephalopathies (TSEs). Examples of TSEs or prion diseases include scrapie in sheep, chronic 

wasting disease (CWD) in deer and elk, bovine spongiform encephalopathy (BSE) or mad cow 

disease in cattle, and both kuru and variant Creutzfeldt - Jakob disease (vCJD) in humans. 

Prion protein usually occurs in a normal (“correctly folded”), non-infectious form but sometimes 

occurs in an abnormal (“misfolded”), infectious form. Prion protein in its normal form, or 

conformation, is usually designated PrPc (“cellular” isoform) while abnormal conformations of 

prion proteins are generally called prions. The prions can cause neurological disease and 

different types of prions are often designated by the type of diseases they produce. Two 

examples are PrPSc, prions associated with scrapie, and PrPBSE, prions associated with bovine 

spongiform encephalopathy (mad cow disease). 

2.1 BACKGROUND

The most common TSE in the U.S. is chronic wasting disease (CWD), which occurs in wild and 

domestic cervids (deer, elk, and moose), mostly in the western states.1 In 2003, the Agency 

became aware that certain veterinary research laboratories were using various disinfectant 

products for the purpose of inactivating prions on non-porous laboratory surfaces which had 

been in contact with CWD-contaminated animal tissues. These products were not registered or 

labeled for this use and the Agency had taken no public position on whether prions were within 

the scope of the FIFRA definition of “pest.” However, the World Health Organization (WHO) 

recommends the use of certain chemicals for inactivating prions, including registered disinfectant 

products which are referenced by the Centers for Disease Control and Prevention (CDC). 

In the face of the growing need to reduce the infectivity of prions on inanimate surfaces in 

veterinary laboratories, the use of unregistered disinfectants/chemicals for this purpose and 

questions about the potential health and environmental impacts of these practices, the Agency 

considered the FIFRA section 2(t) definition of “pest” and on September 10, 2003, determined 

that products intended to prevent, destroy, repel, or mitigate prions are pesticides subject to the 

 

1

 Chronic Wasting Disease (CWD) was first recognized as a clinical "wasting" syndrome in 

1967 in captive mule deer in a wildlife research facility in Colorado. It was identified as a TSE 

in 1978. In 1981, CWD was detected in a wild elk and in 1985 it was detected in a wild mule 

deer in Colorado; shortly thereafter it was shown to be present as an endemic focus in wild deer, 

elk and moose in northeastern Colorado and southeastern Wyoming. Since nationwide wildlife 

surveillance was instituted in 1997, CWD has been identified in wild deer and elk in several 

additional states: Illinois, Kansas, Nebraska, New Mexico, New York, South Dakota, Utah, West 

Virginia and Wisconsin (www.aphis.usda). 
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requirements of FIFRA (refer to EPA’s Record of Decision memorandum of April 29, 2004). 

The Agency’s rationale included the following key points: 

• Prions are unquestionably injurious to human and animal health. 

• Prions share many characteristics of deleterious microorganisms. 

• Prions share enough characteristics of “other micro-organism” or “form of life” to fall 

within the scope of FIFRA section 2(t)(2). They originate in living organisms, 

replicate within host organisms, and can be transmitted to other hosts. 

• If prion products were not regulated under FIFRA, the Agency could not provide 

assurance that such products would be effective or safe. 

• It appears that the intent of Congress in the 1972 FIFRA was that the Agency should 

regulate products used against entities that share the characteristics of viruses and 

microorganisms 

Having decided that prions should be considered a pest under FIFRA, the Agency commenced 

the present effort to amend the regulatory definition of pests at 40 CFR §152.5 to explicitly 

include prions. Meanwhile, in reliance on the September 10, 2003 decision, the Agency granted 

quarantine exemptions under FIFRA Section 18 to eight states (California, Montana, Colorado, 

North Dakota, South Dakota, Utah, Wyoming, and Maine) for the sale and distribution (and use) 

of a commercial aqueous acid phenolic product, Environ LpH®, for inactivation of various TSE 

agents on hard, nonporous surfaces and equipment in government and commercial laboratories. 

2.2 PROBLEM STATEMENT

Currently, several chemical products are being used, primarily by government and commercial 

veterinary laboratories, with the intent of reducing the infectivity of prions on potentially 

contaminated surfaces and equipment. The Agency has issued FIFRA Section 18 emergency 

exemptions to allow the sale and distribution (and use) of Environ LpH® to deactivate prions. 

The Agency also believes that some other pesticide products (e.g., sodium hypochlorite) are 

being used for this purpose in accordance with WHO recommendations but in a manner 

inconsistent with the EPA labeling. For example, WHO has recommended treatment of surfaces 

with undiluted sodium hypochlorite (i.e., about 50,000-60,000 ppm) for one hour, whereas the 

maximum use concentration of registered sodium hypochlorite products is a 10 to 1 dilution 

(5,000-6,000 ppm) for a 10 minute contact time. A dosage, concentration or frequency of 

application greater than what is specified on the label is not permissible under FIFRA section 

2(ee) or 12(a)(2)(G). 

There are at least three major problems with the current situation. First, the use of chemical 

products with the intent of reducing prion infectivity could cause negative externalities in the 

form of effects to human health and/or the environment. Second, imperfect information about 

the efficacy of prion products could lead to exposure to prions which could result in disease. 

Finally, the lack of clear regulatory guidelines may increase transaction costs (i.e., paperwork 

burden) for registrants and the Agency and regulatory uncertainty for potential registrants. These 

problems are described in further detail in the following section. 
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2.2.1 Three Problems 

2.2.1.1 Externalities 

An externality is a negative (or positive) impact of a transaction on a third party that did not 

receive the full benefits (or bear the full costs) of that transaction. Externalities could include 

chemical safety hazards to applicators and to the environment (e.g., fish, birds, and aquatic 

organisms). An example of an externality for not regulating products used to reduce the 

infectivity of prions is the potential hazard to humans and/or the environment from the use of 

sodium hypochlorite (NaOCl). In the re-registration eligibility decision (RED) for sodium 

hypochlorite (NaOCl), the Agency noted that acute toxicity of bleach (Toxicity Category 1 for 

skin and eye effects) is significant and that labels should require goggles and protective 

clothing to protect applicators. Sodium hypochlorite generally has low toxicity to birds but can 

be highly toxic to freshwater fish and freshwater invertebrates. Pesticide labels prohibit 

discharge of pesticides into lakes, streams, or ponds to mitigate such hazards. 

Regarding potential hazards of sodium hypochlorite and sodium hydroxide to humans, higher 

concentrations could result in greater risk to people that apply the chemicals. Sodium hydroxide 

is in Toxic Category I (the highest toxicity category) for its acute eye and skin irritation effects. 

The chemical can irritate the skin, eyes, and mucous membranes, but exposure and negative 

health effects can be adequately mitigated by following label instructions. Acute toxicity of 

sodium hypochlorite is possible and precautions, such as goggles and protective clothing, should 

be taken to minimize contact. 

Table 2-1 compares the concentrations and contact times recommended by WHO to inactivate 

prions on a hard surface to current EPA label rates for disinfection. For treatment of 

contaminated surfaces, WHO recommends a 5% (v/v) solution of sodium hypochlorite (NaOCl) 

(i.e., 50,000 ppm available chlorine) with a one hour contact time. In comparison, the maximum 

EPA label concentration for disinfection is for a 1:10 dilution of bleach (5,000 ppm available 

chlorine) with a ten minute contact time. For sodium hydroxide (NaOH), another product 

recommended for reducing prion infectivity, WHO recommends a 1 normal (4% w/v) solution 

with a contact time of one hour, followed by autoclaving. In comparison, a common household 

ready-to-use disinfectant contains 0.34% NaOH with a contact time of ten minutes. For both 

chemicals, the concentration that WHO recommends is approximately ten times greater than the 

EPA label instructs. 

 

Table 2-1. Comparison of Applications Rates Recommended by WHO to inactivate prions 
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versus EPA-Registered Disinfectant Label Rates 

WHO Recommendations 

For prion inactivation

EPA Label Rate 

For disinfection

Chemical

Use 

Concentration 

(%)

Contact Time

Use 

Concentration 

(%)

Contact Time

Sodium 

Hypochlorite 

(Bleach) 

5.0 60 minutes 0.5 10 minutes 

Sodium 

Hydroxide 

(Lye) 

4.0 60 minutes 0.34 10 minutes 

Source: World Health Organization, 1999; EPA OPPIN database, 2009 

The Agency believes that the toxicity hazards to humans who mix and apply WHO 

recommended concentrations of bleach and sodium hydroxide are ten times higher than those 

associated with the registered pesticide concentrations and contact times. The personal 

protective equipment (PPE) required on bleach and sodium hydroxide labels generally includes 

protective eyewear and gloves (depending on the label’s signal word such as “Danger,” 

“Warning” or “Caution”), whereas the PPE for WHO-recommended concentrations of bleach 

and sodium hydroxide should be protective eyewear, gloves, long-sleeve shirt and pants, and an 

appropriate chemical-cartridge respirator. 

2.2.1.2 Product performance 

Currently, WHO provides end users with guidance on the efficacy of various methods for 

cleaning surfaces to inactivate prions. This guidance has not been updated for several years, and 

it is not clear whether it reflects current scientific knowledge. The prion decontamination 

recommendations by WHO appear to have been developed by consensus by scientists who 

attended a "WHO Consultation on Caring for Patients and Hospital Infection Control in Relation 

to Human Transmissible Spongiform Encephalopathies held in Geneva, Switzerland, March 24-

26, 1999." In that document, WHO also specified what protective equipment should be worn by 

people during the decontamination process. Whether WHO's recommendations are "sufficient" 

to reduce prion infectivity is unknown since the WHO document did not cite the scientific 

studies upon which the participating scientists apparently relied in coming up with a consensus 

opinion. 

The lack of consistent guidance and a performance standard for efficacy testing guidelines on 

which to base prion-related claims could potentially lead to exposure to prions by: 1) leading end 

users to be overly confident in the efficacy of products or 2) causing potential end users to not 
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use the products because they lack confidence in their efficacy. Whether products are not as 

effective as claimed or their effectiveness has not been established, there may be exposure to 

prions. Efficacy tests conducted according to validated, federal test guidelines and product 

performance standards would help assure that products would effectively perform their intended 

function. 

Producers’ claims about performance could potentially be regulated by the Federal Trade 

Commission if they were to make false or misleading claims in advertising, but the Agency’s 

pesticide registration program would provide a more efficient and appropriate regulatory 

mechanism for reviewing the efficacy of pesticide products and providing guidance on how 

companies should design efficacy test protocols. Potential users of prion products would be 

assured that products whose claims were reviewed and permitted by the Agency had 

demonstrated, through appropriate testing methods, efficacy in reducing the infectivity of prions 

when used in accordance with the products’ labeling. 

2.2.1.3 Regulatory uncertainty and inefficiency 

Prions and their control are emerging fields, and the applicable regulatory framework may be 

less familiar to persons working in these fields than would be the case in a more mature field. In 

addition, it is not clear which data should be submitted to support the registration of a prion 

product, especially with regard to efficacy data. This may create an uncertain investment 

environment for research and development of prion deactivation products, marketing of those 

products, and production. 

In addition to this regulatory uncertainty, the lack of clear efficacy data guidelines can lead to 

wasted resources by both the Agency and an entity that applies for a pesticide registration. Both 

parties may spend time and resources identifying data requirements and efficacy standards on a 

case-by-case basis. As a result, data may be generated and submitted that are unnecessary or do 

not meet the regulatory requirements. There may be delays in registering products because data 

which could be generated during the research and development phase of the product are only 

identified when a registration is sought. Delays in registering products would result in a delay of 

the products’ benefits. Finally, uncertainties about the time and costs of the registration process 

can deter research and development (R&D). 

2.2.2 Agency Goals 

The Agency’s goal of regulatory action in this case is to find the best regulatory solution given 

expected costs for the regulated community and resource constraints (e.g., paperwork, 

monitoring, etc.) of the Agency. The ideal solution would eliminate any potential negative 

externalities from the use of prion products, fix existing market imperfections to the extent 

possible by providing information so that the market could work efficiently, and alleviate any 

regulatory uncertainty that may be curbing R&D investment. 
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2.3 OVERVIEW OF PROPOSED RULE

Pursuant to EPA’s September 10, 2003 determination that prions should be considered a pest, 

prion products are already subject to regulation under FIFRA, and any additional economic 

impact of the proposed rule is arguably nil. However, EPA believes that there is benefit in using 

this rulemaking proceeding for a full public consideration of the decision to regulate these 

products under FIFRA. Accordingly, EPA has chosen to compare the economic impact of the 

proposed rule to what it would be if prions were not considered pests and prion products were 

not subject to FIFRA. 

Under the proposed rule, the Agency would add prions to the list of entities that are included in 

the definition of “pests” under the regulation promulgated pursuant to FIFRA and require prion 

products to go through the FIFRA Section 3 registration process. By requiring FIFRA Section 3 

registration, EPA would be able to require any needed toxicity and exposure data specific to each 

prion product. These data would make it possible for EPA to assess the risks of prion products 

and require risk mitigation measures thereby preventing health and environmental externalities 

that may otherwise occur. 

In addition to requiring data for risk assessments, the Agency would also be able to require 

product performance (i.e., efficacy) data needed to support the registration of prion mitigation 

products. The Agency has developed draft guidance for efficacy testing of products with prionrelated claims. This guidance describes efficacy test protocols that would be acceptable for 

demonstrating the performance of prion mitigation products. This new guidance document 

addresses labeling statements, test methods and performance standards applicable to prion 

products. This prion-specific data guideline addresses the problem of incomplete information 

about the efficacy of prion products. If the proposed rule is promulgated final at a future date, 

then the efficacy guidance would be made final and effective at that time. 

Both classes of data requirements (general and prion-specific) will allow the Agency to obtain 

information that may not otherwise be generated or publicly available, thereby improving the 

Agency’s ability to make regulatory decisions on prion products. 

Finally, establishing consistent data requirements and testing guidelines will inform potential 

registrants of data needs for prion products, thereby reducing regulatory uncertainties that 

impose transaction costs on industry and the Agency. 

2.3.1 Appropriateness of Regulation at the National Level 

Regulation of prion products at the national level is appropriate because potential human health 

and environmental risks associated with prions and prion products may cross State and local 

boundaries. Reliance on State requirements and differences in state resource availability may 

lead to significantly divergent or duplicate approaches. A single and central authority is needed 

to set appropriate standards for acceptable levels of efficacy and safety for prion products. 
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2.4 STATUTORY AUTHORITY FOR THE PROPOSED RULE

2.4.1 Statutory Authority for Considering Prions to be Pests under FIFRA 

FIFRA provides EPA the authority to decide what entities are considered to be a “pest” under 

FIFRA. The sections that are potentially relevant to prions include: 

• FIFRA Section 2(t): A pest is “... (2) any other form of terrestrial or aquatic plant or 

animal life or virus, bacteria or other micro-organism (except viruses, bacteria, or other 

microorganisms on or in living man or other living animals) which the Administrator 

declares to be a pest under section 25(c)(1).” 

• FIFRA Section 25(c)(1): “The Administrator, after notice and opportunity for hearing, is 

authorized–(1) to declare a pest any form of plant or animal life ... which is injurious to 

health or the environment.” 

FIFRA also provides EPA the authority to register pesticides. FIFRA Section 2(u) defines a 

pesticide, in part, as “...any substance or mixture of substances intended for preventing, 

destroying, repelling, or mitigating any pest....” Section 3 describes the Agency’s authorities for 

registering pesticides and Section 18 describes the authorities for exempting any Federal or State 

agency from any provision of FIFRA. 

2.4.2 Statutory Authority for Registration Data Requirements 

Pesticide data requirements are issued under the authority of Sections 3, 4, 5, 10, 12 and 25 of 

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). The data generally required for a registration, 

reregistration/registration review, or tolerances/exemptions from the requirements of a tolerance 

are set forth in 40 CFR Parts 158 and 161. 

Under FIFRA, every pesticide product must be registered or exempted from registration by the 

EPA 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 determination 

generally entails a finding by the Agency that the risks of the use of a pesticide are outweighed 

by its benefits. The Agency must determine that this standard is met before granting a 

registration. 

Section 3 of FIFRA contains the requirements for registration. Specifically, FIFRA section 

3(c)(2) provides EPA broad authority, before and after registration, to require scientific 

testing and submission of the resulting data to the Agency by 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 section 3(c)(2)(B) to require a registrant 

to develop and submit additional data necessary to maintain a registration. 
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2.5 AFFECTED PERSONS

Persons that may be directly or indirectly affected by the proposed regulation fall into three 

primary categories: 

1. Pesticide producers 

Persons seeking to market products with prion related claims and/or with “actual or 

constructive knowledge” that their products are used with the intent of reducing infectivity of 

prions may be directly affected by the proposed rule. 40 CFR Part 167.20 states, in part, 

“Any establishment where a substance is produced must be registered with the Agency if the 

producer intends the substance to be used as an active ingredient of a pesticide, or has actual 

or constructive knowledge that the substance will be used by any person as an active 

ingredient of a pesticide.” 

2. Users of prion products 

Persons such as employees of commercial and government veterinary laboratories may be 

indirectly affected if changes to the regulatory environment (e.g., higher regulatory costs) 

encourage or discourage the development and/or marketing of prion products. Such changes 

could result in more or fewer products from which to choose, more expensive products, 

and/or restrictions in the way products are used. 

3. Researchers 

Persons who conduct scientific studies on and/or develop prion products (either for detection or 

reducing infectivity) may be indirectly affected by the proposed rule, even if they do not register 

prion products themselves. For example, persons who sell the patent or license the rights to the 

prion product or those that accept funding to investigate prion products may be indirectly 

affected by the proposed rule. 

Category #1 

Products currently used to reduce the infectivity of prions generally fall into the category of 

antimicrobial pesticides (e.g., disinfectants, sterilants, etc.). Antimicrobial pesticides are 

chemicals intended to be used to control microbiological contamination and deterioration in 

industrial and consumer products and applications, and in crop agriculture. Products intended to 

control prions on hard surfaces would fall within the class of antimicrobial pesticides. 

Antimicrobial pesticides are intended to “(i) disinfect, sanitize, reduce, or mitigate growth or 

development of microbiological organisms; or (ii) protect inanimate objects, industrial processes 

or systems, surfaces, water, or other chemical substances from contamination, fouling, or 

deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime” [FIFRA Sec. 2(mm)]. 

The potential prion product industry would also be likely to resemble the antimicrobial industry 

with regards to use patterns. 
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Antimicrobial product manufacturers may fall under a number of different NAICS2 codes, but 

the majority is primarily engaged in the formulation and preparation of agricultural and 

household pest control chemicals (except fertilizers). This function is primarily captured in 

NAICS code 325320 (Pesticide and Other Agricultural Chemical Manufacturing). A complete 

description of NAICS categories are in Appendix A. 

Category #2 

The size or nature of the current market for prion products is not fully understood. 

Commercial users of prion products would be industries or professions that come into contact 

with prion contaminated tissues, such as mammalian nerve tissue, and, therefore, want to clean 

surfaces to prevent infection to humans or other animals. Based on this criterion, the Agency 

originally speculated that end users of products intended to reduce the infectivity of prions may 

include: 

• veterinary laboratories 

• clinical (human pathology) laboratories 

• medical and dental surgeons 

• morticians 

• taxidermists 

• hunters 

• workers in meat processing plants. 

Initial outreach to fewer than ten representatives of these industries suggested that market 

demand for such products did exist but was somewhat ambiguous. Contacts were made to 

national organizations, where available, via telephone or e-mail asking about the industry’s use 

of chemical products to reduce infectivity of prions. One contact was made with a state level 

organization. Only a single attempt was made to contact a representative of each organization. 

If there was no response, no additional attempt was made to contact the organization or another 

organization in that industry. 

One contact at a veterinary laboratory referred to their guidelines which recommend that workers 

use chlorine bleach, sodium hydroxide or an aqueous acid phenolic solution to reduce the 

infectivity of prions on non-disposable items used in necropsy. Use of aqueous phenolic acid for 

prion control in the veterinary laboratory industry and other locations is also verified by the fact 

 

2 NAICS stands for North American Industrial Classification System. The numbering system is used by Federal 

statistical agencies to classify establishments including businesses, federal and state agencies, non-profit and 

political orgs, and others. 
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that there are several FIFRA Section 18s for this type of product issued to several states, United 

States Department of Agriculture (USDA) Animal Plant Health Inspection Service, and USDA 

Food Safety and Inspection Service, specifically for use in laboratories. However, Section 18 

use reports indicate that only about 100 gallons of the product have ever been used. 

Taxidermists and other types of game processors at one point communicated concerns to the 

Agency that they could be affected by a rule establishing prions as pests, if it requires them to 

use only registered pesticides. Many of these businesses currently use unregistered bleach and 

sodium hydroxide. The Agency notes that use of unregistered chemicals for reducing the 

infectivity of prions on inanimate surfaces by persons on their own premises is not prohibited by 

FIFRA and would not be impacted by the proposed rule, provided that they do not sell or 

distribute these chemicals for pesticidal purposes such as for reducing prions infectivity, or 

provide such services on other persons’ property. 

Meat processors expressed concern about an apparent disconnect between USDA’s and EPA’s 

approaches to cleaning and disinfection. USDA only requires normal sanitation practices for 

cleaning up after slaughter of animals (e.g., cleaning and disinfection with bleach), whereas the 

proposed rule would require registration of bleach and other materials intended for initial 

disinfection and also for inactivating prions. However, USDA guidance on cleaning and 

disinfection does recommend the use of EPA-registered products, and the Agency has always 

required registration of disinfectant products that claim to treat pests. The proposed rule would 

ensure that products for which prion claims are made are also required to be registered. 

Outreach to a hunting organization indicated that bleach was used to clean butchering work 

stations but that it was probably routine cleaning practice to prevent infection from other 

pathogens and not related to fear of prion infection. It was further suggested that people working 

with animal carcasses would not likely be inclined to use a product intended for reducing prion 

infectivity unless they perceived prions to be a threat. The contact for the hunting industry 

believed that hunters currently do not see prions as a threat. However, the contact also noted that 

this general lack of apprehension about prion infection could be due to the fact that CWD had 

not yet been discovered in the contact organizations’ state; it is possible that practices would 

change if that were to happen. 

Outreach to a hospital organization indicated that there would be some interest in a product that 

could reduce infectivity of prions on hard surfaces, especially if such infection reduction 

requirements were written into the hospital infection control guidelines. This practice is 

currently not the case. 

Category #3 

This category comprises researchers who may be indirectly affected by the proposed rule. Two 

types of institutions – colleges/universities engaged in research or other entities whose primary 

function is research – could be affected by a change in the demand for prion products. These 

institutions or entities would likely fall under NAICS Code 611310 (Colleges, Universities, and 

Professional Schools) and NAICS 541712 (R&D in the Physical, Engineering, and Life 

Sciences). 
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3 REGULATORY AND DATA REQUIREMENT OPTIONS AND BENEFITS

The Agency is considering two regulatory options through formal rulemaking: Option 1: to 

maintain the Agency’s current interpretation that prions are pests under FIFRA and codify it 

through an explicit reference to prions in 40 CFR §152.5, or Option 2: to reverse the September 

10, 2003 decision and determine that prions are not pests under FIFRA. Under the Agency’s 

current interpretation that prions are pests (Option 1), prion products are subject to the 

requirements of FIFRA including, but not limited to, Section 3 (registration) and Section 18 

(emergency exemption), as applicable. When applications are submitted for FIFRA Section 3 

registration or Section 18 emergency exemption, the Agency must decide which data are 

required to support the registration of a new active ingredient or a new use and whether the 

intended use is considered one of high exposure or low exposure for an antimicrobial pesticide. 

If the Agency changes its interpretation and determines that prions are not pests (Option 2), prion 

products will not be subject to the requirements of FIFRA. 

1. So long as prions are considered to be pests within the scope of FIFRA (Option 1), 

the Agency is able to use its regulatory framework to mitigate externalities, improve 

information about the efficacy of prion products, and alleviate regulatory 

uncertainty. However, these benefits come at a cost to the regulated community. 

2. If the Agency determines that prions are not pests (Option 2), prion products will not 

be regulated under FIFRA, and Section 3 registration and Section 18 emergency 

exemption will not be necessary for sale or distribution of prion products. If prions 

are determined not to be pests, it will not be necessary for the Agency to make any 

further decisions on this matter. Also, the Agency would not be able to reduce the 

uncertainty regarding the efficacy of products, but would alleviate regulatory 

uncertainty with no cost to the regulated community. 

This section outlines the two regulatory options, describing each of their benefits in terms of 

achieving the Agency’s goals of mitigating externalities, improving information about the 

efficacy of prion products, and alleviating regulatory uncertainty. This section also describes the 

benefits of each option. Table 3-1 summarizes this information. 
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Table 3-1. Summary of Option Components and Utility for Achieving Agency Goals 

Option 1: 

Codify Determination that 

Prions are Pests

Option 2: 

Determine that 

Prions are not Pests

ACTIONS TAKEN BY AGENCY UNDER DIFFERENT OPTIONS

Amend 40 CFR 152.5 X 

FIFRA Section 3 registration X 

Registration of chemicals X 

Use restrictions through 

labeling X 

General data collected (for 

risk assessments) X 

Product efficacy data 

collected X 

UTILITY OF OPTIONS FOR ACHIEVING AGENCY GOALS 

Mitigate health & 

environmental externalities

Data collected through FIFRA 

Sec. 3 registration and through 

registration review, as they may 

be needed, will contribute to 

risk assessments that will 

inform use instructions and 

safety precautions on product 

labels. 

No data are collected for risk 

assessments

Correct imperfect information 

that may lead to prion 

exposure

Product efficacy data collected 

for FIFRA Sec. 3 registration of 

a public health pesticide will 

verify whether a product meets 

a certain standard of 

performance deemed 

acceptable to claim that it can 

“reduce the infectivity of 

prions.”

No product efficacy data are 

collected; continued reliance on 

WHO recommendations

Alleviate regulatory 

uncertainty 

Regulatory uncertainty is 

alleviated.

Regulatory uncertainty is 

alleviated.

3.1 OPTION #1: DETERMINE PRIONS ARE PESTS 

The Agency has identified two regulatory options. In the first option, the Agency would follow 

up its September 2003 decision to declare prions a pest with formal rulemaking. If the Agency 

adds prions to the list of FIFRA pests through rulemaking, it would increase the likelihood that 

persons will recognize that prion products are subject to FIFRA and would definitively resolve 

any uncertainties about whether prion products are subject to FIFRA, thereby clarifying the 
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regulatory process. This includes any questions about the Agency’s authority to require data 

needed to support registrations and specify directions for proper use. This option would be most 

beneficial in helping to meet all three of the Agency’s goals discussed in Section 2.2. First, the 

Agency can require the data necessary for risk assessments. Based on those risk assessments, the 

Agency can establish proper labeling safety precautions and specify use directions that would 

help assure effective use patterns, appropriate use rate, and methods of application. This helps to 

meet the goal of reducing potential externalities that may be caused by higher concentrations 

and/or longer contact times associated with WHO’s recommendations for treatment of surfaces 

with bleach and sodium hydroxide. Though risk assessments and labeling instructions are not a 

panacea for all chemical externalities, the labeling of pesticides is the most efficient tool 

available to the Agency for guiding the behavior of end users. 

Second, since prions can pose risks to public health, the Agency can require the submission of 

product performance data to ensure a certain level of efficacy for prion products. This helps to 

correct imperfect information, providing accurate information about the efficacy of prion 

products. 

Finally, issuing a formal rule that clearly lays out the Agency’s position on this issue will 

stabilize expected returns on R&D investment and may even lead to more research in this area by 

companies that were previously unwilling to be active in the industry due to regulatory 

uncertainty. Even though the regulatory burden will be higher for registrants if FIFRA Section 3 

registration is required, it will be fully known. Unless the Agency issues a rule, researchers and 

producers of prion products may have difficulty estimating regulatory burden and potential 

return on investment. 

3.1.1 General Data Requirements 

Data submitted by registrants in support of FIFRA Section 3 registration for antimicrobial 

pesticides fall into nine data disciplines: Product Performance, Product Chemistry, Toxicology, 

Non-target Organisms, Non-target Plant Protection, Applicator Exposure, Post-Application 

Exposure, Environmental Fate and Residue Chemistry. All of these, with the exception of postapplication exposure data, would be necessary for conducting risk assessments of prion products. 

Post-application exposure data are not likely to be required because the use patterns do not 

involve residential areas and because the existing chemicals likely to be registered (e.g., sodium 

hydroxide, sodium hypochlorite, phenolics) have not demonstrated “potentially significant 

adverse effects” that would trigger such data requirements. 

Data requirements for registration are the primary source of costs under the status quo. 

However, they are also the primary source of benefits. Data requirements relevant to prion 

products would contribute to risk assessments that should help the Agency to accurately assess 

the magnitude of externalities to human health and the environment, and to determine whether or 

not a product should be registered. Data disciplines are listed in Table 3-2 along with a brief 

explanation of how they are used in risk assessment. 
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Table 3-2. Purpose of Data Requirements by Discipline 

Data Discipline Purpose / Contribution to Risk Assessments 

Product 

Chemistry 

Data on product composition are needed for risk assessments:

(i) To support the conclusions expressed in the statement of formula; and

(ii) To compare to the composition of materials used in required testing

Toxicology 

Data used to assess hazards to humans and domestic animals; includes a variety of 

acute, subchronic and chronic toxicity tests, and tests to assess mutagenicity and 

pesticide metabolism.

Nontarget 

Organisms 

Nontarget Plant 

Protection 

Data used to determine effects of pesticides on birds, mammals, fish, terrestrial 

and aquatic invertebrates and plants; includes short term acute, subacute, 

reproduction, simulated field and full field studies; provides data which determine 

the need for (and appropriate wording for) precautionary label statements to 

minimize the potential adverse effects to nontarget organisms.

Exposure 

Data used to evaluate exposures to persons in occupational and non-occupational 

settings, including agricultural, residential, commercial, institutional and 

recreational sites; includes oral, dermal and inhalation exposure data, postapplication residue data, post-application monitoring data, use information, and 

human activity information; these data are used to determine whether application 

or post-application risks are of concern, and, where appropriate, to develop postapplication restrictions such as reentry restrictions.

Post-Application 

Exposure 

Data used to assess the level of pesticide residues in air, soil or on surfaces that 

remain and may expose humans to some level of risk. Generally, antimicrobial 

products break down or dissipate such that there usually is no need for postapplication exposure data.

Environmental 

Fate 

Data used to: (1) Assess exposure of humans to pesticide residues remaining after 

application upon reentering treated areas , (2) assess the presence of widely 

distributed and persistent pesticides in the environment which may result in loss 

of usable land, surface water, groundwater and wildlife resources, and (3) assess 

the potential environmental exposure of other nontarget organisms, such as fish 

and wildlife, to pesticides; also used to estimate expected environmental 

concentrations of pesticides in endangered species habitats.

Residue 

Chemistry 

Data used to evaluate exposure of humans to pesticide residues in/on food or on 

food-contact surfaces; such data may be used to establish either tolerances or 

exemptions from the requirement of a tolerance under FFDCA and/or to evaluate 

dietary exposure. 

Product 

Performance 

Product performance data provide a mechanism to ensure that pesticide products 

will perform their intended function as claimed on the label. Product performance 

data are required to be submitted for all public health use products such as 

disinfectants used to control microorganisms infectious to man and rodenticides 

used to control vertebrates (such as rodents, birds, bats and skunks) that may 

directly or indirectly transmit diseases to humans. EPA evaluates these data to 

assure that the products meet EPA’s product performance criteria.

Source: 40 CFR 161 and proposed 158W 
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Many different tests fall into the disciplines outlined in Table 3-2. Which data are required from 

each discipline depends on the type of registration action and the use pattern. Basing data 

requirements on these two factors ensures that only the tests needed to conduct a proper risk 

assessment are collected by the Agency thereby minimizing the cost burden to the registrants. In 

addition, data requirements are waived where justified, and information available from publicly 

available literature may be accepted in place of EPA guideline studies, provided that the 

literature studies are valid and relevant. 

3.1.1.1 Data Requirements by Type of Registration Action 

In general, data requirements are imposed to support a potential registration action. They differ 

depending on the type of registration being sought. For example, data requirements for a new, 

unregistered active ingredient are different from the data required for a new use for a currently 

registered active ingredient. The types of registration actions that generally trigger significant 

data requirements are new active ingredient registrations and major new use registrations. Table 

3-3 describes these types of registrations. 

Table 3-3. Types of Registration Actions 

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 

Product 

An application for registration of a new product that adds a use pattern 

that is not currently registered for one or more registered active 

ingredient(s) contained in the product. The proposed use pattern is 

significantly different from any use pattern registered for an existing 

use. 

Major New Use 

Amendment 

An application for an amended registration of a product that adds a use 

pattern that is not currently registered for one or more active 

ingredient(s) contained in the product. 

For example, WHO and other sources of scientific literature on infection prevention recommend 

the use of sodium hypochlorite (bleach) to reduce the infectivity of prions on inanimate surfaces. 

Since sodium hypochlorite is already registered for other uses, any registrant wishing to make a 

label claim that bleach could reduce the infectivity of prions would be required to register a 

major new use but not a new active ingredient. 
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3.1.1.2 Data Requirements by Exposure Category 

Within each of the data requirement categories listed above, a variety of individual tests may be 

necessary depending on the product’s exposure category – high, medium, or low. The exposure 

category depends on how and where the product will be used. Table 3-5 describes each exposure 

category and lists examples of use sites that would fall into each category. 

Table 3-4. Exposure Categories and Examples 

Exposure category Description 

High Exposure 

Agricultural premises and equipment; Household sites; Aquatic 

sites (swimming pools, human drinking water); Commercial, 

industrial, and institutional sites (food and non-food contact 

surfaces, hospitals and others health care facilities, metalworking 

fluids, laundry and dry cleaning) 

Medium Exposure Aquatic sites (industrial processing water systems, air washers and cooling 

towers) 

Low Exposure 

Aquatic sites (lakes, ponds, rivers, sewage systems, secondary oil 

recovery systems); Commercial, industrial, and institutional sites 

(adhesives, paperboards, coatings, paints) 

3.1.2 Product Performance Data Requirements 

Efficacy data have been and would be required for prion products because pesticide products 

claiming to control public health pests must achieve a specified level of efficacy associated with 

the claims made on the product label. Prions are designated as a public health pest in PR Notice 

2002-1. Test guidelines developed by the Agency, with input from the scientific community, are 

used as a reference for determining whether the product meets an acceptable level of 

performance according to the best available testing methods. 

The Agency currently recommends a carrier-based, incubation time interval assay if the 

intended use of a product is for treating environmental surfaces and a suspension-based, 

incubation time interval assay if the intended use of a product is for treating liquids. 

3.1.2.1 Performance Standards and Labeling Claims 

Product performance data are used to address the problem of imperfect information by requiring 

all products to meet a certain performance standard and by communicating that standard to the 

end user through labeling. 

The draft efficacy guidance document recommends a target criterion for success of a prion 

product as no less than six (6) logs of reduction of infectivity in the treated versus untreated 

(control) groups. 
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The draft efficacy guidance document recommends a carefully worded labeling claim statement: 

“Has been demonstrated to reduce infectivity of prions (TSE agents) by (X) logs (insert log 

reduction number supported by data) based on a bioassay of the (insert prion type) in (insert type 

of organism in which the prions were tested).” For example, “Has been demonstrated to reduce 

infectivity of prions (TSE agents) by six (6) logs based on a bioassay of the bovine BSE strain in 

transgenic mice.” 

The Agency sees two important issues pertaining to the label claim. First, the Agency’s draft 

efficacy test guidance indicates that claims that would normally be stated on labels with respect 

to other microorganisms (e.g., “destroy,” “mitigate,” “eliminate,” “control”) are not supported by 

currently available test methods for prions. Because currently available test methods can only 

measure a reduction in infectivity of prions (that is, the absolute quantity of elimination or 

destruction of prions cannot be measured), the Agency believes that “reduce infectivity” would 

be the only appropriate claim for prion products. 

Second, the Agency has considered the issue of whether 1) to require an infectivity assay for 

each separate type of prion (e.g., scrapie, BSE, vCJD, etc.) and limiting labeling claims to just 

the prion types tested, or 2) to require testing on only one type of prion and permit a general 

claim of prion infectivity reduction. On the one hand, current scientific knowledge cannot speak 

to whether one prion type is more resistant to infectivity reduction. This fact would tend to 

support the requirement of a separate infectivity assay for each prion type and permission for 

label claims only for the specific prion types tested. On the other hand, requiring testing on each 

type of prion would be economically burdensome and conflicts with the Agency’s previous 

decisions to issue quarantine exemptions for use of an antimicrobial product (Environ LpH) 

against any type of prion based solely on data for hamster-adapted 263K scrapie. In its draft 

guidance, the Agency specifies that the label claim informs the user of the exact prion type tested 

(i.e., scrapie, BSE) as well as the test system used but does not specify that use for any prion 

type. This approach informs the user as to which prion type the product has been tested against 

and shown be effective against, but does not prohibit the user from applying a product against 

other types of prions, if the user chooses to do so. 

3.2 OPTION #2: DETERMINE THAT PRIONS ARE NOT PESTS

As Option #2, the Agency could change its interpretation and decide that prions are not a pest. 

In this case, FIFRA Section 3 registration or Section 18 exemption would no longer be required, 

and there would be no further decisions to make regarding data requirements, labeling, 

marketing claims or other matters that the Agency normally regulates under FIFRA. 

With respect to the Agency’s goals, this option would fulfill only one of the three – it would 

reduce regulatory uncertainty. If prions are not declared to be a pest, the Agency will not be able 

to regulate prion products under FIFRA, which means that they would not be required to obtain a 

FIFRA Section 3 registration or FIFRA Section 18 emergency exemption. The Agency would 

not be able to collect the data needed to conduct risk assessments, so this approach would not 

help to reduce externalities. The Agency also would not be able to collect product performance 

data so there would still be imperfect information regarding the efficacy of prion products which 

could lead to unforeseen prion exposure. 
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4 ECONOMIC IMPACTS ON PESTICIDE REGISTRANTS DUE TO CHANGES IN 

DATA REQUIREMENTS

This section describes the methods used to assess the incremental cost of compliance with the 

proposed rule. The costs of the baseline and the proposed rule are compared. To calculate the 

incremental costs, comparisons were made for each type of registration action. The three types 

of registration actions which are possible under the proposed rule are the registration of a new 

active ingredient, a new use product, or a new use amendment registration (see Table 4-1). 

The data necessary to estimate the costs of the proposed rule are: 

1. The unit test costs of each data requirement. 

2. The frequency (percent of registration actions for which the test is required) of the data 

requirements per registration action. 

With these data, costs are estimated in the following ways: 

• Estimate the costs per registration action. 

• Estimate the industry-wide impacts. 

• Estimate the impact per small firm. 

To estimate the costs of the proposed rule, the unit test costs are multiplied by the amount of the 

data requirements at the baseline and the amount under the proposed rule; the incremental test 

costs per registration action are the difference in the test costs per registration action between the 

baseline and the proposed rule. The incremental costs per registration action are multiplied by 

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

and the number of registration actions by each firm to get the incremental impact per firm. 

4.1 THE BASELINE

The baseline scenario in an economic analysis can be treated as equivalent to current practice or 

equivalent to an earlier set of conditions before the Agency took a certain action. Although the 

Agency has not yet issued a formal rulemaking, EPA has regulated prion products as pesticides 

since its 2003 decision that prions should be considered pests under FIFRA. Since that time, and 

as an interim measure while no applications for registration have been received for a prion 

product, the Agency has been granting Section 18 exemptions for the use of one product to 

reduce the infectivity of prions. However, EPA has chosen to compare the economic impact of 

the proposed rule to what it would be if prions were not considered pests and prion products 

were not subject to FIFRA. Accordingly, the baseline in this analysis is pre-2003, and the 

economic impact of the rule stems primarily from the cost of Section 3 registration of prion 

products under the proposed rule compared to the cost of producing prion products without 

registering them under FIFRA. This baseline is chosen for two reasons: 

1) To enhance the clarity of the analysis 
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Inasmuch as applicants for registration have already been generating data and EPA has 

already been reviewing data in response to emergency exemption requests, this analysis will 

assume a pre-2003 baseline – a time when there were no data requirements under FIFRA for 

the use of products to reduce the infectivity of prions. 

2) To account for the full potential range of impacts of the decision to consider prions to be 

pests and thereby regulate prion products 

Using the pre-2003 conditions as the baseline will allow the analysis to account for the full 

range of potential impacts of the rule. 

4.2 DESCRIPTION OF DATA AND SOURCES

The EPA regulation “Data Requirements for Registration,” which was issued in 1984 as 40 CFR 

Part 158, specifies the types of data and information generally required to make sound regulatory 

judgments under FIFRA for each registration with respect to a pesticide product’s potential for 

causing unreasonable adverse effects. On October 26, 2007, the Agency promulgated final rules 

establishing updated data requirements for conventional, biochemical, and microbial pesticides. 

These final rules were effective on December 24, 2007 and comprise the current Part 158. As 

part of those actions, on October 24, 2007, the Agency preserved the original Part 158 data 

requirements to provide continued regulatory coverage for antimicrobial pesticides until the 

Agency could promulgate a final regulation. To accomplish this, the Agency transferred intact 

the original 1984 data requirements into a new Part 161, entitled “Data Requirements for 

Antimicrobial Pesticides,” which contains the current data requirements for antimicrobial 

pesticide chemicals. 

On October 8, 2008, the Agency issued a proposed rule that would update and codify in Part 

158W the existing data requirements for antimicrobial pesticides found in Part 161. Once 

subpart W of Part 158 is promulgated as a final rule and becomes effective, Part 161 will be 

obsolete and will be removed. Until that occurs, registrants are to consult Appendix A of Part 

161 (the Use Pattern Index) and the data requirements table as they seek to determine what data 

may be required for any particular use pattern. Although the final 158W has not been 

promulgated and is not in effect, the Agency believes that the proposed Part 158W contains 

useful information that registrants may wish to consult in trying to determine what data may be 

required for particular use patterns of antimicrobial pesticides. 

4.2.1 Data Requirements / Test Costs 

To register a pesticide product, registrants must submit an application for registration that 

includes, among other things, test results or citations for test results (submitted by other 

registrants or available in published literature) to satisfy data requirements. The costs of 

complying with the specific data requirements vary depending on the type of registration and use 

pattern. 
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Section 3.1.1 explained that the Agency would expect to require data from eight of the nine 

disciplines for the registration of prion products. Those disciplines are: Product Chemistry, 

Toxicology, Nontarget Organisms, Nontarget Plant Protection, Applicator Exposure, 

Environmental Fate, Residue Chemistry, and Product Performance. In the case of currently 

registered active ingredients, the Agency would have already collected data for most of the tests 

within these disciplines with the exception of the Product Performance test. On the other hand, 

in the case of a new active ingredient that would be registered just to treat prions, the data 

requirements would be much higher. 

In order to estimate the cost of each study, the Agency surveyed fewer than ten testing 

laboratories to obtain their estimates of how much it would cost for them to conduct specific 

studies that would be required under the proposed rule. Laboratories made these estimates using 

study design options that were provided to them. The study designs were constructed using 

existing test protocols, and adhered to Office of Pesticide Prevention and Toxic Substances 

guidelines. High cost and low cost estimates were requested for each study protocol from the 

laboratories in order to provide upper- and lower-bounds for the study costs. Note that these 

study costs are strictly laboratory estimates, and do not reflect the actual costs that registrants 

incurred or will incur when registering a prion product. 

4.2.2 Frequency of Data Requirements 

The probabilities that certain data will be required under the proposed rule in accordance with 

Option 1 are based on statistics from EPA OPP registration data (how often certain data are 

commonly required for a particular registration action) and on the professional judgment of 

experienced EPA staff. 

The estimated probabilities of data requirements relating to the proposed prions rule are based on 

the probabilities from the proposed Part 158W Antimicrobial Data Requirements Rulemaking 

plus the probability of prion-specific product performance data being required for a prion 

product. Appendix B shows the percentage of actions that tests are likely to be required (should 

the proposed rule be finalized) for new active ingredients and major new use registrations and 

amendments. 

4.2.2.1 Cost Variation Based on Type of Registration Action 

In order to estimate the potential costs of the proposed rule by registration action, the Agency has 

identified three possible types of registration actions that could occur – applications for 

registration of: (1) a new active ingredient (AI), (2) a major new use product, or (3) a major new 

use amendment. Costs estimates for these registration actions types are discusses in Section 

4.3.1 and listed in Table 4-2. There are more data requirements to register a new active 

ingredient than to register a new product with an existing AI or a new use of an existing AI, 

which makes the costs different. 
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4.2.2.2 Cost Variation Based on Exposure Category 

One factor that determines whether an individual test will be required for a product is the 

exposure category associated with the “end use.” End uses fall into one of three exposure 

categories: high exposure, medium exposure, and low exposure. 

To date, all FIFRA Section 18s for prion products have been for use on hard, non-porous 

surfaces, primarily laboratory surfaces and equipment, which are classified as high-exposure. 

Another potential end use, treatment of meat-processing equipment, is also classified as high 

exposure. Potential low exposure uses of prion products would include wastewater treatments 

(See Table 3-4). 

4.3 COST ESTIMATION 

4.3.1 Incremental Costs per Registration Action 

To estimate the cost of a registration action, the costs of data requirements under the proposed 

rule are multiplied by the probabilities (percentage of registration actions each test is likely to be 

required) and summed for all tests for the type of registration action and the use pattern (i.e., 

exposure category). 

Methodology 

The expected cost of data to register a prion product of a given type, E[data costi], is the sum, 

over all data requirements, of the cost of meeting a requirement multiplied by the probability that 

the test will be required. The type of prion product refers to the registration type (i.e., new AI, 

new use) and the use pattern for which it will be registered. The expected cost of data is 

expressed mathematically in Equation 4.1 

E data cost c prob t i i t

[ (4.1) i] = ∑ t ⋅ ( | ) ∀

where 

i designates the type of prion product (e.g, new AI or new use of existing AI) 

t designates tests or informational requirements 

ct, is the average cost of test t

prob(t|i) is the probability that a requirement is invoked, conditional on the type of 

prion product 

The estimation of the proposed costs of the data requirements proceeds on the assumption that 

new data are generated according to EPA testing guidelines to meet registration requirements. 

Applicants, however, can sometimes meet the requirements by submitting substantially 

equivalent information, which could lower the costs. For example, applicants may cite existing 
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data that were previously generated and submitted by another registrant for a similar product or 

data found in the public literature provided it meets the testing guidelines. If previously 

generated information is proprietary as in the case where another registrant owns the data, an 

applicant may have to compensate the owner of the data, but that may still be less costly than 

generating new information. If the information belongs to the applicant or is publicly available, 

however, the costs may essentially be zero. However, some data are product specific (such as 

efficacy data); therefore, some data would need to be generated for every prion product. 

Expected registration costs at the baseline and under the proposed rule vary by the type of 

registration action and the exposure category. Different combinations of these categories make a 

total of eight possible prion-product registration scenarios and eight “baseline to proposed rule” 

comparisons. Table 4-1 presents descriptions of the eight possible registration scenarios. The 

incremental costs between the baseline and the proposed rule for the eight scenarios are 

presented in Table 4-2. 
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Table 4-1. Possible Registration Scenarios 

New Active 

Ingredient 

(AI) 

An unregistered AI with antimicrobial properties which is intended to reduce 

prion infectivity for a high exposure use (e.g., food or hospital use). Regulation 

of prion products under FIFRA requires the producer of such a product to apply 

for a new active ingredient registration with data requirements similar to those 

that would be required to register a new sterilant or disinfectant AI. 

New Use 

Product 

A currently registered AI with antimicrobial properties which is intended to 

reduce prion infectivity for a high exposure use (e.g., indirect food use). This 

scenario would apply to a case where an antimicrobial product with a currently 

registered pesticide is to be used for prions for high exposure uses along with 

other non-prion uses. Regulation of prion products under FIFRA requires the 

producer of such a product to apply for a major new use registration with data 

requirements similar to those that would be required to register a major new use 

for a currently registered sterilant or disinfectant. 

High Exposure 

New Use 

Amendment 

A currently registered AI with antimicrobial properties which is intended to 

reduce prion infectivity for a high exposure use (e.g., indirect food use). 

Regulation of prion products under FIFRA requires the producer of such a 

product to apply for a major new amendment; however, the only data requirement 

would be product-specific efficacy data. 

New AI 

An unregistered AI with antimicrobial properties which is intended to reduce 

prion infectivity in a wastewater or another low exposure use (e.g., wastewater). 

Regulation of prion products under FIFRA requires the producer of such a 

product to apply for a new active ingredient registration but with substantially 

fewer data requirements similar to those that would be required to register a new 

sterilant or disinfectant AI. 

New Use 

Product 

A currently registered AI with antimicrobial properties which is intended to 

reduce prion infectivity for a low exposure use (e.g., wastewater). This scenario 

would apply to a case where an antimicrobial product with a currently registered 

AI is being used for prions for low exposure uses along with other non-prion low 

exposure uses. Regulation of prion products under FIFRA requires the producer 

of such a product to apply for a major new use registration with substantially 

fewer data requirements than for a currently registered high exposure use of a 

sterilant or disinfectant. 

Low Exposure 

New Use 

Amendment 

A currently registered AI with antimicrobial properties which is intended to 

reduce prion infectivity in a low exposure use (e.g., wastewater). Regulation of 

prion products under FIFRA requires the producer of such a product to apply for 

a major new amendment; however, the only data requirement would be productspecific efficacy data. 
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Table 4-2 presents the expected costs of registration at the baseline, expected costs of 

registration under the proposed rule, and the incremental costs of the proposed rule based on 

the methods for cost calculation described in Section 4.3.1. It is important to note that the 

costs for major new use product registrations represent upper bounds. It is possible and even 

likely that some of the generic data requirements could be satisfied by existing data and 

would not need to be regenerated by the registrant. For example, if a registrant wanted to 

pursue a registration for a major new use product to reduce the infectivity of prions, it would 

be required to meet the data requirements listed in the appropriate column from the tables in 

Appendix B. However, since the active ingredient of the product would already be 

registered, some of the data previously submitted by the registrant for an existing product 

may be sufficient to conduct the risk assessments necessary to approve the registration of the 

new use. It is not possible to say how much lower the costs might actually be for the 

registrant in such a situation since it would differ across products and active ingredients. The 

requirement of product-specific efficacy data (and the associated cost) would, however, 

remain constant. 

Table 4-2. Incremental Cost Per Prion Product Registration Action ($000s) 

NEW ACTIVE 

INGREDIENT

MAJOR NEW USE 

PRODUCT

MAJOR NEW USE 

AMENDMENT

High 

Exposure

Low 

Exposure

High 

Exposure

Low 

Exposure

High 

Exposure

Low 

Exposure

Baseline (BL) $ 0 $ 0 $ 0 $ 0 $ 0 $ 0 

Generic Data 

Required under 

Proposed Rule (PR)

$ 4,286 $ 1,227 $ 1,920 $ 744 $ 0 $ 0 

Efficacy Data 

Required Under 

Proposed Rule (PR)

$ 431 $ 424 $ 431 $ 424 $ 431 $ 417 

Total Incremental 

Costs (PR – BL) $ 4,716 $ 1,650 $ 2,350 $ 1,168 $ 431 $ 417 

Note: Costs may not add due to rounding. 

4.3.2 Industry-Wide Impacts 

For previous data requirements, the Agency has estimated the total cost of the proposed rule by 

multiplying the incremental cost of each type of registration action by the number of actions 

expected per year. The estimate of registration actions per year is sometimes extended over a 

time horizon, typically ten years, to capture the total impact of the rule on industry. However, 

given that the market for prion products is not well understood and will likely be impacted by 

changes in scientific knowledge and/or outbreaks that cause market scares, it is not appropriate 

to speculate about the number of registration actions in the future. 
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4.3.2.1 Methodology 

The expected annual cost of the rule to industry is the expected per-product incremental cost 

times the expected number of products registered per year. 

 ] [ ] [ ] [ , i

i

t i t E Industry Cost = ∑E N ⋅ E incremental cost (4.2) 

where, 

Ni,t is the number of prion products of type i registered in year t and 

E[incremental costi] is the difference between data costs under current practices and under 

the proposed rule. 

The net present value of the cost stream can then be calculated as 

∑ + = t

t t

r

E Industry Cost NPV Industry Cost 1

[ ] ( ) (4.3) 

where, 

r is a discount rate.

The industry-wide impacts are estimated by: 

1. Multiplying the incremental costs of registration actions of each type and use group by 

the expected number of registration actions of each type and use group per year for the 

industry 

2. Summing these costs for all registration action types and use groups 

4.3.2.2 Expected Number of Registrations by Type and Exposure Category 

Overall, it is estimated that there would be approximately three registrations for prion products in 

the first year after the rule takes effect. It is important to note that this number is highly 

speculative and may be an overestimate. Based on information from Section 18 exemptions, 

recommendations in the scientific literature, and knowledge of the market for prion products, the 

Agency assumes that there may be three applications for major new use product registrations in 

high exposure end uses. 

Section 18 exemptions have been issued to eight states for an aqueous phenolic product to treat 

prions on hard, non-porous surfaces in government, commercial, and institutional laboratories. 

There are also two common chemicals recommended by the WHO and other scientific literature 

for reducing the infectivity of prions, namely sodium hypochlorite and sodium hydroxide. 
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The Agency predicts that the company which produces the aqueous phenolic product currently 

being used under the Section 18 emergency exemptions issued to several states will apply for a 

registration; its interest in doing so is inferred from its willingness to support the Section 18 

exemption for its product. This product is an antimicrobial pesticide already registered for other 

uses, so it would incur only the costs of data requirements for a major new use.3 Furthermore, it 

seems possible that one or two producers of sodium hypochlorite and/or sodium hydroxide 

would deem it worthwhile to submit efficacy data and registration fees to market these chemicals 

for reducing prion infectivity. These types of registrations would also be classified as major new 

uses since they are already registered as active ingredients. 

Once one producer of an active ingredient has submitted data for a new active ingredient, a new 

use product, or a new use amendment of one of these products, and EPA has registered that 

product, any subsequent “me-too” registrant (i.e., a registrant that produces a product which has 

the same active ingredients and uses as a currently registered product) may be able to cite the 

initial registrant’s generic data and submit product-specific efficacy data for a major new use 

amendment. Whether any firms choose to pursue a registration for a major new use amendment 

after the initial registrations would depend on market conditions. It is difficult to speculate much 

beyond what would happen after registrations that may occur in the first year since the market 

for prion products is very small at this time, but unforeseen events could change the market. 

Sodium hydroxide and sodium hypochlorite are used in numerous settings other than as prion 

products, including water treatment, household sanitation, and industrial processes. Sodium 

hypochlorite, for example, is used to treat 85 to 90% of recreational water, and both sodium 

hypochlorite and sodium hydroxide are commodity chemicals. Based on the scale of the sodium 

hydroxide and sodium hypochlorite markets, the Agency does not believe that prion products are 

an important market segment for sodium hydroxide or sodium hypochlorite producing firms and 

does not anticipate many applications for product registrations beyond the first year the proposed 

rule takes effect. 

The total industry costs are highly sensitive to the number of registration actions. As mentioned 

earlier, this analysis conjectures that there may be a total of three registrations in Year 1. There 

might be more or less, but the Agency did not see any reason to think that there would be more 

than this in the first year. 

The costs of data requirements for a major new use product registration for a high exposure use 

are approximately $2.35 million (See Table 4-2). Accordingly, the total cost to industry for the 

hypothetical scenario three new major new use products in the first year would be approximately 

$7.05 million (See Table 4-3). If all three registrations were for low exposure uses, the cost per 

registration would be $1.17 million for a total cost to industry of $3.51 million. However, based 

on current Section 18 emergency exemptions for laboratory surfaces, the Agency believes that 

registrations for prion product would most likely fall into the high exposure category. 

 

3 Prions would be treated as a “new use” of an existing chemical because the use concentration and contact time 

required to reduce the infectivity of prions are much greater than those currently reflected on the label. EPA would 

require additional data to conduct a risk assessment on the higher use concentration and contact time to determine 

whether this new use would cause unreasonable adverse effects. 
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Table 4-3. Total Industry Cost in First Year After Rule Takes Effect ($000s)* 

NEW ACTIVE 

INGREDIENT

MAJOR NEW USE 

PRODUCT

MAJOR NEW USE 

AMENDMENT

High 

Exposure

Low 

Exposure

High 

Exposure

Low 

Exposure

High 

Exposure

Low 

Exposure

Generic Data 

Required under 

Proposed Rule 

$ 4,286 $ 1,227 $ 1,920 $ 744 $ 0 $ 0 

Efficacy Data 

Required Under 

Proposed Rule 

$ 431 $ 424 $ 431 $ 424 $ 431 $ 417 

Total Possible 

Actions 0 0 3 0 0 0 

Total Industry 

Costs $ 0 $ 0 $ 7,053 $ 0 $ 0 $ 0 
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5 SMALL BUSINESS ANALYSIS

The Regulatory Flexibility Act (RFA) requires federal agencies to consider the impacts of 

regulations on small business and to design, to the extent possible, regulations to minimize those 

impacts. The purpose of this section is to determine whether the proposed rule is likely to have a 

significant impact on a substantial number of small entities. 

5.1 METHODOLOGY

To evaluate the impacts of the proposed rule on small firms, the Agency did the following: 

• Created a profile of the relevant industry. 

• Gathered financial information on the small firms. 

• Estimated the number of small firms that may be impacted annually by the proposed rule. 

• Compared the costs of the rule to the revenues of small firms. 

5.2 INDUSTRY PROFILE

Products used to reduce the infectivity of prions are typically classified as antimicrobial 

pesticides. Antimicrobial pesticides are chemicals that are used to control microbiological 

contamination and deterioration in industrial and consumer products and applications. Also 

referred to as ”specialty biocides,”’ antimicrobial agents work to “disinfect, sanitize, reduce, or 

mitigate growth or development of microbial organisms” and are useful to “protect inanimate 

objects, industrial processes or systems, surfaces, water, or other chemical substances from 

contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or 

slime” (FIFRA Sec 2(mm)). 

5.2.1 Number of Firms in the Industry 

The Agency determined the size of the antimicrobial pesticide industry using information from 

the Office of Pesticide Programs Information Network (OPPIN), a database containing 

information on pesticide registrations. The exercise identified 859 companies having one or 

more FIFRA Section 3 or FIFRA Section 24(c) antimicrobial pesticide registrations of which it 

was estimated that 748 were unique parent firms (i.e., not a subsidiary of another firm). 

Of the 748 firms that comprise the antimicrobial pesticide industry, the Agency believes that 

only a very small portion of the firms are likely to be impacted by the proposed rule. In Section 

4, the Agency estimates that three prion products may apply for registration of prion products in 

the first year that the proposed rule takes effect. This includes one product that currently lists 

prions as a target pest under FIFRA Section 18s, one sodium hydroxide based product, and one 

sodium hypochlorite based product. In addition, the Agency believes that there is a possibility 

that additional registrants of sodium hydroxide based products and sodium hypochlorite based 

products will pursue me-too registrations. Therefore, the portion of the antimicrobial industry 

potentially impacted by the proposed rule is comprised of sodium hydroxide and sodium 
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hypochlorite registrants, as well as the potential registrants of Environ LpH®. In total, there are 

209 firms in the OPPIN database that produce one of these chemicals. 

5.2.2 Characterization of Firms Identified as Potential Prion Product Registrants 

Table 5-1 below lists firms that the Agency identified as potentially being impacted by the 

proposed rule by North American Industry Classification System (NAICS). The identified firms 

span a broad range of NAICS code classifications. The most common classification is 

“Chemical Manufacturing.” Out of the 209 firms from the OPPIN database, the Dun & 

Bradstreet (D&B) Market Spectrum Database (2009)4

, (which includes NAICS code, was 

available for 177 firms; 11 firms were listed as unclassified establishments and 22 firms were not 

listed in the D&B database. 

Table 5-1. Potential Prion Product Registrants Classified by NAICS Code 

NAICS Code (3-digit) NAICS Description Number of 

Firms

211 Oil and Gas Extraction 1

213 Support Activities for Mining 1

238 Specialty Trade Contractors 3

313 Textile Mills 1

314 Textile Product Mills 1

322 Paper Manufacturing 2

324 Petroleum and Coal Products Manufacturing 2

325 Chemical Manufacturing 68

331 Primary Metal Manufacturing 1

333 Machinery Manufacturing 3

339 Miscellaneous Manufacturing 3

423 Merchant Wholesalers, Durable Goods 9

424 Merchant Wholesalers, Nondurable Goods 51

453 Miscellaneous Store Retailers 7

488 Support Activities for Transportation 2

522 Credit Intermediation and Related Activities 1

525 Funds, Trusts, and Other Financial Vehicles 1

533 Lessors of Nonfinancial Intangible Assets 

(except Copyrighted Works) 2

541 Professional, Scientific, and Technical Services 4

551 Management of Companies and Enterprises 3

561 Administrative and Support Services 10

812 Personal and Laundry Services 1

0 Unclassified Establishments 11

0 Unlisted Establishments(no data available) 21

TOTAL 209

 

4 The D&B database 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). 
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Sources: Calculated from 2009 Dun & Bradstreet data and the OPPIN database. 

5.2.2.1 Parent Firm Employment and Industry Financial Performance 

According to SBA small business size standards (SBA, 2008), what is classified as a small 

business varies according to revenues and number of employees across and within NAICS 

categories. A small business is defined by revenues for some categories and by number of 

employees for others. For example, within NAICS code 325, a small business is defined as less 

than 500 or less than 1,000 employees. Within NAICS code 561, a small business is defined as 

less than $3.5 million in revenues or less than $35.5 million. Firms operating in the pesticide and 

other agricultural chemical manufacturing industry are considered small businesses when they 

have less than 500 employees. Many of the firms identified as potential prion product registrants 

operate primarily in other industries, but because the proposed rule will affect only the 

registration of pesticide products, all firms with less than 500 employees are considered small. 

For the 177 firms for which employment data was available in D&B, employment and revenue 

data at the parent firm level were obtained from the D&B database. Table 5-2 summarizes 

employment and annual revenue data for parent firms. As shown in the table, 140 firms (79%) 

have less than 500 employees while firms with more than 1,500 employees constituted the 

majority of the remaining firms (18% of 177). Total parent company sales of potential prion 

product registrants is about $535 billion making average sales per firm approximately $3 billion 

for each firm. Firms with more than 1,500 employees accounted for more than 99% of total 

sales with average per-firm sales of over $17 billion. Firms with less than 500 employees 

accounted for less than 1% of total sales at about $22 million per firm. 

Table 5-2. Bleach (NaOCl) and Lye (NaOH) Registrants, Number of Firms and Sales 

Firm Size Number of 

Firms

Total Sales 

of Firms 

($ millions)

Per Firm 

Average Sales 

($ millions)

0-99 109 $931 $9

100-249 24 $1,561 $65

250-499 7 $586 $84

<500 140 $3,078 $22 

500-749 4 $985 $246

1000-1499 2 $548 $274

>500 37 $532,196 $14,384 

>1500 31 $530,663 $17,118

Total: 177 $535,274 $3,024 

Source: Calculated from 2009 Dun & Bradstreet data and the OPPIN database. 
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5.3 INCREMENTAL IMPACT PER SMALL FIRM

Of the three major new use product registration applications that the Agency expects may be 

received in the first year that the proposed rule is in effect, one of the products is held by a large 

company (Environ LpH® registered by Steris Corporation). 

Using the employment criterion, 79% of the three remaining potential registrants of prion 

products are considered small firms with fewer than 500 employees. Based on this proportion, at 

least one or both of the other two major new use product registration applications that the 

Agency anticipates it may receive in the first year (a sodium hydroxide or sodium hypochlorite 

based prion product) could be submitted by a small firm. According to Table 5-2, the average 

annual revenue of a small firm in this industry is approximately $22 million. If these firms 

registered major new use products for high exposure uses, the most likely registration scenario, 

the cost would be $2.35 million (Table 4-2), just under 11% of annual revenues. If they 

registered a major new use product for a low exposure use, the cost would be $1.17 million, 

about 5.3% of average annual revenues. However, the Agency believes its estimate of the cost to 

register a high exposure major new use to be an upper bound. Firms registering major new uses 

of products to reduce the infectivity of prions should be able to fill many data requirements by 

citing existing data. 

If a small firm sought to register a new active ingredient to reduce the infectivity of prions, the 

cost of registration would be $4.72 million, which would be 21.5% of average annual revenues. 

This would only be the case if a small company were marketing an existing product with 

antimicrobial properties to reduce the infectivity of prions. However, the Agency knows of no 

products that would meet these criteria and, therefore, does not consider this a potential scenario. 

In many cases, after an original new use was registered, a subsequent “me-too” registrant may be 

able to cite the initial registrant’s generic data and submit product-specific efficacy data for the 

registration of a major new use amendment at a cost ranging from $417 to $431 thousand, 

depending on whether the use was low or high exposure, respectively. This cost would represent 

approximately 2% of a small firm’s average annual revenues. 

Firms may even be able to further reduce the cost of generic and/or efficacy data by 

compensating another registrant to cite its data. The Agency is not involved in agreements on 

data compensation process and does not have data indicating the required level of compensation. 

5.4 CONCLUSIONS

The Agency concludes that the proposed rule will not have a significant impact on a substantial 

number of small entities. As discussed in Section 4, only three firms are expected to apply for 

registrations of prion products and one of these firms is already known to be a large firm. Given 

that 79% of the firms in the antimicrobial industry are small firms, it is possible that any or all of 

the remaining two possible registrants could be small entities. The incremental costs of the 

proposed rule could represent from 2-11% of the average annual revenues of a small firm. In 

general, the Agency does not believe that prion products are an important market segment for 

sodium hydroxide or sodium hypochlorite producing firms and does not anticipate a large 
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number of product registrations beyond the first year the proposed rule takes effect. If small 

entities apply to register products for prion control, they would likely pursue a registration where 

they could likely cite a substantial amount of data and not incur 100% of the initial costs of 

testing. 
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6 ICR ANALYSIS

In addition to the cost associated with changes to registration requirements and corresponding 

data requirements, both the registrant and the Agency are subject to paperwork burden. The 

Paperwork Reduction Act requires federal agencies to estimate the burden of complying with 

regulations that require firms or individuals to file reports, maintain records, or otherwise incur a 

paperwork burden. Agencies must also estimate their resources expended in these activities. The 

Agency’s estimates are summarized in a document called an Information Collection Request 

(ICR), which is reviewed and approved by the President’s Office of Management and Budget. 

There are two ICRs relevant to the registration of antimicrobial pesticides making prion related 

claims: the existing Section 3 registration ICR (Application for New and Amended Pesticide 

Registration, OMB Control Number 2070-0060) and the tolerance petition ICR (Tolerance 

Petitions for Pesticides on Food/ Feed Crops and New Inert Ingredients, OMB Control Number 

2070-0024). 

The Agency anticipates that existing total burden estimates in the ICR’s for Section 3 registration 

and tolerance petitions may require amending to account for changes arising from this rule over 

the duration of the ICR. These changes will account for the increased number of registration 

activities associated with the proposed rulemaking. The Agency does not believe that 

amendments of respondent burden hour estimates for single registration and tolerance petition 

actions are warranted because the process and activities involved in preparing and submitting a 

registration or tolerance petition are not impacted by the proposed rule. 

In summary, since the requirements being proposed here will not impact the average registration 

or tolerance petition burden estimate, when the rule becomes final, the Agency will only 

recalculate the projected number of respondents participating under those programs and adjust 

the burden due to the increase in program participation prompted by the final rule. In other 

words, the Agency expects three additional registration/tolerance actions to be submitted in the 

first year that will be subject to this rule. Given data limitations and uncertainty about future 

events, the Agency does not make further speculation about the expected number of prion 

product registrations. 

6.1 REGISTRANT PAPERWORK BURDEN 

Table 6-1 presents the Agency’s current estimate of registrant paperwork burden (EPA, 2008b) 

for the registration of a new active ingredient or a major new use product. The estimated burden, 

194 hours, covers all activities associated with assembling and submitting a registration 

application. These activities are similar for all registrations under FIFRA Section 3, whether for 

a conventional pesticide, an antimicrobial pesticide, or a biopesticide. Because of the similarities 

in the activities associated with each type of pesticide registration, the Agency does not 

separately estimate the paperwork burden for the different categories. Estimates, therefore, 

reflect the burden associated with conventional pesticides, which make up the bulk of the 
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registrations, i.e., 89 out of 140 of the anticipated annual registration actions over the course of 

the ICR period. 
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Table 6-1. Estimated Cost of Paperwork Burden per Registration of New Active Ingredient 

or Major New Use Product for an Antimicrobial Pesticide 

Burden Hours Total 

Collection Activities Management 

$103.62/hr 

Technical 

$67.05/hr 

Clerical 

$33.85/hr Hours Costs ($) 

Read Instructions 18 0 0 18 1,865.16

Plan activities 4 0 0 4 414.48

Gather/create info 0 120 0 120 8,046.00

Compile and review 4 8 0 12 950.80

Complete paperwork 0 0 30 30 1,015.50

Store/maintain data 0 0 10 10 338.50

TOTAL 26 128 40 194 $12,630.52

Sources: Wage rates based on data from the U.S. Department of Labor, Bureau of Labor Statistics, May, 2006; 

Burden hours from EPA, 2008b. 

Table 6-2 presents the Agency’s estimates of the paperwork burden for preparing and submitting 

a tolerance petition for conventional pesticides, antimicrobial pesticides, or biopesticides (EPA, 

2009). The Agency estimates 1,726 total hours for paperwork burden per registration of each 

new active ingredient or major new use product. 
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Table 6-2. Estimated Cost of Paperwork Burden per Tolerance Petition 

Burden Hours Total 

Collection Activities Management 

$138/hr 

Technical 

$73/hr 

Clerical 

$42/hr Hours Costs ($) 

Review FFDCA 

regulations CFR 

citation; PRN 97-1 

25 48 24 97 7,962 

Conduct Field Trial 252 1,080 25 1,357 114,666 

Prepare Petition 42 30 116 188 12,858 

Read Notice of any 

petition deficiency 1 1 1 3 253 

Prepare response 2 44 12 58 3,992 

Maintain information 1 8 14 23 1,310 

TOTAL 323 1,211 192 1,726 $141,041 

Sources: Wage rates based on data from the U.S. Department of Labor, Bureau of Labor Statistics, May, 2007; 

Burden hours from EPA, 2009. 

New antimicrobial active ingredients or uses making prion related claims are expected to be a 

very small portion of total new registration application and tolerance petitions submitted to the 

Agency. In this assessment, the Agency estimates that there will be three major new use product 

registrations in the first year of registration of antimicrobial products making prion related claims 

(see Section 4.3.2). Given data limitations and uncertainty about future events, the Agency does 

not make further speculation about the expected number of prion product registrations. However, 

for the purposes of the ICR’s and to be conservative, the Agency assumes that there may also be 

one additional major new use amendment per year for the entire ICR renewal cycle (10 years) 

and that each new product will require a tolerance, i.e., they might be labeled for an indirect food 

use, such as on meat processing equipment. This is unlikely since no Section 18 exemptions 

have not yet been requested for an indirect food use. But high exposure uses such as these are 

possible, so it is assumed here to render a more conservative estimate. 

The additional registration of three antimicrobial products making prion related claims will result 

in an increase in new registration applications from 140 to 143 and an increase in respondent 

paperwork burden of nearly 600 hours and $38,000. Likewise, the additional registration of three 

antimicrobial products making prion related claims will result in an increase in tolerance 

petitions of from 64 to 67 and an increase in respondent paperwork burden of about 5,200 hours 

and $423,000. 
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6.2 AGENCY PAPERWORK BURDEN 

The Agency (EPA, 2008b) estimates that evaluating 140 Type A registration applications per 

year, over a three year period, requires 27,160 hours or about 13 Full Time Equivalents (FTE) of 

staff time. The majority of the burden is for technical staff and much of that is for the review of 

data submitted by registrants and the evaluation of risks posed by a pesticide. The small increase 

in data requirements expected for antimicrobial active ingredient and new use registrations will 

not significantly impact the Agency’s overall burden. Therefore, the Agency does not expect to 

amend the existing agency burden estimates in the ICR for registration activities. 

Similarly, the Agency (EPA, 2009) estimates that evaluating 64 tolerance petitions per year, over 

a three year period, requires 49,920 hours or about 24 Full Time Equivalents (FTE) of staff time. 

The majority of the burden is for technical staff and much of that is for the review of the data 

submitted by registrants and the evaluation of risks posed by a pesticide. The small increase in 

data requirements expected for antimicrobial active ingredient and new use registrations will not 

significantly impact the Agency’s overall burden. Therefore, the Agency does not expect to 

amend the existing agency burden estimates in the ICR for Tolerance Petitions. 
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REFERENCES 

EPA, 2004 memo of decision 

EPA, 2008 

EPA, 2009 

PR Notice 2002-1

World Health Organization. 1999. WHO infection control guidelines for transmissible spongiform 

encephalopathies. Report of a WHO consultation, Geneva, Switzerland, 23-26 March 1999
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APPENDIX A: DESCRIPTIONS OF NAICS CODES

Pesticide and Other Agricultural Chemical Manufacturing (NAICS 325320) 

The pesticide manufacturing industry includes establishments primarily engaged in the 

formulation and preparation of agricultural and household pest control chemicals. Many of these 

companies register products with EPA as required by FIFRA. According to an analysis 

conducted by EPA in 2005, the antimicrobial pesticide manufacturing universe comprises 

approximately 859 companies, all of which the proposed rule may impact. 

Colleges, Universities, and Professional Schools (NAICS 611310) 

This industry comprises establishments primarily engaged in furnishing academic courses and 

granting degrees at baccalaureate or graduate levels. These entities also engage in research and 

experimental development in the physical, engineering, or life sciences, such as agriculture, 

environmental sciences, biology, botany, biotechnology, chemistry, food, fisheries, forestry, 

health, medicine, physics, veterinary and other allied subjects. 

R&D in the Physical, Engineering, and Life Sciences (NAICS 541712) 

This industry comprises establishments primarily engaged in conducting research and 

experimental development (except biotechnology research and experimental development) in the 

physical, engineering, or life sciences, such as agriculture, electronics, environmental, biology, 

botany, computers, chemistry, food, fisheries, forests, geology, health, mathematics, medicine, 

oceanography, pharmacy, physics, veterinary and other allied subjects. 
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APPENDIX B: EXPECTED COSTS OF DATA REQUIREMENTS

Frequencies of Data Requirements E

Test Name Guideline No. High Exposure Low Exposure High Exposure 

Average Test Cost

NAI* MNUP* MNUA* NAI MNUP MNUA NAI MNUP MNU

PRODUCT PERFORMANCE $430,600 $430,600 $430Products for hard surfaces - EPA Disinfectant test 810.2100 $6,600 100% 100% 100% 0% 10% 10% $6,600 $6,600 $6Products for hard surfaces - Sanitizer test, non food 810.2100j $4,000 100% 100% 100% 0% 0% 0% $4,000 $4,000 $4Products for hard surfaces - Hard inanimate surface, non food 

810.2100l $4,000 100% 100% 100% 0% 0% 0% $4,000 $4,000 $4

Products for fabrics/textiles - EPA Carpet Sanitizer 810.2300b $3,250 0% 0% 0% 0% 3% 3% $0 $0 Products for air sanitizers 810.2400 $5,500 0% 0% 0% 0% 0% 0% $0 $0 Products for microbial pests associated with human and animal waste 

810.2600 $5,720 0% 0% 0% 0% 0% 0% $0 $0 

Products for treating water systems AOAC - water disinfectants pools 

810.2700d $7,500 0% 0% 0% 100% 100% 0% $0 $0 

Products with Prion Related Claims 810.xxxx $416,000 100% 100% 100% 100% 100% 100% $416,000 $416,000 $416PRODUCT CHEMISTRY $133,709 $40,871 Product identity and composition 830.1550 $223 100% 38% 0% 71% 47% 0% $223 $85 Description of materials used to produce the product 830.1600 $334 100% 25% 0% 57% 40% 0% $334 $84 Description of production process 

830.1620 $418 50% 38% 0% 71% 33% 0% $209 $159 

Description of formulation process 

830.1650 $418 100% 38% 0% 57% 33% 0% $418 $159 

Discussion of formulation of impurities 830.1670 $418 0% 38% 0% 71% 33% 0% $0 $159 Preliminary analysis 830.1700 $29,465 100% 38% 0% 71% 30% 0% $29,465 $11,197 Certified limits 830.1750 $248 100% 25% 0% 100% 50% 0% $248 $62 Enforcement analytical method 830.1800 $15,455 100% 13% 0% 14% 37% 0% $15,455 $2,009 Submittal of samples 830.1900 $495 0% 0% 0% 0% 7% 0% $0 $0 * NAI = New Active Ingredient; MNUP = Major New Use Product; MNUA = Major New Use Amendment 
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Frequencies of Data Requirements E

Test Name High Exposure Low Exposure High Exposure 

Guideline No. Average Test Cost NAI MNUP MNUA NAI MNUP MNUA NAI MNUP MNU

PRODUCT CHEMISTRY (cont)Color 830.6302 $700 100% 38% 0% 86% 37% 0% $700 $266 Physical state 830.6303 $700 100% 38% 0% 86% 47% 0% $700 $266 Odor 830.6304 $700 100% 38% 0% 86% 33% 0% $700 $266 Stability to normal and elevated temperatures, metals, and metal ions 

830.6313 $8,250 100% 38% 0% 73% 23% 0% $8,250 $3,135 

Oxidation/reduction: chemical incompatibility 830.6314 $2,994 100% 0% 0% 57% 20% 0% $2,994 $0 Flammability 830.6315 $2,000 100% 25% 0% 57% 23% 0% $2,000 $500 Explodability 830.6316 $4,163 100% 25% 0% 29% 23% 0% $4,163 $1,041 Storage stability 830.6317 $11,500 100% 25% 0% 57% 23% 0% $11,500 $2,875 Miscibility 830.6319 $1,100 50% 0% 0% 0% 17% 0% $550 $0 Corrosion characteristics 830.6320 $2,750 100% 0% 0% 43% 40% 0% $2,750 $0 Dielectric breakdown voltage 830.6321 $2,525 50% 0% 0% 0% 7% 0% $1,263 $0 pH 830.7000 $750 100% 13% 0% 71% 37% 0% $750 $98 UV/visible light absorption 830.7050 $2,022 33% 25% 0% 14% 7% 0% $667 $506 Viscosity 830.7100 $1,400 100% 0% 0% 14% 30% 0% $1,400 $0 Melting point/melting range 830.7200 $1,200 100% 25% 0% 14% 20% 0% $1,200 $300 Boiling point/boiling range 830.7220 $1,500 50% 38% 0% 29% 17% 0% $750 $570 Density/relative density/bulk density 830.7300 $1,400 100% 38% 0% 86% 47% 0% $1,400 $532 Dissociation constants in water 830.7370 $4,845 50% 25% 0% 29% 17% 0% $2,423 $1,211 Particle size, fiber length, and diameter distribution 830.7520 $1,333 5% 5% 0% 5% 5% 0% $67 $67 Partition coefficient (noctanol/water) - shake flask method 

830.7550 $6,667 50% 13% 0% 0% 13% 0% $3,334 $867 

Partition coefficient (noctanol/water) -generator column 

830.7560 $6,667 50% 13% 0% 0% 13% 0% $3,334 $867 

Partition coefficient (noctanol/water) -estimation chromatography 

830.7570 $4,388 50% 13% 0% 0% 13% 0% $2,194 $570 

Water Solubility: column elution/shake flask 830.7840 $9,635 100% 38% 0% 43% 17% 0% $9,635 $3,661 
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Water solubility 830.7860 $9,635 100% 38% 0% 43% 17% 0% $9,635 $3,661 Vapor pressure 830.7950 $15,000 100% 38% 0% 43% 17% 0% $15,000 $5,700 
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Frequencies of Data Requirements E

Test Name High Exposure Low Exposure High Exposure 

Guideline No. Average Test Cost NAI MNUP MNUA NAI MNUP MNUA NAI MNUP MNU

TOXICOLOGY $2,348,869 $1,445,413 Acute Testing Acute oral toxicity - rat 870.1100 $3,474 100% 38% 0% 86% 40% 0% $3,474 $1,320 Acute dermal toxicity 870.1200 $5,437 50% 38% 0% 71% 37% 0% $2,719 $2,066 Acute inhalation toxicity - rat 870.1300 $26,275 50% 38% 0% 43% 30% 0% $13,138 $9,985 Acute dermal irritation 870.2500 $2,000 100% 38% 0% 71% 37% 0% $2,000 $760 Dermal sensitization 870.2600 $7,589 100% 38% 0% 71% 30% 0% $7,589 $2,884 Acute neurotoxicity - rat 870.6200 $89,597 50% 25% 0% 14% 10% 0% $44,799 $22,399 Subchronic Testing 90-day oral toxicity - rodents 870.3100 $138,106 100% 63% 0% 71% 17% 0% $138,106 $87,007 90-day oral toxicity - nonrodents 870.3150 $221,047 50% 63% 0% 14% 7% 0% $110,524 $139,260 21/28-day dermal toxicity 870.3200 $83,240 0% 0% 0% 0% 10% 0% $0 $0 90-day dermal toxicity 870.3250 $137,604 50% 13% 0% 14% 10% 0% $68,802 $17,889 90-day inhalation toxicity - rat 870.3465 $489,879 0% 13% 0% 43% 3% 0% $0 $63,684 90-day Neurotoxicity - rat 870.6200 $184,039 50% 0% 0% 0% 3% 0% $92,020 $0 Chronic Testing Chronic oral toxicity - rodent 870.4100 $1,071,401 50% 25% 0% 14% 10% 0% $535,701 $267,850 Carcinogenicity - two rodent species - rat and mouse preferred 

870.4200 $1,508,341 50% 25% 0% 0% 3% 0% $754,171 $377,085 

Developmental Toxicity & Reproduction Prenatal developmental toxicity - rat and rabbit preferred 

870.3700 $76,941 100% 50% 0% 86% 23% 0% $76,941 $38,471 

Reproduction and fertility effects 870.3800 $379,856 50% 63% 0% 0% 7% 0% $189,928 $239,309 Developmental neurotoxicity 870.6300 $407,020 10% 5% 0% 10% 5% 0% $40,702 $20,351 Mutagenicity Reverse mutation assay 870.5100 $4,257 100% 38% 0% 86% 7% 0% $4,257 $1,618 In vitro mammalian gene mutation 870.5300 $19,211 100% 63% 0% 57% 20% 0% $19,211 $12,103 
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In vitro mammalian chromosomal aberration 870.5375 $26,856 100% 63% 0% 57% 20% 0% $26,856 $16,919 Mammalian spermatogonial chromosomal aberration 870.5380 $19,382 100% 63% 0% 57% 20% 0% $19,382 $12,211 Mammalian bone marrow chromosomal aberration 870.5385 $30,004 100% 63% 0% 57% 20% 0% $30,004 $18,903 

Frequencies of Data Requirements E

Test Name Guideline High Exposure Low Exposure High Exposure 

No. Average Test Cost NAI MNUP MNUA NAI MNUP MNUA NAI MNUP MNU

TOXICOLOGY (cont)Mammalian erthrocyte micronucleus 870.5395 $20,536 100% 63% 0% 57% 20% 0% $20,536 $12,938 Special Testing Companion animal safety 870.7200 $156,000 0% 0% 0% 0% 0% 0% $0 $0 Metabolism and pharmacokinetics 870.7485 $182,729 50% 13% 0% 0% 7% 0% $91,365 $23,755 Dermal penetration 870.7600 $147,529 0% 0% 0% 0% 3% 0% $0 $0 Immunotoxicity 870.7800 $56,648 100% 100% 0% 100% 100% 0% $56,648 $56,648 NONTARGET ORGANISM $937,211 $135,387 Tier One Testing Acute avian oral toxicity 850.2100 $10,100 100% 38% 0% 100% 25% 0% $10,100 $3,838 Acute freshwater invertebrate toxicity 850.1010 $17,000 100% 38% 0% 100% 25% 0% $17,000 $6,460 Acute freshwater fish toxicity 850.1075 $11,957 100% 38% 0% 100% 25% 0% $11,957 $4,544 Higher Tier Testing Avian dietary toxicity 850.2200 $6,480 100% 13% 0% 29% 13% 0% $6,480 $842 Avian reproduction 850.2300 $168,250 1% 1% 0% 1% 1% 0% $1,683 $1,683 Acute freshwater invertebrate toxicity 850.1010 $17,000 100% 38% 0% 100% 25% 0% $17,000 $6,460 Acute oyster toxicity 850.1025 $20,138 100% 13% 0% 14% 10% 0% $20,138 $2,618 Acute mysid toxicity 850.1035 $20,138 100% 13% 0% 14% 10% 0% $20,138 $2,618 Acute penaeid toxicity 850.1045 $20,138 100% 13% 0% 14% 10% 0% $20,138 $2,618 Acute bivalve larval toxicity 850.1055 $20,138 100% 13% 0% 14% 10% 0% $20,138 $2,618 Acute estuarine & marine organism toxicity 850.1075 $11,576 100% 38% 0% 100% 17% 0% $11,576 $4,399 Acute freshwater fish toxicity 850.1075 $11,957 100% 38% 0% 100% 25% 0% $11,957 $4,544 Aquatic invertebrate lifecycle - daphnid chronic 850.1300 $118,063 100% 1% 0% 5% 1% 0% $118,063 $1,181 
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toxicity Aquatic invertebrate lifecycle - mysid chronic toxicity 850.1350 $36,334 100% 1% 0% 5% 1% 0% $36,334 $363 Fish early-life stage toxicity 850.1400 $37,279 50% 13% 0% 5% 10% 0% $18,640 $4,846 Fish life-cycle toxicity 850.1500 $512,500 50% 13% 0% 1% 3% 0% $256,250 $66,625 Aquatic Bioavailability/ Biomagnification: Oyster BCF 

850.1710 $123,919 50% 1% 0% 5% 7% 0% $61,960 $1,239 

Aquatic Bioavailability/ Biomagnification: Fish BCF 850.1730 $140,452 50% 1% 0% 5% 7% 0% $70,226 $1,405 
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Frequencies of Data Requirements E

Test Name High Exposure Low Exposure High Exposure 

Guideline No. Average Test Cost NAI MNUP MNUA NAI MNUP MNUA NAI MNUP MNU

TOXICOLOGY (cont)Aquatic food chain transfer - Bioavailability 850.1850 $325,000 50% 1% 0% 5% 7% 0% $162,500 $3,250 Simulated or actual field testing - aquatic organisms 850.1950 $600,000 1% 1% 0% 1% 1% 0% $6,000 $6,000 Simulated or actual field testing - field animal 850.1950 $512,500 1% 1% 0% 1% 1% 0% $5,125 $5,125 Simulated or actual field testing - insect predators 850.1950 $87,500 1% 1% 0% 1% 1% 0% $875 $875 Simulated or actual field testing - plants 850.1950 $62,500 1% 1% 0% 1% 1% 0% $625 $625 Whole sediment; acute freshwater invertebrates toxicity 

850.1735 $23,750 100% 1% 0% 5% 3% 0% $23,750 $238 

Whole sediment; acute marine invertebrates toxicity 850.1740 $37,500 5% 1% 0% 5% 3% 0% $1,875 $375 Honey bee acute contact toxicity 850.3020 $3,175 0% 0% 0% 0% 0% 0% $0 $0 Toxicity of residues to honeybees 850.3030 $13,368 50% 0% 0% 0% 3% 0% $6,684 $0 NONTARGET PLANT PROTECTION $92,748 $35,955 Seedling emergence, Tier II 850.4225 $20,375 50% 1% 0% 5% 3% 0% $10,188 $204 Vegetative vigor, Tier II 850.4250 $24,500 50% 1% 0% 5% 3% 0% $12,250 $245 Terrestrial plants field study, Tier III 850.4300 $76,682 0% 0% 0% 0% 0% 0% $0 $0 Aquatic plant toxicology test using Lemna spp., Tier II 850.4400 $35,155 100% 1% 0% 5% 7% 0% $35,155 $352 Aquatic plants field study, Tier III 850.4450 $0 0% 0% 0% 0% 0% 0% $0 $0 Algal Toxicity Tier I and Tier II 850.5400 $35,155 100% 100% 0% 100% 100% 0% $35,155 $35,155 APPLICATOR EXPOSURE $87,838 $49,169 Dermal outdoor exposure 875.1100 $167,857 10% 5% 0% 10% 3% 0% $16,786 $8,393 Dermal indoor exposure 875.1200 $126,429 10% 5% 0% 10% 5% 0% $12,643 $6,321 Inhalation outdoor exposure 875.1300 $164,286 10% 5% 0% 10% 3% 0% $16,429 $8,214 Inhalation indoor exposure 875.1400 $126,429 10% 5% 0% 10% 5% 0% $12,643 $6,321 Biological monitoring 875.1500 $188,378 10% 5% 0% 10% 5% 0% $18,838 $9,419 Data reporting and 875.1600 $7,500 100% 100% 0% 100% 100% 0% $7,500 $7,500 
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calculations Product use information 875.1700 $3,000 100% 100% 0% 100% 100% 0% $3,000 $3,000 
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Frequencies of Data Requirements E

Test Name High Exposure Low Exposure High Exposure 

Guideline No. Average Test Cost NAI MNUP MNUA NAI MNUP MNUA NAI MNUP MNU

POST-APPLICATION EXPOSURE $73,038 $38,269 Soil residue dissipation 875.2200 $83,125 0% 0% 0% 0% 0% 0% $0 $0 Indoor surface residue dissipation 875.2300 $35,000 25% 10% 0% 0% 0% 0% $8,750 $3,500 Dermal exposure 875.2400 $125,500 10% 5% 0% 10% 5% 0% $12,550 $6,275 Inhalation exposure 875.2500 $73,000 10% 5% 0% 10% 5% 0% $7,300 $3,650 Biological monitoring 875.2600 $166,875 10% 5% 0% 0% 0% 0% $16,688 $8,344 Product use information 875.2700 $3,000 100% 100% 0% 100% 100% 0% $3,000 $3,000 Description of human activity 875.2800 $3,000 100% 100% 0% 100% 100% 0% $3,000 $3,000 Data reporting and calculations 875.2900 $3,000 100% 100% 0% 100% 100% 0% $3,000 $3,000 Non-dietary ingestion exposure 875.3000 $75,000 25% 10% 0% 0% 0% 0% $18,750 $7,500 ENVIRONMENTAL FATE $340,859 $72,162 Degradation Studies - Laboratory Hydrolysis 835.2120 $25,230 100% 100% 0% 100% 100% 0% $25,230 $25,230 Photodegradation in water 835.2240 $47,875 50% 13% 0% 5% 7% 0% $23,938 $6,224 Photodegradation on soil 835.2410 $42,350 0% 0% 0% 0% 0% 0% $0 $0 Biodegradation Studies - Laboratory Activated Sludge Sorption Isotherm 835.1110 $10,051 100% 100% 0% 100% 100% 0% $10,051 $10,051 Ready Biodegradability 835.3110 $10,364 100% 100% 0% 100% 100% 0% $10,364 $10,364 Modified Activated Sludge, Respiration Inhibition 850.6800 $5,126 100% 100% 0% 100% 100% 0% $5,126 $5,126 Mobility Studies Sediment and soil adsorption/desorption 835.1230 $23,750 50% 13% 0% 5% 10% 0% $11,875 $3,088 Leaching and adsorption/desorption 835.1240 $46,780 50% 13% 0% 5% 7% 0% $23,390 $6,081 Metabolism Studies - Laboratory Aerobic soil metabolism 835.4100 $94,375 50% 1% 0% 5% 7% 0% $47,188 $944 Anaerobic soil metabolism 835.4200 $71,300 50% 1% 0% 5% 3% 0% $35,650 $713 
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Aerobic aquatic metabolism 835.4300 $44,475 100% 1% 0% 5% 7% 0% $44,475 $445 Anaerobic aquatic metabolism 835.4400 $79,400 100% 1% 0% 5% 10% 0% $79,400 $794 Dissipation Studies - Field Aquatic field dissipation 835.6200 $267,250 1% 1% 0% 1% 1% 0% $2,673 $2,673 
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Frequencies of Data Requirements E

Test Name High Exposure Low Exposure High Exposure 

Guideline No. Average Test Cost NAI MNUP MNUA NAI MNUP MNUA NAI MNUP MNU

ENVIRONMENTAL FATE (cont) Ground and Surface Water Monitoring Monitoring of representative U.S. waters none $215,833 0% 0% 0% 0% 0% 0% $0 $0 Special Studies Leaching study none $43,000 50% 1% 0% 0% 1% 0% $21,500 $430 RESIDUE CHEMISTRY $271,485 $102,633 Supporting Information Chemical identity 860.1100 $1,250 100% 25% 0% 0% 0% 0% $1,250 $313 Directions for use 860.1200 $4,000 100% 25% 0% 0% 0% 0% $4,000 $1,000 Proposed tolerance 860.1550 $5,362 100% 25% 0% 0% 0% 0% $5,362 $1,341 Reasonable grounds in support of petition 860.1560 $10,000 100% 25% 0% 0% 0% 0% $10,000 $2,500 Submittal of analytical reference standards 860.1650 $334 50% 10% 0% 0% 0% 0% $167 $33 Nature of the Residue Nature of the residue in plants 860.1300 $100,000 5% 1% 0% 0% 0% 0% $5,000 $1,000 Nature of the residue in livestock 860.1300 $105,833 5% 1% 0% 0% 0% 0% $5,292 $1,058 Analytical Methods Residue analytical method - plants 860.1340 $21,125 5% 1% 0% 0% 0% 0% $1,056 $211 Residue analytical method - livestock 860.1340 $65,500 5% 1% 0% 0% 0% 0% $3,275 $655 Multiresidue method 860.1360 $24,000 5% 1% 0% 0% 0% 0% $1,200 $240 Magnitude of the Residue Storage stability data 860.1380 $18,500 50% 25% 0% 0% 0% 0% $9,250 $4,625 Water 860.1400 $53,750 0% 0% 0% 0% 0% 0% $0 $0 Fish 860.1400 $104,000 0% 0% 0% 0% 0% 0% $0 $0 Irrigated crops (one-crop) 860.1400 $18,000 0% 0% 0% 0% 0% 0% $0 $0 Food handling 860.1460 $205,000 50% 10% 0% 0% 0% 0% $102,500 $20,500 Meat/milk/poultry/eggs 860.1480 $149,000 5% 1% 0% 0% 0% 0% $7,450 $1,490 Crop field trials 860.1500 $163,667 5% 25% 0% 0% 0% 0% $8,183 $40,917 
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Processed food/feed 860.1520 $35,000 5% 1% 0% 0% 0% 0% $1,750 $350 Reduction of Residues 860.1540 $15,000 5% 1% 0% 0% 0% 0% $750 $150 Migration Studies none $105,000 100% 25% 0% 0% 0% 0% $105,000 $26,250 
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