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RIN 2070-AJ26



## ECONOMIC ANALYSIS OF TH E 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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Page 2 of 58 

### 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 Nation al Level..........................................................................11

2.4 Statutory Authority fo r the Proposed Rule ...................................................................................... .........12

2.4.1 Statutory Authority for Considering Prions to be Pe sts under FI FRA.................................................12

2.4.2 Statutory Authority for Regist ration Data Re quirements.....................................................................12

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

Categor y #1.................................................................................................................... ....................................13

Categor y #2.................................................................................................................... ....................................14

Categor y #3.................................................................................................................... ....................................15

3 Regulatory and Data Requi rement 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 Registrant s due to Changes in Data Requirements .................................24

4.1 The Base line ................................................................................................................... ..........................24

4.2 Description of Da ta and Sources ................................................................................................ ..............25

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

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

4.3 Cost Estim ation ................................................................................................................ ........................27

4.3.1 Incremental Costs per Registratio n Action ...................................................................................... ....27

4.3.2 Industry-Wid e 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 Pro duct 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 Paperw ork Bu rden........................................................................................................ ...............43

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

Appendix A: Descriptio ns of NAICS Codes ........................................................................................ ....................45

Appendix B: Expected Cost s of Data Requirements ................................................................................ ..............46

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Page 3 of 58 TABLE OF TABLES

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

Disinfectant La bel Ra tes ....................................................................................................... ...............................8
Table 3-1. Summary of Optio n Components and Utility for Achieving Agen cy Goals..............................................18
Table 3-2. Purpose of Data Requirements by Discipline.......................................................................... ...................20
Table 3-3. Types of Registratio n Actions....................................................................................... .............................21
Table 3-4. Exposure Ca tegories an d Examples .................................................................................... .......................22

Table 4-1. Possible Re gistration Scenarios..................................................................................... .............................29

Table 4-2. Incremental Cost Per Prio n Product Registratio n Action ($ 000s)...................................................... ........30
Table 4-3. Total Industry Cost in First Year After Rule Take s Effect ($000s)*.................................................. ........33

Table 5-1. Potential Prion Product Re gistrants Classified by NAICS Code........................................................ ........35
Table 5-2. Bleach (NaOCl) and Lye (NaOH) Re gistrants, 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 Antimic robial Pesticide ......................................................................................... .....................41
Table 6-2. Estimated Cost of Pape rwork Burden per Tolerance Petition ........................................................... .........42

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### 1 E XECUTIVE 

### S UMMARY

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 cu rrently 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 hea lth and the environment that could stem from using prion products without FIFR A 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 ar e subject to regulation under FIFRA, including all data and labeling requirements. This Economic Analysis (EA) presents the Agency’s assessment of the poten tial costs and benefits expected to result from the proposed rule. Although the proposed rule wi ll not alter the regulatory status of prion products, in order to take into account the full economic impact of the decision to regulat e 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 consid ered 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 external ities 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 pr ions, 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 ar e 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 extern alities (unintended negative effects).

The EA further discusses the costs of various ty pes of registrations that are likely to occur initially under the proposed rule and presents expected incrementa l costs for eight potential types of prion product registration scenar ios. Of these eight, three are considered likely to occur: new active ingredient, new use product, and new use am endment. Using the pre-2003 scenario as the baseline, the incremental costs of the proposed rule per registrati on 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 nu mber of registrations

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Page 5 of 58 in subsequent years. However, registrations that occur after the ini tial major new use product registrations would probably be major new use am endments. 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 pesticid e 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 registra tions, 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 ne w use product registrations in the first year, the additional registration of three antimicrobial products making prion rela ted 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 a nd a little more than $423,000 (5,200 hours for three registrations) for tolerance petitions’ documentation.

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Page 6 of 58 

### 2 I NTRODUCTION

Prion (“ pr oteinaceous in fectious particle”) is a term used to describe an infectious agent that causes progressive neurodegenerative diseases of the central nervous system (CNS). These neurodegenerative prion dis eases are known collectively as transmissible spongiform encephalopathies (TSEs). Examples of TSEs or prion diseases include sc rapie 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 PrP c (“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 PrP Sc , prions associated with scrapie, and PrP BSE , prions associated with bovine spongiform encephalopathy (mad cow disease).

2.1 B ACKGROUND

The most common TSE in the U.S. is chronic was ting 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 laborator y surfaces which had

been in contact with CWD-contaminated animal tissues. These products we re 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 Heal th Organization (WHO)

recommends the use of certain chemicals for inactiv ating prions, incl uding registered disinfectant products which are referenced by the Centers fo r 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 us e of unregistered disinfectants/c hemicals for this purpose and questions about the pote ntial health and environmental impa cts 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 reco gnized as a clinical "wasting" syndrome in 1967 in captive mule deer in a wildlife research fa cility 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 thereaft er it was shown to be present as an endemic focus in wild deer,

elk and moose in northeastern Colorado and sout heastern Wyoming. Si nce nationwide wildlife surveillance was instituted in 1997, CWD has been identified in wild deer and elk in several additional states: Illinois, Kansas, Nebraska, Ne w Mexico, New York, Sout h Dakota, Utah, West Virginia and Wisconsin (www.aphis.usda).

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Page 7 of 58 requirements of FIFRA (refer to EPA’s Record of Decision memorandum of April 29, 2004). The Agency’s rationale incl uded 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 s ection 2(t)(2). They orig inate in living organisms, replicate within host organisms, and can be transmitted to other hosts.

• If prion products were not regulated u nder 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 consider ed 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 (Californi a, Montana, Colorado, North Dakota, South Dakota, Utah, Wyoming, and Ma ine) for the sale and distribution (and use) of a commercial aqueous acid phe nolic product, Environ LpH®, fo r inactivation of various TSE agents on hard, nonporous surfaces and equipment in government and commercial laboratories.

2.2 P ROBLEM S TATEMENT

Currently, several chemical products are bei ng used, primarily by government and commercial veterinary laboratories, with th e intent of reducing the infectivity of prions on potentially contaminated surfaces and equipment. The Ag ency 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 accordan ce with WHO recommendations but in a manner inconsistent with the EPA labeling. For exampl e, WHO has recommended treatment of surfaces with undiluted sodium hypochlorite (i.e., a bout 50,000-60,000 ppm) for one hour, whereas the maximum use concentration of registered sodi um 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 pr oblems with the current situation. First, the use of chemical products with the intent of reduc ing prion infectivity could caus e negative extern alities in the

form of effects to human health and/or the en vironment. Second, imperfect information about the efficacy of prion products could lead to expos ure to prions which could result in disease. Finally, the lack of clear regulat ory guidelines may increase transaction costs (i.e., paperwork burden) for registrants and the Agency and regulat ory uncertainty for potential registrants. These problems are described in further de tail in the following section.

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Page 8 of 58 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. Ex ternalities 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 requir e goggles and protective clothing to protect applicators. Sodium hypochlorite generally has low toxicity to birds but can be highly toxic to freshwater fi sh and freshwater invertebrate s. Pesticide labels prohibit discharge of pesticides into lakes, streams, or ponds to mitigate such hazards.

Regarding potential hazards of sodium hypochl orite and sodium hydroxide to humans, higher concentrations could result in greater risk to pe ople 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, a nd mucous membranes, but exposure and negative health effects can be adequately mitigated by fo llowing 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 labe l 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 fo r 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 contai ns 0.34% NaOH with a contact ti me 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 Rate s Recommended by WHO to inactivate prions

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Page 9 of 58 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 Organizati on, 1999; EPA OPPIN database, 2009

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

recommended concentrations of bleach and s odium hydroxide are ten times higher than those associated with the registered pesticide c oncentrations and contact times. The personal protective equipment (PPE) required on bleach and sodium hydroxide labels generally includes protective eyewear and gloves (d epending on the label’s signal word such as “Danger,” “Warning” or “Caution”), whereas the PPE fo r WHO-recommended concentrations of bleach and sodium hydroxide should be protective eyewear , gloves, long-sleeve shir t and pants, and an appropriate chemical-car tridge respirator.

2.2.1.2 Product performance

Currently, WHO provides end users with guida nce on the efficacy of various methods for cleaning surfaces to inactivate prions. This guida nce has not been updated for several years, and

it is not clear whether it refl ects current scientific knowledge . The prion decontamination recommendations by WHO appear to have been developed by consen sus by scientists who

attended a "WHO Consultation on Caring for Patients and Hospital Infection Control in Relation to Human Transmissible Spongiform Encephalopa thies held in Geneva, Switzerland, March 24- 26, 1999." In that document, WHO also specifie d what protective equipment should be worn by people during the decontamination process. Whet her WHO's recommendations are "sufficient" to reduce prion infectivity is unknown since the WHO document di d not cite the scientific studies upon which the participati ng scientists apparent ly relied in coming up with a consensus opinion.

The lack of consistent guidance and a performa nce standard for efficacy testing guidelines on which to base prion-related claims could potentially lead to exposur e 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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Page 10 of 58 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, ther e may be exposure to prions. Efficacy tests conducted according to validated, federal test guidelines and product performance standards would help assure that pr oducts would effectively perform their intended

function.

Producers’ claims about performance could pot entially be regulated by the Federal Trade Commission if they were to make false or misl eading claims in adver tising, but the Agency’s pesticide registration program would provide a more efficien t and appropriate regulatory mechanism for reviewing the e fficacy of pesticide products a nd 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, an d the applicable regula tory 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 uncer tainty, 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 registeri ng 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 pr oducts would result in a delay of the products’ benefits. Finally, uncertainties about the time and costs of the registration process

can deter research a nd development (R&D).

2.2.2 Agency Goals

The Agency’s goal of regulatory action in this case is to find the best re gulatory solution given expected costs for the regulated community and resource constraint s (e.g., paperwork, monitoring, etc.) of the Agenc y. The ideal solution would el iminate any potential negative externalities from the use of prion products, fi x existing market imperf ections 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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Page 11 of 58 2.3 O VERVIEW OF P ROPOSED R ULE

Pursuant to EPA’s September 10, 2003 determinati on 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. Howe ver, EPA believes that there is benefit in using this rulemaking proceeding for a full public cons ideration of the decision to regulate these products under FIFRA. Accordingly, EPA has c hosen to compare the economic impact of the proposed rule to what it would be if prions were not consider ed pests and prion products were not subject to FIFRA.

Under the proposed rule, the Agency would add prions to the list of entiti es that are included in the definition of “pests” under th e regulation promulgated pursuant to FIFRA and require prion products to go through the FIFRA S ection 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 possibl e for EPA to assess the risks of prion products and require risk mitigation measures thereby pr eventing 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 guidan ce for efficacy testing of products with prionrelated claims. This guidance describes efficacy test protocols that would be acceptable for demonstrating the performance of prion mitig ation products. This new guidance document addresses labeling statements, te st methods and performance st andards applicable to prion products. This prion-specific data guideline ad dresses 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 a nd prion-specific) will allow the Agency to obtain information that may not otherwise be generate d or publicly available, thereby improving the Agency’s ability to make regulator y decisions on prion products.

Finally, establishing consistent data requirement s and testing guidelines will inform potential registrants of data needs for prion products, thereby reducing regulator y uncertainties that impose transaction costs on i ndustry and the Agency.

2.3.1 Appropriateness of Regulati on 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 ma y cross State and local boundaries. Reliance on State requirements and di fferences in state resource availability may lead to significantly divergent or duplicate approach es. 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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Page 12 of 58 2.4 S TATUTORY A UTHORITY FOR THE P ROPOSED R ULE

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 poten tially 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 (excep t viruses, bacteria, or other microorganisms on or in living man or othe r living animals) which the Administrator declares to be a pest under section 25(c)(1).”

• FIFRA Section 25(c)(1): “The Administrator, after not ice 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 regist er pesticides. FIFRA Section 2(u) defines a pesticide, in part, as “...any substance or mixture of subs tances intended for preventing, destroying, repelling, or mitigating any pest....” S ection 3 describes the Ag ency’s authorities for registering pesticides and Secti on 18 describes the authorities fo r exempting any Federal or State agency from any provision of FIFRA.

2.4.2 Statutory Authority for Regist ration Data Requirements

Pesticide data requirements are issued under th e 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 re gistered or exempted from registration by the EPA before being sold or distributed in the Un ited 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 human s or the environment. This determination generally entails a finding by the Agency that th e 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 th e requirements for registrati on. 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 produc ts. An applicant for registration must furnish EPA with

substantial amounts of data on the pesticide, its compos ition, toxicity, potential human exposure, environmental properties and ecologi cal effects, as well as information on its efficacy in certain cases. Although the data requ irements are imposed primarily as a part of initial registration, EPA is authorized under FIFR A section 3(c)(2)(B) to require a registrant to develop and submit additional data necessary to maintain a registration.

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Page 13 of 58 2.5 A FFECTED P ERSONS

Persons that may be directly or indirectly affected by the pro posed regulation fall into three primary categories:

1. Pesticide producers

Persons seeking to market products with pri on related claims and/ or with “actual or constructive knowledge” that their products are used with the inte nt of reducing infectivity of prions may be directly affected by the propos ed 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 pe sticide, 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 change s to the regulatory environmen t (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 th e way products are used.

3. Researchers

Persons who conduct scientific studies on and/or develop prion products (e ither 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 li cense 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, ster ilants, etc.). Antimicrobial pesticides are

chemicals intended to be used to control micr obiological contamination and deterioration in industrial and consumer products and applications, and in crop ag riculture. Products intended to control prions on hard surfaces would fall within the class of antimicrobial pesticides. Antimicrobial pesticides are intended to “(i) di sinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or (ii) protect inanimate object s, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, pr otozoa, algae, or slime” [FIFRA Sec. 2(mm)]. The potential prion product industr y would also be likely to rese mble the antimicrobial industry with regards to use patterns.

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Page 14 of 58 Antimicrobial product manufacturers may fall under a number of different NAICS 2 codes, but the majority is primarily engaged in the fo rmulation and preparati on of agricultural and household pest control chemicals (except fertiliz ers). This function is primarily captured in NAICS code 325320 (Pesticide and Other Agricultu ral Chemical Manufactur ing). A complete description of NAICS categorie s are in Appendix A.

Category #2

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

Commercial users of prion products would be industries or profe ssions that come into contact with prion contaminated tissues, such as mammalia n nerve tissue, and, therefore, want to clean surfaces to prevent infection to humans or othe r animals. Based on this criterion, the Agency originally speculated that end users of products intended to re duce the infectivity of prions may

include:

• veterinary laboratories

• clinical (human pa thology) laboratories

• medical and dental surgeons

• morticians

• taxidermists

• hunters

• workers in meat processing plants.

Initial outreach to fewer than ten representati ves of these industries suggested that market demand for such products did exist but was so mewhat ambiguous. Contacts were made to national organizations, where avai lable, via telephone or e-mail asking about the industry’s use of chemical products to reduce in fectivity 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 additi onal attempt was made to cont act the organization or another organization in that industry.

One contact at a veterinary laboratory referred to their guidelines whic h 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 la boratory industry and other locations is also verified by the fact

2 NAICS stands for North American Indu strial Classification System. The nu mbering system is used by Federal statistical agencies to classify esta blishments including businesses, fede ral and state agenci es, non-profit and political orgs, and others.

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Page 15 of 58 that there are several FIFRA Secti on 18s for this type of product i ssued to several states, United States Department of Agricultu re (USDA) Animal Plant Health Inspection Serv ice, 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 processo rs at one point communicated concerns to the Agency that they could be affected by a rule esta blishing 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 us e of unregistered chemicals for reducing the infectivity of prions on inanimate surfaces by pe rsons 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 con cern about an apparent disconn ect 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 disinf ection with bleach), whereas the proposed rule would require registration of bl each and other material s intended for initial

disinfection and also for inact ivating prions. However, USDA guidance on cleaning and disinfection does recommend the use of EPA-regist ered products, and the Agency has always required registration of disinfectan t products that claim to treat pe sts. The proposed rule would ensure that products for which prion claims ar e made are also require d to be registered.

Outreach to a hunting organization indicated that bleach was used to clean butchering work stations but that it was proba bly routine cleaning practice to prevent infection from other pathogens and not related to fear of prion infecti on. It was further suggested that people working with animal carcasses would not likely be inclin ed 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 apprehensi on about prion infection could be due to the fact that CWD had not yet been discovered in the contact organizatio ns’ state; it is possibl e that practices would change if that were to happen.

Outreach to a hospital organization indicated that there would be so me interest in a product that could reduce infectivity of pr ions on hard surfaces, especial ly if such infection reduction requirements were written into the hospital infe ction 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/uni versities 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 woul d 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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Page 16 of 58

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Page 17 of 58 

### 3 R EGULATORY AND 

### D ATA 

### R EQUIREMENT 

### O PTIONS AND 

### B ENEFITS

The Agency is considering tw o regulatory options through formal rulemaking: Option 1: to maintain the Agency’s current interpretation th at prions are pests unde r 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 pri ons are pests (Option 1), pri on products are subject to the requirements of FIFRA including, but not limite d to, Section 3 (registration) and Section 18 (emergency exemption), as applicable. When applications are submitted for FIFRA Section 3 registration or Section 18 emergency exempti on, the Agency must decide which data are required to support the registration of a new ac tive ingredient or a ne w 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 determ ines that prions are not pests (Option 2), prion products will not be subject to th e requirements of FIFRA.

1. So long as prions are consid ered to be pests within th e scope of FIFRA (Option 1), the Agency is able to use its regulatory framework to mitigate externalities, improve information about the efficacy of pr ion products, and al leviate 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), pr ion 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 pest s, it will not be necessary for the Agency to make any further decisions on this matter. Also, th e Agency would not be able to reduce the uncertainty regarding the efficacy of products, but would al leviate regulatory uncertainty with no cost to the regulated community.

This section outlines the two regulatory options, de scribing each of their benefits in terms of achieving the Agency’s goals of mitigating ex ternalities, improving information about the efficacy of prion products, and alle viating regulatory uncertainty. Th is section also describes the benefits of each option. Table 3-1 summarizes this information.

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Page 18 of 58 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

A CTIONS TAKEN BY A GENCY 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

U TILITY OF O PTIONS FOR ACHIEVING A GENCY 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 O PTION #1: D ETERMINE P RIONS ARE P ESTS

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 w ould increase the likelihood that persons will recognize that prion products are subject to FIFRA and would definitively resolve any uncertainties about whether prion products ar e subject to FIFRA, thereby clarifying the

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Page 19 of 58 regulatory process. This includes any questions about the Agency’s auth ority to require data needed to support registrations a nd specify directions for proper use. This option would be most beneficial in helping to meet a ll three of the Agency’s goals disc ussed 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 pre cautions 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 externalitie s that may be caused by higher concentrations and/or longer contact times asso ciated with WHO’s recommendations for treatment of surfaces with bleach and sodium hydroxide . Though risk assessments and la beling instructions are not a panacea for all chemical externalities, the labelin g of pesticides is the most efficient tool available to the Agency for guiding the behavior of end users.

Second, since prions can pose risk s 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 ma y even lead to more research in this area by companies that were previously unwilling to be active in the industr y due to regulatory uncertainty. Even though the regu latory burden will be higher for registrants if FIFRA Section 3 registration is required, it will be fully known. Un less the Agency issues a rule, researchers and producers of prion products may have difficu lty estimating regulatory burden and potential

return on investment.

3.1.1 General Data Requirements

Data submitted by registrants in support of FI FRA Section 3 registration for antimicrobial pesticides fall into nine data disciplines: Product Performance, Product Chemistry, Toxicology, Non-target Organisms, Non-target Plant Prot ection, Applicator Expos ure, Post-Application Exposure, Environmental Fate and Residue Chemis try. All of these, with the exception of postapplication exposure data, would be necessary for conducting risk assessments of prion products. Post-application exposure data ar e not likely to be required becau se the use patterns do not

involve residential areas and because the existing chemicals like ly to be registered (e.g., sodium hydroxide, sodium hypochlorite, phenolics) have not demonstrated “potentially significant adverse effects” that would trigge r such data requirements.

Data requirements for registration are the pr imary source of costs under the status quo. However, they are also the primary source of be nefits. Data requireme nts relevant to prion products would contribute to risk assessments th at 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 discip lines are listed in Tabl e 3-2 along with a brief explanation of how they are used in risk assessment.

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Page 20 of 58 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 pes ticides on birds, mammals, fish, terrestrial and aquatic invertebrates and plants; includes short term acute, subacute, reproduction, simulated field and full fiel d 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 pers ons in occupational and non-occupational settings, including agricultural, reside ntial, commercial, institutional and recreational sites; includes oral, derm al and inhalation exposure data, postapplication residue data, post-applicati on 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 le vel of risk. Generally, antimicrobialproducts break down or dissipate such that there usually is no need for postapplication exposure data.

Environmental

Fate Data used to: (1) Assess exposure of human s to pesticide residues remaining after application upon reentering treated ar eas , (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 ot her 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 to lerance under FFDCA and/or to evaluate dietary exposure.

Product

Performance Product performance data provide a mechanis m to ensure that pesticide products will perform their intended function as clai med on the label. Product performance data are required to be submitted for a ll public health use products such as disinfectants used to control microorganism s infectious to man and rodenticides used to control vertebrates (such as rode nts, 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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Page 21 of 58 Many different tests fall into the disciplines outlined in Table 3-2. Which data are required from each discipline depends on the type of registra tion action and the use pattern. Basing data requirements on these two factors ensures that on ly the tests needed to conduct a proper risk assessment are collected by the Agency thereby mini mizing the cost burden to the registrants. In addition, data requirements are waived where jus tified, and information available from publicly available literature may be accepted in plac e 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 supp ort a potential registration action. They differ depending on the type of registra tion 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 ingredie nt. The types of registration actions that generally trigger significant data requirements are new active in gredient registrations and majo r new use registrations. Table

3-3 describes these t ypes 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 fo r one or more registered active ingredient(s) contained in the produc t. 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 regist ration of a product that adds a use pattern that is not currently re gistered for one or more active ingredient(s) contained in the product.

For example, WHO and other sources of scientif ic literature on infection prevention recommend the use of sodium hypochlorite (bleach) to reduce th e infectivity of prions on inanimate surfaces. Since sodium hypochlorite is alread y registered for other uses, any registrant wishing to make a

label claim that bleach could re duce the infectivity of prions w ould be required to register a major new use but not a new active ingredient.

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Page 22 of 58 3.1.1.2 Data Requirements by Exposure Category

Within each of the data requirement categories li sted above, a variety of individual tests may be necessary depending on the product’s exposure cate gory – 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 th at would fall into each category.

Table 3-4. Exposure Categories and Examples
Exposure category Description

High Exposure Agricultural premises and equi pment; Household sites; Aquatic sites (swimming pools, human drinking water); Commercial, industrial, and institutional sites (food and non-food contact surfaces, hospitals and others heal th care facilitie s, metalworking fluids, laundry and dry cleaning)

Medium Exposure Aquatic sites (industrial pr ocessing 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 e fficacy 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 whethe r 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 tr eating environmental surfaces and a suspension-based, incubation time interval assay if the intended use of a pr oduct is for treating liquids.

3.1.2.1 Performance Standards and Labeling Claims

Product performance data are used to address th e problem of imperfect information by requiring all products to meet a certain performance sta ndard 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 tr eated versus untreated (control) groups.

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Page 23 of 58 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 bioassa y 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 bioa ssay 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,” “mitigat e,” “eliminate,” “control”) are not supported by currently available test methods for prions. Be cause currently available test methods can only measure a reduction in infectivity of prions (that is, the absolu te quantity of elimination or destruction of prions cannot be measured), the Agency believes that “reduce infectivity” would be the only appropriate cl aim for prion products.

Second, the Agency has considered the issue of wh ether 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 testi ng on only one type of prion and permit a general claim of prion infectivity reduc tion. On the one hand, current sc ientific knowledge cannot speak to whether one prion type is more resistant to infectivity reduction. This fact would tend to support the requirement of a sepa rate infectivity assay for each prion type and permission for label claims only for the specific prion types te sted. On the other hand, requiring testing on each type of prion would be economically burdensom e and conflicts with th e Agency’s previous decisions to issue quarantine ex emptions 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 prio n 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 wh ich 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 th e user chooses to do so.

3.2 O PTION #2: D ETERMINE T HAT P RIONS ARE NOT P ESTS

As Option #2, the Agency could change its interpre tation and decide that pr ions are not a pest. In this case, FIFRA Section 3 registration or Section 18 exemp tion would no longer be required,

and there would be no further decisions to ma ke regarding data requirements, labeling, marketing claims or other matters that th e Agency normally regulates under FIFRA.

With respect to the Agency’s goals, this optio n would fulfill only one of the three – it would reduce regulatory uncertainty. If pr ions are not declared to be a pe st, the Agency will not be able to regulate prion products under FIFRA, which mean s 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 conduc t risk assessments, so th is approach would not help to reduce externalities. The Agency also would not be ab le to collect product performance data so there would still be imperfect informa tion regarding the efficacy of prion products which could lead to unforeseen prion exposure.

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Page 24 of 58 

### 4 E CONOMIC 

### I MPACTS ON 

### P ESTICIDE 

### R EGISTRANTS DUE TO 

### C HANGES IN


### D ATA 

### R EQUIREMENTS

This section describes the methods used to asse ss the incremental cost of compliance with the proposed rule. The costs of the baseline and th e 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 th e costs of the proposed rule are:

1. The unit test costs of each data requirement.

2. The frequency (percent of registration actions fo r 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 un it test costs are multiplie d 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 regist ration action between the baseline and the proposed rule. The incrementa l costs per registration action are multiplied by the number of registration actions for the industr y 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 T HE B ASELINE

The baseline scenario in an econom ic analysis can be treated as e quivalent to current practice or equivalent to an earlier set of conditions befo re 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 cons idered pests under FIFRA. Since that time, and as an interim measure while no ap plications for registration ha ve been received for a prion product, the Agency has been gr anting 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 pri ons were not considered pests and prion products were not subject to FIFRA. Accordingly, the baseline in this analys is 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 pr oducing 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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Page 25 of 58 Inasmuch as applicants for registration have already been generating data and EPA has already been reviewing data in response to em ergency exemption requests, this analysis will assume a pre-2003 baseline – a time when ther e 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 impact s of the decision to consider prions to be pests and thereby regul ate prion products

Using the pre-2003 conditions as the baseline wi ll allow the analysis to account for the full range of potential imp acts of the rule.

4.2 D ESCRIPTION OF D ATA AND S OURCES

The EPA regulation “Data Requirements for Regist ration,” 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 Oct ober 26, 2007, the Agency promulgated final rules establishing updated data requirements for conventi onal, 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 Ag ency preserved the original Part 158 data requirements to provide continue d regulatory coverage for antimi crobial pesticides until the Agency could promulgate a final regulation. To accomplish this, the Agency transferred intact the original 1984 data requirements into a ne w 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 antimic robial pesticides found in Part 161. Once subpart W of Part 158 is promulgated as a fina l rule and becomes effective, Part 161 will be

obsolete and will be removed. Un til that occurs, registrants are to consult Appendix A of Part 161 (the Use Pattern Index) and the data requirement s table as they seek to determine what data may be required for any particular use pa ttern. 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 dete rmine 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 mu st submit an applicati on for registration that includes, among other things, test results or citations for test resu lts (submitted by other registrants or available in publis hed literature) to satisfy data requirements. The costs of complying with the specific data requirements va ry depending on the type of registration and use

pattern.

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Page 26 of 58 Section 3.1.1 explained that the Ag ency would expect to require data from eight of the nine disciplines for the registration of prion produc ts. Those disciplines are: Product Chemistry, Toxicology, Nontarget Organisms, Nontarge t Plant Protection, Applicator Exposure, Environmental Fate, Residue Chemistry, and Produc t Performance. In the case of currently registered active ingredients, the Agency would have already collect ed 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 woul d 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 estim ates of how much it would cost for them to conduct specific studies that would be required unde r the proposed rule. Laboratories made these estimates using study design options that were provided to th em. The study designs were constructed using existing test protocols, and a dhered to Office of Pesticide Pr evention and Toxic Substances guidelines. High cost and low cost estimates we re 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 da ta will be required under the propos ed rule in accordance with Option 1 are based on statistics from EPA OPP re gistration data (how often certain data are commonly required for a particular registrati on action) and on the pr ofessional judgment of experienced EPA staff.

The estimated probabilities of da ta requirements relating to the pr oposed 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 acti ons that tests are likely to be required (should the proposed rule be finalized) for new active in gredients 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 c ould occur – applications for registration of: (1) a new active ingredient (AI), (2) a major new use produc t, or (3) a major new use amendment. Costs estimates for these regi stration 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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Page 27 of 58 4.2.2.2 Cost Variation Based on Exposure Category

One factor that determines whether an indivi dual test will be requi red 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 pr oducts have been for use on hard, non-porous surfaces, primarily laboratory surfaces and equipm ent, which are classified as high-exposure. Another potential end use, treatm ent of meat-processing equipment, is also classified as high exposure. Potential low exposure uses of pri on products would include wastewater treatments (See Table 3-4).

4.3 C OST E STIMATION

4.3.1 Incremental Costs per Registration Action

To estimate the cost of a registration action, th e 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 an d the use pattern (i.e., exposure category).

Methodology

The expected cost of data to regist er a prion product of a given type, E[data cost i ] , is the sum, over all data requirements, of the cost of mee ting a requirement multiplied by the probability that the test will be required. The t ype of prion product refers to th e 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

i i t prob c cost data E

t t i ∀

⋅ = 

## ∑ ) | ( ] [ (4.1)

where

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

t designates tests or informational requirements

c t , 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 cost s. For example, applicants may cite existing

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Page 28 of 58 data that were previously generated and submitte d by another registrant for a similar product or data found in the public literature provided it me ets the testing guideline s. If previously generated information is proprieta ry as in the case where another registrant owns the data, an applicant may have to compensate the owner of th e data, but that may sti ll be less costly than generating new information. If the information bel ongs to the applicant or is publicly available, however, the costs may essentially be zero. Howeve r, some data are product specific (such as efficacy data); therefore, some data would n eed 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-pr oduct registration scenarios and ei ght “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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Page 29 of 58 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 antimic robial 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 fo r prions for high exposure uses along with other non-prion uses. Regulation of pr ion 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 antimic robial 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 anot her 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 th at would be required to register a new

sterilant or disinfectant AI.

New Use

Product A currently registered AI with antimic robial 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 e xposure uses along with other non-prion low exposure uses. Regulation of prion pr oducts 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 antimic robial 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 fora major new amendment; however, the only data requirement would be productspecific efficacy data.

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Page 30 of 58 Table 4-2 presents the expected costs of regi stration at the baseline, expected costs of registration under the proposed rule, and the incr emental costs of the proposed rule based on

the methods for cost calculati on described in Section 4.3.1. It is important to note that the costs for major new use product registrations re present upper bounds. It is possible and even likely that some of the generic data require ments could be satisfied by existing data and would not need to be regenerated by the registra nt. 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 ingr edient 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)

N EW A CTIVE
I NGREDIENT M AJOR N EW U SE
P RODUCT M AJOR N EW U SE
A MENDMENT

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 no t 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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Page 31 of 58 4.3.2.1 Methodology

The expected annual cost of the rule to industr y is the expected per-product incremental cost times the expected number of products registered per year.

] [ ] [ ] [

, i

i t i t cost l incrementa E N E Cost Industry E

⋅ = 

## ∑ (4.2)

where,

N

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

E[incremental cost i ] is the difference between data co sts 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 Cost Industry E Cost Industry NPV 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 regi stration 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 appr oximately three registratio ns for prion products in the first year after the rule take s effect. It is important to not e that this number is highly speculative and may be an overestimate. Base d on information from Section 18 exemptions, recommendations in the scientific literature, a nd knowledge of the market for prion products, the Agency assumes that there may be three applicat ions for major new use product registrations in high exposure end uses.

Section 18 exemptions have been issued to eigh t 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 recommende d by the WHO and other scientific literature for reducing the infectivity of prions, namely sodium hypochlorite and sodium hydroxide.

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Page 32 of 58 The Agency predicts that the company which produces the aqueous phe nolic product currently being used under the Section 18 emergency exempti ons issued to several states will apply for a registration; its interest in doing so is inferre d from its willingness to support the Section 18 exemption for its product. This product is an an timicrobial 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 regi strations would also be classified as major new uses since they are already register ed 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 produc es a product which has the same active ingredients and uses as a currently registered product) may be able to cite the initial registrant’s ge neric data and submit product-specifi c efficacy data for a major new use amendment. Whether any firms choose to pursu e a registration for a major new use amendment after the initial registrations woul d 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 hypo chlorite are used in numerous settings other than as prion products, including water treatment, household sa nitation, and industrial processes. Sodium hypochlorite, for example, is used to treat 85 to 90% of recrea tional water, and both sodium hypochlorite and sodium hydroxide are commodity ch emicals. Based on the scale of the sodium hydroxide and sodium hypochlorite markets, the Agency does not be lieve that prion products are an important market segment for sodium hydroxi de or sodium hypochlorite producing firms and does not anticipate many applications for product registrations beyond the fi rst 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 se e any reason to think that there would be more than this in the first year.

The costs of data requirements for a major ne w use product registration for a high exposure use are approximately $2.35 million (See Table 4-2). Acco rdingly, the total cost to industry for the hypothetical scenario three new major new use produc ts in the first year would be approximately $7.05 million (See Table 4-3). If all three registrati ons 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 produc t 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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Page 33 of 58 Table 4-3. Total Industry Cost in First Year After Rule Takes Effect ($000s)*

N EW A CTIVE
I NGREDIENT M AJOR N EW U SE
P RODUCT M AJOR N EW U SE
A MENDMENT

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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Page 34 of 58 

### 5 S MALL 

### B USINESS 

### A NALYSIS

The Regulatory Flexibility Act (RFA) requires fe deral 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 sect ion is to determine whether the pr oposed rule is likely to have a significant impact on a substantial number of small entities.

5.1 M ETHODOLOGY

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 I NDUSTRY P ROFILE

Products used to reduce the infectivity of pri ons are typically classi fied as antimicrobial pesticides. Antimicrobial pesticides are chemic als that are used to control microbiological

contamination and deterioration in industrial an d consumer products and applications. Also referred to as ”specialty biocides,”’ antimicrobial agents work to “disinfe ct, 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 antimicro bial pesticide industry using information from the Office of Pesticide Programs Informati on Network (OPPIN), a database containing information on pesticide registrations. The ex ercise identified 859 companies having one or

more FIFRA Section 3 or FIFRA Section 24(c) antimicrobial pest icide 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 fi rms 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 include s one product that currently lists prions as a target pest unde r FIFRA Section 18s, one sodium hydroxide based product, and one sodium hypochlorite based product. In addition, the Agency believe s that there is a possibility that additional registrants of sodium hydroxide based products and sodium hypochlorite based products will pursue me-too registrations. Theref ore, the portion of th e antimicrobial industry potentially impacted by the proposed rule is comprised of sodium hydroxide and sodium

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Page 35 of 58 hypochlorite registrants, as well as the potential registrants of Envi ron 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 classifi cations. The most common classification is “Chemical Manufacturing.” Out of the 209 fi rms 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 we re listed as unclassified establ ishments and 22 firms were not

listed in the D&B database.

Table 5-1. Potential Prion Product Regi strants 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 Ameri can Industrial Classificati on System code (NAICS).

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Page 36 of 58 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 standard s (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 re venues 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 ma nufacturing industry are considered small businesses when they have less than 500 employees. Many of the firms id entified as potential prion product registrants operate primarily in other industries, but b ecause the proposed rule will affect only the registration of pesticide products, all firms with less than 500 empl oyees are considered small.

For the 177 firms for which employment data wa s 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 sa les 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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Page 37 of 58 5.3 I NCREMENTAL I MPACT PER S MALL F IRM

Of the three major new use product registration a pplications that the Agency expects may be received in the first year that th e 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 th ree 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 a pplications 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 sma ll firm. According to Table 5-2, the average

annual revenue of a small firm in this industr y is approximately $22 million. If these firms registered major new use products for high exposur e uses, the most likely registration scenario, the cost would be $2.35 million (Table 4-2), ju st 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, th e 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 redu ce 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 comp any 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 cr iteria and, therefore, does not cons ider this a potential scenario.

In many cases, after an original new use was regist ered, a subsequent “me-t oo” registrant may be able to cite the initial registrant’s generic da ta 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 expos ure, respectively. This cost would represent approximately 2% of a small firm ’s average annual revenues.

Firms may even be able to further reduce th e cost of generic a nd/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 C ONCLUSIONS

The Agency concludes that the proposed rule will not have a significant impact on a substantial

number of small entities. As discussed in Sect ion 4, only three firms are expected to apply for registrations of prion products a nd 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 possi ble 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 pri on products are an important market segment for sodium hydroxide or sodium hypochlorite produc ing firms and does not anticipate a large

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Page 38 of 58 number of product registrations beyond the first y ear the proposed rule ta kes effect. If small entities apply to register products for prion control, they would likely pursue a registration where they could likely cite a substa ntial amount of data and not incu r 100% of the initial costs of testing.

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Page 39 of 58 

### 6 ICR A NALYSIS

In addition to the cost associated with cha nges to registration requi rements 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, mainta in 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 docum ent called an Information Collection Request (ICR), which is reviewed and approved by the Pr esident’s Office of Management and Budget.

There are two ICRs relevant to the registration of antimicrobial pesticid es making prion related claims: the existing Section 3 registration I CR (Application for New and Amended Pesticide Registration, OMB Control Number 2070-0060) a nd the tolerance petition ICR (Tolerance Petitions for Pesticides on Food/ Feed Crops and New Inert Ingredient s, 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 acco unt for the increased number of registration activities associated with the proposed rule making. The Agency does not believe that amendments of respondent burden hour estimate s for single registration and tolerance petition actions are warranted because the process and ac tivities 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 partic ipation prompted by the final rule. In other words, the Agency expects three additional regist ration/tolerance actions to be submitted in the first year that will be subject to this rule. Gi ven data limitations and uncertainty about future events, the Agency does not make further specu lation about the expect ed number of prion product registrations.

6.1 R EGISTRANT P APERWORK B URDEN

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 antimic robial pesticide, or a biopestici de. 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 conventi onal pesticides, which make up the bulk of the

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Page 40 of 58 registrations, i.e., 89 out of 140 of the anticipated annual registra tion actions over the course of the ICR period.

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Page 41 of 58 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 conventiona l pesticides, antimicrobial pest icides, or biopesticides (EPA, 2009). The Agency estimates 1,726 total hours fo r paperwork burden per registration of each new active ingredient or major new use product.

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Page 42 of 58 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 maki ng prion related claims are expected to be a very small portion of total new registration appl ication and tolerance petitions submitted to the Agency. In this assessment, the Agency estima tes that there will be th ree major new use product registrations in the first year of registration of antimicrobial pr oducts making prion related claims (see Section 4.3.2). Given data limitations and un certainty 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 conservati ve, 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 requir e 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 re nder a more conservative estimate.

The additional registration of three antimicrobial products making prion rela ted 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. Like wise, the additional registration of three antimicrobial products making prion related clai ms will result in an in crease 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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Page 43 of 58 6.2 A GENCY P APERWORK B URDEN

The Agency (EPA, 2008b) estimates that evalua ting 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 techni cal 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 bur den. 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 pe titions per year, over a three year period, requires 49,920 h ours or about 24 Full Time Equivalents (FTE) of staff time. The majority of the burden is for technical staff a nd 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 activ e 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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Page 44 of 58 

### 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 consu ltation, Geneva, Swit zerland, 23-26 March 1999

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Page 45 of 58 

### A PPENDIX 

### A: D ESCRIPTIONS OF 

### NAICS C ODES

Pesticide and Other Agricultural Chem ical Manufacturing (NAICS 325320)

The pesticide manufacturing i ndustry includes establishments primarily engaged in the formulation and preparation of agricultural and ho usehold pest control chemicals. Many of these companies register products with EPA as re quired by FIFRA. According to an analysis conducted by EPA in 2005, the antimicrobial pe sticide manufacturing universe comprises approximately 859 companies, all of wh ich the proposed rule may impact.

Colleges, Universities, and Profes sional Schools (NAICS 611310)

This industry comprises establishments primaril y engaged in furnishing academic courses and granting degrees at baccalaureate or graduate levels. These entitie s also engage in research and experimental development in the physical, engine ering, or life sciences, such as agriculture, environmental sciences, biology, botany, biotech nology, chemistry, food, fisheries, forestry, health, medicine, physics, veteri nary and other allied subjects.

R&D in the Physical, Engineering, a nd Life Sciences (NAICS 541712)

This industry comprises establishments pr imarily engaged in conducting research and experimental development (except biotechnology re search and experimental development) in the physical, engineering, or life sciences, such as agriculture, electronics, environmental, biology, botany, computers, chemistry, food, fisheries, fore sts, geology, health, mathematics, medicine, oceanography, pharmacy, physics, veteri nary and other allied subjects.EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 46 of 58APPENDIXB:EXPECTEDCOSTS OFDATAREQUIREMENTSFrequencies of Data RequirementsExpected CostsHigh Exposure Low ExposureHigh Exposure Low ExposureTest NameGuideline No.AverageTest CostNAI*MNUP* MNUA* NAI MNUP MNUANAI MNUP MNUA NAI MNUP MNUAPRODUCTPERFORMANCE$430,600 $430,600 $430,600 $423,500 $424,258 $416,660Products for hard surfaces -EPA Disinfectant test810.2100 $6,600 100% 100% 100% 0%10% 10% $6,600 $6,600 $6,600 $0 $660 $660Products for hard surfaces -Sanitizer test, non food810.2100j $4,000 100% 100% 100%0% 0% 0% $4,000 $4,000 $4,000 $0 $0 $0Products for hard surfaces -Hard inanimate surface, nonfood810.2100l $4,000 100% 100% 100%0% 0% 0% $4,000 $4,000 $4,000 $0 $0 $0Products for fabrics/textiles -EPA Carpet Sanitizer810.2300b $3,250 0% 0% 0%0% 3% 3% $0 $0 $0 $0 $98 $0Products for air sanitizers 810.2400 $5,500 0% 0% 0% 0%0% 0% $0 $0 $0 $0 $0 $0Products for microbial pestsassociated with human andanimal waste810.2600 $5,720 0% 0% 0%0% 0% 0% $0 $0 $0 $0 $0 $0Products for treating watersystems AOAC - waterdisinfectants pools810.2700d $7,500 0% 0% 0% 100%100% 0% $0 $0 $0 $7,500 $7,500 $0Products with Prion RelatedClaims810.xxxx$416,000 100% 100% 100% 100%100% 100% $416,000 $416,000 $416,000 $416,000 $416,000 $416,000PRODUCT CHEMISTRY $133,709 $40,871 $0 $63,159 $35,222 $0Product identity andcomposition830.1550 $223 100% 38% 0% 71%47% 0% $223 $85 $0 $158 $105 $0Description of materials used toproduce the product830.1600 $334 100% 25% 0% 57%40% 0% $334 $84 $0 $190 $134 $0Description of productionprocess830.1620 $418 50% 38% 0% 71%33% 0% $209 $159 $0 $297 $138 $0Description of formulationprocess830.1650 $418 100% 38% 0% 57%33% 0% $418 $159 $0 $238 $138 $0Discussion of formulation ofimpurities830.1670 $418 0% 38% 0% 71%33% 0% $0 $159 $0 $297 $138 $0Preliminary analysis 830.1700 $29,465 100% 38%0% 71% 30% 0% $29,465 $11,197 $0 $20,920 $8,840 $0Certified limits 830.1750 $248 100% 25%0% 100% 50% 0% $248 $62 $0 $248 $124 $0Enforcement analytical method 830.1800 $15,455 100%13% 0% 14% 37% 0% $15,455 $2,009 $0 $2,164 $5,718 $0Submittal of samples 830.1900 $495 0%0% 0% 0% 7%0% $0 $0 $0 $0 $35 $0* NAI = New ActiveIngredient; MNUP = MajorNew Use Product; MNUA =Major New Use AmendmentEO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 47 of 58Frequencies of Data Requirements Expected CostsHigh ExposureLow ExposureHigh ExposureLow ExposureTest NameGuidelineNo.AverageTestCostNAIMNUPMNUANAIMNUPMNUANAIMNUPMNUANAIMNUPMNUAPRODUCT CHEMISTRY(cont)Color 830.6302 $700 100% 38% 0% 86% 37% 0% $700 $266 $0 $602 $259 $0Physical state 830.6303 $700 100% 38% 0% 86% 47% 0% $700 $266 $0 $602 $329 $0Odor 830.6304 $700 100% 38% 0% 86% 33% 0% $700 $266 $0 $602 $231 $0Stability to normal andelevated temperatures,metals, and metal ions830.6313 $8,250 100% 38% 0% 73% 23% 0% $8,250 $3,135 $0 $6,023 $1,898 $0Oxidation/reduction:chemical incompatibility830.6314 $2,994 100% 0% 0% 57% 20% 0% $2,994 $0 $0 $1,707 $599 $0Flammability 830.6315 $2,000 100% 25%0% 57% 23% 0% $2,000 $500 $0 $1,140 $460 $0Explodability 830.6316 $4,163100% 25% 0% 29% 23%0% $4,163 $1,041 $0 $1,207 $957 $0Storage stability 830.6317 $11,500 100% 25%0% 57% 23% 0% $11,500 $2,875 $0 $6,555 $2,645 $0Miscibility 830.6319 $1,100 50% 0%0% 0% 17% 0% $550 $0 $0 $0 $187 $0Corrosion characteristics 830.6320 $2,750 100% 0% 0% 43% 40% 0% $2,750 $0 $0 $1,183 $1,100 $0Dielectric breakdown voltage 830.6321 $2,52550% 0% 0% 0% 7% 0% $1,263 $0 $0 $0 $177 $0pH 830.7000 $750 100% 13% 0% 71% 37% 0% $750 $98 $0 $533 $278 $0UV/visible light absorption 830.7050 $2,02233% 25% 0% 14% 7% 0% $667 $506 $0 $283 $142 $0Viscosity 830.7100 $1,400 100% 0% 0% 14% 30% 0% $1,400 $0 $0 $196 $420 $0Melting point/melting range 830.7200 $1,200 100%25% 0% 14% 20% 0% $1,200 $300 $0 $168 $240 $0Boiling point/boiling range 830.7220 $1,500 50% 38% 0% 29% 17% 0% $750 $570 $0 $435 $255 $0Density/relative density/bulkdensity830.7300 $1,400 100% 38% 0% 86% 47% 0% $1,400 $532 $0 $1,204 $658 $0Dissociation constants inwater830.7370 $4,845 50% 25% 0% 29% 17% 0% $2,423 $1,211 $0 $1,405 $824 $0Particle size, fiber length, anddiameter distribution830.7520 $1,333 5% 5% 0% 5% 5% 0% $67 $67 $0 $67 $67 $0Partition coefficient (noctanol/water) - shake flaskmethod830.7550 $6,667 50% 13% 0% 0% 13% 0% $3,334 $867 $0 $0 $867 $0Partition coefficient (noctanol/water) -generatorcolumn830.7560 $6,667 50% 13% 0% 0% 13% 0% $3,334 $867 $0 $0 $867 $0Partition coefficient (noctanol/water) -estimationchromatography830.7570 $4,388 50% 13% 0% 0% 13% 0% $2,194 $570 $0 $0 $570 $0Water Solubility: columnelution/shake flask830.7840 $9,635 100% 38% 0% 43% 17% 0% $9,635 $3,661 $0 $4,143 $1,638 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 48 of 58Water solubility 830.7860 $9,635 100% 38%0% 43% 17% 0% $9,635 $3,661 $0 $4,143 $1,638 $0Vapor pressure 830.7950 $15,000 100% 38% 0% 43% 17% 0% $15,000 $5,700 $0 $6,450 $2,550 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 49 of 58Frequencies of Data Requirements Expected CostsHigh ExposureLow ExposureHigh ExposureLow ExposureTest NameGuidelineNo.AverageTestCostNAIMNUPMNUANAIMNUPMNUANAIMNUPMNUANAIMNUPMNUATOXICOLOGY$2,348,869$1,445,413 $0 $779,702 $418,902 $0Acute TestingAcute oral toxicity - rat 870.1100 $3,474 100%38% 0% 86% 40% 0% $3,474 $1,320 $0 $2,988 $1,390 $0Acute dermal toxicity 870.1200 $5,437 50%38% 0% 71% 37% 0% $2,719 $2,066 $0 $3,860 $2,012 $0Acute inhalation toxicity - rat870.1300 $26,275 50% 38% 0% 43% 30% 0% $13,138 $9,985 $0 $11,298 $7,883 $0Acute dermal irritation 870.2500 $2,000 100%38% 0% 71% 37% 0% $2,000 $760 $0 $1,420 $740 $0Dermal sensitization 870.2600 $7,589 100% 38%0% 71% 30% 0% $7,589 $2,884 $0 $5,388 $2,277 $0Acute neurotoxicity - rat 870.6200 $89,597 50% 25%0% 14% 10% 0% $44,799 $22,399 $0 $12,544 $8,960 $0Subchronic Testing90-day oral toxicity - rodents 870.3100 $138,106 100% 63% 0% 71% 17% 0% $138,106 $87,007 $0 $98,055 $23,478 $090-day oral toxicity -nonrodents870.3150 $221,047 50% 63% 0% 14% 7% 0% $110,524 $139,260 $0 $30,947 $15,473 $021/28-day dermal toxicity 870.3200 $83,2400% 0% 0% 0% 10% 0% $0 $0 $0 $0 $8,324 $090-day dermal toxicity 870.3250 $137,604 50% 13%0% 14% 10% 0% $68,802 $17,889 $0 $19,265 $13,760 $090-day inhalation toxicity -rat870.3465 $489,879 0% 13% 0% 43% 3% 0% $0 $63,684 $0 $210,648 $14,696 $090-day Neurotoxicity - rat 870.6200 $184,039 50%0% 0% 0% 3% 0% $92,020 $0 $0 $0 $5,521 $0Chronic TestingChronic oral toxicity - rodent 870.4100$1,071,40150% 25% 0% 14% 10% 0% $535,701 $267,850 $0 $149,996 $107,140 $0Carcinogenicity - two rodentspecies - rat and mousepreferred870.4200$1,508,34150% 25% 0% 0% 3% 0% $754,171 $377,085 $0 $0 $45,250 $0Developmental Toxicity &ReproductionPrenatal developmentaltoxicity - rat and rabbitpreferred870.3700 $76,941 100% 50% 0% 86% 23% 0% $76,941 $38,471 $0 $66,169 $17,696 $0Reproduction and fertilityeffects870.3800 $379,856 50% 63% 0% 0% 7% 0% $189,928 $239,309 $0 $0 $26,590 $0Developmental neurotoxicity 870.6300 $407,020 10% 5%0% 10% 5% 0% $40,702 $20,351 $0 $40,702 $20,351 $0MutagenicityReverse mutation assay 870.5100 $4,257 100%38% 0% 86% 7% 0% $4,257 $1,618 $0 $3,661 $298 $0In vitro mammalian genemutation870.5300 $19,211 100% 63% 0% 57% 20% 0% $19,211 $12,103 $0 $10,950 $3,842 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 50 of 58In vitro mammalianchromosomal aberration870.5375 $26,856 100% 63% 0% 57% 20% 0% $26,856 $16,919 $0 $15,308 $5,371 $0Mammalian spermatogonialchromosomal aberration870.5380 $19,382 100% 63% 0% 57% 20% 0% $19,382 $12,211 $0 $11,048 $3,876 $0Mammalian bone marrowchromosomal aberration870.5385 $30,004 100% 63% 0% 57% 20% 0% $30,004 $18,903 $0 $17,102 $6,001 $0Frequencies of Data RequirementsExpected CostsHigh ExposureLow ExposureHigh ExposureLow ExposureTest NameGuidelineNo.AverageTestCostNAIMNUPMNUANAIMNUPMNUANAIMNUPMNUANAIMNUPMNUATOXICOLOGY (cont)Mammalian erthrocytemicronucleus870.5395 $20,536 100% 63% 0% 57% 20% 0% $20,536 $12,938 $0 $11,706 $4,107 $0Special TestingCompanion animal safety 870.7200 $156,0000% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Metabolism andpharmacokinetics870.7485 $182,729 50% 13% 0% 0% 7% 0% $91,365 $23,755 $0 $0 $12,791 $0Dermal penetration 870.7600 $147,529 0%0% 0% 0% 3% 0% $0 $0 $0 $0 $4,426 $0Immunotoxicity 870.7800 $56,648 100% 100% 0%100% 100% 0% $56,648 $56,648 $0 $56,648 $56,648 $0NONTARGETORGANISM$937,211 $135,387 $0 $154,294 $106,318 $0Tier One TestingAcute avian oral toxicity 850.2100 $10,100 100%38% 0% 100% 25% 0% $10,100 $3,838 $0 $10,100 $2,525 $0Acute freshwater invertebratetoxicity850.1010 $17,000 100% 38% 0% 100% 25% 0% $17,000 $6,460 $0 $17,000 $4,250 $0Acute freshwater fish toxicity 850.1075 $11,957 100%38% 0% 100% 25% 0% $11,957 $4,544 $0 $11,957 $2,989 $0Higher Tier TestingAvian dietary toxicity 850.2200 $6,480 100%13% 0% 29% 13% 0% $6,480 $842 $0 $1,879 $842 $0Avian reproduction 850.2300 $168,250 1% 1%0% 1% 1% 0% $1,683 $1,683 $0 $1,683 $1,683 $0Acute freshwater invertebratetoxicity850.1010 $17,000 100% 38% 0% 100% 25% 0% $17,000 $6,460 $0 $17,000 $4,250 $0Acute oyster toxicity 850.1025 $20,138 100% 13%0% 14% 10% 0% $20,138 $2,618 $0 $2,819 $2,014 $0Acute mysid toxicity 850.1035 $20,138 100% 13%0% 14% 10% 0% $20,138 $2,618 $0 $2,819 $2,014 $0Acute penaeid toxicity 850.1045 $20,138 100% 13%0% 14% 10% 0% $20,138 $2,618 $0 $2,819 $2,014 $0Acute bivalve larval toxicity 850.1055 $20,138100% 13% 0% 14% 10% 0% $20,138 $2,618 $0 $2,819 $2,014 $0Acute estuarine & marineorganism toxicity850.1075 $11,576 100% 38% 0% 100% 17% 0% $11,576 $4,399 $0 $11,576 $1,968 $0Acute freshwater fish toxicity 850.1075 $11,957 100%38% 0% 100% 25% 0% $11,957 $4,544 $0 $11,957 $2,989 $0Aquatic invertebrate lifecycle - daphnid chronic850.1300 $118,063 100% 1% 0% 5% 1% 0% $118,063 $1,181 $0 $5,903 $1,181 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 51 of 58toxicityAquatic invertebrate lifecycle - mysid chronic toxicity850.1350 $36,334 100% 1% 0% 5% 1% 0% $36,334 $363 $0 $1,817 $363 $0Fish early-life stage toxicity 850.1400 $37,279 50%13% 0% 5% 10% 0% $18,640 $4,846 $0 $1,864 $3,728 $0Fish life-cycle toxicity 850.1500 $512,500 50% 13%0% 1% 3% 0% $256,250 $66,625 $0 $5,125 $15,375 $0Aquatic Bioavailability/Biomagnification: OysterBCF850.1710 $123,919 50% 1% 0% 5% 7% 0% $61,960 $1,239 $0 $6,196 $8,674 $0Aquatic Bioavailability/Biomagnification: Fish BCF850.1730 $140,452 50% 1% 0% 5% 7% 0% $70,226 $1,405 $0 $7,023 $9,832 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 52 of 58Frequencies of Data RequirementsExpected CostsHigh ExposureLow ExposureHigh ExposureLow ExposureTest NameGuidelineNo.AverageTestCostNAIMNUPMNUANAIMNUPMNUANAIMNUPMNUANAIMNUPMNUATOXICOLOGY (cont)Aquatic food chain transfer -Bioavailability850.1850 $325,000 50% 1% 0% 5% 7% 0% $162,500 $3,250 $0 $16,250 $22,750 $0Simulated or actual fieldtesting - aquatic organisms850.1950 $600,000 1% 1% 0% 1% 1% 0% $6,000 $6,000 $0 $6,000 $6,000 $0Simulated or actual fieldtesting - field animal850.1950 $512,500 1% 1% 0% 1% 1% 0% $5,125 $5,125 $0 $5,125 $5,125 $0Simulated or actual fieldtesting - insect predators850.1950 $87,500 1% 1% 0% 1% 1% 0% $875 $875 $0 $875 $875 $0Simulated or actual fieldtesting - plants850.1950 $62,500 1% 1% 0% 1% 1% 0% $625 $625 $0 $625 $625 $0Whole sediment; acutefreshwater invertebratestoxicity850.1735 $23,750 100% 1% 0% 5% 3% 0% $23,750 $238 $0 $1,188 $713 $0Whole sediment; acutemarine invertebrates toxicity850.1740 $37,500 5% 1% 0% 5% 3% 0% $1,875 $375 $0 $1,875 $1,125 $0Honey bee acute contacttoxicity850.3020 $3,175 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Toxicity of residues tohoneybees850.3030 $13,368 50% 0% 0% 0% 3% 0% $6,684 $0 $0 $0 $401 $0NONTARGET PLANTPROTECTION$92,748 $35,955 $0 $39,157 $38,962 $0Seedling emergence, Tier II 850.4225 $20,375 50% 1% 0% 5% 3% 0% $10,188 $204 $0 $1,019 $611 $0Vegetative vigor, Tier II 850.4250 $24,500 50%1% 0% 5% 3% 0% $12,250 $245 $0 $1,225 $735 $0Terrestrial plants field study,Tier III850.4300 $76,682 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Aquatic plant toxicology testusing Lemna spp., Tier II850.4400 $35,155 100% 1% 0% 5% 7% 0% $35,155 $352 $0 $1,758 $2,461 $0Aquatic plants field study,Tier III850.4450 $0 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Algal Toxicity Tier I and TierII850.5400 $35,155 100% 100% 0% 100% 100% 0% $35,155 $35,155 $0 $35,155 $35,155 $0APPLICATOREXPOSURE$87,838 $49,169 $0 $87,838 $42,526 $0Dermal outdoor exposure 875.1100 $167,857 10% 5%0% 10% 3% 0% $16,786 $8,393 $0 $16,786 $5,036 $0Dermal indoor exposure 875.1200 $126,429 10% 5%0% 10% 5% 0% $12,643 $6,321 $0 $12,643 $6,321 $0Inhalation outdoor exposure 875.1300 $164,286 10% 5%0% 10% 3% 0% $16,429 $8,214 $0 $16,429 $4,929 $0Inhalation indoor exposure 875.1400 $126,429 10% 5%0% 10% 5% 0% $12,643 $6,321 $0 $12,643 $6,321 $0Biological monitoring 875.1500 $188,378 10% 5%0% 10% 5% 0% $18,838 $9,419 $0 $18,838 $9,419 $0Data reporting and 875.1600 $7,500 100% 100%0% 100% 100% 0% $7,500 $7,500 $0 $7,500 $7,500 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 53 of 58calculationsProduct use information 875.1700 $3,000 100%100% 0% 100% 100% 0% $3,000 $3,000 $0 $3,000 $3,000 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 54 of 58Frequencies of Data RequirementsExpected CostsHigh ExposureLow ExposureHigh ExposureLow ExposureTest NameGuidelineNo.AverageTestCostNAIMNUPMNUANAIMNUPMNUANAIMNUPMNUANAIMNUPMNUAPOST-APPLICATIONEXPOSURE$73,038 $38,269 $0 $28,850 $18,925 $0Soil residue dissipation 875.2200 $83,1250% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Indoor surface residuedissipation875.2300 $35,000 25% 10% 0% 0% 0% 0% $8,750 $3,500 $0 $0 $0 $0Dermal exposure 875.2400 $125,500 10% 5% 0%10% 5% 0% $12,550 $6,275 $0 $12,550 $6,275 $0Inhalation exposure 875.2500 $73,000 10% 5%0% 10% 5% 0% $7,300 $3,650 $0 $7,300 $3,650 $0Biological monitoring 875.2600 $166,875 10%5% 0% 0% 0% 0% $16,688 $8,344 $0 $0 $0 $0Product use information 875.2700 $3,000 100%100% 0% 100% 100% 0% $3,000 $3,000 $0 $3,000 $3,000 $0Description of human activity 875.2800 $3,000 100%100% 0% 100% 100% 0% $3,000 $3,000 $0 $3,000 $3,000 $0Data reporting andcalculations875.2900 $3,000 100% 100% 0% 100% 100% 0% $3,000 $3,000 $0 $3,000 $3,000 $0Non-dietary ingestionexposure875.3000 $75,000 25% 10% 0% 0% 0% 0% $18,750 $7,500 $0 $0 $0 $0ENVIRONMENTALFATE$340,859 $72,162 $0 $73,841 $82,673 $0Degradation Studies -LaboratoryHydrolysis 835.2120 $25,230 100% 100% 0% 100% 100% 0% $25,230 $25,230 $0 $25,230 $25,230 $0Photodegradation in water 835.2240 $47,875 50%13% 0% 5% 7% 0% $23,938 $6,224 $0 $2,394 $3,351 $0Photodegradation on soil 835.2410 $42,3500% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Biodegradation Studies -LaboratoryActivated Sludge SorptionIsotherm835.1110 $10,051 100% 100% 0% 100% 100% 0% $10,051 $10,051 $0 $10,051 $10,051 $0Ready Biodegradability 835.3110 $10,364 100% 100% 0%100% 100% 0% $10,364$10,364 $0 $10,364 $10,364 $0Modified Activated Sludge,Respiration Inhibition850.6800 $5,126 100% 100% 0% 100% 100% 0% $5,126 $5,126 $0 $5,126 $5,126 $0Mobility StudiesSediment and soiladsorption/desorption835.1230 $23,750 50% 13% 0% 5% 10% 0% $11,875 $3,088 $0 $1,188 $2,375 $0Leaching andadsorption/desorption835.1240 $46,780 50% 13% 0% 5% 7% 0% $23,390 $6,081 $0 $2,339 $3,275 $0Metabolism Studies -LaboratoryAerobic soil metabolism 835.4100 $94,375 50% 1% 0% 5% 7% 0% $47,188 $944 $0 $4,719 $6,606 $0Anaerobic soil metabolism 835.4200 $71,300 50% 1% 0% 5% 3% 0% $35,650 $713 $0 $3,565 $2,139 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 55 of 58Aerobic aquatic metabolism 835.4300 $44,475 100%1% 0% 5% 7% 0% $44,475 $445 $0 $2,224 $3,113 $0Anaerobic aquaticmetabolism835.4400 $79,400 100% 1% 0% 5% 10% 0% $79,400 $794 $0 $3,970 $7,940 $0Dissipation Studies - FieldAquatic field dissipation 835.6200 $267,250 1% 1% 0% 1% 1% 0% $2,673 $2,673 $0 $2,673 $2,673 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 56 of 58Frequencies of Data RequirementsExpected CostsHigh ExposureLow ExposureHigh ExposureLow ExposureTest NameGuidelineNo.AverageTestCostNAIMNUPMNUANAIMNUPMNUANAIMNUPMNUANAIMNUPMNUAENVIRONMENTALFATE (cont)Ground and Surface WaterMonitoringMonitoring of representativeU.S. watersnone $215,833 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Special StudiesLeaching study none $43,000 50% 1%0% 0% 1% 0% $21,500 $430 $0 $0 $430 $0RESIDUE CHEMISTRY$271,485 $102,633 $0 $0 $0 $0Supporting InformationChemical identity 860.1100 $1,250 100% 25% 0% 0% 0% 0% $1,250 $313 $0 $0 $0 $0Directions for use 860.1200 $4,000 100%25% 0% 0% 0% 0% $4,000 $1,000 $0 $0 $0 $0Proposed tolerance 860.1550 $5,362 100% 25% 0% 0% 0% 0% $5,362 $1,341 $0 $0 $0 $0Reasonable grounds insupport of petition860.1560 $10,000 100% 25% 0% 0% 0% 0% $10,000 $2,500 $0 $0 $0 $0Submittal of analyticalreference standards860.1650 $334 50% 10% 0% 0% 0% 0% $167 $33 $0 $0 $0 $0Nature of the ResidueNature of the residue inplants860.1300 $100,000 5% 1% 0% 0% 0% 0% $5,000 $1,000 $0 $0 $0 $0Nature of the residue inlivestock860.1300 $105,833 5% 1% 0% 0% 0% 0% $5,292 $1,058 $0 $0 $0 $0Analytical MethodsResidue analytical method -plants860.1340 $21,125 5% 1% 0% 0% 0% 0% $1,056 $211 $0 $0 $0 $0Residue analytical method -livestock860.1340 $65,500 5% 1% 0% 0% 0% 0% $3,275 $655 $0 $0 $0 $0Multiresidue method 860.1360$24,000 5% 1% 0% 0% 0% 0% $1,200 $240 $0 $0 $0 $0Magnitude of the ResidueStorage stability data 860.1380 $18,500 50%25% 0% 0% 0% 0% $9,250 $4,625 $0 $0 $0 $0Water 860.1400 $53,750 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Fish 860.1400 $104,000 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Irrigated crops(one-crop)860.1400 $18,000 0% 0% 0% 0% 0% 0% $0 $0 $0 $0 $0 $0Food handling 860.1460 $205,000 50% 10% 0%0% 0% 0% $102,500 $20,500 $0 $0 $0 $0Meat/milk/poultry/eggs 860.1480 $149,000 5% 1% 0% 0% 0% 0% $7,450 $1,490 $0 $0 $0 $0Crop field trials 860.1500 $163,667 5% 25% 0% 0% 0% 0% $8,183 $40,917 $0 $0 $0 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 57 of 58Processed food/feed 860.1520 $35,000 5% 1% 0% 0% 0% 0% $1,750 $350 $0 $0 $0 $0Reduction of Residues 860.1540 $15,0005% 1% 0% 0% 0% 0% $750 $150 $0 $0 $0 $0Migration Studies none $105,000 100% 25%0% 0% 0% 0% $105,000 $26,250 $0 $0 $0 $0EO 12866 ReviewDRAFT – DO NOT Cite, Quote or ReleasePage 58 of 58