**Draft Document**  **for Public Review** 

- EPA is releasing this draft document solely

for the purpose of public review and comment. This draft document is not now, and has not yet been, formally disseminated by EPA. It does not represent and should not be const rued to represent any Agency policy or determination. Please submit comments to **Docket ID # EPA** **- HQ**  **- OPP**  **- 2007**  **- 0923**  at www.regulations.gov

. 

### At**tachment H** 

Office of Pesticide Programs O ctober 200 7 

# General Methodology Used to Estimate Paperwork Burden Hours and Costs by the Office of Pesticide Programs for Submission of Requi red Data/Information for Responding to a

Data Call

- In Notice**Page 2**  **of 30** 

**SECTION I**

**................................ ................................**  **................................ ............**  **3** BACKGROUND

................................ ................................ ................................ .... 3 I. Wh at is the purpose of this document?

................................ ........................... 3 II. Wh y does EPA issue DCIs ?

................................ ................................ ........... 3 III. How do PRA requirements relate to DCIs?

................................ ..................... 4 IV. H ow d oes a DCI recipient respond to a DCI?

................................ ................. 5 V. DCI b urd en a ctivities tables

................................ ................................ ............ 6 Ta ble 1

................................ ................................ ................................ ............ 6 Ta ble 2

................................ ................................ ................................ ............ 7 V I . Variations of the response to a DCI

................................ ................................ 8 a. Data generation in response to a DCI

................................ ..................... 8 b. Non

- data generation in responses a DCI

................................ ................ 9 **SECTION II**

**................................ ................................**  **................................ .........**  **10** ESTIMATING PAPERW ORK ACTVITIES OF DATA GENERATION

.................. 10 I. Wh at are the key assumptions when estimating PRA burden hours and costs for data generation?

................................ ................................ ............................ 10 a. Paperwork burden is generally 35% of the cost of the study.

................ 10 b. All registrants generate all DCI data

................................ .................... 1 2 II. How are test cost estimates developed?

................................ ....................... 12 III. Wh at if test cost estimates are unavailable?

................................ ................. 12 IV

. Wh at if the available test cost estimates vary?

................................ ............. 13 V. Wh at are the steps in calculating the p aperwork burden (hours and costs)? 13 a. Calculate test costs

. ................................ ................................ .............. 13 b. Distribute p aperwork activities a mong l abor categories.

....................... 13 c. Calculate p aperwork b urden h ours from l abor cost d istribution.

............ 14 V I

. Is the burden for those not generating data covered?

. ................................ 15 Attachment A: Case Studies: Agency analysis of response costs of non

- data generation

................................ ................................ ................................ .......... 1 7 1. S tudy #1 Review of the Application for New and Amended Pesticide Registration, OMB No. 2070

- 0060, (EPA ICR No. 0277.14) for non

- data generated burden hours and costs

. ................................ ........................... 1 7 2. Study #2 Data Generation for Pesticide Reregistration ICR, OMB No. 2070

- 0107, (EPA ICR No. 1504.05).

................................ .......................... 1 9 3. Study #3 Economic Analysis for Proposed Changes in Data Requirements Rule for Biochemical and Microbial Pesticides

– Cost Estimates for Data W aivers.

................................ ................................ ....... 2 1 Attachment B: FIFRA estimated test cost chart and PRA cost estimates

.......... 2 2 

## Contents**Page 3**  **of 30** 

**I. What is the purpose of this document?**  The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , requires federal agencies to estimate the “paperwork burden” for “information collection” activities . Under the PRA, “paperwork burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. Under the PRA, an

“ information collection ” means any request for information made by a federal agency of ten or more respondents, and may include a request to report, retain records, or disclose information to third parties. This document describes the methodology used by the Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) to est imate the paperwork burden hours and costs for stakeholders responding to Data Call

- In (DCI) Notices issued by OPP under section 3(c)(2)(B) of the Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA)

. T he methodology is intended to provide a descri ption of the process used by EPA to derive the estimated paperwork burden hours and costs associated with submitting a response to EPA u nder a DCI

. The methodology presented in this document should also enable stakeholders to reproduce the burden estimate s made by the Agency for DCI related collection activities. This increased transparency will enable the public to provide more substantive and meaningful feedback during public comment periods. This feedback will better enable the Agency to periodically amend the burden estimates. In addition, since the methodology presented here will be used by the Agency to estimate the paperwork burden for DCI requests, this document will serve as a reference for such calculations in the future. **II . Why**  **does EPA**

**iss ue DCIs**  **?** Wi th few exceptions, FIFRA requires EPA to evaluate all pesticides marketed and used in the United States to ensure that they will not pose unreasonable risks to h uman health and the environment. Pesticides that meet the requirements are grante d a license or “ registration ” that permits their distribution, sale, and use according to specific use directions and requirements identified on the label. Under the Federal Food, Drug, and Cosmetic Act (FFDCA) , EPA establishes tolerances ( defined as maxi mum allowed pesticide residue levels) to specify the amount of the pesticide residue that can legally remain in or on food or animal feed, using a safety standard of a “ reasonable certainty of no harm.”
EPA’s review and evaluation of a new, amended , or existing pesticide registration or tolerance require data of sufficient quality and quantity to characterize the pesticide ’s hazards and the potential risk from its intended uses. The data requested by the Agency, including the data requested in the DCI, a llow 

## Section I **. Background Page**  **4 of**  **30**

EPA to evaluate whether a pesticide meets the statutory standard for registration, and allow the Agency to establish the appropriate tolerance(s) for the pesticide under section 408 of the FFDCA

. Under section 3(c)(2)(B) of FIFRA EPA can require pest icide registrants to generate and submit data to the Agency, when such data are required to maintain an existing registration of a pesticide. EPA’s determination that additional data are needed could occur for various reasons, with the following four reas ons being the most common :

 **The Re**  **r egistration**  **Program :**  Section 4 of FIFRA requires EPA to re assess the health and safety data for all pesticide active ingredients registered before November 1, 1984, to determine whether these “older” pesticides meet the criteria for registration that would be expected of a pesticide being registered today for the first time. Section 4 directs EPA to use s ection 3 (c) ( 2 )( B) authority to obtain the required data

.  **The Registration Review**  **Program :**  S ection 3(g) of FIFRA contai ns provisions to ensure that each pesticide will be reviewed every 15 years to en sure that the pesticide continues to pose no risk of unreasonable adverse effects on human health or the environment . Section 3(g) instructs EPA to use the section 3 (c) ( 2 )( B) authority to obtain the required data.

 **The Special Review**  **Program :**  Though rare, EPA may conduct a Special Review if EPA believes that a registered pesticide poses risks of unreasonable adverse effects on human health or the environment. Section 3 (c) ( 2 ) ( B) of FIFRA provides a means of obtaining any needed data.

 **An ticipated Residue/Percent Crop Treated**  **Information :**  Under FFDCA , EPA can consider information on the anticipated levels of pesticide residues in food (the actual levels of pesticide residues tha t have been measured in food ) and data on the actual percent of food treated with the pesticide chemical

. The Agency must also provide for periodic re

evaluation of this information. Under FFDCA section 408(b)(2)(E), EPA can issue a DCI for information rel ating to anticipated residues , and under section 408(b)(2)(F) EPA can issue a DCI for percent crop treated estimates

. **III . How**  **do the PRA**

**requirements relate to DCIs ?**  The PRA states, “An agency may not conduct or sponsor, and a person is not required to respond to a “collection of information,” as defined at 5 CFR 1320.3(c), unless the “collection” displays a currently valid control number issued by the Office of Management and Budget (OMB)

. 1 EPA’s issuance of a DCI

1 OMB is part of the Executive Office of the President.**Page 5**  **of 30** 

under FIFRA section 3(c)(2)(B) is su bject to the PRA requirements because the DCI is considered a “collection of information” under the PRA. To comply with the PRA requirements, EPA must submit an Information Collection Request (ICR) that provide s specific information to OMB about the data that EPA intends to call in for a given pesticide, including: a list of required studies, the practical utility of the data, the estimated testing costs, and the estimated paperwork burden. Under the PRA, “ practical utility” means the actual, not merely the theoretical or potential, usefulness of information to or for an agency, taking into account its accuracy, validity, adequacy, and reliability, and the agency's ability to process the information it collects in a useful and timely fashion. 2 “Burden” means the time, effort, or financial resources expended by persons to generate, maintain, or provide information to or for a Federal Agency. 3 ” including resources to:

 review instructions;

 develop, acquire, install, and use technology and systems;

 search data sources;

 collect, review, validate, and verify information/data;

 process and maintain information/data;

 disclose and transmit/submit information/data;

 change/adjust the existing ways of complying with any previously applicable instructions and requ irements to comply with new requirements; and/or

 train personnel

. **I V.**  **How d**  **oes a**  **DCI r** **ecipient r** **espond t** **o a**  **DCI ?**  Response to a DCI can generally be divided into three phases.

 **Phase 1: Initial response:**  After receiving a DCI, the re cipient has 90 da ys to provide the initial response , which states how the recipient plans to comply with the DCI

. A registrant may avoid generating the data if he qualifies for a generic data exemption (i.e., he uses a registered pesticide as the source of the active ingredient in his own product), cancel s the product’s registration, submits or cite s existing data, or requests a waiver.

 **Phase 2: Data generation:**  Unless the DCI recipient can cite existing studies or is granted a waiver by the Agency, the DCI recipient must then generate the required data.

 **Phase 3: Data submission:**  DCI recipient submits the studies/information to EPA

. **V. DCI**  **b urden**  **a ctivities**  **t ables** 

2 5 CFR 1320.3(l) 3 5 CFR 1320.3(b)**Page 6**  **of 30** 

Table 1 illustrates the paperwork activities that would typical ly be performed by a DCI recipient during e ach of the three phases

. Note that the activities that are likely to occur have been divided into three categories of duties: managerial, technical and clerical. For this table, it was assumed that the data generation was performed at the request of the DCI recipient by a contract laboratory. Although DCI recipients can certainly choose to generate the data themselves, the Agency believes that the assumption used provides a sufficiently conservative estimate, and does not expect the burden estimate for DCI recipients to be more than the estimate. Table 1 includes **only** those duties performed directly by the DCI recipient.

**Table 1**
**– Response Phases**  **Managerial Duties Technical Duties**  **Clerical Duties PHA** **SE 1: INITIA L RESPONSE**  Read regulations Read re gulations Complete other required paperwork Review EPA’s DCI notice Review EPA’s DCI notice Communicate with EPA Assist with review of internal company information Plan DCI response Search for existing data Assist with search for existing data Sign and send initial response forms to EPA Prepare initial response forms for submission Oversight of employee activities **PHA SE 2(a): DA** **TA**

**GENERA TION USING CONTRA** **CT LA BORATORY**  Planning/oversight of employee and contract activities Plan the data collecti on activities with the laboratory Complete/file/archive other required paperwork Make decisions Electronic data entry Secure contract lab services and approve statement of work (SOW ) Create test protocols for SOW Communicate with EPA Ensures contract laboratory maintains records and procedures during testing period in accordance with the Good Laboratory Practices (GLPs)**Page 7**  **of 30** 

Oversight of employee and contract activities Routine contact with testing laboratory which can include on

site visits Analyze interim report and/or monthly report Proof draft final report Generate acceptance report **PHA SE 3: DA** 

**TA SUBMISSION TO EPA**  Sign

-off on submission to EPA Draft summary of the data for cover letter Prepare submission to EPA Close

- out contract Ove rsight of employee activities Complete other required paperwork Complete/file/archive other required paperwork Table 2 represents the PRA activities conducted at a contract laboratory . D ata are generated by following standard operating procedures , which involve mostly technical duties. As part of their duties under G ood L aboratory P ractices (GLP) , the scientists and technicians maintain logbooks and other records from which the final report is written. This table lists activities that occur in the cond uct of studies where the test subjects are animals. Activities associated with animal care would not occur in studies where the test subject is inanimate, such as product chemistry studies, environmental fate studies or residue chemistry studies. **Table 2**  **PHA SE 2(b): PRA** 

**DA TA**  **GENERA TION**  **ACTIVITIES CONDUCTED A T THE**  **CONTRA CT LA** **BORATORY*** **Technical Duties** Individual animal care records Records on the rooms in which animals are housed and procedures are performed Necropsy records Equipment logbooks and co mputer

-generated records such as chromatograms Records on preparation of analytical standards Freezer and storage area logbooks Chain

-of

- custody forms Quality control/quality assurance forms and review checks for accuracy Archive and transmittal of da ta forms *The Agency recognizes that in certain instances these activities might be conducted “in

- house

. ”

**V I**  **. Variations of**  **the r** **esponse to a DCI Page**  **8 of**  **30**

Because t here are multiple ways of responding to a DCI, not all DCI recipients participate in all three phases. A registrant would participate only in phase 1 if they:

 Voluntarily cancel the pesticide registration

 Delete the uses of the product to which the requirements apply

 Qualify for a generic data exemption

 Request and receive a data waiver

 Purchase/c ite existing data A registrant who purchase s/cite s existing data perform s Phase 1 I nitial response and Phase 3 Data S ubmission activities only . The initial response phase and the data submission phase are considered to have more -or- less fixed hours and co sts since reading the regulations and preparing submissions to the Agency are independent of the type of information submitted. U ntil the Agency receives the 90

- day response letters to the DCI notice from the registrants indicating what studies, if any, they will conduct, it is not possible to accurately predict the total cost and burden of developing the data. This methodology was prepared so that an average burden could be presented for a DCI recipient, regardless of the response they choose. Clearly , by assuming that all DCI recipients engage in all three activities the Agency has chosen to overestimate the burden for a DCI recipient who may not engage in any activities beyond Phase 1. The cost for DCI recipients who engage in a taskforce for data g eneration, voluntarily cancel the product or affected uses, submit or cite existing data, or are granted a waiver incur fewer burden hours and costs. 

### a. Data **g eneration in response to a DCI**  A registrant who chooses to generate data in response to the DC I may either:

 g enerate and submit the required data on their own , or
 g enerate and submit the required data as part of a taskforce

. D ata generation is considered the most expensive of the three phases

. However, the amount of the expense is highly dependent on the type of data required. Therefore, it is logical to assume that the more expensive the study, the greater the paperwork burden hours and costs

. For a DCI recipient to generate and submit the required data on their own is the most expensive of the response scenarios

. However, the cost for DCI respondents who pool their resources for data generation with other stakeholders is less than those who engage in data generation activities on their own. Therefore, t he Agency encourage s cost

-sharing agreements among manufacturers of specific pesticide chemicals to minimize the duplication of laboratory tests conducted in response**Page 9**  **of 30** 

to a DCI. DCI notices explain the statutory provisions for cost sharing agreements for FIFRA. 

### b. **Phase 1 an d Phase 3 response activities**  **for data generaters**
Phase I and Phase 3 DCI response activities a re a subset of the paperwork burden hours and costs estimates related to generating data to respond to a DCI notice. Unlike the wide variation of the costs for data generation, Phase 1 and Phase 3 response costs are more or less fixed costs. Generally, less than twenty

-five ( 25) burden hours are spent on these activities at a cost of around $2,000 (indexed to 2006 dollars) . Section II of this document presents a discussion of these burden hours and costs

.**Page 10**  **of 30** 

**I. What**  **are the key** 

**assumptions when estimating**  **PRA burden**  **hours and costs**  **for data generation?** 

### a. Paperw**ork activities are**  **generally 35**  **% of the cost of the**  **s tudy** 

**.** For more than a decade, EPA has been estimating all the paperwork burden hours and costs of responding to a DCI notice as approximately 35% of the cost of the study , see Figure

- 1 Relationship of Test Costs to Response Phases. This formula allows the Agency to derive a reasonable estim ate of for PRA activities (Phases 1, 2, and 3) by using the average estimated cost of specific tests. This approach was adopted because it allows the Agency to consider the potential for there to be more burden s related to a more complex study. The premi se is that a more expensive test may cause the respondent to incur more burden hours and costs than a less expensive test would. This estimate is only applicable to DCI

- related data generation. This percentage was d eveloped from numerous sources of inform ation including agency expertise, industry consultation, and repeated review by the public, industry, key stakeholders, and OMB on the Agency’s information collection activities. EPA assumes that 35% of the cost of any given test reflects all burdens and costs necessary for the completion of the paperwork activities

. The paperwork burden and cost fall into two general categories of activity burden, administrative and technical : Administrative Paperwork Burden is defined as the labor time spent communicati ng and working with the Agency and planning a response to the DCI and the planning of data collection and submittal activities

. Generally , the respondent will conduct collection activities listed in the Section 1, Table 1

- Response Phase s (Phase 1 and Phas e 3 )

. The labor cost related to the Administrative category of paperwork burden is assumed to equal 2% of the total test cost (2% of total test cost = Administrative Paperwork Burden Cost). Technical Paperwork Burden is the labor time needed to complete t he paperwork associated with the initiation of testing, collecting and maintaining data, use of laboratory standards, data analysis, data compiling, data entry, oversight of contractor or employee activities, and decision

- making. Generally , the respondent will conduct collection activities listed in Table 1

- Response Phase s (Phase 2(a))

. This contract laboratory will conduct collection activities listed in Table 2 (Phase 2(b))

. The labor cost for the technical category of paperwork burden is assumed to equ al 33% of the total test cost. (33% of total test cost = Technical Paperwork Burden Cost) Thus, [Administrative paperwork (2% of total test cost)] + [Technical paperwork 

### Section II. Estimating Paperw**ork Ac** **tivities Of Data Generation Page**  **11 of**  **30**

(33% of total test cost)] = total test

- related paperwork burden hours and costs (35% of total test cost). This aggregate paperwork burden and cost estimate of 35% for data generation activities is used in a number of DCI

- related Agency information collection activities, including :

 Data Acquisition for Registration ( OMB #2070

- 0122; EPA #1 503 ) ;

 Data Generation for Pesticide Reregistration ( OMB #2070

- 0107; EPA #1504 ) ;

 Data Call

- Ins for Special Review and Registration Review Programs ( OMB #2070

- 0057; EPA #0922 ) ; and

 Anticipated Residue/Percent Crop Treated ( OMB #2070

- 0164; EPA #1911 )

.

**Phase III:** Data Submission to EPA **Phase II (a&b)** Data Generation including technical duties conducted at Laboratories **Phase 1:** Initial Response to DCI

35% of test cost covers the PRA burden hours and costs of all three phases of a DCI response**Page 12**  **of 30** 

Figure

- 1 Relationship of Test Costs to Response Phases



### b. A**ll registrants generate all DCI**  **data**
T he paperwork activity estimates are based on the average cost of generating new data. T he total cost of the paperwork b urden hours and costs is equal to approximately 35 % of the total costs to generate new data. This approach assumes:

 Registrants generate all of the data as specified in the DCI notice. 4

 A ll data generation was pe r formed by an independent laboratory.

 Pa perwork burden consists of an administrative (2%) and technical (33%) burden. These two categories relate to office and laboratory activities, respectively.

 Paperwork burden is disaggregated by labor category as follows: 5 a. Managerial (20%) b. Technical (65%) c. Clerical (15%)

 Labor rates are derived from the parent ICR

 Labor rates are “fully loaded 6 ” To estimate paperwork activities for each type of labor category (managerial, technical, and clerical), the disaggregated paperwork burden costs are divided by their corresponding labor rates ($/hr). EPA assumes that DCI respondents who generate all requested data on their own is the most expensive of the response options considered and represents the maximum potential estimate of overall burden. **II. How are te** **st cost estimates developed?** The Agency maintains an archive of the basic FIFRA study cost estimates that were developed through surveys of independent testing laboratories, Agency economic analyses, and registrant comments during ICR renewal periods. To the extent possible, EPA uses multiple sources to provide test cost estimates , which are updated as needed. Attachment B contains a listing of the FIFRA study cost estimates currently on file with the Agency. The chart also provides the paperwork burden hour and cost estimates for specific studies. **III. What if test cost estimates are unavailable?** 

4 Assumes registrants perform most of the P RA activities highlighted in, Section I

-V, “DCI burden activity tables;” Table 1

– Response Phases 5 See Section I

-V, “DCI burden activity tables;” Table 1

– Response Phases; which lists specific ma nagerial, technical, and clerical duties. 6 “Fully loaded ” labor rates are meant to be the estimated costs of wages, overhead, and benefits paid to an employee.**Page 13**  **of 30** 

The Agency may request certain special studies or non

-guideline studies that have not been previously required, and for which test cost estimates have n ot yet been calculated. If the estimated test cost is not readily available to the Agency at the time that a particular test is requested, EPA will estimate the cost on the basis of:

 EPA staff expertise and experience;

 similarity with another study protocol for which cost estimates are available;

 type of study requested (e.g. , animal studies, field monitoring, and other possible test parameters);

 level of work that EPA expects will be involved in generating the data (high medium, or low effort required); and/or

 time required to complete the test. The Agency’s estimate would then serve as the default test cost for use in calculating the paperwork burden. EPA will update and revise these default test costs as more reliable estimates are obtained.
**I V.**  **Wh at if the available test cost estimates vary?**  To the extent possible, EPA uses multiple sources to provide test cost estimates. If several cost estimate exist for a particular study, but the differing estimates fall within an acceptable range, EPA will use the average estimate as its estimate. For example, if test cost estimates for a study were quoted at $20,000, $30,000, and $40,000, these estimates would be considered to fall within an acceptable range, and the average of $30,000 would be used in EPA’s estimation of paperwork burden. If EPA finds that the quoted test costs for a given test varies widely among sources (i.e., the varia tion is not within a reasonable range), then EPA will make a case

- by

- case decision on how to estimate an average test cost using the criteria listed in section II

- III (W hat if tests costs are unavailable).

**V. What are the steps in calculating the**  **p aperwork burden (hours and**  **costs)?** 

### a. Calculate **test cost s**  Using the EPA archive information of FIFRA study cost estimates, the Agency calculate s the total paperwork burden hours and costs for a test as 35% of the total test cost (administrative paperwork burden as 2% and technical paperwork burden as 33% of the total test cost). This percent

- based estimate of paperwork b urden is reflective of expert opinion, information from industry, various proprietary information/data, and a general assessment of test costs. 

### b. Distribute **p aperw** **ork activities a**  **mong l**  **abor c** **ategories. Page**  **14 of**  **30**

As an entity prepares a data generating response to the DCI notice, EPA assumes managerial, technical, and clerical staff will undertake certain activities

. Paperwork burden costs are divided among managerial, technical, and clerical staff labor categories (s e e Table 3 , below) to reasonably reflect, on a verage, the percent of work performed.

**Table 3**  **: Distribution of Paperwork A** **ctivities Ac**  **ross Labor Categories** ***** Labor category % of Paperwork Activities Performed Managerial 20% Technical 65% Clerical 15% Using this percentage system, EPA can ass ign a paperwork activity cost to each labor category. For example**,** study guideline 850.1735, W hole Sediment Acute Toxicity, has an estimated cost of $20,250. To assign a paperwork activity cost to each labor category, and to eventually arrive at a total estimate of paperwork burden in hours and costs , the steps below are taken. Labor category a ctivities: Managerial labor: $1,417.50 = ($7,087.50 * 0.20) Technical labor: $4,606.88 = ($7,087.50 * 0.65) Clerical labor: $1,063.12 = ($7,087.50 * 0.15) T otal paperwork activities cost: = $7,087.50 EPA would estimate that $7,087.50 or 35% of the total test cost represents the cost of the total paperwork burden activities

. 

### c. Calculate **p aperw** **ork b**  **urden h**  **ours f** **rom l**  **abor c**  **ost d**  **istribution.** The second compon ent for estimating DCI PRA activities is to estimate the average amount of time required to complete activities such as obtaining, compiling, preparing and submitting information to EPA. After distributing the paperwork costs among the managerial, technical and clerical labor categories, the paperwork burden hours are then derived by dividing the costs using fully

loaded wage rates ($/hour) compiled from the Department of Labor’s Bureau of Labor Statistics which are shown in Table 4

. **Table 4**  **: Fully -**  **Load ed Hourly**  **Wage Rates, by**

**Labor Category******* Labor category Rate ($/hour) Managerial $ 100.86 Technical $ 64.80 Clerical $ 33.05**Page 15**  **of 30** 

To estimate paperwork burden in hours, using the hourly wage rates listed in Table 4 , the steps below are taken

. Distribut ion of paperwork burden h ours and costs for labor categories : Managerial labor: 1 4 .0 5 hours ($1,417.50) Technical labor: 71

. 04 hours ($4,606.88) Clerical labor: 32.17 hours ($1,063.12) Total paperwork burden hours = 117.31 hours
**V I**  **. Is the**  **burden for t hose not generating data cover** **ed ?**  As discussed in S ection 1

-VI, (Variations of the response to a DCI ) , there are multiple ways of responding to a DCI and not all DCI recipients will generate and submit data as part of the DCI response . Until the Agency receives the 90

- day response letters to the DCI notice from the registrants indicating what studies, if any, they will conduct, it is not possible to predict the burden and costs of developing the data. Since the Agency cannot predict the number of DCI recipients who will actually generate data or the amount of data that might be submitted, EPA submits paperwork burden estimates to OMB for DCI response activities under all three Phases (1, 2, and 3). Therefore the Agency uses a default assumption that a ll DCI recipients will need to generate all of the data requested. The Agency recognizes that using this default assumption inflates the paperwork burden estimates associated with the DCI and renders an overstatement of the burden and cost. The P hase I an d Phase 3 response activity burden hours and costs are accounted for in the existing DCI ICRs as a subset of the paperwork burden estimates for information collection activities that are related to generating data to respond to a DCI notice. 7
In 2006, th e Agency conducted a preliminary analysi s of existing information from certain collections to estimate the PRA burden of paperwork activities that do not involve data generation , such as Phase 1 responses to DCIs

. For the study , t he Agency chose two ICRs in which PRA burden hours and costs for paperwork activities that do not involve data generation are clearly defined . The first, the Application for New and Amended Pesticide Registration ICR, OMB No. 2070

- 0060, (EPA ICR No. 0277.14) represents the majori ty of paperwork activities that do not involve data generation for applications for pesticide registration and the second ICR, the Data Generation for Pesticide Reregistration ICR, OMB No. 2070

- 0107, (EPA ICR No. 1504.05) represents all DCI related PRA burden and costs. The subset of paperwork activities that do not involve data generation was tallied and the burden hours and costs from both ICRs were estimated. Finally, information from the Economic Analysis of the Proposed Change to Data Requirements Ru le for Biochemical and Microbial Pesticides, September 2,

7 See Section 1

-V “DCI burden activity tables; ” Table 1

– Response Phases.**Page 16**  **of 30** 

2005, 8 was also used to extract costs for activities that do not involve data generation

. Of these three studies, t he estimates of costs of paperwork that do not involve data generation were 1) $11 69.00; 2) $1417.00 and 3) $2000.00 per response respectively. T he Agency believes th ese costs gene rally represent the range for paperwork burden and cost that registrants who are not generating data might be incur when creating P hase 1 responses

. These an alys es are discussed in detail in Attachment A.

8 See Environmental Protection Agency proposed rule 40 CFR parts 158 and 17 2, Subparts L&M: Data Requirements for Registration of Biochemical and Microbial Pesticides, (45 FR 12072 We dnesday March 8, 2006), section XVII Regulatory Assessment. For specific information refer to the docket EPA

- HQ

- OPP

- 2004

- 0415, document 6, U.S. EPA, 2005, “Economic Analysis of the Proposed Change to Data Requirements Rule for Biochemical and Microbial Pesticides,” FEAD/OPP/U.S. EPA, W ashington, DC.**Page 17**  **of 30** 



## At**tachment A Case Studies**  **: Agenc** **y An**  **al ys**  **is of Response Costs for** 

**Phase 1 Responses**

In this study, EPA assumes: 1. Paperwork activities for applications for registration for “me

-too” pesticides 9 are similar to paperwork activities for developing a DCI respon se that do es not entail generating new data or requesting a waiver

. 2. Estimated burden and costs listed in Table A are fixed, consistent costs for every respondent , and are not derived from any test cost estimates

. 3. Technical labor efforts are not calculated because the Agency assumes no technical burden would be involved in developing a DCI response that does not entail generating new data or requesting a waiver. 10 4. The pa perwork burden for phase 1 responses that are similar to activities in developing registration applications may be described as follows: a. read and discuss test requirements (read the DCI letter to understand what data are to be submitted); b. plan activities (includes time for reviewing internal company information); c. complete paperwork (prepare necessary correspondence, documents to EPA); d. Store/maintain information (maintain information submitted to the

9 “Me too” pesticides are pesticides that are substantially similar to an existing pesticide. Wh en applying for a “me

-too” registration, a registrant would either cite existing data or claim eligibility for a formulator’s exemption. A registrant is eligible for a formulators exemption if he uses a registered pesticide product as the source of the active ingredient in his product. Little or no technical labor is involved for this type of response. 10 As an example, consider the DCI respondent who claims a generic data exemption (GDE) as their response to a DCI. A generic data exemption is the same as a formulator’s exemption. Little or no technical labor burden is involved for this type of response. 

### 1. Study

**#1: Review of the A** **pplication for New and Amended**  **Pesticide Registration, OMB No. 2070**  **- 0060, (EPA**  **ICR No. 0277.14) representing burden hours and costs for paperw** **ork activities that do**  **not involve data generation for applications for pesticide registration** **Page 18**  **of 30**  Agency in company files). 5. Paperwork burden for such acti vities may be disaggregated by labor category as follows (percentages are approximations): a. Managerial (65%) b. Technical (0%) c. Clerical (35%) 6. Labor rates are derived from the parent ICR

. 7. Labor rates are fully loaded

. The supporting statement of the Applicatio n for New and Amended Pesticide Registration ICR characterizes the activities that would be needed for an application/notification. T hese activities are substantially similar to those of Phase 1: Initial Response that do not involve generating data or req uesting a data waiver

. The applicable activities are reproduced in Table A below:

**Table A**  **: Estimated Burden/Cost for Phase 1 Response******* Collection Activity Burden Hours Totals Management Technical Clerical Hours Cost Read instructions 7 0 0 7 938 Pla n activities 0.5 0 0 0.5 67 Complete Paperwork 0 0 3 3 123 Store/maintain data 0 0 1 1 41 Totals 7.5 0 4 11.5 1169 ( * In dexed to 2005 dollars ) After distributing the paperwork costs among the managerial and clerical staff labor categories, the paperwo rk burden hours are then derived by dividing the costs using the fully

- loaded wage rates ($/hour) compiled in the parent ICR, Review of the Application for N ew and Amended Pesticide Registration, OMB No. 2070

- 0060, (EPA ICR No. 0277.14) approved by Office of Management and B udget , November 8 , 2005

.**Page 19**  **of 30** 

In this study EPA assumes : 1) The total paperwork burden hours and costs for P hase 1 responses are approximately 7 percent of the estimated average cost to generate new data. 2) Registrant responses to the DCI notice that do not involve data generation include voluntary cancellation, submitting or citing existing data, request ing a data waiver, or claiming eligibilitygeneric data exemption

. 3) P aperwork activities that do not involve data generation may be descri bed as follows: a. read and discuss test requirements (read the DCI letter to understand what data are to be submitted); b. plan activities (develop ing options for not generating new data includes reviewing internal company information for existing data); c. com plete paperwork (prepare necessary correspondence, documents and/or waiver requests to avoid having to submitting data to EPA); d. record , maintain and file information (maintain information submitted to the Agency in company files). 4) Paperwork burden for Phas e 1 DCI responses activities may be disaggregated by labor category as follows (percentages are approximations): e. Managerial (50%) f. Technical (5%) g. Clerical (45%) 5) Labor rates are derived from the parent ICR 6) Labor rates are fully loaded. a. Calculate Cost of Paperwork

**.** Using the EPA maintained database of test cost estimates, the Agency calculate s the total paperwork burden cost for a test as 7% of the total test cost because b ased on the percentage breakdown for paperwork burden applicable to non

- data gen eration activities for this ICR

. T his percent

- based estimate of paperwork burden is reflective of expert opinion, information from industry, various proprietary information/data, and a general assessment of test costs. These activities represent the Phas e I DCI response activities discussed in section IV. b. Distribute Paperwork Costs Among Labor Categories. As an entity prepares a response of non

- data generation in response to the DCI notice, EPA assumes certain acti vities will be conducted by managerial, tech nical, and clerical staff. Paperwork activities are divided among these labor categories (see Table B below) to reasonably reflect, on average, the percent of work performed. These 

### 2. Study

**#2: Data Generation for Pesticide Reregistration ICR, OM**  **B No. 2070 -** **0107, (EPA ICR No. 1504.05).** **Page 20**  **of 30** 

percentage breakdowns by labor category, derived from the parent ICR Data Generation for Pesticide Reregistration ICR, OMB No. 2070

- 0107, (EPA ICR No. 1504.05), are consistent for burden activities associated with confirmatory DCIs, product specific DCIs, and submission of voluntary studies cited within the parent ICR. **Table B**  **: Distribution of Burden A cross Labor Categories**  Labor category % of Paperwork Burden Activities Performed Managerial 50% Technical 5% Clerical 45% For example the study guideline 850.1735, Whole Sediment Acute Toxicity, has an estimated cost of $20,250 . E stimates for p aperwork cost for these n on - d ata g eneration a ctivities would be: Managerial labor: $708.75 = ($1,417.50 * 0.50) Technical labor: $70.88 = ($1,417.50 * 0.05) Clerical labor: $637.87 = ($1,417.50 * 0.45) Total labor : $ 1,417.50 EPA would estimate that $1,417.50 or 7% of the total test cost represents the cost of the total paperwork burden activities. c. Calculate Paperwork Burden Hours From Labor Cost Distribution. After distributing the paperwork costs among the mana gerial, technical and clerical staff labor categories, the paperwork burden hours are then derived by dividing the costs using fully

- loaded wage rates ($/hour) cited in the parent ICR and listed in Table C

.
**Table C**  **: Fully -**  **Loaded Hourly Wage Rates, by** 

**L abor Category** ***** Labor category Rate ($/hour) Managerial $130 Technical $88 Clerical $40 ( Labor costs cited in the parent ICR

- Indexed to 200 4 dollars) To estimate paperwork burden in hours, using the hourly wage rates listed in Table C , the ste ps below are taken. Managerial labor: 5.45 hours ($708.75 ÷ $130/hr) Technical labor: 0.81 hours ($70.88 ÷ $88/hr) Clerical labor: 15.95 hours ($637.87 ÷ $40/hr) Total hours: 22.21 hours**Page 21**  **of 30** 

Under 40 CFR 158.45, the Agency may waive data requirements on a case

- by

case basis in response to specific requests by applicants

. The Agency believes the paperwork burden and cost for developing a data waiver request is a relatively fixed cost

. When the Agency a nalyzed burden and cost for data waivers in the Economic Analysis for Proposed Changes in Data Requirements Rule for Biochemical and Microbial Pesticides in 2005, the cost of applying for waivers was estimated to be approximately $2,000 per firm per registration action, regardless of the number of tests a waiver is applied for, if at least one waiver was granted. 11 EPA believes this un it of cost/burden may be applicable to the data waivers submitted to the Agency in response to a DCI. Under this assumption , all non

- data generation paperwork activities would be placed at a fixed burden of 20 hours and the burden hours would be distributed as represented in Table D below.

**Table D**  **: Industry**

**Estimated Burden/Cost Submitting a Data Waivers Response** * Collection Activity Burden Hours Totals Management Technical Clerical Hours Cost Research, Literature searches, Calculations & analysis 10 10 1000
Compiling rational 8 8 800 Review document file and submit 1 1 2 200 Total 2 0 2000

11 The Biopesticide Industry Alliance Regulatory Committee provided additional informal cost estimates to EPA. Burden breakdown and costs estimates wou ld be: Research, literature searches, calculations, analysis etc. = 10 hours = $1000 writing; compiling the rationale = 8 hours = $800; and managerial/clerical = 2 hours = $200. For a total of $2,000.00 for each waiver. A general $100.00 per hour for con sultant costs was provided to EPA. 

### 3. Study

**#3: Economic A nal**  **ys is for Propose**  **d Changes in Data Requirements Rule for Biochemical and Microbial**  **Pesticides**
**– Cost Estimates for Data Waivers.** **Page 22**  **of 30** 



## At**tachment B**  **Char t:**  **FIFRA Estimated**  **Study Costs**  **An d Paperw** **ork**

**Burden Hour And Cost Estimates Test Information**  **Paperwork Burden Totals (35% of study** 

**cost)**

**Test Guideline/ Section**  **Test Name A** **v e** **r a** **g e** **T e** **s t** **C o** **s t** **T o** **t a** **l P** **a p** **e r** **w o** **r k** **B u** **r d** **e n** **C o** **s t** **T o** **t a** **l P** **a p** **e r** **w o** **r k** **B u** **r d** **e n** **H o** **u r** **s H** **i g** **h T** **e s** **t C** **o s** **t**(HighAVGfor2005SciReg)**L o** **w T** **e s** **t C** **o s** **t**(LowAVGfor2005SciReg)

**Product Performance**

810.1000 Overview, Definitions, and General Considerations $100,000.0 $35,000.0 443.6 $100,000.0 $100,000.0 810.1550 Prod uct Identity and Disclosure of Ingredients (Composition) (Chemical Identity) $223.0 $78.1 1.0 $223.0 $223.0 810.2100 Products for hard surfaces

- EPA Disinfectant test $6,600.0 $2,310.0 29.3 $7,200.0 $6,000.0 810.2100 Products for hard surfaces

- AOAC Fun gicide test $1,600.0 $560.0 7.1 $2,000.0 $1,200.0 810.2100(b)&(i) Chemical Analysis $5,339.0 $1,868.7 23.7 $6,701.0 $3,976.0 810.2100(m)(2) Products for hard surfaces

- AOAC Germicidal, detergent sanitizers $3,500.0 $1,225.0 15.5 $4,000.0 $3,000.0 810. 21000(j) Products for hard surfaces

- Sanitizer test non food $4,000.0 $1,400.0 17.7 $5,000.0 $3,000.0 810.2100b,c,d or i Products for hard surfaces

-AOAC use dilution test, germicidal $6,000.0 $2,100.0 26.6 $7,000.0 $5,000.0 810.2100c,d,e Products for hard surfaces

-AOAC Use dilution/germicidal spray/carrier $6,000.0 $2,100.0 26.6 $7,000.0 $5,000.0 810.2100(f) Products for hard surfaces

- Fungicidal test $1,600.0 $560.0 7.1 $2,000.0 $1,200.0 810.2100(g) Products for hard surfaces

- Virucidal activity method $4,000.0 $1,400.0 17.7 $6,000.0 $2,000.0 810.2100(g) Products for hard surfaces

-AOAC Tuberculocidal test $3,250.0 $1,137.5 14.4 $5,000.0 $1,500.0 810.2100(l) Products for hard surfaces

- Hard inanimate surface non food $4,000.0 $1,400.0 17.7 $5 ,000.0 $3,000.0 810.2200 Products for hard surfaces

- AVG $6,187.0 $2,165.5 27.4 $6,187.0 $6,187.0 810.2200

- itemized Limited disinfectant $4,201.0 $1,470.4 18.6 $5,010.0 $3,391.0 810.2200

- itemized Broad spectrum disinfectant $5,763.0 $2,017.1 25.6 $6,720.0 $4,806.0 810.2200

- itemized Hospital disinfectant $5,993.0 $2,097.6 26.6 $7,000.0 $4,986.0 810.2200

- itemized Fungicidal disinfectant $4,219.0 $1,476.7 18.7 $4,865.0 $3,572.0 810.2200

- itemized Virucidal disinfectant $13,068.0 $4,573.8 58.0 $19,574.0 $6,561.0 810.2200

- itemized Tuberculocidal disinfectant $4,691.0 $1,641.9 20.8 $5,633.0 $6,748.0**Page 24**  **of 30** 

810.2200

- itemized Additional bacteria $4,082.0 $1,428.7 18.1 $4,803.0 $3,361.0 810.2200

- itemized Non

-food contact $5,198.0 $1,819.3 23.1 $6,0 26.0 $4,370.0 810.2200

- itemized Food contact

- Halide products $4,455.0 $1,559.3 19.8 $5,195.0 $3,714.0 810.2200

- itemized Food contact

- Non

- halide products $6,086.0 $2,130.1 27.0 $7,301.0 $4,870.0 810.2200

- itemized Sanitizers for urinal and toilet bowl water and in

-tank sanitizers $5,672.0 $1,985.2 25.2 $6,902.0 $4,441.0 810.2200

- itemized Residual self

- sanitizing

- wet surfaces $5,210.0 $1,823.5 23.1 $3,969.0 $6,451.0 810.2200

- itemized Sterilants $11,803.0 $4,131.1 52.4 $11,936.0 $11,669.0

810.2300b Products for fabrics/textiles

- EPA Carpet Sanitizer $3,250.0 $1,137.5 14.4 $5,000.0 $1,500.0 810.2400 Products for air sanitizers $5,500.0 $1,925.0 24.4 $6,500.0 $4,500.0 810.2400(b)(j) Chemical Analysis $175.0 $61.3 0.8 $350.0 $0.0 810.2400( b)(l) Chemical Analysis $4,000.0 $1,400.0 17.7 $4,000.0 $4,000.0 810.2600 Products for microbial pests associated with human and animal waste $5,720.0 $2,002.0 25.4 $5,720.0 $5,720.0 810.2700(d) Products for treating water systems AOAC

- water disinfectan ts pools $7,500.0 $2,625.0 33.3 $10,000.0 $5,000.0 810.3000 General considerations for Efficacy of invertebrate control agents $600.0 $210.0 2.7 $600.0 $600.0 810.3100 Soil treatments for imported fire ants $140,000.0 $49,000.0 621.1 $200,000.0 $80,000.0 810.3200 Livestock,poultry,fur and wool bearing animal treatments $30,000.0 $10,500.0 133.1 $50,000.0 $10,000.0 810.3300 Treatments to control pests of human and pets $50,000.0 $17,500.0 221.8 $60,000.0 $40,000.0 810.3400 Mosquito,blackfly and biting m idge treatments $140,000.0 $49,000.0 621.1 $200,000.0 $80,000.0 810.3500 Premises Treatments $700,000.0 $245,000.0 3,105.3 $800,000.0 $600,000.0 810.3600 Structural Treatments $1,200.0 $420.0 5.3 $1,200.0 $1,200.0 810.3700 Insect repellants for human sk in and outdoor premises $5,000.0 $1,750.0 22.2 $5,000.0 $5,000.0 810.3800 Methods for efficacy testing of termite baits $60,000.0 $21,000.0 266.2 $100,000.0 $20,000.0 **Product Chemistry**

830.1550 Product identity and composition $23 3.0 $81.6 1.0 $223.0 830.1600 Description of materials used to produce the product $334.0 $116.9 1.5 $501.0 $167.0 830.1620 Description of production process $418.0 $146.3 1.9 $167.0 $668.0 830.1650 Description of formulation process $418.0 $146.3 1.9 $167.0 $668.0 830.1670 Discussion of formulation of impurities $418.0 $146.3 1.9 $167.0 $668.0 830.1700 Preliminary analysis $31,715.0 $11,100.3 140.7 $50,054.0 $8,875.0 830.1750 Certified limits $248.0 $86.8 1.1 $330.0 $165.0 830.1800 Enforcement ana lytical method $15,454.0 $5,408.9 68.6 $21,538.0 $9,371.0 830.1900 Submittal of samples $495.0 $173.3 2.2 $660.0 $330.0 830.6302 Color $700.0 $245.0 3.1 $1,000.0 $400.0 830.6303 Physical state $700.0 $245.0 3.1 $1,000.0 $400.0 830.6304 Odor $700.0 $245 .0 3.1 $1,000.0 $400.0 830.6313 Stability to normal and elevated temperatures, metals, and metal ions $8,250.0 $2,887.5 36.6 $12,000.0 $4,500.0 830.6314 Oxidation/reduction: chemical incompatibility $2,994.0 $1,047.9 13.3 $3,044.0 $2,944.0 830.6315 Flam mability $2,000.0 $700.0 8.9 $3,000.0 $1,000.0 830.6316 Explodability $4,163.0 $1,457.1 18.5 $4,163.0 $4,163.0 830.6317 Storage stability $11,500.0 $4,025.0 51.0 $15,000.0 $8,000.0**Page 25**  **of 30** 

830.6319 Miscibility $1,100.0 $385.0 4.9 $1,500.0 $700.0 830.6320 Corro sion characteristics $2,750.0 $962.5 12.2 $3,500.0 $2,000.0 830.6321 Dielectric breakdown voltage $2,525.0 $883.8 11.2 $2,675.0 $2,375.0 830.7000 pH $750.0 $262.5 3.3 $1,000.0 $500.0 830.7050 UV/visible light absorption $2,022.0 $707.7 9.0 $2,072.0 $1,9 72.0 830.7100 Viscosity $1,400.0 $490.0 6.2 $2,000.0 $800.0 830.7200 Melting point/melting range $1,200.0 $420.0 5.3 $1,600.0 $800.0 830.7220 Boiling point/boiling range $1,500.0 $525.0 6.7 $2,000.0 $1,000.0 830.7300 Density/relative density/bulk densi ty $1,400.0 $490.0 6.2 $2,000.0 $800.0 830.7370 Dissociation constants in water $4,845.0 $1,695.8 21.5 $4,845.0 $4,845.0 830.7520 Particle size, fiber length, and diameter distribution $1,333.0 $466.6 5.9 $1,333.0 $1,333.0 830.7550 Partition coefficient (n

- octanol/water)

- shake flask method $6,667.0 $2,333.5 29.6 $7,333.0 $6,000.0 830.7560 Partition coefficient (n

- octanol/water)

- generator column $6,667.0 $2,333.5 29.6 $7,333.0 $6,000.0 830.7570 Partition coefficient (n

- octanol/water)

- estimation chromatography $4,388.0 $1,535.8 19.5 $4,700.0 $4,075.0 830.7840 Water Solubility: column elution/shake flask $9,635.0 $3,372.3 42.7 $11,322.0 $7,947.0 830.7860 Water solubility $9,635.0 $3,372.3 42.7 $11,322.0 $7,947.0 830.7950 Vapor pressure $15,000.0 $ 5,250.0 66.5 $20,000.0 $10,000.0 **Spray Drift**  840.1100 Spray droplet size spectrum $258,750.0 $90,562.5 1,147.9 $340,000.0 $177,500.0

840.1200 Spray drift field deposition $16,250.0 $5,687.5 72.1 $25,000.0 $7,500.0 **Ecological Effects Tests**

850.1000 Use Profile $251.0 $87.9 1.1 $334.0 $167.0 850.1010 Aquatic invertebrate acute toxicity, freshwater daphnids $17,000.0 $5,950.0 75.4 $20,000.0 $14,000.0 850.1020 Gammarid acute toxicity test $0.0 $0.0 0.0 $0.0 $0.0 850.1025 Oyster acute toxicity test $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0 850.1035 Mysid acute toxicity test $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0 850.1045 Penaeid acute toxicity test $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0 850.1055 Bivalve acute tox larval (embryo/larval) $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0 850.1075 Fish acute toxicity (freshwater) $17,000.0 $5,950.0 75.4 $28,061.0 $10,066.0 850.1075 Fish acute toxicity test (estaurine/marine) $20,138.0 $7,048.3 89.3 $20,138.0 $20,138.0 850.1300 Daphnid chronic toxicity test $118,063.0 $41,322.1 523.7 $162,800.0 $73,325.0 850.1350 Mysid chronic tox

- aquatic invertebrate life

- cycle (saltwater) $36,333.0 $12,716.6 161.2 $41,000.0 $31,667.0 850.1400 Fish early

- l ife stage toxicity test (freshwater) $37,279.0 $13,047.7 165.4 $41,379.0 $33,179.0 850.1450 Fish early

- life stage toxicity test (saltwater) $75,000.0 $26,250.0 332.7 $0.0 $0.0 850.1500 Fish life

- cycle toxicity $512,500.0 $179,375.0 2,273.5 $650,000.0 $37 5,000.0 850.1710 Aquatic Bioavailability/Biomagnification: Oyster BCF $123,919.0 $43,371.7 549.7 $143,919.0 $103,919.0 850.1730 Aquatic Bioavailability/Biomagnification: Fish BCF $140,452.0 $49,158.2 623.1 $169,279.0 $111,624.0 850.1735 Wh ole sediment acute toxicity invertebrates (freshwater) $20,250.0 $7,087.5 89.8 $21,500.0 $26,000.0 850.1740 Wh ole sediment acute toxicity invertebrates (marine) $37,500.0 $13,125.0 166.4 $50,000.0 $25,000.0 850.1790 Chironomid sediment toxicity test $83,000.0 $29,05 0.0 368.2 $83,000.0 $83,000.0 850.1800 Tadpole/sediment subchronic toxicity test $195,856.0 $68,549.6 868.9 $195,856.0 $195,856.0 850.1850 Aquatic food chain transfer

- Bioavailability $325,000.0 $113,750.0 1,441.8 $500,000.0 $150,000.0 850.1900 Generic freshwater microscosm test (laboratory) $295,000.0 $103,250.0 1,308.7 $360,000.0 $230,000.0**Page 26**  **of 30** 

850.1925 Site

-specific aquatic microcosm test (laboratory) $250,000.0 $87,500.0 1,109.0 $250,000.0 $250,000.0 850.1950 Simulated or actual field testing

- field animal $512,500.0 $179,375.0 2,273.5 $650,000.0 $375,000.0 850.1950 Simulated or actual field testing

- aquatic $600,000.0 $210,000.0 2,661.7 $700,000.0 $500,000.0 850.1950 Simulated or actual field testing

- insect predators $87,500.0 $30,625.0 388.2 $ 100,000.0 $75,000.0 850.1950 Simulated or actual field testing

- plants $62,500.0 $21,875.0 277.3 $75,000.0 $50,000.0 850.2100 Avian acute oral toxicity test $10,100.0 $3,535.0 44.8 $13,800.0 $6,400.0 850.2200 Avian dietary toxicity test $6,480.0 $2,268 .0 28.7 $6,647.0 $6,313.0 850.2300 Avian reproduction test $168,250.0 $58,887.5 746.4 $215,500.0 $121,000.0 850.2400 Wi ld mammal acute toxicity $35,000.0 $12,250.0 155.3 $50,000.0 $20,000.0 850.2500 Simulated or actual field testing terrestrial wildlife $527,502.0 $184,625.7 2,340.1 $552,000.0 $502,000.0 850.2500 Simulated or actual field testing

- birds $600,000.0 $210,000.0 2,661.7 $700,000.0 $500,000.0 850.3020 Honey bee acute contact toxicity $3,175.0 $1,111.3 14.1 $3,175.0 $3,175.0 850.3030 Honey bee toxicity of residues on foliage $13,368.0 $4,678.8 59.3 $16,670.0 $10,065.0 850.3040 Field testing for pollinators $47,500.0 $16,625.0 210.7 $65,000.0 $30,000.0 850.4000 Background

- Nontarget plant testing $0.0 $0.0 0.0 $0.0 $0.0 850.4025 Target a rea phytotoxicity $0.0 $0.0 0.0 $0.0 $0.0 850.4100 Terrestrial plant toxicity (seedling emergence, Tier I) $14,625.0 $5,118.8 64.9 $15,625.0 $13,625.0 850.4150 Terrestrial plant toxicity (vegetative vigor, Tier I) $14,625.0 $5,118.8 64.9 $15,625.0 $13,62 5.0 850.4200 Seed germination/root elongation toxicity test $10,292.0 $3,602.2 45.7 $15,875.0 $4,709.0 850.4200 Seed germination/root elongation toxicity test $25,602.5 $8,960.9 113.6 $30,930.0 $20,275.0 850.4230 Early seed growth toxicity test $0.0 $0. 0 0.0 $0.0 $0.0 850.4225 Seedling emergence, Tier II $20,375.0 $7,131.3 90.4 $22,000.0 $18,750.0 850.4250 Vegetative vigor, Tier II $24,500.0 $8,575.0 108.7 $26,500.0 $22,500.0 850.4300 Terrestrial plants field study, Tier III $111,863.0 $39,152.1 496.2 $126,863.0 $26,500.0 850.4400 Aquatic plant toxicology test using Lemna spp., Tier I $35,155.0 $12,304.3 156.0 $39,525.0 $18,750.0 850.4400 Aquatic plant toxicology test using Lemna spp., Tier II $35,155.0 $18,632.2 236.2 $35,155.0 $35,155.0 850.4450 Aquatic plants field study, Tier III $0.0 $0.0 0.0 $0.0 $0.0 850.5400 Algal Toxicity Tier I and Tier II $35,155.0 $12,304.3 156.0 $35,155.0 $35,155.0 na Acute toxicity to aquatic insects $0.0 $0.0 0.0 $0.0 $0.0 na Aquatic insect life

- cycle study $0.0 $0. 0 0.0 $0.0 $0.0 na Simulated or actual field testing for aquatic insects $0.0 $0.0 0.0 $0.0 $0.0 na Nontarget insect testing

- predators and parasites $0.0 $0.0 0.0 $0.0 $0.0 na Nontarget insect testing

- predators and parasites $0.0 $0.0 0.0 $0.0 $0.0
**Health Effects** 870.1100 Acute oral toxicity (rat) $3,473.0 $1,215.6 15.4 $4,015.0 $2,932.0

870.1200 Acute dermal toxicity $2,000.0 $700.0 8.9 $3,000.0 $1,000.0 870.1300 Acute inhalation toxicity (rat) $2,000.0 $700.0 8.9 $3,0 00.0 $1,000.0 870.1300 Acute inhalation tox (microbials) $12,000.0 $4,200.0 53.2 $20,000.0 $4,000.0 870.2400 Acute eye irritation (rabbit) $2,000.0 $700.0 8.9 $3,000.0 $1,000.0 870.2500 Acute dermal irritation $2,000.0 $700.0 8.9 $3,000.0 $1,000.0 870. 2600 Skin (dermal) sensitization $8,000.0 $2,800.0 35.5 $10,000.0 $6,000.0 870.3100 90

- day oral toxicity in rodents $138,106.0 $48,337.1 612.7 $142,517.0 $133,695.0 870.3150 90

- day oral toxicity in non

- rodents $221,047.0 $77,366.5 980.6 $221,047.0 $221,0 47.0 870.3200 21/28

- day dermal toxicity $83,240.0 $29,134.0 369.3 $84,681.0 $81,798.0**Page 27**  **of 30** 

870.3250 90

- day dermal toxicity $137,094.0 $47,982.9 608.2 $138,114.0 $137,094.0 870.3465 90

- day inhalation toxicity (rat) $300,000.0 $105,000.0 1,330.9 $350,000.0 $30 0,000.0 870.3700 Prenatal developmental toxicity study (rat and rabbit, preferred) $76,844.0 $26,895.4 340.9 $77,037.0 $76,844.0 870.3800 Reproduction and fertility effects (multigeneration) $378,479.0 $132,467.7 1,679.0 $381,233.0 $378,479.0 870.4100 Chronic tox (rodent and non

- rodent) $950,000.0 $332,500.0 4,214.4 $1,100,000.0 $950,000.0 870.4200 Carcinogenicity (rat and mouse, preferred) $1,730,000.0 $605,500.0 7,674.6 $2,060,000.0 $1,730,000.0 870.4200 Carcinogenicity (microbials) $922,244.0 $322, 785.4 4,091.2 $925,806.0 $922,244.0 870.5100 Bacterial reverse mutation assay $4,057.0 $1,420.0 18.0 $4,457.0 $4,057.0 870.5300 In vitro mammalian cell gene mutation test $18,654.0 $6,528.9 82.8 $19,767.0 $18,654.0 870.5375 In vitro mammalian chromoso mal aberration test $0.0 $0.0 0.0 $0.0 $0.0 870.5380 Mammalian spermatogonial chromosomal aberration test $19,382.0 $6,783.7 86.0 $19,382.0 $19,382.0 870.5385 Mammalian bone marrow chromosomal aberration test $30,004.0 $10,501.4 133.1 $30,004.0 $30,004.0 870.5395 Mammalian erthrocyte micronucleus test $20,477.0 $7,167.0 90.8 $20,594.0 $20,477.0

none Reference list of all studies/papers known to the applicant concerning mutagenicity $418.0 $146.3 1.9 $418.0 $418.0 870.5450 Rodent dominant lethal assay $ 0.0 $0.0 0.0 $0.0 $0.0 870.5500 Bacterial DNA damage or repair tests $0.0 $0.0 0.0 $0.0 $0.0 870.5550 Unscheduled DNA synthesis in mammalian cells in culture $30,000.0 $10,500.0 133.1 $0.0 $0.0 870.6100 Acute and 28 day delayed neurotoxicity organophosp horus substances (hen) $79,375.0 $27,781.3 352.1 $80,625.0 $72,125.0 870.6200 Acute neurotoxicity (rat) $89,596.0 $31,358.6 397.5 $91,680.0 $87,513.0 870.6200 90

- day Neurotoxicity (rat) $184,039.0 $64,413.7 816.4 $186,410.0 $181,668.0 870.6300 Developme ntal neurotoxicity study $406,904.0 $142,416.4 1,805.1 $417,135.0 $396,904.0 870.6500 Schedule

- controlled operant behavior $164,000.0 $57,400.0 727.5 $164,000.0 $164,000.0 870.6850 Peripheral nerve function $110,000.0 $38,500.0 488.0 $110,000.0 $110,00 0.0 870.6855 Neurophysiology: sensory evoked potentials $110,000.0 $38,500.0 488.0 $110,000.0 $110,000.0 870.7200 Companion animal safety $156,000.0 $54,600.0 692.0 $167,667.0 $144,333.0 870.7485 Metabolism and pharmacokinetics $182,729.0 $63,955.2 810. 6 $217,729.0 $147,729.0 870.7600 Dermal penetration $147,529.0 $51,635.2 654.5 $175,346.0 $119,711.0 870.7800 Immunotoxicity $56,648.0 $19,826.8 251.3 $57,731.0 $55,565.0 **Occupational and Residential Exposure**

875.1100 Dermal o utdoor exposure $167,857.0 $58,750.0 744.6 $192,143.0 $143,571.0 875.1200 Dermal indoor exposure $126,429.0 $44,250.2 560.9 $150,714.0 $102,143.0 875.1300 Inhalation outdoor exposure $164,286.0 $57,500.1 728.8 $181,429.0 $147,143.0 875.1400 Inhalation i ndoor exposure $126,429.0 $44,250.2 560.9 $150,714.0 $102,143.0 875.1500 Biological monitoring $188,393.0 $65,937.6 835.7 $219,256.0 $157,500.0 875.1600 Application exposure data reporting and calculations $7,500.0 $2,625.0 33.3 $10,000.0 $5,000.0 875. 1700 Product use information $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0 875.2100 Dislodgeable foliar residue dissipation and turf transferable residues $55,100.0 $19,285.0 244.4 $56,100.0 $54,100.0 875.2200 Soil residue dissipation $83,125.0 $29,093.8 368 .8 $85,000.0 $81,250.0 875.2300 Indoor surface residue dissipation $35,000.0 $12,250.0 155.3 $35,000.0 875.2400 Dermal exposure $125,500.0 $43,925.0 556.7 $133,000.0 $118,000.0 875.2500 Inhalation exposure $73,000.0 $25,550.0 323.8 $81,000.0 $65,000. 0 875.2600 Biological monitoring $166,875.0 $58,406.3 740.3 $191,667.0 $142,083.0 875.2700 Product use information $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0**Page 28**  **of 30** 

875.2800 Description of human activity $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0 875.2900 Data reporting and calculations $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0 875.3000 Nondietary ingestion exposure $75,000.0 $26,250.0 332.7 $83,333.0 $66,667.0 **Environmental Fate**

none Use Profile $251.0 $0.0 0.0 $334.0 $167.0 835.1 230 Sediment and soil adsorption/desorption $23,750.0 $8,312.5 105.4 $24,583.0 $22,917.0 835.1240 Leaching and adsorption/desorption $46,780.0 $16,373.0 207.5 $51,880.0 $41,680.0 835.1410 Laboratory volatility $45,000.0 $15,750.0 199.6 $5,000.0 $40,000.0 835.2120 Hydrolysis $25,230.0 $8,830.5 111.9 $29,900.0 $20,560.0 835.2240 Photodegradation in water $46,875.0 $16,406.3 207.9 $47,875.0 $47,875.0 835.2370 Photodegradation in air $110,000.0 $38,500.0 488.0 $120,000.0 $100,000.0 835.2410 Photodegradati on on soil $42,350.0 $14,822.5 187.9 $45,183.0 $39,517.0 835.4100 Aerobic soil metabolism $94,375.0 $33,031.3 418.7 $98,625.0 $90,125.0 835.4200 Anaerobic soil metabolism $71,300.0 $24,955.0 316.3 $71,300.0 $71,300.0 835.4300 Aerobic aquatic metabolism $44,475.0 $15,566.3 197.3 $47,350.0 $41,600.0 835.4400 Anaerobic aquatic metabolism $80,900.0 $28,315.0 358.9 $86,525.0 $72,275.0 835.6100 Terrestrial field dissipation $317,767.0 $111,218.5 1,409.7 $366,067.0 $269,467.0 835.6200 Aquatic field dissipati on $267,250.0 $93,537.5 1,185.6 $354,000.0 $180,500.0 835.6300 Forestry dissipation $275,500.0 $96,425.0 1,222.2 $362,500.0 $188,500.0 835.6400 Combination and tank mixes $219,200.0 $76,720.0 972.4 $219,200.0 835.8100 Field volatility $230,900.0 $80,8 15.0 1,024.3 $230,900.0 835.7100 Groundwater Monitoring $1,225,000.0 $428,750.0 5,434.3 $2,000,000.0 $450,000.0 none Monitoring of representative U.S. waters $215,833.0 $75,541.6 957.5 $263,333.0 $168,333.0 none Leaching study $43,000.0 $15,050.0 190. 8 $48,000.0 $38,000.0 **Residue Chemistry**

860.1100 Chemical identity $1,250.0 $437.5 5.5 $2,000.0 $500.0 860.1200 Directions for use $4,000.0 $1,400.0 17.7 $5,000.0 $3,000.0 860.1300 Nature of the residue in plants $100,000.0 $ 35,000.0 443.6 $105,000.0 $95,000.0 860.1300 Nature of the residue in livestock $105,833.0 $37,041.6 469.5 $118,333.0 $93,333.0 860.1340 Residue analytical method

- plants $22,125.0 $7,743.8 98.2 $23,250.0 $19,000.0 860.1340 Residue analytical method

- livestock $65,500.0 $22,925.0 290.6 $76,800.0 $54,200.0 860.1360 Multiresidue method $24,000.0 $8,400.0 106.5 $25,667.0 $22,333.0 860.1380 Storage stability data $18,500.0 $6,475.0 82.1 $18,500.0 $18,500.0 860.1400 Water $53,750.0 $18,812.5 238.4 $55,0 00.0 $52,500.0 860.1400 Fish $104,000.0 $36,400.0 461.4 $130,000.0 $78,000.0 860.1400 Irrigated crops (one

-crop) $18,000.0 $6,300.0 79.9 $20,500.0 $15,500.0 860.1460 Food handling $205,000.0 $71,750.0 909.4 $230,000.0 $180,000.0 860.1480 Meat/milk/poul try/eggs $149,000.0 $52,150.0 661.0 $152,333.0 $145,667.0 860.1500 Crop field trials $163,667.0 $57,283.5 726.1 $177,000.0 $150,333.0 860.1520 Processed food/feed $35,000.0 $12,250.0 155.3 $37,333.0 $32,667.0 860.1540 Reduction of Residues $15,000.0 $5,250.0 66.5 $20,000.0 $10,000.0 860.1550 Proposed tolerance $5,363.0 $1,877.1 23.8 $6,600.0 $4,124.0**Page 29**  **of 30** 

860.1560 Reasonable grounds in support of the petition $10,000.0 $3,500.0 44.4 $15,000.0 $5,000.0 860.1650 Submittal of analytical reference standard s $334.0 $116.9 1.5 $501.0 $167.0 860.1850 Confined accumulation in rotational crops $249,845.0 $87,445.8 1,108.4 $269,845.0 $229,845.0 860.1900 Field accumulation in rotational crops $137,500.0 $48,125.0 610.0 $125,000.0 $150,000.0 none Migration Stud ies $105,000.0 $36,750.0 465.8 $120,000.0 $90,000.0
**Microbial Pesticides**

880.1100 Product identity $233.0 $81.6 1.0 $300.0 $165.0 880.1200 Description materials, production, formulation $908.0 $317.8 4.0 $1,650.0 $165.0 880.1 400 Discussion of formation of impurities $330.0 $115.5 1.5 $495.0 $165.0 880.3800 Immune Response $85,000.0 $29,750.0 377.1 $100,000.0 $70,000.0 880.4350 Non

-target insect testing $15,000.0 $5,250.0 66.5 $18,000.0 $12,000.0 880.4425 Dispenser

- water l eaching $25,000.0 $8,750.0 110.9 $30,000.0 $20,000.0 Hypersensitivity incidents $825.0 $288.8 3.7 $1,320.0 $330.0 885.1100 Product Identity $5,000.0 $1,750.0 22.2 $8,000.0 $2,000.0 885.1200a Manufacturing process $3,500.0 $1,225.0 15.5 $5,000.0 $2,000 .0 885.1200b Deposition of samples $3,500.0 $1,225.0 15.5 $5,000.0 $2,000.0 885.1300 Discussion of formulation of unintentional ingredients $3,500.0 $1,225.0 15.5 $5,000.0 $2,000.0 885.1400 Analysis of samples $74,500.0 $26,075.0 330.5 $145,000.0 $4,000 .0 885.1500 Certification of limits $350.0 $122.5 1.6 $500.0 $200.0 885.2000 Background for residue analysis of microbial pest control agents $0.0 $0.0 0.0 $0.0 $0.0 885.2100 Chemical identity $660.0 $231.0 2.9 $825.0 $495.0 885.2200 Nature of the resi due in plants $108,333.0 $37,916.6 480.6 $108,333.0 $108,333.0 885.2250 Nature of the residue in animals $117,144.0 $41,000.4 519.7 $123,750.0 $110,538.0 885.2300 Analytical method

- plants $26,540.0 $9,289.0 117.7 $34,040.0 $19,040.0 885.2350 Analytica l method

- animals $43,908.0 $15,367.8 194.8 $56,325.0 $31,492.0 885.2400 Storage stability, plants $31,017.0 $10,856.0 137.6 $32,683.0 $29,350.0 885.2500 Magnitude of residue in plants $137,160.0 $48,006.0 608.5 $137,587.0 $136,733.0 885.2550 Magnitude of residue in meat/milk/poultry $157,663.0 $55,182.1 699.4 $162,425.0 $152,900.0 885.2600 Magnitude of residue in potable water, fish, and irrigated crops $221,442.0 $77,504.7 982.4 $245,225.0 $197,658.0 885.3000 Background Mammalian Infectivity/pathoge nicity analysis $250,000.0 $87,500.0 1,109.0 $250,000.0 $250,000.0 885.3050 Acute oral toxicity/pathogenicity $33,500.0 $11,725.0 148.6 $41,000.0 $25,000.0 885.3150 Acute pulmonary toxicity/pathogenicity $37,500.0 $13,125.0 166.4 $50,000.0 $25,000.0 885 .3200 Acute injection toxicity/pathogenicity (intravenous) $37,500.0 $13,125.0 166.4 $50,000.0 $25,000.0 885.3200 Acute injection toxicity/pathogenicity (intraperitoneal) $12,500.0 $4,375.0 55.5 $18,000.0 $7,000.0 885.3400 Hypersensitivity incidents $800 .0 $280.0 3.5 $1,300.0 $300.0 885.3500 Cell Culture $30,000.0 $10,500.0 133.1 $35,000.0 $25,000.0 885.3550 Acute toxicity, TI $21,500.0 $7,525.0 95.4 $40,000.0 $3,000.0 885.3600 Subchronic toxicity/pathogenicity $150,000.0 $52,500.0 665.4 $200,000.0 $10 0,000.0 885.3650 Reproductive/fertility effects $162,500.0 $56,875.0 720.9 $20,000.0 $125,000.0 885.4050 Avian Oral, TI $15,000.0 $5,250.0 66.5 $18,000.0 $12,000.0 885.4100 Avian Inhalation toxicity/pathogenicity, TI $16,000.0 $5,600.0 71.0 $20,000.0 $1 2,000.0 885.4150 Wi ld mammal toxicity/pathogenicity,TI $65,000.0 $22,750.0 288.4 $80,000.0 $50,000.0 885.4200 Freshwater fish toxicity/pathogenicity,TI $37,500.0 $13,125.0 166.4 $45,000.0 $30,000.0 885.4240 Freshwater invertebrate toxicity/pathogenicity ,TI $37,500.0 $13,125.0 166.4 $45,000.0 $30,000.0**Page 30**  **of 30** 

885.4280 Estuarine/marine animal testing, TI $40,000.0 $14,000.0 177.4 $48,000.0 $32,000.0 885.4280 Estuarine/marine invertebrate testing,TI $40,000.0 $14,000.0 177.4 $48,000.0 $32,000.0 885.4300 Nontarg et plant studies, TI $30,000.0 $10,500.0 133.1 $40,000.0 $20,000.0 885.4380 Honey bee testing $4,250.0 $1,487.5 18.9 $5,000.0 $3,500.0 885.4600 Avian chronic pathogenicity and reproduction, TIII $175,000.0 $61,250.0 776.3 $200,000.0 $150,000.0 885.4650 Aquatic invertebrate range testing,TIII $75,000.0 $26,250.0 332.7 $1,000.0 $50,000.0 885.4700 Fish life cycle studies,TIII $250,000.0 $87,500.0 1,109.0 $300,000.0 $200,000.0 885.4750 Aquatic ecosystem test $350,000.0 $122,500.0 1,552.7 $400,000.0 $300,00 0.0 885.5200 Terrestrial environmental expression tests $95,000.0 $33,250.0 421.4 $150,000.0 $40,000.0 885.5300 Freshwater environmental expression test $0.0 $0.0 0.0 $0.0 $0.0 885.5400 Marine or estaurine environmental expression tests $95,000.0 $33,25 0.0 421.4 $150,000.0 $40,000.0

**Notes:** Labor Rates in 2003 dollars, but data collected represents 2003

-2007 Clerical: $40/hr Technical: $88/hr Management: $130/hr

**Color Code:** Study has no cost estimate, source or year Test cost estimate has no source or year