Appendix D

This document was originally published as Attachment G to a DCI ICR renewal document posted under the docket identification #EPA-HQ-OPP-2007-0923-0005. See docket in Regulations.gov.  This document is republished in this appendix without change.

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      General Methodology Used to Estimate
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      Paperwork Burden Hours and Costs by the
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      Office of Pesticide Programs for Submission of
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                           Required Data/Information for Responding to a Data Call-In Notice

                                      Office of Pesticide Programs
                                              October 2007

  Contents
 Contents

 SECTION I	3
 BACKGROUND	3
 What is the purpose of this document?	3
 Why does EPA issue DCIs?	3
 How do PRA requirements relate to DCIs?	4
      How does a DCI recipient respond to a DCI?	5
      DCI burden activities tables	6
                                    Table 1	6
                                    Table 2	7
      Variations of the response to a DCI	8
 Data generation in  response to a DCI	8
          Non-data generation in responses a DCI	9
 SECTION II	10
 ESTIMATING PAPERWORK ACTVITIES OF DATA GENERATION	10
 What are the key assumptions when estimating PRA burden hours and costs for data generation?	10
 Paperwork burden is generally 35% of the cost of the study.	10
 All registrants generate all DCI data	12
     How are test cost estimates developed?	12
     What if test cost estimates are unavailable?	12
      What if the available test cost estimates vary?	13
       What are the steps in calculating the paperwork burden (hours and costs)? 13 a.  Calculate test costs	13
 Distribute paperwork activities among labor categories.	13
          Calculate paperwork burden hours from labor cost distribution.	14
      Is the burden for those not generating data covered?.	15
 Attachment A: Case Studies: Agency analysis of response costs of non-data generation	17
 Study #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.	17
 Study #2 Data Generation for Pesticide Reregistration ICR, OMB No. 2070-0107, (EPA ICR No. 1504.05)	19
 Study #3 Economic Analysis for Proposed Changes in Data Requirements Rule for Biochemical and Microbial Pesticides  -  Cost Estimates for Data Waivers.	21
 Attachment B: FIFRA estimated test cost chart and PRA cost estimates	22

   Section I.  Background

 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 estimate 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).  The methodology is intended to provide a description of the process used by EPA to derive the estimated paperwork burden hours and costs associated with submitting a response to EPA under a DCI.  The methodology presented in this document should also enable stakeholders to reproduce the burden estimates 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.

 Why does EPA issue DCIs?

  With 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 human health and the environment.  Pesticides that meet the requirements are granted 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 maximum 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, allow 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 pesticide 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 reasons being the most common:
 The Reregistration Program: Section 4 of FIFRA requires EPA to reassess 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 section 3(c)(2)(B) authority to obtain the required data.
 The Registration Review Program: Section 3(g) of FIFRA contains provisions to ensure that each pesticide will be reviewed every 15 years to ensure 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.
 Anticipated 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 that 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 reevaluation of this information. Under FFDCA section 408(b)(2)(E), EPA can issue a DCI for information relating to anticipated residues, and under section 408(b)(2)(F) EPA can issue a DCI for percent crop treated estimates.

 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).  EPA's issuance of a DCI under FIFRA section 3(c)(2)(B) is subject 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 provides 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.  "Burden" means the time, effort, or financial resources expended by persons to generate, maintain, or provide information to or for a Federal Agency." 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 requirements to comply with new requirements; and/or
 train personnel.

 How does a DCI recipient respond to a DCI?

   Response to a DCI can generally be divided into three phases.
 Phase 1:  Initial response:  After receiving a DCI, the recipient has 90 days 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), cancels the product's registration, submits or cites 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.

 DCI burden activities tables

Table 1 illustrates the paperwork activities that would typically be performed by a DCI recipient during each 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
                          PHASE 1:  INITIAL RESPONSE
Read regulations

Read regulations

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

            PHASE 2(a): DATA GENERATION USING CONTRACT LABORATORY
Planning/oversight of
employee and contract
activities
Plan the data collection 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)

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

                       PHASE 3:  DATA SUBMISSION TO EPA
Sign-off on submission to
EPA
Draft summary of the data for cover letter
Prepare submission to
EPA
Close-out contract

Oversight of employee activities
Complete other required paperwork
Complete/file/archive other required paperwork

  Table 2 represents the PRA activities conducted at a contract laboratory.  Data are generated by following standard operating procedures, which involve mostly technical duties.  As part of their duties under Good Laboratory Practices (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 conduct 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
 PHASE 2(b):  PRA DATA GENERATION ACTIVITIES CONDUCTED  AT THE
                             CONTRACT LABORATORY*

Technical Duties

 Individual animal care records
 Records on the rooms in which animals are housed and procedures are performed
 Necropsy records
 Equipment logbooks and computer-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 data forms
     *The Agency recognizes that in certain instances these activities might be conducted "in-house."

  VI. Variations of the response to a DCI

  Because there 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/cite existing data
  A registrant who purchases/cites existing data performs Phase 1 Initial response and Phase 3 Data Submission activities only.  The initial response phase and the data submission phase are considered to have more-or-less fixed hours and costs since reading the regulations and preparing submissions to the Agency are independent of the type of information submitted.
  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 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 generation, 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 generation in response to a DCI

  A registrant who chooses to generate data in response to the DCI may either:
 generate and submit the required data on their own, or
 generate and submit the required data as part of a taskforce.
  Data 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, the Agency encourages cost-sharing agreements among manufacturers of specific pesticide chemicals to minimize the duplication of laboratory tests conducted in response to a DCI.  DCI notices explain the statutory provisions for cost sharing agreements for FIFRA.
  b. Phase 1 and Phase 3 response activities for data generaters

  Phase I and Phase 3 DCI response activities are 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.
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   Section II.  Estimating Paperwork Activities Of Data Generation

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

  a. Paperwork activities are generally 35% of the cost of the study.

  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 estimate 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 burdens related to a more complex study.  The premise 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 developed from numerous sources of information 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 communicating 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 1Response Phases (Phase 1 and Phase 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 the 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 Phases (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 equal 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 (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 #1503);   :: 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
  Figure - 1 Relationship of Test Costs to Response Phases

b. All registrants generate all DCI data

  The paperwork activity estimates are based on the average cost of generating new data.  The total cost of the paperwork burden 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.
 All data generation was performed by an independent laboratory.
 Paperwork 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:
 Managerial (20%)
 Technical (65%)
 Clerical (15%)
 Labor rates are derived from the parent ICR
 Labor rates are "fully loaded"

  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.
 How are test 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.
 What if test cost estimates are unavailable?

  The Agency may request certain special studies or non-guideline studies that have not been previously required, and for which test cost estimates have not 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.

 What 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 variation 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 (What if tests costs are unavailable).

 What are the steps in calculating the paperwork burden (hours and costs)?

  a. Calculate test costs

 Using the EPA archive information of FIFRA study cost estimates, the Agency calculates 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 burden is reflective of expert opinion, information from industry, various proprietary information/data, and a general assessment of test costs.
  b. Distribute paperwork activities among labor categories.

  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 (see Table 3, below) to reasonably reflect, on average, the percent of work performed.

Table 3: Distribution of Paperwork Activities Across Labor Categories*
Labor category
% of Paperwork Activities Performed
Managerial
20%
Technical
65%
Clerical
15%

  Using this percentage system, EPA can assign a paperwork activity cost to each labor category.
        For example, study guideline 850.1735, Whole 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 activities:
        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)
	Total 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 paperwork burden hours from labor cost distribution.

  The second component 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 fullyloaded wage rates ($/hour) compiled from the Department of Labor's Bureau of Labor Statistics which are shown in Table 4.
Table 4:  Fully-Loaded Hourly Wage Rates, by Labor Category*
Labor category
Rate ($/hour)
Managerial
$100.86
Technical
$64.80
Clerical
$33.05

  To estimate paperwork burden in hours, using the hourly wage rates listed in Table 4, the steps below are taken.
        Distribution of paperwork burden hours and costs for labor categories:
        Managerial labor: 	14.05 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

  VI. Is the burden for those not generating data covered?

  As discussed in Section 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 all 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 Phase I and 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.

  In 2006, the Agency conducted a preliminary analysis 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, the 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. 20700060, (EPA ICR No. 0277.14) represents the majority 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 Rule for Biochemical and Microbial Pesticides, September 2, 2005, was also used to extract costs for activities that do not involve data generation.  Of these three studies, the estimates of costs of paperwork that do not involve data generation were 1) $1169.00; 2) $1417.00 and 3) $2000.00 per response respectively.  The Agency believes these costs generally represent the range for paperwork burden and cost that registrants who are not generating data might be incur when creating Phase 1 responses. These analyses are discussed in detail in Attachment A.

                                 Attachment A
   Case Studies: Agency Analysis of Response Costs for
Phase 1 Responses

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  1.  Study #1:  Review of the Application for New and Amended Pesticide Registration, OMB No. 2070-0060, (EPA ICR No. 0277.14) representing burden hours and costs for paperwork activities that do not involve data generation for applications
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   for pesticide registration
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  In this study, EPA assumes:
 Paperwork activities for applications for registration for "me-too" pesticides  are similar to paperwork activities for developing a DCI response that does not entail generating new data or requesting a waiver.
 Estimated burden and costs listed in Table A are fixed, consistent costs for every respondent, and are not derived from any test cost estimates.
 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.
 The paperwork burden for phase 1 responses that are similar to activities in developing registration applications may be described as follows:
 read and discuss test requirements (read the DCI letter to understand what data are to be submitted);
 plan activities (includes time for reviewing internal company information);
 complete paperwork (prepare necessary correspondence, documents to EPA);
 Store/maintain information (maintain information submitted to the Agency in company files).
 Paperwork burden for such activities may be disaggregated by labor
        category as follows (percentages are approximations):
 Managerial (65%)
 Technical (0%)
 Clerical (35%)
 Labor rates are derived from the parent ICR.
 Labor rates are fully loaded.

  The supporting statement of the Application for New and Amended Pesticide Registration ICR characterizes the activities that would be needed for an application/notification.  These activities are substantially similar to those of Phase 1: Initial Response that do not involve generating data or requesting 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
Plan 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
  (* Indexed to 2005 dollars)

  After distributing the paperwork costs among the managerial and clerical staff labor categories, the paperwork 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 New and Amended Pesticide Registration, OMB No. 2070-0060, (EPA ICR No. 0277.14) approved by Office of Management and Budget, November 8, 2005.
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2.  Study #2: Data Generation for Pesticide Reregistration ICR, OMB No. 2070-0107, (EPA ICR No. 1504.05).

  In this study EPA assumes:
 The total paperwork burden hours and costs for Phase 1 responses are approximately 7 percent of the estimated average cost to generate new data.
 Registrant responses to the DCI notice that do not involve data generation  include voluntary cancellation, submitting or citing existing data, requesting a data waiver, or claiming eligibilitygeneric data exemption.
 Paperwork activities that do not involve data generation may be described as follows:
 read and discuss test requirements (read the DCI letter to understand what data are to be submitted);
 plan activities (developing options for not generating new data includes  reviewing internal company information for existing data);
 complete paperwork (prepare necessary correspondence, documents and/or waiver requests to avoid having to submitting data to EPA);
 record, maintain and file information (maintain information submitted to the Agency in company files).
 Paperwork burden for Phase 1 DCI responses  activities may be disaggregated by labor category as follows (percentages are approximations):
 Managerial (50%)
 Technical (5%)
 Clerical (45%)
 Labor rates are derived from the parent ICR  6) Labor rates are fully loaded.

 Calculate Cost of Paperwork.  Using the EPA maintained database of test cost estimates, the Agency calculates the total paperwork burden cost for a test as 7% of the total test cost because based on the percentage breakdown for paperwork burden applicable to non-data generation activities for this ICR.  This 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 Phase I DCI response activities discussed in section IV.
 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 activities will be conducted by managerial, technical, 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 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 Across 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.  Estimates for paperwork cost for these non-data generation activities 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 $1,417.50 or 7% of the total test cost represents the cost of the total paperwork burden activities.
 Calculate Paperwork Burden Hours From Labor Cost Distribution.  After distributing the paperwork costs among the managerial, technical and clerical staff labor categories, the paperwork burden hours are then derived by dividing the costs using fully-loaded wage rates ($/hour) cited in the parent ICR and listed in Table C.

Table C:  Fully-Loaded Hourly Wage Rates, by Labor Category*
Labor category
Rate ($/hour)
Managerial
$130
Technical
$88
Clerical
$40
      (Labor costs cited in the parent ICR - Indexed to 2004 dollars)

        To estimate paperwork burden in hours, using the hourly wage rates listed in Table C, the steps 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

--------------------------------------------------------------------------------
   3.  Study #3:  Economic Analysis for Proposed Changes in Data Requirements Rule for Biochemical and Microbial Pesticides  -  Cost Estimates for Data Waivers.
--------------------------------------------------------------------------------

  Under 40 CFR 158.45, the Agency may waive data requirements on a case-bycase 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 analyzed 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.  EPA believes this unit 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

                                                                            20
                                                                           2000

Attachment B

    Chart: FIFRA Estimated Study Costs And Paperwork
                 Burden Hour And Cost Estimates

          Test Information

                 Paperwork Burden Totals (35% of study cost)

                             Test Guideline/ Section
                                  Test Name
      AverageTest Cost
         Total Paperwork Burden Cost
     Total Paperwork Burden Hours
     High Test Cost
)
High AVG for 2005 SciReg
(
      Low Test Cost
)
Low AVG for 2005 SciReg
(

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
Product 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 Fungicide 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
                                                   Broad spectrum disinfectant
                                                         Hospital disinfectant
                                                       Fungicidal disinfectant
                            Virucidal disinfectant Tuberculocidal disinfectant
                                                                      $4,201.0
                                                                      $1,470.4
                                                                          18.6
                                                                      $5,010.0
                                                                      $3,391.0
                                                           810.2200 - itemized

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

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

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

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

                                                                      $4,691.0
                                                                      $1,641.9
                                                                          20.8
                                                                      $5,633.0
                                                                      $6,748.0

                                                           810.2200 - itemized
                                                           Additional bacteria
                                                              Non-food contact
                                                Food contact - Halide products
                                            Food contact - Non-halide products
            Sanitizers for urinal and toilet bowl water and in-tank sanitizers
                            Residual self-sanitizing - wet surfaces Sterilants
                                                                      $4,082.0
                                                                      $1,428.7
                                                                          18.1
                                                                      $4,803.0
                                                                      $3,361.0
                                                           810.2200 - itemized

                                                                      $5,198.0
                                                                      $1,819.3
                                                                          23.1
                                                                      $6,026.0
                                                                      $4,370.0
                                                           810.2200 - itemized

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

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

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

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

                                                                     $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 disinfectants 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 midge 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 skin 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
                                                                        $233.0
                                                                         $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 analytical 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
                                                                  Flammability
                                                                      $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

                                                                      830.6319

                                                                   Miscibility
                                                                      $1,100.0
                                                                        $385.0
                                                                           4.9
                                                                      $1,500.0
                                                                        $700.0
                                                                      830.6320

                                                     Corrosion 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
                                                                      $1,972.0
                                                                      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 density
                                                                      $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-life 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
                                                                    $375,000.0
                                                                      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

                      Whole sediment acute toxicity invertebrates (freshwater)
                                                                     $20,250.0
                                                                      $7,087.5
                                                                          89.8
                                                                     $21,500.0
                                                                     $26,000.0
                                                                      850.1740

                          Whole 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
                                                                     $29,050.0
                                                                         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

                                                                      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
                                                    Wild 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 area 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
                                                                     $13,625.0
                                                                      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
                                                                      $3,000.0
                                                                      $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
                                                                    $221,047.0
                                                                      870.3200
                                                     21/28-day dermal toxicity
                                                                     $83,240.0
                                                                     $29,134.0
                                                                         369.3
                                                                     $84,681.0
                                                                     $81,798.0

                                                                      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
                                                                    $300,000.0
                                                                      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