ECONOMIC ANALYSIS OF THE CHANGE IN DATA REQUIREMENTS RULE 

FOR CONVENTIONAL PESTICIDES 

Prepared by: 

BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION 

OFFICE OF PESTICIDE PROGRAMS 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave, NW 

Washington, DC 20640 

June 15, 2007
TABLE OF CONTENTS 

1 EXECUTIVE SUMMARY ....................................................................................................... 1

2 PROBLEM STATEMENT....................................................................................................... 4

2.1 Overview of Pesticide Usage, Exposure, Effects and Regulation ................................. 4

2.2 Nature of Market Failures Inherent from Pesticide Producer and User Behavior... 5

3 ANALYSIS OF OPTIONS CONSIDERED FOR THE PROPOSED RULE..................................... 5

3.1 Selected Option: Decision Criteria Determination of Data Requirement...... 6

3.2 Low-Cost Option: Codification of Current Practice ........................................ 8

3.3 High-Cost Option: Requirement of the Additional Required Data 100% of 

the Time ................................................................................................................................. 8

4 ECONOMIC ANALYSIS OF THE PROPOSED CHANGES IN THE DATA REQUIREMENTS RULE 

FOR CONVENTIONAL PESTICIDES .................................................................................................. 9

4.1 Background for Final Rule .................................................................................. 9

4.2 Reason for the Final Rule..................................................................................... 9

4.3 Overview of the Costs of the Final Rule ........................................................... 10

4.4 Statutory Authority ............................................................................................ 12

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)...................... 12 

The Federal Food, Drug and Cosmetic Act (FFDCA).......................................... 12 

The Food Quality Protection Act (FQPA)............................................................ 13 

4.5 Description of Data Requirements .................................................................... 13

Data Requirements by Data Category (data discipline)........................................ 13 

Data Requirements by Type of Registration Action............................................. 14 

4.6 Description of Final Regulation......................................................................... 15

4.7 Profile of the Regulated Community ................................................................ 17

4.7.1 Registrant Population............................................................................. 17 

4.7.2 Registrant Financial Data ...................................................................... 18 

5 ECONOMIC IMPACTS ON PESTICIDE REGISTRANTS DUE TO CHANGES IN DATA 

REQUIREMENTS ............................................................................................................................ 21

5.1 Unit Test Costs (Step 1) ...................................................................................... 24

5.2 Data Requirements Per Registration Action (Step 2)...................................... 24

5.3 Incremental Costs and Impact Per Registration Action (Step 3)................... 25

5.4 Industry-Wide Impacts (Step 4) ........................................................................ 27

5.5 Average Annual Cost per Firm (Step 5) ........................................................... 27

6 SMALL BUSINESS IMPACTS (STEP 6)................................................................................ 27

6.1 Regulatory Overview.......................................................................................... 27

6.2 Categorization of Small Businesses ................................................................... 27

6.2.1 Estimation of the Number of Small Businesses.................................... 28 

6.2.2 Sales and Employees............................................................................... 29 

6.3 Small Business Impact........................................................................................ 30

7 LIMITATIONS OF ANALYSIS.............................................................................................. 32

8 ESTIMATION OF THE BURDEN OF THE DATA COLLECTION ............................................ 33

9 ESTIMATION OF AGENCY BURDEN .................................................................................. 35

REFERENCES................................................................................................................................. 37
LIST OF TABLES and CHARTS 

Table 4.1: Data Categories and Descriptions........................................................................... 14 

Table 4.2: Types of Registration Actions and Descriptions.................................................... 14 

Table 4.3: Average Number of Registration Actions per Year .............................................. 18 

Table 4.4: Summary of Data Sets Used in Economic Profile of Entities Affected by the Part 

158 Rule................................................................................................................................ 19 

Table 4.5: Primary Industry Sectors Represented in the PRATS Data Set.......................... 20 

Table 4.6: Primary Industry Sectors Represented in the PPIS Data Set .............................. 20 

Chart 5.1 Methodology Flowchart ......................................................................................... 23 

Table 5.1: Cost of Newly imposed Test requirements for Non-Food Active Ingredient...... 26 

Table 6.1: Companies in the PRATS Sample by SBA Size..................................................... 28 

Table 6.2: Average Sales and Employees B PRATS Data Set.................................................. 29 

Table 6.3: Average Sales and Employees B PPIS Data Set ...................................................... 29 

Table 6.4: Number of Entities in Sample per SBA Category from PRATS Sample ............ 30 

Table 6.5: Number of Entities in Sample per SBA Category and PPIS Sample................... 30 

Table 6.6: Estimated Small Business Impacts.......................................................................... 31 

Table 8.1: Estimate for Type A Activities Annual Registrant Burden/Cost Estimates for 

Type A Activities for the Registration Division (RD): New Active Ingredients and New 

Uses....................................................................................................................................... 35 

Table 8.2: Estimate for Type C Activities Annual Registrant Burden/Cost Estimates for 

Type C Activities for the Registration Division (RD): Reduced Risk........................... 35 

Appendix A Test Cost Data Used To Calculate Data Requirement Costs For Part 158 

Rule 

Appendix B Options and Sensitivity Analysis

Appendix C Agency Impacts 

Appendix D Industry Profile

Appendix E Pesticide Registration Action Tracking System (PRATS) Action Codes 

Appendix F Analysis for Final Rule
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1 EXECUTIVE SUMMARY 

The U.S. Environmental Protection Agency (EPA) proposed to update and revise the data 

requirements for the registration of conventional pesticide products listed in part 158 of Title 40 

of the Code of Federal Regulations (CFR) on March 11, 2005 (70 FR 12275). EPA received 

public comments on the proposed rule and is now issuing the final rule. This document 

evaluates the potential benefits and costs expected to result from the revisions presented in the 

final rule. 

Federal law requires that before selling or distributing a pesticide in the United States, a 

person or company must obtain registration, or license, from the EPA. Before registering a new 

pesticide or new use for a registered pesticide, EPA must first ensure that the pesticide, when 

used according to label directions, can be used with a reasonable certainty of no harm to human 

health and without posing unreasonable risks to the environment. Where pesticides may be used 

on food or feed crops, EPA also sets tolerances (maximum pesticide residue levels) for the 

amount of the pesticide that can legally remain in or on foods. To make such determinations, 

EPA requires applicants to provide EPA with the data and other necessary information. 

Since the data requirements in 40 CFR part 158 were first codified in 1984, information 

needed to support the registration of a pesticide chemical has evolved as the general scientific 

understanding of the potential hazards posed by pesticides has grown. Over the years, updated 

data requirements were developed by EPA using a process that involved public participation and 

extensive involvement by the scientific community, including peer review by the FIFRA 

Scientific Advisory Panel (SAP). Most of the data requirements contained in this rule have been 

applied on a case-by-case basis to support individual applications, or imposed via Data Call-In 

(DCI) on all registrants of similar products. Although the data requirements imposed have 

progressed as scientific understanding and concerns have evolved, the codified data requirements 

in part 158 have not been updated to keep pace. 

This rule involves changes to the codified data requirements that pertain to product 

chemistry, toxicology, residue chemistry, applicator exposure, post-application exposure, 

nontarget terrestrial and aquatic organisms, nontarget plant protection, and environmental fate. 

Coupled with updating the data requirements in part 158, EPA is adding a few new data 

requirements, reformatting the presentation of the requirements in part 158, and making a few 

revisions to its general procedures and policies associated with data submission. 

Codifying existing data requirements which are currently applied on a case-by-case basis 

allows the pesticide industry, along with other partners in the regulated community, to attain a 

better understanding and better prepare for the pesticide registration process. In addition, the 

proposed revisions to part 158 are expected to increase EPA’s ability to meet statutory 

requirements; make more informed regulatory and licensing decisions; enhance efficiencies in 

the licensing and decision-making process; improve understanding and expectations with regard 

to the data needed for pesticide registrations; improve the availability of more complete and 

reliable data; improve the Agency’s ability to prepare good quality risk assessments; enhance the 

consideration of risk mitigation measures; and provide better protection to humans and the 

environment. These improvements in EPA’s abilities will benefit a large number of parties, 
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including the regulated industry, pesticide users, the general public, other federal, state, and 

foreign governments, and others who are affected by or interested in pesticide use or regulation. 

To evaluate the potential annual cost to the conventional pesticide industry under three 

options, the Agency examined the historical information of actual pesticide registration actions 

between 1996 and 2002. This included information regarding the type and frequency of the 

various possible pesticide registration actions, the related applicability of the various data 

requirements to those actions, and information about the applicants involved in those actions. 

This information formed the basis for the analysis presented in this document, i.e., to estimate 

the potential annual impacts on industry assuming an average annual number of future pesticide 

registration actions in addition to the type and frequency of future pesticide registration actions. 

EPA identified a total of 120 individual firms involved in one or more of the 986 total 

pesticide registration actions that occurred between 1996 and 2002. EPA estimated an annual 

average of 141 pesticide registration actions, and created an economic profile of the affected 

industry using a large random sample of 1,000 pesticide registrants. 

 In the Economic Analysis (EA) for the proposed rule, the following three options were 

analyzed: 

Proposed approach: Decision criteria determination of data requirement: The estimated annual 

cost under this approach was about $51 million. 

Low-cost option: Codification of Current Practice: The estimated annual cost under this 

alternate approach was about $48 million. 

High-cost option: Require Data 100% of the Time: The estimated annual cost under this 

alternate approach was about $69 million. 

 This final rule is similar to the proposed rule except that some data requirements will no 

longer be commonly required. The estimated annual cost of this final rule will be less than the 

estimated annual cost of the proposed rule. The changes from the proposed rule are as follows: 

• Elimination of Chronic Oral Toxicity Data Requirement – Non-Rodent (One-Year Dog) 

(Guideline 870.4100). This data requirement was required as part of the baseline. The 

cost of the test is approximately $950,000 and was recently required on an average of 

almost 18 times per year for the entire industry. Since this data requirement will no 

longer be required, a savings of almost $16.6 million is expected per year. 

• Elimination of Special Data Requirements. Three special toxicity data requirements, 

expected to be required about 1% of the time, will no longer be required. This reduces 

the cost of the rule by $304,000 per year. The data requirements are: 

o Scheduled Controlled Operant Behavior (Guideline 870.6500) 

o Peripheral Nerve Function (Guideline 870.6850) 

o Neurophysiology: Sensory Evoked Potentials (Guideline 870.6855) 

• Revision of some of the Test Notes Associated with the Ecological Effects Data 
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Requirements. Since these revisions to the test notes will slightly reduce the percent of 

time these tests may be required, the costs in the final rule will be slightly less than the 

proposed rule; however, these costs were not re-estimated for the final rule because of the 

expected minimal impact. 

• Restructure of Subparts. Based on some public comments, EPA in the final rule is 

restructuring the subparts to be more user-friendly. EPA reasons that the users most in 

need of clarity are the infrequent, generally lower-volume-producing applicants, whose 

data requirements are in many cases limited to end-use product data of various types. 

This restructuring does not change the cost of this rule to industry. The benefits to the 

lower-volume-producing applicants would be more qualitative than quantitative. 

• Simplification of Data Requirement Tables. Some of the major use patterns have been 

collapsed under a larger major use pattern for ease of use. For example, the major use 

patterns in the Toxicology Data Requirements table consist of Food and Nonfood. The 

discussion in §158.500(b) explains that the general use patterns of terrestrial food crop, 

terrestrial feed crop, aquatic food, greenhouse food crop, and indoor food have been 

placed under the major use pattern “Food.” The “Nonfood” use patterns include products 

classified under terrestrial nonfood crop, aquatic nonfood, greenhouse nonfood crop, 

forestry, residential outdoor and indoor, and indoor nonfood. Therefore, only two major 

use patterns appear in the data requirement table for Toxicology. Similar adjustments 

have been made to other disciplines as appropriate. These changes do not affect the cost 

of this rule to industry. 

• The agency will adopt alternative approaches of testing as they became available. As 

discussed in the preamble, the proposal from Agricultural Chemical Safety Assessment 

(ACSA) is consistent with EPA's direction and goals to develop a more efficient and 

reliable testing paradigm. EPA will update part 158 data requirements as new science 

develops and is peer reviewed. In the meantime, EPA will work with registrants to 

explore alternative testing strategies on a case-by-case basis. It is difficult to estimate the 

cost of alternative studies without protocols. However, as discussed in the preamble, 

there are case studies underway that will provide more information on expected costs and 

potential cost savings. 

As a result of these changes, the estimated annual incremental cost of the final rule is 

expected to be about $33.6 million for the industry. The elimination of the toxicity tests as 

described above reduces the cost of the rule by almost $17 million. This cost reduction would 

also apply to the high cost option. 

The low cost option (Codification of Current Practice) is no longer the lowest cost option 

under the final rule, because current practice includes data requirements being eliminated in the 

final rule. This option remains the same in both the proposed and final rules. 

The analysis of the potential impact of the proposed rule on small businesses suggested 
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that the proposed rule would not have had a significant impact on a substantial number of small 

entities because only 1.6% of the potentially impacted firms were expected to experience a cost 

increase representing 3% or more of gross sales. Only 2.4 % were likely to experience a cost 

increase representing 1% or more of gross sales (See Section 4). Since the expected incremental 

costs of the final rule are about 33% less than what was estimated for the proposed rule, the 

potential impacts on small businesses would be less than what was estimated for the proposed 

rule. The small business impacts for the final rule were not re-estimated since they were not 

significant under the proposed rule and will therefore be slightly less significant under the final 

rule. 

Using the currently codified requirements as the baseline for estimating the potential 

impact of the final rule, the total annual impact to the pesticide industry is estimated to be about 

$33.6 million. Of this estimated total annual impact, about $28.6 million per year represents the 

cost of new data requirements that were imposed over the years but were not codified in the 

existing CFR, and about $5 million represents the cost of modified, reduced, or expanded 

existing data requirements (i.e., data requirements for certain tests and use patterns in the CFR 

that are changing from conditionally required (CR) to required (R)). These data requirements 

have become more regularly required as they have been applied to an increasing number of 

registrations. As a result, about $2.1 million that is attributable to newly imposed requirements 

is included in the total cost estimate. The costs of the newly imposed requirements represent the 

increase in costs over current practices and therefore provide the estimated practical impact of 

this final rule to the pesticide industry. 

Since the likely impact of this final rule on businesses overall is expected to be small, the 

Agency believes that a deleterious effect on the availability of pesticides to users is unlikely. On 

balance, the Agency believes that the costs of the rule are justified by the benefits from the 

enhanced protection of human health and the environment. 

2 PROBLEM STATEMENT

2.1 Overview of Pesticide Usage, Exposure, Effects and Regulation 

Pesticides are biological poisons, intended to kill or repel biological entities. The mode 

of action is seldom entirely specific as to the time, place and target of the chemical activity. 

Pesticides are often acutely toxic to animals, plants and other lower life forms and at the same 

time are likely to be acutely, if not chronically, toxic to at least some part of the non-target biota 

(flora and fauna of a region). The long-term effects of chronic exposure of human, animal and 

other living organisms to pesticides are uncertain. There are many possibilities for 

chemical/toxicological interactions between pesticides and living organisms, particularly those 

resulting from long-term, low-dosage exposure.

 

 Each year, large quantities of pesticides are released into the environment. In 2001, an 

estimated 4.97 billion pounds of active ingredient (AI) were used in the United States (USEPA 
 5 

2001a). Of this, 1.2 billion pounds AI were used predominately as conventional pesticides in 

agricultural, industrial, commercial, government and house and garden uses. The remaining 

pounds of AI comprise other chemicals such as specialty biocides, chlorine/hypochlorites, and 

wood preservatives. 

Agricultural uses of pesticides account for about 76 percent of the total conventional 

pesticide use in the U.S.; this amounted to 675 million pounds AI in 2001. The 

industrial/commercial/governmental sector is the second-ranked user of pesticides in the U.S., 

accounting for about 13 percent of the total use of conventional active ingredients (111 million 

pounds in 2001) (USEPA 2001a). There are an estimated 422,000 total commercial applicators 

in the U.S. (USEPA 2001a). Pesticides are used on a majority of the 2.2 million commercial 

farms in the U.S. Pesticide use in agriculture may result in residues in feed and food products 

produced on farms, leading to human exposure to pesticides through the food supply. Pesticide 

use can also lead to groundwater contamination, or direct exposure to humans and the 

environment. Groundwater is vulnerable to contamination by pesticides from ordinary usage, 

leaks, spills and disposal. Groundwater is used for drinking water by nearly half of the U.S. 

population. In some rural areas, it is the only source of drinking water (USEPA 1999c). Farm 

use also potentially exposes applicators and farm families to pesticides. Farm field workers, 

numbering 8.8 million in the U.S. in 2002, may be subject to a high degree of exposure to 

pesticides, primarily through dermal contact with residues on plant surfaces (USDA 2003). 

 Home and garden usage of pesticides equals about 7 percent of total conventional 

pesticide usage on an active ingredient basis, amounting to 78 million pounds in 2001 (USEPA 

2001a). People who use pesticides are directly exposed, primarily through dermal contact or 

inhalation. 

 

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

 

 Economic theory suggests that regulatory intervention is justified in the presence of 

market failures. For example, in the case of pesticide residues on food, the two most salient 

sources of failure are externalities and asymmetric information. Externalities arise because some 

of the costs (e.g. groundwater contamination and environmental damage) associated with 

pesticide residues are external to those benefiting from the pesticides (pesticide producers and 

users, and consumers of food). The asymmetric information problem arises because consumers 

cannot easily determine the level of pesticide residue on food. Even if the level were readily 

apparent, the nature of the risks posed by these residues is not well understood. 

3 ANALYSIS OF OPTIONS CONSIDERED FOR THE PROPOSED RULE

Executive Order 12866 directs agencies initiating rulemaking activities to conduct a 

regulatory impact analysis and submit it to the Office of Management and Budget (OMB) prior 

to publication of the proposed rule. The executive order calls for EPA to characterize the costs 

and benefits of the proposed option and compare them with the costs and benefits of other 

options. The proposed option should be the one that maximizes net social benefits. The purpose 
 6 

of this section of the report is to integrate the results of the impact analysis into a benefit/cost 

framework and to report on the analysis required by Executive Order 12866. 

This economic analysis is conducted pursuant to EPA’s guidance on conducting 

regulatory economic analyses (USEPA 1999b; USEPA 2000). 

 EPA considered alternative options in requiring data requirements before arriving at the 

Agency’s preferred option in the proposed rule. The proposed option and two alternative options 

are summarized and compared below. The pros and cons of each of the two alternatives relative 

to the proposed approach are also discussed below. The goal was to arrive at a structure and 

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

registration action, while minimizing the impacts on pesticide registrants. These impacts include 

the direct cost of generating the data as well as less tangible costs brought about by uncertainty 

in registration requirements. The three options are as follows. 

3.1 Selected Option: Decision Criteria Determination of Data Requirement 

Benefits

 The Agency is updating its regulations by codifying current data requirements that are 

not currently codified in part 158 of Title 40 of the Code of Federal Regulations (CFR), but 

which are intended to provide EPA with data and other information necessary to register a 

conventional pesticide chemical. EPA regulates pesticides under FIFRA (Federal Insecticide, 

Fungicide, and Rodenticide Act) and FFDCA (Federal Food, Drug and Cosmetic Act). FIFRA 

requires that an applicant or registrant demonstrates to the Agency’s satisfaction that, among 

other things, the pesticide product, when used in accordance with label instructions, will not 

cause “unreasonable adverse affects” to humans or the environment. FFDCA requires a 

“reasonable certainty of no harm” from pesticide residues in food. Reducing these adverse 

effects reduces the externalities of pesticide use on the environment and the effects of 

asymmetrical information on consumers of food. Requiring additional data enhances EPA’s 

ability to make sound regulatory decisions; prevents the registration of pesticide products that 

may have unreasonable adverse externalities on the environment; and protects consumers of food 

from unreasonable risks. Besides updating data requirements, EPA is adding a few new studies, 

increasing the frequency of a few existing studies, reformatting part 158, and revising the general 

procedures and policies associated with data submission. By codifying these data requirements, 

which are currently applied on a case-by-case basis, and adding a few additional new 

requirements (such as immunotoxicity testing), the pesticide industry, along with other partners 

in the regulated community, gain a better understanding of the date requirements that are likely 

to be required and are better prepared for the pesticide registration process. 

In essence, the data requirements identify the questions that the registrant will need to 

answer regarding the safety of a pesticide product before the Agency can register the product. 

The data requirements address both components of a risk assessment, i.e., what hazards the 

pesticide presents, and what level of exposure to the pesticide. The answer to one question may 

inform the kind of information needed in other questions. For example, a pesticide that is 
 7 

persistent and toxicologically potent may require more extensive exposure and environmental 

fate data to help establish an acceptable level of exposure. If there is negligible exposure, then 

there may be less need for extensive hazard data since any conceivable risk would be low. 

Until 1984, data requirements were based on longstanding requirements initially put in 

place when pesticides were regulated by U.S. Department of Agriculture (USDA) and the Food 

and Drug Administration (FDA). However, because virtually all of EPA’s decisions relating to 

the registration of pesticides or the establishment of tolerances depend on EPA evaluation of 

scientific studies, the Agency has throughout the years developed standardized data requirements 

and test guidelines, and established evaluation procedures and peer review processes to ensure 

the quality and consistency of scientific studies. 

 Since the data requirements in part 158 were first codified in 1984, information needed to 

support the registration of a pesticide chemical has evolved as the general scientific 

understanding of the potential hazards posed by pesticides has grown. Over the years, updated 

data requirements were developed by EPA using a process that involved public participation and 

extensive involvement by the scientific community, including peer review by the FIFRA 

Scientific Advisory Panel (SAP). Most of the data requirements being codified under this 

proposed approach have been applied on a case-by-case basis to support individual applications, 

or imposed via Data Call-In (DCI) notices on all registrants of similar products. Although the 

data requirements imposed have progressed as scientific understanding and concerns have 

evolved, the codified data requirements have not been updated to keep pace. 

Costs

One potential impact of higher data costs for registering a pesticide is that fewer products 

may be registered in a given time period as more time and money may be required to develop the 

data to support a registration. Additionally, the types of products that are developed, and for 

what uses, may be affected. Higher costs may encourage registrants to effectively raise the 

threshold for potential revenue expected from a pesticide use before they would pursue its 

registration, which may mean that research into pesticides for “minor uses” (e.g., crops with 

small acreage or very specific pests) may be reduced. The Agency, in conjunction with USDA, 

has a program called IR-4, which promotes research and development in these areas through 

various incentive measures, including support for data generation to ensure that pesticides are 

available to growers of minor crops. 

Another effect of raising the costs of regulation is higher prices, which decreases 

consumer surplus. The amount of the cost that pesticide producers can pass on to pesticide users 

depends on the price elasticity of the demand for pesticide products. If there were good 

alternative pesticides or means of pest control, the pesticide producer would not be able to pass 

much of the higher costs to pesticide users. If there are no good substitutes, the pesticide 

producer would be able to pass on most of the costs to pesticide users. 

 The estimated incremental costs of this option for conventional pesticides are about $51 

million. A detailed analysis is shown in Appendix F. 
 8 

3.2 Low-Cost Option: Codification of Current Practice 

Benefits

This approach reflects codifying the Agency’s current practice. The data required under 

the current practice relies on the data requirements in the current Part 158 as modified by current 

policies and practices, including DCIs. Entities seeking registration of a pesticide have to submit 

applications based on requirements in the current CFR and then wait for the Agency to 

determine the additional required data not codified in the current CFR for each pesticide 

registration action on a case-by-case basis. EPA considers all of the possible tests used to 

support pesticide registrations, and only requires those tests that would appear to add significant 

information and value to the decision, while ensuring that the registration meets or exceeds 

statutory safety standards. 

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

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

delays in generating data. In terms of data requirements, this option is similar to the selected 

approach except it does not include a few new requirements, such as immunotoxicity testing, 

which the Agency has not currently imposed. EPA believes that the newly imposed 

requirements (that are in the selected option, but not in this low-cost option) are needed to make 

informed decisions on pesticide registration; are worth their cost; and would reduce the 

externalities to the environment and risks to consumers of food. 

Costs

The estimated cost of this approach to industry (additional data requirements compared to what 

is required in the current CFR) is about $48 million. A detailed analysis is shown in Appendix F. 

3.3 High-Cost Option: Requirement of the Additional Required Data 100% of the 

Time 

Benefits

Another alternative approach analyzed by the Agency would be to require all data 

requirements marked “R” 100 percent of the time for any new requirement. “Required” in the 

selected and low cost options means the data requirement is required unless certain conditions 

are met, so the frequency could be less than 100% since it might not apply to all pesticides that 

trigger those conditions. This approach would result in higher costs to pesticide registrants and 

to the Agency than the selected approach, but would ensure availability of this information. 

 This option may reduce the adverse externalities of pesticides and unknown risks to 

consumers of food slightly more than the selected approach. However, the benefits of this 

additional data are speculative, because if certain conditions are met, then this additional data 
 9 

(over and above what the selected option requires) would help inform registration decisions very 

little. Furthermore, if the higher cost of registering pesticides results in fewer products being 

registered, overall risk to humans and the environment may not increase since newer products 

are often safer than the older pesticides they may replace or partly replace. 

Costs

EPA believes that the cost of requiring the data 100% of time for all registrations would 

be too high to warrant the modest benefits of marginally valuable information. Additionally, 

EPA expects that registrants would request waivers of many tests under this approach, resulting 

in inefficiency and uncertainty similar to that described under the case-by-case approach of the 

current practice. EPA believes that this high cost approach would raise the cost of registering a 

pesticide substantially, resulting in fewer products being registered for minor uses, which already 

have a relative shortage of pest control options due to the limited market incentive to registrants. 

 

 The estimated cost of this approach is $69 million. A detailed analysis is shown in 

Appendix B. 

4 ECONOMIC ANALYSIS OF THE CHANGES IN THE DATA REQUIREMENTS IN THE FINAL 

RULE FOR CONVENTIONAL PESTICIDES

 4.1 Background for Final Rule

This rule is one in a series of revisions aimed at updating EPA’s regulations governing 

pesticide data requirements. The regulations governing data requirements have not been 

comprehensively revised since 1984. This rule pertains to the data requirements for 

conventional pesticides, i.e. pesticides that are not classified as antimicrobial (including wood 

preservatives) or biopesticides. EPA is revising the data requirements for conventional 

pesticides in the fields of toxicology, residue chemistry, applicator exposure, post-application 

exposure, non-target terrestrial and aquatic organisms, non-target plant protection, 

environmental fate and product chemistry. 

 4.2 Reason for the Rule 

The data requirements specified in Part 158 of 40 CFR are intended to provide EPA with 

data necessary for the registration of pesticide products, including conventional pesticide 

chemicals. Since the data requirements set out in Part 158 were first published in 1984, 

information needed to support the registration of a pesticide chemical has expanded or has been 

refined as experience with pesticides and the science underlying the data requirements has 

advanced. As a result of the Food Quality Protection Act (FQPA) of 1996, EPA must now 

address additional human health risk issues associated with the use of pesticides, such as 

aggregate and cumulative risks. Additional data are required to perform these assessments. 

The revised data requirements are expected to improve EPA’s ability to make timely 

decisions about the likely human health and environmental effects of pesticide products. These 
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revised data requirements are intended to help EPA better protect people (including sensitive 

populations), wildlife, and the environment. Coupled with revising data requirements, EPA is 

reformatting the tables and revising some general procedures and policies associated with data 

submission. EPA believes that the changes to these regulations will provide the pesticide 

industry and other partners in the regulated community a better understanding of the 

requirements and allow them to better prepare for the pesticide registration process, thus 

reducing delays. 

 4.3 Overview of the Costs of the Final Rule

 The direct costs of the rule affect the pesticide registrant community. EPA estimated the 

likely expenditures to be incurred by regulated entities, which may be an acceptable first-order 

approximation of the true cost given the magnitude of the rule. 

The primary impact of the rule on the regulated community is the increase in registration 

costs associated with developing and submitting required data, and the burden on EPA to process 

and review this data. Over the years EPA has imposed new data requirements on a case-by-case 

basis that are not codified in the current CFR. Over time, as they have been applied to an 

increasing number of registration actions, these data requirements have become more regularly 

required to meet specific needs and are now being codified in this rule. The costs of these newly 

codified data requirements represent most of the cost of the rule (about $28.6 million per year). 

In addition, the data requirements for certain tests and use patterns in the CFR are changing from 

conditionally required (CR) to required (R). These changes would increase the frequency at 

which certain tests are required. The incremental costs of these changes are part of the cost of 

the rule (about $21.6 million per year). However, these increased requirements are offset by a 

test that will no longer be required ($9.5 million). Therefore, the net increased requirements are 

$12.1 million. These impacts are explained in more detail in Sections 3 and 4. 

 This analysis estimates the annual cost only, because all years have the same expected 

(average) annual cost. There are no large costs in the beginning followed by smaller future 

costs. Furthermore, since the benefits of rule could not be quantified, it was not necessary to 

compare costs and benefits in a common denominator such as present value or annualized costs 

to account for different time frames. Since the costs are the same each year, the annualized value 

of the present value of the costs over a period of years at any interest rate is equal to the constant 

annual costs. 

The total estimated annual incremental cost of increased data requirements for registering 

pesticide products is projected to be about $33.6 million to the conventional pesticide industry. 

This estimate is based on an examination of registration actions from 1996-2002. During this 

period 120 firms would have incurred average increased data costs of approximately $280,000 

per firm per year if the rule had been promulgated. 

 An analysis of the impact of the rule on small businesses suggests that the rule will not 

have a significant impact on a substantial number of small entities; out of an estimated 1373 

small firms potentially affected by the rule, only about 23 firms were expected to experience a 
 11 

cost increase representing 3% or more of gross sales. Only 2.4 %, approximately 35 firms out of 

about 1373 small conventional pesticide firms, is expected to experience a cost increase 

representing 1% or more of gross sales (see Section 6). Since the expected incremental costs of 

the final rule are about 20% less than what was estimated for the final rule, the potential impacts 

on small businesses would be less than what was estimated for the final rule. The small business 

impacts for the final rule were not re-estimated since they were not significant under the 

proposed rule and will be less significant under the final rule. 

These estimates are based on an analysis of registration costs and do not include 

reregistration because by the time this rule is promulgated, it is anticipated that virtually all 

requirements for reregistration will have been met. 

In general, the revised data requirements in Part 158 could apply to new pesticides 

submitted for registration, to new uses of currently registered pesticides, and to existing 

chemicals whose data are subject to Agency review to determine if they continue to meet 

registration standards. For these existing chemicals, Part 158 data requirements are potentially 

relevant to three review programs. 

Reregistration (mandated in 1988) and tolerance reassessment (mandated in 1996) are well 

underway. Data requirements under those programs have largely been imposed on registrants of 

existing chemicals, and the data have been submitted. EPA anticipates that by the time this rule 

is promulgated, few of the data requirements will be imposed for existing chemicals. Only those 

requirements that are “new” or “newly codified” (e.g., developmental neurotoxicity, 

immunotoxicity, sediment testing) have not been broadly required and may be imposed in the 

future. Data requirements for existing chemicals are imposed under the Agency’s DCI program. 

 

In those rare cases when such data will be needed for the remaining reregistration or 

tolerance reassessment after promulgation of this rule, EPA will articulate the specific burden 

and costs associated with each DCI in support of the appropriate Information Collection Request 

(ICR) approvals under the Paperwork Reduction Act (PRA). Since the approval process for the 

PRA requires that EPA characterize the information collection burdens and costs incurred by 

registrants to comply with a DCI, a complete estimate of the burden and costs for the DCIs will 

be provided at that time. EPA believes that the public process associated with the PRA approval 

for the ICRs is a reasonable way to account for the data costs without double-counting the 

burden. Accordingly, in this rule EPA has not included the potential burden or costs of the data 

requirements on registrants of registered chemicals. 

A third program, registration review, mandated in 1996, requires that EPA establish a 

program for the periodic review of existing chemicals (the goal is every 15 years). Any data 

requirements to be levied under that program will also be imposed under a DCI. EPA has 

promulgated procedures for the registration review program. Once promulgated, the expanded 

data requirements in this part 158 rule are expected to apply to all chemicals subject to 

registration review (i.e., all existing chemicals), depending on the conditions expressed in both 

final rules (this Part 158 revision and the future registration review rule). 
 12 

 4.4 Statutory Authority

Two primary statutes provide EPA with the authority to regulate pesticides: the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic 

Act (FFDCA). The Food Quality Protection Act (FQPA) amended FIFRA and FFDCA in 1996. 

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

As the standard for registration of a pesticide, FIFRA sec. 3(c)(5) requires that a 

pesticide, when used in accordance with widespread and commonly recognized practices, will 

not generally cause unreasonable adverse effects on the environment. FIFRA sec. 2(bb) defines 

"unreasonable adverse effects on the environment" as "(1) any unreasonable risk to man or the 

environment, taking into account the economic, social, and environmental costs and benefits of 

the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a 

pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 346a)." This standard also applies to the reregistration of 

existing pesticide products under FIFRA section 4, and Agency approval of any experimental 

use of unregistered pesticides under FIFRA section 5. 

FIFRA is a licensing statute, under which regulatory decisions on the registrability of an 

individual product are based upon data specific to the product and its uses. EPA is authorized to 

require the submission of data it needs to make the registration decision in the context of any 

individual application for registration, amended registration, or reregistration. EPA may also 

impose a data requirement after registration in order to maintain the registration, using specific 

DCI authority of FIFRA sec. 3(c)(2)(B). 

In order for the Agency to make registration decisions, FIFRA sec. 3(c)(2) gives EPA 

broad authority, before and after registration, to require specific testing by registrants and 

applicants and submission of the resulting data to the Agency (7 U.S.C. §§ 136a-c). Part 158 of 

40 CFR sets forth general requirements for data submission. On a case-by-case basis, EPA has 

exercised authority to require data in addition to that specified in Part 158. Registrants and 

applicants are under a continuing obligation to provide EPA with adequate information about 

their products to demonstrate that the products meet the statutory standard for registration. 

The Federal Food, Drug and Cosmetic Act (FFDCA)

In addition to the requirements of FIFRA, FFDCA sec. 408 requires that any pesticide 

whose use may result, directly or indirectly, in residues on food (including animal feed), must 

have a tolerance (maximum legal residue level) or an exemption from tolerance. A tolerance or 

tolerance exemption is needed for residues of all ingredients in a pesticide product, both active 

and inert, as well as any transformation products (i.e., metabolites and/or degradates) of the 

pesticide chemical. A food that bears residues not covered by a tolerance or tolerance exemption 

is considered adulterated under FFDCA, may not be shipped in interstate commerce and is 

subject to seizure. 
 13 

The Food Quality Protection Act (FQPA)

On August 3, 1996, FQPA was enacted, amending both FIFRA and FFDCA. The new 

standard for establishing a tolerance or exemption under FFDCA sec. 408(b) is that pesticide 

residues must conform to a ”reasonable certainty of no harm" standard with respect to the general 

population, and to infants and children specifically. To determine whether a tolerance meets this 

standard, EPA must take into account aggregate exposure to the pesticide chemical residue, (dietary, 

non-dietary, and non-occupational exposure), cumulative risks from multiple related chemicals with 

a common mode of action, and other factors enumerated in section FFDCA sec. 408(b)(2)(C) for 

infants and children and in FFDCA section 408(b)(2)(D). 

FFDCA section 408(b)(2)(A)(ii) calls for additional scientific analyses that have not been 

a routine part of the Agency’s risk assessment procedures, such as evaluating multiple pathway 

aggregate exposures from dietary and non-dietary sources. Although this provision is primarily 

directed at food use pesticides, the Agency may apply a similar approach to actions involving 

non-dietary use pesticides that may pose significant risks to infants and children. 

 4.5 Description of Data Requirements

The data requirements for pesticide registration are organized by data category or discipline. 

The specific data required within each data category depends primarily on the pesticide exposure 

and toxic characteristics. 

Data Requirements by Data Category (data discipline)

When an applicant applies for registration of a conventional pesticide product, the 

applicant must submit data in support of that registration application. The following seven 

categories of data may be required (Table 4.1), depending on the type of product being 

registered. Tests are generally performed on the active ingredient, but may also be necessary to 

test contaminants or degradates. 
 14 

Table 4.1: Data Categories and Descriptions 

Data Category Description

Toxicology Tests of acute, subchronic, and chronic toxicity and other human health concerns, 

such as carcinogenicity may be required to determine whether the product may pose 

a hazard to humans. 

Human Exposure Because people may be exposed to the product both during application of the 

product and after application, information about possible oral, dermal, and 

inhalation exposure as well as information on how the product is used are required 

for registration. 

Residue Chemistry To determine whether the chemical may be found in plants, livestock, and fish that 

may be used for food, a variety of information is required, including a proposed 

tolerance in food. 

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

tests of physical and chemical properties are required to characterize the product. 

Ecological Effects Tests of the effects of the active ingredient or a typical pesticide product on aquatic 

and terrestrial vertebrates, invertebrates, and plants are required to determine 

whether the product poses an ecological risk to organisms that may come in contact 

with the product. 

Environmental Fate Information on a pesticide’s transport and dissipation in water, air, and soil may be 

required to determine whether the components of the product persist in the 

environment and where it is likely to concentrate. 

Non-target Plant Protection Testing of a pesticide’s effects on non-target terrestrial and aquatic plant species 

may be required on plants of concern, including crop plants or non-target plants 

such as endangered plants, or plants important to fish and wildlife for food and 

cover. 

Data Requirements by Type of Registration Action

Data requirements are generally levied as a result of a potential registration action. They 

usually differ depending on the type of registration being sought (e.g., whether the product 

contains an active ingredient not previously registered or whether the pesticide is identical to or 

substantially similar to an existing product). The types of registration that generally trigger data 

requirements are grouped in the following categories (Table 4.2): 

Table 4.2: Types of Registration Actions and Descriptions 

Type of Registration Description

New active ingredient An application for registration of a new product that contains an active 

ingredient that is not included in any currently registered product. 

Major New Use An application for a new product that includes the addition of a use pattern 

that is not currently registered for one or more active ingredient(s) 

contained in the product. The proposed use pattern is significantly different 

from any use pattern registered for an existing use. 

Major New Use Amendment An amendment of a registration of a product that includes the addition of a 

use pattern that is not currently registered for one or more active 

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

significantly different from any pattern registered for an existing use. 
 15 

 4.6 Description of the Final Regulation

There are organizational changes to Part 158 in the final rule. Organizational changes 

include expanding the number of subparts. Currently Part 158 is divided into four subparts: 

1. Subpart A, General Provisions; 

2. Subpart B, How to Use Data Tables; 

3. Subpart C, Product Chemistry Data Requirements; and 

4. Subpart D, Data Requirements Tables. 

EPA’s proposed rule structured the subparts of part 158 to match the original sequence of 

guidelines. A number of commenters found this structure confusing and one commenter 

submitted an alternative structure. EPA agreed with the commenters that the current structure is 

not ideal for the average registrant who is seeking to determine which data requirements apply to 

his product. Accordingly, EPA is restructuring the subparts to be more user-friendly. Each 

subpart will address an individual scientific discipline or data type.

 EPA has placed those data requirements applicable to the bulk of applications (new end-use 

product and me-too products) towards the beginning of part 158. The structure of part 158 in the 

final rule proceeds from product chemistry to product performance to hazard/toxicity 

requirements of all types (human health, ecological toxicity); then exposure data requirements of 

all types (pre- and post-application human exposures, exposures to residues in food); and 

environmental fate, which overlaps human exposure through drinking water, ecological 

exposure, and spray drift. EPA has reserved subparts among these various for other data types 

that might arise. EPA has consolidated subparts addressing related topics: plant protection data 

requirements have been incorporated into new subpart G (ecological effects data requirements) 

as have terrestrial and aquatic nontarget organism data requirements. 

In this rule, EPA has new and revised data requirements that encompass three categories of 

requirements: 

1. “New requirements,” never before imposed on any registrant. 

2. “Newly codified requirements,” which have been applied on a case-by-case basis, but are 

not contained in the CFR. 

3. Revisions to “existing requirements.” 

Types of Revisions 

Some of these changes are clarifications or housekeeping changes without cost or burden, 

others have the effect of increasing or decreasing the burden of the data requirement. The types 

of changes may be broadly categorized as follows: 

Potentially substantive changes

• Addition of a requirement. For example, EPA is conditionally requiring the 
 16 

developmental neurotoxicity study and requiring the immunotoxicity study. 

• Elimination of a requirement, sometimes with substitution of a new requirement. For 

example, EPA is eliminating the requirement for the non-rodent chronic study (one 

year dog study) and the seed germination study. By contrast, the existing 

requirement for a battery of mutagenicity studies is being eliminated in favor of a 

specific set of mutagenicity studies. 

• Change to the number or type of species that must be tested. For example, EPA is 

requiring acute avian toxicity testing on a passerine species in some instances and is 

requiring that certain toxicity studies be conducted routinely with two species instead 

of one. 

• A change in the conditional nature of the test requirement. For example, EPA is 

changing a number of requirements from conditionally required to fully required, or 

vice versa. In some cases, this is a minor change in the frequency (and burden) of the 

requirement. In other cases, the change may represent a substantial increase in 

frequency of requirement. 

• A change to the use patterns to which a data requirement applies. For example, EPA 

decided to consolidate the various aquatic nonfood use patterns into one Aquatic 

nonfood use, thus reducing the number of aquatic nonfood use patterns to one. This 

decision was the result of public comments indicating some confusion. The 

elimination of the Indoor medical use pattern and the several aquatic nonfood use 

patterns reduced the final number of use patterns. Thus, the final number of major 

use patterns will be 12, rather than the 15 in the proposed rule. 

• A change to the test substance to be used. Typical test substances include the 

technical grade of active ingredient (TGAI), the manufacturing use product (MP), the 

end use product (EP), or a typical end use product (TEP). For example, EPA is 

requiring primary eye and primary dermal irritation and dermal sensitization testing 

using the TGAI in addition to the EP. 

• A clarification in the test notes. For example, EPA is adding a test note that requires 

analytical methods for residue chemistry and environmental fate to be validated by an 

independent laboratory. 

Technical changes having no substantive effect

 Technical changes include: relocating a data requirement from one discipline to another; 

changing the title of a data requirement; subdividing an existing data requirement to create 

two separate data requirements; and merging two data requirements into a single data 

requirement. These technical changes would not increase or decrease the burden of the data 

requirement. 
 17 

 4.7 Profile of the Regulated Community

The market structure of the basic pesticide production industry can be described as a 

moderately to highly concentrated oligopoly, with only about 20 basic producers of common 

U.S. pesticides. Relatively few firms produce the bulk of pesticide products, and a few products 

tend to dominate national, regional, and local markets for individual site/pest combinations. 

Individual firms tend to significantly influence supply and prices in the markets in which they 

compete. A detailed profile for the conventional pesticide industry, including information on 

product classes for firms registering conventional pesticides is presented in Appendix D, Exhibit 

D-1 through D-12. 

General Pesticide Industry Description

Pesticides are important products that play a significant role in many aspects of the 

economy. They are used by diverse economic sectors such as agriculture, industry, and 

residential. Pesticides reduce or eliminate undesirable weeds, insects, animals, fungi, and 

bacteria and are used to preserve wood and regulate plant growth. All of these pesticide 

uses produce desirable outcomes such as increased agricultural productivity and 

improved human health. However, due to their nature, their use also implies some 

environmental and health risks (USEPA 1999c). 

Pesticide products themselves fall into several categories: conventional pesticides, 

specialty and niche pesticides, and antimicrobial pesticides. Conventional pesticides are 

those products that are commonly available to users as herbicides (weed killers), 

insecticides (“bug“ killers), and fungicides (fungus killers), as well as some special 

classifications such as fumigants used to sterilize soil to remove pathogens. The vast 

majority of pesticides used in the U.S. fall into the category of conventional pesticides. 

The final rule only applies to conventional pesticides. 

4.7.1 Registrant Population

EPA uses the Pesticide Regulatory Action Tracking System (PRATS) to track and 

manage registration activities. Each registration action is assigned a code that defines the 

specific type of registration action. The PRATS database provides a list of pesticide registration 

actions submitted by each applicant or registrant, including the dates the application was 

received by EPA and when the Agency responded to each application. For this analysis, the 

Agency used a subset of the PRATS data base with registration action codes relevant to Part 158 

submitted for conventional chemicals from 1996 through 2002. The action codes relevant to Part 

158 are shown in Table 4.3 below. The PRATS data set in this analysis includes 986 registration 

actions associated with 120 entities. The average number of registration actions per year is 141 

as shown below in Table 4.3. 
 18 

Table 4.3: Average Number of Registration Actions per Year 

Action 

Code Description of Registration Action Average Number of Actions per Year1

100 Application for Registration - New Chemical, Food or Feed 122

115 Application for Registration - New Chemical, Non-Food or Non-Feed Use 52

175 Application for Registration - Old Chemical, New Use: Non-Food or NonFeed Use 26 

180 Application for Registration - Old Chemical, New Use: Food or Feed Use 7 

315 Amendment - New Use: Non-Food or Non-Feed 14 

330 Amendment - Old Chemical: New Use: Food or Feed 77 

Total Actions per year 141 

Source: PRATS 1996-2002. 

1

 Based upon the number of pesticide manufacturers subject to product registration action codes of interest from 

January 1, 1996 to December 31, 2002, in PRATS. 

2

 For these actions, only the first action per active ingredient was counted in the PRATS data, since test results for 

these actions can be reused for registrations with the same active ingredient. For the purpose of the individual 

company analysis, it was assumed that the first company to invoke one of these actions bore the entire cost of 

fulfilling the data requirements even if other companies later invoked the same action with the same active 

ingredient. 

 4.7.2 Registrant Financial Data

Since the PRATS database contains historical data, it is a sound indicator of the types of 

entities that undertook registration actions. However, the PRATS population may not be 

representative of the entities that will undertake registration actions in the future since it only 

captures entities that have made requests during the sample time period. Other entities may, of 

course, do so in the future. Therefore, EPA also compiled a profile of a larger population of 

entities, some of which conceivably will undertake registration actions in the future, from the 

Pesticide Products Information System (PPIS). 

PPIS contains information on all pesticide products registered in the United States: 

registrant names and addresses; chemical ingredients; toxicity categories; product names; 

distributor brand names; site/pest uses; pesticidal types; formulation codes; and registration 

status. PPIS does not contain information on specific registration actions. 

Neither PRATS nor PPIS contains information on the size or financial characteristics of the 

entities. Therefore, it was necessary to collect data on the size or financial characteristics from 

an additional source. EPA used the Dun and Bradstreet (D&B) Market Spectrum database to 

obtain firm size and financial data for EPA’s analysis of the impacts of the rule on individual 

entities. D&B is a comprehensive source of financial information on entities, including firm 

locations, sales, and primary business classifications under North American Industrial 

Classification System code (NAICS). 
 19 

In order to link entities in the PRATS and PPIS data sets with the D&B database, EPA 

identified each entity’s Data Universal Numbering System (DUNS) number. The D&B DUNS 

Number is a unique identifier for a business and links it to the corporate family structure. 

EPA used the DUNS number for each firm to query the D&B database to retrieve the 

ultimate parent firm name, as well as the ultimate parent firm’s annual sales, total employees, 

and primary NAICS code. The ultimate parent firm is defined as a corporation that owns more 

than 50 percent of another corporation. The parent firm, in turn, may also be a subsidiary of 

another corporation. All financial information in this profile is summarized at the domestic 

ultimate parent firm level; the domestic ultimate parent is the highest level within the firm’s 

structure in the United States. EPA evaluated the impacts of the rule at this corporate level to 

capture the annual sales of each firm. EPA identified 120 entities by using seven years of 

PRATS data (Table 4.4). EPA was then able to identify 81% of the parent firms of these 120 

entities. Ninety-five of these parent entities provided D&B with revenue information, but one 

small and one large entity reported the number of employees but no revenue data to D&B. 

Twenty three companies did not have sufficient D&B financial data. 

 

Using the PPIS data, a set of 1,804 unique pesticide registrants were identified as having one 

or more FIFRA Section 3 or FIFRA Section 24(c) pesticide registrations. For Small Business 

Administration (SBA)-defined small businesses, a random sample of 1,000 unique pesticide 

registrants was used to develop the economic profile. Of the 1,000 unique parent companies, 

57% were identified having sufficient financial information at the global DUNS number level to 

be included in the analysis. 

The PRATS data has a smaller number of firms because only those firms that would have 

experienced an incremental impact if the rule had been in effect during the sample period 1996-

2002 were selected. The PPIS data includes all conventional pesticide firms. 

Table 4.4: Summary of Data Sets Used in Economic Profile of Entities Affected by the Part 158 Rule 

Data 

Set 

Entities 

in Sample 

% of Entities With 

Ultimate Parent 

Firm Identified 

Entities Without 

Sufficient D&B 

Financial Data 

Ultimate Parent 

Entities With 

Revenue 

Information 

Entities With 

Employment 

Information But 

No Revenue Data 

PRATS 120 81% 23 95 2 

PPIS 1804 57% N/A 565 N/A 

Source: Dun & Bradstreet 2002. 

D&B reports the 6-digit NAICS code for each firm. The less refined 3-digit NAICS code, 

which is derived from the 6-digit code, is more useful in summarizing the types of businesses 

included in the data set. Table 4.5 shows that 51 percent (46 entities) of the parent entities from 

the PRATS data set are primarily identified as Chemical Manufacturing (NAICS 325). Some 

subsectors represented in this population are: 

• pesticide and other agricultural chemical manufacturing (325320); 
 20 

• pharmaceutical preparation manufacturing (325412); and 

• all other basic inorganic chemical manufacturing (325199). 

Table 4.5: Primary Industry Sectors Represented in the PRATS Data Set 

NAICS Code1 Sector Description Number of Parent Companies2

325 Chemical Manufacturing 46 

424 Merchant Wholesalers, Nondurable Goods 27 

423 Merchant Wholesalers, Durable Goods 4 

339 Miscellaneous Manufacturing 2 

531 Real Estate 2 

541 Professional, Scientific and Technical Services 2 

561 Administrative and Support Services 2 

711 Performing Arts, Spectator Sports and Related Industries 2 

 Others 4 

Source: USEPA 2003, Dun & Bradstreet 2003. 

1

 Government entities are excluded from the analysis. 

2

 Seven parent companies reported data without a NAICS code to Dun & Bradstreet (D&B) and 23 companies were 

not found in D&B, yielding a total of 30 companies without a NAICS code. EPA assumed the seven companies with 

D&B data but no NAICS code were associated with NAICS code 325320 - Pesticide and Other 

Agricultural Chemical Manufacturing for the analysis. 

Table 4.6 provides the same information for the PPIS sample. Here 107 entities, or 30 percent, 

are primarily identified as Chemical Manufacturing (NAICS 325). 

Table 4.6: Primary Industry Sectors Represented in the PPIS Data Set 

NAICS Code Sector Description Number of Parent Entities 

325 Chemical Manufacturing 107 

422 Wholesale Trade - Nondurable goods 45 

311 Food Manufacturing 12 

561 Administrative and Support Services 10 

541 Professional, Scientific and Technical Services 8 

421 Wholesale Trade - Durable goods 5 

333 Machinery Manufacturing 4 

 Other 27 

133 parent firms did not report a NAICS code to Dun & Bradstreet. 

Source: USEPA 2001b, Dun & Bradstreet 2002. 

Revenues

Market data indicate that sales of conventional pesticide active ingredients total over $11 

billion per year (USEPA 1999a). Extrapolating this to the population of conventional pesticide 

firms producing AIs (20) and adjusting for the number of identified suppliers, results in average 

sales of $579 million. In other words, each of the major pesticide producers has an average of 

approximately 5 percent of the estimated industry total annual sales. Market data also indicate 
 21 

that the core number of conventional active ingredients is about 891. Therefore, each active 

ingredient generates an average revenue of $12 million. 

Since 1992 the pesticide industry has undergone a period of consolidation. Many firms have 

merged or been purchased, decreasing the number of firms producing active ingredients. This 

has affected the concentration of active ingredient producers as a few large competitors are 

emerging in each sector. For example, the herbicides market had a concentration of 45 percent 

(market share held by top three competitors) in 1999, and it is estimated that the concentration 

will continue to increase. (Frost & Sullivan 2000). 

Consolidation of the Industries By Mergers and Acquisitions

Conventional pesticide producers have experienced a period of consolidation in the past few 

years, as several major producers of active ingredients have either merged or been acquired. The 

following is a list of the mergers and acquisitions. 

$ Novartis merged with Astra Zeneca 

$ AgrEvo and Rhone Poulenc merged to form Aventis 

$ Monsanto acquired DeKalb 

$ Dupont acquired Pioneer Hi-Bred Seed Company 

$ Zeneca merged with Astra 

$ BASF acquired American Cyanamid 

5 ECONOMIC IMPACTS ON PESTICIDE REGISTRANTS DUE TO CHANGES IN DATA 

REQUIREMENTS

Summary of Findings

To simplify and clarify the process of applying for a pesticide registration, EPA is revising 

part of its regulations pertaining to data requirements for the registration of conventional 

pesticide products. As discussed in Section 2, the Agency is revising the data requirements that 

pertain to product chemistry, toxicology, residue chemistry, applicator exposure, postapplication exposure, non-target terrestrial and aquatic organisms, non-target plant protection, 

and environmental fate. Some new data requirements, not currently codified in Part 158, are 

being added and some are being dropped. In addition, conditions under which studies are 

required are being updated, i.e., major use patterns are being revised; test substances are being 

revised; and other changes have been made to the conditions under which certain studies are 

required. 

The total cost of changes in data requirements for the conventional pesticide industry is 

estimated to be approximately $33.6 million per year in 2003 dollars for the selected option in 

the final rule. 

Overview of Methodology
 22 

The data requirements for Part 158 were compared to the baseline, the data requirements 

currently codified in 40 CFR Part 158. These comparisons were conducted for each type of 

registration action. A registration action is either the registration of a pesticide product or an 

amendment to an existing registration. When a registrant submits an application to register or 

amend a product, EPA assigns an action code, which identifies the type of registration action. 

The incremental costs of each type of registration action due to the changes were then multiplied 

by the number of each type of registration action, in order to estimate the expected total industry 

impact and the impacts per firm. This analysis was done in the following six steps: 

Step 1. Determine the unit test costs of each data requirement 

Step 2. Determine the data requirements per registration action 

Step 3. Determine the incremental costs per registration action 

Step 4. Determine the incremental industry-wide impacts 

Step 5. Determine the incremental impact per firm 

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

Chart 5.1 is a flow chart describing the methodology. The unit test costs (Step 1) are 

multiplied by the data requirements (Step 2) for both the baseline and final rule to estimate the 

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

the difference in the test costs per registration action between the baseline and the rule. The 

incremental costs per registration action are multiplied by the number of registration actions for 

the industry to get the industry-wide incremental impacts (Step 4) and the number of registration 

actions by each firm to get the distribution of incremental impacts per firm (Step 5). The 

incremental costs per small firm are divided by the entity’s sales revenue to get the distribution 

of incremental impacts per small firm as a percent of sales revenue (Step 6 - SBREFA analysis -

Section 6). 
 December 7, 2004 23 

Chart 5.1 Methodology Flowchart 

STEP

1

2

3 Test Costs per 

Registration Action

Baseline

Unit Test 

Costs

Annual # of

Registration 

Actions

Industry-wide

Incremetal Cost

Annual # of 

Registration 

Actions by Firm

Distribution of 

Incremental 

Costs by Firm

Distribution of 

Incremental 

Costs as a % 

of Sales/Firm

Sales Revenue 

by Small Firm

4

5

Test Requirements by 

Registration Action

Baseline

Test Costs per 

Registration Action

Proposed Rule

Test Costs per 

Registration Action

Incremental Costs

5

6

Exhibit 2-1. Methodology Flowchart

Test Requirements by 

Registration Action

Proposed Rule
 December 7, 2004 24 

5.1 Unit Test Costs (Step 1) 

In order to provide the data required for a registration, registrants must submit or cite test 

results or other information to satisfy the data requirements. The test costs are the costs of 

complying with the specific data requirements, which depend on the type of product and use 

pattern. 

EPA contacted a number of laboratories to obtain cost data for different data requirements 

conducted by testing labs. Laboratories were asked to identify the method, range, analytical, and 

fixed cost for each data requirement based on a set of predetermined protocols. If for any test the 

component costs were not available, the laboratories were asked to provide a total cost. 

Knowing that the laboratory costs could vary considerably based on the study protocol chosen by 

the laboratory, we established two protocols, a high cost protocol and a low cost protocol, for 

each test in order to bracket the costs. To establish the protocols, we initially identified the 

various study design options for each test based on the Office of Pesticide Prevention and Toxic 

Substances (OPPTS) guidelines. 

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

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

high cost estimates provided by the various laboratories (see Appendix A: Test Cost Data Used 

to Calculate Data Requirement Costs for Part 158). The estimated low costs of complying with 

individual tests range from $2,000 (product use information and description of human activity) 

to $1,000,000 (field testing for non-aquatic non-target organisms). The estimated high costs of 

conducting individual tests range from $3,180 (honey bee acute contact LD50) to an estimated 

$2,000,000 (groundwater monitoring and field testing for aquatic non-target organisms). 

5.2 Data Requirements Per Registration Action (Step 2)

A registration action is a decision on an application from a registrant to register a product 

containing a new active ingredient or another type of new product, to add new uses to existing 

products, or to amend existing products. The data required for a registration action depends on 

several factors as described in Section 2. In this section data requirements are summarized in 

terms of the following variables: 

A. Data Category (Data Discipline) 

B. Major Use Pattern 

C. Type of Registration Action 

A. Data Category

The data requirements (as described in detail in Section 2.6) of Part 158 are organized into 

the following six data categories or disciplines: 

Toxicology 

Human Exposure 

Residue Chemistry 
 December 7, 2004 25 

Product Chemistry 

Ecological Effects 

Environmental Fate 

B. Use Pattern

Within each of the six data requirement categories listed above, a number of individual tests 

may be necessary. One of the factors that determine whether a particular test will be required for 

a product is how the product will be used, known as the pesticide’s major use pattern. Twelve 

major use patterns will replace the nine use patterns found in the current CFR. 

C. Type of Registration Action

The specific data required depend partly on the type of registration action. The following 

types of registration actions are affected by the rule: 

New active ingredient 

Major new use 

Substantive amendment 

Registration actions are tracked in an EPA database called PRATS (Pesticide Registration 

Action Tracking System). Each registration action is assigned an action code that defines the 

specific type of registration action. Appendix E contains a list of PRATS action codes relevant 

to this analysis. For each general type of registration action listed above, there are several 

specific types of registration actions identified by action codes, which define specific data 

requirements more exactly than the general type registration action. 

 There are two ways to satisfy data requirements: data may be newly developed for a 

registration action, or data previously submitted for an existing product may be cited for a new 

registration action. This analysis considers only the costs of developing and submitting new 

data. 

5.3 Incremental Costs and Impact Per Registration Action (Step 3)

The incremental costs are the differences in test costs between the baseline test costs, i.e., 

the tests described in current Part 158, and the cost of tests as required under the rule. 

Changes Included in Estimating Incremental Costs:

Newly imposed: The cost of new tests and increased frequency of data requirements not 

currently imposed are shown in Appendix A as “Newly Imposed.” They are a subset of the 

newly codified new tests and expanded major use patterns. A sample of the newly imposed 

studies for non-food pesticides are shown below in Table 5.1. 

Newly codified new tests: Test requirements that are not currently codified in 40 CFR Part 

158 are not included in the baseline, even though they may be currently imposed in practice on a 
 December 7, 2004 26 

case-by-case basis. Therefore, the incremental costs include the cost of all tests in the rule that 

are not now codified in the CFR. 

Table 5.1: Cost of Newly imposed Test requirements for Non-Food Active Ingredient 

Guideline # Newly Imposed Test Requirements for 

Non-Food Active Ingredient Test Cost % of Time Test is Required 

Average 

Test Cost 

850.2100 Avian Oral Toxicity $10,100 100% $10,100 

835.4100 Aerobic Soil $94,375 1% $944 

835.6200 Aquatic field $267,250 1% $2,673 

870.7800 Immunotoxicity $54,648 100% $54,648 

870.3700 Developmental Toxicity $76,844 25% $19,211 

Subtotal $87,576 

Newly codified expanded major use pattern: In some cases, the rule increases the frequency 

of data required in the tests currently in 40 CFR Part 158. Examples include: 

Data not currently required will be required in the rule for certain use patterns. 

Data currently conditionally required would be routinely required by the rule for certain use 

site categories. 

Some current footnotes specifying when data are required have been changed in a manner 

that expands the application of the data requirement. 

Estimation of Incremental Costs

EPA is retaining its current system of identifying the applicability of data requirements in 

the data tables. Because of the variety of chemicals and use patterns, and because EPA must 

retain flexibility to tailor data requirements to its needs, it uses only qualitative descriptors in the 

tables. These are used for convenience to make the table format feasible, but serve only as a 

general indication of the applicability of a data requirement. In all cases, the registrant must 

consult with EPA with respect to the test notes referred to in the table to determine the actual 

applicability of the data requirement. The table descriptors NR (not required), R (required), and 

CR (conditionally required) could be considered as indicators along a spectrum of likelihood of 

requirement (0% to 100%) for that data requirement. 

The unit test costs of new tests are multiplied by the percentage of times each test is likely 

to be required for a particular action on a yearly basis. The Agency determined the percentages 

by using The Office of Pesticide Programs (OPP) database which contains the listing of all 

registration test data submitted to the Agency. This database was analyzed and EPA scientists 

used their expert judgment to estimate the percent of time the tests are likely to be required for 

the rule and the baseline. (See Exhibits B.1 through B.6 of Appendix B). 

In cases where the frequency of a data requirement would change under the rule, the 

incremental cost of a registration action is estimated by multiplying the change in frequency 

(percent of time data requirement is required) by the unit test cost. 
 December 7, 2004 27 

5.4 Industry-Wide Impacts (Step 4)

In order to calculate the impact of the rule on the whole industry, the incremental costs for 

each type of registration action (Step 3) is multiplied by the average number of registration 

actions per year (shown in the row below the action codes in Exhibits B.1 - B.6). In order to 

estimate the number of times each newly codified test is likely to be required per year, the 

percentage of each type of registration action is multiplied by the average annual number of the 

type of registration action. These amounts are summed for all registration actions and multiplied 

by the unit test costs as shown in the right hand columns in Exhibits B.1 - B.6. The total annual 

industry incremental impact based on an average of 141 registration actions per year is estimated 

to be about $33.6 million. The average incremental impact per registration action is about 

$289,000. 

5.5 Average Annual Cost per Firm (Step 5)

According to the PRATS database, 120 firms would have experienced incremental impacts 

from the rule during the 7-year period, 1996-2002. A total annual impact of $33.6 million 

represents an average impact per firm of $280,000. 

6 SMALL BUSINESS IMPACTS (STEP 6)

This section describes the method for defining and identifying the small entities affected by 

the rule, followed by an analysis of the number and percentage of entities incurring economic 

impacts. The incremental costs of registration actions for each small conventional pesticide firm 

is estimated and compared to its annual sales revenue to determine the incremental impact as a 

percent of sales revenue. 

6.1 Regulatory Overview

The Regulatory Flexibility Act (RFA) of 1980 and its 1996 amendment, the Small Business 

Regulatory Enforcement Fairness Act (SBREFA), require that special consideration be given to 

the effects of the regulations on small business entities. The regulations require that a 

determination be made as to whether the regulation will have a significant impact on a 

substantial number of small entities (USEPA 1999b). EPA measured the economic impact by 

the annual compliance costs as a percentage of sales to assess the small business impacts. 

6.2 Categorization of Small Businesses

The Small Business Act authorizes the Small Business Administration (SBA) to establish 

the definition of a small business. The SBA has set size standards under the North American 

Industrial Classification System (NAICS), using various thresholds on employee number and 

revenue amount, which vary by NAICS code. In determining the size of a firm, the SBA applies 

its standards to the parent level of a business entity.1

 The SBA also bases its determinations on 

 

 1

 Specifically, the SBA treats a firm that has a substantial portion of its assets and/or liabilities shared with a 

predecessor entity as part of that predecessor entity.
 December 7, 2004 28 

the primary industry of the firm. In this analysis, the firm’s primary NAICS code is assumed to 

be its primary industry, and the definition of small business is determined by the SBA based on 

maximum number of employees or sales for small businesses in each industry sector, as defined 

by a 6-digit NAICS code. For example, entities defined as Pesticide and Other Agricultural 

Chemical Manufacturing (325320) are considered small if they employ 500 or fewer people; 

Pharmaceutical Preparation Manufacturing (325412) entities are small if they employ 750 or 

fewer people. Other entities are defined by sales. For example, Testing Laboratories (541380) 

are considered small entities if they have annual sales of $5.0 million or less. 

 6.2.1 Estimation of the Number of Small Businesses

As discussed in Section 4.7, EPA used the following databases to estimate the number of 

businesses registering pesticides: 

PRATS, which tracks registration actions. 

PPIS, which includes all registered pesticide products and their registrants. 

Dunn & Bradstreet (D&B), which includes financial and firm size data on many firms. 

The PRATS sample includes 120 firms that would have incurred incremental costs as a 

result of the rule had it been in place from 1996-2002. Of these, 97 ultimate parent entities were 

identified. Twenty-three firms had insufficient D&B financial data to be classified by SBA size 

definitions. (One small and one large firm had employee data but not revenue data in D&B.) 

Table 6.1 shows the size distribution of the 97 parent entities in the PRATS sample. Of these 97 

parent companies, 51% are small and 49% are large. 

Table 6.1: Companies in the PRATS Sample by SBA Size. 

Size2 Number of Parent Companies Percentage of Parent Companies 

Small 49 50.52% 

Large 48 49.48% 

Total 97 100.00% 

Source: USEPA 2003, Dun & Bradstreet 2003. 

1

 Twenty-three companies did not have sufficient Dun & Bradstreet (D&B) financial data to be classified by SBA 

size definitions. 

2

 Size definitions vary according to the SBA small business definition associated with each NAICS code.

The PPIS database was queried in Fall 2002 for all companies having one or more FIFRA 

Section 3 or FIFRA Section 24(c) (state) pesticide registrations. Companies with unique EPA 

company numbers in the PPIS database were consolidated based on the following criteria: (1) 

matching EPA company numbers with Dun & Bradstreet DUNS and ultimate parent DUNS 

numbers; (2) results of recent mergers and acquisitions; (3) matching company names associated 

with unique EPA company numbers; and (4) recommendations by EPA to be consolidated based 

on nearly identical name matching and/or prior knowledge. As a result, 1,804 unique companies 

represent the total universe of conventional pesticide registrants. 

An attempt was made to match all 1,804 unique pesticide registrants with company 

information (total revenue and number of employees) from the Dun & Bradstreet (D&B) 
 December 7, 2004 29 

database. We assume D&B company information is available for all relatively large companies. 

 However, D&B company information is not easily collected or readily available for relatively 

small companies. 

A D&B data analysis of the 1,804 pesticide registrants identified 146 SBA-defined large 

pesticide registrants. This was done in two ways. First, 116 companies were successfully 

identified as “large” through cross-referencing D&B company numbers and associated company 

information with EPA company numbers from the 1,804 companies identified in the PPIS 

database. Second, the remaining companies were manually reviewed and we determined 30 

additional companies met the SBA definition as large. The average revenue and employee 

numbers were determined for the 146 large pesticide registrants based on the company 

information reported in the D&B database. 

The remaining 1,658 pesticide registrants were considered small companies (1,804 - 146). 

The average revenue and employee number for small pesticide registrants was determined from a 

random sample because sufficient D&B company information was not available for many small 

registrants. A random sample of 1,000 companies was taken from the original PPIS registrant 

data set and matched with company information (total revenue and number of employees) 

queried from the D&B database. Sufficient D&B company information was available for 565 of 

the 1,000 sample companies for classifying companies as “small” or “large” according to SBA 

standards. Of the 565 sample companies classified, 449 met the SBA definition for “small.” 

The average revenue and employee number for these 449 companies is assumed to be 

representative for all small pesticide registrants. 

 6.2.2 Sales and Employees

Tables 6.2 and 6.3 show the average sales and average number of employees for parent 

entities in the PRATS and PPIS databases. The average sales for small parent entities in the 

PRATS data set is $24.3 million and the average sales for large parent entities is $9 billion. The 

average number of employees for small parent entities is 87, and the average number of 

employees for large parent entities is 33,274. The average sales for small parent entities in the 

PPIS data set is $8.8 million; the average sales for large parent entities is $5 billion. In PPIS 

data, the average number of employees for small parent entities is 39, and the average number of 

employees for large parent entities is 18,681. 

Table 6.2: Average Sales and Employees B PRATS Data Set 

Sales Employees 

Size Number of Parent 

Companies with Data1 Average Sales Number of Parent Companies with Data 

Average Number 

of Employees 

Small 48 $24,293,120 49 87 

Large 47 $9,074,010,059 48 33,274 

Source: USEPA 2003, Dun & Bradstreet 2003. 

1

 One small and one large company reported employee data but no revenue data to D&B.

Table 6.3: Average Sales and Employees B PPIS Data Set 
 December 7, 2004 30 

Size Number of Parent 

Companies Average Sales Average Number of Employees 

Small 1658 $8,840,000 39 

Large 146 $5,041,690,000 18,681 

Source: USEPA 2001b, Dun & Bradstreet 2002 

Tables 6.4 and 6.5 show the distribution of annual revenues and employees by SBA 

threshold level from PRATS and PPIS. 

Table 6.4: Number of Entities in Sample per SBA Category from PRATS Sample 

SBA Threshold Criteria for Defining 

Small Businesses Number of Sample Firms Percentage of Sample Firms

100 or fewer employees 35 36% 

500 or fewer employees 54 56% 

750 or fewer employees 57 59% 

1000 or fewer employees 59 61% 

1,500 or fewer employees 60 62% 

$4.0 million or less in revenue 20 21% 

$5.0 million or less in revenue 21 22% 

$6.0 million or less in revenue 21 22% 

$7.0 million or less in revenue 22 23% 

$12.0 million or less in revenue 28 29% 

$18.5 million or less in revenue 32 34% 

$20.0 million or less in revenue 33 35% 

Table 6.5: Number of Entities in Sample per SBA Category and PPIS Sample 

SBA Threshold Criteria for Defining 

Small Businesses Number of Sample Firms Percentage of Sample Firms 

100 or fewer employees 409 72% 

500 or fewer employees 477 84% 

750 or fewer employees 486 86% 

1000 or fewer employees 492 87% 

1,500 or fewer employees 501 89% 

$4.0 million or less in revenue 299 53% 

$5.0 million or less in revenue 314 56% 

$6.0 million or less in revenue 329 58% 

$7.0 million or less in revenue 349 62% 

$12.0 million or less in revenue 380 67% 

$18.5 million or less in revenue 399 71% 

$20.0 million or less in revenue 404 72% 

6.3 Small Business Impact
 December 7, 2004 31 

As discussed above, the historical data suggest that the 120 entities in the PRATS sample 

are most likely to incur costs under the rule over a given 7-year period. However, the number of 

small entities that are potentially subject to the regulation is actually much larger. In fact, any 

firm that might register or hold a registration for a conventional pesticide could be subject to the 

final rule. Therefore, the number of small entities subject to the final rule is equal to the number 

of small entities in our PPIS sample. In order to determine the number of small entities that will 

have compliance costs over a given cost-revenue threshold, it is necessary to consider all small 

entities subject to the regulation, even those that are expected to incur no additional cost. The 

overall PPIS data set includes 1804 entities. For those entities that the Agency was able to 

determine a size, 79 percent were small businesses. Assuming that 79 percent of all the PPIS 

entities are small, EPA estimated the number of regulated small entities to be 1434. 

The Agency then looked at the number of entities that would have incurred costs under the 

rule had it been in place from 1996-2002. The PRATS data set includes 120 entities. For those 

entities for which a size could be determined, 50.5 percent were small. Assuming that 50.5 

percent of all the PRATS entities are small, EPA estimated the number of regulated small 

entities that would have incurred additional costs to be 61. From the 49 small parent entities in 

our cost analysis (where we had both firm size and revenue information) the Agency projected 

the distribution of impacts to the 61 small firms. Most of small entities (1373) are not expected 

to incur additional costs as a result of the final rule (1434 PPIS small entities - 61 PRATS small 

entities). The results of the analysis by percent impact are provided in Table 6.6. 

Table 6.6: Estimated Small Business Impacts 

Number of Small Companies Percentage of Small Companies 

Measure Mean 

Lab Cost 

Low Lab 

 Cost 

High Lab 

Cost 

Mean 

Lab Cost 

Low Lab 

Cost 

High Lab 

Cost 

Compliance Costs = 0 % of 

Revenue 1,373 1,373 1,373 95.7% 95.7% 95.7% 

Compliance Costs >0% of 

Revenue 61 61 61 4.3% 4.3% 4.3% 

Compliance Costs >1% of 

Revenue 35 32 34 2.4% 2.2% 2.4% 

Compliance Costs >3% of 

Revenue 23 20 24 1.6% 1.4% 1.7% 

In summary, the above table shows that for the mean lab cost: 

61 small entities (4.3%) are likely to experience an impact greater than zero. 

35 small entities (2.4%) of the 1373 small conventional entities that are subject to the proposed 

rule are likely to experience an economic impact of 1% or more of gross sales and, 

23 small entities (1.6%) are likely to experience an economic impact of 3% or more of gross 
 December 7, 2004 32 

sales. 

7 LIMITATIONS OF ANALYSIS

The major costs of this rule are associated with the increased cost of generating data in 

support of pesticide registration. Several variables contribute to the uncertainty and complexity 

of estimating costs. 

Unit Test Costs

Costs for tests related to data requirements were gathered from a limited survey of 

commercial labs because few laboratories conduct such tests (see Appendix A, Test Cost Data 

Used to Calculate Data Requirement Costs for Part 158 Rule). For a number of data 

requirements there is a wide range of cost estimates. Although the Agency is not in a position to 

know the particular underlying reasons for this range, it believes the wide range of cost estimates 

is based on laboratory economic considerations and particular experiences with the studies. Inhouse labs used by many companies were not surveyed; their costs might be expected to be 

lower than that of an independent laboratory. 

Frequency of Various Tests Being Required

There is flexibility built into complying with Part 158 data requirements. Agency 

experience has shown that pesticides and their uses vary widely. Individual chemical, 

toxicological, and exposure profiles may suggest quite different risk potentials. To the extent 

practicable, the Agency has tried to guide users of data requirement tables to the applicable data 

requirements by including major use patterns and test notes; however the utility of this guidance 

is limited. Ultimately, in certain cases, there is no substitute for registrant consultation with the 

Agency so that appropriate “alternate” approaches or data can be considered for situations that 

are not explicitly covered by the data requirement tables. 

It is very difficult to predict the extent to which a registrant may be able to satisfy a data 

requirement through a waiver request, bridging of existing data, or development of new data that 

adequately responds to the data requirement without performing a “guideline study.” In 

estimating costs of newly codified data requirements, the Agency has relied upon the scientific 

judgment of experienced staff to produce reasonable estimates of how often we expect to receive 

newly generated guideline studies to satisfy the data requirements. 

Number of Future Requested Registration Actions

Future registration actions may not closely reflect the past seven years of actions that the 

Agency used as a baseline for its estimate to predict future actions. This could be due to a 

number of factors including unforeseen changes in markets or scientific knowledge. 

Other limitations include: 
 December 7, 2004 33 

• Industry Structure. The analysis was based on 2002 financial data, but currently there is a 

trend for large companies to take over smaller companies. For example, several large 

companies have purchased others and become vertically integrated, leaving a few large 

companies. 

• Sales Data. About 449 of the 1,000 randomly sampled entities in the conventional pesticide 

industry could be classified as large or small entities with sales data. Therefore, the analysis 

was based on this sample and projected to the industry. However, EPA cannot determine 

whether or to what extent this sample is truly representative of the total population of 

conventional pesticide entities. 

• Cost Incidence. Because data limitations made it difficult to determine precisely when and 

who bears the costs, several assumptions were made as listed below. Two of these 

assumptions, which average costs, tend to spread the costs to a greater number of entities at a 

lower cost per firm. Not allowing for data cost sharing has the opposite effect of limiting the 

distribution of costs. EPA was not able to determine whether the net effect of these 

assumptions results in cost estimates that are overly concentrated or too diffuse. 

a. Data Cost Sharing. The analysis assumed that the registrants initiating registration 

actions would pay the full costs of the data required by these actions. Since many 

other registrants may pay to be able to cite data, the costs of data may be distributed 

more widely, resulting in a larger number of entities incurring smaller costs than 

estimated above. 

b. Annual Average Costs. EPA averaged the costs over a 7 year period (1996-2002). 

Therefore, in any given year there are likely to be fewer entities bearing higher costs 

than what was estimated because it is unlikely that a specific entity will be introducing 

a new chemical every year. 

c. Average Data Requirement Costs. Much of the data are not required for all 

registration actions. EPA estimated the average data requirement cost per registration 

action by multiplying the data requirement cost times the percent of time the data are 

likely to be required. In reality, specific registration actions which require most of the 

data may be more expensive, while others requiring less data may be less expensive 

than the estimated averages. 

In spite of these limitations, EPA concludes that there would not be a substantial number of 

small entities that would be significantly affected as a result of the rule. The analysis shows a 

very low impact. Since the likely impact on small businesses is small, the Agency believes that 

the final rule will not have a deleterious effect on the availability of pesticides to users. On 

balance, the Agency believes that the costs of the rule are justified by the benefits from enhanced 

protection of human health and the environment. 

8 ESTIMATION OF THE BURDEN OF THE DATA COLLECTION
 December 7, 2004 34 

The reporting and record keeping burden associated with the rule is approximately 35,123 

hours, and the burden cost is estimated to be $3,041,816 per year. These burdens are covered in 

the existing FIFRA Section 3 (Registration) ICR (Information Collection Request). The cost is 

shared by all respondents. This cost is an upper-bound estimate. The Agency has already 

captured the burden for most of the data requirements it currently imposes (except for about 5 

data requirements) through ICRs for the DCIs (Data Call-In). The calculation of the burden 

hours is shown in Table 8.1 below. Under FIFRA Section 3 registration, registrants or applicants 

submit information in three categories: 

• Type A activities involve a registrant or applicant assembling and submitting an application 

for registration of a new active ingredient (AI) or a major new use for a currently registered 

active ingredient. Typically for new AIs, an application must be submitted for at least two 

new products: the manufacturing use product (either imported or made in the U.S.) that may 

be formulated into an end use product and at least one end-use product (that bears the 

directions for the intended end use). 

• Type B activities involve a registrant or applicant assembling and submitting an application 

for registration of a new or amended product that contains an active ingredient currently 

registered for the same use pattern. Often, the formulation of this product is identical or 

substantially similar to that of a currently registered end-use product. This is called “me-too” 

registration. In this case, the applicant only needs to cite data from the registered product. 

There are actually many cases where an applicant can cite data from one or more studies for 

another product (selective method) or cite all data supporting a particular active ingredient 

(called the “cite-all” method) to support a new product. 

• Type C activities involve registration of new conventional AI or uses that may qualify as a 

“reduced risk” chemicals and/or organophosphate replacements, which are given expedited 

processing. An applicant must prepare an application that includes specific information, as 

described in PR notice 97-3 and/or PR 98-7, to explain why the new AI or use may have a 

lower toxicity, exposure, or profile than currently-registered products for the same 

commodity. 

In this rule only Type A and Type C activities are affected. Since Type B activities are metoo activities, the applicant only needs to cite data from another source to support the new 

registration; Type B activities are not affected by this final rule. 
 December 7, 2004 35 

Table 8.1: Estimate for Type A Activities Annual Registrant Burden/Cost Estimates for Type A Activities for 

the Registration Division (RD): New Active Ingredients and New Uses 

Burden Hours (per year) Total

Collection Activities Management 

$121/hr. 

Technical 

$81/hr 

Clerical 

$37/hr Hours Costs $ 

Read Instructions 19.44 0 0 19.44 $2,352 

Plan activities 4.32 0 0 4.32 $ 523 

Gather/create information 0 129.60 0 129.6 $10,498 

Compile and review 4 8.64 0 12.96 $1,223 

Complete paperwork 0 0 32.40 32.40 $1,199 

Store/maintain data 0 0 10.80 10.08 $ 400 

TOTAL 28.08 138.24 43.20 209.52 $16,194 

ANNUAL BURDEN: 

 209.52 hours x 141 new active and new uses = 29,542 Hours 

ANNUAL COSTS: 

 (a) Management: 28 hours x $121 x 141 new active and new uses = $ 477,708 

 (b) Technical: 138 hours x $81 x 141 new active and new uses = $1,576,098 

 (c) Clerical: 43 hours x $37 x 141 new active and new uses = $ 224,331

Total = $ 2,590,963 

Table 8.2: Estimate for Type C Activities Annual Registrant Burden/Cost Estimates for Type C Activities for 

the Registration Division (RD): Reduced Risk 

Burden Hours (per year) Total 

Collection Activity Management 

$121 

Technical 

$81 

Clerical 

$37 Hours Cost 

Read instructions 23.76 0 0 23.76 $2,875 

Gather Information 0 397.44 0 397.44 $32,193 

Process, Compile and Review Information 86.4 86.4 0 172.8 $17,453 

Record and Report Information 0 0 77.76 77.76 $2,877 

Store, File and Maintain Information 0 0 25.92 25.92 $959 

TOTAL 110.16 483.84 103.68 697.68 $56,357 

ANNUAL BURDEN: 

 697.68 hours x 8 new reduced risk = 5,581 Hours 

ANNUAL COSTS: 

 (a) Management: 110.16 hours x $121 x 8 new reduced risk = $ 106,634.88 

 (b) Technical: 483.84 hours x $81 x 8 new reduced risk = $ 313,528.32 

 (c) Clerical: 103.68 hours x $37 x 8 new reduced risk = $ 30,689.28

Total = $ 450,852.48 

Total burden hours are: 29,542 + 5,581 = 35,123. 

Total burden cost is: $2,590,963 + 450,852.48 = $3,041,815. 

9 ESTIMATION OF AGENCY BURDEN 

EPA would incur costs primarily in reviewing the additional data required in the Part 158 

rule. EPA estimates the total annual cost to the Agency of reviewing the additional data to be 

approximately $1.5 million. The analysis is based on: 
 December 7, 2004 

36 

 The average time spent reviewing the data (based on EPA experience). 

The average hourly labor cost (based upon typical contractor costs and wage rate plus 

overhead for an employee at GS -13, Step 5). 

This cost is multiplied by the average annual number of additional times each test is likely 

to be required to estimate the total incremental annual EPA cost of reviewing data from each 

requirement. The number of times a test is likely to be required annually was estimated in 

Section 3, where the average annual number of registration actions was multiplied by the 

percentage of time each test is likely to be required. See Appendix C for Agency impacts. 
 December 7, 2004 

37 

REFERENCES

Dun & Bradstreet. 2002. Spectrum Database. 

Dun & Bradstreet. 2003. Spectrum Database. 

Frost & Sullivan. 2000. U.S. Crop Protection Chemical Markets. 

USDA. 2003. Agricultural Statistics. 

USEPA. 1998. 40 CFR Part 158. 

USEPA. 1999a. Pesticide Industry Sales and Usage Report 1998 & 1999. 

USEPA. 1999b. Revised Interim Guidance for EPA Rule Writers: Regulatory Flexibility Act 

as amended by the Small Business Regulatory Enforcement Act. March 1999. 

USEPA. 1999c. Safe Drinking Water Act, Section 1429, Groundwater Report to Congress, 

October 1999. EPA-816-R-99-016. Available at 

http://www.epa.gov/ogwdw000/gwr/finalgw.pdf. 

USEPA. 2000. Guidelines for Preparing Economic Analyses. 

USEPA. 2001a. Pesticides Industry Sales and Usage Report, 2000 and 2001 Market Estimates. 

USEPA. 2001b. Pesticide Products Information System (PPIS). 

USEPA. 2001c. Pesticide Regulatory Action Tracking System (PRATS). 

USEPA. 2003. Pesticide Regulatory Action Tracking System (PRATS). 
 December 7, 2004 38 

APPENDIX A: 

TEST COST DATA USED TO CALCULATE DATA REQUIREMENTS COSTS1

FOR PART 158 RULE 

Guideline 

Number2

Number 

of Labs3

Data Requirement 

Average Cost 

Average 

Low Cost 

Average 

High 

Cost 

73-3 1 

Whole sediment - acute toxicity to 

pore water, fish and invertebrates $37,500 $25,000 $50,000

74-1 2 

Whole sediment - chronic toxicity, 

freshwater and marine 

invertebrates $51,350 $34,700 $68,000

830.6313 8 

Stability to normal and elevated 

temperatures, metals, and metal 

ions $6,400 $5,557 $7,244

830.7050 8 UV/Visible light absorption $2,022 $1,972 $2,072

830.7520 3 

Particle size, fiber length, and 

diameter distribution $1,333 $1,333 $1,333

830.7550, 

830.7560, 

830.7570 8 

Partition coefficient 

(n-octanol/water) $5,792 $5,372 $6,212

835.2120 5 Hydrolysis $25,230 $20,560 $29,900

835.2370 1 Photodegradation in air $110,000 $100,000 $120,000

835.2410 6 Photodegradation on soil $42,350 $39,517 $45,183

835.4100 4 Aerobic soil metabolism $94,375 $90,125 $98,625

835.4300 4 Aerobic aquatic metabolism $44,475 $41,600 $47,350

835.4400 4 Anaerobic aquatic metabolism $80,900 $75,275 $86,525

835.6100 3 Terrestrial field dissipation $317,767 $269,467 $366,067
 December 7, 2004 39 

APPENDIX A: 

TEST COST DATA USED TO CALCULATE DATA REQUIREMENTS COSTS1

FOR PART 158 RULE 

Guideline 

Number2

Number 

of Labs3

Data Requirement 

Average Cost 

Average 

Low Cost 

Average 

High 

Cost 

835.6200 2 

Field dissipation studies for 

aquatic uses and aquatic impact 

uses $267,250 $180,500 $354,000

835.6300 2 Forestry field dissipation $275,500 $188,500 $362,500

835.7100 2 Groundwater monitoring $1,225,000 $450,000

$2,000,00

0

850.1025 

850.1035 

850.1045 

850.1055 

850.1075 4 

Acute LC50/EC50 estuarine and 

marine organisms $16,969 $7,538 $26,400

850.1300 4 

Fish early stage life and aquatic 

invertebrates $118,063 $73,325 $162,800

850.1350 3 Mysid chronic toxicity $36,333 $31,667 $41,000

850.1400 5 Fish early-life stage (freshwater) $37,279 $33,179 $41,379

850.1950 2 

Field testing in aquatic non-target 

organisms $512,500 $375,000 $650,000

850.2100 1 Avian single-dose oral LD50 $10,100 $6,400 $13,800

850.2200 3 Avian dietary $6,480 $6,313 $6,647

850.2300 1 Avian reproduction test $168,250 $121,000 $215,500

850.2500 1 Simulated or actual field testing $650,000 $600,000 $700,000

850.3020 4 Honeybee acute contact LD50 $3,175 $3,175 $3,175

850.3040 2 Field testing for pollinators $30,000 $21,250 $38,750
 December 7, 2004 40 

APPENDIX A: 

TEST COST DATA USED TO CALCULATE DATA REQUIREMENTS COSTS1

FOR PART 158 RULE 

Guideline 

Number2

Number 

of Labs3

Data Requirement 

Average Cost 

Average 

Low Cost 

Average 

High 

Cost 

850.4100 4 Seedling emergence Tier I $14,625 $13,625 $15,625

850.4150 4 Vegetative vigor Tier I $15,875 $14,875 $16,875

850.4225 4 Seedling emergence Tier II $20,375 $18,750 $22,000

850.4250 4 Vegetative vigor Tier II $24,500 $22,500 $26,500

850.4400a 4 Aquatic plant toxicology Tier I $35,155 $30,784 $39,525

850.4400b 4 Aquatic plant toxicology Tier II $35,155 $30,784 $39,525

860.1300 3 Nature of the residue in animals $105,833 $93,333 $118,333

860.1340 5 Residue analytical method $62,850 $51,700 $74,000

860.1460 2 

Magnitude of Residue - food 

handling $205,000 $180,000 $230,000

870.1735 4 

Whole sediment - acute 

invertebrates, fresh water $20,250 $18,200 $22,300

870.1740 4 

Whole sediment - acute 

invertebrates, marine $20,625 $18,575 $22,675

870.3200 8 21/28-day dermal $83,240 $81,798 $84,681

870.3250 8 90-Day dermal $137,094 $136,074 $138,114

870.3700 6 

Prenatal developmental toxicity - 

rats $76,844 $76,651 $77,037

870.3800 6 Reproduction and fertility effects $378,479 $375,725 $381,233

870.6100 4 28 - day neurotoxicity $79,375 $78,125 $80,625

 
 December 7, 2004 41 

APPENDIX A: 

TEST COST DATA USED TO CALCULATE DATA REQUIREMENTS COSTS1

FOR PART 158 RULE 

Guideline 

Number2

Number 

of Labs3

Data Requirement 

Average Cost 

Average 

Low Cost 

Average 

High 

Cost 

870.6200a 6 Acute neurotoxicity - rat $89,596 $87,513 $91,680

870.6200b 6 Chronic 90-day neurotoxicity - rat $184,039 $181,668 $186,410

870.6300 5 Developmental neurotoxicity $406,904 $396,672 $417,135

870.6500 2 

Scheduled controlled operant 

behavior $164,000 $164,000 $164,000

870.6850 1 Peripheral nerve function $110,000 $110,000 $110,000

870.6855 1 

Neurophysiology: sensory evoked 

potentials $110,000 $110,000 $110,000

870.7800 2 Immunotoxicity $56,648 $55,564 $57,731

875.1100 7 Dermal outdoor exposure $167,857 $143,571 $192,143

875.1200 7 Dermal indoor exposure $126,429 $102,143 $150,714

875.1300 7 Inhalation outdoor exposure $164,286 $143,571 $185,000

875.1400 7 Inhalation indoor exposure $126,429 $102,143 $150,714

875.1500 7 Biological monitoring $188,393 $157,500 $219,286

875.1600 0 

Applicator exposure data reporting 

and calculations $7,500 $5,000 $10,000

875.1700 0 Product use information $3,000 $2,000 $4,000

875.2100 5 

Dislodgeable foliar residue and 

turf transferable $55,100 $54,100 $56,100

875.2200 4 Soil residue dissipation $83,125 $81,250 $85,000

875.2300 4 Indoor surface residue dissipation $35,000 $32,000 $38,000
 December 7, 2004 42 

APPENDIX A: 

TEST COST DATA USED TO CALCULATE DATA REQUIREMENTS COSTS1

FOR PART 158 RULE 

Guideline 

Number2

Number 

of Labs3

Data Requirement 

Average Cost 

Average 

Low Cost 

Average 

High 

Cost 

875.2400 5 Dermal exposure $125,500 $118,000 $133,000

875.2500 5 Inhalation exposure $73,000 $65,000 $81,000

875.2600 6 Biological monitoring $166,875 $142,083 $191,667

875.2700 0 Product use information $3,000 $2,000 $4,000

875.2800 0 Description of human activity $3,000 $2,000 $4,000

875.2900 0 

Post application exposure data 

reporting and calculations $3,000 $2,000 $4,000

875.3000 3 Non-dietary ingestion exposure $75,000 $66,667 $83,333

1

 Only guidelines with non-zero action code probabilities are included (i.e., only those that affect the cost of 

the new Part 158 data requirements). 

2

 A letter attached the end of a guideline number denotes a guideline which may have several different 

implementations, each with its own set of probabilities and costs (e.g. neurotoxicity testing could be 

performed on both rats and rabbits under the same OPPTS guideline). Therefore, in some instances each 

specific application of an OPPTS guideline is given a unique identifier for the analysis. 

3

 Represents the number of unique laboratories that reported cost information for the OPPTS guideline of 

interest. For instances where two or more laboratory cost estimates were collected from a particular lab 

based on variability in study design, costs were not “double-counted” and one average test cost per lab per 

OPPTS guideline was used. In instances where the number of labs reporting costs is zero, this is due to 

certain OPPTS guidelines where field or laboratory data are not required and documentation preparation 

usually is required. For these OPPTS guidelines, the costs were estimated using best professional judgment 

by SciReg, a multidisciplinary scientific, regulatory, and quality assurance consulting firm. 
 December 7, 2004 43 

APPENDIX B 

OPTIONS AND SENSITIVITY ANALYSIS 
 December 7, 2004 44 
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Appendix C 

Agency Impacts 

Estimate of Annual Cost of Reviewing Data by EPA 

Review hours/test

Guideline Data Requirement EPA Contractor 

Cost per 

Test

Average 

number of 

additional 

tests/year

Annual 

Cost

Toxicology

Acute Testing 

 870.6200 Acute neurotoxicity - rat 30 30 $3,763 23.6 $88,813 

Subchronic Testing 

 870.3200 21-day dermal 20 20 $2,509 1.7 $4,337 

 870.3250 90-day dermal 45 45 $5,645 2.7 $15,241 

 870.6100 28-day neurotoxicity -hen 20 20 $2,509 7.9 $19,856 

 870.6200 90-day neurotoxicity - rat 55 55 $6,899 29.8 $205,403 

Developmental Toxicity and Reproduction 

 870.3700 Prenatal developmental toxicity - rat 

and rabbit, preferred 

 30 30 $3,763 6.2 $23,461 

 870.3800 Reproduction 20 20 $2,509 2.2 $5,645 

 870.6300 Developmental neurotoxicity 60 60 $7,527 20.8 $156,552 

Special Testing 0 0 $0 0.0 $0 

 870.6500 Schedule controlled operant behavior 45 45 $5,645 0.8 $4,468 

 870.6850 Peripheral nerve function 45 45 $5,645 0.8 $4,468 

 870.6855 Neurophysiology: sensory evoked 

potentials 

 45 45 $5,645 0.8 $4,468 

 870.7800 Immunotoxicity 45 45 $5,645 13.9 $78,537 

Total Toxicology $611,247

Applicator Exposure

 875.1100 Dermal outdoor exposure 40 40 $5,018 9.7 $48,457 

 875.1200 Dermal indoor exposure 40 40 $5,018 9.7 $48,457 

 875.1300 Inhalation outdoor exposure 40 40 $5,018 9.7 $48,457 

 875.1400 Inhalation indoor exposure 40 40 $5,018 9.7 $48,457 

 875.1500 Biological monitoring 40 40 $5,018 1.4 $7,068 

 875.1600 Data reporting and calculations 2 0 $131 116.2 $15,205 

 875.1700 Product use information 2 0 $131 116.2 $15,205 

 Total Applicator Exposure $231,304

Post-Application Exposure 

 875.2100 Dislodeagable foliar residue and turf 

transferable residues 

 40 40 $5,018 10.5 $52,829 

 875.2200 Soil residue dissipation 40 40 $5,018 9.5 $47,811 

 875.2300 Indoor surface residue dissipation*** 40 40 $5,018 16.7 $83,795 

 875.2400 Dermal exposure 40 40 $5,018 10.5 $52,829 
 December 7, 2004 

60 

Review hours/test

Guideline Data Requirement EPA Contractor 

Cost per 

Test

Average 

number of 

additional 

tests/year

Annual 

Cost

 875.2500 Inhalation exposure 40 40 $5,018 7.0 $35,339 

 875.2600 Biological monitoring*** 40 40 $5,018 1.4 $7,068 

 875.2700 Product use information*** 2 0 $131 116.2 $15,205 

 875.2800 Description of human activity*** 2 0 $131 116.2 $15,205 

 875.2900 Data reporting*** 2 0 $131 116.2 $15,205 

 875.3000 Nondietary ingestion Exposure*** 40 40 $5,018 3.0 $14,938 

Total Post-Application Exposure $340,225

Terrestrial and Aquatic Non-target Organisms

Avian and Mammalian Testing 

 850.2100 Avian oral LD50 2 6 $491 18.7 $9,161 

 850.2200 Avian dietary 2 6 $491 -0.5 ($245) 

 850.2300 Avian reproduction 8 30 $2,324 8.3 $19,280 

 Aquatic Organism Testing 

 850.1025 

 850.1035 

 850.1045 

 850.1055 

 850.1075 

 

Acute toxicity estuarine and marine 

organisms 

2 6 $491 16.1 $7,927 

Sediment Testing 

 Whole Sediment -Acute Invertebrates 

 870.1735 --freshwater 2 6 $491 9.5 $4,659 

 870.1740 --marine 2 6 $491 8.7 $4,251 

 Whole sediment

 none -Chronic invertebrates 8 30 $2,324 7.4 $17,256 

Insect Pollinator Testing 

 850.3020 Honeybee acute contact toxicity 2 6 $491 14.5 $7,103 

 850.3040 Field Testing for Pollinators 10 50 $3,654 0.8 $3,032 

Total Terrestrial & Aquatic $82,688 

Environmental Fate

Degradation Studies-Laboratory 

 835.2120 Hydrolysis 14 45 $3,616 1.2 $4,341 

 835.2370 Photodegradation in air 14 45 $3,616 0.8 $2,832 

Metabolism Studies-laboratory 

 835.4100 Aerobic soil 18 60 $4,778 0.3 $1,383 

 835.4400 Anaerobic aquatic 21 70 $5,574 13.6 $76,029 

 835.4300 Aerobic aquatic 21 70 $5,574 13.6 $76,029 

Dissipation Studies - Field 
 December 7, 2004 

61 

Review hours/test

Guideline Data Requirement EPA Contractor 

Cost per 

Test

Average 

number of 

additional 

tests/year

Annual 

Cost

 835.6100 Terrestrial 26 85 $6,801 1.4 $9,524 

 835.6200 Aquatic (sediment) 21 70 $5,574 1.4 $7,805 

 835.6300 Forestry 21 70 $5,574 (1.7) ($9,667) 

Accumulation Studies 

 850.1950 In aquatic non-target organisms 21 70 $5,574 0.1 $739 

Ground Water Monitoring 

 835.7100 Ground water monitoring 21 70 $5,574 0.8 $4,412 

Total Environmental Fate $173,427

Non-target Plant Protection

Nontarget Area Phytoxicity Tier I 

850.4100 Seedling emergence 10 20 $1,854 1.7 $3,232 

850.4150 Vegetative vigor 10 20 $1,854 1.7 $3,232 

850.4400a Aquatic plant growth 10 20 $1,854 1.7 $3,232 

Nontarget Area Phytoxicity Tier II 

850.4225 Seedling emergence 10 20 $1,854 0.5 $970 

850.4250 Vegetative vigor 10 20 $1,854 0.5 $970 

850.4400b Aquatic plant growth 10 20 $1,854 1.9 $3,555 

Total Non-target Plant Protection $15,190

Residue Chemistry

 860.1300 Nature of the residue in livestock 8 60 $4,124 22.0 $90,718 

 860.1340 Residue analytical methods 8 60 $4,124 26.3 $108,390 

 860.1460 Food handling 8 60 $4,124 29.0 $119,759 

Total Residue Chemistry $318,867

Product Chemistry

830.7550 

 830.7560 

830.7570 

Partition Coefficient (n-octanol/water) 10 60 $4,254 14.0 $59,623 

830.6313 Stability 10 60 $4,254 -14.9 ($63,330) 

830.7050 UV/visible light absorption 10 60 $4,254 29.8 $126,660 

830.7520 Particle size 10 60 $4,254 7.0 $29,963 

Total Product Chemistry $152,916

Total All Tests $1,939,115

*Sums are not exact due to rounding off.
Appendix − 62 

Appendix D 

Industry Profile

This profile relies on a number of sources of information on the pesticide industry. The 

major sources include the following: 

· EPA Office of Pesticide Programs (OPP) publications and estimates 

· Pesticide industry profiles prepared for previous regulatory analyses for EPA’s Offices of 

Pesticide Programs, Water, and Air 

· Industry profiles prepared by private research firms 

· Dunn & Bradstreet industry data 

· Research on specific companies using publicly available business databases accessed 

through the Internet 

· Searches of academic and industry literature 

· Economic Census data from the U.S. Census Bureau 

· Other U.S. Department of Commerce sources 

Use of Census Data

Whenever a data source contained complete information to illustrate a certain aspect of the 

pesticide industry, we chose to present that information. In other cases, the only source of 

national level information was the U.S. Census Bureau’s Economic Census of Manufacturers. 

There are inherent difficulties associated with using data from the Economic Census preformed 

by the U.S. Census Bureau to characterize certain industrial sectors contained in this profile. 

The Census Bureau has recently revised its industry classification system and now uses 

“North American Industrial Classification System” (NAICS) codes to describe industrial sectors. 

 Information in the 1997 Census is organized according to the NAICS. The NAICS replaces the 

Standard Industrial Classification (SIC) system that had been used in all earlier Census 

publications. NAICS assignment for an establishment is made according to one of 20 major 

industrial sectors. These sectors are further divided into 96 subsectors, 313 industry groups, and 

1,170 industries. 

In some cases, the relevant Census data required for this economic profile was available at a 

sufficiently disaggregated level that it corresponds reasonably accurately to the establishments in 

the industrial sectors of interest here. In other cases, the Census categorization reflects a very 

large and diverse industry, of which the relevant sector may be a small part. Finally, many 

pesticide industry participants are classified into entirely different Census industry categories 

because their primary product is not related to pesticides. In the latter cases, the Census data do 

not provide a precise representation of the characteristics of establishments of interest. 

Exhibit D.1 provides descriptions of the NAICS categories used to present Census data for 

each sector examined in this profile. It also indicates whether NAICS-based data correspond to 

SIC-based data over time. The Census categories used for each of the major pesticide industry 
Appendix − 63 

sectors included in this profile and their relative precision as a measure of the pesticide and 

related industries are discussed in more detail below. 

Exhibit D.1: Census Industry Classifications Used in Profile 

Profile Sector 

NAICS/ 

SIC Description 

SIC - NAICS 

Correspondence 

325199/ 

2869 

All Other Basic Organic 

Chemical Manufacturing no 

Conventional Active 

Ingredient Producers and 

Formulators, Packagers, 

and Repackagers 

325320/ 

2879 

Pesticide and Other 

Agricultural Chemical 

Manufacturing yes 

Source: U.S. Department of Commerce, 1992 and 1997. 

EPA has incorporated data from several public sources in addition to using the Economic 

Census. For the most part, these sources continue to use the SIC system to organize and present 

information. These data are noted as SIC-based data in the text. EPA uses time series data from 

these sources because of the consistent categorization of industry groups across time. 

General Pesticide Industry Description

Pesticides are important products that play a significant role in many aspects of the 

economy. They are used by diverse economic sectors such as agriculture, industry, and 

residential. Pesticides reduce or eliminate undesirable weeds, insects, animals, fungi, and 

bacteria and are used to preserve wood and regulate plant growth. All of these pesticide uses 

produce desirable outcomes such as increased agricultural productivity and improved human 

health. However, due to their nature, their use also implies some environmental and health risks 

(U.S. EPA, 1999c). 

Pesticide products themselves fall into several categories: conventional pesticides, specialty 

and niche pesticides, and antimicrobial pesticides. Conventional pesticides are those products 

that are commonly available to users including herbicides (weed killers), insecticides (“bug” 

killers), and fungicides (fungus killers), as well as some special classifications such as fumigants 

used to sterilize soil to remove pathogens. The vast majority of pesticides used in the U.S. fall 

into this category. 

Pesticide production involves combining a more than one substance into a formulation. The 

main ingredient of a pesticide product is the active ingredient: the chemical that is toxic to the 

targeted pest. Some pesticide formulations contain more than one active ingredient, depending 

on their target or targets. These pesticide active ingredients, or active ingredients, cannot be 

applied in their basic form for reasons of safety and effectiveness. EPA regulates both active 

ingredients and formulations through a registration process. There are roughly 890 active 

ingredients registered with EPA, and nearly 18,000 registered formulations. Depending on the 
Appendix − 64 

context or the data source, this profile will make a distinction between discussions of active 

ingredient and discussions of formulations. 

Exhibit D.2 presents a summary of the number of regulated conventional pesticide products and 

tolerances. 

Exhibit D.2: Regulated Pesticide Products 

Product Segment Number of Products 

Active Ingredients with Active Registrations 

(Federal and State) 

891 

Active Ingredients with Food/Feed 

Tolerances 

(September 1998) 

523 

Formulated Products with Federal 

Registrations 

(June 1998) 

17,713 

Tolerances in Place 

(September 1998) 

9,783 

Source: U.S. EPA, 1999c 

The pesticide industry participants addressed in this profile include the entities that 

manufacture active ingredients, formulate, package, and repackage pesticides. These companies 

are presented in Exhibit D.3 below. 

Exhibit D.3: Pesticide Industry Participants 

Production Segment Number of Establishments 

Major Basic Active Ingredient Producers 18 

Other Active Ingredient Producers 100 

Formulators - Major 150-200 

Formulators - Other approx. 2000 

Sources: EPA, 1999c 

While all the economic sectors mentioned previously consume pesticide products, the 

agricultural sector is by far the largest conventional pesticide user. Figure D.4 provides a 

schematic of how pesticide products flow from manufacturer to agricultural end users. The 
Appendix − 65 

entities that manufacture active ingredients ship their products either in raw form or as 

formulated product. The majority of pesticides are shipped to distributors and dealers as 

formulations. A small portion of pesticides are shipped to independent formulators for further 

preparation. Distributors and dealers may receive the product in a packaged form ready for sale 

to agricultural end users or may repackage the product for final sale. Some pesticide products 

reach agricultural end users through production cooperatives. 

Figure D.4: Structure of the U.S. Pesticide Industry (Agricultural Uses) 

Source: SRI International, 1999. 

Conventional Pesticide Market 

The conventional pesticide market comprises the majority of the pesticide industry. There are 

four major types of conventional pesticide products: 

· Herbicides 

· Insecticides 

· Fungicides 

· Other, including plant growth regulators (PGRs), etc. 

Herbicides, insecticides, and fungicides make up the largest portion of the conventional 

pesticide market. All pesticide products have certain characteristics that affect demand. These 

characteristics include the following: 
Appendix − 66 

· Spectrum of control – the range of pests controlled 

· Efficacy – the ability to control pests, and the application rates needed for control 

· Ease of use – the ability to mix with other products, low equipment requirements, etc. 

· Toxicity (human and wildlife) – the degree to which toxicity determines limitations on 

usage 

· Price – the cost of the pesticide input relative to its return in improved conditions such as 

crop yield 

Over time, some of these basic product characteristics have changed. For example, more 

reduced risk (low toxicity) pesticides are now available (U.S. EPA, 1999c). In addition, low-use 

pesticide are available that require lower application rates to maintain efficacy. 

Exhibit D.5 presents the U.S. pesticide sales at user level for 1997, as well as volume of 

active ingredients at user levels. 

Exhibit D.5: U.S. Pesticide Sales at User Level 

1997 Estimates 

User expenditures Volume of Active 

Pesticide Ingredient 

Class 

Millions 

($) Percent 

Millions 

(lbs.) Percent 

Herbicides 6,846 58 568 46 

Insecticides 3,553 30 129 10 

Fungicides 802 7 81 7 

Other* 696 6 453 37 

Total 11,897 100 1,231 100 

* Includes sulfur and petroleum/other chemicals but does not 

cover industrial wood preservatives, specialty biocides and 

chlorine/ hypochlorites. 

Source: U.S. EPA, 1999c. 

Herbicides, insecticides, and fungicides represent approximately 95 percent of U.S. 

pesticide sales, and 63 percent of the active ingredients used by the pesticide industry. 

Pesticide products within each major category (i.e., herbicides, insecticides, fungicides) 

often tend to be developed to meet specific crop requirements. Each of these pesticide type/crop 

combinations, termed “use clusters,” can be thought of as a distinct market. U.S. EPA’s Office 

of Pesticide Programs has defined 57 use clusters, which were used as the basis for the market 
Appendix − 67 

analysis for two economic analyses of proposed effluent guidelines affecting the pesticide 

industry (U.S. EPA, 1993 and 1994). 

Herbicides

Herbicides are largely used on crops for the purpose of controlling weeds. Weeds compete 

with crops for nutrients, space, water, and sunlight. Controlling weeds decreases the need for 

farm labor and improves crop quality. Demand for herbicides is greatly affected by the weather. 

 A warm and wet spell can cause high growth of weeds, resulting in a greater demand for 

herbicides, whereas a dry and cold spell can lower demand considerably. The two major types 

of herbicides are as follows: 

· Pre-emergent herbicides – applied soil before the seed is planted, to resist the growth of 

weeds 

· Post emergent herbicides – applied to weeds after germination 

Herbicides are used on a variety of crops: 

· Corn 

· Soybeans 

· Other crops (cotton, rice, pastures, small grains, and fruit and vegetables) 

Herbicides have end uses in industries other than agriculture as well: the forestry, 

industrial, turf, nursery and ornamental, and home and garden industries use herbicides. Exhibit 

D.6 and Exhibit D.7 show the percentage of revenues by application for herbicide market. Corn 

and soybean crops represent the greatest users of herbicides. From 1996 to 1999 the mainstream 

crop users (corn and soybean) decreased expenditures on herbicides relative to other users by 6.5 

percent of total annual herbicide use, with corn crop applications falling the most. Soybean 

planted acreage increased over this period by nearly 15 percent (USDA, 1999b). Corn planted 

acreage was relatively constant between 1996 and 1998, and fell by 3.4 percent in 1999 (USDA, 

2000a). In contrast to the relative drop in herbicide expenditures on major crops, other crop and 

non-crop expenditures on herbicides increased, with the largest increase occurring between 1998 

and 1999 (Frost & Sullivan, 2000). 
Appendix − 68 

Exhibit D.6: Percent of U.S. Herbicide Sales by Year, 1996 - 1999 

Source: Frost & Sullivan, 2000. 

Exhibit D.7: Percent of U.S. Herbicide Sales by Year, 1996 - 1999 

Year Corn Soybean Other 

Crop 

Non-crop Total 

1996 31.9% 26.4% 29.1% 12.5% 100% 

1997 31.8% 26.0% 29.1% 13.2% 100% 

1998 31.7% 25.0% 29.6% 13.8% 100% 

1999 27.7% 23.3% 33.0% 16.0% 100% 

% Change 

1996-1997 

-4% -3% 4% 4% 

Note: Values may not add to 100 due to rounding. 

Source: Frost & Sullivan, 2000. 
Appendix − 69 

Insecticides

Insecticides are used to control insects that damage crops by killing the plant or spoiling the 

fruit. Chlorinated hydrocarbons, organophosphates, and carbamates are used the most, with 

organophosphates the most commonly used of the three groups (Frost & Sullivan, 2000). 

Insecticide use is greatly influenced by weather and outbreaks of insects. A warm and wet 

spell can be conducive to insect growth, which causes an increase in the demand for insecticides. 

 Another factor currently affecting the demand for insecticides is the introduction of genetically 

modified (GM) crops. Genetic modification may alter crops to make them more insect resistant, 

often by modifying the plant to produce toxins that repel or kill insect pests. This is a new 

technology and to date has been confined to a few row crops like corn, cotton, and soybeans. It 

is extremely difficult to make plants resistant to all types of insects. Thus, even some GM crops 

are still being treated with insecticides (Frost & Sullivan, 2000). There are also concerns about 

the likelihood of insects adapting to the genetically modified crops and overcoming the plants’ 

defenses. 

The following are the main crop uses of insecticides: 

· Corn 

· Cotton 

· Other crops (including potatoes, vegetables, fruits, sugar beets, peanuts, and tobacco) 

· Non-crop uses (including turf, home and garden, professional care, public health, nursery, 

and ornamental) (Frost & Sullivan, 2000) 

Exhibits D.8 and D.9 present the market use data for insecticide applications from 1996 to 

1999 by percent of total annual use. Use of insecticides by the corn/corn soil category fell by 

three percent from 1998 to 1999 relative to other insecticide uses, fairly consistent with recent 

changes in cultivated acreage. While use of insecticides on cotton relative to other crops fell 

over all between 1996 and 1999, there was an upward trend from 1996 to 1998. Planted cotton 

acreage stayed nearly constant. Other crop and non-crop uses together accounted for over 65 

percent of total insecticide use as of 1999. From 1996 to 1999, both sectors increased their use 

of insecticides relative to the other sectors, with the greatest increase occurring between 1998 to 

1999. 
Appendix − 70 

Exhibit D.8: Percent of U.S. Insecticide Sales by Year, 1996 - 1999 

Source: Frost & Sullivan, 2000. 

Exhibit D.9: Percent of U.S. Insecticide Sales by Year, 1996 - 1999 

Year Corn/Soil Cotton Other 

Crop 

Non-crop Total 

1996 24.8% 18.5% 25.7% 31.0% 100% 

1997 22.0% 18.9% 26.5% 32.6% 100% 

1998 19.8% 19.0% 26.9% 34.3% 100% 

1999 16.8% 17.9% 28.2% 37.1% 100% 

% Change 

1996 - 1997 

-8% -1% 2% 6% 

Note: Values may not add to 100 due to rounding. 

Source: Frost & Sullivan, 2000. 
Appendix − 71 

Fungicides

Fungicides control plant molds and diseases. The applications of fungicides are very 

diverse because any material is susceptible to a fungal attack. In agriculture, they are primarily 

used on specialty crops such as fruits and vegetables. Fungicides are used to retard or eliminate 

fungal infections that can produce toxicants. 

Weather plays an important role in the fungicide market, as it does in both the herbicide and 

insecticide markets. Wet weather can cause an increase in fungal attacks on crops, boosting 

agricultural demand for fungicides. Some of the major uses of fungicides are as follows: 

· Vegetables 

· Potatoes 

· Fruits (including grapes and citrus) 

· Other crops (including corn, cotton, small grains, peanuts, rice, and tobacco) 

· Non-crop uses (including turf, nursery, and ornamental) 

Exhibit D.10 and Exhibit D.11 present the market use data for fungicide applications from 

1996 to 1999 by percent of total annual use. 

Exhibit D.10: Percent of U.S. Fungicide Sales by Year, 1996 - 1999 

 

Source: Frost & Sullivan, 2000. 
Appendix − 72 

Exhibit D.11: Percent of U.S. Fungicide Sales by Year, 1996 - 1999 

Year Vegetables Potatoes Fruits Other 

Crops 

Non Crop 

Uses 

Total 

1996 12.8% 8.6% 23.5% 36.7% 18.4% 100% 

1997 12.8% 8.6% 23.4% 36.8% 18.4% 100% 

1998 12.4% 9.0% 23.4% 36.6% 18.6% 100% 

1999 12.6% 8.7% 23.2% 35.8% 19.7% 100% 

% Change 

1996 - 1997 

-0.2% 0.1% -0.3% -0.9% 1.3% 

Note: Values may not add to 100 due to rounding. 

Source: Frost & Sullivan, 2000. 

Plant Growth Regulators

Plant growth regulators (PGRs) are used to increase yields and facilitate harvesting. PGRs 

have varied functions, depending on the crop. PGRs are used on fruits to inhibit rotting and 

maintain color and other aesthetic attributes during storage or transfer from field to market. 

Cotton is the largest source of demand for PGRs, representing approximately 40 percent of total 

PGR demand (Frost & Sullivan, 2000). Rice, tree fruits, peanuts, and potatoes are other major 

crop application sources of PGR demand. The major non-crop applications of PGRs are for turf 

and nursery and ornamental applications. Like all other pesticides, PGR demand is dependent 

upon weather conditions, with wet conditions promoting fungal growth (Frost & Sullivan, 2000). 

Industry Structure

There are many different indicators of how an industry is structured. One approach is to 

evaluate Census data on the concentration of the industry to evaluate whether there is a tendency 

toward concentrated market power. Another approach is to obtain information on market share 

for specific market participants. Finally, recent trends in market structure can be suggested by 

reviewing the ownership and market share patterns of major producers in an industry. This 

section presents the first and third of these approaches. 

Concentration

The U.S. Census provides two measures to indicate the degree of concentration in an 

industry: the “m-firm concentration ratio” and the “Herfindahl-Hirschman (HH) Index.” The mfirm concentration ratio is simply the sum of the value of shipments of the largest “m” firms. A 

market is generally considered highly concentrated if the 4-firm concentration ratio is greater 

than 50 percent. 
Appendix − 73 

The HH index is an alternative measure of concentration equal to the sum of the squares of 

the market shares for the 50 largest firms in the industry. The higher the index, the more 

concentrated the industry is at the top. The U.S. Justice Department uses 1,000 as a benchmark 

for the presence of market concentration, where any industry with a Herfindahl-Hirschman index 

less than 1,000 is considered to be unconcentrated. 

Exhibit D.12 shows concentration ratios by SIC code for the three census years, 1982, 1987, 

and 1992 for conventional pesticides industries, and for the industries that include antimicrobial 

producers and inert manufacturers. 

Exhibit D.12: Concentration Ratios by SIC* Code, 1982-1992 

Percent of value of industry shipments shipped by the 

Year largest (in terms of shipment value) 

4 

Companies 

8 

Companies 

20 

Companies 

50 

Companies 

HerfindahlHirschman 

Index 

Conventional Active Ingredient Producers and FPRs 

Industrial Organic Chemicals (SIC 2869) 

1982 36 52 73 90 475

1987 31 48 68 86 376

1992 29 43 67 86 336

Pesticides and Other Agricultural Chemicals (SIC 2879) 

1982 44 66 85 94 703

1987 49 69 88 94 789

1992 53 69 87 95 834

Source: U.S. Department of Commerce 1992 Economic Census. 

*NAICS codes were not available then. 

The concentration ratios presented in Exhibit D.12 show only moderate evidence of market 

concentration in the relevant industries in 1992. Four-firm concentration ratios for all identified 

SIC codes are below 53. The HH indices for all SIC codes are well below the benchmark of 

1,000. However, two important SIC codes have become noticeably more concentrated: 2879 

(Pesticides and Other Agricultural Chemicals) and 2842 (Polishes and Sanitation Goods). The 

remainder have increased only slightly, remained constant, or decreased in concentration. In the 

case of the SIC codes associated with active ingredient, antimicrobial, inert, and adjuvant 

products, it is important to note that the data represent the entire chemical industry, not just firms 

supplying to the pesticide industry. 
Appendix − 74 

Increasing concentration in the agricultural chemicals industry is not entirely confirmed by comparison with 

earlier m-firm concentration ratios (U.S. EPA, 1993). The 1987 4-firm concentration ratio for Pesticide and Other 

Agricultural Chemicals overall was 49 percent, increasing from 34 percent in 1972, which is consistent with Exhibit 

D.12. On the other hand, the 1982 Census of Manufactures permitted identification of concentration ratios at a more 

disaggregated level (5-digit SIC) (which are not directly comparable) and indicates concentration ratios decreasing 

since 1972/1977 for many subsectors of the pesticide formulating industry. The 4-firm concentration ratios for 

synthetic organic pesticides (SIC 28694), herbicide preparations (SIC 28796), fungicide preparations (SIC 28797), 

and household pesticidal preparations (SIC 28799) were all over 50 percent in 1982 and had been decreasing from 

1972 through 1982. 

Since 1992 the pesticide industry has undergone a period of consolidation. Many firms have merged or been 

purchased, decreasing the number of firms producing active ingredients. This has affected the concentration of active 

ingredient producers in that each sector is shifting to a few large competitors in each sector. For example, the 

herbicides market had a concentration of 45 percent (market share held by top three competitors) in 1999, and it is 

estimated that the concentration will continue to increase. (Frost & Sullivan, 2000). 

Consolidation Through Mergers and Acquisitions

Conventional pesticide producers have experienced a period of consolidation in the past few years, as several 

major producers of active ingredients have either merged or been acquired. The following is a list of the mergers and 

acquisitions that recently occurred or are underway. 

Mergers and Acquisitions

· Novartis with Astra Zeneca (expected 2000) 

· AgrEvo and Rhone Poulenc to form Aventis (1999) 

· Monsanto acquired DeKalb (1998) 

· Dupont bought Pioneer Hi-Bred seed company(1999) 

· Zeneca with Astra (1999) 

· BASF acquired American Cyanamid (2000) 

There are several reasons why there has been a recent trend towards mergers and acquisitions in the pesticide 

industry. The market is very saturated and therefore there is little room for growth, other than through gaining 

market share. Top companies have been purchasing smaller companies, as well as merging with each other in order 

to gain market share. Another way to gain market share is to expand operations into other sectors of the pesticide 

industry, including generic production. Since chemical manufacturing requires significant investment, it makes sense 

to align one company with another that already has the desired technology, instead of attempting to break into that 

sector of the market through new investment. Finally the threat of the introduction of genetically modified seeds is 

driving consolidation as well. There are two typical types of merger occurring: either a chemical company and a 

seed/life science company or a research company and a generic manufacturer. The first is in response to the growing 

acceptance of genetically modified seeds, while the second alliance is intended to combat increased competition from 

generic manufacturers. 
Appendix − 75 

Appendix E 

 Pesticide Registration Action Tracking System (PRATS) Action Codes

A. Registration (OPP Registration Division use only) 

100 - Application for Registration - New Chemical - Food or Feed 

115 - Application for Registration - New Chemical - Non-Food or Non-Feed Use 

117 - Proposed Test Protocol - New Chemical 

 160 - Application for Registration - Routine "Me-Too" (Use 165 if science review required) 

165 - Application for Registration - Old Chemical (Minor changes, i.e, substantial change in 

percentage of active ingredients, inerts, etc.) Requires Science review. 

170 - Application for Registration - Old Chemical - "Me-Too" with an Additional Use (Use 175 

if Science review required) 

175 - Application for Registration - Old Chemical - New Use - Non-Food or Non-Feed - 

Requires Science review. 

180 - Application for Registration - Old Chemical - First New Food or Feed Use 

B. Amendments 

305 - Amendment - Technical - Label Revision - Data Required (i.e., change in toxicity 

category, etc.) Use 320 if science review required. 

 310 - Amendment - Technical - Added "Me-Too" Use (Use 325 if science review required) 

315 - Amendment - New Use - Non-Food or Non-Feed 

320 - Amendment - Label revision - Data required - Requires science review. 

325 - Amendment - Added "Me-too" use - Data required - requires science review. 

330 - Amendment - Technical - New Use - Food or Feed (Use 370/371 if first food or feed use 

for chemical) 

345 - Amendment - Technical - Formula Change - (Use 347 if review required. 

347 - Amendment - Formula Change - Unregistered source of the active ingredient. (Requires 

Science review) 
Appendix − 76 

370 - Amendment - New Use - First Food or Feed Use for Chemical 

385 - Amendment - Special Packaging (Sect. 162.16) 

390 - Amendment - Inert Substitution 

392 - Amendment - Minor Formulation Change for End Use Product - (Acceleratred Review) 

395 - Amendment - Inert Label Warning Statement