Epa Pesticide Registration Fee Schedule Explained

The EPA Pesticide Registration Fee Schedule can be a bit overwhelming, but it's actually pretty straightforward once you understand the basics. The fee schedule is divided into three categories: Active, Inactive, and Reduced.

There are two types of active pesticide registrations: full registration and provisional registration. Full registration requires a more comprehensive review process and has a higher fee, while provisional registration has a lower fee and is typically used for pesticides that have a lower risk profile.

The fee for full registration is currently $2,111, while the fee for provisional registration is $2,011. This is a significant difference, and it's essential to understand which type of registration your pesticide falls under to avoid any confusion.

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The EPA pesticide registration process can be a complex and time-consuming one, but it's essential for ensuring the safety and efficacy of pesticides. The simplest type of registration is me-too Product registration, which is determined based on the similarity of the product to an already registered one.

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There are two main types of me-too Product registration: identical Product registration and similar Product registration. Identical Product registration requires the product to have identical active ingredients, AI content, form, inert ingredients, and use, with only administrative changes to the label.

Similar Product registration, on the other hand, requires the product to have identical or substantially similar active ingredients, AI content, form, inert ingredients, and use, with only minor changes to the label.

Here's a breakdown of the key differences between identical and similar Product registration:

Both types of registration are cost-effective compared to other registration types, which can cost hundreds of thousands of dollars and take up to two years to review.

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The regulatory framework for pesticide registration fees is governed by the Environmental Protection Agency (EPA) and is outlined in Subpart U. This section prescribes fees for pesticide regulatory activities performed by the EPA.

The EPA charges a flat fee of $3,000 per product for pesticide registration, regardless of type, profit from sales, toxicity, or size of company. This fee is the same for both large and small manufacturers.

Here is a breakdown of the EPA's fee schedule for different types of pesticide reviews:

Individual states also require registration of manufacturers that wish to sell their products in state, but most do not offer exemptions.

In the regulatory framework, definitions play a crucial role in understanding the different types of pesticide registration reviews.

The Environmental Protection Agency (EPA) defines a "new use pattern registration review" as the review of an application for registration, or for amendment of a registration entailing a major change to the use pattern of an active ingredient contained in a product registered under FIFRA or pending Agency decision on a prior application at the time of application.

A "new use pattern registration review" can involve significant changes, such as shifting from non-food to food use, or from outdoor to indoor use.

The EPA also defines an "old chemical registration review" as the review of an application for registration of a new product containing active ingredients and uses which are substantially similar or identical to those currently registered or for which an application is pending Agency decision.

Here are the definitions of fee categories as outlined in the EPA's regulations:

Note that the fee for experimental use permit review does not apply to small-scale field testing of microbial pest control agents.

The purpose of Subpart U is to prescribe fees for pesticide regulatory activities performed by the Environmental Protection Agency. These fees are authorized by 31 U.S.C. 9701 and Pub. L. 100-202.

The fees are intended to cover the costs of reviewing and approving pesticide registrations. In order to understand the specifics of these fees, let's take a look at the types of reviews and their corresponding fees.

Here are the types of reviews and their fees:

These fees can be quite high, especially for small companies or those producing niche products. However, the EPA does offer exemptions for "minimal use" products, which can provide some economic relief to small companies.

The EPA pesticide registration fee schedule is a complex system, but understanding the procedures and schedules can help you navigate it more efficiently.

The EPA has retained the format of the tables included in the Pesticide Registration Improvement Extension Act of September 28, 2012.

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The fee schedule is presented in 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee.

You'll find fee tables for the Registration Division (RD), the Antimicrobials Division (AD), the Biopesticides and Pollution Prevention Division (BPPD), Inert Ingredients, and Miscellaneous.

The fee amounts for different types of reviews are outlined in a clear table. Here are the fee amounts for different types of reviews:

The Pesticide Improvement Act, also known as PRIA 3, was implemented in 2012 and requires registrants to pay an annual maintenance fee for certain pesticide registrations.

The fee is $3,250 per product, up to pre-set limits determined by legislation, and is due by January 15th of each year. No extensions of this due date are possible.

To be eligible for a reduced maintenance fee, applicants must meet specific criteria, including having 500 or fewer employees globally and average annual gross revenue from all sources that do not exceed $10,000,000.

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There are also maintenance fee waivers available for products that meet certain narrow criteria, such as minor agricultural use products and public health pesticides.

Here are the requirements for a reduced maintenance fee:

The Pesticide Improvement Act, specifically the Pesticide Registration Improvement Extension Act, established a fee schedule that identifies registration service fees and decision times. This fee schedule is organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA.

The fee categories differ by Division, and not all application types are covered by or subject to the fee system. This means you'll need to check if your application type is included before proceeding.

All section 3 and section 24(c) registrations are subject to an annual maintenance fee, which is described in FIFRA Section 4(i)(5). This fee is required for each of the five years of PRIA 3 (FY’13 – FY’17).

The amount of the maintenance fee is $3,250 per product up to pre-set limits determined by legislation. This amount may vary from year to year based on the projected number of products for which registrants will pay this fee.

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If you're eligible, you can request a 25% reduction in the maintenance fee for your first registration. To qualify, you'll need to show that your company has 500 or fewer employees globally, average annual gross revenue from all sources that don't exceed $10,000,000, and holds a total of 5 or fewer registrations subject to the maintenance fee.

Here are the specific requirements for requesting a fee reduction:

Additionally, there are maintenance fee waivers for products that meet certain narrow criteria in two categories: minor agricultural use products and public health pesticides.

The Pesticide Registration Improvement Act (PRIA) is based on a specific authority found in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The law requires the publication of a fee schedule, which is a requirement by section 33(b)(6)(C) of FIFRA as amended.

The PRIA was first established in 2003, creating a new section 33 of FIFRA that established a registration service fee system for certain types of pesticide applications. This law also created a schedule of decision review times for applications covered by the service fee system.

There are 189 fee categories under PRIA 3, grouped into three major types of pesticidal products: antimicrobial, biopesticide, and conventional active ingredients. The fee categories are also based on the type of action, inert ingredients, and miscellaneous actions.

PRIA 3 requires that $27.8 million in maintenance fees be collected for each of the five years of PRIA 3 (FY’13 – FY’17). The amount of the per product fee will vary from year to year as the fee is dependent upon the projected number of products for which registrants will pay this fee.

Here are some specific types of actions that require a fee under PRIA 3:

Note that some actions, such as the re-establishment of a time-limited tolerance and review of confirmatory data submitted in support of an already-issued registration, do not require a fee.

The EPA pesticide registration fee schedule is a complex system with various fees and exemptions. The fees for registration activities are prescribed in § 152.404, with different rates for new chemical, biochemical or microbial, new use pattern, experimental use permit, old chemical, amendment, and new biochemical or microbial registration review.

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The fees for registration activities are as follows: new chemical $184,500, new biochemical or microbial $64,000, new use pattern $33,800, experimental use permit $4,500, old chemical $4,000, amendment $700, and new biochemical or microbial registration review $64,000.

You can request a waiver or exemption from some of these fees under certain circumstances. For example, if you're requesting a minor use exemption, you'll need to provide supporting documentation that demonstrates the anticipated revenues from the uses will be insufficient to justify imposing the full application fee.

If two or more applicants apply for a new chemical registration for products with the same active ingredient, each will be charged the full new chemical registration review fee if they developed their data independently.

Each applicant will be charged an equal share of the total fee if they jointly developed or paid for a common set of data to support their registration applications.

This joint development fee is calculated as the sum of the new chemical registration review fee for one product and the old chemical registration review fee for each additional product.

You'll need to pay the full new chemical registration review fee for each active ingredient if your product contains two or more new chemical active ingredients and a different set of generic data is required for registration.

Exemptions can be a lifesaver for those applying for pesticide registration. You can request a fee exemption if your application is solely associated with an Inter-Regional Research Project Number 4 (IR-4) tolerance petition and the exemption is in the public interest.

The Agency will review your exemption request and confirm that it meets the criteria in section 33. This includes determining whether the application is solely associated with an IR-4 tolerance petition and whether the exemption is in the public interest.

Some applications are automatically exempt from registration service fees. For example, applications from federal and state government agencies are exempt.

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If you're part of a federal or state government agency, you'll need to establish that you qualify as a state agency under applicable state law. The Agency will generally defer to the opinion of a state attorney general on matters of state law.

Here are some examples of exemptions:

Biopesticides and Pollution Prevention are key aspects of sustainable agriculture, and they can also impact fees and exemptions.

Many biopesticides are exempt from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration process, which can save farmers money on application and registration fees.

Biopesticides are made from living organisms or their byproducts, such as bacteria, fungi, and plants, and they can be used to control pests and diseases in a more environmentally friendly way.

The use of biopesticides can also help prevent pollution by reducing the amount of chemical pesticides and fertilizers used in agriculture.

Some biopesticides, like those containing Bacillus thuringiensis (Bt), are even registered as exempt from FIFRA registration due to their low toxicity and short persistence in the environment.

Biopesticides can be used in a variety of ways, including as sprays, granules, and seed treatments, and they can be applied to a range of crops, including fruits, vegetables, and grains.

The Environmental Protection Agency (EPA) has established a voluntary program for biopesticides, which allows manufacturers to self-certify their products as safe for use.

Annual maintenance fees are a crucial part of the EPA's pesticide registration process. These fees are due annually for section 3 and section 24(c) registrations, and the amount is determined by projected product numbers.

The EPA collects $27.8 million in maintenance fees each year for the five-year period of PRIA 3 (FY'13 – FY'17). If you're a registrant, you can expect to receive a mailing in November with instructions on how to submit the fee, which is due by January 15.

If you're eligible, you can request a fee waiver for individual products, but there are specific criteria to meet: you must have 500 or fewer employees globally, average annual gross revenue from all sources that do not exceed $10,000,000, and hold a total of 5 or fewer registrations subject to the maintenance fee.

Here are the specific criteria for requesting a fee waiver for individual products:

Additionally, there are maintenance fee waivers for products that meet specific criteria in two categories: minor agricultural use products and public health pesticides.

Annual pesticide registration maintenance fees are a thing, and they're due by January 15th. The amount of the fee varies from year to year, but it's based on the number of products you have registered.

You'll be contacted by mail in November with instructions on how to submit the fee. If you don't pay by the deadline, you won't be able to get an extension.

To qualify for a reduced maintenance fee, you need to meet certain criteria. You must have 500 or fewer employees globally, average annual gross revenue from all sources that don't exceed $10,000,000, and hold a total of 5 or fewer registrations subject to the maintenance fee.

If you meet these conditions, your maintenance fee will be reduced by 25% for your first registration.

The Agency Action section is where things get interesting. The Pesticide Registration Improvement Act of 2003 established a new section 33 of FIFRA, creating a registration service fee system for certain pesticide applications.

This system was put into place to help the Agency manage its workload and prioritize applications. The Agency began administering the registration service fee system for covered applications received on or after March 23, 2004.

The system was designed to have a schedule of decision review times for applications covered by the service fee. This means that applicants can expect a certain timeframe for their applications to be reviewed and processed.

The Pesticide Registration Improvement Extension Act of 2012 revised FIFRA section 33, reauthorizing the service fee system through fiscal year 2017. This extension included new fees and review times for applications received during fiscal years 2013 through 2017.

As of October 1, 2015, registration service fees for covered pesticide registration applications increased by 5% rounding up to the nearest dollar. This change was made according to FIFRA section 33(b)(6)(A).

Actions that require a fee are quite specific, and it's essential to know what they are to avoid any surprises or additional costs. A fee or a waiver from paying the fee is required for certain types of actions, including new active ingredients, new uses, and new products.

Some examples of actions that require a fee include manufacturing use products (MUPs), experimental use permits (EUPs), and human study protocols. These actions require a fee, and the fee is due upon submission of the application.

Certain amendments, tolerances, inert ingredients, and combination products also require a fee. In fact, there are 189 fee categories under PRIA 3, which are grouped by type of pesticidal product and action.

Here are some specific examples of actions that require a fee:

It's also worth noting that some actions, such as re-establishing a time-limited tolerance, reviewing confirmatory data, and submitting a sub-registrant/supplemental distributor label, do not require a fee. However, these actions may still have specific requirements or guidelines that must be followed.

Applicants can submit supplementary data to supplement pending applications without incurring additional charges if the proper fee was paid with submission of the original application.

This is a great opportunity to provide additional information to support your application without breaking the bank.

Subsequent submissions of supplementary data do not constitute a change in the type of registration action requested, as long as the original fee was paid.

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Submission of supplementary data can be submitted without incurring additional charges if the proper fee was paid with the original application.

This is a great benefit for applicants who need to provide additional information to support their application.

If the original application fee was paid, subsequent submissions of supplementary data do not constitute a change in the type of registration action requested.

This means you can keep submitting data without worrying about extra fees or delays.

However, it's essential to note that supplementary data submissions must be made in a timely manner to avoid any potential issues with the review process.

To submit your application, make sure to attach documentation that the fee has been paid, which is usually an electronic acknowledgement from pay.gov.

You'll also need to attach a fee waiver request if you're eligible, which should be easy to identify and separate from the rest of the application. This request should be submitted with documentation that at least 25% of the fee has been paid.

If you don't submit evidence of fee payment, EPA will reject your application and won't process it further.

The Pesticide Registration Improvement Act of 2003, also known as PRIA, was created to establish a more predictable evaluation process for affected pesticide decisions. This amendment to FIFRA introduced a registration service fee system for applications for specific pesticide registration, amended registration, and associated tolerance actions.

The registration service fee system was designed to couple the collection of individual fees with specific decision review periods. This means that each category of application corresponds to a certain registration service fee and decision review period.

The fees and decision review periods may change between fiscal years and fees are periodically increased as prescribed by statute. This means that applicants should always check the most recent fee schedule before paying a fee.

The Pesticide Registration Improvement Extension Act, or PRIA 3, reauthorized the registration service fee system until September 30, 2019. However, the decision times or timeframe for making a decision under the system do not apply to applications received after September 30, 2017.

Here's a breakdown of the fee categories and decision review periods:

Applicants should refer to the most recent fee schedule available on the PRIA 3 Web page prior to paying a fee. Changes in policy and process may also occur, so it's essential to stay up-to-date with the latest information.