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Pesticide Registration Manual:
Chapter 10 - Data Compensation Requirements

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Current as of July 2010

In this Chapter:


Introduction

This chapter describes the information that an applicant must submit with the application for registration, amended registration, reregistration or registration review to comply with the provisions of FIFRA section 3(c)(1)(F). This chapter also describes the procedures by which data submitters may challenge registration actions that allegedly failed to comply with these procedures. Addressing data compensation obligations is a critical part of the registration and reregistration processes. If the Agency determines that an applicant has failed to comply with the requirements in FIFRA and its implementing regulations, the application may be denied or a registration previously issued may be canceled.

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FIFRA Provisions Relating to Data Compensation Obligations

A substantial amount of scientific data and information are required to support the registration of a pesticide. These data and information can be very costly to the data submitter. To protect the interests of data submitters, Congress included provisions in FIFRA that provide data submitters certain rights to the data they submit to EPA. In particular, FIFRA section 3(c)(1)(F) (PDF) provides for both “exclusive-use” and compensation rights in data submitted to EPA to support registration actions.

“Exclusive-use” treatment for data means that the data may not be relied upon by other applicants or registrants to support FIFRA registration and reregistration actions without the permission of the data submitter. As a general matter, exclusive-use protections apply to those data that are submitted to support the initial registration of a product containing a new active ingredient. A 10-year period of protection for such data begins from the date of the original registration of the pesticide. This 10-year period of protection also extends to data submitted solely to support the addition of any new use to that registration during the 10-year period (note that such new use data are entitled to exclusive-use treatment only for the balance of the 10-year period remaining following addition of the new use to the registration).

While exclusive-use rights apply to data submitted to EPA in support of the first registration of a pesticide, “compensation” rights extend to all data necessary to support or maintain a registration or that are necessary to support of an experimental use permit. Applicants and registrants may not rely on data that retain compensation rights to support registration or reregistration unless they have first offered the data submitter compensation for the use of such data. Section 3(c)(1)(F) provides for a 15-year period of protection for such data following the date of submission of that data to the Agency. There is a more detailed discussion below describing how the Agency protects data rights.

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Expansion of Exclusive-Use Rights by FQPA

The Food Quality Protection Act (FQPA) of 1996 amended the data protection rights section of FIFRA by expanding exclusive-use rights. Under FIFRA section 3(c)(1)(F)(ii) (PDF), the Agency may extend the 10-year period of exclusivity for a period of up to three years by the addition of new minor uses to the original registration (three minor uses required for each additional year of exclusive-use protection). The new minor uses must have been registered within seven years of the date the original registration was granted to qualify and they must also meet at least one of the statutory criteria (e.g., there are insufficient efficacious alternatives registered).

It is the registrants’ responsibility to request the extension. Registrants must also provide information to the Agency explaining how they meet the applicable statutory criteria in order for EPA to determine whether the registration is entitled to the extension of exclusive-use protection rights. Read more about expanding exclusive-use rights (PDF) (15 pp, 133k).

FQPA also amended the FIFRA data protection provisions by adding section 3(c)(1)(F)(vi) that provides the Agency with the authority to afford exclusive-use protection to data submitted by an applicant, or by a registrant to support an amendment adding a new minor use to an existing registration that does not retain any period of exclusive use. The data associated with the new minor use are entitled to 10 years of exclusive-use protection from the date the data are submitted if the data relate solely to a new minor use. In order to obtain the exclusive-use protection, the applicant or registrant must at the time the new use is requested notify the Agency that to the best of its knowledge the exclusive-use period for the pesticide has expired and that the data pertaining solely to the minor use of a pesticide are eligible for the protection under this section of FIFRA.

Important Notes: The registrant or applicant must request the exclusive-use protection of section 3(c)(1)(F)(vi) at the time they request the amendment for the new minor use.

Under 3(c)(1)(F)(ii), as appropriate, EPA shall modify or terminate the exclusive-use period if the registrant voluntarily cancels the product or deletes from the registration the minor uses that formed the basis for the extension of exclusive use, or if EPA determines that the registrant is not actually marketing the product for such minor uses.

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Complying with Data Compensation Procedures

As stated in 40 CFR 152.81(a) (PDF) (2 pp, 149.19 k About PDF) , data compensation procedures apply to each application for:

However, (a) is limited by 40 CFR 152.81(b) in that data compensation procedures do not apply to the following types of applications (40 CFR 152.81 (PDF) (2 pp, 149.19 k About PDF) ):

Methods for Complying with the Data Compensation Requirements of FIFRA Section 3(c)(1)(F)

In order for the Agency to evaluate an application for registration or to amend a registered product, the applicant generally must either submit its own data or cite to data previously submitted by it or others that cover the required data to support the application or amendment. 40 CFR 152.80‑99(PDF) (1 pp, 132.00 k About PDF) and 152.116‑119(PDF) (1 pp, 143.39 k About PDF) provide detailed information on how to comply with the data compensation provisions of FIFRA section 3(c)(1)(F).

The methods for complying with data requirements may be addressed in one of two ways and are discussed in detail in this chapter:

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Categories of Data

FIFRA section 3(c)(1)(F) establishes three categories of data and the regulations and legislative history provide further information on each:

As described above, FIFRA sections 3(c)(1)(F)(ii) and (vi) provide for extensions of the 10-year period and establish exclusive-use protection for certain minor use data where the data no longer retain exclusive-use protection, respectively.

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The Cite-All Method of Support

Applicants may comply with the data compensation requirements under the cite‑all method (40 CFR 152.86 (PDF) (2 pp, 146.35 k About PDF) and 40 CFR 152.95 (PDF) (2 pp, 146.10 k About PDF) ) for an application to register a new product or to amend or reregister a product by:

Information to be submitted if an applicant chooses the cite-all method of support:

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The Selective Method of Support

Applicants may comply with the data compensation requirements under the selective method by listing the specific data requirements that apply to their product (its active ingredients and/or use patterns) and by demonstrating compliance with the data requirements by either submitting the actual studies, citing individual studies, or by demonstrating that no study has been previously submitted to the Agency (a data gap). The selective method also allows an applicant to “cite all” data in the Agency’s files to satisfy specific data requirements. This is known as the “cite-all” option under the selective method. Please refer to 40 CFR 152.90 (PDF) (2 pp, 146.17 k About PDF) for a detailed discussion of the selective method.

Important Note:The Data Gap option is not available to certain applicants, i.e., those seeking the registration of a product containing a new active ingredient or those seeking to add a new use pattern to a registered product. Please refer to 40 CFR 152.96 (PDF) (2 pp, 146.17 k About PDF) for additional information on documentation of a data gap.

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Data Compensation Charges/Payment Disputes

FIFRA sections 3(c)(1)(F)(iii) and 3(c)(2)(B)(iii) state that the terms and amount of compensation may be fixed by agreement between the original data submitter and the applicant or, failing such agreement, by binding arbitration under the procedure and rules of the Mediation and Conciliation Service. EPA is not involved with such disputes or the procedures for arbitration. The arbitrator is to be appointed from the roster of arbitrators maintained by such Service.

The findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator. All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. Please refer to 29 CFR Part 1440 (PDF) (2 pp, 147.13 k About PDF) for details on the arbitration procedures.

Petitions to Cancel Registration

40 CFR 152.99 (PDF) (2 pp, 146.19 k About PDF) describes the procedures by which data submitters may challenge registration actions that allegedly failed to comply with FIFRA section 3(c)(1)(F).

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Questions and Answers

The following questions reflect those most frequently asked inquiries regarding data compensation procedures:

  1. What data compensation information does the Agency require for a product or an amendment under the Cite‑All Method of Support?

    The Agency requires a completed and signed Certification With Respect to Citation of Data (EPA Form 8570‑34 (PDF) (1 pg, 58k)) including a completed list of companies sent offers of compensation. Data Matrix (EPA Form 8570-35 (PDF) (3 pp, 90k)) should be used for this purpose. The PRIA Web page provides information on the contents of an application. Information on exclusive use and data rights extensions can be found on the minor use Web page.

  2. What are the data compensation requirements when submitting an application for an amendment to the registration of a product, when the Selective Method of Support is selected?

    If an applicant wishes to use the Selective Method of Support, the Agency requires a completed and signed Certification With Respect to Citation of Data (EPA Form 8570‑34) and a Data Matrix (EPA Form 8570-35 (PDF) (3 pp, 90k)) with appropriate information showing how each data requirement is to be satisfied for the amendment, taking into consideration the most up‑to‑date information, i.e., the data tables and bibliography in the most recent Registration Standard or Reregistration Eligibility Document (if any) and the data requirements in 40 CFR Part 158 and for antimicrobials, 40 CFR 161. The PRIA Web page provides information on the contents of an application.

    If a data matrix previously submitted in support of the product's initial registration or amendment is still valid, and no additional data are required, an applicant may reference that data matrix in support of its current applications for amended registration. If additional data are required to support their current amendment requests, then an updated data matrix must be submitted.

  3. Does an applicant requesting a registration for 100% repackaging of a registered technical grade, manufacturing-use or end-use product qualify for a formulators’ exemption?

    Yes, within the limits prescribed in 3(c)(2)(D) and 40 CFR 152.85 (PDF) (1 pp, 143.27 k About PDF). Other than the formulators’ exemption form, no other data compensation form needs to be submitted to EPA. Under 40 CFR 152.116 (PDF) (1 pp, 143.39 k About PDF), if the registered product to be repackaged has exclusive-use data associated with it, OPP will send a Notice of Intent to register the product to the original data submitter(s).

  4. When submitting an application for an amendment to the registration of a product, and data are required to support the proposed amendment, does an applicant have to once again offer to pay compensation for all of the data necessary to support the amendment?

    Yes. The entire product is subject to the data compensation provisions, including any amendment. There are several reasons for this requirement:

    • either generic data or product-specific data may have been submitted to the Agency to fill data gaps since the first offer to pay compensation was made with the initial application for registration or amendment; and

    • some of the data initially used to support the registration may have been determined to be unacceptable and may have been replaced. As a result, if additional data are required to support the proposed amendment to the registration, the entire product including the proposed amendment is subject to the data compensation requirements of section 3(c)(1)(F) of FIFRA.

  5. If an applicant obtains a letter from a company on the Data Submitters List indicating that the company does not want any compensation for its data, may the applicant use this letter to demonstrate that the company has granted permission to use its data? What is necessary to comply with the permission required for the use of exclusive-use data?

    The contents of a letter of authorization are described in 40 CFR 152.93(b)(1) (PDF) (2 pp, 145.95 k About PDF) . Only in the case of exclusive use is explicit permission required. Otherwise, if the applicant goes through the proper data compensation procedures, permission from the data submitter is not required.

  6. If an applicant has a letter from a data submitter in its files granting the applicant permission to use the data submitter's data, can the applicant use the letter to support its application without getting new authorization to use the same data?

    EPA will allow an applicant to use such a letter to certify that it has received written permission from the data submitter to cite its data, provided the letter of authorization is sufficiently clear that it extends to the use of the data to support the action in question.

    The Agency will honor the terms and conditions of an original letter of authorization to cite data and will not accept a letter withdrawing that authorization unless both the original data submitter and the applicant relying on the data submitter's data agree that such authorization has been withdrawn.

  7. If an applicant has a product that contains multiple active ingredients, some of which are purchased from registered sources and others that are not, can they claim a formulators’ exemption for those active ingredients that are purchased from a registered source?

    Yes, within the limits prescribed in 3(c)(2)(D) and 40 CFR 152.85, EPA will allow the formulators’ exemption for the registered active ingredients if the use patterns on the applicant’s label are supported by the applicant’s registered source. Applicants should submit a properly completed Formulator's Exemption Statement (EPA Form 8570‑27(PDF) (2 pp, 104k)).

  8. If the Cite‑All Method of Support is used, does the applicant also have to submit a list of data requirements and references?

    The cite-all method does not require an accompanying list of data requirements such as that required for the selective method; however, the Data Matrix (EPA Form 8570-35 (PDF) (3 pp, 90k)) must be submitted under the cite‑all method to indicate the companies to whom offers of compensation were made.

  9. What is the specific timeframe by which a data submitter must respond to an applicant’s offer to pay for data compensation, and if a data submitter does not respond, is the applicant still liable to pay for data compensation?

    FIFRA and the regulations in 40 CFR Part 152, Subpart D (PDF) (1 pp, 132.00 k About PDF) do not require a data submitter to respond to offers within a specific timeframe to preserve data compensation rights. A data submitter may seek compensation at any time. Generally, the offer is made and negotiation commences shortly thereafter concerning the amount of compensation and the timing of payment.

  10. If an applicant writes to a company on the Data Submitters' List via certified mail and the letter is returned with an indication that the data submitter's company cannot be located, what else is required to find the company?

    If the applicant has obtained a certified or registered mail statement that there is no known address for the data submitter’s company, then the applicant has made a reasonable effort to notify that company. Of course, the applicant may pursue the matter further if so desired. Under these circumstances, the applicant should indicate in the application the actions undertaken to locate the data submitter. This documentation would be especially useful should a data submitter wish to challenge a registration in the future based on the applicant’s failure to make an offer of compensation.

  11. If eligible for the formulators’ exemption, does an applicant have to submit anything else in addition to the Formulator's Exemption Statement (EPA Form 8570‑ 27 (PDF)) (2 pp, 104k)) and the Confidential Statement of Formula (EPA Form 8570‑4 (PDF)) (2 pp, 1.1 MB)?

    Unless the product is a 100% repack, i.e., the registered product purchased from another producer has only been repackaged or placed in a different container with no changes to the formulation, an applicant must submit information required for either the Selective or the Cite All Method of Support in addition to submitting the Formulator’s Exemption Statement and Confidential Statement of Formula.

  12. Do applicants have to get permission from, or make an offer to pay, the person whose study appears in the public literature in order to cite that literature?

    No, there is no such requirement. Under 40 CFR 152.94(b) (PDF) (1 pp, 143.15 k About PDF) , submission of a public literature study or government-generated study does not confer any rights on the data submitter to exclusive use of data or compensation.

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Contacts for Additional Information

For assistance concerning the data compensation procedures, please contact the appropriate Branch for your pesticide product. Refer to Chapter 21.

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References Cited in Chapter 10

Refer to Chapter 19 for information on the sources of these documents.

Code of Federal Regulation, Title 40

Federal Insecticide, Fungicide, and Rodenticide Act (PDF), as amended by the Food Quality Protection Act of August 3, 1996

PR Notices

Data Submitters List

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