Pesticide Registration

Conditional Pesticide Registration

Under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA), EPA registers pesticides that are distributed and sold in the United States. EPA determines the appropriate labeling and other regulatory requirements to prevent unreasonable adverse effects on human health and the environment. This Web page specifically addresses conditional pesticide registrations that are issued under FIFRA section 3(c)(7). 

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Introduction

FIFRA section 3(c)(5) sets the basic legal standard for granting pesticide registrations. It provides that EPA shall register a pesticide if, among other findings:

  • The pesticide will perform its intended function without unreasonable adverse effects on human health and the environment; and

  • The pesticide will not generally cause unreasonable adverse effects on human health and the environment when used in accordance with widespread and commonly recognized practice.

After reviewing the data and information submitted to support an applicant/registrant's pesticide product application under consideration, EPA determines whether the pesticide meets this statutory standard. If EPA determines that the pesticide meets the statutory standard and there are no outstanding data requirements, the Agency may approve an “unconditional” registration.

If, on the other hand, EPA finds that the pesticide meets the standard for registration, but there are outstanding data requirements, the Agency may, under certain circumstances, grant a “conditional” registration pursuant to FIFRA section 3(c)(7).

However, before granting a conditional registration, EPA must determine that, although an application lacks some of the necessary data, use of the pesticide would not significantly increase the risk of unreasonable adverse effects on the environment during the time needed to generate the necessary data.

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Conditional Registration

History

The first pesticide control law was enacted in 1910. The modern law known as FIFRA was enacted in 1947. Since that time, FIFRA has undergone many important revisions. In 1970 Congress transferred the responsibility for regulating pesticides to EPA and in 1972, Congress essentially rewrote FIFRA. Among other things, the 1972 amendments established a new standard for the registration of pesticides, which shifted the emphasis to protection of human health and the environment. In doing so, Congress gave EPA the authority to register a pesticide only if the Agency had sufficient data to show the pesticide would not cause unreasonable adverse effects on human health and the environment when used according to the use directions and restrictions provided on the pesticide product label.

After this standard was added, EPA could not register a new pesticide unless its registration application provided all the information required under then-current scientific standards. Because scientific standards evolve over time, applicants seeking registrations for new pesticide products were required to provide significantly more data than had been required in the past. This led to a paradoxical situation:

  • When considering the registration of a new product that was identical to a currently registered product, EPA was required to deny registration if the data requirements had evolved to require additional information that was not required from the original applicant.;
  • The grounds for this denial were that EPA lacked the data necessary to conclude that the new product met the “unreasonable adverse effects” on human health and the environment standard, even though the identical product was still allowed to be sold and used.

To remedy this situation, in 1978, Congress amended FIFRA by adding section 3(c)(7), which gave EPA the authority to register a pesticide product “conditionally” if it was identical or substantially similar to a currently registered product, even if there were gaps in the data, as long as EPA could make the necessary statutory findings. Congress also gave EPA the authority to register products conditionally in certain other limited circumstances, i.e., to conditionally amend a registration to permit additional uses of an existing product and to conditionally register new active ingredients allowing time for the generation and submission of data necessary for registration.

The provisions of Section 3(c)(7) are discussed in more detail below.

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Overview of FIFRA Section 3(c)(7) – Authority to Grant Conditional Registrations

FIFRA Section 3(c)(7) authorizes EPA to conditionally register pesticides under certain well-defined circumstances. As with unconditional registrations, the first step in the Agency’s evaluation is to determine that a pesticide’s proposed use meets the registration standard to ensure the protection of human health and the environment.

If EPA determines the pesticide meets the standard for registration, the Agency may grant the application for registration with conditions that require the registrant to provide additional information within a specified time. If the registrant does not comply with the conditions, EPA may cancel the registration pursuant to FIFRA section 6(e). The amount of time given to a registrant to comply is usually based upon the amount of time EPA determines is necessary for the registrant to conduct a study or otherwise satisfy the missing data requirement.

The following are the limited circumstances where EPA may grant a conditional registration:

  • FIFRA Section 3(c)(7)(A) - Identical/Substantially Similar Products (generally called “me-too” products)

EPA may conditionally approve an application for registration or amended registration of a pesticide product under FIFRA section 3(c)(7)(A) if the agency determines that:

  1. the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and
  2. approving the registration or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.

Under all conditional registrations, each registrant must ultimately submit or cite the same data that would be required for the unconditional registration of a similar product under FIFRA section 3(c)(5).

The data to support the conditional registration must be submitted or cited to no later than the time the data are required to be submitted for the previously registered similar pesticide product(s). If a notice requiring these data has been issued under FIFRA section 3(c)(2)(B) before the new product’s application has been approved, the applicant must submit or cite those data at the time specified in the notice.

Since EPA is periodically requiring registrants of existing products to perform new studies to show their products continue to meet the statutory safety standards of FIFRA, and since pesticide companies frequently apply to bring new products to market, conditional registrations granted under this authority are relatively common.

  • FIFRA Section 3(c)(7)(B) - New Uses of an Existing Registered Product

EPA may conditionally amend the registration of a pesticide to permit additional uses, even if the data concerning the pesticide may be insufficient to support an unconditional registration, if the Agency determines that:

  1. the applicant has submitted satisfactory data pertaining to the proposed additional use, and
  2. amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.

Each registrant must at a later date, submit or cite the same data that would be required for the unconditional registration of a similar product under FIFRA section 3(c)(5).

  • FIFRA Section 3(c)(7)(C) - New Active Ingredients

EPA may conditionally register a pesticide containing an active ingredient not in any currently registered product for a period reasonably sufficient for the generation and submission of data necessary for registration under FIFRA section 3(c)(7)(C)(109 pp, 288 K, About PDF), if the agency determines that:

  1. insufficient time has elapsed since the imposition of the data requirement for those data to be generated and submitted;
  2. EPA receives the required data by the end of the time allowed for submission of the data, and such data do not show that the use will meet or exceed risk criteria stated in the regulations issued under FIFRA and other conditions issued by the Agency;
  3. the use of the pesticide during such period will not cause any unreasonable risk to the environment; and
  4. the use of the pesticide is in the public interest.

For full statutory text see: http://www.gpo.gov/fdsys/pkg/USCODE-2012-title7/html/USCODE-2012-title7-chap6-subchapII-sec136a.htm

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EPA Internal Reviews of Conditional Pesticide Registrations

2010 Review of Conditional Registration Decisions

In September 2010, EPA initiated an internal review of its conditional registration decisions. The internal review was intended to determine:

  • the number of conditional registrations issued;
  • whether there was consistency across and within registering divisions in the criteria for defining what qualifies for a conditional registration; and
  • the procedures and tools for tracking the registrations.

EPA completed the internal review in March 2011. Based on the results of this review, EPA identified ways it could improve its handling of conditional registrations, including a more centralized tracking system and increased consistency in conditional registration procedures.

EPA had used the term “conditional registration” imprecisely to describe a variety of registration actions in a number of contexts. This review also highlighted the limitations of EPA’s internal tracking system for conditional registrations. As a result, EPA began to implement changes to address these issues.

2012 More Detailed Analysis of Conditional Registration Decisions

In May 2012, EPA initiated a more in-depth internal analysis. EPA examined a subset of conditional product registration decisions, those involving new active ingredients issued from 2000-2010, to ascertain if the data required as part of the conditional registration had been submitted and reviewed. To ensure a thorough analysis, the program examined the paper records associated with these registrations.

This analysis showed that the vast majority of registrants had submitted the data, and EPA had completed data review. In addition, EPA confirmed that of the products for which the conditional registrations were examined, no conditional registration caused unreasonable adverse effects on the environment. Overall, the analysis of the data supported EPA’s findings at the time of the initial registration. In other words, the pesticides were properly reviewed and labeled, and the products continued to meet the statutory standards stated above.

Even though the detailed review found that EPA had at times misclassified the status of conditionally and unconditionally registered pesticides in its record-keeping, the registration decisions met the statutory standards. For example, some EPA actions such as requiring label changes were at times misclassified as conditional, when in fact there were no outstanding data needs.

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GAO’s Assessment and Report on Conditional Pesticide Registrations

In 2013, the Government Accountability Office (GAO) conducted a review of EPA’s registration program as it relates to conditional registrations and reported that the total number of conditional product registrations granted was unclear, in part due to the limitations of EPA’s databases and the Agency’s incorrect classification of some registrations as conditional. 

GAO recommended that EPA:

  • Complete plans to automate data related to conditional registrations to more readily track the status of these registrations and related registrant and Agency actions and identify potential problems requiring management attention.
     
  • Pending development of an automated data system for tracking the status of conditional registrations, develop guidance to ensure that product managers use a uniform methodology to track and document this information, including when data are submitted by registrants and reviewed by EPA, in the files maintained by each pesticide product manager.
     
  • Review and correct, as appropriate, EPA’s website on conditional registrations to ensure that the information presented is clear, concise, and accurate, including defining terms.

Read the GAO report (PDF) (56pp, 3.4MB, about PDF)

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EPA’s Efforts to Improve Information about Conditional Registration

Amendments to PRIA Regarding Conditional Registration Decision Tracking

The Pesticide Registration Improvement Extension Act (PRIA) of 2012 amended FIFRA to provide, among other things, funding to improve information systems capabilities for EPA. The amendments provide this funding to support enhancing the EPA information system capacity to track pesticide registration decisions, including the status of conditional registration decisions.

Agency Efforts to Improve Conditional Product Registrations

EPA is taking steps to improve the accuracy of information about and tracking of conditional registration decisions and amendments to registrations. These efforts are intended to promote consistency, enhance transparency and create better understanding of decision-making under FIFRA Section 3(c)(7).

This work includes the following:

  • Development and implementation of new response codes for EPA’s integrated database OPPIN (Office of Pesticide Programs Information Network), which will permit better tracking of conditional registrations and modification of OPPIN to make it easier to check the Data Call-In status for any active ingredient and formulated product. (FIFRA § 3(c)(2)(B), authorizes EPA to issue “Data Call-Ins,” or require pesticide registrants to generate and submit data to the Agency, when such data are needed to maintain an existing registration of a pesticide.)
     
  • Mandatory staff training on the appropriate use and tracking of Section 3(c)(7) conditional registration decisions. 

Tracking of Pesticides Registered Under Conditional Registration Authority

The table, Conditional Registration Status - 2000-2014, provides information regarding all pesticide active ingredients that were initially registered under the conditional registration authority in FIFRA sec. 3(c)(7)(C) from FY2000 to the present. EPA will update this table periodically.

The table contains the following information:

  • Chemical refers to the pesticide’s active ingredient.
  • Division:   identifies which of the three Divisions responsible for pesticide registration in OPP has the lead for the registration:  the Registration Division (RD); the Antimicrobial Division (AD); or the Biopesticides and Pollution Prevention Division (BPPD).
  • Registration Notice Date:  The date on which OPP issued the notice of registration for the first product containing the active ingredient.
  • Conditional Data Requirements:  The specific data requirements imposed as part of the registration.
  • Due Date:  the date the conditional data were/are due to EPA.
  • Date Received:  the date EPA received/will receive the data.
  • MRID:  Master record identification number - the number which EPA has assigned to track each submitted study.
  • Status:  indicates whether the conditions of registration have been satisfied.
  • Comments:  This column includes additional information regarding the status of these registrations.  

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