![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Conditional Registration
EPA STATEMENT, March 28, 2013
Consistent with federal pesticide laws, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA), EPA registers pesticides only upon completion of a rigorous evaluation of required scientific information to ensure the product is safe for use. Due to EPA’s regulatory authority, a pesticide never enters the marketplace without testing to ensure safety for both human health and the environment. After determining that a pesticide’s use is safe, EPA allows expanded uses through the conditional registration authority only if there are sufficient data to ensure that human health and the environment are protected.
Background
In 2012, EPA completed an analysis of pesticides that were listed as conditional registrations and concluded that the new data confirmed our initial findings that the pesticides were safe. Over 90 percent of the conditionally registered products involve pesticides that are identical to pesticides already in the marketplace, or they differed only in ways that would not significantly increase the risk of unreasonable adverse effects.
Further, 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.
EPA also acknowledges that many of the pesticide products in our data system are incorrectly identified as conditional registrations and should have been identified as non-conditional registrations. But, it’s important to note that the Agency’s review showed that the misidentified products were legally approved and that they met all applicable safety standards. EPA is implementing a plan to correct these record keeping errors.
May 10, 2012
The Office of Pesticide Programs (OPP) initiated and recently completed an internal review of the use of conditional registrations. The review looked at the variability in the use of the term "conditional registration" in the program, how the internal computer coding associated with conditional registrations has been applied, the status of actions that have been characterized as conditional registrations, and the potential for improvements and clarifications.
Conditional registrations are intended to allow market entry for a product in the absence of certain data where the Agency can make appropriate findings. Those findings include a determination that granting the application will not cause unreasonable adverse effects on the environment and on the condition that the missing data will be provided in a timely manner.
On This Page:
- Conditional Registration
- Related Regulatory Authority
- Issues with Tracking Conditional Registrations
- Evaluating the Role of Conditional Registrations
Conditional Registration
Section 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the conditional registration of a pesticide in certain circumstances where the Agency determines that some necessary data are missing, but the Agency can still make the required findings to support registration under the various scenarios set forth in that section. The following are the statutorily permissible situations for the use of a conditional registration:
- Identical/Substantially Similar (Formerly 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:
- it possesses all data necessary to make the determinations required by FIFRA section 3(c)(7)(A) with respect to the pesticide product that is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application);
- the pesticide and proposed uses are identical or substantially similar to any currently registered pesticide and its uses, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment (See 40 CFR 152.113(b)); and
- approving the registration or amendment in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment (40 CFR 152.113(a)(2)).
- New Uses: 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 the unconditional registration, if the Agency determines that:
- the applicant has submitted satisfactory data pertaining to the proposed additional use,
- amending the registration would not significantly increase the risk of any unreasonable adverse effect on the environment, and
- 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), if the Agency determines that:
- insufficient time has elapsed since the imposition of the data requirement for those data to be developed, on the condition that when the Agency receives such data that they do not meet or exceed risk criteria stated in the regulations issued under FIFRA and other conditions issued by the Agency;
- the use of the pesticide during such period will not cause any unreasonable risk to the environment; and
- the use of the pesticide is in the public interest.
Each registrant must submit or cite the same data that would be required for unconditional registration of a similar product under FIFRA section 3(c)(5).
These data must be submitted or cited no later than the time the data are required to be submitted for similar pesticide product(s) already registered. If a notice requiring these data has been issued under FIFRA section 3(c)(2)(B) before the application has been approved, the applicant must submit or cite those data at the time specified in the notice.
Each registrant must submit or cite the same data that would be required for unconditional registration of a similar product under FIFRA section 3(c)(5).
For full statutory language see:
http://www.law.cornell.edu/uscode/html/uscode07/usc_sec_07_00000136---a000-.html
Related Regulatory Authority
While Section 3(c)(7) authorizes a narrow set of actions, FIFRA provides EPA with broad authority to establish or modify data needs and timing for individual pesticide registration actions to achieve statutory and program objectives. Data requirements for pesticide registration actions are found in the Code of Federal Regulations (CFR) at 40 CFR Parts 158 and 161. These regulations provide the Agency with substantial discretion to make registration decisions on the basis of what the Agency determines to be the most relevant and important data for that particular action.
Issues with Tracking Conditional Registrations
The pesticide program has two systems which track conditional registrations and associated data requirements. For the Registration Review process, OPP utilizes the PRISM Registration Review module which provides comprehensive tracking of data requirements that are a result of a Data Call-In (a data call in is an order issued to a pesticide registrant or registrants which requires the submission of scientific data within a specified time frame). The OPPIN system is used to track basic information about conditional registrations which require additional data submissions (see New Active Ingredients above). The OPPIN system is an older system and is not as robust in its features, but it is supplemented by detailed paper records for each registered product. The OPPIN system, does not have the ability to automate the tracking of deadlines for conditional registrations. When data is submitted, that data is logged into OPPIN and tracked through the review process. The Agency is planning to improve the features for tracking conditional registrations in OPPIN or in a replacement system in the near future.
Evaluating Program Use of Conditional Registrations
To evaluate the role of conditional registrations, OPP gathered extensive data on the historic use of such actions. The review was intended to collect information, determine if the use of the same term was creating confusion and if any clarifying actions were needed.
In operating the pesticide program, OPP has used the term “conditional registration” to describe a variety of actions in a number of contexts. Conditional registrations have been used to register pesticides containing new active ingredients where new data requirements have recently been established. Consistent with the Section 3(c)(7) statutory provisions, conditional registrations have also been used to permit additional uses of a registered pesticide where satisfactory data has been submitted to support making a safety finding, but some additional data would provide more confidence in the assessment and confirm the decision.
A number of other actions have also been labeled as conditional registrations. Many are cases where product-specific formulation data has been requested. Other situations described as conditional registrations are where approval of an application for registration contingent upon the applicant accepting certain label changes (e.g., precautionary statement upgrades). These actions typically follow the Agency determination that the pesticide or new use meets the statutory safety standard.
The Findings
The OPP review indicates that the program has used the term “conditional registration” to cover actions intended by Section 3(c)(7) of FIFRA and other activities beyond that narrow scope. While the latter activities, such as requiring label changes, are legitimate program actions, OPP has been imprecise in describing the appropriate regulatory basis. Most of these program actions were taken pursuant to the authority of 40 CFR Parts 158 and 161 and should have been so identified.
OPP’s assessment found that these Part 158/161 transactions constitute almost 95% of the registration decisions described as conditional registrations in the OPPIN data base. In the future, such actions will be differently and more accurately identified to eliminate potential confusion with the actions that meet the Section 3(c)(7) conditional registration criteria.
The OPPIN data system provides the following information on registrations and registration actions. As of September 2010, there were 16,156 active Section 3 registrations. Of these:
- 3,928 were identified as unconditionally registered,
- 11,205 were identified as conditionally registered,
- 1,023 with other identifications.
OPPIN records historic information on the approximately 90,000 distinct registration decisions for currently registered Section 3 products. Over time, there can be multiple decisions for a single Section 3 registration. These records provide data to distinguish among different actions that have been labeled as conditional registrations in the system. The review determined that among these actions,
- There are 65,000 registration decisions classified as unconditional.
- There are 25,421 registration decisions classified as conditional for the 11,205 Section (c)(7)(B) and (C) conditionally registered products:
- 1,408 are related to new active ingredients and new uses, and
- 24,013 are related to other actions (product formulation data, label amendments, “me-too” registrations, etc.).
Therefore, only about two percent of the registration decisions identified in OPPIN as conditional registrations are actions within the statutory scope of FIFRA Section 3(c)(7)(B) and (C). The overwhelming majority of actions identified in the data systems as conditional registrations are non-Section 3(c)(7) program actions. This indicates that, as statutorily intended, the authority for conditional registrations for registering new uses or new ingredients has been used in narrow circumstances.
OPP also investigated whether the data submission conditions on conditional registrations were satisfied in a timely manner; whether the data were in turn reviewed by OPP in a timely manner; and, whether the review led to changes to the terms of registration. To have a manageable universe, OPP targeted the analysis on the data submittals required to comply with the 544 Section 3(c)(7)(B) and (C) conditional registrations for new active ingredients and new uses since the Pesticide Registration Improvement Act (March, 2004). This subgroup represents recent, and likely the most important, actions relative to assessments of potential risk. For those 544 conditional registrations:
- Registrants had submitted data for 533 actions.
- Of those submissions, the conditional data had been reviewed by the Agency for 523 actions.
- For this universe, it appears OPP has not altered previous regulatory decisions based upon the data submitted to satisfy the conditional registration.
For 96% of this universe, all actions intended by the conditional registration have been completed in a timely fashion. In addition, OPP’s review of the data submitted for these conditional registrations has not justified a change in either the initial risk assessments or the risk management label conditions.
We do not have similar status data for the other conditional registrations and related actions. However, as with those actions we analyzed, there are reasons that the conditions for most of those conditions have likely been satisfied as a result of routine program operations that constitute a quality assurance check:
- Good faith submissions by the registrants and routine OPP followup on the submissions.
- Targeted followup initiated by individual product managers and divisions.
- In some cases, states, as part of their registration process, have prompted registrant action to satisfy conditional registration requirements.
- For pesticides covered by the reregistration program, those proceedings should have required satisfaction of the conditional registration terms. For those still in the product reregistration queue, OPP actions will require satisfaction soon.
- Subsequent registrant-initiated actions (e.g., label amendments) will have triggered conditional registration completion activities for other registrants.
Improving the Use and Tracking of Conditional Registrations
Based upon this analysis, OPP will take steps to improve the use, tracking and description of Section 3(c)(7) conditional registrations and similar actions. This will promote consistency, enhance transparency and create better understanding of the role of Section 3(c)(7) conditional registrations and related actions in the national pesticide program.
Use of Conditional Registrations. OPP will provide staff training on the appropriate characterization of Section 3(c)(7) conditional registrations and related actions to provide internal and external clarification on the basis for Agency actions and eliminate potential confusion.
Based upon the small number of conditional registrations that have necessitated modifications in risk assessments and label requirements, the Agency will explore reducing the use of Section 3(c)(7) conditional registrations.
Information Technology Systems. OPP is in the process of replacing the OPPIN data system. As the new system is designed, the upgrades will include tools to improve the identification, tracking, reporting and program management of conditional registrations.
Since the analysis determined that most of the conditional registration status characterizations in OPPIN are out of date and inaccurate, we are taking several steps to ensure the information in OPPIN is not misleading:
- removing the conditional status classifications from the system for those registrations identified as not being new active ingredient or new use registrations;
- having the current system allow conditional registration classification only for new active ingredients/new use products;
- classifying “other” registration actions that include additional actions on the part of the registrant to “registered with comments;”
- ensuring future system developments include the ability to accurately track conditional registrations; and
- conducting quarterly OPP meetings to review the status of conditional registration actions.