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What is the Conventional Reduced Risk Pesticide Program?
Reduced Risk Program Coordinator
Stephen Schaible
- Application Procedures
- Streamline Procedures for New Uses on Active Ingredients Already Granted Reduced Risk or Organophosphate (OP) Replacement Status
The Office of Pesticide Program's Conventional Reduced Risk Pesticide Program expedites the review and regulatory decision-making process of conventional pesticides that pose less risk to human health and the environment than existing conventional alternatives. The goal of this program is to quickly register commercially viable alternatives to riskier conventional pesticides such as neurotoxins, carcinogens, reproductive and developmental toxicants, and groundwater contaminants. This ensures that these Reduced Risk pesticide uses get into the marketplace and are available to growers as soon as possible. Expected participants in this program are the chemical companies and state or Federal agencies that submit to the Agency initial registration and amended registration applications for pesticide products. The Food Quality Protection Act of 1996 (FQPA) formalized the program and mandated that the Agency continue and enhance it.
This program does not apply to biological or antimicrobial pesticides which are handled through separate expediting processes.
An Important Distinction to Note: While most Reduced Risk discussions refer to conventional Reduced Risk pesticides, a Reduced Risk decision is actually made at the use level, for a pesticide/use combination. The Reduced Risk decision is based on comparison between the proposed use of the pesticide and existing alternatives currently registered on that use site. Registered pesticide alternatives may differ depending on the use in question, thus risk comparisons across uses may also differ.
What are the Advantages of Conventional Reduced Risk
Pesticides Over Existing Conventional Pesticides?
Which Chemicals/Uses have Received Reduced Risk and/or Organophosphate (OP) Alternative Status?
Why Should I Apply for Reduced Risk Status?
How Do I Apply for Reduced Risk Status?
Can I Apply for the Streamlined Procedure for New Uses of Active Ingredients
Already Granted Conventional Reduced Risk Pesticide or OP Replacement Status?
What are the Advantages of Conventional Reduced Risk Pesticides Over Existing Conventional Pesticides?
- low impact on human health
- lower toxicity to non-target organisms (birds, fish, plants)
- low potential for groundwater contamination
- low use rates
- low pest resistance potential
- compatibility with Integrated Pest Management (IPM) practices
Which Chemicals/Uses have Received Reduced Risk and/or Organophosphate (OP) Alternative Status?
For a list of registered chemical/use combinations which have received Reduced Risk or OP Alternative Status since the inception of the Conventional Reduced Risk Pesticide Program, refer to the List of Reduced Risk/Organophosphate Alternative Registration Decisions for Conventional Pesticides (78KB, 12pp., PDF). This table is updated as Reduced Risk or “OP Alternative” pesticide products are registered by the Agency.
Alternatives to Organophosphate Pesticides - Organophosphates (OPs) are a group of closely related pesticides used in agriculture and non-agricultural sites that affect functioning of the nervous system. They are among the Agency's first priority group of pesticides to be reviewed under the Food Quality Protection Act. The Agency, in PR Notice 98-7, made alternatives to organophosphate (OP) pesticides a priority for review and regulatory decision-making. The conventional Reduced Risk pesticide Program screens OP alternatives for this initiative. Unlike Reduced Risk status, expedited decision timeframes for OP alternatives are not specifically described in the Pesticide Registration Improvement Act (PRIA). However, these actions remain a priority and the Agency will continue to seek expedited introduction to the marketplace while still meeting its registration obligations under PRIA.
Why Should I Apply for Reduced Risk Status?
The following are advantages to receiving Reduced Risk Status for you registration action:- Expedited decision timeframe under the (PRIA)
- Expedited decision timeframe under the NAFTA Joint Review process
- Opportunity for expedited establishment of maximum residue limits (MRLs) by the Codex Alimentarius Commission
- Marketing advantage: although companies are not allowed to put a Reduced Risk pesticide claim on their labels, EPA believes that companies use the conventional Reduced Risk pesticide status to their marketing advantage
- End users of treated crops give preference to crops treated with Reduced Risk pesticide products
- State Agency level advantages:
- NY State reporting requirements waived for Reduced Risk uses
- Expedited decision timeframe by California Department of Pesticide Registration for Reduced Risk uses
How Do I Apply for Reduced Risk Status?
The information below provides guidance to registrants interested in participating in the Conventional Reduced Risk Pesticide Program.
What information should I include in my Reduced Risk rationale?
Guidance for preparing your conventional Reduced Risk pesticide or OP alternative status rationale is provided in PR Notices 97-3 , Part VII, and 98-7, respectively. In short, your request should fully address the following areas:
- executive summary of your chemical
- human health effects
- environmental fate and effects
- other hazards
- pest resistance and management (e.g., Integrated Pest Management)
- risk comparisons to registered alternatives
- comparative performance
If you have received Reduced Risk status for labeled use(s) of your active ingredient in the past, you may wish to explore whether you qualify for streamlined processing of your application.
Where do I submit my Reduced Risk request, and how many copies should I provide?
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For prompt processing, please contact the Reduced Risk Program Coordinator, Steve Schaible at (703)308-9362, prior to sending copies of the rationales. Also let your product manager know that you are applying for conventional Reduced Risk pesticide status.
Because the PRIA code assigned to your registration application is dependent on whether or not you are pursuing Reduced Risk status, please submit your Reduced Risk rationale with the Section 3 application and clearly indicate in your cover letter that you are requesting Reduced Risk status for the registration action. The Agency will not entertain conventional Reduced Risk pesticide or OP alternative status requests prior to receiving a complete Section 3 application.
What are the next steps in the process once I have submitted my request?
The Reduced Risk Committee meeting is normally scheduled for approximately one month from receipt of your request, and the Agency’s decision occurs at the conclusion of that meeting. For new chemical Reduced Risk use submissions and first food use submissions of previously registered chemicals, it will take longer as the Committee meeting date will not be scheduled until after the Agency's science screens for data completeness have been completed. You should receive a call with information on your conventional Reduced Risk pesticide meeting date within one to two weeks of your submission. If you have not been contacted within this time, please contact Steve Schaible at (schaible.stephen@epa.gov) or (703)308-9362. In most cases your company will be invited to attend the conventional Reduced Risk pesticide meeting. Exceptions to this may include submissions of new uses for active ingredients already granted conventional Reduced Risk pesticide or OP replacement status and rebuttals of previous decisions.
How is the Reduced Risk Committee meeting structured?
The structure of the Reduced Risk Committee meeting is as follows:
- 10-15 summary presentation of Reduced Risk argument by the registrant
- Questions from the Committee members for your company's technical representatives. The primary purpose of the meeting is to clarify or resolve any outstanding issues with your company's request for Reduced Risk status.
- Internal Committee deliberation
- Committee vote on Reduced Risk status at the conclusion of the meeting
- Registrant informed of Committee’s decision at the conclusion of the meeting
Do I have an opportunity to rebut the Agency's decision if I am denied Reduced Risk status?
If the Agency denies your Reduced Risk request, you have 30 days from receipt of the Agency’s letter documenting the decision to submit a written rebuttal to the decision addressing the concerns conveyed in the Agency’s letter. The rebuttal should be delivered by mail or courier to Steve Schaible, using the appropriate address listed above. The Committee will consider the additional information and convene to reevaluate the Reduced Risk decision based on the additional information or arguments provided.Can I Apply for Streamlined Procedure for New Uses of Active Ingredients Already Granted Conventional Reduced Risk Pesticide or OP Replacement Status?
If you have received Reduced Risk status for use(s) of a pesticide in the past and you are requesting Reduced Risk status for new uses of that same pesticide, the Agency offers a streamlined process for review of the request. This streamlined process assumes that the current submission does not present any issues that would require complex deliberation by the Reduced Risk Committee. Typically, a meeting of the committee will not be required and the Agency will have a Reduced Risk decision no more that 30 days after the receipt of the Reduced Risk rationale.
The Agency will accept these new uses of active ingredients already granted Reduced Risk in an abbreviated submission format. The format of the request should be similar to that of an expanded executive summary with supporting tabular information. For instruction on where to send your submission and how many copies to provide, refer to Application Procedures.
Examples of situations where this streamlined approach may not be appropriate include the following:- requested use(s) significantly change the risk picture for the chemical (e.g. use(s) are the first food uses, first outdoor uses, etc.)
- previous Reduced Risk determination involved complex and difficult-to-resolve issues
- new information about the chemical requires significant analysis
- risk comparison to alternatives for requested use(s) not as clear cut as original submission which received Reduced Risk determination
- insufficient information in the rationale for the Committee to make a decision.
In such cases the Committee would require that the requestor submit a more detailed rationale and/or meet with the Committee as part of a formal conventional Reduced Risk pesticide meeting. If you choose to submit a Reduced Risk rationale using the streamlined approach, the request should include:
- Proposed use sites, and pests to be controlled for those use sites.
- A summary of the major reduced risk advantages the product offers from proposed uses and the major reasons why these uses qualify for conventional Reduced Risk pesticide status.
- A discussion of how the overall risk picture will change with the addition of these new uses (e.g. what percent of the Reference Dose is now used, how close are levels of concern (LOC's) for non target species to being exceeded, any new risk concerns, etc.).
- Any other reasons why the proposed uses are important (e.g. resistance management, limited alternatives, etc.)
- List of the major alternative pesticides in use for the above site and pest combinations. This list should include percentage of market share by dollars and acres treated and should include the major currently used products as well as up-and-coming lower risk alternatives.
- Projected market share over a five year period and from what products it will take this market share.
- Tables summarizing the toxicology, environmental effects, and environmental fate of the product in comparison to the products identified in #5 above.
- Tables summarizing application rates and comparative performance of the product to the products identified in #5 above.
- Product formulation and application method(s)
- Representative seasonal treatment program(s) for the active ingredient on the requested use sites.
- Amount reduction represented by requested use pattern as compared to typical current use programs. (Please make sure that these programs are indeed typical for major growing regions.)
- Copy of proposed label(s).
If you have questions about whether this streamlined approach is appropriate for your submission, please contact Steve Schaible at schaible.stephen@epa.gov or call (703)308-9362.