PRN 2001-XXXX Draft: Guidelines for Expedited Review of Experimental Use Permits for Conventional Pesticides

Draft Pesticide Registration Notice
Guidelines For Expedited Review Of Experimental Use Permits For Conventional Pesticides

Pesticide Registration (PR) Notice 2001-XXXX

Notice to: Manufacturers, Formulators, Producers And Registrants Of Pesticide Products

Attention: Persons Responsible for Registration of Pesticide Products

Subject: Guidelines for Expedited Review of Experimental Use Permits for Conventional Pesticides

This PR Notice provides criteria that, if met, can result in a greater number of food use Experimental Use Permits (EUPs) being issued on an expedited basis for conventional pesticides.

EUP applications submitted that meet all of the criteria identified in this Notice will be expedited through the Agency's review process and registrants will not need to utilize their priority slots.

The Agency believes that, to aid growers in their transition to new pesticides, it is important to adequately test these compounds, particularly methyl bromide alternatives, reduced-risk pesticides, and alternatives for the organophosphates (OPs). In response to requests from interested parties, the Agency has considered what conditions and criteria could be developed that would allow for more EUPs, while maintaining EPA's ability to meet the applicable safety findings under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). This analysis has resulted in the criteria discussed in this PR Notice.

This Notice is effective as of the date of issuance.

1. Applicability
2. Background On the Agency's EUP Review Process
3. Criteria for Expedited Review of EUPs For Conventional Pesticides
4. Eligible Pesticides
5. Formatting and Submittal Procedures
6. Scope Of The Policy
7. For Further Information

1. Applicability

   This Notice applies to all applicants for EUPs for non-antimicrobial, conventional pesticides. This Notice does not apply to biological pesticides because these pesticides present different risk factors and because the Agency has not heard that the lack of biological pesticide EUPs is an issue.




2. Background On The Agency's EUP Review Process

   Under Section 5 of FIFRA, Congress authorized the U.S. Environmental Protection Agency (EPA) to issue EUPs in order to allow interested parties the ability to gather sufficient information on a new pesticide or a new use of an existing pesticide to support registration under Section 3 of FIFRA. In order to allow any foods treated with the experimental pesticide to enter commerce, EPA must establish a tolerance (maximum residue level) utilizing the procedures and standards of section 408 of FFDCA, as amended by the Food Quality Protection Act of 1996 (FQPA).

   Before issuing an EUP, EPA must make several statutory findings. Under FIFRA, EPA must determine that use of the experimental product, under the conditions proposed in the EUP application, will not result in "unreasonable adverse effects" to man or the environment. If the applicant seeks to treat food under the EUP and to allow that food to enter domestic commerce, EPA must also determine, under FFDCA, that "there is a reasonable certainty of no harm" from aggregate exposures to the pesticide, including exposures resulting from use under the EUP.

   Prior to passage of FQPA, EPA issued approximately 20 EUPs and established corresponding tolerances each year. Since passage of FQPA, however, the Agency has issued at most 3 EUPs for food uses each year. Applicants have cited the Agency's priority planning system as a major reason for this decline in the number of EUPs. As described in PR Notice 97-2 Search EPA Archive, a registrant must use a priority slot before the Agency will review a new EUP application. In addition, the Agency's review times for EUPs, particularly EUPs for evaluating new active ingredients, are approximately equal to the review times for registration of these same new active ingredients. As a result, many registrants have elected to pursue full registration of these new technologies rather than to evaluate the product under field conditions with an EUP.

   Interested parties, including growers, registrants, and the Agency, realize, however, that information gathered under EUPs can be extremely useful. EUPs allow a better understanding of new and emerging pesticide technologies, prior to full market introduction, providing an opportunity to refine the product's use. The Agency gains valuable information on pesticide alternatives for higher-risk pesticides - information that can also be used to support both registration and reregistration decisions.

   In response to requests from several interested parties, the Agency evaluated whether conditions and criteria could be established that would allow for more EUPs, while maintaining the Agency's ability to meet the applicable safety findings under FIFRA and FFDCA, thereby allowing the Agency to issue the EUP and to establish tolerances for crops treated during the EUP. The Agency believes the criteria in this Notice will:

   • Meet grower needs and desire for more EUPs;
   • Allow EPA to make the necessary safety findings under FIFRA and FFDCA;
   • Minimize the impact on Agency resources; and,
   • Provide flexibility in administration.



3. Criteria For Expedited Review Of EUPs For Conventional Pesticides

   In evaluating how more EUPs could be issued, the Agency identified several issues. As described in Unit II, resources needed to evaluate a new chemical EUP are virtually equivalent to those needed to review a new chemical for registration. The resources needed to review a registered chemical that has not been evaluated under FQPA are also nearly equivalent to those needed to evaluate new active ingredient applications. Finally, EUPs for new uses utilizing significant new use patterns for a chemical impact resources allocated for other reviews.

   To minimize these resource trade-offs while ensuring that the Agency could fulfill its statutory requirements, EPA identified several criteria that, if met, could result in a greater number of food use EUPs being issued on an expedited basis. These criteria do not prevent a registrant, however, from submitting an EUP application for a chemical or new use not satisfying these criteria. However, if the registrant chooses to do so, the company must utilize one of its registration priority slots. Please note that the Agency cannot ensure that non-conforming applications can be expedited through the approval process. EUP applications submitted that meet all of the criteria identified below will be expedited through the Agency's review process and registrants will not need to utilize their priority slots.

   1. Active Ingredient Criteria (must meet each of these criteria)
      1. Methyl Bromide alternatives, reduced-risk chemicals, or OP alternatives with registered food uses; and
      2. Active ingredients registered or reregistered by EPA since October 1998; and
      3. Application methods and use rates that are similar to or present less exposure than those previously approved for other crops.
   
   
   2. Risk Criteria (must meet each of these criteria)
      1. Registered uses utilize less than 50 percent of the existing aggregate (food, water, and non-occupational) acute risk cup and less than 60 percent of the existing aggregate chronic risk cup; and
      2. Proposed EUP use utilizes less than 10 percent of either risk cup; and
      3. Limited acreage: Less than 2,000 total acres for a major use; less than 100 total acres for an aquatic or minor use; and
      4. No more than 100 acres per watershed (as defined by the US Geological Survey's 8 digit cataloging units. For more information, consult (add USGS website address).
      
      
      
      
      
      
       
      5.  
      6.  
      7.  
      8.  
   3. Other Considerations
      1. No counties will be allowed to be included in the EUP program if the Agency determines that the level of concern for endangered species risks are exceeded
      2. Residential uses generally will not be eligible for consideration under this expedited review program
      3. The application should be accompanied by letters of support from recognized grower and commodity organizations.
    

   The Agency has chosen initially to limit the expedited EUP program to methyl bromide alternatives, reduced-risk pesticides, and OP alternatives because these are the types of pesticides that EPA believes will benefit most from an expedited EUP program. Growers want to make sure that the products are effective alternatives to currently-registered alternatives before they move from higher-risk options and they want to know how to best utilize a new product and incorporate it into their agronomic system.

   The objective of this expedited EUP program is to bring to the Agency's attention those EUPs which could be approved based on existing hazard characterizations and exposure assessments without the need for substantial additional review. The Agency, therefore, chose the October 1998 cut-off date because as of this date, most of the current FQPA assessment methodologies had been fully implemented and, as a result, these chemicals already have been evaluated using the most current risk assessment standards.

   The Agency has limited the expedited EUP program to application methods and use rates similar to those previously approved by the Agency for the same chemical on other crops because significantly different application methods or use rates would require more detailed review of the potential risks to farm workers and pesticide applicators. For example, if the only registered use of a chemical is as a seed treatment, an EUP proposing use as a foliar spray just prior to harvest, would require a new worker exposure scenario quite different from the Agency's existing exposure assessment.

   Regarding the risk criteria, the Agency selected these cut-offs to ensure that the proposed new EUP use would not result in an unacceptable level of aggregate dietary risk. Acreage and watershed limitations were established in order to prevent a significant increase in dietary (food and drinking water) and ecological exposures.

   Regarding the other criteria, the stipulation regarding endangered species is similar to that currently used for all EUPs. The residential use criterion was added in order that the Agency would not have to re-evaluate its previous aggregate exposure determinations. The Agency will consider extensions to this criterion on a case-by-case basis. The grower support criterion was added to provide growers and commodity associations with the opportunity to identify prospective candidates for this new program.

4. Eligible Pesticides

   The Agency has conducted a preliminary screen of the active ingredients that would likely satisfy most or all of the active ingredient criteria in III.A. and the risk criteria under III.B.1. Those pesticides are:

   1. Fungicides And Plant Growth Regulators:
      • Azoxystrobin
      • Ecolyst
      • Fenhexamid
      • Fluazinam
      • Fludioxonil
      • Prohexadione Calcium
      • Trifloxystrobin
      • Zoxamid
   
   
   2. Herbicides:
      • Carfentrazone-ethyl
      • Diflufenzopyr
      • Flucarbazone-sodium
      • Glyphosate
      • Halosulfuron-methyl
   
   
   3. Insecticides And Insect Growth Regulators:
      • Buprofezin
      • Indoxacarb
      • Methoxyfenozide
      • Pyriproxyfen
      • Spinosad
      • Tebufenozide
   
   
   
   
   
   
    
   4.  
   5.  
   6.  
   7.  

   The Agency is also willing, on a case-by-case basis, to consider other active ingredients for expedited review under this program. Registrants should consult the appropriate EPA product manager before submitting their application.

5. Formatting And Submittal Procedures

   Formatting and submittal procedures for expedited EUP requests are provided below. These procedures will allow EPA to easily identify the application for consideration. Also, applicants should note that it is unlawful to falsify any portion of an application. FIFRA sections 12(a)(2)(M), 12(a)(2)(R) and 18 U.S.C. Section 1001 make such actions unlawful and can result in civil or criminal penalties. An application which does not conform to the procedures outlined below may not receive expedited processing.

   1. Format. Applicants should submit the expedited review EUP request as they would for any other EUP submitted to the Agency. The registrant should succinctly explain how the application satisfies all of the conditions outlined in this notice and include copies of correspondence from grower or commodity groups supporting the EUP request.
   
   
   2. Submission. The EUP application must be accompanied by all other information required to be submitted as part of an EUP application. The EUP must also be accompanied by a tolerance petition, as necessary for food use EUPs. This PR Notice does not supersede established submittal procedures as addressed in PR Notice 2000-4; rather this PR Notice provides guidance for registrants seeking expedited review of certain EUP applications. The Office of Pesticide Programs (OPP) uses distribution codes to facilitate the delivery of registration and other submissions within the program. When preparing your submission to mail or deliver to OPP, direct your submission to the Document Processing Desk and include the following distribution code: EUP-EXPEDITE
   
   
   
   
   
   
    
   3.  
   4.  
   5.  
   6.  

   The submission delivered via the U.S. Postal Service should be directed to OPP using the following address:

   Document Processing Desk (EUP-EXPEDITE)
   Office of Pesticide Programs (7504C)
   U.S. Environmental Protection Agency
   1200 Pennsylvania Avenue NW
   Washington, D.C. 20460-0001

    

   Submissions via personal or courier delivery should be directed to the Document Processing Desk between the hours of 8:00 a.m. and 4:00 p.m., Monday through Friday, excluding Federal holidays. OPP's Document Processing Desk is located at the following address:

   Office of Pesticide Programs
   Document Processing Desk (EUP-EXPEDITE)
   Room 266A, Crystal Mall 2
   1921 Jefferson Davis Highway
   Arlington, VA 22202




6. Scope Of The Policy

   This PR Notice describes the requirements set forth in Agency regulations and FIFRA, and provides general guidance to EPA and to affected parties as well. While the requirements in FIFRA and Agency regulations are binding on EPA and applicants, this notice is intended to provide guidance to EPA personnel, pesticide registrants and applicants, and the public. As a guidance document, this policy is not binding on either EPA or any outside parties, and the EPA may depart from this guidance where circumstances warrant and without prior notice.




7. For Further Information

   For further information on this program, contact Rachel Holloman, Chief, Registration Support Branch, Registration Division at (703) 305-7193 or via e-mail at [email protected].