                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            -  -  - WASHINGTON D.C., 20460
                                        -  - 
                                                   		
                                                                  
                                                                 
                                                            OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                                                                 
                                       

MEMORANDUM


SUBJECT:	Response to Comments received on PRN 2017-1, an update to PRN 2001-5 ["Guidance for Pesticide Registrants on Resistance Management Labeling"]

FROM:	Nikhil Mallampalli, Entomologist
		Leonard Yourman, Plant Pathologist
		Bill Chism, Senior Biologist
  		Biological Analysis Branch
		Biological and Economic Analysis Division (7503P) 

THRU:	Wynne Miller,	Division Director
            Biological and Economic Analysis Division (7503P)
            
            Anita Pease, Acting Deputy Director
            Biological and Economic Analysis Division (7503P)


Peer Review Panel Date:  May 17, 2017

INTRODUCTION

In May 2016, EPA (also referred to as "the Agency" in this memorandum) released and requested public comment on Pesticide Registration Notice (PRN) 2016-X, which was entitled, "Draft Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling." After considering public comments, EPA is finalizing PRN 2016-X as PRN 2017-1. This document updates an existing Notice, PRN 2001-5, and provides guidance to pesticide registrants on resistance-management (RM) information for users of agricultural pesticides. 

The updated PRN applies to all field use agricultural pesticide products, as well as pesticides which are labeled for greenhouse production, sod farms, ornamental crops, aquatic vegetation, rights-of-way, and pest management along roadways. This guidance is not intended to apply to products labeled for use by the general consumer, such as residential use pesticides, or plant-incorporated protectants (PIPs). RM information for PIPs is covered by separate guidance issued by the Biopesticides and Pollution Prevention Division (BPPD). For further information on RM approaches for PIPs, please refer to BPPD's web site:  https://www.epa.gov/pesticides/biopesticides. The updates in PRN 2017-1 focus on pesticide labeling, and are aimed at improving information that registrants can provide to assist pesticide users to minimize and manage pest resistance. 

A similar and related PRN (2017-2, also released for public comment in May 2016 as "PRN 2016-XX) is intended for herbicide registrants exclusively. That PRN, titled "Guidance on EPA's Framework for Herbicide Resistance Management Labeling, Education, Training, and Stewardship", focuses on the overall strategy to manage herbicide resistance during registration and registration review. It is also being released in final form, concurrently with PRN 2017-1.

The Agency received 19 comments related to draft PRN 2016-X from various stakeholders. Commenters included industry experts on RM who serve on Resistance Action Committees (RACs), professional scientific societies, pesticide registrants and retailers, crop producer groups, the Western IPM Center, non-governmental organizations (NGOs) representing environmental advocacy groups, and the Office of Pest Management Policy (OPMP) in the U.S. Department of Agriculture (USDA). All commenters were generally supportive of the effort to improve RM labeling. However, there were several recommendations and suggestions to edit various parts of the PRN. EPA has considered and incorporated many of these comments into the final version of the PRN. Summaries of the comments received and the Agency's response are provided below.


COMMENTS RECEIVED AND THE AGENCY'S RESPONSE

This document groups comments based on the similarity of various commenters. The groups are as follows: (i) the Resistance Action Committees (RACs) and scientific societies; (ii) pesticide registrants, (iii) non-governmental organizations (other than registrants); and (iv) USDA. Comments from multiple stakeholders within each group are summarized and a single response is provided. In the interest of brevity, the summaries focus on the general themes and suggestions made by various commenters and are not intended to be an exhaustive discussion of all details from comments. All comments are available to the public at the PRN docket (EPA-HQ-OPP-2016-0242) at www.regulations.gov.

Comments received from Resistance Action Committees (RACs) and scientific societies

Summary

The Fungicide and Insecticide Resistance Action Committees (FRAC and IRAC, respectively) submitted detailed comments suggesting changes to the proposed RM statements in PRN 2016-X for fungicides and insecticides. In addition, the American Phytopathological Society (APS), a professional scientific society for plant pathologists, submitted a comment that was similar to one from the FRAC. The RACs are technical specialist groups formed by a collaborative effort between universities and pesticide manufacturers (registrants). RACs provide their own guidance on RM tactics to the public and classify pesticides within their purview into "Mode (or "Mechanism") of Action" (MoA) groups to facilitate identification of chemical groups with common physiological target sites. MoA information is fundamental to the practice of rotating pesticide chemistries across treatments targeting the same pest population as a means to reduce selection pressure on shared target sites and thus delay the development of pesticide resistance. In general, these commenters were supportive of EPA's effort to improve label guidance on RM.

The IRAC suggested formatting changes (e.g., moving a footnoted text piece into the body of the PRN text), and also commented on a few of the suggested RM statements for insecticides. They asked that there be less emphasis on the use of tank mixtures of insecticides with different MoAs, because this practice could actually speed the rate of resistance development if users follow this advice too frequently. They also suggested changes to the tank mixture guidance to help pesticide users appropriately select components of tank mixtures. Additionally, the IRAC suggested changes to guidance language asking users to monitor treated pest populations and to discontinue use of products that do not effectively control the pest population of concern.

The FRAC and APS suggested changes to the guidance for fungicide RM that asks users to monitor treated pests for resistance and the related "disease continuation" statements, in order to provide clearer direction to fungicide users. Furthermore, they suggested changes to the rotation of fungicides with different MoAs for the same reason. 

[Docket numbers to locate comments: EPA-HQ-OPP-2016-0242-0015 (FRAC); -0014 (IRAC); -0016 (APS)].

Response

EPA appreciates the detailed suggestions and general support provided by these commenters, who represent recognized scientific experts in pesticide RM. The guidance and discussion in the final PRN (i.e., PRN 2017-X) will reflect the changes suggested by these groups for fungicide, bactericide, insecticide and acaricide labels.

Comments received from registrants and affiliated groups

Summary
   
Comments were received from pesticide registrants (including Bayer, Dow, DuPont, Drexel, FMC, NuFarm, and Syngenta). Similar comments were also received from CropLife America and Responsible Industry for a Sound Environment (RISE), two groups that represent many registrants, producers and suppliers of pesticides. All commenters were generally supportive of the effort. The Biotechnology Innovation Organization (BIO), a trade organization representing "more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations", was particularly supportive of EPA's efforts. BIO urged the Agency to work closely with growers and pesticide developers to identify flexible, up-to-date RM practices that accommodate the diversity of agricultural practices and crops in the United States. Other commenters also mentioned that the Agency remain flexible in its use of the guidance, so that best management practices for individual products can be tailored to specific pest management needs and up-to-date scientific recommendations.
   
Many registrants pointed out that their labels already contain most, if not all, of the RM information that was suggested in the PRN. Some registrants urged EPA to go beyond the guidance and provide incentives for registrants to develop pesticides with new MoAs, or to bring back older pesticides that have been removed from the marketplace (due to risk concerns) to facilitate RM in agriculture. 
   
A few commenters pointed out many of the same issues that were raised by the RACs regarding the proposed RM statements. One registrant claimed that some state pesticide regulators are unaware of EPA's published guidance. Some commenters also indicated that scouting for pests before and after pesticide application may not be feasible in non-agricultural use sites such as forestry and aquatic sites. Thus, they suggested that statements in the PRN advocating scouting be removed explicitly for such sites, or that the description of the "scope" of the PRN be clarified to "clarify and further define the scope of products and uses for which these labeling elements are to be recommended" (as excerpted from the comment by NuFarm). 
   
There were also some points of confusion among commenters regarding the scope and nature of the guidance in the PRN. Some commenters seemed to believe that EPA is creating its own RM language; they asked that we rely on the RACs and scientific societies for such information. Other were concerned that EPA will treat RM statements on labels as enforceable language, or felt that labels will be rejected if some of the RM statements (suggested in the PRN) are not included on a proposed label.  
   
Finally, some commenters asked that the implementation timeline not specify two years as a specific deadline for adding RM language to all labels after the final PRN is issued, because some pesticide active ingredients have many dozens of labels and complex sets of use sites.

[Docket numbers to locate comments: EPA-HQ-OPP-2016-0242-0008 (Drexel); -0012 (NuFarm); -0017 (Dow); -0018 (BIO); -0019 (BASF); -0020 (RISE); -0021 (FMC); -0022 (Bayer); -0023 (CropLife); -0025 (DuPont); -0026 (Syngenta)].

Response

The Agency appreciates the input and general support for RM guidance that was expressed by this group of commenters. Where comments were similar to those submitted by the RACs, EPA will incorporate these changes to the final PRN. EPA notes that the draft PRN relied on information from RACs and scientific societies, and many of the suggested RM statements originate from these sources as well as the 2001 guidance that has been long-standing policy. Regarding one commenter's suggestion that older pesticides be brought back into the marketplace as a way to help RM, the Agency notes that this recommendation is beyond the scope of the PRN under consideration.
     
The PRN guidance in 2017-1 is meant to be a general resource rather than absolutely prescriptive. Details on RM tactics described in the PRN are included because they represent `best practices' identified by subject matter experts in the scientific community. However, the Agency understands that every such practice is not always applicable to every pest management or pesticide use scenario. For example, if scouting in non-crop use sites is impractical, registrants may discuss the issue with registration reviewers to clarify why such a statement may not be applicable to their labeling. Given the labeling flexibility that this PRN allows, the Agency does not plan to alter the scope of the PRN to exclude specific non-crop use sites (e.g., turf) that are typically treated with pesticides by commercial pest control operators or other certified pesticide applicators. However, the description of the scope of the PRN has been revised to more clearly identify and describe the broad categories of pesticide use sites where labels could include RM information. 

The Agency continues to view RM language on pesticide labeling as advisory in nature, as opposed to enforceable requirements such as adhering to a seasonal maximum application amount. In this regard, registrants are reminded that PRN 2000-5 provides guidance on how to word mandatory vs. advisory language on labeling (see https://www.epa.gov/pesticide-registration/prn-2000-5-guidance-mandatory-and-advisory-labeling-statements).

EPA appreciates the feedback from one commenter that some state-level pesticide regulatory agencies are unaware of the existing two PRNs addressing RM guidance. EPA will make additional efforts going forward to notify state regulators about these documents.

The timeline for implementation has been adjusted to remove the description of a two-year deadline for label amendments, where necessary. The Agency acknowledges that, given the volume of labels involved, a two-year timeline may be unrealistic. However, the Agency continues to expect that registrants will move quickly to add RM language and MoA information to any labels they have that currently lack such information.


Comments received from non-governmental organizations and grower groups

Summary

Comments were received from an environmental advocacy organization, Beyond Pesticides, as well as the Western IPM Center, the National Cotton Council, and the California Specialty Crops Council. All commenters expressed general support for the idea of having RM guidance on labels, especially the MoA information. Some commenters suggested that guidance be more prescriptive, or even be codified into an enforceable rule. 

Some commenters reflected issues raised by registrants, RACs, or the USDA (see below). For example, they suggested that guidance for bactericides be separated from fungicides, and expressed confusion as to whether the guidance in the PRN is enforceable or voluntary. There was confusion regarding the relationship between PRN 2016-X and PRN 2016-XX. A few commenters seemed to assume that PRN 2016-X superseded the other PRN, when in fact they are separate but related. They also expressed concern that adding too much RM guidance could increase label length and make it confusing or difficult to read. 

[Docket numbers to locate comments: EPA-HQ-OPP-2016-0242-0010 (Beyond Pesticides); -0011 (Western IPM Center); -0013 (California Specialty Crops); -0024 (Cotton Council)].

Response

The Agency acknowledges that RM language may add to label length. However, since most users read them carefully, labeling is well-suited to provide RM guidance in an immediately accessible way. Going forward, EPA will attempt to use the `smart label' effort currently under development to add RM guidance to labeling in a way that is more accessible and less time consuming for pesticide registrants. For more information on this effort, please see the following website: https://www.epa.gov/pesticide-registration/pesticide-smartlabel-pilot.

To resolve potential confusion over how the two RM-related PRNs relate to one another, EPA will clarify the narrative in both PRNs to indicate that the two guidance documents are separate but consistently address the same topic of RM. However, regarding whether to make RM guidance mandatory (as proposed by some commenters in this group), the Agency has determined that encouraging incorporation of the labeling language in this PRN on a voluntary basis is sufficient because registrants are aware of the importance of RM to sustain the utility of their pesticide products.


Comment received from USDA-OPMP
   
Summary
   
The USDA's Office of Pest Management Policy (OPMP) was the only federal office that commented. OPMP suggested edits to the introductory sections of the PRN, where RM concepts and MoA information are discussed. Similar to other commenters, OPMP also expressed concerns regarding the enforceability and scope of the guidance, and suggested increased emphasis on the utility of tank mixes in various parts of the guidance. OPMP also suggested that the PRN clarify the use of the term "unreasonable" where there is discussion of resistance as an adverse effect, since there can be multiple causes for resistance in a pest population (e.g., an inherently high genetic propensity to evolve resistance with little fitness cost to the population), and not all of these are adequately addressed by the RM language suggested in the PRN. This issue was also raised in some comments from registrants. The relevant section of the OPMP comment is excerpted in the following paragraph:

      "When using the term "adverse effect" in this document, EPA should clarify whether the term "adverse effect" in this context will have regulatory implications as FIFRA mandates the Agency to prevent "unreasonable adverse effects." If it is EPA's intention to regulate the development of "unreasonable adverse effects," then the Agency's criteria should be posted for public comment if such criteria are not codified through rulemaking. Also, if this is EPA's intention, the first sentence of paragraph 4 could be modified to the following; "The Agency considers the development of pest resistance to be an unreasonable adverse effect when reasonable steps have not been undertaken through the judicious use of agricultural pesticides to minimize resistance. Genetics also play a role in the evolution of pest resistance."
      
[Docket number to locate comment: EPA-HQ-OPP-2016-0242-0006]
Response

The Agency appreciates the detailed edits and suggestions made by OPMP. Some editorial suggestions will be incorporated into the introductory background sections of the PRN. For example, in the final PRN, the Agency will acknowledge that resistance can evolve even when RM practices are followed by pesticide users. In addition, as noted in other responses (above), the Agency has described the inclusion of RM text on pesticide labeling as voluntary, and will continue to consider RM information on labeling as advisory guidance to pesticide end-users, as opposed to mandatory instructions. 

In the final PRN, the Agency will also clarify the meaning of resistance as an adverse effect to avoid any unintended implication of the word as "unreasonable" and resulting regulatory implications under FIFRA. EPA notes that while pesticide resistance is clearly an undesirable (and thus, in many ways, an `adverse') phenomenon, the intention of the guidance in this PRN is to help registrants provide pesticide users easily accessible, scientifically based RM information.

Regarding the discussion of tank mixes of pesticides, the Agency notes that comments by the IRAC cautioned against giving pesticide users the impression that tank mixtures are always useful in RM. However, EPA generally agrees with OPMP that tank mixes can be a useful component of a larger RM program, provided they are judiciously used. To acknowledge both issues, the Agency will revise the guidance on the use of tank mixes  -  particularly for insecticides  -  to incorporate suggestions by the RAC while also retaining a description of the strategy as a potentially useful RM tactic for all types of pesticides.



