By Lisa M. Campbell, Sheryl Lindros Dolan, and Margaret R. Graham, M.S.
On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. Comments on the draft guidance are due by May 28, 2019.
EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants (PBS) to regulation under FIFRA as plant regulators. While EPA has not yet promulgated a regulatory definition for a PBS, the draft guidance describes a PBS as “a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.” EPA is seeking comment on the draft guidance itself, as well as on whether it should develop a definition for PBSs. EPA states that there is currently no statutory definition for PBSs under FIFRA and that development of a definition for PBSs would require rulemaking. The guidance also notes that the 2018 Farm Bill, enacted on December 20, 2018, does provide a statutory definition for PBSs, which is: “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield.”
In developing the draft guidance, EPA states that it “considered whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators under FIFRA thereby triggering regulation as a pesticide” and that “a key consideration is what claims are being made on product labels.” Further, as FIFRA Section 2(v) both defines plant regulator and explains which substances are excluded from the definition, “many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.”
The draft guidance provides several examples of both product label claims that are considered plant regulator claims and claims that that are not considered plant regulator claims. The examples are described in the Tables below.
- “Product label claims generally considered ‘non-pesticidal’ (i.e. non-plant regulator claims),” including: “plant nutrition-based claims” (Table 1a); “plant inoculant-based claims” (Table 1b); and “soil amendment-based claims” (Table 1c):
- “Generic product label claims for products not covered by the exclusions in the FIFRA Section 2(v) definition of a plant regulator,” including “examples of generic product label claims generally considered by the Agency to be ‘non-pesticidal’” (Table 2):
- “Plant regulator product label claims that are consistent with the FIFRA Section 2(v) plant regulator definition” including “examples of label claims that are considered … to be plant growth regulator claims that trigger regulation under FIFRA as a pesticide” (Table 3):
- “EPA-registered, naturally-occurring, plant regulator active ingredients having modes of action and associated product label claims that are consistent with the FIFRA definition of a plant regulator” (Table 4):
By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham
On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.
EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."
Some of the more substantive comments noted the following issues:
- Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients. Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
- One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.” The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.”
- Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”
More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.
By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson
On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments. EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.” EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.
PR Notices are issued by the Office of Pesticide Programs (OPP). EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” The PR Notice lists the changes from PRN 98-10 in a table. Those changes include:
In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:
- F. Product Composition: (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification. Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
- F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume. Under the proposed PR Notice, these terms were removed.
Minor Formulation Amendments
- A. Minor Formulation Amendments: (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
- A. Minor Formulation Amendments: (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review.
- A. Minor Formulation Amendments: (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product.
- Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
- Pet spot-on products;
- Change to an active ingredient source;
- Change to nominal concentration of the active ingredient; or
- Addition of new or additional Confidential Statements of Formula (CSF).
EPA Procedures to Review Notifications
Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same.
One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.
Registrants Submitting Minor Formulation Amendments
Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs. EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.
Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.
Registrants should review the draft PR Notice carefully, as it includes important changes. For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe. As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification. Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market. Comments on issues of concern should be considered.
By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments. EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance. The two test methods are:
The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance.
The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.” EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals. In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.”
The Draft Guidance also sets forth examples of acceptable label claims against public health biofilms and acceptable non-public health claims. The examples of acceptable label claims against public health biofilms are:
- Kills 99.9999% of bacteria* in biofilm on a hard, non-porous surface;
- Kills a minimum of 99.9999% of bacteria* in biofilm;
- Reduces at least 99.9999% of bacteria* growing in biofilm;
- Formulated to kill 99.9999% of bacteria* in biofilm;
- Other related claims:
- Kills biofilm bacteria*; and
- Penetrates biofilm, killing the bacteria* living there.
*[List of bacteria “tested as a biofilm”; at a minimum, Pseudomonas aeruginosa and Staphylococcus aureus].
Examples of acceptable non-public health claims supported by appropriate efficacy data include:
- Cleans away microorganism slime/grunge;
- Maintains control of slime; and
- Controls slime-forming microorganisms.
Comments will be accepted until December 5, 2016.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On June 7, 2016, the U.S. Environmental Protection Agency (EPA) announced that it was making two draft Pesticide Registration Notices (PR Notices) available for public comment: (1) PR Notice 2016-X: Draft Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling; and (2) PR Notice 2016-XX: Draft Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship. In its news release, EPA states that it has started a “more widespread effort aimed at combating and slowing the development of pesticide resistance,” in an effort to “address the growing issue of resistance and preserve the useful life of pesticides.”
Draft PR Notice 2016-X
Draft PR Notice 2016-X, which revises and updates PR Notice 2001-5, applies to all conventional agricultural pesticides (i.e., herbicides, fungicides, bactericides, insecticides and acaricides). The focus of the updates in PR Notice 2016-X is on pesticide labels and improving information about how pesticide users can minimize and manage pest resistance.
Specifically, EPA is proposing that specific resistance-management statements be included with the Directions for Use section under the heading “Resistance Management Recommendations.” EPA states that the proposed labeling statements “focus on the mitigation of pest resistance and should be used where applicable based on the availability of other pesticides and production practices specific to that crop.” As one example, EPA recommends the following general resistance management labeling statements for insecticide/acaricide products containing only a single active ingredient or multiple active ingredients that are from the same Mode of Action (MOA) group:
- For resistance management, (name of product) contains a Group (mode of action group number) insecticide (or acaricide). Any (insect/mite) population may contain individuals naturally resistant to (name of product) and other Group (mode of action group number) insecticides/acaricides. The resistant individuals may dominate the insect/mite population if this group of insecticides/acaricides are used repeatedly in the same fields.
Since the recommended resistance-management statements depend on an active ingredient’s MOA, PR Notice 2016-X also addresses MOA grouping and identification symbols for agricultural uses of herbicides, fungicides/bactericides, and insecticides/acaricides. The pesticide groupings are provided by the Weed Science Society of America (WSSA), the Herbicide Resistance Action Committee (HRAC), the Fungicide Resistance Action Committee (FRAC) and the Insecticide Resistance Action Committee (IRAC). The MOA groups, and the identifier numbers and/or letters (i.e., symbols or codes) for herbicides, fungicides/bactericides and insecticides/acaricides may be accessed through the websites of the different Resistance Action Committees. For example, for insecticides, IRAC uses a combination of numbers and letters to identify various MOA groups. EPA recommends that the IRAC MOA identifier codes be used for designating insecticide MOA grouping information on labels for pesticides containing insecticides. The IRAC MOA list and identifier codes can be found online.
While current PR Notice 2001-5 contains similar guidance in terms of MOA groupings and general pesticide-resistance statements, the Draft PR Notice 2016-X provides: (1) additional guidance, and recommended format, for resistance management statements or information to place on labels; (2) includes references to external technical resources for guidance on resistance management (e.g., professional scientific societies, resistance action committees for different types of pesticides); and (3) updates the instructions on how to submit changes to existing labels to enhance resistance management language. In addition, while PR Notice 2001-5 states that “implementation of this program is purely voluntary by the pesticide industry,” the language in Draft PR Notice 2016-X is arguably stronger, with EPA “encouraging” registrants to add the appropriate resistance-management statements through notification, amendment, or as part of an application for a new product.
Draft PR Notice 2016-XX
Draft PR Notice 2016-XX, which only applies to herbicides, is intended to provide guidance on labeling, education, training, and stewardship for herbicides undergoing registration review or registration (i.e., new herbicide actives, new uses proposed for use on herbicide-resistant crops, or other case-specific registration actions). EPA states it is focusing on the holistic guidance for herbicides first because:
- Herbicides are the most widely used agricultural chemicals;
- No new herbicide mechanism of action has been developed in the last 30 years; and
- Herbicide-resistant weeds are rapidly increasing. In the future, the Agency plans to evaluate other types of pesticides (e.g., fungicides, bactericides, insecticides, and acaricides) to determine whether and what guidance may be appropriate for these types of pesticides.
Under guidance described in PR Notice 2016-XX, EPA proposes to divide 28 herbicide Mechanisms of Actions into three categories of concern (low, moderate, high) based on the risk of developing herbicide-resistant weeds. Appendix I to PR Notice 2016-XX provides three tables with herbicide Mechanisms of Actions of “Low Concern,” “Moderate Concern,” and “High Concern” for herbicide resistance. EPA states its intent to make these tables available on its website, noting that the tables would need to be “checked periodically to determine if there are changes to the groupings or level of concern categories.” Appendix II to PR Notice 2016-XX sets forth the following eleven elements that are focused on labeling, education, training, and stewardship strategies:
- Element 1. List Mechanism of Action Group Number on label.
- Element 2. List seasonal and annual maximum number of applications and amounts.
- Element 3. Provide Resistance Management language from PR Notice 2016-X, and/or Best Management Practices language from WSSA and HRAC, and/or HRAC proposed guidelines for herbicide labels. Note that Best Management Practices (BMP) should be appropriate to crop and production system.
- Element 4. Instruction to user to scout before and after application.
- Element 5. Provide definition of Likely Resistance.
- Element 6. Instruction to user to report lack of performance to registrant or their representative.
- Element 7. List confirmed resistant weeds in a separate table and list recommended rates for these weeds with the table.
- Element 8. Registrant report new cases of likely and confirmed resistance to EPA and users yearly. This is in addition to any adverse effects reporting.
- Element 9. Provide growers with:
- Resistance Management Plan;
- Remedial Action Plan (to control resistant weeds this season or next season);
- Educational materials on resistance management; and
- Plans should be locally developed and easily modified. EPA recommends that registrants work with Extension, Consultants, Crop Groups, HRAC, and the U.S. Department of Agricultute (USDA).
- Element 10. For combination products with multiple Mechanisms of Action, list which herbicide is controlling which weed (a three-way mixture may only have one effective Mechanism of Action for some problem weeds). List minimum recommended rate if resistance is suspected.
- Element 11. Any additional specific requirements (e.g., mandatory crop rotation, unique agronomic aspects, additional training, time limited registration, etc.).
Elements 1 through 4 are proposed for Mechanisms of Actions of Low Concern, elements 1 through 8 are proposed for Mechanisms of Actions of Moderate Concern, and elements 1 through 11 are proposed for Mechanisms of Actions of High Concern.
The PR Notices are available on www.regulations.gov under Docket Numbers EPA-HQ-OPP-2016-0242 for PR Notice 2016-X; and EPA-HQ-OPP-2016-0226 for PR Notice 2016-XX. Comments are due by August 2, 2016.
With regard to PR Notice 2016-XX, EPA states that while comments are welcome on all aspects of this Notice, EPA is especially interested in comments on the following: (1) the approach, elements and categorization used to address herbicide resistance; (2) limiting the application of these measures during registration review to new herbicide active ingredients, new uses of herbicides proposed for use on herbicide-resistant crops, and other case-specific registration actions; (3) other effective measures to inform the stakeholder community of the occurrence of likely resistance; and (4) other useful strategies that, when implemented, would slow the development of herbicide resistance and prolong the useful life of herbicides.
More information on pesticide resistance management is available on EPA’s website.
Avoiding the onset of resistance to any pesticide product is a widely shared goal of users and registrants of the pesticide to maintain the effectiveness and profitability of the product. There is controversy, however, when EPA suggests specific instructions to the user community, since pesticide applications are site and situation specific, making general “one size fits all” approaches, even “flexible” ones, suspect among much of the user community. When the instructions involve label requirements, which are enforceable, concerns about flexibility and the need to adapt to local conditions increase.
Resistance management has been a stated goal of EPA for some time; here EPA seems to argue it is of the utmost importance to preserve useful pest control tools since it is better to have more “tools in the toolbox.” Yet, when EPA seeks to restrict a product or class of products and users and registrants cite the need for that product for resistance management, few benefits seem to be associated with resistance management in such cases. Overall, there is also suspicion that EPA’s concerns regarding herbicide resistance masks a political response to critics of the widespread adoption of herbicide-resistant genetically engineered crops -- since the high value of resistance management gains little value when EPA attempts to restrict other products. An example is EPA’s approach to organophosphate insecticides, where EPA is currently seeking to eliminate many uses that otherwise are viewed as important for insecticide resistance management.
Having EPA attempt to address resistance management via label instructions will be controversial, notwithstanding broad consensus that avoiding resistance is a shared goal. So, the likely debate will focus less on the goal, and more on the means of achieving the goal, as this issue moves forward.
By: Lisa M. Campbell and Susan Hunter Youngren, Ph. D.
Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which focused on issues that were key in the chlorpyrifos petition response, and more recently, at least one registration review decision that reflects current and still evolving EPA policy on spray drift and volatilization issues.
How potential for spray drift and for volatilization are identified and then managed are likely to be key elements of ongoing and future risk assessments underlying forthcoming EPA registration and reregistration, with significant potential impact on these decisions. Registrants should monitor closely the policies, EPA decisions implementing them, and their potential impact on their products, particularly given the public interest in these issues.
The EPA documents issued in the past eight or so months are significant, particularly given the years of controversy and difficulty in past attempts to propose a clear and “simple” definition of “drift.” The perception by some advocacy groups is that EPA is not adequately addressing alleged harms posed by drift, and resulting appeals for court intervention will undoubtedly complicate the matrix of considerations influencing EPA’s policy. These reasons alone make monitoring the development of these policies critical for registrants.