Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method).  84 Fed. Reg. 22120.  It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide feedback. 

The Draft Revised Method states it is intended to be “used in the evaluation of potential risks from pesticides to listed species” and that it will be “used by EPA for making effects determinations under registration review, which will also be used to inform biological opinions from the Fish and Wildlife Service and the National Marine Fisheries Service [(the Services)].”

EPA states that the Draft Revised Method document “describes proposed revisions to the interim methods used to conduct effects determinations as documented in EPA’s [biological evaluations (BE)] for federally threatened and endangered species for pesticides.”  EPA states the revisions are based on: (1) “refinements” following the method used in the first three national-level BEs for chlorpyrifos, diazinon, and malathion; (2) consideration of public comments provided through stakeholder meetings and submitted to the docket for the pilot draft BEs; (3) consideration of National Research Council (NRC) recommendations; and (4) “lessons learned during the development of the first three BEs.”

EPA states that the following are major aspects of its proposed revisions on which it is seeking comments:

  • To more accurately represent where and to what extent a pesticide is likely to be applied, EPA is proposing an approach for incorporating pesticide-specific usage data into Steps 1 and 2 of the BEs.  While the pilot BEs relied on use assumptions from pesticide product labels to represent where the pilot chemicals were likely to be applied (e.g., applied to all labeled crops at maximum application rates simultaneously), the Draft Revised Method proposes to incorporate usage data (e.g., survey data, including actual application rates) in the determination.
  • Based on the accuracy of the spatial data utilized and the conservative assumptions related to the action area and potential drift, EPA’s notice states that it is proposing to interpret “a <1% overlap of listed species’ ranges with potential use sites as unreliable and not representative of real exposure potential.”
  • EPA is proposing an approach for introducing components of probabilistic analysis into the BE, as the “goal of the probabilistic analysis is to more fully capture and characterize the variability in the range of potential exposures and toxicological effects to listed species to better inform the biological opinion.”
  • EPA is proposing a weight-of-evidence framework “to distinguish those listed species that are likely to be adversely affected (LAA) from those that are not likely to be adversely affected (NLAA), based on criteria (e.g., dietary preferences, migration patterns, extent of range potentially exposed) associated with the likelihood that an individual will be exposed and affected.”

The June 10 public meeting, which EPA states “is part of the federal government’s coordinated effort to improve the Endangered Species Act (ESA) process that is used when pesticides are federally registered,” will be held from 9:00 a.m. to 12:00 p.m. (EDT) in the lobby-level conference center of EPA’s offices at Potomac Yard South in Arlington, Virginia.  Those wishing to attend either in person or via teleconference/webinar must register by May 30, 2019.  Registration is available online.  Comments on the Draft Revised Method are due by July 1, 2019, in Docket No. EPA-HQ-OPP-2019-0185 on www.regulations.gov.

Commentary

This is the latest chapter in the long saga of coordination between ESA review by the Services and EPA registration activities.  The steps outlined in the Draft Revised Method are designed to improve the coordination of work between the agencies and represent an important step in designing a framework which might make the current situation more reliable, predictable, and efficient.  The current process has been subject to criticism on a number of fronts, with the current BE process seen as unsustainable given the amount or resources and time consumed by the first BEs. 

The goal is eventually to have the Services and EPA “play nice together” and implement a leaner and more efficient process, which is considered absolutely necessary if EPA hopes ever to complete appropriate ESA assessments on hundreds of active ingredients formulated into thousands of end use pesticide products.  Such efforts could also represent a cornerstone of the agencies’ meeting provisions in the 2018 Farm Bill (Section 10115) which includes requirements for the agencies to “… increase the accuracy and timeliness” of the ESA consultation process, as well as implement these same policies stated in the Memorandum of Agreement between EPA, the Department of the Interior, and the Department of Commerce on Establishment of an Interagency Working Group to Coordinate Endangered Species Act Consultations for Pesticide Registrations and Registration Review.


 

By Lisa M. Campbell and Lisa R. Burchi

On May 15, 2019, the U.S. Environmental Protection Agency announced that it is extending the comment period for the Draft Guidance for Plant Regulator Label Claim, Including Plant Biostimulants that was made available on March 27, 2019.  94 Fed. Reg. 21773.  The original comment date was May 28, 2019; comments are now due by July 28, 2019, in Docket No. EPA-HQ-OPP-2018-0258.  Several trade groups and a number of individual companies had requested an extension due to the complexity and breadth of the guidance.  EPA’s grant of additional time is likely very welcome to many stakeholders, given the significant issues that this guidance addresses and given the work that that many stakeholders have done on the issues it addresses. 

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. 

A memorandum providing more information on the guidance is available in our April 2, 2019, memorandum “EPA Releases Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants.”


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential risk to terrestrial and aquatic plants from off-site spray drift, consistent with glyphosate’s use as a herbicide.”  Even with these potential risks, the PID states that “EPA concludes that the benefits outweigh the potential ecological risks when glyphosate is used according to label directions” and proposes certain risk mitigation strategies, including:

  • “To reduce off-site spray drift to non-target organisms, the EPA is proposing certain spray drift management measures” with specific spray drift mitigation language to be included on all glyphosate product labels for products applied by liquid spray application;
  • “To preserve glyphosate as a viable tool for growers and combat weed resistance, the EPA is … proposing that herbicide resistance management language be added to all glyphosate labels” and to require measures “for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds”;
  • Inclusion on labels of a non-target organism advisory statement to alert users of potential impact to non-target organisms; and
  • “EPA is also proposing certain labeling clean-up/consistency efforts to bring all glyphosate labels up to modern standards.”

EPA states that these measures were discussed with glyphosate registrants, who do not oppose the proposed risk mitigation measures outlined in the PID.

The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.  Public comments are due by July 5, 2019.  In addition to the PID, EPA is also posting to the glyphosate docket EPA’s response to comments on glyphosate’s usage and benefits (dated April 18, 2019), EPA’s response to comments on the human health risk assessment (dated April 23, 2018), and EPA’s response to comments on the preliminary ecological risk assessment (dated November 21, 2018). 

This PID was issued shortly after the Agency for Toxic Substances and Disease Registry’s announcement on April 8, 2019, of the opening of a docket on the draft toxicological profile for glyphosate.  84 Fed. Reg. 13922.  ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019.

Commentary

EPA’s PID and related documents, along with ATSDR’s draft profile and the peer review which will follow, can be expected to become part of the larger debate about the potential risks of glyphosate.  In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments.  See our December 19, 2017, blog item "EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment" for more information. 

EPA’s PID is interesting not only for the conclusions EPA reached following its review of data submitted by registrants in response to a data call-in (DCI) and following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) meeting to consider and review scientific issues related to EPA’s evaluation of the carcinogenic potential of glyphosate, but for the issues that remain to be addressed.  Notably, EPA states that it has not considered the petition filed on September 27, 2018, to reduce glyphosate’s tolerance because the petition was filed after the comment period for the human health and ecological risk assessments closed.  Instead, EPA plans to post the petition in the glyphosate docket and address the petition concurrently with the development of the Interim Registration Review Decision.

In addition, EPA has not in the PID or related documents addressed issues regarding its Endangered Species Act (ESA) assessment or its Endocrine Disruptor Screening Program (EDSP) activities.  EPA states it intends to complete an assessment of risk to ESA-listed species prior to completing its final registration review decision for glyphosate, and that it also will make an EDSP determination under Federal Food, Drug, and Cosmetic Act (FFDCA) Section 408(p) before completing its registration review.  EPA also notes that it continues to evaluate risks to pollinators, and that if it determines “that additional pollinator exposure and effects data are necessary to help make a final registration review decision for glyphosate, then the EPA will issue a DCI to obtain these data.”  Although there are significant areas that remain to be resolved, EPA issued the PID “so that it can (1) move forward with aspects of the registration review case that are complete and (2) implement interim risk mitigation.”

More information on glyphosate issues is available on our blog.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300:  Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests.  The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) website.  Comments on the candidates are due by May 18, 2019, to the Designated Federal Official (DFO) Dr. Suhair Shallal (.(JavaScript must be enabled to view this email address)).  EPA is requesting these comments prior to the FIFRA SAP public in-person meeting scheduled for June 11-14, 2019, from 9:00 a.m. to 5:00 p.m. (EDT), which will review EPA’s proposed guidelines referenced above and the supplemental document Sample Size for Pet Product Studies84 Fed. Reg. 15214.  The charge questions to the panel are available here (Charge Questions). 

EPA’s Federal Register notice announcing the meeting states that the meeting will be augmented with additional experts to provide independent scientific advice on the proposed guidelines.  Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review.  The in-person meeting on June 11-14, 2019, will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Building), 2777 South Crystal Drive in Arlington, Virginia.  The meeting will also be available via webcast.

EPA’s original Product Performance Test Guidelines, OPPTS 810.3300, Treatments to Control Pests of Humans and Pets were published in March 1998.  EPA’s Charge Questions state that “[t]o increase clarity and consistency in efficacy testing and to include current scientific standards, the agency is revising this product performance guideline.”  Further, the proposed guidelines apply to products “in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies”; do not apply “to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other agency guidelines”; and, in addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline “also includes testing methods for evaluating efficacy under simulated environmental conditions.”

EPA believes the current Draft Guidelines represent the state of the science with regard to efficacy testing for these products; but is still seeking advice and recommendations from the FIFRA SAP on scientific issues related to the Draft Guidelines.  EPA states that it is committed to reducing the use of animals in testing but, at this time, no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes, and biting flies.  EPA is soliciting comment from the FIFRA SAP on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.

Information on attending the meeting in person and via webcast can be found on the FIFRA SAP website.  EPA is requesting that written comments on the documents undergoing peer review be submitted to Docket No. EPA-HQ-OPP-2019-0161 by May 17, 2019, to provide the FIFRA SAP the time necessary to consider and review the written comments.


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W.  84 Fed. Reg. 18993.  The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text.  EPA initially proposed this change on August 18, 2017 (82 Fed. Reg. 39399) because it agreed to do so in a settlement agreement with the American Chemistry Council (ACC) after ACC filed a petition for review of the 2013 final rule titled “Data Requirements for Antimicrobial Pesticides” (78 Fed. Reg. 26936 (May 8, 2013)) in the U.S. Court of Appeals for the District of Columbia Circuit.  Specifically, EPA agreed to make this correction to “make the language consistent” with the U.S. Food and Drug Administration’s (FDA) policy set forth in FDA’s “Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.”  EPA states that the change is intended to “enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously promulgated requirements” and that it is not establishing “any new data requirements or any other revisions (substantive or otherwise) to existing requirements.”  The final rule will become effective on July 2, 2019.


 

By Timothy D. Backstrom

On April 19, 2019, the U.S. Circuit Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order following an en banc rehearing in League of United Latin Am. Citizens (LULAC) v. Wheeler, No. 17-71636.  The February 6, 2019, Ninth Circuit decision to grant a U.S. Environmental Protection Agency (EPA) request for rehearing effectively vacated an August 9, 2018, decision in LULAC that had ordered EPA to revoke all tolerances and cancel all registrations for chlorpyrifos.  After rehearing, the en banc panel issued a writ of mandamus directing EPA “to issue, no later than 90 days after the filing of this order, a full and fair decision on LULAC’s objections" to an initial EPA order denying a 2007 petition to revoke all tolerances for chlorpyrifos.  The en banc order states that the court has discretion to construe the Petitioners' opening brief as a request for mandamus relief, even though the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections and even though they did not file a petition for mandamus under the applicable procedural rule.  The court then states that “[c]onsidering the history and chronology of this matter and the nature of the claims, we conclude mandamus is appropriate, and we hereby GRANT the Petition for a Writ of Mandamus.”

The court states that “EPA represented that it could issue a final decision with respect to petitioners’ objections within 90 days of an order issued by this court” during oral argument on March 26, 2019.  The en banc ruling, however, does not discuss the jurisdictional issues presented when the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections.  Moreover, the ruling does not discuss the substantive dispute concerning EPA's authority to decline to revoke the tolerances and cancel the registrations for chlorpyrifos based on the current administrative record.

Commentary

The procedural questions presented in the LULAC litigation are unusual and reflect a long and contentious history.  EPA’s April 5, 2017, decision to deny a 2007 petition to revoke the tolerances and cancel the registrations for chlorpyrifos came after issuance of a prior writ of mandamus that required EPA to take action on the pending petition, an EPA proposal to revoke the tolerances for chlorpyrifos issued in response to the prior writ, and a subsequent decision by EPA during the early days of the Trump administration to reverse course on the proposal and keep the tolerances in place while EPA completed the registration review process.  The Petitioners in LULAC duly filed objections to the initial denial of their tolerance petition, which was a necessary statutory prerequisite to pursuing further judicial review.  In addition, however, they elected to file for judicial review of EPA's initial denial of their tolerance petition on the same day as they filed their objections.  The Petitioners could not yet reasonably seek mandamus at that time because EPA had not been afforded any time yet to respond to their objections.  Instead, the Petitioners argued that requiring them to follow the normal administrative process would be futile.

Although the Ninth Circuit's decision after en banc rehearing may appear to a procedural victory for EPA, it can also be seen as a solution to the quandary created by the Petitioners' actions and the first court decision.  The Ninth Circuit as a whole was apparently not comfortable with the decision by the first panel that the Petitioners should be allowed to obtain review of a non-final order because waiting for final and reviewable EPA action would be a futility.  Nevertheless, by issuing a new writ of mandamus, the court seems to be sending a clear signal that it will not countenance further delays in EPA’s taking final action on the petition to revoke the chlorpyrifos tolerances.  In the relatively brief time remaining before the court deadline for final action, EPA confronts a significant challenge of ensuring all relevant data have been adequately and appropriately considered, particularly given the many controversies concerning the data that EPA used to support its initial decision to revoke the tolerances. 

More information on the protracted litigation concerning chlorpyrifos is available on our blog under key words chlorpyrifos and ninth circuit.


 

By James V. Aidala and Susan M. Kirsch

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making available its Interpretive Statement addressing whether the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) permit program applies to releases of a pollutant from a point source to groundwater (Interpretive Statement) for comment.  84 Fed. Reg. 16810.  EPA is issuing the Interpretative statement to “provide clarity on [EPA’s] interpretation of the [CWA] given the mixed record of prior [EPA] statements and a split in the federal circuit courts regarding this issue.” EPA’s Interpretive Statement states that it “sets forth [its] interpretation of the [CWA NPDES] permit program’s applicability to releases of pollutants from a point source to groundwater that subsequently migrate or are conveyed by groundwater to jurisdictional surface waters” and “EPA concludes that the [CWA] is best read as excluding all releases of pollutants from a point source to groundwater from NPDES program coverage and liability under Section 301 of the CWA, regardless of a hydrologic connection between the groundwater and a jurisdictional surface water.”  EPA also released a fact sheet on its Interpretive Statement, available online.

The April 23 Federal Register notice states that the Interpretative Statement reflects EPA’s consideration of the public comments received in response to its February 20, 2018, Federal Register notice (83 Fed. Reg. 7126) which requested comment on EPA’s previous statements regarding whether pollutant discharges from point sources that reach jurisdictional surface waters via groundwater or other subsurface flow that has a direct hydrologic connection to the jurisdictional surface water may be subject to CWA regulation.  EPA received over 50,000 comments from a wide range of stakeholders, many of which affirmed that additional clarity from EPA was necessary.  EPA reached its conclusion based on the comments received and on “a holistic analysis of the [CWA], its text, structure, and legislative history.”  EPA also references numerous policy considerations that support excluding groundwater discharges from NPDES permitting, including existing state and federal authorities and statutes that play a role in regulating groundwater quality (e.g., Safe Drinking Water Act (SDWA) Underground Injection Control (UIC) program).

EPA is soliciting public comments on the Interpretive Statement, specifically regarding what may be needed to provide further clarity and regulatory certainty on this issue.  Comments are due by June 7, 2019.

EPA’s Interpretive Statement comes at a critical time when the U.S. Supreme Court is set to address the question of “[w]hether the [CWA] requires a permit when pollutants originate from a point source but are conveyed to navigable waters by a nonpoint source, such as groundwater” (see SCOTUSblog) in its review of the Ninth Circuit decision in County of Maui v. Hawaii Wildlife Fund (Maui).  A petition for U.S. Supreme Court review is also pending on the Fourth Circuit decision in Kinder Morgan Energy Partners v. Upstate Forever (Kinder Morgan), which held similarly to Maui that “a discharge that passes from a point source through ground water to navigable waters may support a claim under the CWA.”  A pair of September 2018 Sixth Circuit decisions (Kentucky Waterways Alliance v. Kentucky Utilities Co. and Tennessee Clean Water Network v. TVA) expressly disagreed with the holdings in Maui and Kinder Morgan -- resulting in a “circuit split.”  Although the facts in Maui (wastewater injected into UIC wells) and Kinder Morgan (gas spilled from underground pipeline) may not involve activities common in agriculture and pesticide applications, the new judicial “tests” created in these decisions could dramatically expand the scope of the NPDES universe in ways that could potentially implicate agricultural/pesticide practices.  For example, in Maui, the Ninth Circuit held that Maui County’s discharges from UIC wells to groundwater should require CWA discharge permits because the pollutants from the UIC wells that reached a navigable water were “fairly traceable” and levels reaching the navigable water were “more than de minimis.”  The Ninth Circuit’s Maui holding could be stretched broadly to support the assertion that pesticides and fertilizers applied to agricultural lands that migrate through groundwater and eventually reach a CWA jurisdictional water could be subject to NPDES permitting.  Agriculture and pesticide stakeholders may wish to closely monitor developments around groundwater discharge issues at EPA and the U.S. Supreme Court.  


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 19, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 8, 2019, from 9 a.m. to 5 p.m. and May 9, 2019, from 9 a.m. to 12:00 p.m. (EDT) in the first-floor conference center at One Potomac Yard South, 2777 South Crystal Drive in Arlington, Virginia.  84 Fed. Reg. 16486.  The Federal Register notice states that the agenda is not yet available but that this meeting will provide advice and recommendations to EPA’s Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides.  The draft agenda will be available on or before May 5, 2019, on the PPDC webpage.  The meeting is open to the public and no advance registration is required.


 

By Lisa M. Campbell and James V. Aidala

On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket on the draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019.

The draft profile includes a chapter on glyphosate’s potential for human exposure, which states the following in the overview:

  • “Glyphosate has not been identified in any of the 1,832 hazardous waste sites that have been proposed for inclusion on the [U.S. Environmental Protection Agency (EPA)] National Priorities List (NPL) (ATSDR 2015). However, the number of sites evaluated for glyphosate is not known.” 
  • “Occupational and residential exposure is a result of glyphosate’s use in agricultural, nonagricultural, industrial, and residential settings. The highest potential for dermal, inhalation, and ocular exposure is expected for pesticide applicators, farm workers, and home gardeners who use herbicides containing glyphosate.”
  • “The general population is exposed to glyphosate via ingestion of crops, plants, and foods with residues of this chemical. Residential exposure may occur via inhalation, dermal contact, and/or ocular contact during mixing or application of consumer products containing glyphosate or by coming into contact with crops, soils, or water to which glyphosate-containing products have been applied.”
  • “Occupational exposure to glyphosate may occur via inhalation, dermal contact, and/or ocular contact during manufacture, transport, mixing, loading, application, and disposal processes. Accidental oral exposure may occur via unintentional ingestion. Dermal contact appears to be the major route of exposure to glyphosate for individuals involved in its application.”
  • “Glyphosate mainly enters the environment as a direct result of its herbicidal use. Fate of this chemical in the environment includes degradation, transport, and partitioning processes, which are governed by its physicochemical properties and by abiotic or biotic degradation under certain environmental conditions. Glyphosate is a nonvolatile, highly polar, non-residual herbicide that has low potential for environmental persistence and is unlikely to bioaccumulate.”

 Commentary

ATSDR’s draft profile and the peer review which will follow can be expected to become part of the larger debate about the potential risks of glyphosate.  Meanwhile, EPA continues its work on the registration review of the herbicide.  In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments.  See our December 19, 2017, blog item EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment for more information.  After the public comment period for the draft human health and ecological risk assessments ended in April 2018, EPA officials have stated they hope to complete the registration review sometime this year.

 


 

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):


 
 1 2 3 >  Last ›