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 and Lisa R. Burchi

On May 30, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order in National Family Farm Coalition v. EPA, No. 17-70810 (filed Mar. 21, 2017) regarding the scope of its review of a petition challenging a 2017 U.S. Environmental Protection Agency (EPA) Notice of Pesticide Registration.  This 2017 order addresses Dow AgroSciences LLC’s Enlist Duo product.  The Petitioners include the National Family Farm Coalition and the Natural Resources Defense Council.

The May 30, 2019, order addresses whether the court could review two prior EPA orders, one issued in 2014 and one in 2015, regarding the registration of Enlist Duo.  Those 2014 and 2015 EPA orders had also been challenged in court, and subsequently remanded to EPA to consider additional information.  Following EPA’s consideration of this additional information, EPA increased the allowed use sites for the Enlist Duo registration to include cotton and increased the number of states authorized to use Enlist Duo from 15 to 34 states.

The Ninth Circuit’s May 30, 2019, order finds that the 2017 order “reissues the original Enlist Duo registration and amendment addressed in the 2014 and 2015 orders, thus making the full registration of Enlist Duo for GE corn, soybean and cotton for use in 34 states subject to [its] review.”  The court based its decision on the language of EPA’s 2017 order and EPA’s Final Registration Decision.  The court found persuasive, for example, that EPA’s 2017 order states that it “supercedes” EPA’s 2014 order, which the court stated is “consistent with our determination that the 2014 order previously remanded to EPA has now been finalized.”  Since EPA identified its 2017 order as final and had characterized its 2014 and 2015 orders as having an incomplete record, the court stated that it will “review the 2017 order on the combined records of the 2014, 2015 and 2017 orders, all of which is incorporated into the 2017 order’s record.”

The court further noted that EPA’s “2017 order also purports to extend the 2014 registration’s (and that of the 2015 amendment) initial 2020 expiration date by two years.”  Since the court found that nothing “suggests that this term is specific to the new uses on GE cotton in 34 states or GE corn and soybean in the additional 19 states,” the court stated that the 2017 EPA order could not have been limited to adding only these post-2015 uses as EPA had asserted. 

Following this determination, the Ninth Circuit stated that “submission of this case is deferred” pending additional briefing to address “all challenges to the initial registration (2014 order) and the original amendment (2015 order), as that registration and amendment has been reissued in the 2017 order -- including challenges to all supporting documentation” and “what relief [it] should provide if Petitioners’ claims are successful, ‘in whole or in part.’”  The timing for such briefing is as follows:

  • Counsel for each Petitioner is directed to file a supplemental brief of 7,000 words or less within 60 days of the date of the order (by July 30, 2019);
  • Counsel for Respondent and Intervenor are directed to file a responsive brief of 7,000 words or less within 60 days from the date of filing of Petitioners’ briefs; and
  • Petitioners may each file reply briefs not to exceed 3,500 words within 30 days from the date of the filing of Respondent’s brief. 

 

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 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 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 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 James V. Aidala and Margaret R. Graham, M.S.

On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was updating its Residual Time to 25% Bee Mortality (RT25) Data Table with information it has collected since the table was first published in 2014.  EPA states that the “RT25 data help farmers and beekeepers know about how long a specific pesticide may remain toxic to bees and other insect pollinators following foliar application to crops,” and the new data “reflect the results of studies the agency has analyzed as part of [its] routine pesticide regulatory activities.”  One example that EPA provides regarding how this new data will work is that farmers can now “choose pesticides that quickly lose their toxicity to bees,” and that applying the products in the evening “helps ensure that by morning the pests have been dealt with and blooming crops are safe for bees.” 

EPA states that RT25 values are a function of a number of factors including application rate, physical-chemical properties, dissipation, crop, and pesticide formulation.  The values provided were compiled from registrant-submitted data submitted to fulfill the data requirement for Honey Bee (Apis mellifera) Toxicity of Residues on Foliage study (OCSPP Guideline 850.3030).  EPA states that the honey bee toxicity of residues on foliage study “is a laboratory test designed to determine the length of time over which field weathered foliar residues remain toxic to honey bees, or other species of terrestrial insects” and, depending on the chemical tested, “either the technical grade active ingredient or a specific formulation was tested using either the honey bee, alfalfa leaf cutting bee, or alkali bee.”  The data table lists the test material, the species tested, and the plant species on which residues were aged.

EPA plans to update the table annually as it collects additional data going forward.  More information on EPA’s actions intended to protect pollinators is available on EPA’s website.

Commentary

In addition to providing the residual toxicity values, the table also illustrates the wide range of toxicity values among the various pesticides.  RT25 times for the different active ingredients can range between a few and over 500 hours to reach the RT25 threshold.  Even different formulations using the same active ingredient can have a significant difference in toxicity values.  This illustrates the importance of reading the specific label instructions for a pesticide, even one that might be generally familiar to the user.

EPA’s publication of this information online also imposes a duty for EPA to continually update the table, especially to capture any changes in the information appearing in an earlier listing of the data.  If, upon further review or later data submissions there are changes to the table for a product, EPA will need to alert users to potentially important changes in the information.  Again, this illustrates the need for reading the label for each pesticide at the time of application, since some important information may have changed.


 

By James V. Aidala

On February 14, 2019, the Senate approved S. 483 to reauthorize the Pesticide Registration Improvement Extension Act (PRIA 4).  The Senate bill did not have the specific categories and timelines of earlier reauthorization language, referring instead to more general legislative language that the Senate approved during the Farm Bill authorization in 2018.  Legislation in this new session of Congress was necessary since PRIA was not reauthorized as part of the appropriations language approved by Congress to end the government shutdown.  More information on the Senate bill is available in our blog item “PRIA Not Extended in Appropriations Bill; PRIA 4 Bill Passed by Senate.”

When, on February 25, 2019, the House of Representatives also approved S. 483, the legislation included the specific timelines and PRIA categories which appeared in the original PRIA 4 proposal.  This meant that either the different language in the legislation would need a House-Senate conference, or, the Senate could simply vote again and approve the House version of S. 483.  That is the course of action taken by the Senate, which then approved the amended text (the House approved language) of S. 483 on February 28, 2019.

The legislation now awaits signature by the President, and then PRIA 4 will become law.  It extends PRIA through fiscal year (FY) 2023.  The legislation raises the industry registration fees and refines some of the categories of actions from PRIA 3 (specific legislative text is available here).


 

By Carla N. Hutton

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Under the proposed rule, products that combine sunscreens with insect repellents would not be GRASE.  Publication of the proposed rule in the Federal Register will begin a 90-day comment period.

Sunscreen-insect repellent products are jointly regulated by FDA as sunscreen drugs and by the U.S. Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  On February 22, 2007, FDA and EPA both issued advance notices of proposed rulemaking (ANPR) requesting comment on the appropriate regulatory status of these products.  FDA published a notice seeking information to formulate a regulatory position on insect repellent products that contain OTC sunscreen ingredients.  72 Fed. Reg. 7941.  EPA published a similar notice announcing that it was also seeking information to determine how insect repellent-sunscreen combination products should be regulated to complete the reregistration review described in the Reregistration Eligibility Decision document for the insect repellent N,N-diethyl-meta-toluamide (DEET). 72 Fed. Reg. 7979.

In the proposed rule, FDA states that it reviewed comments submitted in response to the 2007 ANPRs, as well as pertinent scientific literature and publicly available EPA regulatory documents.  Based on that review, FDA has tentatively concluded that sunscreen-insect repellent combination products, as a class, are not GRASE and are misbranded because conflicting labeling requirements for the sunscreen and insect repellent components cannot be reconciled to create labeling that will sufficiently ensure the safe and effective use of the sunscreen component, as well as adequate directions for use as a sunscreen.  FDA states that even if it did not have this labeling concern, it would still tentatively determine that available data regarding the safety and effectiveness of these products for their use as sunscreens are insufficient to classify these sunscreen products as GRASE for such use.  Specifically, according to FDA, evidence suggests that interactions between some sunscreen active ingredients and insect repellents may decrease safety by increasing systemic absorption of one or both components, and potential synergistic effects on the efficacy of sunscreen active ingredients apparently have not been studied.  

The proposed rule states that FDA tentatively determines that sunscreen-insect repellent combination products are not GRASE for nonprescription sunscreen use.  FDA seeks comment on this tentative determination.  Publication of the proposed rule in the Federal Register on February 26, 2019, will begin a 90-day comment period.  More information on the proposed rule is available in our memorandum, "FDA Will Publish Proposed Rule for OTC Sunscreen Drug Products."


 

By Sheryl Lindros Dolan and James V. Aidala

The Appropriations Bill that is expected to be signed into law on February 15, 2019, provides funding for the rest of Fiscal Year (FY) 2019 and averts another federal government shutdown.  It does not, however, include either an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or Reauthorization, widely referred to as PRIA 4.  This omission was a surprise to industry and to the U.S. Environmental Protection Agency (EPA).  On February 13, 2019, the Senate introduced a stand-alone PRIA 4 bill (S. 483).  Acting swiftly, the Senate passed the bill on February 14, 2019, by unanimous consent.  S. 483 directly references H.R. 1029, the Pesticide Registration Enhancement Act of 2017, from the last Congress, with amendments passed by the Senate on June 28, 2018.  

S. 483 has moved to the House, where the timing of a vote currently is unclear.  The House will go into a week-long recess after today.  It is possible that the bill will not further progress until the House reconvenes on February 25, 2019. 

The effect on EPA and the regulated community during this transition is also unclear.  Currently, EPA is sorting out applications and PRIA deadlines along with workload planning in the aftermath of the recently concluded federal government shutdown.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides for a reduction in applicable fees if PRIA is not reauthorized, but it is unclear if applications submitted during the transition will be assigned a PRIA review date.  If PRIA 4 is passed, we expect that the fee provisions will be retroactive and that EPA will send invoices to applicants for submissions made during the transition period for the difference between what was paid and the new PRIA 4 fee. 

More information on these topics is available in our blog items "Federal Budget Deal Negotiations Fail to Advance PRIA Reauthorization" and "Continuing Resolution to Re-open the Government Includes PRIA Extension."


 

By James V. Aidala, Sheryl Lindros Dolan, and Susan M. Kirsch

As reported in the trade press on February 14, 2019, following budget negotiations late on Wednesday, February 13, several legislative riders did not make it into the conference report for the final fiscal year (FY) 2019 omnibus spending package.  This purportedly includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or the long-awaited Reauthorization known as “PRIA 4.”  This may be the result of political pressure to avoid another government shutdown with a “clean bill” package capable of garnering the necessary votes.  The Senate and House are expected to vote on the omnibus package today, February 14, 2019, ahead of the expiration of the current budget resolution on February 15.  While much is still in flux, the final omnibus package, once passed, will provide a clearer picture on any PRIA implications.  At this time it appears that, contrary to past budget resolutions, PRIA 3 will not be extended.  More information on the recent PRIA extensions is available in our blog items Continuing Resolution to Re-open the Government Includes PRIA Extension and Registrants Face PRIA and Shutdown Issues.

In the event of a lapse, the “phase-down” provisions in the statute will mean that new submissions require a reduced fee schedule, but submissions will no longer have an associated PRIA deadline for a decision on the application.  The U.S. Environmental Protection Agency (EPA) will likely “clarify” in the coming days and weeks what this means for any expectation for an application submitted during this time.  During the recent shutdown, EPA stated that applications submitted during that temporary lapse only required the reduced fee.  At that time, however, since no deadline was required for such an application, EPA advised that applicants should expect guidance as to when to expect a decision (that is, in effect, do not bother to submit things during the shutdown period since PRIA actions with an associated deadline will have priority for the foreseeable future).  When the federal government reopened on January 28, however, EPA processed all applications received during the shutdown as PRIA actions submitted on January 28.

Now with PRIA likely not in effect after February 15, 2019, even with an approved EPA budget for FY2019, EPA will have to evaluate what to communicate to applicants about what to expect during the time of the PRIA 3 phase-down.  Any plans for this period may be affected by provisions in PRIA 4.  On February 13, 2019, the Senate introduced standalone PRIA 4 legislation (S. 483) with bipartisan support which could facilitate relatively quick Senate action on a PRIA 4 proposal.  The House would also need to take action to renew the program.

Because no PRIA action was taken in the budget agreement, important questions now swirl about the program, including:  

  • What happens to any new submissions?  
  • Will there be impacts on pending deadlines?  
  • What exactly will happen to any submissions made during the current “no PRIA” period?  
  • What might be the longer term impact of this (in)action on general pesticide program operations (e.g., staffing, contracts, schedules for non-PRIA actions)?

EPA will be addressing these and many other important questions over the next few days. 


 
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