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.
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.
By Heather F. Collins, M.S. and Margaret R. Graham, M.S.
The March 1, 2019, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2018 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”
Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.
EPA has created the electronic reporting system to submit pesticide producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, it saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.
Link to EPA Form 3540-16, as well as instructions on how to report, and how to add and use EPA’s SSTS electronic filing system are available below.
Further information is available on EPA’s website.
By James V. Aidala
The short-term continuing resolution (CR) includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) through the duration of the funding measure, February 15, 2019. This was expected, and is welcome news to registrants who have delayed submittal of registration applications due to the shutdown.
The status of applications submitted during the shutdown period is uncertain at best. As described in our earlier blog item Registrants Face PRIA and Shutdown Issues, registrants were advised to not submit applications during the shutdown as the U.S. Environmental Protection Agency (EPA) has previously indicated that applications submitted during the shutdown would not be subject to any PRIA deadline. During this period of budget battles and shutdown uncertainty, it would appear to be prudent to ensure that any applications for registration are submitted while EPA (and PRIA) are operational under appropriated funding.
While this is good news, the uncertainty surrounding the possibility of another shutdown at the end of this period not only makes planning difficult for registrants, it also creates workload management problems at EPA to deal with backlogs and unpredictable resources for processing pending and new applications. EPA will have to clarify what the extended shutdown period means for processing times and priorities. As of today, EPA is still literally sorting out applications and PRIA deadlines along with workload planning to determine how best to proceed.
Stay tuned …