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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).
This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides: past, present, and future.
In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it. Listen to the full episode and subscribe here.
On February 6, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting the U.S. Environmental Protection Agency’s (EPA) and Acting EPA Administrator Andrew Wheeler’s (collectively EPA or Respondents) September 24, 2018, petition for an en banc rehearing concerning the Ninth Circuit’s August 9, 2018, decision that vacated an EPA order maintaining chlorpyrifos registrations and remanded the case to EPA with directions to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.
The Ninth Circuit’s order granting the Respondent’s petition that the case be re-heard en banc does not provide an explanation for its decision. The Ninth Circuit evidently found the arguments offered by Respondents and other interested parties that filed amicus curiae briefs more persuasive than Petitioners’ brief (including the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC)), who argued against submission of certain amicus curiae briefs and also that, with limited exception, Respondent’s petition for rehearing lacked merit and should be denied.
The en banc oral argument will be held March 26, 2019, at 2:30 p.m. (PST).
Arguments for Rehearing
Prior to the February 6, 2019, order, on October 15, 2018, three amicus curiae briefs were filed in support of EPA’s petition by CropLife America (CLA), Agribusiness Council of Indiana (Agribusiness), and Dow Agrosciences LLC (DAS). Despite Petitioners’ objection to the motions of Agribusiness and CLA for leave to file amicus curiae briefs in support of Respondent’s petition for rehearing, on November 13, 2018, the Ninth Circuit granted the motions for leave to file amicus curiae briefs.
EPA’s petition for rehearing made multiple arguments as to why an en banc and panel rehearing should be granted, including the Panel’s lack of jurisdiction, the Panel’s order conflicting with applicable Supreme Court precedent, and specific modifications to be addressed to the order to comply with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements. More information regarding EPA’s petition is available in our blog item “EPA Petitions for En Banc and Panel Rehearing in Ninth Circuit Chlorpyrifos Case.”
The amicus curiae briefs supported EPA’s arguments and also made arguments supporting rehearing in addition to those previously set forth by EPA. CLA’s brief focused on the fact that the Panel’s decision disregarded FIFRA’s cancellation process, stating: “if EPA ultimately were to determine that any chlorpyrifos registration would need to be cancelled, such an action could not be accomplished in the way the panel majority prescribed: by circumventing the procedures Congress required to ensure that pesticide cancellation decisions are not made unless and until these harms and the best science available are properly vetted.” DAS’ brief addressed in detail the Panel’s violation of administrative law in dictating how EPA must act (i.e., cancel the chlorpyrifos registrations) and the potential violation of FIFRA by EPA if forced to comply with the Panel’s order regarding the timing for cancelling such registrations. The amicus curiae briefs also sought to provide information on the practical consequences that chlorpyrifos registrants and users would face if the panel opinion is not revised. For example, DAS discussed its proprietary interest in protecting its registrations and defending its product, while Agribusiness in its brief provided some background on the use and benefits of chlorpyrifos, the lack of viable alternatives, and the ramifications of the order on insect pest resistance and the ability to combat new invasive pests.
Petitioners’ response to the petition for rehearing and rehearing en banc argued that there was no basis for rehearing. Petitioners noted that en banc review is “disfavored” and appropriate in limited “extraordinary circumstances” and in the face of “an irreconcilable conflict between the holdings of controlling prior decisions of this court.” Petitioners argued that the Panel decision was in accord with precedent and that a request for rehearing “would only result in further delay.” Petitioners did concede on two points: (1) modifying the order to direct EPA to cancel the registrations under the FIFRA cancellation process, which necessitates more time than the 60 days set forth in the order; and (2) clarifying that the order is limited to cancelling registrations that can result in residues on food.
EPA, chlorpyrifos registrants and users, and industry generally should be encouraged by the decision to grant an en banc rehearing in this case, but the outcome is far from certain. Given the issues at stake, registrants should monitor this hearing closely.
FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Combination Sunscreen-Insect Repellent Products
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."
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."
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:
EPA will be addressing these and many other important questions over the next few days.
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.
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 …
On December 28, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-26 changing its Notice of Decision (NOD) and public report documentation for proposed registration decisions to ensure continued compliance with its certified regulatory program obligations under the California Environmental Quality Act (CEQA). The new changes to the NODs and public report documentation will be effective May 1, 2019.
These changes are as a result of a 2014 lawsuit brought by Pesticide Action Network North America (PANNA), et al. challenging DPR’s acceptance of label amendments for two previously registered dinotefuran pesticide products. The First District Court of Appeal held that DPR’s NODs and public reports supporting the dinoteferan registration actions were deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA. In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record. Specifically, the court found that DPR failed to include a checklist or other documentation with meaningful analysis explaining how DPR reached its conclusion that the approval of the proposed label changes would not cause a significant adverse impact to human health, flora, fauna, water, and air.” The court also found DPR’s discussion of alternatives and cumulative impacts inadequate. Information about that case is available in our blog item California Court of Appeal Reverses Trial Court Decision Denying PANNA’s Petition Challenging Approval by DPR of Pesticides Containing Dinotefuran.
CEQA is intended to ensure projects permitted by public agencies consider the long-term protection of the environment. DPR states that CEQA “requires state and local agencies to develop an environmental impact report (EIR) for any proposed or approved project that may have a significant effect on the environment (including human health) or a negative declaration if there is substantial evidence of no significant impacts.” EIRs provide public agencies and the public “with detailed information about a proposed project’s significant effects on the environment, describe ways these effects can be minimized, and indicate alternatives to the proposed project.” CEQA and its implementing regulations set forth in Title 3, California Code of Regulations (3 Cal. Code Regs.) Sections 6254 and 6255, also require DPR to issue a weekly Notice of Proposed Decisions to Register Pesticide Products and Public Report, listing each proposed decision to register and amend pesticide products for a 30-day public comment period.
Changes to the NOD and Public Report Documentation
To address concerns raised by the court and to protect its certified program status, on January 3, 2018, DPR issued California Notice 2018-01 (“Expanding Use of Pesticide Products Under Reevaluation”), providing that, effectively immediately, DPR “will not act upon an Application for Pesticide Registration or Application to Amend Pesticide Product if DPR determines the registration or acceptance would potentially ‘expand use’ … of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.”
With Notice 2018-26, DPR will change the documentation associated with its environmental analysis in the NODs and public reports. According to Notice 2018-26, the revised NODs and public reports will address the following areas for each pesticide product noticed for registration:
In addition, each public report will include the proposed label. For label amendments, DPR will include both the proposed label and currently accepted label.
In summary, effective May 1, 2019, DPR “will no longer post new products and label amendments exiting the formal evaluation process as proposed to register for the 30-day public comment period until DPR completes a public report explaining why the new product or label amendment is not reasonably expected to cause a significant adverse impact to human health, flora, fauna, water, and air.” New products and label amendments that exit the formal evaluation process prior to May 1, 2019, will be posted for the 30-day public comment period using the current NOD documentation.
The impact of these changes could be substantial from a timing and DPR workload perspective and, thus, of significant concern to registrants. DPR has stated it is reviewing its internal processes and procedures and hiring additional staff to accommodate changes in workload as a result of the NOD and public report documentation changes. This is based, in part, on the fact that if current evaluation reports are not available for each CEQA checklist area (i.e., human health, flora, fauna, water, and air), DPR staff may need to review prior evaluation reports, documentation in product files, U.S. Environmental Protection Agency (EPA) risk assessments, and other available information to develop the public report. Moreover, DPR states that if it does not have adequate information to address each CEQA checklist area, the product may need to reenter DPR’s formal evaluation process. All of these factors could significantly extend the amount of time DPR takes to review a new product or amendment, as it must now develop these public reports prior to proposing registration decisions with a 30-day public comment period, and that time could be even longer in cases where DPR determines it requires additional evaluation of the product and/or data necessary to complete such public reports.
Due to the government shutdown and to the late notification to applicants, the U.S. Environmental Protection Agency (EPA) has extended the annual maintenance fee submission date for pesticide registrants from January 15, 2019, to February 15, 2019. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A), each registrant of a pesticide must pay an annual fee by January 15 of each year for each registration; the fee for 2019 is $ 3,392. The notification of the extension is only available if you call the Pesticide Maintenance Fee information line, however; EPA has provided the information in a voice message. More information on the annual maintenance fees is available on EPA’s website.
On another note, on January 2, 2018, we understood that EPA had confirmed that Imports and Notice of Arrivals (NOA) were continuing to be processed by EPA Regional offices notwithstanding the shutdown. We were mistaken. We now understand that EPA is not completely clear if NOAs are being processed during the shutdown. The EPA Regional offices are working with the U.S. Customs and Border Protection (CBP), but no additional information is available at this time on the processing of Imports and NOAs.