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 …
By Lynn L. Bergeson and Margaret R. Graham
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.
By James V. Aidala, Lisa M. Campbell, and Sheryl Lindros Dolan
Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down.
Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown. According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B) [7 USC § 136w-8(m)(2)(B)], the fee for any pesticide application that is subject to a service fee and submitted after December 21, 2018, will be reduced by 70 percent below the fee in effect on September 30, 2017, but no corresponding review period will be assigned. Any applications submitted now thus will not have a required EPA review period and thus will likely be the lowest priority for EPA review when the shutdown ends. For this reason, despite the lower fees, registrants should not submit applications until PRIA is enacted and defined review periods once again are established.
The enactment of some version of PRIA is expected soon, especially given the consequences of the current situation for EPA and government functions generally. Most likely any kind of authorization for funding government operations, such as a CR for a limited time period or for Fiscal Year 2019, is expected to include at least a simple reauthorization of the PRIA 3 for the duration of the CR. This would also mean the new Congress will have to act sometime in the next session to reauthorize PRIA either to continue PRIA 3 beyond a new CR time period or approve amendments such as those considered as PRIA 4 during the 115th Congress. Given the difficulty of Congress in reaching agreement on appropriations legislation, it is possible that PRIA reauthorizations continue to be included as part of CRs for an indefinite time period.
This uncertainty about the status of PRIA may also impact generally the program’s ability to plan and schedule review of registration applications.
Regardless of when PRIA is enacted, however, the shutdown will prevent EPA action on newly submitted applications. OPP states on its web site:
- Applications received on or prior to December 21, 2018, will be reviewed under the decision time frames specified in PRIA 3;
- Applications received after December 21, 2018, will be subject to the provisions of FIFRA Section 33(m)(2)(B); and
- Applications received after December 28, 2018, will not be considered as received or processed until the shutdown ends.
Registrants should monitor developments closely.
By James V. Aidala and Lisa M. Campbell
On December 19, 2018, the Senate passed a short-term Continuing Resolution (CR) to prevent a government shutdown and continue funding for the government through February 8, 2019. Currently, however, given the uncertainty over border wall funding, it appears likely that there may well be a government shutdown for some period of time. Until the immigration issue is ultimately resolved in an eventual agreement, however, the majority and Democratic staff of the U.S. House of Representatives Agriculture Committee expect that the Pesticide Registration Improvement Act (PRIA) extension will be included in the CR. Both the majority and minority in both the House and Senate have reportedly agreed to support PRIA in the new year.
The recent House Conference Report for H.R. 2, the Agriculture Improvement Act of 2018, or the Farm Bill, deleted previously inserted provisions regarding the Pesticide Registration Improvement Enhancement Act of 2017. The House version of the Farm Bill included the enactment of the Pesticide Registration Improvement Enhancement Act of 2017 (H.R. 1029, Section 9119), but the Senate version contained no comparable provisions. More information on the Farm Bill Conference Report is available in our memorandum “Congress Passes Farm Bill Conference Report.”
The positive news is that many members of both the House and Senate appear to remain committed to legislative reauthorization of PRIA. At the same time, with the change in party control in the House of Representatives, reauthorization may continue to be delayed as the new Congress with new Committee leadership devotes time and energy to competing priorities.
In addition, as PRIA amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it could provide an opportunity for amendments to FIFRA outside of the funding context to be offered by members interested in other pesticide-relevant issues. Debate on additional pesticide issues would only likely lead to further delay and uncertainty about long-term reauthorization of PRIA.
By Lynn L. Bergeson and Carla N. Hutton
On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.” According to the FWP, EPA has identified the following use patterns to date: swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics. The FWP states that people may be exposed to nanosilver through inhalation and dermal exposures while applying the products to swimming pools and from incidental oral exposures during swimming. Further exposures may come from material preservative uses either while applying or from nanosilver that leaches out when textiles and plastics are washed. Nontarget organisms can be exposed when swimming pool water is released or when nanosilver used as a material preservative leaches.
According to the FWP, EPA “anticipates the need to require generation and submission of human health hazard and exposure data and to conduct a human health risk assessment for nanosilver during registration review.” The FWP states that EPA plans to conduct an environmental risk assessment for the nanosilver uses, “particularly focusing on materials preservative uses, such as plastics and textiles if the particular nanosilver chemistries are shown to leach, and swimming pool uses.” Any of the other use patterns may also be subject to ecological assessment if the fate and product chemistry profiles indicate the potential for environmental exposures. According to the FWP, the risk assessment integrates the environmental fate and effects data to determine if any uses pose risks to nontarget organisms. Potential risks to fish, aquatic invertebrates, aquatic plants, and birds and mammals will be assessed after the data gaps specified in the FWP are satisfied and the relevant data are available.
EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity. EPA anticipates issuing in 2018 a DCI requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.”
By Margaret R. Graham
On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on November 1, 2018, from 8:30 a.m. to 12:00 p.m., it will be hosting an informational seminar on biotechnology-pesticide issues for stakeholders. 83 Fed. Reg. 50921. The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777 S. Crystal Dr., Arlington, Virginia, in the lobby-level Conference Center. EPA’s draft agenda for the PPDC meeting has been posted to the PPDC website.
The PPDC meeting agenda lists the following seven sessions:
- Pesticide Registration Improvement Act (PRIA) -- session goal is to “provide the PPDC with an update on EPA’s progress in implementing PRIA”;
- Smart Label Project/e-CSF -- session goal is to “provide the PPDC with an overview the electronic pesticide label, the benefits to EPA and stakeholders, and next steps”;
- Emerging Application Technologies -- session goal is “to inform the PPDC about how new unmanned aerial vehicle (UAV) technology is working in the field for pesticide applications and how this new technology may benefit the agricultural sector”;
- Benefits of Biological Products: Industry Perspective -- session goal is to explain “BPPD’s focus on low risk products and biopesticides, how EPA encourages low risk products by having a different division and registration timelines and costs” and “how pesticides, whether conventional or biological, are reviewed with rigor and held to the same safety standard”;
- Integrated Mosquito Management Training -- session goal is to “provide awareness of on-line training and manual (in English and Spanish) focusing on Integrated Mosquito Management created by AMCA with funding by the Centers for Disease Control and Prevention”;
- Public Health Workgroup -- session goal is to “report on the progress of the group’s Emergency Preparedness Plan and solicit feedback”; and
- 21st Century Toxicology: OPP’s Efforts on Non-Animal Alternative Testing for the Acute 6-Pack -- session goal is to “update the PPDC on OPP’s recent progress toward the reduction of animal use in testing, and the implementation of alternative methods.”
Nancy Beck, Ph.D., Deputy Assistant Administrator of the Office of Chemical Safety and Pollution Prevention and Richard Keigwin, OPP Director, will make the opening remarks. After the sessions, EPA is providing a 15-minute window for public comments. PPDC meetings are free, open to the public, and no advance registration is required.
By Lisa M. Campbell and Lara A. Hall, MS, RQAP-GLP