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 Lisa M. Campbell and Heather F. Collins, M.S.
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation.
During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:
- Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
- Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
- Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
- Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
- Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.
Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.
Specific times for this and other breakout sessions, as well as more detail, will be made available online. The Stakeholder Forum is open to the public, with advance registration. Space is limited and registrations will be accepted on a first-come-first-served basis. Registration is available online.
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 Lisa R. Burchi and Lisa M. Campbell
On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards. Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) allows EPA to “grant federal and state lead agencies the authority to approve -- in certain emergency situations -- the limited application of a pesticide not registered for that particular use. These short-term pesticide use approvals are called emergency exemptions.” OIG states that the scope of the audit “focused on the emergency exemption management process and the internal controls necessary to consistently implement and administer it.” OIG did not “evaluate the science used to review emergency exemptions or the subsequent emergency exemption application decisions.”
OIG’s main criticisms of EPA’s emergency exemption program listed in the report are:
- EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption application process, including the total acres affected, the proposed and actual quantities of the exempted pesticide applied, and the estimated economic losses but it does not use these data to support outcome-based performance measures that capture the scope of each exemption, to measure the potential benefits or risks of each exemption, or to determine how well the emergency exemption process maintains human health and environmental safeguards.
- OPP does not consistently communicate emergency exemption information with its stakeholders. OPP previously sent a “year in review” letter to states that summarized the emergency exemption activity for that year and provided additional information regarding the emergency exemption process. OPP has not sent this letter since 2015, however.
- There were significant deficiencies in the OPP’s online database management, in its draft Section 18 emergency exemption standard operating procedure and application checklist, and in its reports to Congress and the Office of Management and Budget.
The eight OIG recommendations in the report for the Assistant Administrator (AA) for the Office of Chemical Safety and Pollution Prevention’s (OCSPP) consideration, and OCSPP’s response to those recommendations, are as follows:
Recommendation 1: Develop and implement applicable outcome-based performance measures to demonstrate the human health and environmental effects of the EPA’s emergency exemption decisions.
- OCSPP Response and OIG Resolution: OCSPP did not agree with this recommendation, stating that development of an outcome-based performance measure for the Section 18 emergency exemption process was neither appropriate nor feasible. No proposed corrective actions were proposed and this issue remains unresolved.
Recommendation 2: Determine which application review performance target for emergency exemption applications the OPP plans to meet, and make that target consistent between its Annual Performance Goal and its internal controls governing the emergency exemption process.
- OCSPP Response and OIG Resolution: OCSPP did not agree or disagree with Recommendation 2, but it nevertheless provided a corrective action “to avoid future confusion” and a completion date (July 31, 2019) that was considered acceptable to OIG.
Recommendation 3: Update and prepare the draft standard operating procedure in final that OPP uses to guide the emergency exemption process.
- OCSPP Response and OIG Resolution: OCSPP agreed with this recommendation and provided planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.
Recommendation 4: Develop formal emergency exemption application review procedures that detail specific data collection, management and reporting control steps, and procedures that require specific management controls for accurately and consistently updating the OPP’s Section 18 database.
- OCSPP Response and OIG Resolution: OCSPP agreed with this recommendation and provided acceptable planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.
Recommendation 5: Develop concise emergency exemption application guidance that specifies the minimum requirements of an application submission and is available on the OPP’s Section 18 website.
- OCSPP Response and OIG Resolution: OCSPP did not agree or disagree with Recommendation 2, but it nevertheless proposed to: (1) evaluate how its web resources can be enhanced to respond to this recommendation; and (2) if it determines that enhancements to the Section 18 website are necessary, implement any needed web updates by December 2019. OIG does not believe the proposed corrective action for this recommendation is sufficient to meet the intent of the recommendation and states this recommendation remains unresolved.
Recommendation 6: Provide clear guidance to state lead agencies on how and when they can use efficacy data from other state lead agencies to satisfy the emergency exemption application criteria.
- OCSPP Response and OIG Resolution: OCSPP did not agree with this recommendation, stating that the only example provided by OIG to support this recommendation represents an extremely rare situation. No corrective actions were proposed and this issue remains unresolved.
Recommendation 7: Expand the data presented in the OPP’s Section 18 database by considering additional data points, such as application acreage requested, actual acreage applied, and registration status of each exempted pesticide.
- OCSPP Response and OIG Resolution: OCSPP agreed with this recommendation and stated it would “consider additional data points, such as application acreage requested, decision documents, and registration status of each exempted pesticide, as OCSPP explores ways to improve the website database and its overall content.” OCSPP proposed that by December 2019 recommendations would be made to the OPP Director for enhancing the Section 18 database and a memorandum would be provided to the OCSPP AA with a plan for updating the Section 18 database addressing these recommendations. OIG states that OCSPP did not commit to expanding the data presented in the Section 18 database and, thus, this issue remains unresolved.
Recommendation 8: Provide an annual update and information summary to state lead agencies to better inform them about any changes to the emergency exemption application-and-review process.
- OCSPP Response and OIG Resolution: OCSPP agreed with this recommendation and stated it would “explore how to provide periodic and useful program updates to applicants.” OCSPP proposed by that December 2019 it would “work with State Lead Agencies to identify the types of information they may find helpful for periodic updates” and “develop a strategy which details the activities that might be conducted to provide periodic and useful program updates to applicants.” OIG states that OCSPP found the term “periodic” unclear and stated the issue remains unresolved.
Although several of these recommendations and EPA’s proposals remain unresolved, registrants should monitor for actions to be taken by EPA in response to the OIG Report.
By Carla N. Hutton
On April 10, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft Science Policy document intended to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation, or sensitization of the skin. According to EPA, the document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, “describes the science behind the non-animal alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization.” The draft Science Policy states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions of new approach methodologies (NAM) and defined approaches (DA) as described in the draft Science Policy. EPA notes that there are multiple domestic and international activities ongoing that will allow for refinement and expansion of this draft Science Policy to other DAs and additional NAMs and support global harmonization of DAs for skin sensitization. According to the draft Science Policy, OPP and OPPT “will continue to be active participants in these activities to ensure regulatory acceptance and will continue to support cross-sector collaborations that enhance animal welfare, and accelerate the implementation of NAMs.” Comments on the draft Science Policy document must be submitted to Docket Number EPA-HQ-OPP-2016-0093 by June 9, 2018.
The draft Science Policy is the result of national and international collaboration between the Interagency Coordinating Committee on the Validation of Alternative Methods, the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods, the European Union Reference Laboratory for Alternatives to Animal Testing, and Health Canada’s Pest Management Regulatory Agency.
By Lisa M. Campbell and James V. Aidala
On September 18, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs to Manage Pesticide Funds More Efficiently.” OIG states that it conducted the audit “to determine whether EPA manages the Pesticides Reregistration and Expedited Processing Fund (known as the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] Fund) and the Pesticide Registration Fund (known as the [Pesticide Registration Improvement Act (PRIA)] Fund) effectively to minimize reliance on appropriated funds.”
In the report, OIG states its finding that “EPA should manage the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and [Pesticide Registration Improvement Act (PRIA)] Funds more effectively by reducing excess fund balances to within a target range. As of September 30, 2016, [OIG] identified excess funds of approximately $21.4 million for FIFRA and $8.5 million for PRIA, for a total of $29.9 million. A reduction in fund balances would increase the availability of appropriated funds for other environmental purposes.”
In the report, OIG makes the following recommendations to EPA:
- For the Assistant Administrator for Chemical Safety and Pollution Prevention (OCSPP) to “establish a target range for its FIFRA and PRIA Fund balances and develop and implement a plan to reduce excess funds to within the target range”; and
- For the Chief Financial Officer to “reconcile the FIFRA and PRIA Funds’ balances to the corresponding liabilities.”
The report states that EPA concurred with establishing a target range and developing a plan to reduce excess funds for FIFRA Fund balances, but did not agree with establishing a target range and developing a plan to reduce excess funds for PRIA Fund balances, citing the lack of predictability of PRIA collections. OIG stated that it “still believe[s] PRIA has excess funds that should be addressed,” and “[t]he agency agreed to reconcile FIFRA and PRIA balances.”
This report follows two OIG reports issued on August 14, 2017, on audits of the financial statements of (1) the FIFRA Fund; and (2) the PRIA Fund for fiscal years (FY) 2015 and 2016. OIG is required to perform an annual audit of the financial statements of the FIFRA Fund under the Food Quality Protection Act (FQPA), and of the PRIA Fund under PRIA.
OIG states in its reports on the audits for FYs 2015 and 2016, of both the FIFRA and the PRIA Funds, that it “noted a material weakness in that the EPA cannot adequately support its FY 2016 [PRIA/FIFRA] Fund costs.” OIG further stated, however, that this issue has been noted in prior audit reports, and that EPA is taking corrective actions.” For those reasons, OIG stated that it was making “no new recommendations for [these] material weakness[es].” In FYs 2016 and 2015, EPA “lost the audit trail to properly support how much of the [PRIA/FIFRA] payroll expenses were paid for by appropriations.” To address these losses, in October 2016, EPA instituted an enhancement to its timekeeping system’s cost allocation that will allow for “the creation of an audit trail to capture costs incurred by the [PRIA/FIFRA] Fund and other appropriations that support [PRIA/FIFRA]-related activities.”
More information on other EPA OIG reports is available on our blog under key terms OIG and EPA OIG.
The reality of why the FIFRA funds are in surplus is a political response to the overall budgetary politics of Congress. The Office of Pesticide Programs (OPP) has not been authorized to utilize these funds fully or freely hire staff due to the budget agreements of Congress, and, more recently, due to the attempt by the new Administration to keep the Presidential budget proposal more in balance. The OIG knows this also, but “politics” is not the concern of a good audit, and this is not helped by the problem of EPA having “lost the audit trail” of how these monies were spent. PRIA reauthorization is soon to be overdue, and now appears perhaps to be in some jeopardy, at least in the near term. Fortunately for OPP, the surplus in these funds that OIG addresses will be able to buy the program some time to continue relatively “as is” while waiting for PRIA politics to subside to the point where reauthorization is approved and the program can focus more on the improvements suggested by the OIG report.
By Barbara A. Christianson
On September 19, 2017, the U.S. Environmental Protection Agency (EPA) announced an update to Chapters 15 and 16 of the Office of Pesticide Programs’ (OPP) Label Review Manual.
Updates to Chapter 15: Company Name and Address, include removing non-label related instructions on submitting address change requests and updating the National Pesticide Information Center’s contact information, including new hours of operation. Updates to Chapter 16: Graphics and Symbols, include adding hyperlinks to graphic and logo examples and allowing a QR (Quick Response) code as an acceptable symbol when used only for retail pricing.
EPA states that the Label Review Manual, which began as a guide for EPA label reviewers, serves as a tool to assist registrants in understanding the pesticide labeling process and assists registrants in understanding approaches for how labels should generally be drafted. Pesticide product labels provide critical information about how to safely and legally handle and apply pesticides. EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers -- Form.
By Heather F. Collins
On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year. The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically. The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration.
This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases. Users can submit study citations, data matrices (Form 8570-35), cover letters and studies (protocols, study profiles, supplemental study data) using the new "Voluntary Submission" link on the PSP home page. This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported. EPA states: “This action is another step in a phased approach that will ultimately lead to EPA’s ability to accept all pesticide applications electronically, a move that will help modernize the pesticide registration process, increase operational efficiencies and reduce paper waste.” EPA indicates that in addition to these changes, this update introduces enhancements and bug fixes.
EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4 which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission.
Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration Notice 2011-3 is applicable only to paper submissions. Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA.
More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.
By Susan M. Kirsch and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has announced that it will be hosting several events to gather input on regulatory actions that could be repealed, replaced or modified as part of EPA’s regulatory reform efforts under Executive Order (EO) 13777.
The Office of Pesticide Programs (OPP) will host a public meeting on the Pesticide Program Dialogue Committee (PPDC) on May 3, 2017, from 9:00 a.m. to 4:45 p.m. (EDT), and on May 4, 2017, from 8:30 a.m. to 12:00 p.m. (EDT). The session on May 4, 2017, will focus on receiving public feedback on pesticide regulatory reform issues. Registration will be required to attend the May 4, 2017, meeting only. Interested participants may register here. The deadline for registration is April 27, 2017.
The Office of Water (OW) will also host a listening session on May 2, 2017, from 11:00 a.m. to 2:00 p.m. (EDT) and participants may either pre-register here to join by phone (space limited) or join via web conference here. Pre-registration is not required for web participation. The deadline for registration is April 27, 2017.
In the pesticide space, EPA-OW is responsible for the National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit (PGP), which requires NPDES permitting for pesticide applications into, over and near “Waters of the United States,” including mosquito abatement activities. The U.S. Court of Appeals for the Sixth Circuit issued a 2009 decision requiring EPA to regulate pesticides under the NPDES program. Both industry and state co-regulators have criticized PGP requirements as duplicative, burdensome, and unnecessary for pesticides applied in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Attempts to pass legislation that would eliminate NPDES permitting for FIFRA-compliant pesticides applications have not been successful to date. EPA’s actions under EO 13777 may offer an administrative mechanism to repeal the PGP. It is unclear, however, if a repeal would be legally defensible in light of the Sixth Circuit ruling. Alternatively, EPA could modify the PGP to eliminate the reporting and recordkeeping requirements that opponents find overly burdensome. Pesticide stakeholders may wish to join the May 2, 2017, OW listening session to provide recommendations.
Written comments on regulatory reforms on all regulatory reforms, including OW and OPP issues, will also be accepted in docket EPA-HQ-OA-2017-0190, Evaluation of Existing Regulations, currently open through May 15, 2017. More details on the NPDES permit for pesticides are available in our blog item EPA Issues Final 2016 NPDES Pesticide General Permit.
By Lisa M. Campbell and James V. Aidala
On May 9, 2016, Jack Housenger, Director of the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP), announced the selection of Anna Lowit for the Senior Science Advisor Position in OPP’s Immediate Office.
Lowit has been a toxicologist in OPP’s Health Effects Division since 1998. Housenger’s announcement of Lowit’s selection notes that she has “provided expert technical advice and guidance to senior management on issues related to toxicity testing, human risk assessment, and science policy issues,” and that she “provided substantial input to enhance science quality and ensured that scientifically accepted procedures and consistent criteria were applied, so that OPP’s risk assessments were recognized as reflecting the state-of-the-science.”
In light of the many current and expected issues involving fundamental science policy issues -- such as the application of the Food Quality Protection Act (FQPA) 10X safety factor, endocrine effects tests and their meaning, utilization of information from epidemiological studies, regulatory application of constantly evolving cancer assessment methodologies, and the appropriate approach to evaluating products of synthetic biology -- the Senior Science Advisor position is among the most important positions on the organization chart of OPP.