By Lisa M. Campbell and Lisa R. Burchi
On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions.
The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and competitiveness. Information about the RCC and the released RPSs is available at: http://www.trade.gov/rcc/.
There are now RPSs between the following agencies focusing on four main sectors: agriculture and food; environment; transportation; and health and personal care products:
- U.S. Food and Drug Administration (FDA) -- Health Canada (HC);
- U.S. Environmental Protection Agency (EPA) -- Pest Management Regulatory Agency (PMRA);
- U.S. Occupational Safety & Health Administration (OSHA) -- HC;
- U.S. Animal and Plant Health Inspection Service (APHIS) and U.S. Food Safety and Inspection Service (FSIS) -- Canadian Food Inspection Agency (CFIA);
- FDA -- CFIA;
- U.S. Department of Transportation (DOT) -- Transport Canada (TC);
- U.S. Coast Guard (USCG) -- TC;
- U.S. Environmental Protection Agency (EPA) -- TC;
- U.S. Department of Energy (DOE) -- Natural Resources Canada (NRCan);
- U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA) -- NRCan;
- EPA -- Environment Canada (EC); and
- U.S. National Oceanic and Atmospheric Administration (NOAA) -- Fisheries and Oceans Canada (DFO).
With regard to agreements between EPA and PMRA for pesticides, the agencies have agreed to a plan and timeframes for three initiatives:
- Joint Template For Project Chemistry Review: The agencies plan, by March 2016, to commence use of a joint template for product chemistry reviews intended to present study findings in a concise, easily reviewable manner to “facilitate the evaluation of joint review products for new active ingredients, use expansions, and product chemistry only submissions, with the ultimate goal being mutual acceptance of study reviews.” Prior to commencing use of the joint template, EPA and PMRA intend to conduct a webinar, solicit comments, and initiate a pilot project to test the use of the template.
- Neonicotinoid Insecticides: EPA and PMRA are collaborating on a bilateral pesticide re-evaluation process for neonicotinoid pesticides, and implementing a risk assessment framework. Harmonizing re-evaluation schedules and aligning risk assessment approachines are ongoing; a progress report will be published by December 2015, but the completion of risk assessments and mitigation actions are not expected until 2017-2018.
- Joint IT Solutions: EPA and PRMA are working together to develop information technology submissions and “move towards the establishment of a single application for crop protection products that will be accepted in both countries.” The technology platforms include an eDossier Builder based on the Organization for Economic Co-operation and Development (OECD) Global Harmonized Submission Transport Standard and an Electronic Confidential Statement of Product Specifications Form Wizard tool (eCSPS Wizard). The agencies are currently developing these tools and state that the eDossier may be released in 2017, but have not set timeframes for the release of the eCSPS Wizard.
EPA, Health Canada, and Environment Canada also have a RPS regarding two initiatives for chemical substances management:
- Significant New Use Rule (SNUR) and Significant New Activity (SNAc): The agencies are collaborating to develop common approaches for regulatory reporting requirements to improve predictability, understanding, and compliance of SNURs and SNAcs under the Toxic Substances Control Act (TSCA) and the Canadian Environmental Protection Act, 1999 (CEPA), respectively. Working groups have been established with representatives of industries and nongovernmental organizations, and several meetings and web conferences are scheduled through June 2016 to review potential alignment collaboration opportunities. A final summary document outlining the agencies’ findings, recommendations, and short and long term implementation plans is expected by December 2016. A workshop to discuss the final results for both predictability and improved compliance is now planned for January 2017.
- Risk Assessments: The agencies are working to align chemical regulatory processes, “specifically through the development of common approaches to address emerging risk issues and jointly consider how the use of novel data can inform the assessment of chemicals.” The agencies have already formed a Technical Working Group and the first workshop will be held in October 2015 with several web conferences scheduled through December 2016. A draft assessment collaboration framework will thereafter be developed including: (1) common high-level principles for chemical risk assessment; (2) identification of opportunities and impediments to joint work; (3) forward plan to build on opportunities (e.g., peer review); and (4) forward plan to explore mechanisms to address impediments. The final summary document outlining the assessment collaboration framework is expected in December 2017.
The RPS developments are a welcome development for many in industry that conduct business in the U.S. and Canada and are interested in streamlined procedures. The SNUR and SNAc processes, for example, have many similarities that could potentially be leveraged and aligned. The working groups that have been formed to review and discuss the TSCA/CEPA initiatives anticipate industry and nongovernmental organizations’ involvement that should assist these agency partnerships. Continued work with stakeholders and opportunities for comment will be critical moving forward in developing effective regulatory approaches that promote efficiency, safety, trade, and competitiveness.
By Lisa M. Campbell and Lisa R. Burchi
On April 20, 2015, the U.S. Environmental Protection Agency (EPA) announced it had reached settlements with three major pesticide registrants, for the actions of a third-party pesticide distributor, Harrell’s LLC (Harrell’s), a Florida-based lawn and turf care business that was distributing the registrants’ respective products. EPA alleged that Harrell’s sold improperly labeled products that contained the pesticides dithiopyr, chlorantra-niliprole, and imidacloprid.
Without admitting liability, each registrant agreed to pay a penalty with one agreeing, in addition to completing a supplemental environmental project (SEP), to create a $231,000 educational website for the pesticide industry that will feature information on complying with federal pesticide laws.
A 2012 EPA investigation found more than 350 instances of Harrell’s products having been sold without proper pesticide labels -- in some cases, labels were either illegible or were not on the products at all. The products at issue were registered and were sold and distributed by Harrell’s under supplemental distributor relationships. In late 2013, Harrell’s agreed to pay a $1,736,560 civil penalty to EPA, one of the largest ever for a pesticide case.
Under EPA regulations, supplemental distributors like Harrell’s are agents of the registrants, and those registrants are thus responsible and liable for the actions of their supplemental distributors. In its recent National Enforcement Program Managers Guidance (NPMG), EPA’s Office of Enforcement and Compliance Assurance identifies Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) supplemental distribution as a mandatory “focus area.” Specifically, EPA states:
Although required to be consistent with the labels of the basic registered products, distributor product labels frequently deviate substantially from the EPA accepted labels. Such unapproved product labeling can lead to misuse and misapplication as well as pose significant risks to the users who rely on product labels to inform them about proper and safe pesticide use. Due to the potential risk associated with the use of improperly labeled pesticides, it is important that the EPA aggressively pursue compliance for supplemental registrations.
Bergeson & Campbell, P.C. (B&C®) recently issued a memorandum discussing the enforcement actions, the regulatory requirements for supplemental distribution, and what issues companies should address to help avoid such an enforcement action. That memorandum, “EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance,” is available online.
B&C also presented a webinar, “EPA's Supplemental Distribution Enforcement Actions Are Buzzing: How to Avoid Getting Stung,” on July 23, 2014, highlighting the most important steps that both registrants and supplemental distributors can take to ensure compliance and avoid being stung in the current heightened enforcement environment. A recap of the webinar is available online.
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.
This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.
To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.
By Lynn L. Bergeson and Carla N. Hutton
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or otherwise contribute any new interpretations of existing EPA pesticide registration or enforcement policy.
Briefly, the key decisions articulated in EPA’s response to the petition are:
* EPA will treat products containing nanosilver as pesticides under FIFRA if intended for pesticidal purposes, even in the absence of explicit pesticidal claims.
* EPA rejected ICTA’s claim that all products containing nanosilver are categorically pesticides and should be regulated as such.
* EPA will continue to apply its statutory and regulatory criteria as to what is a pesticide on a case-by-case basis. The determination “would be fact specific, typically based upon information on the use patterns intended, the claims or other advertising used to distribute or sell the ingredient or product, and any other information or knowledge made known to or known by the distributor or seller.”
* Importantly, EPA disagrees with ICTA’s claim that the treated article exemption should not apply to any nanosilver pesticide product because nanosilver specifically is not the registered pesticide active ingredient. According to EPA, application of the treated article exemption is available if a registered pesticide product is used, consistent with any terms and conditions of use of the registered product.
* EPA granted ICTA’s request to review the health and safety impacts from use of a nanosilver ingredient in a pesticide product based on nanosilver data for the portion released as nanosilver and based on macro-scaled silver for the portion released as silver ions, and agrees that FIFRA Section 3(c)(7)(C) is the appropriate authority for review of applications for registration of products containing nanosilver ingredients.
* EPA rejected ICTA’s claim that EPA must comply with the National Environmental Policy Act (NEPA) to assess the environmental impacts of EPA’s decision regarding nanopesticides, citing EPA’s well-settled view that it is exempt from NEPA requirements under FIFRA under Merrell v. Thomas, 807 F.2d 776 (9th Cir. 1986).
* EPA denied ICTA’s request to use a particular enforcement strategy to address unregistered pesticides sold or distributed in the U.S., believing that EPA lacks a factual basis to conclude that all nanosilver products are pesticides and thus does not have the legal basis upon which to conclude that all products are illegally sold or distributed.
By Lisa M. Campbell and Lisa R. Burchi
The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential information related to substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. EPA and FDA state in the MOU that the sharing of such information will “open channels of communication between the agencies” and will “serve to facilitate [EPA and FDA’s] accomplishment[s] of their respective missions.” The MOU sets forth the safeguards to be implemented with regard to the sharing of confidential information to “protect against unauthorized use or disclosure of any non-public information shared or exchanged pursuant to this MOU.”
EPA and FDA’s decision to share information will have a direct impact on companies with substances that have pesticidal and non-pesticidal applications. As noted in an example in the MOU, an antimicrobial food wash that can also be a labeled pesticide for other uses could have data submitted to FDA demonstrating that the product’s use is safe and does not adulterate food and data submitted to EPA demonstrating that the pesticide will not cause unreasonable adverse effects on the environment. Companies that have submitted information to EPA and FDA should be mindful of the potential that such information could be shared between the agencies, and consider whether additional safeguards or data compensation protection may be needed.
By Lisa M. Campbell and Lisa R. Burchi
On March 1, 2015, the U.S. Environmental Protection Agency (EPA) released the 11th Annual Report on EPA’s implementation of the Pesticide Registration Improvement Extension Act (PRIA 3) that is required under Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This annual report details changes in processes, practices, and policies for Fiscal Year (FY) 2014 that ran from October 1, 2013, through September 30, 2014. The report is divided into different sections related to: (1) pesticide registration service fees; (2) maintenance fees; and (3) process improvements in the pesticide program; all of which can be accessed on EPA’s website at the below links. Specifically, the report covers the following topics:
Pesticide Registration Service Fees
* Fees Collected, Waived, Exempted and Expended
o Pesticide Worker Protection
o Partnership Grants
o Progress in Meeting Decision Times
* Fees Collected and Expended
o Expedited Processing FIFRA Section 3(c)(3)(B)
o Pesticide Reevaluation Programs
Process Improvements in the Pesticide Program
* Pesticide Reevaluation Programs
* Information Technology and Labeling
* Science Review/Assessment Improvements
EPA’s report addressing process improvements in the pesticide program discusses several areas where EPA believes its registration programs have improved, either through increased efficiency, consistency, and/or transparency. The areas discussed are:
* EPA’s use of the “Lean” business model to improve business processes;
* Delegation of authority to EPA’s Biopesticides and Pollution Prevention Division (BPPD) to expedite fast track and notification actions to reduce approval times and the number of actions in backlog status;
* Biopesticide Industry Alliance Registration Workshops to improve quality of application submissions;
* Release of testing guidelines to clarify scenarios under which efficacy testing at the lower certified limit is needed;
* Reduction of registered products for which EPA is taking action under the Antimicrobial Testing Program;
* Continued crop grouping regulations to save resources and reduce the number of required residue studies;
* Establishment of a Pre-decisional Determination Due Date to provide adequate time to reach agreement with the registrant on required label changes prior to EPA approving the label; and
* International work sharing to assist in individual country registration decisions while striving to harmonize regulatory decisions with global partners.
With regard to EPA’s review of electronic labels, EPA states the following:
1. Of approximately 6,300 labels submitted to EPA in FY 2014, almost half included an electronic label. Comparing the statistics from FY 2011 to FY 2014 reveals a steady increase of approximately 10 percent each year in the percentage of labels submitted in electronic format.
2. The use of electronic label review software varies significantly across the three regulatory divisions with the Registration Division reporting the highest use, the Antimicrobials Division reporting moderate use, and BPPD the lowest use.
PRIA 3 is effective from October 1, 2013, through September 30, 2017.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
The U.S. Environmental Protection Agency (EPA) has announced its new more “user-friendly” website for minimum risk pesticides. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) and EPA’s implementing regulations at 40 C.F.R. § 152.25(f), pesticides meeting certain criteria (e.g., containing only specified, listed active and inert ingredients, not bearing public health claims) are determined by EPA to pose little to no risk to human health or the environment and exempt from FIFRA registration requirements. EPA states the website “highlights the most-requested information and has been redesigned based on historic website traffic, with a focus on stakeholders who are interested in manufacturing, selling or distributing minimum risk pesticides.” Specifically, the website is now focused on four main areas:
* About Minimum Risk Pesticides;
* Conditions to Qualify as a Minimum Risk Pesticide Product;
* Clarifications about Minimum Risk Active and Inert Ingredients; and
* Regulation and Enforcement of Minimum Risk Pesticides.
Although the scope of application of minimum risk pesticides has been the focus of proposed regulatory changes in recent years, EPA states that this website is not intended to include any regulatory changes or new requirements. There is, however, a December 2010 rule proposing changes to the minimum risk pesticide requirements that has yet to be issued in final. It is noteworthy that EPA has highlighted and clarified its Section 25(b) policies, but has not yet issued a final rule. A memorandum regarding EPA’s proposed rule is available at http://www.lawbc.com/regulatory-developments/entry/epa-proposes-revisions-to-minimum-risk-exemption-for-pesticides/.
Instead, EPA states it has included more information to be clearer about the conditions that a product must meet to be considered minimum risk. Any clarifications of the applicable requirements could be helpful for manufacturers that are responsible for ensuring compliance at the federal level for minimum risk pesticides since EPA does not review or approve such registrations. It is important to note that minimum risk pesticides exempt from EPA registration are still frequently subject to registration requirements at the state level, and state regulators perennially identify non-compliance by products asserting eligibility for minimum risk status. Any outreach that makes the eligibility and compliance requirements clearer should assist companies in navigating both federal and state requirements.
The address for the new website is www2.epa.gov/minimum-risk-pesticides.
By Lisa R. Burchi
An ad hoc committee of the National Research Council (NRC) released a report, Review of California's Risk-Assessment Process for Pesticides, following its scientific and technical evaluation of the California Environmental Protection Agency’s (EPA) risk assessment process for pesticides.
The NRC committee review, which commenced in October 2013, examined documents provided by the California EPA’s Department of Pesticide Regulation (DPR) regarding the processes it uses for hazard identification, exposure assessment, dose-response analysis, and risk characterization. The Report discusses the following issues:
■ Setting Priorities Among Pesticides: The NRC committee generally supported DPR’s process under which pesticides are reviewed as candidates for risk assessment, but made recommendations for DPR to: (1) update and provide more details regarding its documentation of the priority setting process; (2) provide more explicit documentation and support for how pesticides are categorized into groups of high, medium, and low priority; and (3) develop a more objective and structured approach for ranking high-priority pesticides.
■ Risk Assessment Methods and Practices: The NRC committee reviewed DPR’s risk assessment guidance documents as well as three recently completed risk assessments for chloropicrin, carbaryl, and methyl iodide. The NRC committee found DPR’s documents to be comprehensive but questioned “whether the extensive effort needed to conduct a comprehensive risk assessment independently of EPA is justified in light of DPR’s resources.” The Committee recommended that DPR: (1) determine whether an independent and comprehensive evaluation of pesticides is required in every case where a risk assessment is performed; (2) incorporate problem formulation and other relevant elements recommended in the 2009 NRC report Science and Decisions: Advancing Risk Assessment into its risk assessment process; and (3) update its guidance documents “regularly and perhaps develop additional reference materials to reflect the most current risk-assessment practices.”
■ California Data to Inform Priority-Setting and Risk Assessment: The NRC committee found DPR’s practice of supplementing its exposure assessments with California-specific information to be “among the most valuable contribution to DPR’s risk-assessment process.” The committee suggests expanding DPR’s current Pesticide Use Reporting (PUR) program to include all licensed pesticide applicators and, if resources allow, “PUR data should be reviewed in relation to air-monitoring data and pesticide-illness surveillance data to determine whether any patterns are evident and to judge the accuracy of exposure assumptions or models.” The committee also had recommendations to improve the reporting of pesticide-related illnesses, including, for example, improving the training of physicians and searching electronic health records.
By Sheryl Lindros Dolan
The U.S. Environmental Protection Agency (EPA) announced that it has “decided to postpone the [Pesticide Program Dialogue Committee (PPDC)] meeting scheduled for December 11-12, 2014.” EPA notes that “this is a particularly busy time of year in [the Office of Pesticide Programs (OPP)] as we are working to complete several major decisions and projects by the end of the year/early next year. We want to keep the momentum going so that we can share our progress with you early in 2015.” At this time, EPA intends to hold a half-day update via the web in February 2015 to bring stakeholders “up-to-date on these activities.” According to EPA’s November 21, 2014, Federal Register notice announcing the December PPDC meeting, the PPDC Work Group on Integrated Pest Management and Work Group on Pollinator Protection were scheduled to meet on December 10, 2014. EPA has scheduled the next two PPDC “in-person” meetings for May 14-15, 2015, and October 22-23, 2015.
By Sheryl Lindros Dolan
On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.