By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated). Both motions requested that the court stay an October 15, 2014, decision by the U.S. Environmental Protection Agency (EPA) to register Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on corn and soybeans in six Midwestern states.
NRDC and CFS, et al. (Petitioners), filed these stay motions in a case consolidating petitions for review challenging EPA’s decision to register Enlist Duo. The registrant of Enlist Duo (Dow AgroSciences) has intervened in the consolidated case. The Petitioners argue that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D. In response, both EPA and Dow AgroSciences argue that approval of Enlist Duo will not lead to increased use of glyphosate, and that EPA fully considered all of the human health effects of 2,4-D before granting the registration.
The motions for a stay filed by the Petitioners were effectively motions for preliminary injunctive relief, an extraordinary remedy requiring that those seeking such relief show that they are likely to succeed on the merits, that there is likely to be irreparable harm, that the balance of equities tips sharply in their favor, and that an injunction is in the public interest. In denying the stay motions, the court cited Winter v. NRDC, 555 U.S. 7 (2008). In the Winter case, the Supreme Court held that irreparable injury must be likely and that a mere possibility of irreparable injury will not suffice in awarding injunctive relief. Although the court did not opine further on its rationale for denying the Petitioners’ stay motions, it may be inferred that the court determined that the Petitioners had not satisfied the rigorous prerequisites for injunctive relief.
While this decision avoids an immediate disruption in the marketing of pesticides, the potential for disruption to the registration remains until the court challenge has been resolved. As Enlist is a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D, any disruption now would be especially impactful to the registrant and customers of the product. Further, it could also have a chilling effect on efforts to introduce similar new or pending products if growers perceive too great a risk of uncertainty for this or similar pesticides.
By Lisa M. Campbell and Lisa R. Burchi
On July 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice extending the public comment period regarding its proposed Antimicrobial Pesticides Use Site Index (USI) from July 31, 2015 to August 31, 2015. The initial Federal Register notice announcing the availability of EPA’s guidance on the USI was issued on July 1, 2015.
By way of background, in 2014, EPA issued a final rule on Data Requirements for Antimicrobial Pesticides amending the regulations setting forth the data requirements that support an application to register a pesticide product. The final rule contains the data requirements specifically applicable to antimicrobial pesticides that were codified in 40 C.F.R. Part 158, subpart W. The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201. The data requirements applicable to a pesticide product depend in part on the product’s use pattern. The general use patterns are broad designations, and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.
EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and to assist EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product. EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.
The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit.
In addition to extending the comments, EPA also published in the docket a Question and Answer document on the USI Webinar for questions submitted to EPA prior to the July 14, 2015, webinar. Additional information regarding the USI is available in EPA Docket EPA-HQ-OPP-2015-0302.
By Lisa M. Campbell and Margaret R. Graham
On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning the draft final rule entitled ''Pesticides; Revisions to Minimum Risk Exemption.'' This notice states that the draft final rule will not be available to the public until after it has been signed and made available to EPA. Sections 25(a)(2)(B) and 21(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the EPA Administrator to provide to the Secretary of USDA and the Secretary of HHS a copy of any draft final rule at least 30 days before signing it in final form for publication in the Federal Register; EPA must only provide any draft final rules pertaining to public health pesticides, however, to HHS.
The Spring 2015 Regulatory Agenda stated that EPA is developing the final rule related to revisions it proposed in December 2012: "Specifically, EPA proposed to more clearly describe the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides. These lists would be reorganized by adding specific chemical identifiers that would make it clearer which ingredients are permitted in minimum risk pesticide products. No ingredients would be added or removed from the exemption. The label requirements in the exemption would also be modified to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label. These changes are intended to maintain the availability of minimum risk pesticide products while providing more consistent information for consumers, clearer regulations for producers, and easier identification by states, tribes and EPA as to whether a product is in compliance with the exemption." Further information regarding the proposed rule is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.
By Lynn L. Bergeson and Carla N. Hutton
In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. The Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture, is short, but clear as to timetable and deliverables.
Last updated in 1992, and first rolled out in 1986, the Coordinated Framework is the blueprint for federal regulatory policy for ensuring the safety of products of biotechnology. The Coordinated Framework is of significant interest to the agribusiness community as USDA and EPA regulate genetically modified crops and plant pests. According to the New York Times, more than 90 percent of the corn, soybeans, and cotton grown in the U.S. have foreign genes inserted into the DNA to make the crops resistant to herbicides, insects, or both. While acknowledging the Coordinated Framework is working as intended in ensuring the safety of biotechnology products, the OSTP was quick to note in their blog item “Improving Transparency and Ensuring Continued Safety in Biotechnology,” that “the complexity of the array of regulations and guidance documents developed by the three federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.”
The goal of the update effort, according to the memorandum, is to ensure public confidence in the regulatory system, improve transparency, predictability, coordination, and efficiency in the regulatory system, and encourage and support innovation in the area of biotechnology and products of biotechnology. According to the OSTP blog item:
- “First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
- Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
- Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.”
According to the memorandum, the following elements will support the process to achieve these objectives:
- Biotechnology Working Group Under the Emerging Technologies Interagency Policy Coordination Committee: The Biotechnology Working Group will include representatives from the Executive Office of the President, EPA, FDA, and USDA.
- Mission and Function of the Biotechnology Working Group: Within one year of the date of the memorandum, the Biotechnology Working Group shall take steps detailed below and others, as appropriate, to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology. The Working Group will:
- Update the Coordinated Framework to clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology, after input from the public; and
- Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.
- Independent Assessment: EPA, FDA, and USDA shall commission an external, independent analysis of the future landscape of biotechnology products that will identify (1) potential new risks and frameworks for risk assessment, and (2) areas in which the risks or lack of risks relating to the products of biotechnology are well understood. The review will help inform future policy making. Due to the rapid pace of change in this arena, an external analysis should be completed at least every five years.
- Budgeting for Efficiency: EPA, FDA, and USDA shall work with OSTP and OMB, within the annual President’s budget formulation process, to develop a plan for supporting the implementation of this memo in agency fiscal year (FY) 2017 budget requests and, as appropriate, in future budget submissions.
- Annual Reporting: For at least five years, starting one year after the release of the strategy described above, the Biotechnology Working Group will produce an annual report on specific steps that agencies are taking to implement that strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products. This report will be made available to the public by the Executive Office of the President.
A number of reports have .issued in the recent past calling for exactly what the Administration announced on July 2. Last year, the Venter Institute issued a landmark analysis of the domestic biotechnology regulatory system in which it highlighted the critical need for modernizing the Coordinated Framework. J. Craig Venter Institute. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (May 2014).
More recently, the National Research Council of the National Academies issued, on March 13, 2015, Industrialization of Biology: A Roadmap to Accelerate the Advance Manufacturing of Chemicals. The report, prepared by the Board on Chemical Sciences and Technology, Board on Life Sciences, Division on Earth and Life Studies, identified the challenges and opportunities posed by the current regulatory system relating to biotechnology and synthetic biology.
The Woodrow Wilson International Center for Scholars Synthetic Biology Project issued a statement praising the Administration’s decision: “The Synthetic Biology Project supports the effort by the White House Office of Science and Technology Policy (OSTP) to update the Coordinated Framework for the Regulation of Biotechnology to address emerging technologies like synthetic biology.” The statement goes on to say: “We see this as a positive development and one that is long overdue considering the rapid advancement of biotech-related fields like synthetic biology.”
A forthcoming report from the Synthetic Biology Project examines the regulatory pathways of new applications that are close to entering the market. That report finds confusion about the regulatory jurisdiction of different agencies in the framework and questions which statutes apply to the applications. Earlier this year, the Project released an interactive, crowdsourced inventory to track applications and products that utilize synthetic biology techniques.
The memorandum is welcome news as the Coordinated Framework needs updating for all the reasons outlined in the reports noted above. Despite the Framework’s inherent elasticity and nimbleness, the pace of innovation and complexity of new biotechnology products require a modernized, forward-focused framework.
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.