FIFRA

Lynn L. Bergeson, "Political Turmoil Muddies Regulatory Moves," Chemical Processing, January 16, 2019.

2019 started with a political bang. The President’s decision to allow a partial government shutdown in the absence of funding for the “wall” will continue to inspire federal administrative and regulatory havoc for months to come. This is particularly true of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) as it administers the programs under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), both of which maintain hugely important fees-for-service programs.

Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala, "EPA’s Evaluation and Determination of Epidemiological Data for Chlorpyrifos," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

Among the many legal, regulatory, and policy issues being watched closely by pesticide registrants as the U.S. Environmental Protection Agency’s (EPA) long and contentious review of chlorpyrifos registrations continues is the controversy concerning when EPA may appropriately apply a tenfold uncertainty factor pursuant to the Food Quality Protection Act (FQPA 10X). This issue centers around EPA’s novel and unprecedented use of epidemiological data and the statutory requirements that govern EPA’s determination that sufficient uncertainty exists to warrant applying the FQPA 10X, not only to chlorpyrifos itself, but to all organophosphate (OP) pesticide products. This issue has drawn much attention and concern from pesticide registrants, and from other interested parties. The issues directly affecting chlorpyrifos have played out not only in EPA’s registration review process for chlorpyrifos, but also in a court challenge to EPA’s decision.

Lynn L. Bergeson, Timothy D. Backstrom, and Bethami Auerbach, "Something Inside That Shoebox Really Stinks," Focus, February 2017.

Each year, millions of consumers, including large numbers of children, are exposed to unknown quantities of anti-mold pesticides when they open a shoebox. Although the active ingredient in these mostly unregistered anti-mold pesticides is undisclosed and the products are marketed as all natural, many stickers contain allyl isothiocyanate (AITC). These stickers have not been registered for this use, nor has this use, or the resulting exposure to consumers, been reviewed for safety by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or by any other regulatory agency. 

It’s unlikely that shoe retailers and distributors are aware of the staggering tort liability that could be hibernating in shoeboxes. Someday, millions of unsuspecting and unprotected consumers, including children, could allege they were harmed by products few ever noticed. Even more alarming is that any consumer claims of injury from exposure to an unregistered pesticidal agent cannot be subject to preemption under FIFRA Section 24(b), 7 U.S.C. § 136v(b) because the products are unregistered and have not been reviewed by EPA. This puts U.S. distributors or retailers at risk, especially if they knew that an unregistered pesticide was present in the product and failed to warn consumers. 

Lynn L. Bergeson, "Enlisting Modern Technologies to Ensure a Safe Food Supply," Natural Resources & Environment, Volume 31, Issue 3, Winter 2017.

Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the twenty-first century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.

 

These emerging technologies do not come without potential risks, however. How to regulate them is a  subject upon which stakeholders disagree.

 

Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed below, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures  to educate policy makers and regulators on these technologies, and greater involvement by the private  sector in facilitating a predictable flow of information on these technologies to all stakeholders.

Lynn L. Bergeson, "Evolving Global Chemical Management Programs and Why They Matter," Trends, the ABA Section of Environment, Energy, and Resources Newsletter, November 2014.

Chemicals play a central role in our personal and professional lives. As consumers, we focus keenly on the chemicals in the products we use and with which we come into contact. Globalization and the emergence worldwide of sophisticated chemical management programs invite complex legal, commercial, and scientific challenges. These challenges extend far beyond compliance questions that, by comparison, seem now nostalgically straightforward. Understanding these programs and their evolution can only help inform our judgment as lawyers, consultants, and educated consumers.

Lisa M. Campbell, James V. Aidala, Susan Hunter Youngren, "EPA Guidance on Pesticide Drift Will Affect Product Registrations," CPDA Quarterly, June, 2014.

How to address and manage potential risks posed by pesticide “drift” -- the unintentional movement of some level of pesticide outside of the intended area of application -- has long been a challenging, complex regulatory policy issue. It is difficult to dispute that when applying a pesticide product some small amount may, in some circumstances, move off-site. In other words: “drift happens.” The issue quickly becomes whether, from a risk management perspective, the amount of off-site movement matters. That question is, in turn, heavily dependent on factors specific to the pesticide application at issue, such as the nature of the specific pesticide (e.g., its volatility), the application method used (e.g., aerial or ground application), and climatic conditions. Because many such factors must be considered, the U.S. Environmental Protection Agency (EPA) has found it challenging to devise a “drift policy” or define generally what, if any, level of potential drift is acceptable. This article explores the current situation.

Andrew R. Bourne, Lara A. Hall, Lisa R. Burchi, "EU Biocidal Products Regulation and Its Impact on Industry: A Practical Briefing," Bloomberg BNA Daily Environment Reporter, February 26, 2014.

The European Union Biocidal Products Regulation dramatically changes the way biocidal active substances and biocidal products are regulated under European law. This new regulatory system is subtly different from those in other jurisdictions and EU neighboring countries, and fundamentally redefines biocidal products and treated articles. Companies exporting to the EU as a component of their global business must ensure that their supply chains and product designs are compliant with the regulation. This article presents a snapshot of existing industry norms and anticipates how these standard practices will be affected by the regulation.

James V. Aidala, "Neonicotinoids: EPA’s New Get-Tough Measures," Law360, September 25, 2013.

Throughout 2013, the issue of the contribution of pesticide use to the decline in honeybee colony health, known as colony collapse disorder (CCD), has been increasingly controversial. Of particular concern is the role that a particular class of pesticides, known as neonicotinoids, may play in CCD. While EPA generally maintains its view that pesticides, including the neonicotinoids, are one of many factors in contributing to CCD, in July 2013, it took steps to control more stringently the foliar use of neonicotinoid pesticides, including the ones affected by the EU suspension. EPA's most recent "get tough" approach is a new labeling requirement issued Aug. 15, 2013, and available online, and it holds some additional implications. This article reviews U.S. and European regulatory developments and offers commentary on how new restrictions will affect users and applicators of neonicotinoids.

Lynn L. Bergeson, "Obama’s Second Term: What Does It Mean for US EPA and the Regulated Community?," Environmental Quality Management, Spring 2013.

President Obama won a decisive victory on November 6, 2012, and the forecast for the next four years is clearer now than it was pre-election. This Washington Watch column offers some preliminary observations on what lies ahead for domestic environmental management issues at the legislative and regulatory levels.

Lynn L. Bergeson, "Landmark Ruling Affects Pesticide Makers," Chemical Processing, April 2013.

On February 21, 2013, the Fourth Circuit Court of Appeals issued a landmark decision in Dow Agrosciences v. National Marine Fisheries Service (NMFS). It set aside a Biological Opinion (BiOp) prepared by the NMFS that found use of pesticides chlorpyrifos, diazinon, and malathion could jeopardize certain species of salmon and their habitat. The decision will have significant implications for the government and pesticide registrants alike. Here’s why.

Lisa R. Burchi and Lynn L. Bergeson, "Pesticide Data Compensation in the EU and Canada," Bloomberg BNA Daily Environment Report, November 5, 2012.
The European Union in recent years has promulgated new regulations to set forth the procedures by which pesticides (called biocides and plant protectants in the EU) are registered and how companies can address issues related to the citation and compensation of data submitted that support those pesticide registrations. Canada also recently issued regulations setting forth new requirements on how data used to support a pesticide registration are protected. This article provides a broad overview of these regulations, the new procedures by which biocides and plant protectants will be registered in the EU, and the new ways that data citation and compensation will be addressed in the EU and Canada.
Lynn L. Bergeson, "Harmful Effects?," Manufacturing Today, September 2012.

NRDC challenges EPA’s FIFRA registration of nanosilver.

Lynn L. Bergeson, "Predictions for EPA’s Office of Chemical Safety and Pollution Prevention," ABA Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-To-Know Committee Newsletter, February 2012.
Lynn L. Bergeson, "Nanosilver Conditionally Registered as New Active Ingredient," Pollution Engineering, February 2012.

In August 2010, EPA announced that it was considering allowing the Swiss company HeiQ Materials Ag to enter the U.S. market with a new nanosilver pesticide and textile preservative, HeiQ AGS-20. On Dec. 1, 2011, the EPA issued a conditional registration for a pesticide product.

Lynn L. Bergeson, "NRDC Sues EPA Over Nanosilver," Chemical Processing, February 2012.

On January 26, 2012, the Natural Resources Defense Council (NRDC) sued the U.S. Environmental Protection Agency (EPA) for approving a pesticide product containing nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This article summarizes the lawsuit, explains what’s at stake, and discusses the lawsuit’s implications.

Lynn L. Bergeson, "EPA Registers Nanosilver As Active Ingredient," Chemical Processing, December 2011.

The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it granted a conditional registration for a pesticide product containing nanosilver as a new active ingredient. This is a momentous regulatory decision and very good news for supporters of nanopesticides.

Lisa R. Burchi, Lisa M. Campbell, Leslie S. MacDougall, and Lynn L. Bergeson, co-authors, "Data Citation and Compensation: How REACH Compares With the FIFRA Scheme," BNA Daily Environment Report, June 1, 2011.

The European Union's REACH regulation is a complex chemical management regulation intended to replace approximately 40 previously existing legal instruments with a single EU regulatory scheme for all chemical substances (both new and existing substances). It also creates a data compensation scheme for entities that must rely upon studies another entity generated to complete their registration for a particular chemical substance. This article provides background on REACH registration, data compensation and sharing procedures, and compares REACH's data compensation principles with how similar issues are addressed in the context of FIFRA data compensation arbitrations.

Lynn L. Bergeson, "Nanosilver Pesticide Products: What Does the Future Hold?," Environmental Quality Management, Summer 2010.

Last issue’s installment of the “Washington Watch” column discussed some key issues surrounding nanosilver and noted an ongoing review by the U.S. Environmental Protection Agency (US EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP). Now that the SAP has issued its much-anticipated report and recommendations, it is worth revisiting the topic of nanosilver pesticides.

Lynn L. Bergeson, "FIFRA SAP Convenes First Nano Review," NanoBusiness Alliance Newsletter, Issue 13, January 18, 2010.

On November 3-5, 2009, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met to consider for the first time scientific issues related to the assessment of potential hazard and exposure associated with nanosilver and other nanometal pesticide products. This column briefly summarizes the discussion, and speculates on the outcome.

Lynn L. Bergeson, "FIFRA Scientific Advisory Panel Considers Nanosilver," Environmental Law Reporter, December 2009.

On November 3-5, 2009, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” The decision to convene an SAP was nominally motivated by the U.S. Environmental Protection Agency’s (EPA’s) need to consider four applications pending at the Office of Pesticide Programs (OPP) seeking registration of products containing nanosilver-based active ingredients.

Lynn L. Bergeson, "Nanotechnologies and FIFRA," ChemADVISORY, July 2006.

This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

Lynn L. Bergeson, "Nanotechnologies and FIFRA," Gradient Corporation EH&S Nano News, April 2006.

This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).


 
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