Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.
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By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi


On March 2, 2015, European Union (EU) Ministers approved a Directive previously approved by the European Parliament with regard to genetically modified organisms (GMO). EU Directive 2010/0208, entitled Directive of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, will allow individual Member States to determine whether they will allow, ban, or otherwise restrict the cultivation of GMOs, even in cases where the EU has authorized use of a GMO following the European Food Safety Authority’s (EFSA) assessment of the risks to health and the environment.

Specifically, the Directive provides: “a Member State may adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs defined by crop or trait, once authorised in accordance with Part C of this Directive or with Regulation (EC) No 1829/2003, provided that such measures are in conformity with Union law, reasoned, proportional and non-discriminatory and, in addition, are based on compelling grounds.” The grounds stated include those related to:

* Environmental policy objectives;
* Town and country planning;
* Land use;
* Socio-economic impacts;
* Avoidance of GMO presence in other products without prejudice to Article 26a;
* Agricultural policy objectives; and
* Public policy.

A Member State also can seek to have all or part of its territory excluded from the geographical scope during the authorization procedure for a GMO.

The passage of this Directive is the culmination of years of negotiations between EU Member States that have disagreed over the cultivation of GMOs in their territories. The new rules, which will allow EU countries to opt-out from otherwise approved EU GMOs, are sure to be controversial as Member States, industry, farmers, and the public work out details related to the potentially non-scientific grounds that a particular Member State relies upon in restricting or banning use of a GMO, and as Member States develop measures that allowed GMOs must take to avoid “possible cross-border contamination.”

The legislation will enter into force following its publication in the Official Journal of the EU, which is expected in Spring 2015.

As various members of the EU continue to oppose production of GMO crops, these policies will remain trade irritants to the U.S. and other countries where GMO crops have been widely adopted. This comes as trade negotiations are ongoing and the EU allowance of trade barriers based on the “precautionary principle” remains a major point of disagreement between the EU and the U.S. (with its reliance on “science-based risk assessment policies”). This latest development, which further allows EU Member States to reject GMO crops under various criteria, will not make resolving any current or future trade disagreements any easier.

 


 
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By Lisa M. Campbell and Susan Hunter Youngren, Ph.D.

The U.S. Environmental Protection Agency (EPA) issued an updated schedule for the Pesticide Registration Review program that sets forth a timetable for opening dockets for the next three years, through end of fiscal year 2017 (September 2017).

Through the Pesticide Registration Review program, EPA reviews all registered pesticides at least every 15 years, as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Following the newly issued schedule, all pesticides registered as of October 1, 2007, will have entered the registration review process with the exception of certain biopesticides. All pesticides registered by October 1, 2007, are scheduled to be assessed by October 1, 2022.

The rodenticide and triazole groups of chemicals have had their schedules adjusted so that all chemicals in the groups will be assessed during the same time frame. The rodenticides have dockets opening in first and second quarter 2016, while the triazoles have dockets opening from fourth quarter 2015 through third quarter 2016. In addition, EPA states that it has moved some chemicals that it believes may have significant data needs earlier in the schedule, but does not specify which were moved. Those with significant moves forward in the schedule (all moved from fourth quarter 2015 to first quarter 2015) include yellow mustard seed, sulfonic acids, fluazifop butyl, isomers, and flonicamid.

More information about the Pesticide Registration Review schedule is available here.
 


 
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REMINDER

Border Security: EPA's Increased FIFRA Import Enforcement Initiative
March 12, 2015
2:00 p.m. - 3:00 p.m. (EDT)
Register online


Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.
This webinar will highlight recent developments and suggest steps importers should take to ensure compliance and avoid potential enforcement. There will be 45 minutes of presentation, followed by a 15 minute Q&A period.
Topics will include:
*  Requirements for importation of registered and unregistered pesticides
* Revised NOA "recommendations" and "optional" sections -- what they really mean
* EPA's recent enforcement priority on pesticide importations and examples of EPA and U.S. Customs detentions of imported pesticides
* Industry perspective and steps to avoid non-compliance

Speakers:
* Eileen B. Salathé Gernhard, Lead Counsel, Regulatory and EH&S at Dow AgroSciences, LLC
* Lisa M. Campbell, Partner, B&C
* Lisa R. Burchi, Of Counsel, B&C
* Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice with Jacobs Stotsky PLLC


For questions regarding this webinar, please contact .(JavaScript must be enabled to view this email address).
 


 
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By Lisa M. Campbell and Lisa R. Burchi


On February 27, 2015, the California Department of Pesticide Regulation (DPR) released California Notice 2015-3, entitled Concurrent Submission of Pesticide Products to the Department of Pesticide Regulation and the U.S. Environmental Protection Agency. In this Notice, DPR describes the four types of applications that may be submitted concurrently to DPR and to the U.S. Environmental Protection Agency (EPA), the procedure applicants should follow to request concurrent submission, and how DPR will process such requests.

This notice supersedes California Notice 2005-10, and there are some changes. For example, Notice 2015-3 now includes a process for an applicant to seek concurrent submission when the application is not one of the four specified types for which concurrent submission is permitted. Under this new procedure, the applicant must send a letter requesting approval to the Pesticide Registration Branch Chief before submitting an application to DPR and provide the following: (1) a statement that the product/amendment is not yet federally registered or accepted; (2) a request for concurrent acceptance of the application; and (3) justification with supporting documentation for the concurrent submission request (e.g., no other effective alternatives available for a specific pest problem). In addition, regarding data submissions with an application, DPR now states clearly: “All data and information required by California statutes and regulations, including all data and information submitted to U.S. EPA, must still be submitted with your California registration request.”
 


 
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By  Lisa M. Campbell and Susan Hunter Youngren, Ph.D.

The California Department of Pesticide Regulation (DPR) announced on February 26, 2015, a revision to the process for evaluation of the potential for a pesticide to move off-site into surface water when the pesticide is used in an urban area. The former evaluation method followed the U.S. Environmental Protection Agency (EPA) approach with California specific parameters. This revision will continue to use the EPA approach but allow incorporation of a module specific for California urban settings.

Potential adverse impacts on surface water from use of pesticides are assessed in California by DPR’s Environmental Monitoring Branch’s Surface Water Protection Program (SWPP) using EPA methodology. The SWPP uses the EPA evaluation method for proposed agricultural pesticide registrations based on PE5 (PRZM-EXAMS version 5) and Tier 2 modeling scenarios but there have been no consistent methods for assessing potential pesticide runoff on impervious surfaces in an urban setting. The new California urban module includes the following improvements that are designed to be further representative of urban conditions in California:

* Introduction of four types of surfaces by permeability and water sources;
* Consideration of pesticide transport induced by dry-weather runoff from impervious surfaces;
* Separation of impervious and pervious portions in the modeling scenarios;
* Use of prescheduled lawn irrigation;
* Characterization of residential and commercial/industrial areas to reflect California urban conditions; and
* Aggregations of water, sediment, and pesticide yields for the urban watershed.

The urban model is designed particularly for evaluating pesticides applied outdoors in areas with large amounts of impervious surfaces such as residential areas, commercial/industrial facilities, and highway and road rights-of-way applications. Pesticide products of interest would be those that have the potential for impact to surface waters through overspray to impervious surfaces in these areas
 


 
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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

Center for Food Safety v. EPA is a case in the U.S. Court of Appeals for the 9th Circuit (9th Circuit) that consolidates two petitions for review of a decision by the U.S. Environmental Protection Agency (EPA) to register the new herbicide product Enlist Duo for use in six Midwestern states. A group of non-governmental organizations filed one of the petitions and the Natural Resources Defense Council (NRDC) filed a separate petition. Enlist Duo combines the active ingredients glyphosate and 2,4-D. The registrant Dow AgroSciences (Dow) has intervened in the case. The petitioners focus primarily on the purported failure of EPA to consider properly the effects of Enlist Duo on certain endangered species.

Each petitioner has now filed a motion to stay the EPA action registering Enlist Duo due to Endangered Species Act (ESA) challenges. The first stay motion filed by NRDC is based primarily on the risk to monarch butterflies, and that stay motion has now been fully briefed. The other petitioners filed a separate stay motion focusing on whooping cranes and Indiana bats, but they waited until two weeks after EPA and Dow filed their briefs opposing the first stay motion. Before either stay motion was filed, Dow filed a motion seeking transfer of the case to the D.C. Circuit Court of Appeals. Arguing that the two independent successive stay motions were abusive, Dow later filed a motion to hold the briefing on the second stay motion in abeyance, pending a ruling on its transfer motion.

The 9th Circuit denied Dow’s motion to hold the briefing on the second stay motion in abeyance only three days later. This procedural ruling does not dispose of the underlying transfer motion, but it does suggest that the court is not inclined to transfer the case. If the case is not transferred, the court will ultimately consider and rule on both pending stay motions. The court’s interim order does not suggest how it views the pending stay motions. The petitioners have a heavy burden to show both a substantial likelihood of success on the merits and irreparable harm to obtain the requested interim relief. EPA and Dow contend that the petitioners have not established either of these things. Overall, this ESA challenge to a new genetically modified organism (GMO) product may indicate a new front in the ESA litigation arena, since new products have generally not been challenged under ESA requirements. 2,4,-D itself is not a new herbicide, so this case is not quite a challenge to a totally new active ingredient; such a challenge was made recently in the case of cyantraniliprole. CBD, et al. v. EPA, No. 14-00942 (D.D.C. filed Oct. 10, 2014). Challenges to new active ingredients and GMO products, however, could threaten to hinder the introduction of new products into the marketplace.


 


 
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By Lynn L. Bergeson

Not a moment too soon, the European Chemicals Agency (ECHA) released a useful and clearly written Practical Guide on Biocidal Products Regulation, ECHA-14-B-19-EN. ECHA is the European Union (EU) agency tasked with implementing the Biocidal Products Regulation (BPR), along with other EU chemical laws and regulations. Adopted in 2012, the BPR revised the Biocidal Products Directive and imposes requirements on producers of active substances and biocidal products. Starting on September 1, 2013, all legal entities producing active ingredients or biocidal products available in the EU are required to obtain an approval for each active substance in the biocidal product and an authorization for the biocidal product itself. The Guide provides a “how to” comply with the BPR to “help companies to better fulfill their obligations and tasks under the BPR.” The Guide is organized into sections and explains the obligations imposed on regulated entities, who is responsible for the obligations, what are the relevant timelines and the deadlines, which are the information requirements and procedures to follow, and the expected results of the process. The Guide also highlights the exceptions and cases for some of the processes, and lists the relevant fees for each obligation.

The Guide contains the following chapters:

■ Approval of active substance;
■ Article 95: list of active substances and suppliers;
■ Technical equivalence;
■ National authorizations;
■ Mutual recognition;
■ Renewal of national authorization and authorizations subject to mutual recognition;
■ Union authorization;
■ Simplified authorizations;
■ Changes of biocidal products;
■ Data sharing; and
■ Appeals (on ECHA decisions).

The following additional chapters are expected to be published at a later date:

■ Renewal of approval of active substance;
■ Review of an approval of active substance; and
■ Research and development.
 

Tags: BPR, ECHA

 
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By Lisa M. Campbell

The California Department of Pesticide Regulation (DPR) recently issued its Progress Report 2012-2014, which highlights DPR’s view of achievements under the leadership of Director Brian Leahy. Among the achievements noted are the following; others are also discussed in the report.

• Restricting sales of Second Generation Anticoagulant Rodenticides (SCAR). This action is described as having been “the catalyst for a national change, as the manufacturer agreed with U.S. EPA to phase out these products after DPR’s action.”

• Implementing surface water regulations for pyrethroids. This action is described as “an aggressive preventative measure for environmental protection starting at the first point of pesticide applications.”

• Committing more than $3 million in research for alternatives to field fumigants since 2012 and “reducing risks to the public from field fumigations,” as well as “protecting workers and the public from structural fumigations.”

• Efforts to reduce pesticide use in schools and child care centers.

• Collecting air monitoring data, regulating volatile organic compounds, as well as a number of other actions addressing environmental monitoring.

• Efforts to reevaluate neonicotinoids.

The Progress Report highlights and achievements reflect well many DPR priorities and the direction DPR is continuing to forge on a number of issues, some of which are subject to significant controversy.

 


 
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By Lisa R. Burchi

The California Department of Pesticide Regulation (DPR) has extended, from February 27, 2015, to Friday, March 13, 2015, the submission of written comments following DPR’s January 14, 2015, Registration Fee Workshop where DPR discussed the potential increase in registration fees for pesticide products pursuant to Food and Agricultural Code (FAC) § 12812(a).

Under the proposal, DPR would increase fees for applications and renewals from $750 to $1,150, decrease fees for certain label amendments supported by scientific data from $100 to $25, and create a new fee of $25 for label amendments not supported by scientific data, including substantive label amendments, non-substantive label amendments, label changes required by the U.S. Environmental Protection Agency or any other federal or state agency, amendments to the formulation of the pesticide product, and notifications.

The Registration Fee Workshop presentation and the meeting minutes from the Registration Fee Workshop can be viewed on DPR’s Web site. Comments may be submitted via email to .(JavaScript must be enabled to view this email address). DPR states it plans to make a final decision by April 2015 and have the revised fees effective by July 2015.
 


 
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By Lisa M. Campbell and James V. Aidala


On January 28, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has made available for public comment its proposal to improve the corn rootworm insect resistance management program currently in place for registrations of plant-incorporated protectants (PIP) derived from Bacillus thuringiensis (Bt) in corn. The EPA framework contains a number of controversial provisions, including the following proposed restriction of soil applied insecticides (SAI): “SAIs must be prohibited from use in combination with Bt corn for controlling corn rootworm. This can be done via bag tag language, grower guides, and terms of registration.” Concerns with the process by which this and other provisions can or should be developed and published for public comment are among the issues of concern. Comments are due March 16, 2015.
 


 
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By Lynn L. Bergeson

The Environmental Law Institute will host a complimentary webinar, “Neonicotinoids and Colony Collapse Disorder: Regulating and Product Stewardship in the Face of Uncertainty,” on Tuesday, February 24, 2015, from 12:00 p.m. - 1:30 p.m. (EST). The webinar is open to the public but registration is required.

Fraught with both scientific uncertainty and the potential for significant agricultural and ecological consequences, the debate over neonicotinoid regulation is at the forefront of environmental policy discussions, raising important issues about regulation and product stewardship in the face of scientific uncertainty paired with significant risk. This webinar will address the current questions regarding neonicotinoid pesticides and their regulation, including:

          ■ What is the state of the science around the role neonicotinoids may play in pollinator decline?

          ■ What other factors may be significant causes?

          ■ What should be the approach of regulators and company product stewards given the scientific uncertainty?

Bergeson & Campbell, P.C.’s (B&C®) Senior Government Consultant James V. Aidala will moderate the webinar. Mr. Aidala, former Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention) is a leading expert on the policy and regulatory issues associated with the confluence of pollinators and pesticides. He writes and speaks frequently on the subject; recent works include “Presidents and Pesticides: What’s Up with the Presidential Memo on Pollinators?,” “Neonicotinoids: EPA’s New Get-Tough Measures,” and the keynote address at the 2014 Spring Board Meeting of the Association of American Pesticide Control Officials. Mr. Aidala is also a regular contributor to B&C’s Pesticide Law and Policy Blog.
 


 
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By Lynn L. Bergeson

On January 30, 2015, the U.S. Environmental Protection Agency (EPA) released drafts of new guidelines for animal testing of the endocrine disrupting effects of pesticides and other chemicals. The proposed guidelines outline how scientists can use Japanese quail, medaka fish, or amphibian larvae to conduct various endocrine tests. EPA reportedly also considered including mysid crustaceans on its list of non-mammals acceptable to use in endocrine testing, but did not because the data were not deemed "fully reliable" across all endpoints. Comments are due March 31, 2015.


 
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March 12, 2015
2:00 p.m. - 3:00 p.m. (EST)

Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.

Speakers who will be highlighting recent developments and steps for importers to take to ensure compliance and avoid potential enforcement include: Eileen B. Salathé Gernhard, Lead Counsel -- Regulatory and EH&S at Dow AgroSciences, LLC, B&C's Lisa M. Campbell and Lisa R. Burchi, and attorney Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice at Jacobs Stotsky PLLC. There will be 45 minutes of presentation followed by a 15 minute Q&A period.

Please save the date -- registration details will follow.


 
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By Lynn L. Bergeson and Christopher R. Bryant

On February 10, 2015, the European Union’s (EU) chief negotiator on the Transatlantic Trade and Investment Partnership (TTIP) agreement released the EU’s initial proposal for the “legal text” of the all-important regulatory cooperation chapter. The text was tabled for discussion with the United States in the negotiating round on February 6, 2015, and released to the public shortly thereafter. The text of the final agreement will be a result of negotiations between the EU and U.S. Among the 16 “Articles” in the chapter is Article 14-Establishment of the Regulatory Cooperation Body,” or RCB, to monitor and facilitate the implementation of the provisions in the TTIP chapter on regulatory cooperation. While short on details, the tone and general content of the chapter is encouraging. The EU’s initial draft contains two sets of proposals: one on good regulatory practices, including transparency, impact assessment, stakeholder participation, and how to make them operational, and another on steps to reinforce and make more effective current cooperation on types of legislation and regulatory initiatives that have a significant impact on EU-U.S. trade or investment. The EU Commission also released on February 10 a document titled TTIP and Regulation: An Overview. The document includes a section on horizontal provisions, including a section on sanitary and phytosanitary measures, and a section on sectoral provisions, including “chemicals.” The documents are available at http://trade.ec.europa.eu/doclib/press/index.cfm?id=1230#regulatory-cooperation.

 


 
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By Lisa M. Campbell and Timothy D. Backstrom

On February 12, 2015, the Ninth Circuit Court of Appeals will hear arguments in El Comite Para El Bienestar De Earlimart v. EPA, a case challenging the U.S. Environmental Protection Agency’s (EPA) approval of provisions in a State Implementation Plan (SIP) adopted by California under the Clean Air Act (CAA) that regulate emissions of pesticides (primarily fumigants like methyl bromide) that potentially may contribute to possible exceedances of the National Ambient Air Quality Standard (NAAQS) for ozone. The El Comite case is the latest action in a series of challenges to California’s regulation of emissions of pesticides considered to be volatile organic compounds (VOC) stretching back to 2004. The case will consider substantive issues pertaining to the enforceability of the limits on pesticide VOC emissions in the SIP and the adequacy of those limits to attain compliance with the NAAQS. Of significant interest, it will also include a novel argument that EPA’s conclusion under CAA Section 7410(a)(2)(E) that the SIP did not violate Title VI of the Civil Rights Act is unsupported by the record.

The Plaintiffs will confront a stiff burden in litigating their Civil Rights claim. The Supreme Court has held that Title VI is violated only when actions have a discriminatory impact and such discrimination is intentional. EPA contends that California gave sufficient assurances that the pesticide controls in the SIP do not violate Title VI of the Civil Rights Act, and that it was reasonable for EPA to rely on those assurances when it approved the SIP. The Plaintiffs point to a preliminary finding made in 2011 by the EPA Office of Civil Rights (OCR) concerning the Angelina C. complaint, where OCR determined that emissions of methyl bromide during the years 1995-2001 had a disparate impact on Latino school children. This preliminary finding was later withdrawn following a settlement with California. The Plaintiffs say that given this history, EPA should have required California to provide a more detailed explanation of why its current regulation of pesticide emissions is not violative of Title VI. The Plaintiffs recently attempted to bolster their Title VI argument by asking the Court to take judicial notice of a report on pesticide use near schools issued by the California Environmental Health Tracking program in 2014, but EPA has opposed consideration of this report because it was not part of the administrative record when EPA approved the SIP revisions in 2012.
 


 
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