United States: Caveat Emptor: EPA Limits Hearing Rights For Some Conditional Registrants Under FIFRA

On April 25, 2016, Susan L. Biro, Chief Administrative Law Judge at the US Environmental Protection Agency (EPA), issued an order holding that a registrant of a conditionally registered pesticide product does not have a right to a full cancellation hearing under section 6(b) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Judge Biro held that a conditional registrant is instead limited to a narrow hearing under FIFRA §6(e), if the registrant wishes to challenge an EPA Notice of Intent to Cancel alleging that a pesticide product no longer meets a requirement of conditional registration, even a requirement to voluntarily cancel the product when the agency determines that continued registration of the product will result in unreasonable adverse effects.

A hearing under section 6(e) is truncated: It must be completed within 75 days after EPA receives a request for a hearing, and the only issues for resolution in the hearing are (i) whether the registrant has initiated appropriate action to comply with the conditions of the conditional registration and (ii) whether the agency's decision on existing stocks is appropriate. In contrast, the scope of a section 6(b) hearing is whether substantial evidence supports EPA's decision that the pesticide product no longer meets FIFRA's registration standard. Judge Biro held that a conditional registrant is not entitled to the more encompassing cancellation hearing under section 6(b): The conditional registrant may not challenge EPA's decision as to whether the registrant's product meets FIFRA's registration standard, only whether the registrant took all steps required by the conditional registration.

The lesson from Judge Biro's order is clear: Caveat emptor. Companies that accept conditional registrations must recognize that their due process rights are potentially far more limited in a truncated hearing under section 6(e) than in an extended and more encompassing hearing under section 6(b). Thus, an applicant should consider the possible implications and alternatives before agreeing to a conditional registration.

Judge Biro's order arose from the EPA's issuance to two applicants in 2008 of time-limited conditional registrations for pesticide products that contained a new active ingredient. The terms of the conditional registrations and an accompanying agreement required the registrants to submit additional environmental fate studies. The conditional registrations also required the registrants to request voluntary cancellation of their products within one week of EPA's determining, on the basis of the registrants' additional environmental fate studies, that continued registration of the products would cause unreasonable adverse effects on the environment. In January 2016, after reviewing the registrants' additional data, EPA notified the registrants that continued use of their products would result in unreasonable adverse effects on the environment and that the registrants were obligated to request voluntary cancellation of their products.

The registrants declined to request voluntary cancellation of their products, and EPA issued a notice of intent to cancel them under section 6(e), based on the registrants' failure to submit voluntary cancellation requests in accordance with the conditional product registrations. The registrants requested a hearing and filed a motion for accelerated decision, arguing that an abridged cancellation hearing under section 6(e) was unlawful and that cancellation of their conditional registrations required the full, unabridged hearing process under section 6(b). They also argued that the notice of intent to cancel was, in effect, premised upon EPA's adverse effects determination, not a mere violation of the conditional registrations.

Judge Biro disagreed. Contrasting unconditional and conditional pesticide product registrations under FIFRA, she explained that unconditional registrations are granted under FIFRA §3(c)(5) for an indefinite period, unless the agency lacks all of the information necessary to register a pesticide product under section 3(c)(5), in which case it grants a conditional registration under section 3(c)(7). Relying upon decisions in Woodstream Corp. v. Jackson, 845 F. Supp. 2d 174 (D.D.C. 2012) and 2011 U.S. Dist. LEXIS 151994 (D.D.C. June 3, 2011), Judge Biro held that EPA may grant a FIFRA §3(c)(7) registration upon a condition other than the submission of additional test data. For example, the agency may impose an expiration date or, as in the present case, require a conditional registrant to submit a request for voluntary cancellation, if the EPA determines that the conditionally registered product will cause an unreasonable adverse effect on the environment based upon the submission of the additional test data.

Quoting the Woodstream decisions, Judge Biro emphasized that limiting the conditional registrant to a truncated §6(e) hearing is not an "end run" around the lengthier and more encompassing section 6(b) hearing, because a registrant can choose to accept the conditions of the section 3(c)(7) registration and then apply for an amended registration that has no restrictions. EPA presumably would deny the amendment application, and the registrant could then invoke its right to a full section 6(b) hearing. In addition, the registrant can refuse conditions to registration at the outset, in which case EPA presumably would deny the registration application, and the registrant could again request a full hearing under section 6(b).

The registrants may appeal Judge Biro's decision to the EPA's Environmental Appeals Board. Alternatively, they may reapply for registration and appeal EPA's likely denial in a full hearing under section 6(b). Meanwhile, companies that accept conditional registrations—including any that require the registrant to voluntarily cancel its product when EPA determines that the product causes unreasonable adverse effects—must recognize that they will have only the very limited hearing rights of section 6(e) under Judge Biro's decision.

Order on Petitioner's Motion for Accelerated Decision, Bayer CropScience LP, Docket No. FIFRA-HQ-2016-0001 (U.S. Envtl. Prot. Agency ALJ Apr. 25, 2016).

Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries. www.dentons.com.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Events from this Firm
26 Sep 2018, Conference, New York, United States

Dentons is delighted to support a global IT services and consulting firm Miratech as an event host partner at their annual conference called M-Force18 New York on September 27th. The event will be held at Dentons New York office in the heart of Midtown Manhattan, opposite Rockefeller Center.

2 Oct 2018, Seminar, Dallas, United States

We are pleased to offer a program of five sessions designed specifically for in-house counsel. Topics will include:

  • In-house corporate ethical issues
  • What recent Supreme Court decisions mean for business
  • Keeping lawyers out of your benefit plans
  • Litigation tactics for in-house counsel
  • Employment issues in the age of #MeToo
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions