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Pesticides & Antimicrobials

Steptoe & Johnson LLP is a leading national firm with extensive experience in chemical and pesticide regulation and litigation.  With the ability to draw on the full resources of more than 500 attorneys and other professionals located in Washington, New York, Los Angeles and Phoenix, Steptoe provides a high level of representation in US chemical regulatory matters and provides sophisticated guidance to clients negotiating the complex regulation of pesticide products, with a primary focus on antimicrobials and industrial biocides.

Steptoe has a nationally known practice in the field of antimicrobial and pesticide regulation in both the United States and the European Union, focusing on the regulation of antimicrobials and other pesticides for more than 20 years.

In the United States, all pesticides, including antimicrobial, are regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  They must be registered by the US Environmental Protection Agency (EPA), and additionally by individual states, before they may be sold. FIFRA requires EPA to determine that a pesticide will not cause "unreasonable adverse effects on man or the environment" in order to grant a registration.  It also authorizes EPA to require registrants and applicants to perform scientific studies and submit test data both before and after registration. In addition, EPA grants tolerances and exemptions from tolerance for pesticide residues in or on certain foods under section 408 of the Federal Food Drug and Cosmetic Act (FFDCA), as amended.

Our professionals represent registrants and applicants with respect to a very broad range of regulatory and policy issues.

The scope of products handled include, for example, drinking water and swimming pool treatment chemicals; preservatives for paints, coatings, adhesives, plastics, metal working fluids and other materials; pulp and paper mill products; wood preservatives; marine antifoulants; and a wide variety of other use areas.

This extensive experience is supplemented by our firm’s work on pesticide regulatory policy issues.  Virtually every day, Steptoe professionals interface with the EPA and state officials on antimicrobial and other pesticide regulatory matters.  This continuous, close work with EPA personnel provides Steptoe professionals with the experience to anticipate and avoid problems, and the creativity and credibility to solve them.  

Registrations. Our professionals work directly with staff in EPA’s Antimicrobial Division and Registration Division on a daily basis to obtain registrations in the most expeditious possible manner.  With this experience, we also are in a position to recommend the best resources to complete necessary scientific work. 

Reregistration and Data Call-ins. We combine advanced legal knowledge with deep regulatory experience to assist clients in developing optimal responses to these EPA initiatives.  Steptoe’s professionals are managers of a number of data development consortia that were created to respond to EPA data call-ins. 

Enforcement. Steptoe has significant capabilities in defending civil enforcement actions under FIFRA and other environmental statutes.

Data Compensation. FIFRA provides original data submitters with a period of 10 or 15 years during which time any follow-on registrants are required to offer compensation for studies submitted in support of registration and reregistration.  Requirements for data and the costs of the data have increased significantly since 1988, and the importance of antimicrobial data compensation issues have increased proportionately.

Seth Goldberg leads our pesticides and antimicrobials practice.  Sue Crescenzi, a non-lawyer technical specialist, coordinates our registration practice under his supervision. 

Click here to e-mail the Pesticides & Antimicrobials team with questions or comments.

Representative Matters

Registrations

  • Provided advice and guidance in the initial registration of a significant number of active ingredients and formulated products 
  • Consistently engaged to obtain registrations for products with such uses as paint, coating, and materials preservatives, water treatment products, algaecides and slimicides, swimming pool products, wood preservatives, products used to preserve metal working fluids and other applications 

Reregistration and Data Call-ins

  • Regularly supports registrants through the reregistration process and in responding to EPA data call-ins (requirements to provide additional data on already registered products) 

Enforcement

  • Defending enforcement actions, most often civil administrative actions in which EPA is seeking penalties for FIFRA violations 
  • Working with registrants that conduct compliance audits, to ensure that the companies get the maximum advantage from EPA’s policy encouraging voluntary disclosure of violations 

Data Compensation 

  • Assisted clients in developing defensible offers and demands for compensation to negotiate with other parties and in handling FIFRA data compensation proceedings

Other Regulatory and Policy Matters

  • Assists registrants faced with numerous other considerations regarding EPA’s regulations of antimicrobials  
  • Provide advice and support on reporting requirements for adverse effects information that EPA requires for all registered pesticides following registration and on the intricacies of EPA’s exemption from regulation for "pesticide-treated articles"
  • Conduct training sessions, tailored to an individual company’s focus, to familiarize company personnel with EPA’s pesticide regulatory requirements

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