Antimicrobials (FIFRA) & Biocides (BPD & BPR)

Steptoe has an internationally respected practice in the field of antimicrobial and biocide regulation covering the United States, the European Union, and China.  Pesticides have been a principle focus of our practice for more than 25 years, with a particular emphasis on antimicrobials and biocides. In these jurisdictions, our deep knowledge and constructive interaction with regulators enables us to be uniquely effective in accomplishing our clients’ goals.  Steptoe’s multi-disciplinary team brings together legal, regulatory, and scientific specialists to efficiently deliver the broad range of services needed to be effective in this complex area.

US Practice
Steptoe’s Washington based US practice interacts on a daily basis with the EPA Office of Pesticide Programs (OPP).  We assist companies, groups of companies, and trade associations in addressing the broad range of issues that arise under US pesticide regulation, such as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the powerful regulatory statute applicable to all pesticides, and the Federal Food Drug and Cosmetic Act (FFDCA) which governs allowable residue levels of pesticides on certain foods.  

Among the many areas in which we work are:

Registrations, Amendments, Re-Registrations & Registration Review
Steptoe’s attorneys and specialists work together with the OPP Antimicrobials, Registration and BioPesticides divisions to guide applications through EPA’s application/registration and amendment processes.  With the re-registration process required by the Food Quality Protection Act (FQPA) nearing its conclusion, outstanding data-development obligations and the new “Registration Review” process will bring many challenges.  Steptoe’s chemical regulatory team is provides sophisticated advice in connection with the full range of issues related to pesticide registrations.

Data Requirements & Data Call-ins
For decades, Steptoe has worked with registrants and EPA on data requirements and data call-ins.  We focus on assisting clients in using innovative approaches to provide the information needed for risk assessment, including using existing or unconventional data.  We also help organize groups of registrants to respond to EPA’s data needs. 

Data Compensation
FIFRA data protection and compensation is a vital and complex component of the pesticide program.  Steptoe provides strategic and tactical advice to data owners to manage their portfolios.  We also support our clients in compensation negotiations and arbitration. 

Regulatory Development and Policy
Steptoe’s practice also focuses on developing and advocating positions for our clients on key OPP policy and regulatory development activities.  We provide sophisticated advice and aggressive advocacy on behalf of clients before agency decision-makers.  We also advise and submit comments on regulatory proposals that impact our clients’ interests.

Enforcement and Compliance Audits
Steptoe has an active practice defending clients in enforcement actions, including pesticide enforcement cases.  Recently, we handled a number of matters arising out of alleged efficacy failures in EPA’s Antimicrobial Testing Programs.  We also design and implement compliance audit programs.  Where violations are discovered, we provide strategic advice on responding, including possible voluntary disclosure. 

EU Practice
Our Brussels office has one of the most respected practices in the EU focused on the regulation of pesticides and biocides. Chambers & Partners Europe 2012, reports that Steptoe “enjoys a fantastic reputation for biocides.”  We support the authorization of active substances (at the EU level) and formulated products (at the national level in all 28 EU Member States) from regulatory, competition law (antitrust), and commercial perspectives. Our relationships with Commission and Member State officials help us to obtain prompt and accurate feedback on even the most difficult issues.  In addition, our close working relationship with technical consultants enables us to ensure the effective and efficient preparation of dossiers, resulting in greater overall efficiency and lower cost for clients. Typical assignments include the following:

  • Dossier preparation
  • Compliance audits
  • Strategy for obtaining marketing authorization of biocidal products within the EU
  • Managing the transition from national regimes to EU-wide regulation of biocidal and plant protection products
  • Assisting in transfers of authorizations, including work under national regimes with an experienced network of counsel in many EU member states
  • Negotiation of consortium agreements
  • Representation of clients on/in consortium meetings
  • Managing consortia
  • Data protection
  • Data compensation, negotiations, and valuation
  • Advocacy before the European Commission and Member State competent authorities
  • Defense against enforcement actions and advice on self-disclosure
  • Representation before the European Courts of Justice
  • Advocacy before the Commission and European Parliament on legislative issues of concern to the biocides and pesticides industries, including the upcoming Biocidal Products Regulation and proposed devolution to the EU member states of regulation of GM crops

China Practice

Steptoe’s Beijing office advises multinational companies on interpreting and ensuring compliance in the emerging regulation of antimicrobials and biocides.  We also advise non-Chinese companies entering and doing business in the Chinese market, in particular, with regulatory, government relations, and corporate matters associated with their operations in China.  We also help resolve market access and other issues before various national and provincial Chinese government agencies.