Practice Areas & Industries: Keller and Heckman LLP

 





Group Profile Lawyers in this Group Offices Locations for this Group
 

Practice/Industry Group Overview

Keller and Heckman's team of attorneys and scientists help clients develop product approval programs and produce high quality registration applications and technical product dossiers. We also help clients defend existing markets worldwide against governmental pressure and environmentalist activism. With extensive and direct experience in regulatory and compliance counseling, legislative issues, and environmental audits, we provide assistance in a multitude of areas affecting the pesticides industry, including:

  • Register a new active ingredient in NAFTA countries, the European Union and the Pacific Rim;
     
  • Develop EU Biopesticide Product Dossiers;
     
  • Defend against an EPA enforcement action;
     
  • Protect your data rights;
     
  • Manage complex studies;
     
  • Obtain approval for a new inert material;
     
  • Secure successful tolerance reassessments;
     
  • Obtain Product Re-registrations;
     
  • Develop a global pesticide business or regulatory strategy; and
     
  • Comment on an EPA or EU rule or policy.

Through Keller and Heckman's unique ability to integrate science and law, we help industry bring its most innovative new pesticide product ideas through the regulatory approval process and into the market. Our attorneys and scientists, most with Ph.D.s, have a history of success in forging a path through the tangle of technical and legal regulatory requirements involved in registering a new pesticide product. On behalf of our pesticide clients, we regularly address matters before the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC), the European Commission and member country Competent Authorities in the EU, the Canadian Pest Management Regulatory Agency, and the U.S. state regulatory agencies, including, in particular, California's Department of Pesticide Regulation.

Our Clients

We represent a broad range of clients that are involved with pesticides, including:

  • Agricultural pesticide companies;
     
  • Antimicrobial, water treatment, and wood preservative pesticide companies;
     
  • Manufacturers of pesticide intermediates;
     
  • Manufacturers and distributors of pesticide inert ingredients;
     
  • Manufacturers of industrial chemicals, fibers, fabrics and other materials treated with pesticides;
     
  • Manufacturers of paints, caulks and coatings;
     
  • Manufacturers of pesticide devices;
     
  • Chemical companies with products used as pesticides;
     
  • Farmers;
     
  • Food and feed producers and distributors;
     
  • Consumer and commercial product companies;
     
  • Soap and detergent manufacturers;
     
  • Pesticide applicators;
     
  • Research organizations; and
     
  • Industry trade associations.

An International Perspective

In Brussels, just as in our Washington office, attorneys and scientists team to represent our client's interests before the European Commission and the Member States' National Competent authorities on all issues related to the marketing of active substances and finished pesticide and biocidal products, including all issues related to the preparation of petitions for the authorization of these products and related data right/share issues.

In addition to our experience in securing approvals in the U.S., we have extensive experience representing clients in other countries. Worldwide regulatory harmonization efforts have made it possible for the data generated to support approvals in one country to be used, at least in part, as a basis for approval elsewhere. Working routinely in partnership, our Brussels and Washington offices track both harmonized requirements and the principal ways in which requirements differ from country to country. In Brussels, just as in our Washington office, attorneys and scientists team seamlessly to clear the path for new pesticide products to market.

U.S. Experience

Keller and Heckman attorneys and scientists have strong working relationships with government authorities and a seasoned staff of experts who can assist clients in even the most difficult and non-routine matters (e.g., petitioning under FFDCA § 408 for an exemption from tolerance for a treated article; negotiating an enforcement settlement with EPA that allowed a company to retain a brand name that EPA had alleged constituted an unregistered pesticide claims). The areas in which we work include:

  • EPA and state registration of new pesticide active ingredients under Section 3 of FIFRA;
     
  • EPA and state registration of pesticide intermediates and end-use products under FIFRA;
     
  • Approval of products with joint EPA/FDA or EPA/USDA regulatory requirements;
     
  • Design, placement, monitoring, final report preparation and review for major laboratory and field studies;
     
  • Preparation and submission of petitions for tolerance or exemptions from tolerance under § 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA);
     
  • Preparation and submission of food additive petitions under § 409 of the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA) and the Antimicrobial Regulation Technical Corrections Act of 1998 and Food Contact Notifications;
     
  • Preparation of pesticide registration applications (including innovative and unprecedented applications) and reregistration responses;
     
  • Preparation and submission of applications for approval of pesticide inert ingredients;
     
  • Legal and technical representation in matters involving data rights under FIFRA § 3(c)(1)(F), including data compensation negotiations and the filing of "petitions to deny or cancel" pesticide registrations;
     
  • Legal defense and settlement negotiations in enforcement matters, including challenges to EPA's Stop Sale, Use and Removal Orders (SSURO);
     
  • Preparation of dietary, aggregate and cumulative exposure and risk assessments;
     
  • Defense of products in the pesticide reregistration (FIFRA § 4) and tolerance reassessment (FFDCA § 408(q)) processes;
     
  • Exploration and implementation of technical and legal strategies for product and product line development;
     
  • Legal advice and analysis regarding labeling for consumer goods containing preservatives under EPA's new interpretation of the "treated articles exemption" (40 C.F.R. § 152.25(a));
     
  • Counseling with respect to the reporting of adverse effects information under FIFRA § 6(a)(2);
     
  • Negotiations with EPA, FDA and USDA over regulatory requirements;
     
  • Negotiation and preparation of pesticide supply, distribution and subregistration (supplemental distribution) agreements;
     
  • Preparation of detailed comments on new policies and proposed rules;
     
  • Design and formation of trade associations; and
     
  • Representation before the U.S. Congress.

 

Services Available

 
Upcoming Seminars
  Practical Primer on Pesticides Seminar - Indianapolis, IN, Indianapolis, IN, September 17, 2015
 
Past Seminar Materials
  Practical Primer on Pesticides Seminar - Washington, DC, Washington, DC, April 14, 2015
 
 
Articles Authored by Lawyers at this office:

Summary of EPA's Proposed Rule for Nanoscale Substances
, April 15, 2015
EPA is proposing to collect information from companies that have manufactured, imported, or processed chemical substances at the nanoscale in the three years prior to the effective date of the rule. Reports are due 6 months from the effective date of the rule.

Taiwan Releases Draft Regulation on New and Existing Chemical Notification
Thomas C. Berger,Wilfred Feng,Chen Hu, September 23, 2014
On August 25, 2014, the Republic of China’s (Taiwan) Environmental Protection Administration (EPA) released a draft “Regulation of Chemical Substance Registration and Management” (Regulation). The Regulation was developed to implement amendments to Taiwan’s Toxic Chemical...

Senator Boxer Releases Confidential TSCA Reform Proposal
Thomas C. Berger,Herbert Estreicher,Martha E. Marrapese,Adrienne M. Timmel, September 22, 2014
U.S. Senator Barbara Boxer (D-CA) has publicly released her proposed amendments to a confidential proposal that Senators David Vitter (R-LA) and Thomas Udall (D-NM) have been working on for over a year to build bipartisan support for passage of TSCA reform. Senator Boxer, who chairs the Senate...

What Happens Next to Earthjustice's Demand for CBI Reassertion and Resubstantiation?
Herbert Estreicher,Eric P. Gotting,Martha E. Marrapese, September 18, 2014
The designation and treatment of Confidential Business Information (“CBI”) is frequently at the center of the Toxic Substances Control Act (“TSCA”) reform debate. One issue receiving increased attention is whether chemical companies should be required to reassert or...