CAPABILITY

Chemical Regulatory Support in the U.S.

Chemical Regulatory Support in the US 

Gain expert support for state-by-state chemical regulatory demand

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDC) are U.S. laws that govern how pesticides must be regulated and used; pesticides must also be approved and licensed annually by each individual state before pesticide products can be shipped into that state and moved into the channels of trade. Exponent has the expertise to manage state-specific registration needs, from initial registration and management of annual renewals to issue tracking and preparing and submitting experimental-use permit applications.

Chemical regulatory guidance in every U.S. state

After the initial registration of a pesticide in a given state, in most cases, the registration must be renewed annually, and the renewal date, annual fee, and administrative requirements differ from state to state. Exponent has the expertise and personnel necessary to provide management services for all state registration needs, from initial registration and management of annual renewals to issue tracking and management. In addition, Exponent can handle state fertilizer approvals, which are not regulated under the pesticide laws in the United States and prepare and submit experimental-use permit applications.

Exponent has extensive experience managing U.S. Federal and State registrations on behalf of our clients, including registration and EUP submissions, serving as an authorized agent or representative, preparing and submitting product amendments, reviewing EPA correspondence and responding appropriately, label reviews, EPA product notifications, and other regulatory actions. Exponent can serve as your regulatory department or can be available to assist with specialized projects. We tailor our level of service to your needs so that you can focus on manufacturing and selling your products and growing your business.

All U.S. states have basic annual pesticide registration and renewal procedures, which differ in detail, i.e., dates, fee amounts, etc. from state to state. At a minimum, to issue a product registration for the first time, each state normally requires a properly completed application form, product labels, copies of the federal approval documents, and payment of a registration fee. For states such as California and New York, the initial registration also requires the submittal of all data previously reviewed by EPA (California), and (in New York) submittal of the EPA's scientific reviews of all studies supporting the Federal Registration. The state of Florida requires abbreviated summaries of the federal studies. A few other states have been moving toward a more scientific approach, as opposed to a purely administrative approach.

Services

Exponent offers the following pesticides regulatory strategy development services:

  • Strategy implementation to support and maintain registration submissions
  • Environmental and human health risk assessments
  • Risk mitigation, support strategy, and data generation program development
  • Scientific data and risk assessment outcomes review
  • Communication with regulatory authorities
  • Rapid respond to short-term crisis situations