When you need to understand complex regulatory requirements across North America, Exponent is uniquely positioned to offer you rigorous scientific and regulatory support.
Exponent's multidisciplinary teams of regulatory specialists, chemists, toxicologists, biostatisticians, ecotoxicologists, epidemiologists, risk assessors, and health scientists combine expertise to solve your most formidable challenges when it comes to taking your product to market and navigating complex and sometimes inconsistent regulatory frameworks across North America.
Exponent helps clients understand the requirements of the U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), which govern pesticides, antimicrobials, and pesticide residues. Similarly, Exponent supports you in registering and maintaining products with Canada's Pest Management Regulatory Agency (PMRA) and Pest Control Products Regulations (PCPR), requiring stringent regulatory approvals and annual notifications.
Chemical regulatory guidance in the U.S. at the federal and state levels
Exponent consultants have assisted hundreds of clients in the approval and management of U.S. federal and state registrations, including new product applications and experimental use permit submissions; serving as an authorized agent or representative; preparing and submitting product amendments; reviewing and responding to U.S. Environmental Protection Agency (EPA) correspondence; reviewing labels; preparing EPA product amendments/notifications; and conducting other related regulatory actions.
Meeting state-by-state requirements
All states have their own pesticide laws, and while those laws do not supersede federal laws, certain states such as California, New York, and Florida have data or other requirements that are sometimes an addition to the federal requirements. In California, applicants must submit all data previously reviewed by EPA, and in New York, applicants must submit the EPA's scientific review of all studies supporting the federal registration. Florida requires abbreviated summaries of the federal studies, and a few other states have been moving toward a more scientific approach, as opposed to a purely administrative approach.
All U.S. states have basic annual pesticide registration and renewal procedures, which differ from state to state in detail, i.e., dates, and fee amounts. 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.
Exponent has the expertise and geographic footprint necessary to provide management services for all U.S. 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. These products still require preparation and submission of fertilizer registration applications.
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With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
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