Pesticides and Agricultural Chemicals in North America

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Risk Management of Bacillus Thuringiensis Use in Agriculture

When you need to understand complex regulatory requirements across North America, Ģ��tv is uniquely positioned to offer you rigorous scientific and regulatory support.

Ģ��tv'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.

Ģ��tv 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, Ģ��tv 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

Ģ��tv 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.

Ģ��tv 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, Ģ��tv can handle state fertilizer approvals, which are not regulated under the pesticide laws. These products still require preparation and submission of fertilizer registration applications.

Capabilities and Services

Ģ��tv's teams supply expert support for the evolving regulatory landscape of chemicals in Canada — in the environment as well as their impact on consumers — and offer the integrated expertise of ecologists, toxicologists, polymer scientists, material chemists, and chemical regulation professionals to help you prepare for, and respond to, Canadian Pest Management Regulatory Agency (PMRA) regulatory requirements.
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The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) 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 sold, shipped into that state, and moved into the channels of trade. Ģ��tv has the expertise to manage state-specific registration needs, including initial registration in the states, management of state renewals, issue resolution, and state enforcement action support.
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Often favored for being less toxic than conventional pesticides, biopesticides are derived from natural materials and living organisms, have the ability to target specific pests, are effective in smaller quantities, are less likely to be resistant, and typically decompose rapidly. Like pesticides, however, biopesticides are still heavily regulated for safety and efficacy. Ģ��tv's chemical regulations team has extensive experience with crop protection and regulatory strategy and can provide a complete and tailored service to support the registration and management of biocontrol agents.
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When it comes to biostimulants, fertilizer, and soil and plant amendment products, Ģ��tv provides you with streamlined support for all phases of your product's lifecycle. From product formulation assessments, import and permit considerations, product labeling and claims reviews, and supporting data guidance to product type determinations, we offer seamless coordination of all applicable regulatory requirements throughout North America.
For 50+ years, we've thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
- EPA, PMRA, PCPR, and state strategy implementation to support and maintain registration submissions
- Rapid respond to short-term crisis situations
- Environmental and human health risk assessments
- Risk mitigation including Endangered Species Act (ESA)
- Study placement, monitoring, and review of study results
- Scientific data review and recommendations
- Communication with regulatory authorities
- Pesticide registration

Our Capabilities Are Unparalleled

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.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.