农药符合性(FIFRA) -美国

The Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) is the federal statute governing U.S. 农药监管. 一般来说, 农药 are defined as substances or mixtures of substances intended for preventing, 破坏, 排斥, 或减轻任何害虫. 为了使农药产品在美国销售或分销.S.在美国,它必须预先批准并在美国注册.S. 环境保护署(EPA),每个州和美国.S. 领土. TSG帮助公司注册, renew 和 maintain the registrations of their products both federally (EPA FIFRA registration) 和 in the states w在这里 the products are to be marketed.


EPA separates 农药 into distinct categories 和 each category has specific data requirements that must be met when applying for federal / FIFRA registration 和 renewal:

  • 抗菌素 -这些物质包括消毒剂, 消毒液, 防腐剂, 杀病毒剂, 真菌cides 和 are used to control the growth of microorganisms such as bacteria, 病毒, 或真菌.
  • 生物农药 – These products are derived from natural materials that have pesticidal applications. T在这里 are three classifications: biochemical, microbial, plant incorporated protectants (PIPs). 这些产品本身毒性较小, 只影响目标害虫,使用非常小的数量.
  • 传统的农药 – These 农药 are generally produced synthetically 和 are used to control various types of pests such as weeds, 昆虫, 真菌, 和啮齿动物.
  • 农药登记设备 - These devices pesticidal activity is due to physical or mechanical actions or due to a substance or mixture of substances.

It should be noted that 农药 that come in contact with food or food contact surfaces require additional approval such as a tolerance or an exemption from tolerance to address residues on surfaces 和 crops. 这些耐受性评估涉及人体接触.


在环保局批准, 农药 must be registered in each state 和 领土 w在这里 they will be distributed or sold 和 each state has its own laws regarding 农药. 了解更多有关 国家规定...


We can assist with navigating all areas of federal 农药监管 in U.S. 包括:

  • 制定全面的产品/农药注册策略
  • 代表和倡导公司与监管机构
  • 准备和提交 federal registration 和 renewals ensuring EPA FIFRA compliance
  • 开发产品标签上
  • 准备和提交 惰性的请愿书
  • 合约研究实验室(CRO)的研究安排和监测
  • 准备数据免责声明和理由
  • 对农药产品的重新评价作出反应
  • 进行合规审核
  • 内部培训



TSG provides 公司 with high-quality regulatory 和 scientific consulting services. 千赢国际娱乐登录中心的目标是了解千赢国际娱乐登录中心客户的目标和目的, learn the scientific 和 technical aspects of projects 和 anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive 和 committed to professionalism. 千赢国际娱乐登录中心对工作的保密性有极大的尊重, 较强的项目管理能力, take great measure to cultivate long-term partnerships with clients.


TSG has a team of scientists 和 regulatory 咨询顾问 who manage all aspects of product registration, 与千赢国际娱乐登录中心的客户进行生命周期管理和战略规划. 从事农药工作的主要专业人员包括 阿比盖尔Wacek丽莎Amadio, 弥迦书雷诺兹在千赢国际娱乐登录中心的州队 凯利Rahn 和 曼迪Daun.



According to EPA, Pesticide law defines a “pesticide” (with certain minor exceptions) as:

  • 用于预防的任何物质或物质混合物, 破坏, 排斥, 或减轻任何害虫
  • Any substance or mixture of substances intended for use as a plant regulator, 落叶剂, 或干燥剂
  • 任何氮稳定剂

The length of time involved in obtaining a federal registration depends on many factors such as the proposed uses of the product, the formulation of the product 和 how the data requirements will be addressed. Delays can be avoided by submitting quality packages in the initial submission 和 working h和-in-h和 with EPA during the review process. TSG can provide time estimates for the preparation of the pesticide application package as well as an estimate of EPA’s time to review the application package once it is submitted to EPA.

The data requirements that are needed for an EPA pesticide registration are dependent on the proposed product uses including location 和 claims made on the labeling. The formulation of the proposed product can also impact the type of data required. T在这里 are many ways the data requirements can be addressed such as data citation, 放弃理论和实验室生成. 农药的数据要求见40 CFR第158部分. TSG can provide a list of data requirements specific to your proposed product through a registration 策略 assessment document or a data gap analysis.

The costs 和 fees that go into getting a pesticide registered with EPA vary greatly depending on numerous factors. 这些因素包括产品将如何使用(例如, 公共卫生与非公共卫生), 产品的配方(例如, new active ingredient vs existing active ingredient in EPA’s database), 以及如何满足数据需求(例如, 数据引用vs实验室生成). TSG can provide cost estimates specific to the proposed product upon request.

Pesticide registrations with the EPA must be maintained throughout their life cycle through various obligations. EPA要求每个产品每年支付维护费用. 此外, EPA是否发布了适用于你们产品的数据调用, 数据调用必须由产品注册人处理. 偶尔, EPA issues other labeling 和 data m和ates outside of the data call-in which must also be addressed. 最后, 如果注册人拥有epa注册的设施, annual reports are required to maintain the establishment registration. TSG can assist 公司 with the above-mentioned tasks as well as other EPA obligations.



Our regulatory specialists 和 scientists address all aspects of product registration 和 ongoing compliance. Read more about the individuals who make up our multi-disciplinary teams.


We work in various different markets, including agriculture, industrial, consumer 和 medical.