农药合规(FIFRA) -美国

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the federal statute governing U.S. 农药监管. 一般来说, 农药被定义为用于预防的物质或物质混合物, 破坏, 排斥, 或者减轻任何害虫. 为了使农药产品在美国销售或分销.S.在美国,它必须预先获得批准并在美国注册.S. 环境保护署(EPA),每个州和美国.S. 领土. 钱柜平台帮助公司注册, renew and maintain the 登记s of their products both federally (EPA FIFRA 登记) and in the states w在这里 the products are to be marketed.

了解联邦农药要求

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

  • 抗菌素 -这些物质包括消毒剂, 消毒液, 防腐剂, 杀病毒剂, 而杀菌剂则用于控制细菌等微生物的生长, 病毒。, 或真菌.
  • 生物农药 -这些产品来源于具有杀虫作用的天然材料. T在这里 are three classifications: biochemical, microbial, and plant incorporated protectants (PIPs). 这些产品本身毒性较低, 只对目标害虫有影响,而且用量很小.
  • 传统的农药 – These 农药 are generally produced synthetically and are used to control various types of pests such as weeds, 昆虫, 真菌, 和啮齿动物.
  • 除害剂仪器登记 - 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 and crops. 这些耐受性评估涉及人类接触.

解决国家农药法规问题

经EPA批准后, 农药 must be registered in each state and 领土 w在这里 they will be distributed or sold and each state has its own laws regarding 农药. 了解更多关于 国家规定...

钱柜平台可以提供帮助

钱柜手机版可以协助浏览美国联邦农药法规的所有领域.S. 包括:

  • 制定全面的产品/除害剂注册策略
  • 在监管机构中代表和倡导公司的利益
  • 准备和提交联邦注册和更新,确保符合EPA FIFRA
  • 开发产品标签
  • 准备和提交 惰性的请愿书
  • 与合约研究实验室(CRO)安排及监察研究
  • 准备数据豁免和理由
  • 对农药产品再评价的回应
  • 进行合规性审核
  • 内部培训

需要帮助注册农药产品?

为什么次数

钱柜平台为公司提供高质量的钱柜平台Services. 钱柜手机版的目标是了解客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. 钱柜平台的专家团队以截止日期为中心,反应迅速,并致力于专业. 钱柜手机版非常尊重钱柜手机版工作的机密性, 较强的项目管理能力, 大力培育与客户的长期合作伙伴关系.

钱柜手机版的专业人员

钱柜平台's team of scientists and regulatory 咨询顾问 manage all aspects of product 登记, 与客户一起进行生命周期管理和战略规划. 钱柜手机版位于华盛顿特区的联邦事务团队由 阿比盖尔Wacek.

有用的信息

常见问题

根据美国环保署的规定,农药法将“农药”定义为:

  • 用于预防的任何物质或物质混合物, 破坏, 排斥, 或者减轻任何害虫
  • 用作植物调节剂的任何物质或物质混合物, 落叶剂, 或干燥剂
  • 任何氮稳定剂

The length of time involved in obtaining a federal 登记 depends on many factors such as the proposed uses of the product, 产品的配方以及如何处理数据要求. Delays can be avoided by submitting quality packages in the initial submission and working hand-in-hand with EPA during the review process. 钱柜平台 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 登记 are dependent on the proposed product uses including location and claims made on the labeling. 拟议产品的配方也会影响所需数据的类型. 有许多方法可以满足数据需求,例如数据引用, 豁免理由和实验室生成. 农药的数据要求可以在40 CFR第158部分找到. 钱柜平台 can provide a list of data requirements specific to your proposed product through a 登记 strategy assessment document or a data gap analysis.

The costs and 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vs .非公共卫生), 产品的配方(例如, 新的有效成分与EPA数据库中现有的有效成分), 以及如何处理数据需求(例如, 数据引用vs实验室生成). 钱柜平台可以根据要求提供针对建议产品的成本估算.

Pesticide 登记s with the EPA must be maintained throughout their life cycle through various obligations. EPA要求每个产品支付年度维护费用. 此外, 如果EPA发布了适用于你的产品的数据调用, 数据调用必须由产品注册人处理. 偶尔, EPA issues other labeling and data mandates outside of the data call-in which must also be addressed. 最后, 如果注册人拥有epa注册的企业设施, 年度报告须保持设立登记. 钱柜平台可以协助公司完成上述任务以及其他EPA义务.

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