Major Change In Pesticide Labeling And New Active Ingredients
What is a New Active Ingredient Pesticide Product or Major Change in Labeling?
New Active Ingredient (NAI)
Products containing a new active ingredient are those with an active ingredient not contained in any pesticide product currently registered with DEC.
Major Change in Labeling (MCL) (also referred to as major change in use pattern)
A change in the general use pattern involving a category or site previously not registered for the active ingredient. Examples include, but are not limited to:
- addition of terrestrial food or nonfood use
- aquatic food and nonfood use
- domestic outdoor use
- indoor use
- forestry use
- greenhouse food or nonfood
Additionally, a change that is likely to increase the exposure of any non-target organism or that increases the potential for significant impact to humans, property, or the environment. Examples include, but are not limited to:
- addition of aerial application
- addition of direct soil application
- addition of a major crop
Why are MCL and NAI applications reviewed?
Applications containing NAI or MCL products are reviewed in depth because they represent new potential for exposure to humans, fish and wildlife resources, and the groundwater and surface water resources of New York.
Who reviews these applications?
These products are first reviewed by the United States Environmental Protection Agency (USEPA) to evaluate risks and benefits of pesticides to the nation as a whole.
New York has special circumstances that are not necessarily reflected in USEPA decisions. Evaluating pesticide exposure at the state level is important to ensure that factors unique to New York are considered during the registration review.
Applications are distributed to reviewers in the New York State Department of Health; the DEC Division of Fish, Wildlife, and Marine Resources; and the DEC Division of Materials Management's groundwater review staff. Analytical methods are distributed to the DEC's laboratory staff for review.
Time Frames for DEC Review
According to the Environmental Conservation Law §33-0704 the DEC must make a completeness decision for an application within 60 days of receipt. If an application is deemed incomplete, the applicant is notified. Submission of additional information starts a new 60 day completeness review. Once an application is deemed complete, a technical decision is to be made within 150 days.
Application Form and Data Requirements
DEC requires registrants to submit USEPA reviews and/or data evaluation record reports and occasionally the original studies, when needed, in order to conduct our review.
A properly completed application package is vital in achieving a determination of complete on the first attempt and helps DEC to achieve our goal of providing efficiency in the review process. Efficient review timeframes benefit the registrants and their customers by bringing products to market sooner. One determination of incompleteness for an application can add approximately 100 days to the overall time that the application is pending registration in New York State. We recommend you review the data checklist for Conventional Pesticides (PDF, 228 KB) and checklist for Biopesticides (PDF, 193 KB).
In addition to the checklist of supporting data, the following are required to be submitted:
- Pesticide Registration Application Form (PDF, 191 KB) (4 paper copies)
- Check (payable to Commissioner, NYSDEC) for the application fee
- NY Product Information Form (PDF, 312 KB) (4 paper copies)
- USEPA Stamped Label(s) (4 paper copies)
- Final Product Label (4 paper copies)
- Confidential Statement of Formula (4 paper copies)
- Safety Data Sheet (4 paper copies)
- USEPA Review Documents and Data Summaries (4 CDs)
- Analytical Methods (2 CDs)
Pre-application Meeting
DEC strongly suggests that a pre-application meeting be held in order to discuss the product and its characteristics, as well as potential New York State concerns and data requirements. Please email the Pesticide Product Registration Section or call 518-402-8768.
DMM, Bureau of Pesticides Management
625 Broadway
Albany, NY 12233-7257