N.Y. Comp. Codes R. & Regs. tit. 6 § 326.23

Current through Register Vol. 46, No. 45, November 2, 2024

Section 326.23 - Registration application reviews and determinations

(a) All applications and filings will be reviewed for completeness. A determination of completeness will be made within 60 days from the date of receipt by the department. The applicant will be notified in writing of the determination of completeness or incompleteness. If the application or filing is determined to be incomplete, the notice will include a statement of the reasons for the determination. An incomplete application may be returned to the applicant with the notice. The resubmission or submission of additional information shall commence a new review of the completeness.

(b) If a determination of completeness is not made within 60 days of receipt, the application will be deemed complete as of the 61st day.

(c) Upon determination that an application is complete, the department will initiate a technical review of the data submitted as part of the application, in order to evaluate the potential for adverse impacts to human health and the environment which may occur when the product is used in accordance with the label directions. The commissioner will weigh the potential for human health and ecological risks against the potential benefits that could accrue from the use of the product when making a decision whether or not to approve the registration.

(d) Upon completion of the review, the department will issue or deny the registration, or approve or disapprove amended labeling within the following periods, calculated from the date of the completeness determination:

(1) 150 days for applications for a new active ingredient or a major change in labeling;

(2) 90 days for applications not involving a new active ingredient or a major change in labeling;

(3) 60 days for applications for a special local need;

(4) 30 days for amended labeling not involving a major change in labeling; or

(5) 60 days for experimental use permit (EUP) product applications.

(e) The commissioner may place any conditions on the registration of any product that are deemed necessary to prevent damage or injury to health, property and wildlife. Conditions may include, but are not limited to:

(1) the submission of additional data;

(2) classification as restricted use;

(3) recordkeeping or reporting requirements; and

(4) any other use conditions deemed necessary.

(f) Compliance with the conditions of registration is required for the continued registration of the pesticide.

(g) If registration or approval of amended labeling is not granted or denied within the prescribed time period, the applicant may submit a request to grant or deny the registration, by means of certified mail, return receipt requested, addressed to the Commissioner of Environmental Conservation, Attention: Director, Division of Solid and Hazardous Materials, New York State Department of Environmental Conservation, 625 Broadway, Albany, NY 12233-7250. If the registration is not granted or denied within 30 days following the receipt of such request, the registration shall be deemed granted, except that for applications involving a special local need, the application will be deemed granted if a decision is not issued within 10 days. Any denial of registration or disapproval of amended labeling will specify the grounds for denial.

(h) Any time period specified in this Part may be extended with the consent of the applicant.

N.Y. Comp. Codes R. & Regs. Tit. 6 § 326.23