DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES
Division of Agricultural Environmental Services
RULE NO.:RULE TITLE:
5E-2.031Pesticide Registration; Exemptions from Registration; Experimental Use Permits
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 127, July 1, 2014 issue of the Florida Administrative Register.
THE FULL TEXT OF THE PROPOSED RULE IS:
5E-2.031 Pesticide Registration; Exemptions from Registration; Experimental Use Permits.
(1)(a) through (d) No change.
(e) The department will waive specific data requirement provisions of this rule for registration of products for which such data requirements are not pertinent to risk assessment procedures or for those applications for registration for which the department possesses a sufficient data base. The United States Environmental Protection Agency (EPA) “exclusive use of data” provisions of Section 3(c)(1)-(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), September 28, 2012, which is hereby adopted and incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-xxxxx shall be recognized.
(2) Applications for Registration.
(a) Applications for Registration shall contain necessary scientific evidence in the form of data summaries accurately reflecting all scientific documents submitted to the U.S. Environmental Protection Agency (EPA) in support of federal registration under Section 3, FIFRA as adopted in subsection (1)(e) of this rule.
(b) Upon determination that submitted data summaries are inadequate to complete public health and environmental assessments, the department shall require applicants or registrants to submit or generate additional data, as specified by the department, and by methods approved by the department. For standard tests, methods shall be those approved by the EPA in 40 CFR 158, August 26, 2014, which is incorporated by reference herein at http://www.flrules.org/Gateway/reference.asp?No=Ref-xxxxx.
(3) Review of applications for registration shall consider, where applicable, criteria in the data summaries, including but not limited to:
(a) through (b) No change.
(c) Environmental fate data, which shall describe the pesticide’s behavior under Florida conditions or under laboratory or field protocol which adequately represents and reflects actual Florida hydrogeologic conditions. Environmental chemistry data shall include, but is not limited to, information regarding physical and chemical degradation, metabolic transformation, persistence (half-life), bioaccumulation potential, and mobility of the pesticide. Degradation and metabolism data shall describe the behavior of the parent compound and degradation products, contaminants and impurities of toxological concern in soil and water, under aerobic and anaerobic conditions.
(d) Residue chemistry data which adequately describes pesticide residues detected or in or on applicable crops, processed foods and animal feed in accordance with the provisions of 40 CFR 158, as adopted in paragraph (2)(b) of this rule. Registrants shall, where applicable, submit methodology for determination of residues in soil and water (groundwater). Analytical methodology provided by the applicant for determination of residues must be acceptable to the department.
(e) No change.
(4) The department shall consider data from authoritative sources in making determinations regarding a pesticide’s impact on public health and the environment. “Authoritative sources” include pesticide experts in the United States (US) Environmental Protection Agency’s Office of Pesticide Programs, U.S. Fish and Wildlife Services, U.S. Food and Drug Administration, Centers for Disease Control and Prevention, pesticide registrants, the Florida Department of Environmental Protection, the Florida Fish and Wildlife Conservation Commission, the Florida Department of Health, the University of Florida’s Institute of Food and Agricultural Sciences, the Florida Fruit and Vegetable Association, the Florida Fertilizer and Agricultural Association, and the University of Florida’s County Extension Offices. Within the department, the Bureau of Scientific Evaluation and Technical Assistance Pesticides shall identify those areas of concern for which further testing is needed.
(4)(a) No change.
(b) When it is determined by the department Pesticide Review Council that it is necessary that the applicant or registrant conduct Florida field testing of a restricted-use pesticide, that applicant or registrant shall apply to the department for an Experimental Use Permit. During the period of experimentation, the department may deny, revoke, suspend or conditionally accept the registration.
(5) No change.
(6) The department, upon preliminary review of application data shall promptly register products accepted by the EPA under FIFRA, Section 3, as adopted in paragraph (1)(e) of this rule, provided submitted data are adequate to address Florida-specific concerns. The Bureau of Scientific Evaluation and Technical Assistance Pesticides, within 90 days of receipt of complete data summaries, shall:
(a) Fully approve the registration; or
(b) Conditionally register the product subject to generation and submission of data designated by the Bureau of Scientific Evaluation and Technical Assistance Pesticides within the department or require that certain restrictions or limitations be placed on the use or sale of the pesticide in Florida. Such restrictions or limitations shall be described to the applicant or registrant by the department as part of this notification; or
(c) Notify the applicant or registrant of intent to deny registration, and the basis for denial, pursuant to Chapter 120, F.S.
(d) Submit registration application to the Pesticide Review Council for determinations by the Department Council relative to field testing of restricted-use pesticides or other concerns designated by the department.
(7)(a) through (b) No change.
(c) Registration of the product may be accepted or held in abeyance, as determined by the department, pending promulgation of such rules or amendments.
(8) through (10) No change.
(11)(a) Applicants for new or amended pesticide brand registration must shall submit electronically an electronic application and any pesticide registration fees, including supplemental fees and late fees via the Department’s online payment website at www.FreshFromFlorida.com. An applicant will be required to submit online at this website the following information for registration of a new or amended pesticide product brand: the name of the applicant, including whether it is a division or subsidiary and if so, the name of the parent company; the business mailing address and business street address of the applicant; the name of the primary contact person for the applicant and contact information, including e-mail address, telephone number and fax number; the product name and the EPA/Florida number; the registration type; the signal word for the product; and the registration year. Upon completion of this transaction, a confirmation of payment letter shall be mailed to the Florida Department of Agriculture and Consumer Services, Bureau of Pesticides Scientific Evaluation and Technical Assistance, 3125 Conner Boulevard, Building 6, MS L6, Tallahassee, Florida 32399-1650 together with the following documents:
1. One final printed label (that which appears on the product container);
2. One EPA stamped accepted label including a copy of any EPA comment, notification and amendment letter(s) issued in connection with acceptance of the label;
3. One Material Safety Data Sheet (MSDS) as defined in Section 487.2031, F.S., which includes a statement of emergency treatment;
4. For sub-registrations, the information required in item 2. above must be obtained from or submitted by the manufacturer along with the EPA form entitled, “Notice of Supplemental Distribution of a Registered Pesticide Product” (EPA Form 8570-5, (Rev. 8-94) which is hereby adopted and incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-xxxxx http://www.epa.gov/opprd001/forms/8570-5.pdf or.
(b) Applicants for pesticide brand product re-registration must shall submit electronically an electronic application for re-registration via the Department’s online payment website at www.FreshFromFlorida.com. The applicant will be required to submit the same information online set forth in paragraph (11)(a) of this rule as an applicant for a new or amended product brand registration.
Rulemaking Authority 487.041, 487.051(2), 570.07(23) FS. Law Implemented 487.041, 487.042, 487.051(2), 487.0615 FS. History–New 2-20-85, Formerly 5E-2.31, Amended 8-2-89, 7-18-95, 8-26-10,_________.
