Current through Reg. 50, No. 187; September 24, 2024
(1) For each
application for any new, amended, or renewed pesticide registration, the
department may require, in support of registration for sale and use in the
State of Florida, summaries of data from pesticide efficacy studies and
submission of scientific evidence that the pesticide will not cause any
unreasonable adverse effects on public health or the environment.
(a) Material submitted to the department
considered by the registrant to contain trade secrets or to be confidential
shall be clearly marked "confidential" by the applicant or registrant.
Confidential material shall not be distributed to any persons other than those
specified by Chapter 487, F.S. Public disclosure of confidential data by any
person to whom the data has been distributed shall be unlawful as provided in
Section 487.031(5),
F.S.
(b) Data considered
confidential property of another registrant or manufacturer may be cited in an
application to the department if written permission has been obtained from that
registrant or manufacturer and is submitted to the department with the
application.
(c) The department,
upon finding that an applicant or registrant has withheld results or has
submitted false or inaccurate data which precludes the department's ability to
conduct valid risk assessments, shall initiate action to deny, cancel, or
suspend registration pursuant to Section 487.041 and Chapter 120,
F.S.
(d) Those registrants whose
end-use product must be registered in Florida pursuant to Section
487.041(1),
F.S., but which do not manufacture the federally registered basic technical
grade material shall comply with the data requirements of this rule only as it
pertains to the end-use product. Such registrants shall request the
manufacturer supplying the basic technical grade material to provide the
department with required data as it pertains to the technical grade
material.
(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 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-04758
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 paragraph (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, July 1, 2020, which
is incorporated by reference herein at
http://www.flrules.org/Gateway/reference.asp?No=Ref-13809.
(3) Review of applications for registration
shall consider, where applicable, criteria in the data summaries including:
(a) Product chemistry data, which shall
provide information regarding key chemical properties that may influence a
pesticide's relative susceptibility to leaching into groundwater and its
relative stability in groundwater, shall describe the parent compound,
degradation products, contaminants and impurities of toxicological concern.
Chemistry data shall include but is not limited to: water solubility, vapor
pressure, and soil partition coefficient based on organic carbon (Koc) and
octanol/water (Kow). The product material safety data sheet and confidential
statement of formula shall also be included. Formulators shall declare, on
their submitted confidential statement of formula, the name(s) of the
manufacturer(s) supplying the basic technical grade material for their end-use
products and the EPA registration number for each technical grade
material.
(b) Toxicological data,
which shall provide information for human risk assessment and for environmental
impact assessment of the pesticide on non-target organisms (plants, wildlife,
aquatic and soil organisms). Toxicological data shall describe effects of the
parent compound and degradation products, contaminants and impurities of
toxicological concern.
(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, 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 toxicological concern in soil and water, under
aerobic and anaerobic conditions.
(d) Residue chemistry data which describes
pesticide residues detected 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) Worker/applicator safety data, which
shall provide evidence that use of the pesticide in accordance with the label
does not pose any unreasonable risk to applicators or agricultural workers
exposed to treated areas or commodities.
(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 (U.S.) 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 shall identify those areas of concern for which further
testing is needed.
(a) In those cases in which
data are not available and require substantial time to generate (e.g., chronic
toxicity data), the department shall either deny or conditionally approve
registration pending generation of said data by the applicant, registrant or
other sources, pursuant to paragraph (6)(c) of this rule. At such time as data
become available, the department shall reevaluate any conditional registrations
to which said data may pertain.
(b)
When it is determined by the department 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) The department shall subject applications
for registration to timely review and evaluation. Upon notification of the
applicant or registrant by the Bureau of Pesticides of additional data
requests, pursuant to Section
120.60(2),
F.S., the department shall specify the amount of time that will be provided for
response to the request. If, upon expiration of the time allocated for
response, the department has not received a complete written response from the
applicant or registrant, the department may deny, cancel or suspend
registration, or for good cause as demonstrated by the applicant or registrant,
grant an extension to the time allocated to submit the requested
data.
(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, 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 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.
(7) In cases where the department determines
that restrictions, limitations, or conditions attached to registration are
warranted, such restrictions, limitations or conditions shall be accomplished.
(a) By label: registrants may list
restrictions, limitations or conditions as pertains to Florida on the product
label; or
(b) By rule:
restrictions, limitations or conditions may be promulgated into rules of the
department which regulate the sale and use of the product. Registrants shall
cooperate with the department to disseminate the contents of those rules which
apply to their product.
(8) If during the registration process, or at
any time after full or conditional registration is accepted, the registrant
determines that there is preliminary or conclusive scientific evidence of any
adverse effects or risk to public health or the environment from use of the
pesticide, the registrant shall immediately submit to the department the data
and conclusions made by the registrant with respect to said evidence.
(9) The department may, at any time, review
and evaluate any registered pesticide, if new information is made available
which indicates that use of a pesticide has caused or may cause any
unreasonable adverse effect on public health or the environment. Such review
and evaluation may result in revocation, cancellation or suspension of a
pesticide registration, if risk assessment procedures deem such actions
appropriate.
(10) As a result of
review of a registered pesticide or application for registration, the
department may require that the applicant or registrant design a groundwater
and/or surface water and soil monitoring program which will monitor pesticide
use locations for groundwater and/or surface water contamination, and
accumulation of soil residues. Such monitoring programs shall be designed and
implemented in coordination with appropriate state agencies.
(11)
(a)
Applicants for new or amended pesticide brand registration may submit
electronically an application and any pesticide registration fees, including
late fees via the Department's online payment website at
www.FDACS.gov. 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 email 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 e-mailed to
RTS@FDACS.gov or mailed to the Florida Department of Agriculture and Consumer
Services, Bureau of 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 Safety Data Sheet (SDS) as defined in
section 487.2031, F.S., which includes a
statement of emergency treatment;
4. For sub-registrations, the information
required in subparagraph 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-04759.
(b) Applicants for new or amended pesticide
brand registration shall submit a completed Application for New or Amended
Pesticide Product Brand Registration Form (FDACS 13342, Rev. 8/20),
https://www.flrules.org/Gateway/reference.asp?No=Ref-13810
if not utilizing the Department's online payment website. The applicant will be
required to submit the same documents set forth in paragraph (11)(a) of this
rule as an applicant for a new or amended product brand registration.
(c) Applicants for pesticide brand product
re-registration may submit electronically an application for re-registration
via the Department's online payment website at
www.FDACS.gov. 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, 570.07(23) FS. Law
Implemented 487.041, 487.042, 487.051
FS.
New 2-20-85, Formerly 5E-2.31, Amended 8-2-89, 7-18-95,
8-26-10, 11-30-14, 11-3-21.
