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Article 3. Device Registration of California Food And Agricultural Code >> Division 7. >> Chapter 7.5. >> Article 3.
(a) The director shall endeavor to prevent and eliminate
from use in this state any device that meets any of the following
criteria:
(1) The device endangers human health or safety, property, or the environment.
(2) The device is not beneficial or efficacious for the purposes for which it is manufactured for sale, advertised, delivered or otherwise provided, offered for sale or lease, sold, leased, possessed, or used.
(3) Is misrepresented.
(b) The director may establish specific criteria to evaluate a device. The director may establish performance standards and tests of structural pest control devices, which are to be conducted by the applicant for registration, registrant, or parties interested in the registration of the device.
(c) Before a device is registered, the director shall conduct, or cause to be conducted, a thorough and timely evaluation of the device. The director may impose reporting requirements and restrictions upon the use of a device, including, but not limited to, limitations on area and manner of application. The director may reevaluate any registered device.
(1) The device endangers human health or safety, property, or the environment.
(2) The device is not beneficial or efficacious for the purposes for which it is manufactured for sale, advertised, delivered or otherwise provided, offered for sale or lease, sold, leased, possessed, or used.
(3) Is misrepresented.
(b) The director may establish specific criteria to evaluate a device. The director may establish performance standards and tests of structural pest control devices, which are to be conducted by the applicant for registration, registrant, or parties interested in the registration of the device.
(c) Before a device is registered, the director shall conduct, or cause to be conducted, a thorough and timely evaluation of the device. The director may impose reporting requirements and restrictions upon the use of a device, including, but not limited to, limitations on area and manner of application. The director may reevaluate any registered device.
The director shall not determine a device to be beneficial
or efficacious if any of the following exists:
(a) The ability of the device to control pests falls below the standard or quality that the device is represented to have, or the device is of little or no value for the purpose for which it is intended.
(b) Any component or subsystem that is necessary to the effectiveness of the device has been wholly or partially omitted in its manufacture, or other materials have been substituted for that component or subsystem.
(a) The ability of the device to control pests falls below the standard or quality that the device is represented to have, or the device is of little or no value for the purpose for which it is intended.
(b) Any component or subsystem that is necessary to the effectiveness of the device has been wholly or partially omitted in its manufacture, or other materials have been substituted for that component or subsystem.
Every manufacturer of, importer of, vender of, or dealer in,
any device, except a dealer or agent that sells a registered device,
shall obtain a certificate of device registration from the director
before the device is manufactured for sale, advertised, delivered or
otherwise provided, offered for sale or lease, sold, leased,
possessed, or used, in this state, unless the device is used under a
valid device research permit pursuant to Section 15314.
Each applicant for registration of a device, at a minimum,
shall submit all of the following:
(a) A completed application form prescribed by the director.
(b) Proposed labeling for the device.
(c) Valid data supporting each claim on the proposed label and supporting the safety of the device for each proposed labeled use.
(d) A nonrefundable application fee in the amount of two hundred dollars ($200). The application fees shall be deposited in the Department of Pesticide Regulation Fund and shall be available, upon appropriation, for use by the department in administering this division.
(e) Any other information required by regulation of the director.
(a) A completed application form prescribed by the director.
(b) Proposed labeling for the device.
(c) Valid data supporting each claim on the proposed label and supporting the safety of the device for each proposed labeled use.
(d) A nonrefundable application fee in the amount of two hundred dollars ($200). The application fees shall be deposited in the Department of Pesticide Regulation Fund and shall be available, upon appropriation, for use by the department in administering this division.
(e) Any other information required by regulation of the director.
Within a timely manner after receipt of the information and
fee specified in Section 15308, the director shall do one or more of
the following:
(a) Issue a certificate of device registration pursuant to Section 15310.
(b) Notify the applicant that the submission is inadequate and specify the additional data that must be submitted and reviewed before a registration decision is rendered. In issuing a notification pursuant to this subdivision, the director may specify a reasonable timeframe for the submission of the additional data, moneys, labeling, or information to avoid a requirement for submission of a new application and application fee.
(c) Notify the applicant of the director's decision to deny registration.
(a) Issue a certificate of device registration pursuant to Section 15310.
(b) Notify the applicant that the submission is inadequate and specify the additional data that must be submitted and reviewed before a registration decision is rendered. In issuing a notification pursuant to this subdivision, the director may specify a reasonable timeframe for the submission of the additional data, moneys, labeling, or information to avoid a requirement for submission of a new application and application fee.
(c) Notify the applicant of the director's decision to deny registration.
If an applicant for registration of a device complies with
this chapter and the regulations that are adopted pursuant to this
chapter, the director shall register the device and issue a
certificate of device registration to the applicant authorizing the
manufacture and sale of the device in this state.
If the director finds that registration must be denied due
to noncompliance with this chapter or the regulations that are
adopted pursuant to this chapter, the director shall deny
registration. Upon the request of the applicant, the director may
hold a hearing to reconsider the director's decision to deny the
application.
Each applicant for a certificate of device registration
shall inform the director of every brand and trademark of a device
that the applicant intends to manufacture for sale, advertise,
deliver or otherwise provide, offer for sale or lease, sell, lease,
possess, or use. The director may require an applicant to identify
each component in the device.
The registrant of a device shall immediately notify the
director of any proposed change to the device including, but not
limited to, labeling composition, configuration method of
application, and use of the device. The director shall determine
whether the changes require the director's approval before the
changed device may be manufactured for sale, advertised, delivered or
otherwise provided, offered for sale or lease, sold, leased,
possessed, or used in this state. The director shall notify the
registrant of this determination.
The director may issue a device research permit for the
scientific evaluation of new devices for a limited period of time
determined by the director.
(a) Pursuant to Sections 15305 and 15306, after providing
notice to the device registrant or applicant of an opportunity to be
heard, the director may cancel the registration of, or refuse to
register, any device that meets any of the following criteria:
(1) The director determines that the device has demonstrated serious uncontrollable adverse effects on human health or safety, property, or the environment.
(2) The director determines that the use of the device is of less public value or greater detriment to the environment than the benefit received by its use.
(3) The director determines that a false or misleading statement is made or implied by the registrant or his or her agent, or the applicant for registration, either verbally or in writing, or in the form of any advertising literature concerning the device.
(4) The director determines that the registrant, or his or her agent, or applicant for registration has failed to report any adverse effect or risk as required by Section 15316.
(5) The director determines that the registrant has failed to comply with the requirements of a reevaluation of the registrant's device.
(6) The director determines that false information relating to the testing of the device, including the nature of any protocol, procedure, substance, organism, or equipment used, observation made, or conclusion or opinion formed, was submitted to the director.
(b) When taking action or making a determination pursuant to this section, the director may require practical demonstrations and scientific testing that the director finds are necessary to determine the facts. The demonstrations or testing shall be conducted by the applicant for registration, registrant, or parties interested in the device registration.
(1) The director determines that the device has demonstrated serious uncontrollable adverse effects on human health or safety, property, or the environment.
(2) The director determines that the use of the device is of less public value or greater detriment to the environment than the benefit received by its use.
(3) The director determines that a false or misleading statement is made or implied by the registrant or his or her agent, or the applicant for registration, either verbally or in writing, or in the form of any advertising literature concerning the device.
(4) The director determines that the registrant, or his or her agent, or applicant for registration has failed to report any adverse effect or risk as required by Section 15316.
(5) The director determines that the registrant has failed to comply with the requirements of a reevaluation of the registrant's device.
(6) The director determines that false information relating to the testing of the device, including the nature of any protocol, procedure, substance, organism, or equipment used, observation made, or conclusion or opinion formed, was submitted to the director.
(b) When taking action or making a determination pursuant to this section, the director may require practical demonstrations and scientific testing that the director finds are necessary to determine the facts. The demonstrations or testing shall be conducted by the applicant for registration, registrant, or parties interested in the device registration.
If, during the registration process, or at any time after
the registration of a device, the applicant or registrant has factual
or scientific information showing any adverse effect or risk of the
device to human health or safety, property, or the environment that
has not been previously submitted to the director, the applicant for
registration or the registrant, as the case may be, shall immediately
submit the information to the director.
If the director has reason to believe that any of the
conditions stated in Section 15315 are applicable to any registered
device and that the use or continued use of the device constitutes an
immediate substantial danger to human health or safety, property, or
the environment, the director, after notice to the registrant, may
suspend the registration of that device pending a hearing and final
decision. If the director does not file an accusation pursuant to
Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of
Title 2 of the Government Code within 30 days from the date of the
suspension, the suspension shall be terminated.
The director may cancel a certificate of device
registration, or refuse to issue a certificate of device registration
to any manufacturer, importer, or dealer in any device that
repeatedly violates this chapter or the regulations of the director.
Action by the director pursuant to Section 15305, 15311,
15315, 15317, or 15318 is not a condition precedent to the
institution of any action to prosecute or levy a civil penalty for a
violation of this chapter or regulations adopted pursuant to this
chapter.
(a) A registrant at any time may request that the
registration of any of its devices be voluntarily canceled. The
request shall be in writing to the director and shall include a
waiver of the registrant's right to a hearing on the cancellation.
(b) The director shall mail a notice of voluntary cancellation of registration of the device to the registrant. The notice shall specify the effective date of the cancellation.
(b) The director shall mail a notice of voluntary cancellation of registration of the device to the registrant. The notice shall specify the effective date of the cancellation.
