12811. Every manufacturer of, importer of, or dealer in any
pesticide, except a person that sells any raw material to a
manufacturer of any pesticide or a dealer or agent that sells any
pesticide that has been registered by the manufacturer or wholesaler,
shall obtain a certificate of registration from the department
before the pesticide is offered for sale.
12811.5. The director may rely upon any evaluations of previously
submitted data to determine whether to accept an application for
registration of a new pesticide product, an amendment to the
registration of a registered pesticide product, or to maintain the
registration of a registered pesticide product regardless of the
ownership of the data previously evaluated. However, effective
January 1, 2006, applicants will be subject to the following
provisions:
(a) If an applicant for registration of a pesticide product, or an
amendment to the registration of a registered pesticide product,
including a registrant that desires to maintain its registration of a
registered pesticide product after the director makes a formal
reevaluation request for additional data, does not submit its own
data to fulfill a current data requirement imposed by the director
and relies upon data that the applicant does not own or have written
permission to rely upon that was submitted to the director by another
entity after January 1, 1991, and meets the three criteria set forth
in this subdivision, the applicant must either (i) obtain written
permission from the data owner to rely on the data, (ii) formulate or
obtain its product from a source that has data authorization from
the data owner, or a source that complies with subdivision (c), or
(iii) if the data meets the criteria set forth in paragraphs (1),
(2), and (3), irrevocably offer to pay the data owner a share of the
cost of producing the data and comply with the provisions of
subdivision (d). The director may rely upon data submitted prior to
January 1, 1991, or that does not meet the criteria set forth in
paragraphs (1), (2), and (3) to support any application or comply
with any formal reevaluation request for additional data, without
permission from the data owner. An offer to pay, and a payment
pursuant to that offer, shall only be required as to data not
submitted by the applicant that meets the criteria set forth in
paragraphs (1), (2), and (3). To be eligible for cost sharing
pursuant to this subdivision, the data must meet all of the following
requirements:
(1) The data was required by the director in order to obtain,
amend, or maintain the data owner's California registration or
registrations for uses covered by the application, amendment, or
formal reevaluation request for additional data.
(2) There has been no arbitration award, data compensation, or
data cost-sharing agreement pertaining to data supporting the product
at the federal level pursuant to Section 3(c)(1) (F)(iii) or 3(c)(2)
(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. Sec. 136a(c)(1)(F)(iii) or 136a(c)(2)(B)), or, if an award or
agreement exists, the use of data in California was excluded from
compensation or cost sharing on its face.
(3) The data that fulfills a current requirement was submitted to
the United States Environmental Protection Agency or the department
no more than 15 years prior to the date of the applicant's California
registration, application, or amendment or the formal reevaluation
request for additional data to which the registrant's reliance
responds, provided that as to data submitted to the department as of
August 1, 2005, in support of the first registration of a product,
the applicable period shall be 17 years from the date of submission
to the United States Environmental Protection Agency.
(b) If the director previously imposed a specific documented data
requirement after January 1, 1991, to obtain, amend, or maintain the
California registration of a pesticide product substantially similar
to the applicant's product and that data requirement is not currently
imposed in California for registration, amendment, or maintenance of
the applicant's product, the applicant is further obligated to
submit data to meet the requirement, obtain written permission from
an owner of the data to rely upon the data, formulate or obtain its
product from a source that has authorization from the data owner to
rely upon the data or from a source that complies with subdivision
(c), or, if the data meets the criteria set forth in paragraphs (1),
(2), and (3), irrevocably offer to pay the data owner a share in the
cost of producing the data and comply with the provisions of
subdivision (c). An offer to pay, and a payment pursuant to that
offer, shall only be required as to data not submitted by the
applicant that meets the criteria set forth in paragraphs (1), (2),
and (3). To be eligible for cost sharing pursuant to this
subdivision, the data must meet all of the following requirements:
(1) The data met a specific, documented requirement of the
director to obtain, amend, or maintain the California registration of
the data owner's pesticide product for a use covered by the
applicant's application or amendment.
(2) There has been no arbitration award, data compensation, or
data cost-sharing agreement pertaining to data supporting the product
at the federal level pursuant to Section 3(c)(1)(F)(iii) or 3(c)(2)
(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. Sec. 136a(c)(1)(F)(iii) or 136a(c)(2)(B)), or, if an award or
agreement exists, the use of the data in California was excluded from
compensation or cost sharing on its face.
(3) The data was submitted to the U.S. Environmental Protection
Agency or Department of Pesticide Regulation by the data owner after
January 1, 1991, and no more than 15 years prior to the date of the
applicant's California application for registration or amendment or
the response to a formal specific document data requirement to which
the registrant's reliance responds, provided that as to data
submitted to the department as of August 1, 2005, in support of the
first registration of a product, the applicable period shall be 17
years from the date of submission to the U.S. Environmental
Protection Agency.
(c) An applicant may formulate its product from a source that does
not have data authorization provided that source has submitted data
to support the product or makes or has made an irrevocable offer to
pay the data owner a share of the cost of producing the data required
pursuant to subdivision (a) or (b) for the applicant's product and
complies with or has made payment in accordance with the provisions
of subdivision (d). In the event that the source has already reached
a data compensation or cost-sharing agreement or there has been an
arbitration award under the Federal Insecticide, Fungicide, and
Rodenticide Act (commencing at 7 U.S.C. Sec. 136) that excludes the
right to rely on the data to satisfy the California requirement on
its face, the source must make or have made a new irrevocable offer
to pay a share of the cost of producing that data to support the
applicant's product in California and comply with the provisions of
subdivision (d).
(d) If an applicant is required to offer to pay a share in the
cost of producing the data pursuant to subdivision (a) or (b), or if
a source of product makes an offer pursuant to subdivision (c), the
applicant or source must submit to the data owner upon application to
the department an irrevocable offer to pay the data owner a share in
the cost of producing the data and to comply with regulations
promulgated under this subdivision to determine the amount and terms,
if the parties cannot agree. If a data owner for which cost sharing
is required under subdivision (a) or (b) cannot be identified from
information readily available to the applicant, the applicant's
obligation under subdivision (a) or (b) will be absolved if the data
owner does not identify himself or herself to the applicant within 12
months after registration of the pesticide product. If within 12
months of registration, the data owner identifies himself or herself
to the applicant and the applicant has not already made an
irrevocable offer to pay to the data owner, or the applicant's source
of product has not made an offer pursuant to subdivision (c), the
applicant must do so promptly. In either event, the specific terms
and amount of payments to be made shall be fixed by agreement between
the applicant and the data owner, but determination of those amounts
and terms shall not delay approval of the applicant's application.
If agreement cannot be reached about the terms and amount of
payment required by this section at any time more than 90 days after
issuance of an irrevocable offer to pay, either the applicant, source
or data owner may initiate, or with the consent of all parties, join
a proceeding under the Federal Insecticide, Fungicide, and
Rodenticide Act (commencing at 7 U.S.C. Sec. 136), pursuant to
regulations promulgated by the director pursuant to this statute. The
purpose of this proceeding shall be to determine the amount due
under this section. The director shall promulgate those regulations
as emergency regulations within 60 days of the enactment of the bill
that enacts this section. The regulations shall provide all of the
following:
(1) Allow the proceeding authorized by this subdivision, upon
mutual agreement of the parties, to be consolidated with dispute
resolution under the Federal Insecticide Fungicide and Rodenticide
Act (commencing at 7 U.S.C. Sec. 136).
(2) Require that the decisionmaker consider, among other factors,
that the data owner's exclusive right to sell the pesticide resulted
in the data owner recovering all or part of the costs of generating
the data.
(3) Require that the parties to the proceeding share equally in
the payment of the expenses thereof.
(e) If a data owner fails to participate in a procedure for
reaching an agreement or in a proceeding as required by subdivision
(d), or fails to comply with the terms of an agreement or decision
conducted under subdivision (d), then that data owner forfeits his or
her right to cost recovery as a result of the use of the data at
issue.
(f) If the director finds that an applicant has failed to make an
offer to pay as required under subdivision (a) or (b), or if its
source of product has failed to make an offer pursuant to subdivision
(c), or if an applicant or its source of product has failed to
participate in a proceeding for reaching an agreement, or has refused
to participate in a proceeding pursuant to subdivision (d), or has
failed to comply with an agreement or to comply with an order, or to
pay an award resulting from that proceeding, the director shall
cancel the registration of the pesticide product in support of which
the data was used in accordance with the provisions of subdivision
(g), notwithstanding the provisions of Section 12825.
(g) If the applicant subject to subdivision (a) or (b) fails to
comply with the provisions of this article, the data owner shall
notify the director of the specific provision of noncompliance and
provide proof of notification to the applicant of its claim of
noncompliance. All parties shall have 30 days from the date of
receipt of notification by the director to submit written evidence or
arguments to the director regarding the claim and any defenses
thereto. The director shall provide a written finding within 60 days
of the deadline for submission as to the claim and the resulting
consequences.
(h) No hearing or live testimony shall be conducted under
subdivision (g) and this proceeding shall not be used as mechanism to
prevent or delay the registration or payment for cost sharing as
determined by this article. The finding of the director shall be
final and conclusive, except that any party aggrieved by such a
finding may seek review within 30 days of the finding pursuant to
Section 1094.5 of the Code of Civil Procedure.
(i) In lieu of seeking a determination by the director and
cancellation of the registration pursuant to subdivision (f), the
data owner may bring an action in any California court of competent
jurisdiction against the applicant to enforce the obligations of that
party set forth in the provisions of this section.
(j) No cost sharing as provided in subdivisions (a), (b), and (c)
shall be required to support an application for annual renewal of a
pesticide product registration, provided this provision shall not
authorize renewal of a product registered prior to the effective date
of this section if that registration is declared to have been
unlawfully issued by a court of competent jurisdiction.
(k) The Department of Pesticide Regulation shall make available in
the public domain its index of data submitted in support of
registration applications, the ownership of that data, and the date
it was submitted to California.
12812. (a) The director shall establish, by regulation, fees for
the Department of Pesticide Regulation's registration program, as
established pursuant to this division. The fees shall include, but
are not limited to, the following:
(1) Annual fees for each product submitted for registration.
(2) Penalties for the late payment of registration fees.
(3) Fees for amendments to registered products.
(b) The fees established pursuant to this section may include
costs for administration and overhead in connection with
administering the fees.
(c) The fees established pursuant to this section shall be set so
that the total revenue collected each fiscal year is sufficient to
support the expenditure levels for the registration program contained
in the annual Budget Act.
(d) Funds collected pursuant to this section shall be deposited in
the Department of Pesticide Regulation Fund, and shall be available
for expenditure by the department, upon appropriation by the
Legislature, for the purposes of carrying out the department's
pesticide registration program, as established pursuant to this
division.
(e) The regulations adopted pursuant to this section, or any
amendment or readoption thereto, shall be adopted by the director in
accordance with Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code. However, the
adoption, amendment, readoption, or repeal of these regulations shall
be considered by the Office of Administrative Law as an emergency,
and necessary for the immediate preservation of the public peace,
health, safety, and general welfare. Notwithstanding any other
provision of law, the regulations shall remain in effect until
amended by the director.
12814. Any county, state, or federal officer or employee who sells
any pesticide at cost is not required to pay any fee that is imposed
by this chapter.
12815. If a manufacturer, importer, or dealer in pesticides that
applies for registration of pesticides has complied with this chapter
and the regulations that are adopted pursuant to it, the director
shall register each pesticide that is sought to be registered and
issue a certificate of registration to the applicant that authorizes
the manufacture and sale of the pesticide in this state.
12816. If the director finds that registration cannot be permitted
due to noncompliance with this chapter or the regulations which are
adopted pursuant to it, he or she may, after reasonable notice, call
a hearing for the purpose of determining whether the application
shall be reconsidered or denied.
12817. Every registration expires on December 31st of each year
except when renewal is applied for within one month thereafter in the
manner which is provided for registration.
12818. If renewal is not applied for within one calendar month
after the expiration of a registration, a penalty as prescribed by
the director pursuant to Section 12812 shall be added to the
registration fee.
12819. A penalty shall not be collected if the person that makes
application for renewal of registration makes an affidavit that no
business was done during the period of nonregistration.
12820. The payment of any renewal fee or penalty is not a bar to
any prosecution for doing business without proper registry.
12821. Each applicant for a certificate of registration shall also
file a statement of every brand, trademark, and kind of pesticide
that the applicant intends to manufacture or sell, the correct name
and percentage of each active ingredient in the pesticide, and the
total percentage of inert ingredients that are contained in the
pesticide. The director, whenever he or she deems it necessary for
the effective administration of this chapter, may require the
submission of the complete formula for the pesticide.
12822. A supplemental application for registration of any
additional pesticide may be submitted at any time without payment of
the penalty required by Section 12818.
12823. A change in the name or percentage, or both, of an inert
ingredient is not a change in composition of the pesticide that
requires a new registration unless the change in inert material
results in a change in the use or application of the pesticide.
12824. The director shall endeavor to eliminate from use in the
state any pesticide that endangers the agricultural or
nonagricultural environment, is not beneficial for the purposes for
which it is sold, or is misrepresented. In carrying out this
responsibility, the director shall develop an orderly program for the
continuous evaluation of all pesticides actually registered.
Before a substance is registered as a pesticide for the first
time, there shall be a thorough and timely evaluation in accordance
with this section. Appropriate restrictions may be placed upon its
use including, but not limited to, limitations on quantity, area, and
manner of application. All pesticides for which renewal of
registration is sought also shall be evaluated in accordance with
this section.
The director may establish specific criteria to evaluate a
pesticide with regard to the factors listed in Section 12825. The
department may establish performance standards and tests that are to
be conducted or financed, or both conducted and financed, by the
registrants, applicants for registration, or parties interested in
the registration of those pesticides.
12825. Pursuant to Section 12824, the director, after hearing, may
cancel the registration of, or refuse to register, any pesticide:
(a) That has demonstrated serious uncontrollable adverse effects
either within or outside the agricultural environment.
(b) The use of which is of less public value or greater detriment
to the environment than the benefit received by its use.
(c) For which there is a reasonable, effective, and practicable
alternate material or procedure that is demonstrably less destructive
to the environment.
(d) That, when properly used, is detrimental to vegetation, except
weeds, to domestic animals, or to the public health and safety.
(e) That is of little or no value for the purpose for which it is
intended.
(f) Concerning which any false or misleading statement is made or
implied by the registrant or his or her agent, either verbally or in
writing, or in the form of any advertising literature.
(g) For which the director determines the registrant has failed to
report an adverse effect or risk as required by Section 12825.5.
(h) If the director determines that the registrant has failed to
comply with the requirements of a reevaluation or to submit the data
required as part of the reevaluation of the registrant's product.
(i) That is required to be registered pursuant to the federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136 et
seq.) and that is not so registered.
In making a determination pursuant to this section, the director
may require those practical demonstrations that are necessary to
determine the facts.
12825.5. (a) If, during the registration process or at any time
after the registration of a pesticide, the registrant has factual or
scientific evidence of any adverse effect or risk of the pesticide to
human health, livestock, crops, or the environment that has not been
previously submitted to the department, the registrant shall submit
the evidence to the director in a timely manner. All such
information, including, but not limited to, that information required
under Section 6 (a) (2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. Sec. 136d (a) (2)), shall be submitted to
the director.
(b) The director may adopt regulations that are reasonably
necessary to carry out this section.
12826. If the director has reason to believe that any of the
conditions stated in Section 12825 are applicable to any registered
pesticide and that the use or continued use of that pesticide
constitutes an immediate substantial danger to persons or to the
environment, the director, after notice to the registrant, may
suspend the registration of that pesticide pending a hearing and
final decision. If an accusation pursuant to Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code is not filed within 10 days from the date of the
notice, the suspension shall be terminated.
12827. The director may cancel a certificate of registration, or,
refuse to issue certification to any manufacturer, importer, or
dealer in any pesticide that repeatedly violates any of the
provisions of this chapter or the regulations of the director.
The proceedings shall be conducted in accordance with Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code. The director has all the powers that are
granted therein.
12827.5. Whenever the director cancels the registration of, or
refuses to register, any pesticide currently registered by the United
States Environmental Protection Agency, the director shall provide
the applicant or registrant with the basis for the decision and the
reasons why a conclusion different from, contrary to, or inconsistent
with, the conclusion and findings of the United States Environmental
Protection Agency was reached.
12828. Action by the director pursuant to Sections 12824, 12825,
12826, or 12827 is not a condition precedent to the institution of
any action to prosecute a violation of the chapter.
12828.5. (a) A registrant at any time may request that the
registration of any of its pesticides be voluntarily canceled. The
request shall be in writing and shall include a waiver of the
registrant's right to a hearing on the cancellation.
(b) The director shall mail a notice of cancellation of
registration of the pesticides to the registrant. The notice shall
specify the effective date of the cancellation.
(c) The pesticides for which the registration is canceled may be
sold and possessed as if the product's registration was not renewed
unless the director determines that protection of human health or the
environment require otherwise, in which case the cancellation notice
shall specify the conditions under which the product may be sold or
possessed after cancellation of its registration.
12829. If a person has a research authorization for a pesticide
issued pursuant to Section 6260 of Title 3 of the California Code of
Regulations for the purpose of testing the pesticide, and the produce
on which the pesticide was tested is required to be destroyed, any
actual costs incurred by the commissioner to investigate and confirm
the destruction of the produce shall be paid for by the person who
has the research authorization. The costs charged by the commissioner
shall not exceed one hundred twenty-five dollars ($125) per
testsite. The board of supervisors of each county may adopt a fee
schedule to cover the commissioner's costs under this section.
12832. (a) Notwithstanding any other provision of this chapter,
alfalfa and all vegetable crops, when grown for seed production, with
the exception of corn, beans, pumpkin, and peas, shall be considered
a nonfood and nonfeed site of pesticide use for the purpose of
pesticide registration. In order to be determined to be a nonfood or
nonfeed site for the purposes of this section, the following
conditions shall be met:
(1) All seed screenings shall be disposed of in such a way that
they cannot be distributed or used for food or feed. The seed
conditioner shall keep records of screenings disposal for three years
from the date of disposal and shall furnish the records to the
director upon request. Disposal records shall consist of
documentation from a controlled waste disposal site, incinerator,
cogeneration plant, composting facility, or other equivalent disposal
site.
(2) No portion of the seed plant, including, but not limited to,
green chop, hay, pellets, meal, whole seed, cracked seed, or seed
screenings shall be used or distributed for food or feed purposes.
(3) All seed crops grown on a nonfood or nonfeed site in this
state, or conditioned in this state, shall bear a tag or container
label that forbids the use of the seed for human consumption or
animal feed.
(4) No seed grown on a nonfood or nonfeed site in this state, or
conditioned in this state, may be distributed for human consumption
or animal feed.
(b) Nothing in this section prevents the department from imposing
conditions for alfalfa seed sites in addition to those contained in
this section, or from rescinding any current label requirements for
pesticides approved for alfalfa seed production.
(c) Nothing in this section exempts the department from reviewing
worker safety evaluations with regard to the use of pesticides
involving crops specified in subdivision (a).
(d) A violation of any condition specified in subdivision (a) by
the person responsible for the use of the pesticide is a violation of
this chapter, and is subject to the civil and criminal penalties and
injunctive relief provisions specified in Article 12 (commencing
with Section 12996). A violation of any condition specified in
subdivision (a) by the person responsible for the disposition of seed
screenings is a violation of Chapter 6 (commencing with Section
14901) and is subject to enforcement by the Department of Food and
Agriculture.
12833. (a) Notwithstanding any other provision of this chapter, the
director may issue a certificate of emergency registration for a
pesticide if all of the following conditions are met:
(1) The pesticide is currently registered by the United States
Environmental Protection Agency pursuant to Section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136a) for
the use specified in subparagraph (B) of paragraph (5).
(2) The active ingredient of the pesticide was previously
registered under Section 18 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. Sec. 136p) in order to respond to an
emergency pest control problem.
(3) The applicant demonstrates to the department that the
pesticide qualifies for registration pursuant to Section 12815 and
the department determines that it is probable that the pesticide will
receive registration pursuant to this division within one year.
(4) The applicant for emergency registration submits to the
director all data required for registration pursuant to this division
and the regulations adopted pursuant to this division.
(5) The director makes both of the following findings based on
substantial evidence:
(A) The use of the pesticide during the period of emergency
registration will not pose a potential significant risk to public
health or safety or to the environment. In making this finding, the
director shall review the risks associated with the use of the
pesticide and determine if those risks are significant given the
limitations that will be imposed on the use of the pesticide during
the emergency registration period.
(B) The emergency registration of the pesticide is necessary in
order to effectively respond to an emergency pest control problem.
For purposes of this subparagraph, an emergency pest control problem
shall be deemed to exist if the director finds that a pest
infestation is present in the state for which no feasible pest
control method is available that is a reasonable alternative to the
use of the pesticide for which the emergency registration is
requested. In making a determination pursuant to this subparagraph,
the director shall identify the pest infestation that is the subject
of the emergency, describe the pest control methods that have been
demonstrated as ineffective against the infestation or that are
otherwise not reasonable alternatives, and summarize the evidence
that demonstrates that the pesticide for which emergency registration
has been requested is efficacious against the pest infestation.
(b) At the same time as the director issues a certificate of
emergency registration for a pesticide pursuant to this section, the
director shall establish limitations on the use of the pesticide that
the director determines are necessary to prevent a potential
significant risk to human health or safety or the environment. The
director shall limit the use of any pesticide granted a certificate
of emergency registration to the control of the emergency pest
infestation described in subparagraph (B) of paragraph (5) of
subdivision (a).
(c) A certificate of emergency registration may be issued for a
period not to exceed one year and may be renewed one time only.
(d) A certificate of emergency registration may not be renewed
unless the director does all of the following:
(1) Publishes a notice that an application for renewal of the
certificate of emergency registration has been received.
(2) Makes all of the following findings:
(A) That the findings made by the director in support of the
certificate of emergency registration pursuant to paragraph (5) of
subdivision (a) remain valid.
(B) That there are no indications that the pesticide, when used in
accordance with applicable label instructions and the limitations
established pursuant to subdivision (b), poses a significant risk to
worker safety and health. The director shall base this finding on a
review of the data required for registration pursuant to this
division, experience with the use of the pesticide during the period
the certificate of emergency registration was in effect, and any
other information the director has required the applicant to submit
or received from the applicant or any other person.
(C) That the failure to complete the registration of the pesticide
during the period the certificate of emergency registration was in
effect is due to circumstances that were not under the control of the
applicant, and that the data required for registration pursuant to
this division is complete and meets all of the requirements of this
division and the regulations adopted pursuant to this division.
(3) Convenes a workshop, if one is requested by any interested or
aggrieved person, concerning the reasons for the renewal of the
certificate of emergency registration. The director shall review
information and comments provided by persons who attend the workshop
and take that information and those comments into account in
determining if the certificate of emergency registration may be
renewed.
(e) The director shall immediately revoke any certificate of
emergency registration issued pursuant to this section if either of
the following occurs:
(1) The United States Environmental Protection Agency suspends or
cancels the registration of the pesticide or the particular use of
the active ingredient in the pesticide that allows it to be used in
the emergency pest infestation described in subparagraph (B) of
paragraph (5) of subdivision (a).
(2) The director determines during a subsequent review of data
required for registration pursuant to this division that the use of
the pesticide will pose a potential significant risk to the public
health or safety or to the environment.
12836. (a) The director, by January 1, 1999, shall implement a
program for the expedited registration of or for the expedited
amendment of the registration of any pesticide classified by the
United States Environmental Protection Agency as a "public health
pesticide" or "antimicrobial pesticide" and that is determined by the
director to have human health protection benefits that warrant
eligibility for expedited processing. Nothing in this section limits
the director's authority to provide expedited registration for any
other pesticide product.
(b) For the purposes of this section, "expedited registration" and
"expedited amendment of the registration" mean that the director
shall review an application for registration or for amendment of a
registration concurrently in time with the review conducted by the
United States Environmental Protection Agency. This section shall not
be construed to require or authorize modification of any guidelines,
protocols, or standards applicable to the review of an application
for registration.
12836.5. The director shall accept applications for registration of
pesticide products containing a new active ingredient concurrently
with the application to the United States Environmental Protection
Agency. The application for registration must include all data and
information that meet the requirements of this chapter.
12836.6. The director shall, with the assistance of the Legislative
Analyst, conduct a study to consider more carefully the consequences
of data-sharing agreements required under Section 12811.5 and the
volume of high-hazard pesticides sold in California. The report shall
be submitted to the Legislature no later than December 31, 2008.
12837. (a) The director may waive the submission or review, or
both, of efficacy data developed by a registrant as a prerequisite
for registration for any antimicrobial pesticide product if all of
the following conditions have been met with respect to each
antimicrobial pesticide product:
(1) The director finds that the United States Environmental
Protection Agency's guidelines, protocols, and standards of review in
existence at the time the product was reviewed by the United States
Environmental Protection Agency are consistent with, and no less
stringent than, California guidelines, protocols, and standards and
generally accepted scientific practices.
(2) The director finds that, with respect to the particular
antimicrobial pesticide product reviewed under this section, the
United States Environmental Protection Agency actually implemented
the guidelines, protocols, and standards of review for which the
director made the required finding pursuant to paragraph (1). In
making this finding, the director may request any relevant studies or
documentation from the registrant.
(b) Nothing in this section shall be construed as a limitation on
the director to request or to review any efficacy data or studies or
to subject any product to testing, at any time.
12811. Every manufacturer of, importer of, or dealer in any
pesticide, except a person that sells any raw material to a
manufacturer of any pesticide or a dealer or agent that sells any
pesticide that has been registered by the manufacturer or wholesaler,
shall obtain a certificate of registration from the department
before the pesticide is offered for sale.
12811.5. The director may rely upon any evaluations of previously
submitted data to determine whether to accept an application for
registration of a new pesticide product, an amendment to the
registration of a registered pesticide product, or to maintain the
registration of a registered pesticide product regardless of the
ownership of the data previously evaluated. However, effective
January 1, 2006, applicants will be subject to the following
provisions:
(a) If an applicant for registration of a pesticide product, or an
amendment to the registration of a registered pesticide product,
including a registrant that desires to maintain its registration of a
registered pesticide product after the director makes a formal
reevaluation request for additional data, does not submit its own
data to fulfill a current data requirement imposed by the director
and relies upon data that the applicant does not own or have written
permission to rely upon that was submitted to the director by another
entity after January 1, 1991, and meets the three criteria set forth
in this subdivision, the applicant must either (i) obtain written
permission from the data owner to rely on the data, (ii) formulate or
obtain its product from a source that has data authorization from
the data owner, or a source that complies with subdivision (c), or
(iii) if the data meets the criteria set forth in paragraphs (1),
(2), and (3), irrevocably offer to pay the data owner a share of the
cost of producing the data and comply with the provisions of
subdivision (d). The director may rely upon data submitted prior to
January 1, 1991, or that does not meet the criteria set forth in
paragraphs (1), (2), and (3) to support any application or comply
with any formal reevaluation request for additional data, without
permission from the data owner. An offer to pay, and a payment
pursuant to that offer, shall only be required as to data not
submitted by the applicant that meets the criteria set forth in
paragraphs (1), (2), and (3). To be eligible for cost sharing
pursuant to this subdivision, the data must meet all of the following
requirements:
(1) The data was required by the director in order to obtain,
amend, or maintain the data owner's California registration or
registrations for uses covered by the application, amendment, or
formal reevaluation request for additional data.
(2) There has been no arbitration award, data compensation, or
data cost-sharing agreement pertaining to data supporting the product
at the federal level pursuant to Section 3(c)(1) (F)(iii) or 3(c)(2)
(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. Sec. 136a(c)(1)(F)(iii) or 136a(c)(2)(B)), or, if an award or
agreement exists, the use of data in California was excluded from
compensation or cost sharing on its face.
(3) The data that fulfills a current requirement was submitted to
the United States Environmental Protection Agency or the department
no more than 15 years prior to the date of the applicant's California
registration, application, or amendment or the formal reevaluation
request for additional data to which the registrant's reliance
responds, provided that as to data submitted to the department as of
August 1, 2005, in support of the first registration of a product,
the applicable period shall be 17 years from the date of submission
to the United States Environmental Protection Agency.
(b) If the director previously imposed a specific documented data
requirement after January 1, 1991, to obtain, amend, or maintain the
California registration of a pesticide product substantially similar
to the applicant's product and that data requirement is not currently
imposed in California for registration, amendment, or maintenance of
the applicant's product, the applicant is further obligated to
submit data to meet the requirement, obtain written permission from
an owner of the data to rely upon the data, formulate or obtain its
product from a source that has authorization from the data owner to
rely upon the data or from a source that complies with subdivision
(c), or, if the data meets the criteria set forth in paragraphs (1),
(2), and (3), irrevocably offer to pay the data owner a share in the
cost of producing the data and comply with the provisions of
subdivision (c). An offer to pay, and a payment pursuant to that
offer, shall only be required as to data not submitted by the
applicant that meets the criteria set forth in paragraphs (1), (2),
and (3). To be eligible for cost sharing pursuant to this
subdivision, the data must meet all of the following requirements:
(1) The data met a specific, documented requirement of the
director to obtain, amend, or maintain the California registration of
the data owner's pesticide product for a use covered by the
applicant's application or amendment.
(2) There has been no arbitration award, data compensation, or
data cost-sharing agreement pertaining to data supporting the product
at the federal level pursuant to Section 3(c)(1)(F)(iii) or 3(c)(2)
(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. Sec. 136a(c)(1)(F)(iii) or 136a(c)(2)(B)), or, if an award or
agreement exists, the use of the data in California was excluded from
compensation or cost sharing on its face.
(3) The data was submitted to the U.S. Environmental Protection
Agency or Department of Pesticide Regulation by the data owner after
January 1, 1991, and no more than 15 years prior to the date of the
applicant's California application for registration or amendment or
the response to a formal specific document data requirement to which
the registrant's reliance responds, provided that as to data
submitted to the department as of August 1, 2005, in support of the
first registration of a product, the applicable period shall be 17
years from the date of submission to the U.S. Environmental
Protection Agency.
(c) An applicant may formulate its product from a source that does
not have data authorization provided that source has submitted data
to support the product or makes or has made an irrevocable offer to
pay the data owner a share of the cost of producing the data required
pursuant to subdivision (a) or (b) for the applicant's product and
complies with or has made payment in accordance with the provisions
of subdivision (d). In the event that the source has already reached
a data compensation or cost-sharing agreement or there has been an
arbitration award under the Federal Insecticide, Fungicide, and
Rodenticide Act (commencing at 7 U.S.C. Sec. 136) that excludes the
right to rely on the data to satisfy the California requirement on
its face, the source must make or have made a new irrevocable offer
to pay a share of the cost of producing that data to support the
applicant's product in California and comply with the provisions of
subdivision (d).
(d) If an applicant is required to offer to pay a share in the
cost of producing the data pursuant to subdivision (a) or (b), or if
a source of product makes an offer pursuant to subdivision (c), the
applicant or source must submit to the data owner upon application to
the department an irrevocable offer to pay the data owner a share in
the cost of producing the data and to comply with regulations
promulgated under this subdivision to determine the amount and terms,
if the parties cannot agree. If a data owner for which cost sharing
is required under subdivision (a) or (b) cannot be identified from
information readily available to the applicant, the applicant's
obligation under subdivision (a) or (b) will be absolved if the data
owner does not identify himself or herself to the applicant within 12
months after registration of the pesticide product. If within 12
months of registration, the data owner identifies himself or herself
to the applicant and the applicant has not already made an
irrevocable offer to pay to the data owner, or the applicant's source
of product has not made an offer pursuant to subdivision (c), the
applicant must do so promptly. In either event, the specific terms
and amount of payments to be made shall be fixed by agreement between
the applicant and the data owner, but determination of those amounts
and terms shall not delay approval of the applicant's application.
If agreement cannot be reached about the terms and amount of
payment required by this section at any time more than 90 days after
issuance of an irrevocable offer to pay, either the applicant, source
or data owner may initiate, or with the consent of all parties, join
a proceeding under the Federal Insecticide, Fungicide, and
Rodenticide Act (commencing at 7 U.S.C. Sec. 136), pursuant to
regulations promulgated by the director pursuant to this statute. The
purpose of this proceeding shall be to determine the amount due
under this section. The director shall promulgate those regulations
as emergency regulations within 60 days of the enactment of the bill
that enacts this section. The regulations shall provide all of the
following:
(1) Allow the proceeding authorized by this subdivision, upon
mutual agreement of the parties, to be consolidated with dispute
resolution under the Federal Insecticide Fungicide and Rodenticide
Act (commencing at 7 U.S.C. Sec. 136).
(2) Require that the decisionmaker consider, among other factors,
that the data owner's exclusive right to sell the pesticide resulted
in the data owner recovering all or part of the costs of generating
the data.
(3) Require that the parties to the proceeding share equally in
the payment of the expenses thereof.
(e) If a data owner fails to participate in a procedure for
reaching an agreement or in a proceeding as required by subdivision
(d), or fails to comply with the terms of an agreement or decision
conducted under subdivision (d), then that data owner forfeits his or
her right to cost recovery as a result of the use of the data at
issue.
(f) If the director finds that an applicant has failed to make an
offer to pay as required under subdivision (a) or (b), or if its
source of product has failed to make an offer pursuant to subdivision
(c), or if an applicant or its source of product has failed to
participate in a proceeding for reaching an agreement, or has refused
to participate in a proceeding pursuant to subdivision (d), or has
failed to comply with an agreement or to comply with an order, or to
pay an award resulting from that proceeding, the director shall
cancel the registration of the pesticide product in support of which
the data was used in accordance with the provisions of subdivision
(g), notwithstanding the provisions of Section 12825.
(g) If the applicant subject to subdivision (a) or (b) fails to
comply with the provisions of this article, the data owner shall
notify the director of the specific provision of noncompliance and
provide proof of notification to the applicant of its claim of
noncompliance. All parties shall have 30 days from the date of
receipt of notification by the director to submit written evidence or
arguments to the director regarding the claim and any defenses
thereto. The director shall provide a written finding within 60 days
of the deadline for submission as to the claim and the resulting
consequences.
(h) No hearing or live testimony shall be conducted under
subdivision (g) and this proceeding shall not be used as mechanism to
prevent or delay the registration or payment for cost sharing as
determined by this article. The finding of the director shall be
final and conclusive, except that any party aggrieved by such a
finding may seek review within 30 days of the finding pursuant to
Section 1094.5 of the Code of Civil Procedure.
(i) In lieu of seeking a determination by the director and
cancellation of the registration pursuant to subdivision (f), the
data owner may bring an action in any California court of competent
jurisdiction against the applicant to enforce the obligations of that
party set forth in the provisions of this section.
(j) No cost sharing as provided in subdivisions (a), (b), and (c)
shall be required to support an application for annual renewal of a
pesticide product registration, provided this provision shall not
authorize renewal of a product registered prior to the effective date
of this section if that registration is declared to have been
unlawfully issued by a court of competent jurisdiction.
(k) The Department of Pesticide Regulation shall make available in
the public domain its index of data submitted in support of
registration applications, the ownership of that data, and the date
it was submitted to California.
12812. (a) The director shall establish, by regulation, fees for
the Department of Pesticide Regulation's registration program, as
established pursuant to this division. The fees shall include, but
are not limited to, the following:
(1) Annual fees for each product submitted for registration.
(2) Penalties for the late payment of registration fees.
(3) Fees for amendments to registered products.
(b) The fees established pursuant to this section may include
costs for administration and overhead in connection with
administering the fees.
(c) The fees established pursuant to this section shall be set so
that the total revenue collected each fiscal year is sufficient to
support the expenditure levels for the registration program contained
in the annual Budget Act.
(d) Funds collected pursuant to this section shall be deposited in
the Department of Pesticide Regulation Fund, and shall be available
for expenditure by the department, upon appropriation by the
Legislature, for the purposes of carrying out the department's
pesticide registration program, as established pursuant to this
division.
(e) The regulations adopted pursuant to this section, or any
amendment or readoption thereto, shall be adopted by the director in
accordance with Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code. However, the
adoption, amendment, readoption, or repeal of these regulations shall
be considered by the Office of Administrative Law as an emergency,
and necessary for the immediate preservation of the public peace,
health, safety, and general welfare. Notwithstanding any other
provision of law, the regulations shall remain in effect until
amended by the director.
12814. Any county, state, or federal officer or employee who sells
any pesticide at cost is not required to pay any fee that is imposed
by this chapter.
12815. If a manufacturer, importer, or dealer in pesticides that
applies for registration of pesticides has complied with this chapter
and the regulations that are adopted pursuant to it, the director
shall register each pesticide that is sought to be registered and
issue a certificate of registration to the applicant that authorizes
the manufacture and sale of the pesticide in this state.
12816. If the director finds that registration cannot be permitted
due to noncompliance with this chapter or the regulations which are
adopted pursuant to it, he or she may, after reasonable notice, call
a hearing for the purpose of determining whether the application
shall be reconsidered or denied.
12817. Every registration expires on December 31st of each year
except when renewal is applied for within one month thereafter in the
manner which is provided for registration.
12818. If renewal is not applied for within one calendar month
after the expiration of a registration, a penalty as prescribed by
the director pursuant to Section 12812 shall be added to the
registration fee.
12819. A penalty shall not be collected if the person that makes
application for renewal of registration makes an affidavit that no
business was done during the period of nonregistration.
12820. The payment of any renewal fee or penalty is not a bar to
any prosecution for doing business without proper registry.
12821. Each applicant for a certificate of registration shall also
file a statement of every brand, trademark, and kind of pesticide
that the applicant intends to manufacture or sell, the correct name
and percentage of each active ingredient in the pesticide, and the
total percentage of inert ingredients that are contained in the
pesticide. The director, whenever he or she deems it necessary for
the effective administration of this chapter, may require the
submission of the complete formula for the pesticide.
12822. A supplemental application for registration of any
additional pesticide may be submitted at any time without payment of
the penalty required by Section 12818.
12823. A change in the name or percentage, or both, of an inert
ingredient is not a change in composition of the pesticide that
requires a new registration unless the change in inert material
results in a change in the use or application of the pesticide.
12824. The director shall endeavor to eliminate from use in the
state any pesticide that endangers the agricultural or
nonagricultural environment, is not beneficial for the purposes for
which it is sold, or is misrepresented. In carrying out this
responsibility, the director shall develop an orderly program for the
continuous evaluation of all pesticides actually registered.
Before a substance is registered as a pesticide for the first
time, there shall be a thorough and timely evaluation in accordance
with this section. Appropriate restrictions may be placed upon its
use including, but not limited to, limitations on quantity, area, and
manner of application. All pesticides for which renewal of
registration is sought also shall be evaluated in accordance with
this section.
The director may establish specific criteria to evaluate a
pesticide with regard to the factors listed in Section 12825. The
department may establish performance standards and tests that are to
be conducted or financed, or both conducted and financed, by the
registrants, applicants for registration, or parties interested in
the registration of those pesticides.
12825. Pursuant to Section 12824, the director, after hearing, may
cancel the registration of, or refuse to register, any pesticide:
(a) That has demonstrated serious uncontrollable adverse effects
either within or outside the agricultural environment.
(b) The use of which is of less public value or greater detriment
to the environment than the benefit received by its use.
(c) For which there is a reasonable, effective, and practicable
alternate material or procedure that is demonstrably less destructive
to the environment.
(d) That, when properly used, is detrimental to vegetation, except
weeds, to domestic animals, or to the public health and safety.
(e) That is of little or no value for the purpose for which it is
intended.
(f) Concerning which any false or misleading statement is made or
implied by the registrant or his or her agent, either verbally or in
writing, or in the form of any advertising literature.
(g) For which the director determines the registrant has failed to
report an adverse effect or risk as required by Section 12825.5.
(h) If the director determines that the registrant has failed to
comply with the requirements of a reevaluation or to submit the data
required as part of the reevaluation of the registrant's product.
(i) That is required to be registered pursuant to the federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136 et
seq.) and that is not so registered.
In making a determination pursuant to this section, the director
may require those practical demonstrations that are necessary to
determine the facts.
12825.5. (a) If, during the registration process or at any time
after the registration of a pesticide, the registrant has factual or
scientific evidence of any adverse effect or risk of the pesticide to
human health, livestock, crops, or the environment that has not been
previously submitted to the department, the registrant shall submit
the evidence to the director in a timely manner. All such
information, including, but not limited to, that information required
under Section 6 (a) (2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. Sec. 136d (a) (2)), shall be submitted to
the director.
(b) The director may adopt regulations that are reasonably
necessary to carry out this section.
12826. If the director has reason to believe that any of the
conditions stated in Section 12825 are applicable to any registered
pesticide and that the use or continued use of that pesticide
constitutes an immediate substantial danger to persons or to the
environment, the director, after notice to the registrant, may
suspend the registration of that pesticide pending a hearing and
final decision. If an accusation pursuant to Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code is not filed within 10 days from the date of the
notice, the suspension shall be terminated.
12827. The director may cancel a certificate of registration, or,
refuse to issue certification to any manufacturer, importer, or
dealer in any pesticide that repeatedly violates any of the
provisions of this chapter or the regulations of the director.
The proceedings shall be conducted in accordance with Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code. The director has all the powers that are
granted therein.
12827.5. Whenever the director cancels the registration of, or
refuses to register, any pesticide currently registered by the United
States Environmental Protection Agency, the director shall provide
the applicant or registrant with the basis for the decision and the
reasons why a conclusion different from, contrary to, or inconsistent
with, the conclusion and findings of the United States Environmental
Protection Agency was reached.
12828. Action by the director pursuant to Sections 12824, 12825,
12826, or 12827 is not a condition precedent to the institution of
any action to prosecute a violation of the chapter.
12828.5. (a) A registrant at any time may request that the
registration of any of its pesticides be voluntarily canceled. The
request shall be in writing and shall include a waiver of the
registrant's right to a hearing on the cancellation.
(b) The director shall mail a notice of cancellation of
registration of the pesticides to the registrant. The notice shall
specify the effective date of the cancellation.
(c) The pesticides for which the registration is canceled may be
sold and possessed as if the product's registration was not renewed
unless the director determines that protection of human health or the
environment require otherwise, in which case the cancellation notice
shall specify the conditions under which the product may be sold or
possessed after cancellation of its registration.
12829. If a person has a research authorization for a pesticide
issued pursuant to Section 6260 of Title 3 of the California Code of
Regulations for the purpose of testing the pesticide, and the produce
on which the pesticide was tested is required to be destroyed, any
actual costs incurred by the commissioner to investigate and confirm
the destruction of the produce shall be paid for by the person who
has the research authorization. The costs charged by the commissioner
shall not exceed one hundred twenty-five dollars ($125) per
testsite. The board of supervisors of each county may adopt a fee
schedule to cover the commissioner's costs under this section.
12832. (a) Notwithstanding any other provision of this chapter,
alfalfa and all vegetable crops, when grown for seed production, with
the exception of corn, beans, pumpkin, and peas, shall be considered
a nonfood and nonfeed site of pesticide use for the purpose of
pesticide registration. In order to be determined to be a nonfood or
nonfeed site for the purposes of this section, the following
conditions shall be met:
(1) All seed screenings shall be disposed of in such a way that
they cannot be distributed or used for food or feed. The seed
conditioner shall keep records of screenings disposal for three years
from the date of disposal and shall furnish the records to the
director upon request. Disposal records shall consist of
documentation from a controlled waste disposal site, incinerator,
cogeneration plant, composting facility, or other equivalent disposal
site.
(2) No portion of the seed plant, including, but not limited to,
green chop, hay, pellets, meal, whole seed, cracked seed, or seed
screenings shall be used or distributed for food or feed purposes.
(3) All seed crops grown on a nonfood or nonfeed site in this
state, or conditioned in this state, shall bear a tag or container
label that forbids the use of the seed for human consumption or
animal feed.
(4) No seed grown on a nonfood or nonfeed site in this state, or
conditioned in this state, may be distributed for human consumption
or animal feed.
(b) Nothing in this section prevents the department from imposing
conditions for alfalfa seed sites in addition to those contained in
this section, or from rescinding any current label requirements for
pesticides approved for alfalfa seed production.
(c) Nothing in this section exempts the department from reviewing
worker safety evaluations with regard to the use of pesticides
involving crops specified in subdivision (a).
(d) A violation of any condition specified in subdivision (a) by
the person responsible for the use of the pesticide is a violation of
this chapter, and is subject to the civil and criminal penalties and
injunctive relief provisions specified in Article 12 (commencing
with Section 12996). A violation of any condition specified in
subdivision (a) by the person responsible for the disposition of seed
screenings is a violation of Chapter 6 (commencing with Section
14901) and is subject to enforcement by the Department of Food and
Agriculture.
12833. (a) Notwithstanding any other provision of this chapter, the
director may issue a certificate of emergency registration for a
pesticide if all of the following conditions are met:
(1) The pesticide is currently registered by the United States
Environmental Protection Agency pursuant to Section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136a) for
the use specified in subparagraph (B) of paragraph (5).
(2) The active ingredient of the pesticide was previously
registered under Section 18 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. Sec. 136p) in order to respond to an
emergency pest control problem.
(3) The applicant demonstrates to the department that the
pesticide qualifies for registration pursuant to Section 12815 and
the department determines that it is probable that the pesticide will
receive registration pursuant to this division within one year.
(4) The applicant for emergency registration submits to the
director all data required for registration pursuant to this division
and the regulations adopted pursuant to this division.
(5) The director makes both of the following findings based on
substantial evidence:
(A) The use of the pesticide during the period of emergency
registration will not pose a potential significant risk to public
health or safety or to the environment. In making this finding, the
director shall review the risks associated with the use of the
pesticide and determine if those risks are significant given the
limitations that will be imposed on the use of the pesticide during
the emergency registration period.
(B) The emergency registration of the pesticide is necessary in
order to effectively respond to an emergency pest control problem.
For purposes of this subparagraph, an emergency pest control problem
shall be deemed to exist if the director finds that a pest
infestation is present in the state for which no feasible pest
control method is available that is a reasonable alternative to the
use of the pesticide for which the emergency registration is
requested. In making a determination pursuant to this subparagraph,
the director shall identify the pest infestation that is the subject
of the emergency, describe the pest control methods that have been
demonstrated as ineffective against the infestation or that are
otherwise not reasonable alternatives, and summarize the evidence
that demonstrates that the pesticide for which emergency registration
has been requested is efficacious against the pest infestation.
(b) At the same time as the director issues a certificate of
emergency registration for a pesticide pursuant to this section, the
director shall establish limitations on the use of the pesticide that
the director determines are necessary to prevent a potential
significant risk to human health or safety or the environment. The
director shall limit the use of any pesticide granted a certificate
of emergency registration to the control of the emergency pest
infestation described in subparagraph (B) of paragraph (5) of
subdivision (a).
(c) A certificate of emergency registration may be issued for a
period not to exceed one year and may be renewed one time only.
(d) A certificate of emergency registration may not be renewed
unless the director does all of the following:
(1) Publishes a notice that an application for renewal of the
certificate of emergency registration has been received.
(2) Makes all of the following findings:
(A) That the findings made by the director in support of the
certificate of emergency registration pursuant to paragraph (5) of
subdivision (a) remain valid.
(B) That there are no indications that the pesticide, when used in
accordance with applicable label instructions and the limitations
established pursuant to subdivision (b), poses a significant risk to
worker safety and health. The director shall base this finding on a
review of the data required for registration pursuant to this
division, experience with the use of the pesticide during the period
the certificate of emergency registration was in effect, and any
other information the director has required the applicant to submit
or received from the applicant or any other person.
(C) That the failure to complete the registration of the pesticide
during the period the certificate of emergency registration was in
effect is due to circumstances that were not under the control of the
applicant, and that the data required for registration pursuant to
this division is complete and meets all of the requirements of this
division and the regulations adopted pursuant to this division.
(3) Convenes a workshop, if one is requested by any interested or
aggrieved person, concerning the reasons for the renewal of the
certificate of emergency registration. The director shall review
information and comments provided by persons who attend the workshop
and take that information and those comments into account in
determining if the certificate of emergency registration may be
renewed.
(e) The director shall immediately revoke any certificate of
emergency registration issued pursuant to this section if either of
the following occurs:
(1) The United States Environmental Protection Agency suspends or
cancels the registration of the pesticide or the particular use of
the active ingredient in the pesticide that allows it to be used in
the emergency pest infestation described in subparagraph (B) of
paragraph (5) of subdivision (a).
(2) The director determines during a subsequent review of data
required for registration pursuant to this division that the use of
the pesticide will pose a potential significant risk to the public
health or safety or to the environment.
12836. (a) The director, by January 1, 1999, shall implement a
program for the expedited registration of or for the expedited
amendment of the registration of any pesticide classified by the
United States Environmental Protection Agency as a "public health
pesticide" or "antimicrobial pesticide" and that is determined by the
director to have human health protection benefits that warrant
eligibility for expedited processing. Nothing in this section limits
the director's authority to provide expedited registration for any
other pesticide product.
(b) For the purposes of this section, "expedited registration" and
"expedited amendment of the registration" mean that the director
shall review an application for registration or for amendment of a
registration concurrently in time with the review conducted by the
United States Environmental Protection Agency. This section shall not
be construed to require or authorize modification of any guidelines,
protocols, or standards applicable to the review of an application
for registration.
12836.5. The director shall accept applications for registration of
pesticide products containing a new active ingredient concurrently
with the application to the United States Environmental Protection
Agency. The application for registration must include all data and
information that meet the requirements of this chapter.
12836.6. The director shall, with the assistance of the Legislative
Analyst, conduct a study to consider more carefully the consequences
of data-sharing agreements required under Section 12811.5 and the
volume of high-hazard pesticides sold in California. The report shall
be submitted to the Legislature no later than December 31, 2008.
12837. (a) The director may waive the submission or review, or
both, of efficacy data developed by a registrant as a prerequisite
for registration for any antimicrobial pesticide product if all of
the following conditions have been met with respect to each
antimicrobial pesticide product:
(1) The director finds that the United States Environmental
Protection Agency's guidelines, protocols, and standards of review in
existence at the time the product was reviewed by the United States
Environmental Protection Agency are consistent with, and no less
stringent than, California guidelines, protocols, and standards and
generally accepted scientific practices.
(2) The director finds that, with respect to the particular
antimicrobial pesticide product reviewed under this section, the
United States Environmental Protection Agency actually implemented
the guidelines, protocols, and standards of review for which the
director made the required finding pursuant to paragraph (1). In
making this finding, the director may request any relevant studies or
documentation from the registrant.
(b) Nothing in this section shall be construed as a limitation on
the director to request or to review any efficacy data or studies or
to subject any product to testing, at any time.
12811. Every manufacturer of, importer of, or dealer in any
pesticide, except a person that sells any raw material to a
manufacturer of any pesticide or a dealer or agent that sells any
pesticide that has been registered by the manufacturer or wholesaler,
shall obtain a certificate of registration from the department
before the pesticide is offered for sale.
12811.5. The director may rely upon any evaluations of previously
submitted data to determine whether to accept an application for
registration of a new pesticide product, an amendment to the
registration of a registered pesticide product, or to maintain the
registration of a registered pesticide product regardless of the
ownership of the data previously evaluated. However, effective
January 1, 2006, applicants will be subject to the following
provisions:
(a) If an applicant for registration of a pesticide product, or an
amendment to the registration of a registered pesticide product,
including a registrant that desires to maintain its registration of a
registered pesticide product after the director makes a formal
reevaluation request for additional data, does not submit its own
data to fulfill a current data requirement imposed by the director
and relies upon data that the applicant does not own or have written
permission to rely upon that was submitted to the director by another
entity after January 1, 1991, and meets the three criteria set forth
in this subdivision, the applicant must either (i) obtain written
permission from the data owner to rely on the data, (ii) formulate or
obtain its product from a source that has data authorization from
the data owner, or a source that complies with subdivision (c), or
(iii) if the data meets the criteria set forth in paragraphs (1),
(2), and (3), irrevocably offer to pay the data owner a share of the
cost of producing the data and comply with the provisions of
subdivision (d). The director may rely upon data submitted prior to
January 1, 1991, or that does not meet the criteria set forth in
paragraphs (1), (2), and (3) to support any application or comply
with any formal reevaluation request for additional data, without
permission from the data owner. An offer to pay, and a payment
pursuant to that offer, shall only be required as to data not
submitted by the applicant that meets the criteria set forth in
paragraphs (1), (2), and (3). To be eligible for cost sharing
pursuant to this subdivision, the data must meet all of the following
requirements:
(1) The data was required by the director in order to obtain,
amend, or maintain the data owner's California registration or
registrations for uses covered by the application, amendment, or
formal reevaluation request for additional data.
(2) There has been no arbitration award, data compensation, or
data cost-sharing agreement pertaining to data supporting the product
at the federal level pursuant to Section 3(c)(1) (F)(iii) or 3(c)(2)
(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. Sec. 136a(c)(1)(F)(iii) or 136a(c)(2)(B)), or, if an award or
agreement exists, the use of data in California was excluded from
compensation or cost sharing on its face.
(3) The data that fulfills a current requirement was submitted to
the United States Environmental Protection Agency or the department
no more than 15 years prior to the date of the applicant's California
registration, application, or amendment or the formal reevaluation
request for additional data to which the registrant's reliance
responds, provided that as to data submitted to the department as of
August 1, 2005, in support of the first registration of a product,
the applicable period shall be 17 years from the date of submission
to the United States Environmental Protection Agency.
(b) If the director previously imposed a specific documented data
requirement after January 1, 1991, to obtain, amend, or maintain the
California registration of a pesticide product substantially similar
to the applicant's product and that data requirement is not currently
imposed in California for registration, amendment, or maintenance of
the applicant's product, the applicant is further obligated to
submit data to meet the requirement, obtain written permission from
an owner of the data to rely upon the data, formulate or obtain its
product from a source that has authorization from the data owner to
rely upon the data or from a source that complies with subdivision
(c), or, if the data meets the criteria set forth in paragraphs (1),
(2), and (3), irrevocably offer to pay the data owner a share in the
cost of producing the data and comply with the provisions of
subdivision (c). An offer to pay, and a payment pursuant to that
offer, shall only be required as to data not submitted by the
applicant that meets the criteria set forth in paragraphs (1), (2),
and (3). To be eligible for cost sharing pursuant to this
subdivision, the data must meet all of the following requirements:
(1) The data met a specific, documented requirement of the
director to obtain, amend, or maintain the California registration of
the data owner's pesticide product for a use covered by the
applicant's application or amendment.
(2) There has been no arbitration award, data compensation, or
data cost-sharing agreement pertaining to data supporting the product
at the federal level pursuant to Section 3(c)(1)(F)(iii) or 3(c)(2)
(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. Sec. 136a(c)(1)(F)(iii) or 136a(c)(2)(B)), or, if an award or
agreement exists, the use of the data in California was excluded from
compensation or cost sharing on its face.
(3) The data was submitted to the U.S. Environmental Protection
Agency or Department of Pesticide Regulation by the data owner after
January 1, 1991, and no more than 15 years prior to the date of the
applicant's California application for registration or amendment or
the response to a formal specific document data requirement to which
the registrant's reliance responds, provided that as to data
submitted to the department as of August 1, 2005, in support of the
first registration of a product, the applicable period shall be 17
years from the date of submission to the U.S. Environmental
Protection Agency.
(c) An applicant may formulate its product from a source that does
not have data authorization provided that source has submitted data
to support the product or makes or has made an irrevocable offer to
pay the data owner a share of the cost of producing the data required
pursuant to subdivision (a) or (b) for the applicant's product and
complies with or has made payment in accordance with the provisions
of subdivision (d). In the event that the source has already reached
a data compensation or cost-sharing agreement or there has been an
arbitration award under the Federal Insecticide, Fungicide, and
Rodenticide Act (commencing at 7 U.S.C. Sec. 136) that excludes the
right to rely on the data to satisfy the California requirement on
its face, the source must make or have made a new irrevocable offer
to pay a share of the cost of producing that data to support the
applicant's product in California and comply with the provisions of
subdivision (d).
(d) If an applicant is required to offer to pay a share in the
cost of producing the data pursuant to subdivision (a) or (b), or if
a source of product makes an offer pursuant to subdivision (c), the
applicant or source must submit to the data owner upon application to
the department an irrevocable offer to pay the data owner a share in
the cost of producing the data and to comply with regulations
promulgated under this subdivision to determine the amount and terms,
if the parties cannot agree. If a data owner for which cost sharing
is required under subdivision (a) or (b) cannot be identified from
information readily available to the applicant, the applicant's
obligation under subdivision (a) or (b) will be absolved if the data
owner does not identify himself or herself to the applicant within 12
months after registration of the pesticide product. If within 12
months of registration, the data owner identifies himself or herself
to the applicant and the applicant has not already made an
irrevocable offer to pay to the data owner, or the applicant's source
of product has not made an offer pursuant to subdivision (c), the
applicant must do so promptly. In either event, the specific terms
and amount of payments to be made shall be fixed by agreement between
the applicant and the data owner, but determination of those amounts
and terms shall not delay approval of the applicant's application.
If agreement cannot be reached about the terms and amount of
payment required by this section at any time more than 90 days after
issuance of an irrevocable offer to pay, either the applicant, source
or data owner may initiate, or with the consent of all parties, join
a proceeding under the Federal Insecticide, Fungicide, and
Rodenticide Act (commencing at 7 U.S.C. Sec. 136), pursuant to
regulations promulgated by the director pursuant to this statute. The
purpose of this proceeding shall be to determine the amount due
under this section. The director shall promulgate those regulations
as emergency regulations within 60 days of the enactment of the bill
that enacts this section. The regulations shall provide all of the
following:
(1) Allow the proceeding authorized by this subdivision, upon
mutual agreement of the parties, to be consolidated with dispute
resolution under the Federal Insecticide Fungicide and Rodenticide
Act (commencing at 7 U.S.C. Sec. 136).
(2) Require that the decisionmaker consider, among other factors,
that the data owner's exclusive right to sell the pesticide resulted
in the data owner recovering all or part of the costs of generating
the data.
(3) Require that the parties to the proceeding share equally in
the payment of the expenses thereof.
(e) If a data owner fails to participate in a procedure for
reaching an agreement or in a proceeding as required by subdivision
(d), or fails to comply with the terms of an agreement or decision
conducted under subdivision (d), then that data owner forfeits his or
her right to cost recovery as a result of the use of the data at
issue.
(f) If the director finds that an applicant has failed to make an
offer to pay as required under subdivision (a) or (b), or if its
source of product has failed to make an offer pursuant to subdivision
(c), or if an applicant or its source of product has failed to
participate in a proceeding for reaching an agreement, or has refused
to participate in a proceeding pursuant to subdivision (d), or has
failed to comply with an agreement or to comply with an order, or to
pay an award resulting from that proceeding, the director shall
cancel the registration of the pesticide product in support of which
the data was used in accordance with the provisions of subdivision
(g), notwithstanding the provisions of Section 12825.
(g) If the applicant subject to subdivision (a) or (b) fails to
comply with the provisions of this article, the data owner shall
notify the director of the specific provision of noncompliance and
provide proof of notification to the applicant of its claim of
noncompliance. All parties shall have 30 days from the date of
receipt of notification by the director to submit written evidence or
arguments to the director regarding the claim and any defenses
thereto. The director shall provide a written finding within 60 days
of the deadline for submission as to the claim and the resulting
consequences.
(h) No hearing or live testimony shall be conducted under
subdivision (g) and this proceeding shall not be used as mechanism to
prevent or delay the registration or payment for cost sharing as
determined by this article. The finding of the director shall be
final and conclusive, except that any party aggrieved by such a
finding may seek review within 30 days of the finding pursuant to
Section 1094.5 of the Code of Civil Procedure.
(i) In lieu of seeking a determination by the director and
cancellation of the registration pursuant to subdivision (f), the
data owner may bring an action in any California court of competent
jurisdiction against the applicant to enforce the obligations of that
party set forth in the provisions of this section.
(j) No cost sharing as provided in subdivisions (a), (b), and (c)
shall be required to support an application for annual renewal of a
pesticide product registration, provided this provision shall not
authorize renewal of a product registered prior to the effective date
of this section if that registration is declared to have been
unlawfully issued by a court of competent jurisdiction.
(k) The Department of Pesticide Regulation shall make available in
the public domain its index of data submitted in support of
registration applications, the ownership of that data, and the date
it was submitted to California.
12812. (a) The director shall establish, by regulation, fees for
the Department of Pesticide Regulation's registration program, as
established pursuant to this division. The fees shall include, but
are not limited to, the following:
(1) Annual fees for each product submitted for registration.
(2) Penalties for the late payment of registration fees.
(3) Fees for amendments to registered products.
(b) The fees established pursuant to this section may include
costs for administration and overhead in connection with
administering the fees.
(c) The fees established pursuant to this section shall be set so
that the total revenue collected each fiscal year is sufficient to
support the expenditure levels for the registration program contained
in the annual Budget Act.
(d) Funds collected pursuant to this section shall be deposited in
the Department of Pesticide Regulation Fund, and shall be available
for expenditure by the department, upon appropriation by the
Legislature, for the purposes of carrying out the department's
pesticide registration program, as established pursuant to this
division.
(e) The regulations adopted pursuant to this section, or any
amendment or readoption thereto, shall be adopted by the director in
accordance with Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code. However, the
adoption, amendment, readoption, or repeal of these regulations shall
be considered by the Office of Administrative Law as an emergency,
and necessary for the immediate preservation of the public peace,
health, safety, and general welfare. Notwithstanding any other
provision of law, the regulations shall remain in effect until
amended by the director.
12814. Any county, state, or federal officer or employee who sells
any pesticide at cost is not required to pay any fee that is imposed
by this chapter.
12815. If a manufacturer, importer, or dealer in pesticides that
applies for registration of pesticides has complied with this chapter
and the regulations that are adopted pursuant to it, the director
shall register each pesticide that is sought to be registered and
issue a certificate of registration to the applicant that authorizes
the manufacture and sale of the pesticide in this state.
12816. If the director finds that registration cannot be permitted
due to noncompliance with this chapter or the regulations which are
adopted pursuant to it, he or she may, after reasonable notice, call
a hearing for the purpose of determining whether the application
shall be reconsidered or denied.
12817. Every registration expires on December 31st of each year
except when renewal is applied for within one month thereafter in the
manner which is provided for registration.
12818. If renewal is not applied for within one calendar month
after the expiration of a registration, a penalty as prescribed by
the director pursuant to Section 12812 shall be added to the
registration fee.
12819. A penalty shall not be collected if the person that makes
application for renewal of registration makes an affidavit that no
business was done during the period of nonregistration.
12820. The payment of any renewal fee or penalty is not a bar to
any prosecution for doing business without proper registry.
12821. Each applicant for a certificate of registration shall also
file a statement of every brand, trademark, and kind of pesticide
that the applicant intends to manufacture or sell, the correct name
and percentage of each active ingredient in the pesticide, and the
total percentage of inert ingredients that are contained in the
pesticide. The director, whenever he or she deems it necessary for
the effective administration of this chapter, may require the
submission of the complete formula for the pesticide.
12822. A supplemental application for registration of any
additional pesticide may be submitted at any time without payment of
the penalty required by Section 12818.
12823. A change in the name or percentage, or both, of an inert
ingredient is not a change in composition of the pesticide that
requires a new registration unless the change in inert material
results in a change in the use or application of the pesticide.
12824. The director shall endeavor to eliminate from use in the
state any pesticide that endangers the agricultural or
nonagricultural environment, is not beneficial for the purposes for
which it is sold, or is misrepresented. In carrying out this
responsibility, the director shall develop an orderly program for the
continuous evaluation of all pesticides actually registered.
Before a substance is registered as a pesticide for the first
time, there shall be a thorough and timely evaluation in accordance
with this section. Appropriate restrictions may be placed upon its
use including, but not limited to, limitations on quantity, area, and
manner of application. All pesticides for which renewal of
registration is sought also shall be evaluated in accordance with
this section.
The director may establish specific criteria to evaluate a
pesticide with regard to the factors listed in Section 12825. The
department may establish performance standards and tests that are to
be conducted or financed, or both conducted and financed, by the
registrants, applicants for registration, or parties interested in
the registration of those pesticides.
12825. Pursuant to Section 12824, the director, after hearing, may
cancel the registration of, or refuse to register, any pesticide:
(a) That has demonstrated serious uncontrollable adverse effects
either within or outside the agricultural environment.
(b) The use of which is of less public value or greater detriment
to the environment than the benefit received by its use.
(c) For which there is a reasonable, effective, and practicable
alternate material or procedure that is demonstrably less destructive
to the environment.
(d) That, when properly used, is detrimental to vegetation, except
weeds, to domestic animals, or to the public health and safety.
(e) That is of little or no value for the purpose for which it is
intended.
(f) Concerning which any false or misleading statement is made or
implied by the registrant or his or her agent, either verbally or in
writing, or in the form of any advertising literature.
(g) For which the director determines the registrant has failed to
report an adverse effect or risk as required by Section 12825.5.
(h) If the director determines that the registrant has failed to
comply with the requirements of a reevaluation or to submit the data
required as part of the reevaluation of the registrant's product.
(i) That is required to be registered pursuant to the federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136 et
seq.) and that is not so registered.
In making a determination pursuant to this section, the director
may require those practical demonstrations that are necessary to
determine the facts.
12825.5. (a) If, during the registration process or at any time
after the registration of a pesticide, the registrant has factual or
scientific evidence of any adverse effect or risk of the pesticide to
human health, livestock, crops, or the environment that has not been
previously submitted to the department, the registrant shall submit
the evidence to the director in a timely manner. All such
information, including, but not limited to, that information required
under Section 6 (a) (2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. Sec. 136d (a) (2)), shall be submitted to
the director.
(b) The director may adopt regulations that are reasonably
necessary to carry out this section.
12826. If the director has reason to believe that any of the
conditions stated in Section 12825 are applicable to any registered
pesticide and that the use or continued use of that pesticide
constitutes an immediate substantial danger to persons or to the
environment, the director, after notice to the registrant, may
suspend the registration of that pesticide pending a hearing and
final decision. If an accusation pursuant to Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code is not filed within 10 days from the date of the
notice, the suspension shall be terminated.
12827. The director may cancel a certificate of registration, or,
refuse to issue certification to any manufacturer, importer, or
dealer in any pesticide that repeatedly violates any of the
provisions of this chapter or the regulations of the director.
The proceedings shall be conducted in accordance with Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code. The director has all the powers that are
granted therein.
12827.5. Whenever the director cancels the registration of, or
refuses to register, any pesticide currently registered by the United
States Environmental Protection Agency, the director shall provide
the applicant or registrant with the basis for the decision and the
reasons why a conclusion different from, contrary to, or inconsistent
with, the conclusion and findings of the United States Environmental
Protection Agency was reached.
12828. Action by the director pursuant to Sections 12824, 12825,
12826, or 12827 is not a condition precedent to the institution of
any action to prosecute a violation of the chapter.
12828.5. (a) A registrant at any time may request that the
registration of any of its pesticides be voluntarily canceled. The
request shall be in writing and shall include a waiver of the
registrant's right to a hearing on the cancellation.
(b) The director shall mail a notice of cancellation of
registration of the pesticides to the registrant. The notice shall
specify the effective date of the cancellation.
(c) The pesticides for which the registration is canceled may be
sold and possessed as if the product's registration was not renewed
unless the director determines that protection of human health or the
environment require otherwise, in which case the cancellation notice
shall specify the conditions under which the product may be sold or
possessed after cancellation of its registration.
12829. If a person has a research authorization for a pesticide
issued pursuant to Section 6260 of Title 3 of the California Code of
Regulations for the purpose of testing the pesticide, and the produce
on which the pesticide was tested is required to be destroyed, any
actual costs incurred by the commissioner to investigate and confirm
the destruction of the produce shall be paid for by the person who
has the research authorization. The costs charged by the commissioner
shall not exceed one hundred twenty-five dollars ($125) per
testsite. The board of supervisors of each county may adopt a fee
schedule to cover the commissioner's costs under this section.
12832. (a) Notwithstanding any other provision of this chapter,
alfalfa and all vegetable crops, when grown for seed production, with
the exception of corn, beans, pumpkin, and peas, shall be considered
a nonfood and nonfeed site of pesticide use for the purpose of
pesticide registration. In order to be determined to be a nonfood or
nonfeed site for the purposes of this section, the following
conditions shall be met:
(1) All seed screenings shall be disposed of in such a way that
they cannot be distributed or used for food or feed. The seed
conditioner shall keep records of screenings disposal for three years
from the date of disposal and shall furnish the records to the
director upon request. Disposal records shall consist of
documentation from a controlled waste disposal site, incinerator,
cogeneration plant, composting facility, or other equivalent disposal
site.
(2) No portion of the seed plant, including, but not limited to,
green chop, hay, pellets, meal, whole seed, cracked seed, or seed
screenings shall be used or distributed for food or feed purposes.
(3) All seed crops grown on a nonfood or nonfeed site in this
state, or conditioned in this state, shall bear a tag or container
label that forbids the use of the seed for human consumption or
animal feed.
(4) No seed grown on a nonfood or nonfeed site in this state, or
conditioned in this state, may be distributed for human consumption
or animal feed.
(b) Nothing in this section prevents the department from imposing
conditions for alfalfa seed sites in addition to those contained in
this section, or from rescinding any current label requirements for
pesticides approved for alfalfa seed production.
(c) Nothing in this section exempts the department from reviewing
worker safety evaluations with regard to the use of pesticides
involving crops specified in subdivision (a).
(d) A violation of any condition specified in subdivision (a) by
the person responsible for the use of the pesticide is a violation of
this chapter, and is subject to the civil and criminal penalties and
injunctive relief provisions specified in Article 12 (commencing
with Section 12996). A violation of any condition specified in
subdivision (a) by the person responsible for the disposition of seed
screenings is a violation of Chapter 6 (commencing with Section
14901) and is subject to enforcement by the Department of Food and
Agriculture.
12833. (a) Notwithstanding any other provision of this chapter, the
director may issue a certificate of emergency registration for a
pesticide if all of the following conditions are met:
(1) The pesticide is currently registered by the United States
Environmental Protection Agency pursuant to Section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136a) for
the use specified in subparagraph (B) of paragraph (5).
(2) The active ingredient of the pesticide was previously
registered under Section 18 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. Sec. 136p) in order to respond to an
emergency pest control problem.
(3) The applicant demonstrates to the department that the
pesticide qualifies for registration pursuant to Section 12815 and
the department determines that it is probable that the pesticide will
receive registration pursuant to this division within one year.
(4) The applicant for emergency registration submits to the
director all data required for registration pursuant to this division
and the regulations adopted pursuant to this division.
(5) The director makes both of the following findings based on
substantial evidence:
(A) The use of the pesticide during the period of emergency
registration will not pose a potential significant risk to public
health or safety or to the environment. In making this finding, the
director shall review the risks associated with the use of the
pesticide and determine if those risks are significant given the
limitations that will be imposed on the use of the pesticide during
the emergency registration period.
(B) The emergency registration of the pesticide is necessary in
order to effectively respond to an emergency pest control problem.
For purposes of this subparagraph, an emergency pest control problem
shall be deemed to exist if the director finds that a pest
infestation is present in the state for which no feasible pest
control method is available that is a reasonable alternative to the
use of the pesticide for which the emergency registration is
requested. In making a determination pursuant to this subparagraph,
the director shall identify the pest infestation that is the subject
of the emergency, describe the pest control methods that have been
demonstrated as ineffective against the infestation or that are
otherwise not reasonable alternatives, and summarize the evidence
that demonstrates that the pesticide for which emergency registration
has been requested is efficacious against the pest infestation.
(b) At the same time as the director issues a certificate of
emergency registration for a pesticide pursuant to this section, the
director shall establish limitations on the use of the pesticide that
the director determines are necessary to prevent a potential
significant risk to human health or safety or the environment. The
director shall limit the use of any pesticide granted a certificate
of emergency registration to the control of the emergency pest
infestation described in subparagraph (B) of paragraph (5) of
subdivision (a).
(c) A certificate of emergency registration may be issued for a
period not to exceed one year and may be renewed one time only.
(d) A certificate of emergency registration may not be renewed
unless the director does all of the following:
(1) Publishes a notice that an application for renewal of the
certificate of emergency registration has been received.
(2) Makes all of the following findings:
(A) That the findings made by the director in support of the
certificate of emergency registration pursuant to paragraph (5) of
subdivision (a) remain valid.
(B) That there are no indications that the pesticide, when used in
accordance with applicable label instructions and the limitations
established pursuant to subdivision (b), poses a significant risk to
worker safety and health. The director shall base this finding on a
review of the data required for registration pursuant to this
division, experience with the use of the pesticide during the period
the certificate of emergency registration was in effect, and any
other information the director has required the applicant to submit
or received from the applicant or any other person.
(C) That the failure to complete the registration of the pesticide
during the period the certificate of emergency registration was in
effect is due to circumstances that were not under the control of the
applicant, and that the data required for registration pursuant to
this division is complete and meets all of the requirements of this
division and the regulations adopted pursuant to this division.
(3) Convenes a workshop, if one is requested by any interested or
aggrieved person, concerning the reasons for the renewal of the
certificate of emergency registration. The director shall review
information and comments provided by persons who attend the workshop
and take that information and those comments into account in
determining if the certificate of emergency registration may be
renewed.
(e) The director shall immediately revoke any certificate of
emergency registration issued pursuant to this section if either of
the following occurs:
(1) The United States Environmental Protection Agency suspends or
cancels the registration of the pesticide or the particular use of
the active ingredient in the pesticide that allows it to be used in
the emergency pest infestation described in subparagraph (B) of
paragraph (5) of subdivision (a).
(2) The director determines during a subsequent review of data
required for registration pursuant to this division that the use of
the pesticide will pose a potential significant risk to the public
health or safety or to the environment.
12836. (a) The director, by January 1, 1999, shall implement a
program for the expedited registration of or for the expedited
amendment of the registration of any pesticide classified by the
United States Environmental Protection Agency as a "public health
pesticide" or "antimicrobial pesticide" and that is determined by the
director to have human health protection benefits that warrant
eligibility for expedited processing. Nothing in this section limits
the director's authority to provide expedited registration for any
other pesticide product.
(b) For the purposes of this section, "expedited registration" and
"expedited amendment of the registration" mean that the director
shall review an application for registration or for amendment of a
registration concurrently in time with the review conducted by the
United States Environmental Protection Agency. This section shall not
be construed to require or authorize modification of any guidelines,
protocols, or standards applicable to the review of an application
for registration.
12836.5. The director shall accept applications for registration of
pesticide products containing a new active ingredient concurrently
with the application to the United States Environmental Protection
Agency. The application for registration must include all data and
information that meet the requirements of this chapter.
12836.6. The director shall, with the assistance of the Legislative
Analyst, conduct a study to consider more carefully the consequences
of data-sharing agreements required under Section 12811.5 and the
volume of high-hazard pesticides sold in California. The report shall
be submitted to the Legislature no later than December 31, 2008.
12837. (a) The director may waive the submission or review, or
both, of efficacy data developed by a registrant as a prerequisite
for registration for any antimicrobial pesticide product if all of
the following conditions have been met with respect to each
antimicrobial pesticide product:
(1) The director finds that the United States Environmental
Protection Agency's guidelines, protocols, and standards of review in
existence at the time the product was reviewed by the United States
Environmental Protection Agency are consistent with, and no less
stringent than, California guidelines, protocols, and standards and
generally accepted scientific practices.
(2) The director finds that, with respect to the particular
antimicrobial pesticide product reviewed under this section, the
United States Environmental Protection Agency actually implemented
the guidelines, protocols, and standards of review for which the
director made the required finding pursuant to paragraph (1). In
making this finding, the director may request any relevant studies or
documentation from the registrant.
(b) Nothing in this section shall be construed as a limitation on
the director to request or to review any efficacy data or studies or
to subject any product to testing, at any time.
