2005 California Food and Agricultural Code Sections 13121-13135 Article 14. Birth Defect Prevention

13121.  This article shall be known and may be cited as the Birth
Defect Prevention Act of 1984.
13122.  It is the purpose of the Legislature in enacting this
chapter to prevent pesticide induced abortions, birth defects, and
infertility.
13123.  For purposes of this chapter, the following terms mean:
   (a) "Adverse reproductive effect" means a statistically
significant adverse effect on parental reproductive performance and
the growth and development of offspring, including gonadal function,
conception, and parturition; abortions; birth defects; stillbirths;
and resorptions.
   (b) "Data gap" means that the department does not have on file a
full set of valid mandatory health effects studies.
   (c) "Mandatory health effects study" means  adverse reproductive
effect, chronic toxicity, mutagenicity, neurotoxicity, oncogenicity,
and teratogenicity studies required for full registration or
licensing of pesticides in California, as of July 1, 1983.
   (d) "Teratogenic" means the property of a substance or mixture of
substances to produce or induce functional deviations or
developmental anomalies, not heritable, in or on an animal embryo or
fetus.
   (e) "Mutagenic effect" means the property of a substance or
mixture of substances to induce changes in the genetic complement of
either somatic or germinal tissue in subsequent generations.
   (f) "Chronic toxicity" means the property of a substance or
mixture of substances to cause adverse effects in an organism upon
repeated or continuous exposure over a period of at least one-half
the lifetime of that organism.
   (g) "Oncogenic" means the property of a substance or a mixture of
substances to produce or induce benign or malignant tumor formations
in living animals.
   (h) "Neurotoxic effect" means any adverse effect on the nervous
system such as delayed-onset locomotor ataxia resulting from single
administration of the test substance, repeated once if necessary.
   (i) "Initiation" means that the mandatory health effects study or
any necessary preliminary studies, such as pilot studies or range
finding studies, have been commenced.
   (j) "Data generator" means a person who has completed and filed
with the director a data commitment status report.
   (k) "Completion" means that the study has been finished, the data
has been analyzed, and the final report of the results, including all
exhibits, has been prepared and submitted to the department.
   (l) "Submitted" means deliverance of a completed study to the
department.  A study shall be deemed to be submitted until it has
been determined by the department to be unacceptable and not capable
of being upgraded.
   (m) "Suspend" means the director has issued a notice of intent to
suspend the registration of a pesticide product.  The director shall
issue a suspension order at the earliest possible time.
13123.5.  To the extent feasible, health effects studies shall be
conducted in accordance with standards and protocols established
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. Sec. 135 et seq.).
13126.  No new active pesticide ingredient shall be  conditionally
registered or licensed when any of the mandatory health effects
studies, as defined in subdivision (c) of Section 13123, is missing,
incomplete, or of questionable validity unless the registration is
based on previous consultation with the State Director of Health
Services and the Director of Industrial Relations.
13127.  (a) Not later than December 31, 1985, the department shall
identify 200 pesticide active ingredients which the department
determines have the most significant data gaps and widespread use and
which are suspected to be hazardous to people.  Not later than 30
days after the report issued pursuant to former Section 13125, as
added by Chapter 669 of the Statutes of 1984, the department shall
notify each registrant of a pesticide product containing any of the
identified 200 pesticide active ingredients of the applicable data
gap required to be filled pursuant to this section.
   (b) Not later than December 31, 1985, the department shall also
adopt a timetable for the filling of all data gaps on all pesticide
active ingredients, other than those identified by the department
pursuant to subdivision (a), which are currently registered or
licensed in California.  The department shall notify registrants of
the applicable data gaps and the scheduled time to initiate and
complete studies as provided in the timetable.
   (c) (1) Not later than September 1, 1986, the department shall
determine whether a test has been initiated to fill each of the data
gaps for each pesticide active ingredient identified in subdivision
(a).  If no test has been initiated, the department shall fill data
gaps in accordance with procedures provided in subparagraph (B) of
paragraph (2) of subsection (c) of Section 136a of Title 7 of the
United States Code.  In order to carry out this section, the director
has the same authority to require information from registrants of
active pesticide ingredients and to suspend registration that the
Administrator of the Environmental Protection Agency has pursuant to
subparagraph (B) of paragraph (2) of subsection (c) of Section 136a
of Title 7 of the United States Code.  If a hearing is requested
regarding the proposed suspension of registration, it shall be
conducted pursuant to Chapter 5 (commencing with Section 11500) of
Part 1 of Division 3 of Title 2 of the Government Code.  On or before
July 1, 1986, the director shall, by regulation, prescribe
procedures for resolving disputes or funding the filling of data
gaps.  The procedures may include mediation and arbitration.  The
arbitration procedures, insofar as practical, shall be consistent
with the federal act, or otherwise shall be in accordance with the
commercial arbitration rules established by the American Arbitration
Association.  The procedures shall be established so as to resolve
any dispute within the timetable established in subdivision (a).
   (2) The department shall also obtain the data which is identified
in subdivision (b), according to the timetable and procedures
specified in this section.
   (d) The director shall review the timetable established by the
Environmental Protection Agency for the accelerated registration
program under amendments effective in 1989 to the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136 et
seq.).
   (e) (1) This section does not apply to any product which the
director determines has limited use or that substantial economic
hardship would result to users due to unavailability of the product
and there is not significant exposure to the public or workers and
the product is otherwise in compliance with federal law.
   (2) The director may not, pursuant to this subdivision, exempt all
pesticide products containing the same pesticide active ingredient
unless it is determined that the pesticide active ingredient has only
limited use, there is insignificant exposure to workers or the
public, and the products are otherwise in compliance with federal
law.  Any exemption issued pursuant to this paragraph shall expire at
the end of three years after it is issued.
   (f) (1) Whenever the director exercises the authority provided in
paragraph (1) of subdivision (e), he or she shall give public notice
of the action stating the reasons for exempting the pesticide product
from the data requirements of this article.  Copies of this notice
shall be provided to the appropriate policy committees of the
Legislature.
   (2) Whenever the director acts pursuant to paragraph (2) of
subdivision (e), the director shall furnish not less than 30 days'
public notice of the proposed action, stating the reasons for
exempting the pesticide product from the data requirements of this
article and allowing public comment thereon.  Copies of the notice
and the final decision shall be provided to the appropriate policy
committees of the Legislature.
13127.2.  The director shall, on January 15, 1992, issue a notice of
the impending suspension of the registration of any pesticide
product containing an active ingredient identified pursuant to
subdivision (a) of Section 13127 for which the registrant has not
submitted the required data by December 31, 1991.  The data generator
or registrant may petition the director within 30 days of
notification of impending suspension of registration for deferral of
the suspension pursuant to Section 13127.3.  The director shall act
upon such a petition at the earliest possible time and, upon denial
of the petition, suspend the registration of each such product.
13127.3.  (a) The director shall grant an extension of time for
submission of the required data if, and only if, the director, with
the concurrence of the Secretary for Environmental Protection, makes
a finding that both of the following conditions are satisfied:
   (1) The registrant has submitted at least eight of the mandatory
health effects studies, and has initiated the studies required to
fill the remaining data gaps by January 15, 1992, unless the
registrant can demonstrate to the satisfaction of the director that
it failed to have eight studies submitted, and the remaining studies
initiated, in accordance with this paragraph because not more than
two studies were delayed due to specific, written direction of the
department based upon a written evaluation by a department
toxicologist.
   (2) That the registrant has taken appropriate steps to meet the
requirements of this article.  To determine whether appropriate steps
have been taken, the director shall consider the registrant's timely
response to data call-ins on other active ingredients contained in
products registered with the department pursuant to this article and
pursuant to Article 15 (commencing with Section 13141), and whether
the registrant has responded in a timely and appropriate manner to
notices and correspondence from the department relating to data
call-ins and has taken appropriate measures to address study
deficiencies identified by the department.
   (b) A registrant shall not be considered to have taken the
appropriate steps, as provided in subdivision (a), if the registrant
has failed to meet the deadlines established by this article due to
efforts to coordinate compliance with federal data requirements.
13127.31.  Notwithstanding subdivision (a) of Section 13127.3, if
the director finds that delays in submitting the mandatory health
effects studies were primarily caused by actions of the department,
the director, with the concurrence of the Secretary for Environmental
Protection, may extend the deadlines for submitting the mandatory
health effects studies for the following active ingredients creosote,
pentachlorophenol, dicamba, para-dichlorobenzene, methyl bromide,
napropamide, petroleum distillates, and arsenic pentoxide/trioxide.
Registrants of these products shall submit the required studies in a
timely manner, but in no case later than the time allowed in Section
13127.92.
13127.32.  Notwithstanding any other provision of law, none of the
following pesticide products shall remain registered in this state:
   (a) Except as specified in subdivision (b), no pesticide product
containing an active ingredient identified pursuant to subdivision
(a) of Section 13127 for which the required studies have not been
submitted by March 30, 1996, shall remain registered after that date.
   (b) No pesticide product containing methyl bromide or
pentachlorophenol for which the required studies have not been
submitted by December 31, 1997, shall remain registered after that
date.
13127.5.  (a) The director, with the concurrence of the Secretary
for Environmental Protection, may defer the suspension of
registration of a pesticide product, as provided in Section  13127.2,
if both of the following occur:
   (1) The director receives a petition from the registrant or any
other person requesting a deferral of suspension.
   (2) The director makes a written finding of one of the following:
   (A) Suspension of the registration of the product would cause
substantial economic hardship to the users of the product, that there
would be no significant, unmitigated human exposure to the product,
and that no feasible alternatives to the product are available.
   (B) Suspension of the registration of the product would be more
detrimental to the agricultural or nonagricultural environment than
continued use of the product, that there would be no significant,
unmitigated human exposure to the product, and that no feasible
alternatives to the product are available.
   (C) Suspension of the registration of the product would result in
significant risk to the public health and that no feasible
alternatives to the product are available.
   (b) The director shall limit the use of any product granted a
deferral of suspension pursuant to paragraph (2) of subdivision (a)
to specific uses that conform to the director's findings pursuant to
paragraph (2) of subdivision (a).
13127.6.  The director shall levy a charge on data generators of up
to one thousand dollars ($1,000) per day for each day a data gap
continues to exist after the date the director issues a deferral of
suspension of registration pursuant to Section 13127.5.  In
establishing the amount of the charge, the director shall consider
the number of outstanding studies, the registrant's timely response
to data call-ins on other products registered with the department
pursuant to this article, and whether the registrant has responded in
a timely and appropriate manner to notices and correspondence from
the department relating to data call-ins, and whether the registrant
has taken appropriate measures to address study deficiencies
identified by the department.  If the charge levied on the data
generator is not paid, all products containing that active ingredient
shall be suspended.  Revenues collected from the levying of charges
shall be deposited in the Department of Pesticide Regulation Fund.
13127.7.  All documentation relevant to a finding made pursuant to
Sections 13127.3 and 13127.5 shall be available to the public, and
the findings shall be  a public record.
13127.8.  (a) A suspension of registration of a pesticide product
containing any of the active ingredients identified pursuant to
subdivision (a) of Section 13127 shall be revoked when the director
determines that the registrant has submitted all of the mandatory
health effects studies.  If, upon completion of the review of the
studies, the director determines that a data gap still exists, the
director shall suspend the registration.
   (b) If at any time after January 1, 1992, the registrant meets the
requirements of subdivision (a) of Section 13127.3, notwithstanding
the date specified in paragraph (1) of subdivision (a) of Section
13127.3, the director shall revoke the suspension, and shall levy a
charge pursuant to Section 13127.6 or, if a charge has already been
levied on a registrant, the director may revise the charge in light
of the registrant's compliance with the requirements of this article
and Article 15 (commencing with Section 13141).
   (c) The director may modify the amount of the charge levied
pursuant to Section 13127.6 upon the initiation or submission of any
health effects studies required pursuant to this article.
13127.9.  For each mandatory health effects study that is required
for each active ingredient identified pursuant to subdivision (a) of
Section 13127, the registrant shall submit to the department a
progress report in December of each year until the study is
completed.
13127.91.  The director shall suspend the registration of any
pesticide product that contains an active ingredient identified
pursuant to subdivision (a) of Section 13127 for which the registrant
fails to do any of the following:
   (a) Respond to the director's notification of a data gap.
   (b) Submit progress reports as required by Section 13127.9.
   (c) Demonstrate reasonable progress toward completion of all the
mandatory health effects studies.
13127.92.  (a) Extensions of time granted pursuant to Section
13127.3, 13127.31, and 13127.5 shall only be for the time necessary
to complete  the mandatory health effects studies.
   (b) Mandatory health effects studies shall be completed in
accordance with the following timetable:
   (1) Forty-eight months for oncogenicity, chronic feeding, and
reproduction studies.
   (2) Twenty-four months for teratogenicity and neurotoxicity
studies.
   (3) Twelve months for mutagenicity studies.
   (c) A deferral of suspension of registration issued pursuant to
Section 13127.5 shall be subject to an annual review by the director
and shall be limited to the time necessary to compete the required
studies, and shall in no case exceed four years with the time tolling
from the date that the registrant petitioned for an extension.
   (d) Any extension of time for submission of the mandatory health
effects studies granted pursuant to Section 13127.5 shall be canceled
by June 15, 1993, and the registration suspended for the affected
ingredient, if the registrant fails to initiate the required studies
by June 15, 1992.
13128.  No applicant for registration or current registrant of a
pesticide who proposes to purchase or purchases a registered
pesticide from another producer in order to formulate the purchased
pesticide into an end use  product shall be required pursuant to
Section 13127 to submit or cite mandatory health effect data
pertaining to the safety of the purchased product or to offer to pay
reasonable compensation for the use of any such data if the producer
is engaged in fulfilling the requirements of Section 13127.
13129.  (a) If the director, after evaluation of the health effects
study of an active ingredient, finds that a pesticide product
containing the active ingredient presents significant adverse health
effects, including reproduction, birth defects, or infertility
abnormalities, the director shall take cancellation or suspension
action against the product pursuant to Section 12825 or 12826.
   (b) The State Director of Health Services shall have access to
mandatory health effects studies and other health effects studies on
file at the Department of Food and Agriculture, and may, based upon
the determination of the State Director of Health Services, provide
advice, consultation, and recommendations concerning the risks to
human health associated wth exposure to the substances tested.
13130.3.  (a) Notwithstanding subdivision (b) of Section 13127, the
time permitted by the director for submitting data to fill a data gap
shall be as follows:
   (1) For oncogenicity studies and chronic feeding studies, 48
months.
   (2) For reproduction studies, 48 months.
   (3) For teratogenicity and neurotoxicity studies, 24 months.
   (4) For mutagenicity studies, 12 months.
   The time permitted by the director for submitting data to fill a
data gap shall commence upon the date the department notifies the
registrant of the data gap.
   (b) Notwithstanding the time limit established in subdivision (a)
for submitting data to fill a data gap, the department may, with the
concurrence of the Office of Environmental Health Hazard Assessment,
grant an extension of time to complete the required studies, upon a
written finding that events beyond the control of the persons
responsible for submitting the data prevent submission of the data
within the prescribed time, and that those persons have made a good
faith effort to complete the studies within the prescribed time.  Not
more than one extension of time per data requirement may be granted
to complete the required studies.  The length of an extension granted
pursuant to this subdivision shall be limited to the time necessary
to complete the studies, not to exceed the length of time specified
in subdivision (a) for conducting the studies.
13131.1.  (a) Not later than March 1, 1992, the director shall
notify registrants of the data requirements, and the guidelines the
director intends to use in reviewing studies submitted pursuant to
subdivision (b) of Section 13127, for all pesticide active
ingredients other than those identified pursuant to subdivision (a)
of Section 13127.
   (b) Not later than 90 calendar days after the date of notification
of the data requirements, each registrant shall do one of the
following:
   (1) Inform the department, in a manner prescribed by the director,
of how the registrant will comply with the data requirements.
   (2) File a written objection, accompanied by any supporting
evidence and arguments, to all or part of the director's notice of
data requirements.  The objection authorized by this paragraph shall
be the exclusive opportunity for a registrant to object to the
director's notice of data requirements.
   (c) The director may consider and grant a request by a registrant
to initiate the studies necessary to comply with the data
requirements in accordance with a schedule established by the United
States Environmental Protection Agency.  In no event shall a
registrant be authorized pursuant to this subdivision to initiate the
studies necessary for that compliance after January 1, 1994.
13131.2.  (a) Prior to March 1, 1992, or in response to a written
objection filed pursuant to paragraph (2) of subdivision (b) of
Section 13131.1, the department may determine, with the concurrence
of the Office of Environmental Health Hazard Assessment, that one or
more of the mandatory health effects studies are not required in
order to evaluate pesticide active ingredients other than those
identified pursuant to subdivision (a) of Section 13127.  This
determination may be made only in accordance with one or more of the
following criteria:
   (1) The ingredient has been classified as "Generally Recognized as
Safe" by the United States Food and Drug Administration.
   (2) The study is not physically possible due to the nature of the
ingredient.
   (3) The department has on file toxicological data that is adequate
for the assessment of the potential adverse health effects of the
ingredient, and the studies relied upon for that purpose are of the
same study type, are scientifically valid, and, when taken together,
are of a power and sensitivity equivalent to the studies that would
be waived pursuant to this subdivision.
   (b) The director may, in conjunction with the Office of
Environmental Health Hazard Assessment, develop regulations for
modification of mandatory health effects studies.
13131.3.  If the Office of Environmental Health Hazard Assessment
does not concur with the determination of the department pursuant to
Section 13131.2, the issue shall be decided by a majority of the
membership of a panel consisting of the following persons:
   (a) An appointee of the State Director of Health Services who has
expertise in toxicology.
   (b) An appointee of the President of the University of California
who has expertise in toxicology.
   (c) An appointee of the Secretary for Environmental Protection who
has expertise in toxicology.
13131.4.  (a) On or before January 1, 1994, the director shall issue
a final notice of data gaps required to be filled for all pesticide
active ingredients other than those identified pursuant to
subdivision (a) of Section 13127.  This notice shall be the
department's final determination of the data gaps required to be
filled.
   (b) The time allowed under Section 13130.3 to fill the data gaps
shall commence on the date that the final notice of data gaps is
issued pursuant to subdivision (a), unless an extension is granted
pursuant to subdivision (b) of Section 13130.3.
   (c) Not later than 90 calendar days after the date the final
notice of data gaps is issued pursuant to subdivision (a), each
registrant shall inform the department, in a manner prescribed by the
director, how the registrant will fill the data gap, including a
proposed schedule for initiation, completion, and submittal of all
required studies.
13131.5.  The director shall suspend the registration of any
pesticide containing an active ingredient for which the director
notifies a registrant pursuant to Section 13131.1 and for which the
registrant or data generator, in the judgment of the director, fails
to respond appropriately or fails to provide evidence that it is
taking appropriate steps to secure the data that are required
pursuant to Section 13131.1 or the final notice of data gaps pursuant
to Section 13131.4.
13133.  If any provision of this article or the application thereof
to any person or circumstances is held invalid, this invalidity shall
not affect other provisions or applications of the article which can
be given effect without the invalid provision or application, and to
this end the provisions of this article are severable.
13134.  (a) The department, in cooperation with the State Department
of Health Services, shall conduct an assessment of dietary risks
associated with the consumption of produce and processed foods
treated with pesticides.  This assessment shall integrate adequate
data on acute effects and the mandatory health effects studies
specified in subdivision (c) of Section 13123, appropriate dietary
consumption estimates, and relevant residue data based on the
department's and the State Department of Health Services' monitoring
data and appropriate field experimental and food technology
information to quantify consumer risk.  Differences in age, sex,
ethnic, and regional consumption patterns shall be considered.  The
department shall submit each risk assessment to the State Department
of Health Services, with necessary supporting documentation, for peer
review, which shall consider the adequacy of public health
protection.  The State Department of Health Services may provide
comments to the department.  The department shall formally respond to
all of the comments made by the State Department of Health Services.
  The department shall modify the risk assessment to incorporate the
comments as deemed appropriate by the director.  All correspondence
between the department and the State Department of Health Services in
this matter shall be made available to any person, upon request,
pursuant to the California Public Records Act (Chapter 3.5
(commencing with Section 6250) of Division 7 of Title 1 of the
Government Code).
   (b) The department shall consider those pesticides designated for
priority food monitoring pursuant to Section 12535 and the results of
the department's or the State Department of Health Services'
monitoring in establishing priorities for the dietary risk
assessments.
   (c) (1) If the department lacks adequate data on the acute effects
of pesticide active ingredients or mandatory health effects studies
specified in subdivision (c) of Section 13123 necessary to accurately
estimate dietary risk, the department shall require the appropriate
data to be submitted by the registrant of products whose labels
include food uses.  This subdivision shall not be construed to affect
the timeframes established pursuant to Section 13127.
   (2) No applicant for registration, or current registrant, of a
pesticide who proposes to purchase or purchases a registered
pesticide from another producer in order to formulate the purchased
pesticide into an end use product shall be required to submit or cite
data pursuant to this section or offer to pay reasonable
compensation for the use of any such data if the producer is engaged
in fulfilling the data requirements of this section.
   (d) (1) If a registrant fails to submit the data requested by the
director pursuant to this section within the time specified by the
director, the director shall issue a notice of intent to suspend the
registration of that pesticide.  The director may include in the
notice of intent to suspend any provisions that are deemed
appropriate concerning the continued sale and use of existing stocks
of that pesticide.  Any proposed suspension shall become final and
effective 30 days from the receipt by the registrant of the notice of
intent to suspend, unless during that time a request for hearing is
made by a person adversely affected by the notice or the registrant
has satisfied the director that the registrant has complied fully
with the requirements that served as a basis for the notice of intent
to suspend.  If a hearing is requested, a hearing shall be conducted
pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of
Division 3 of Title 2 of the Government Code.  The only matter for
resolution at the hearing shall be whether the registrant has failed
to take the action that served as the basis for the notice of intent
to suspend the registration of the pesticide for which additional
data is required and whether the director's determination with
respect to the disposition of existing stocks is consistent with this
subdivision.
   (2) A hearing shall be held and a determination made within 75
days after receipt of a request for a hearing.  The decision rendered
after completion of the hearing shall be final.  Any registration
suspended shall be reinstated by the director if the director
determines that the registrant has complied fully with the
requirements that served as a basis for the suspension of the
registration.
   (e) If the department finds that any pesticide use represents a
dietary risk that is deleterious to the health of humans, the
department shall prohibit or take action to modify that use or modify
the tolerance pursuant to Section 12561, or both, as necessary to
protect the public.
13135.  The department and the State Department of Health Services
shall jointly review the existing federal and state pesticide
registration and food safety system and determine if the existing
programs adequately protect infants and children from dietary
exposure to pesticide residues.  The review shall commence as early
as possible in 1990, so that any policy or administrative adjustments
determined to be necessary as a result of the joint review can be
made on a timely basis.  The department shall consult with the
University of California and other qualified public and private
entities in conducting the joint review.  The joint review shall
continue for a sufficient time in order to evaluate the report of
infant exposure to pesticide residues, which is presently being
undertaken by the National Academy of Sciences.  Within six months of
the official release of the National Academy of Sciences' study, the
department shall finalize a report describing the evaluation that
was conducted pursuant to this section, including any recommendations
for modification of the existing regulatory system in order to
adequately protect infants and children.