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Peter M. Rooney
Secretary for
Environmental
Protection
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Department of Pesticide Regulation
James W. Wells, Director
830 K Street - Sacramento, California 95814-3510 - www.cdpr.ca.gov
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Pete Wilson
Governor
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CONCURRENT SUBMISSION OF PESTICIDE PRODUCTS TO THE U.S. ENVIRONMENTAL PROTECTION AGENCY AND
THE DEPARTMENT OF PESTICIDE REGULATION
Effective January 1, 1999, the Department of Pesticide Regulation (DPR) will accept submission of the following
types of registration requests, prior to federal registration by the U.S. Environmental Protection Agency (U.S.
EPA):
1. Requests to register new "antimicrobial pesticides" (federal definition enclosed)
that are intended to control pests that pose a threat to human health and requests to amend registered "antimicrobial
pesticides" if the amendment adds a use to the product label to control pests that pose a threat to human
health; and
2. Requests to register new "public health pesticides" (federal definition enclosed)
and requests to amend registered pesticides if the amendment adds a public health use to the product label.
For purposes of this notice, a "public health pesticide" is a minor use pesticide that is labeled for
use in a public health program or is used predominately in a public health program by a public health agency. For
example, a mosquito control product used by a mosquito abatement district or a rat control product used by a county
health agency. The term "public health pesticide" does not include products intended for use by homeowners.
If the "public health pesticide" is not labeled for use by a public health agency, the applicant must
submit documentation from a public health agency of how the agency uses the product in California.
With this notice, DPR implements the requirements of Food and Agricultural
Code (FAC) section 12836 (enclosed). In compliance with FAC section 12836, and as resources allow, DPR will strive
to review the following types of submissions concurrently in time with the review conducted by the U.S. EPA: (1)
requests to register new pesticide products meeting the criteria of #1 and #2 above, that also either: (i) contain
a new active ingredient; or (ii) list a public health threat use for which there are no effective alternatives
to control the public health pest; and (2) requests to amend registered pesticide products meeting the criteria
of #1 and #2 where the label amendment adds a public health threat use for which there are no effective alternatives.
The applicant must provide documentation that no effective alternatives exist.
DPR also accepts the following types of registration requests prior to federal registration or the federal
issuance of experimental use permits by U.S. EPA:
3. Requests to register new products containing microbial or biochemical active ingredients.
4. Requests to amend the label of registered products containing microbial active ingredients to add a new pest
and/or site.
5. Requests to register new products designated by U.S. EPA as "reduced risk."
6. Requests to register or amend experimental use products.
WHEN TO SUBMIT AN APPLICATION FOR CONCURRENT REVIEW
With one exception, applicants may submit registration requests for the types of pesticide products described above
to DPR at the same time as they submit a request to U.S. EPA for federal review. The only exceptions are new pesticide
products designated as "reduced risk." Applications for registration of "reduced risk pesticides"
can only be submitted to DPR after U.S. EPA determines that the product fits their reduced risk criteria. Applicants
must provide DPR with documentation of U.S. EPA's "reduced risk" determination.
Please clearly note in the cover letter accompanying each registration request that the product is not yet federally
registered and indicate which of the above criteria the product meets.
For the most part, DPR reviews concurrent submissions in the order received, along with all other applications
for registration of pesticide products. The acceptance of registration requests prior to federal registration or
issuance
of a federal experimental use permit is not a reduction in any of DPR's data requirements. All required data
and information must still be submitted with the registration request. After federal registration, it is the
applicant's responsibility to submit a copy of U.S. EPA's registration letter, the U.S. EPA stamped-accepted label,
and any additional data submitted to U.S. EPA. California registration of the product will not be granted until
U.S. EPA's stamped approved label and accompanying letter are received and the label is accepted by DPR.
If you have any questions, please contact Ann Prichard, Senior Environmental Research Scientist, Pesticide Registration
Branch, at (916) 324-3931.
Sincerely,
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original signed by Barry Cortez
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12/18/98
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Barry Cortez, Chief
Pesticide Registration Branch
(916) 445-4377 |
Date
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California Environmental Protection Agency
Federal Definitions for the Terms "Antimicrobial Pesticide,"
"Public Health Pesticide," and "Minor Use"
"Antimicrobial Pesticide" - means a pesticide that: (a) is intended to
(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances
from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(b) in the intended use is exempt from, or otherwise not subject to, a tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a food additive regulation under section 409 of such Act.
[7 U.S.C. 136(mm)]
"Public Health Pesticide" - means any minor use pesticide product registered for use and used
predominantly in public health programs for vector control or for other recognized health protection uses, including
the prevention or mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other
microorganisms on or in living man or other living animal) that pose a threat to public health. [7 U.S.C. 136(nn)]
"Minor Use" - means the use of a pesticide on an animal, on a commercial agricultural crop or
site, or for the protection of public health where -
(1) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of
Agriculture; or
(2) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information
provided by an applicant for registration or a registrant, the use does not provide sufficient economic incentive
to support the initial registration or continuing registration of a pesticide for such use and--
(A) there are insufficient efficacious alternative registered pesticides available for the use;
(B) the alternatives to the pesticide use pose greater risks to the environment or human health;
(C) the minor use pesticide plays or will play a significant part in managing pest resistance; or
(D) the minor use pesticide plays or will play a significant part in an integrated pest management program.
[7 U.S.C. 136(ll)]
Food and Agricultural Code section 12836:
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.