Department of Pesticide Regulation Logo 
Peter M. Rooney
Secretary for
Environmental
Protection

Department of Pesticide Regulation


James W. Wells, Director
830 K Street - Sacramento, California 95814-3510 - www.cdpr.ca.gov

 

California Notice 98-7

 

POST UNTIL January 25, 1999

California State Seal
Pete Wilson
Governor

NOTICE OF FINAL DECISION CONCERNING
REEVALUATION OF PESTICIDE PRODUCTS

The Director of the Department of Pesticide Regulation (DPR) files this notice
with the Secretary of the Resources Agency for posting pursuant to Title 3,
Articles 8 and 12 of the California Code of Regulations (CCR). The CCR requires the Secretary of the Resources Agency and DPR to post this notice for 30 days for public inspection.

REEVALUATION

DPR commenced reevaluation of seven registered pesticide products containing one or more of the following active ingredients: (1) potassium orthobenzyl para-chlorophenate; (2) potassium para-tertiary-amylphenate; (3) sodium dodecyl benzene sulfonate; and (4) potassium orthophenylphenate on December 6, 1993. Only products that bore label claims of effectiveness as a tuberculocide were placed into reevaluation.

BASIS OF REEVALUATION

DPR initiated the reevaluation based on adverse effects data submitted on a product containing potassium orthobenzyl para-chlorophenate, potassium para-tertiary-amylphenate, sodium dodecyl benzene sulfonate, and potassium orthophenylphenate. The data indicated that the product was ineffective as a tuberculocide.

Based upon that data, DPR became concerned that other products containing the same active ingredients may also be ineffective as tuberculocides. A search of the database indicated that ten other products contained one or more of the four active ingredients and bore label claims stating that the product was effective as a tuberculocide.

After reviewing the data submitted to support the registrations of the ten products, DPR found the database to be inadequate to determine whether seven of the products would be effective as a tuberculocide.

SUMMARY OF REEVALUATION

DPR placed all seven products into reevaluation and required the registrants of the products to submit efficacy data, including tuberculocidal data derived from two different batch samples tested against Mycobacterium tuberculosis in the presence of five percent serum. The registrants of four products immediately withdrew the registrations of their products, while the registrants of the other three products submitted data. Eventually, the registrants of two of the remaining products also withdrew the registrations of their products, including the registration of the product for which the adverse effects data had been submitted.

Of the products originally placed into reevaluation, only one remains registered for use in California. The remaining product is Legphene Germicidal Cleaner, EPA Reg. No. 2212-5-AA. The registrant responded to the reevaluation by submitting efficacy data for several of the organisms listed on the product label. Additionally, the registrant requested approval for amendments to the product label. The registrant submitted efficacy data derived from three lot samples of Legphene Germicidal Cleaner all of which demonstrated that the product was effective against Mycobacterium tuberculosis. One lot sample was tested in the absence of hard water or organic soil (serum). The results of the second lot sample did not describe whether hard water and/or organic soil were included in the test. The third lot sample was tested in the presence of 400 parts per million water hardness and five percent serum.

FINAL REGULATORY DECISION

The submitted data alleviates DPR's concern that the product may not be effective as a tuberculocide. Other concerns with regard to data and labeling issues for the product will be resolved in the course of the registration process for approving the amendment to the product label. Therefore, DPR concludes this reevaluation.


For further information, please contact Ms. Ann Prichard, Senior Environmental Research Scientist, Pesticide Registration Branch, Department of Pesticide Regulation, 830 K Street, 9th-LL, Sacramento, California 95814-3510 or by telephoning (916) 324-3931.



original signed by Barry Cortez


12/17/98


Barry Cortez, Chief
Pesticide Registration Branch
(916) 445-4377

Date


California Environmental Protection Agency