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

Department of Pesticide Regulation


James W. Wells, Director
1020 N Street - Sacramento, California 95814-5624 - www.cdpr.ca.gov

   
  California Notice 98-5

California State Seal
Pete Wilson
Governor

TO: ALL PESTICIDE REGISTRANTS

SUBJECT: EMERGENCY REGULATION REGARDING CRITICAL AND SEMICRITICAL MEDICAL DEVICE LIQUID CHEMICAL STERILANTS

Effective March 9, 1998, an emergency regulation exempted certain liquid chemical sterilants from the requirement to be registered in California. The criteria are outlined below.

The Office of Administrative Law accepted as an emergency regulation the adoption of section 6146 in Title 3 of the California Code of Regulations (CCR) (enclosed). CCR section 6146 implements Food and Agricultural Code (FAC) section 12804 (Chapter 530, Statutes of 1997).

CCR section 6146 establishes that manufacturers of, importers of, and dealers in liquid chemical sterilant products (including any such products with subordinate disinfectant claims) intended for use on critical or semicritical medical devices are exempt from the requirements of FAC Division 7. As a result, critical and semicritical medical device liquid chemical sterilants are no longer required to be registered with the Department of Pesticide Regulation (DPR) prior to sale and/or use in California, provided the products meet the criteria specified in
CCR section 6146(b)(1)-(3).

The terms "critical medical device" and "semicritical medical device" are defined in CCR section 6146(a). The U.S. Environmental Protection Agency's Pesticide Regulation (PR) Notice 98-2 establishes that tuberculocidal or virucidal claims which support a high level disinfectant use pattern are an example of a "subordinate disinfectant claim" for a critical or semicritical medical device.

DPR retains jurisdiction over: (1) products not bearing sterilant claims, regardless of the use site; (2) any gaseous chemical sterilant, regardless of the use site and any other type of chemical sterilant that is distributed and sold in a non-liquid form, even if in use it will be in a liquid form; and (3) liquid chemical sterilants intended solely for use on devices, surfaces, and objects other than critical or semicritical medical devices.

DPR's exemption of critical and semicritical medical device sterilants is consistent with U.S. EPA's exemption of such products as described in PR Notice 98-2, with one exception. Critical and semicritical medical device liquid chemical sterilants are no longer defined federally as pesticides; however, these products are still pesticides under California law.

Implementation:

1. New products with only FDA-regulated claims.

DPR will no longer accept applications for registration of liquid chemical sterilants bearing sterilant only or sterilant and subordinate disinfectant claims for use solely on critical or semicritical medical devices that meet the criteria of CCR section 6146(b)(1)-(3).

2. Pending applications for products with only FDA -regulated claims.

Each applicant with an application for registration pending at DPR for a chemical sterilant bearing sterilant only or sterilant and subordinate disinfectant claims for use solely on critical or semicritical medical devices that meets the criteria of CCR section 6146(b)(1)-(3) should inform DPR in writing. The letter should be addressed to the contact person listed below. If DPR agrees that the product label only bears FDA-regulated claims, DPR will administratively withdraw the application from the registration process.

3. Pending applications for registration for products with mixed claims.

Each applicant with an application for registration pending at DPR for a liquid chemical sterilant bearing both U.S. EPA and FDA regulated claims
should inform DPR in writing. The letter should be addressed to the contact person listed below. DPR will administratively withdraw the application from the registration process. Applicants may reapply for registration in California when they have complied with the requirements of PR Notice 98-2 and have received U.S. EPA approval for a revised label bearing only U.S. EPA regulated claims. A new application, U.S. EPA approved label, and fee will be required at that time.

4. Registered products with only FDA-regulated claims.

Each registrant of a liquid chemical sterilant bearing sterilant only or sterilant and subordinate disinfectant claims for use solely on critical or semicritical medical devices that meets the criteria of CCR section 6146(b)(1)-(3) should request voluntary withdrawal of the product's registration. The request for voluntary withdrawal of the product's registration should be addressed to the contact person listed below. If DPR agrees that the product label only bears FDA-regulated claims, DPR will administratively withdraw the product's registration.

5. Registered products with mixed claims.

Registrants must comply with the requirements of U.S. EPA's PR Notice 98-2 with regard to such products. Once a registrant has received U.S. EPA approval for a revised label bearing only U.S. EPA regulated claims, that amended label must immediately be submitted to DPR for approval.

Please address all correspondence to: Mr. Jerome Campbell, Supervisor of Registration, Pesticide Registration Branch, Room 332, Department of Pesticide Regulation, Sacramento, California 95814. If you have any questions, please contact Mr. Campbell, by E-mail at (jcampbell@cdpr.ca.gov) or by telephone at (916) 324-3889.


original signed by Barry Cortez


May 20, 1998


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

Date


California Environmental Protection Agency