EPA Posts Revised Draft OCSPP 810 Series Test Guidelines
Posted on: June 15, 2015
What you need to know about the proposed changes to OCSPP 810 Series Test Guidlines
The EPA posted the long-awaited draft revisions to the Office of Chemical Safety and Pollution Prevention (OSCPP) Product Performance 810 Series Test Guidelines. These proposed guidelines outline the requirements for testing antimicrobial agents for registration with the EPA. The EPA has revised three of the eight 810 Series Test Guidelines:
- 810.2000: General Considerations for Testing Antimicrobial Agents
- 810.2100: Sterilants & Sporicides
- 810.2200: Disinfectant for Use on Hard Surfaces
The draft guidance documents, currently released for review and public comment, will ultimately be published in the Federal Register.
As expected, the EPA has done a superb job in revising the guidelines to consolidate redundant information, include missing policy information and format the documents for easier reading and understanding. Currently in draft form, the EPA has stated that there will be a 90 day public comment period. Accuratus will take an active role with industry to provide thorough review of and comments on the proposed changes.
Accuratus Lab Services technical personnel have performed an initial review of the draft revisions and have outlined some of the significant proposed changes to each of the three guidelines below.
Proposed Changes to 810.2000: General Considerations for Testing Antimicrobial Agents
- The Confirmatory Data Requirements section has been removed from the 810.2100 and 810.2200 guidelines and added to 810.2000.
- The draft Lower Certified Limits (LCL) testing guidance published December 6, 2013 has been incorporated into the test guidelines. The draft LCL testing requirements remain unchanged with the exception that Carbapenem-resistance Enterobacteriaceae (CRE) organisms are no longer required to be tested at the LCL.
- The option of performing the Hard Surface Carrier Test to substantiate disinfectant claims for products diluted in distilled water has been removed.
- The EPA has imposed a minimum of 200 ppm hardness level for a hard water claim. The use of deionized water to dilute concentrated products is not recommended unless the product label specifically specifies deionized water. For concentrated products that do not bear a hard water claim, the dilution should be made in sterile tap water and the hardness of the tap water should be reported.
- The allowance to shorten the exposure time under batch replication for modified testing has been removed.
- A repeat testing policy for the allowable levels of contamination in a test has been added. If an unacceptable contamination level is present and the efficacy of the product met the required performance standard, the test may be repeated under the same test conditions. If the product did not meet the required performance standard and had contamination, the product would be considered a failure and repeat testing would not be performed.
- The requirements for antimicrobial fruit and vegetable rinse testing have been removed.
Proposed Changes to 810.2100: Sterilants & Sporicides
- Liquid products applied as a spray using a pump or trigger sprayer should be tested as a liquid. A protocol should be submitted to the EPA for review prior to testing aerosols and other formulations such as mists, foams and gels.
- Specific Clostridium difficile testing guidance has been removed from the document and replaced with a link to the EPA website which outlines the current testing requirements.
- An exposure time of ≤ 20 seconds at ≤ 80°C has been added for products with claims to inactivate spores on hard, non-porous, inanimate surfaces for aseptic packaging.
Proposed Changes to 810.2200: Disinfectants for Use on Hard Surfaces – Efficacy Data Recommendations
- The allowable contamination rate of one carrier per 60 carrier test sets has been added. No contamination is allowed for ten carrier assays (confirmatory and additional microorganisms).
- For fungicidal testing, the product should be tested at the LCL.
- The requirement for testing a ≥60 day old batch of test substance has been removed throughout the document as this has been replaced by testing at the LCL.
- The requirement for testing each test substance batch on independent test dates for the AOAC Use Dilution test has been added to match the current method revision.
- The current performance standard for the AOAC Use Dilution test has been added.
- The allowance for wiping one carrier with the surface area equivalent to ten 1 x 1 inch carriers for towelette testing has been removed.
- Viral claims for bridging of an existing EPA-registered liquid to towelette can be supported for all viruses on the label by testing the most resistant virus on the existing product label.
For more information regarding the proposed changes or antimicrobial testing in general, please contact Karen Ramm, Market Development & Technical Director for Antimicrobials.