Joan Harrigan-Farrelly Director Office of Pesticide Programs, Antimicrobials Division Office of Chemical Safety and Pollution Prevention

U.S. Environmental Protection Agency

November 15, 2011 

## 2011 UDM/OECD Technical Workshop 

## Post Registration Testing

### • The Antimicrobial Testing Program (ATP) is a postregistration testing and enforcement program that was initiated in 1991. 

### • The ATP was designed to focus on products with the greatest public health impact. • The program for many years was run by having products 

### picked up by the Agency for testing. However, this was a slow process as oft times products that were on the list to be picked up were not in production. 

### • In 2008, EPA sought cooperation with the antimicrobial industry to directly ship products to the Agency and contract laboratories for testing. 

## The Antimicrobial Testing Program (ATP)

## • Historically, actions taken in response to the failures encompassed enforcement and regulatory actions. • With the voluntary shipment that began in 2008/09, the agency moved more towards a regulatory fix, working with companies to bring the products into compliance 

## • "Less than 25% of the failures over the past two years have been resolved with regulatory fixes." • Currently, the Agency has moved towards enforcement to bring the products into compliance. 

# The Antimicrobial Testing Program

## • Direct shipment sample received by the lab • COC initiated • Label and other information sent to AD by lab 

## • AD develops test guidance (“parameters”) • Lab develops study protocol • Sample placed in the queue for testing 

## • Product tested/report developed • Quality Assurance Review of data and report • Report Sent to AD 

## • Selected products tested at second lab (verification) 

# Antimicrobial Testing Program Front End Process

4

## • Direct Shipment -163 Tested for Hospital Disinfection Claim (Staphylococcus aureus and Pseudomonas 

## aeruginosa) 24 Tested for Tuberculocidal Claim

(Mycobacterium bovis) • Official Collection -39 Tested for Hospital Disinfection Claim 

## 8 Tested for Tuberculocidal Claim



## Status of Tested Products Between July 1, 2009- November 7, 2011"For official use only/do not cite or

distribute“ 11/7/11 

### Hospital Disinfectant Test Results for Direct Shipment and Official Samples (July 1, 2009 – November 7, 2011)

77 86 27 12

Direct Shipment Official Samples 12 27 Group Pass Fail Quats 42 53 Hypochlorites 16 2 Peroxides 15 6 Phenolics 3 9 Other 10 7 Total 86 77 Group Pass Fail Quats 20 9 Hypochlorites 1 0 Peroxides 1 0 Phenolics 1 2 Other 4 1 Total 27 12"For official use only/do not cite or

distribute“ 11/7/11 

### Tuberculocide Test Results for Direct Shipment and Official Samples (July 1, 2009 – November 7, 2011)

11 13 27 12

Direct Shipment Official Samples 4 4

Group Pass Fail Quats 3 3 Hypochlorites 2 4 Peroxides 5 0 Phenolics 1 2 Other 2 2 Total 13 11 Group Pass Fail Quats 0 1 Hypochlorites 1 1 Peroxides 1 0 Phenolics 1 1 Other 1 1 Total 4 4"For official use only/do not cite or

distribute“ 11/7/11 

### Chemistry Test Results for Direct Shipment and Official Samples (July 1, 2009 – November 7, 2011)

11

112

Direct Shipment Official Samples 3 36 Group Pass Fail Quats 27 2 Hypochlorites 1 0 Peroxides 1 0 Phenolics 2 1 Other 5 0 Total 36 3 Group Pass Fail Quats 74 8 Hypochlorites 13 2 Peroxides 7 1 Phenolics 5 0 Other 13 0 Total 112 11

## • Last Direct Shipment sample received June 15, 2011 • All samples received under the Direct Shipment Initiative have been tested for hospital claims and formulation chemistry • Close to completing all tuberculocidal testing (3-4 reports outstanding) • Goal = test and report on HD claims in 12 weeks

– Issues with neutralization, unusual test parameters, activation may cause delay 

## • Process improvements

– TB testing is run concurrently with HD claims



### – Test report scanned and available in electronic format

– Collecting internal customer feedback (ISO) 

# Status of Direct Shipment Initiative

9

## • Agency is also evaluating claims for products registered 

## against Clostridium difficile • Increased rate of infections in the hospital environment • Utilize registrant supplied data as the 

## foundation for testing • Interim guidance specifies a six log reduction of spores in 

## ten minutes or less • Products purchased from the marketplace 

## • Five products evaluated to date 

# Other Post-registration Testing Initiatives

### • The intent was that the voluntary shipment program would be a good steward opportunity for industry, and failures could be rectified via a regulatory process. 

### • "Less than 25% of the failures over the past two years have been resolved with regulatory fixes." • As the number indicates, resolution using the regulatory 

### approach was very slow • This time lag was an issue for users, for our Office of Inspector General, for us and for you. 

### • This led to a need for a more strict path forward.



# Regulatory Fix vs. Enforcement

### • In August 2011, a letter was sent to CSPA from OPP’s Deputy Office Director clarifying process changes in the Antimicrobial Testing Program. 

### • Messages included: • Retesting is no longer an option for failed products • Failures are sent directly to OECA for possible enforcement action • The Agency is re-evaluating the UDM Performance Standard 

### • Certain failed products will be held in abeyance until further notice from the Agency • In October 2011, a registrant specific letter was mailed to each registrant explaining the current status of their individual products. 

# Regulatory Fix vs. Enforcement• The IG and GAO paid several visits to OPP to discuss the Antimicrobial Testing Program • In response to the September 24th, 2010, OIG Audit, “EPA Needs to Assure Effectiveness of Antimicrobial Pesticide Products” the Agency developed a corrective action plan which included: • Clarifying the roles and responsibilities of Agency programs • Revising SOPs for the collection of sample products • Establishing a database • Developing amendments to the letters sent to pesticide registrants • Actions to ensure consistent and appropriate enforcement responses • Evaluating the future structure and scope of the ATP 

## The Antimicrobial Testing Program (ATP)• In response to an OIG Audit issued Friday September 24th, 2010, “EPA Needs to Assure Effectiveness of Antimicrobial Pesticide Products”, OPP has undertaken a management effectiveness review, “LEAN Review” with the objective of improving the efficiency and effectiveness of the Antimicrobial Testing Program. • Part of the LEAN Review involved examining the long term structure and scope of the ATP. In this context, OPP has considered the OIG’s recommendation of expanding the ATP to include sanitizers. • The Agency has proposed a pilot study in fiscal year 2012 centered on food contact sanitizer testing. A random sampling of sanitizers purchased from the marketplace will be tested to determine if the products meet the label claim. • The Agency is still considering what the long term future outlook for the ATP should be, and will engage the industry and user community as it deliberates this next step 

## Future of the Antimicrobial Testing Program

# Questions?