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"For official use only/do not cite or 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)

Pass

53%

Fail

47%

77

86

27

12

Direct Shipment Official Samples

Pass

69%

Fail

31%

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)

Pass

54%

Fail

46%

11

13 27

12

Direct Shipment Official Samples

Pass

50%

Fail

50% 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?