AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

	

July 17 - 19, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2007-0186

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington,VA 22202

Guidance on Test Methods for Demonstrating the Efficacy of Antimicrobial
Products for Inactivating Bacillus anthracis Spores on Environmental
Surfaces

Tuesday, July 17, 2007

8:30 A.M.	Introduction and Identification of Panel Members -  Steven G.
Heeringa, Ph.D. (FIFRA SAP Chair)  

8:40 A.M.	Administrative Procedures by Designated Federal Official - Mr.
Joseph E. Bailey, Office of Science Coordination and Policy, EPA

8:45 A.M.	Welcome and Opening Remarks – Debbie Edwards, Ph.D.,
Director, Office of Pesticide Programs, EPA

8:50 A.M.	Introduction and Background - Jeff Kempter, Antimicrobials
Division, Office of Pesticide Programs, EPA 

9:15 A.M	Sporicidal Activity of Disinfectants (AOAC Method 966.04)  -
Stephen Tomasino, Ph.D., Microbiology Laboratory Branch, Biological and
Economic Analysis Division, EPA 

10:00 A.M.	Break

10:15 A.M	Overview of Lab-Scale Quantitative Test Methods for Sporicidal
Decontamination Agents - Stephen Tomasino, Ph.D., Microbiology
Laboratory Branch, Biological and Economic Analysis Division, EPA 

11:00 A.M	Quantitative Test Methods for Evaluation of Sporicidal
Fumigants in Relation to Military-relevant Material Surfaces – Vipin
Rastogi, Ph.D., Edgewood Chemical and Biological Center (ECBC),
Department of Defense

11:30 A.M.	EPA's Proposed Measure of Success for Quantitative Sporicidal
Efficacy Test Results - Marty Hamilton, Ph.D., University of Montana 

12:00 P.M.	Lunch

1:15 P.M.	Coupon Materials for Lab-Scale Quantitative Test Methods for
Sporicidal Decontamination Agents - Stephen Tomasino, Ph.D.,
Microbiology Laboratory Branch, Biological and Economic Analysis
Division, EPA 

2:00 P.M.	Surrogate Selection and Attributes for Bacillus anthracis
Spores- Stephen Tomasino, Ph.D., Microbiology Laboratory Branch,
Biological and Economic Analysis Division, EPA 

2:45 P.M.	Break

3:00 P.M.	Molecular Differentiation of Virulent Bacillus anthracis from
Avirulent  Related Surrogate Strains - Vipin Rastogi, Ph.D., Edgewood
Chemical and Biological Center (ECBC), Department of Defense  

3:30 P.M.	NHSRC Research on Decontamination of Bacillus anthracis and
Surrogate Spores on Building Material Surfaces - Joe Wood, M.S., P.E.,
and Shawn Ryan, Ph.D., National Homeland Security Research Center, EPA  

4:30 P.M.	Simulated Use Test - Michele Wingfield, Antimicrobials
Division, Office of Pesticide Programs, EPA 

5:00 P.M. 	Adjournment

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

	

July 17 - 19, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2007-0186

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington,VA 22202

Guidance on Test Methods for Demonstrating the Efficacy of Antimicrobial
Products for Inactivating Bacillus anthracis Spores on Environmental
Surfaces

Wednesday, July 18, 2007

8:30 A.M.	Introduction and Identification of Panel Members - 

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)  

8:40 A.M.	Administrative Procedures by Designated Federal Official - 

		Mr. Joseph E. Bailey, Office of Science Coordination and Policy, EPA

8:45 A.M.	Public Comments

10:00 A.M.	Break

10:15 A.M.	Charge to Panel - Issue 1

Whether a sterilant or sporicide product may claim that it inactivates
B. anthracis spores on inanimate surfaces. 

EPA’s existing efficacy testing guidance specifies that a product that
passes the AOAC Sporicidal Activity of Disinfectants test (AOAC Official
Method 966.04) may be registered as a sterilant/sporicide.  The Agency
is now proposing that a sterilant/sporicide may also bear a claim that
it inactivates B. anthracis spores if it passes confirmatory testing
using the AOAC 966.04 with virulent B. anthracis spores on carriers made
of porcelain penicylinders and silk loops, which represent nonporous and
porous surfaces, respectively.  

The rationale for EPA’s position is that the AOAC Method and
associated EPA performance criteria (e.g., no growth from any carriers
tested) have been required historically by EPA for evaluating the
performance of sporicidal chemicals for regulatory purposes.  The AOAC
Method specifies the use of two spore-forming microbes, B. subtilis and
Clostridium sporogenes; however, the Agency believes that the method is
also suitable for testing spores of other spore-forming bacteria such as
B. anthracis.  The Agency has recognized deficiencies in the AOAC 966.04
Method and has improved the procedure through the official AOAC
modification process – the modifications appear in AOAC 966.04 Method
II. The Agency strongly prefers the use of the Method II to support the
registration of sterilants/sporicides and for confirmatory testing of B.
anthracis.  In addition, the Agency has successfully revised the method
editorially (see Method II), thus providing a more standardized protocol
for use by stakeholders.  The modifications are presented in AOAC 966.04
Method II.  See Reference 1 for the entire method; see References 2 and
3 for experimental details.  

Charge Question 1:  Please comment on the scientific basis that
confirmatory testing of a sporicide/sterilant using AOAC Method 966.04
with virulent B. anthracis spores demonstrates that a product
inactivates B. anthracis spores on inanimate surfaces.

11:15 A.M.	Charge to Panel - Issue 2

Whether a sporicidal decontaminant product may claim that it inactivates
B. anthracis spores on inanimate surfaces, when tested solely with AOAC
Method 966.04 using virulent B. anthracis spores.

The Agency is proposing that an antimicrobial product may be registered
as a “sporicidal decontaminant” if it is tested with the AOAC Method
966.04 using virulent Bacillus anthracis spores (instead of B. subtilis
or C. sporogenes), or using a surrogate acceptable to EPA, on porcelain
penicylinders and/or silk loops, which represent nonporous and porous
surfaces, respectively.  The Agency’s rationale is consistent with the
use of the AOAC 966.04 method for sterilant/sporicidal agents; however,
the Agency will not require registrants to conduct the entire AOAC
Method 966.04 to support a sporicidal decontaminant claim.  The Agency
believes that product efficacy against spores of C. sporogenes, an
anaerobic spore-forming species relevant to clinical environments, has
limited applicability to decontamination scenarios involving spores of
B. anthracis, and thus testing against C. sporogenes will not be
required.  Furthermore, the registrant will be allowed to test against
porcelain and/or silk loops (which represent nonporous and porous
surfaces, respectively) depending on the proposed claims.  Continued use
of EPA product performance criterion (e.g., no growth from any carriers
tested) is appropriate for testing the efficacy of sporicidal
decontaminants against spores of Bacillus anthracis. 

Charge Question 2:  Please comment on the scientific basis that use of
the AOAC Method 966.04 with virulent B. anthracis spores demonstrates
that a sporicidal decontaminant product inactivates B. anthracis spores
on inanimate surfaces.

12:15 P.M.	Lunch

1:30 P.M.	Charge to Panel - Issue 3

Whether a six (6) log (log10) reduction is an adequate measure of
success when employing a well developed, quantitative sporicidal
efficacy test.

The Agency is proposing that an antimicrobial product may be registered
as a “sporicidal decontaminant” if it is tested using a well
developed, quantitative sporicidal test method acceptable to EPA using
virulent  Bacillus anthracis spores  (or a surrogate acceptable to EPA)
on nonporous and/or porous inanimate surfaces and the testing of the
product achieves at least a six (6) log reduction (or a minimum 1 x 106 
spores per carrier)  of virulent B. anthracis spores (or a surrogate
acceptable to EPA).  The use and adoption of standardized quantitative
methods for testing the performance of sporicidal decontaminants for
regulatory purposes is supported by EPA.  The AOAC Method 966.04 is a
qualitative procedure (i.e., provides only positive/negative or
pass/fail results).  Quantitative procedures provide an estimate of
actual spore kill, usually based on the log10 scale, and can be adapted
for multiple product formulations and carrier materials.  Several
well-developed quantitative procedures are available for use.  The
Agency believes that a performance standard for quantitative
laboratory-based assays is essential to establishing consistent product
efficacy under actual decontamination scenarios in the field.  The
proposed 6 log reduction performance standard is a scientifically valid
and rigorous standard.  The standard will give the Agency reassurance
that sporicidal decontaminants when applied per the product’s label
claims are effective against spores of B. anthracis.  

The technical basis of the Agency’s selection of a minimum 6 log
performance standard includes the following: 

(1) the target spore titer currently allowed in AOAC method 966.04
(Method II) is a minimum of 1 x 105 to approximately 1 x 106 spores per
carrier) (Reference 1);

(2) the quantitative methods currently available and published can
reliably generate control carrier spore titers necessary to measure a 6
log reduction (for examples of quantitative methods, please see the
following:  ASTM E 2111-05 (Reference 4); Standard Quantitative Disk
Carrier Test Method, ASTM E 2414-05: Standard Test Method for
Quantitative Sporicidal Three-Step Method (Reference 5); Standard
Quantitative Carrier Test Method, ASTM E 2197-02 (Reference 6); and also
References 7 and 8); 

(3) a minimum 6 log reduction in viable spores has been measured for
commercially available sporicidal agents and technologies designed for
treating sites contaminated with B. anthracis (see References 9-13); and


(4) environmental sampling pre- and post-application of the sporicidal
decontaminant will determine the need for re-treatment.

Charge Question 3:  Please comment on the scientific basis that
achieving a six (6) log reduction using a well developed, quantitative
sporicidal test method demonstrates that a product inactivates B.
anthracis spores on inanimate surfaces.

2:30 P.M.	Break

2:45 P.M.	Charge to Panel - Issue 3.1

What criteria should be used when selecting coupon materials for
quantitative sporicidal tests.

The Agency is proposing to allow only certain nonporous and porous
materials to be used in the quantitative sporicidal tests based on
specific criteria.  The rationale for EPA’s position is that in order
to achieve reproducible results across laboratories, and to ensure that
test materials are suitable to support a particular claim (i.e.,
material type to be treated), basic criteria should be established.  The
EPA also recognizes that the nature of the test material may impact
product performance.  The criteria that EPA intends to establish for the
selection of carriers and carrier materials  include the use of
standardized materials (e.g., quality, grade and consistency), relevancy
of materials to the use site, material availability, data on spore
recovery, ability to clean and sterilize prior to inoculation, and
potential for interaction with the product’s active ingredients.  

Charge Question 3.1:  Please comment on the EPA’s criteria for
selecting coupon materials to represent nonporous and porous surfaces in
quantitative sporicidal efficacy tests.

3:45 P.M.	Charge to Panel - Issue 4  

Whether a surrogate Bacillus species of spores may be used in place of
Bacillus anthracis spores in sporicidal efficacy tests.  

The Agency is proposing to allow certain surrogate, avirulent Bacillus
species to be used in place of virulent Bacillus anthracis spores for
either qualitative or quantitative sporicidal efficacy tests based on
specific criteria.  Surrogate spores should have certain desirable
attributes and be acceptable to EPA.  The use of safe-to-handle
surrogates of virulent B. anthracis spores is supported by the EPA.
Surrogates are frequently used as models or representatives for virulent
strains of pathogens such as B. anthracis Ames.  Federal restrictions
and bio-safety issues limit the number of labs capable of testing select
agents.  Cost, time and resources required for managing studies on
virulent B. anthracis spores are also limiting factors.  Certain
criteria should be met in order for a surrogate to be utilized in the
efficacy testing of sporicidal decontaminants.  To be an acceptable
surrogate, a Bacillus spore species should generally be as resistant or
more resistant to inactivation by a particular chemical on a particular
surface than B. anthracis spores.  

To demonstrate equivalent resistance of the surrogate spore type to the
virulent agent, a comparative efficacy study should be performed using a
well-developed/validated quantitative methodology appropriate for the
test chemical and microbe to measure resistance.  Testing should be
conducted in accordance with the potential product claim.  Replicated
studies with adequate controls and with side-by-side, parallel test
designs are desirable.  It is also desirable to compare carriers with
comparable spore populations.  The same sporulation media should be
utilized for all test microbes.  Percent recovery of spores from
carriers should be determined in advance. The strain of B. anthracis
used in the study should be verified as a pathogenic strain.  Examples
of acceptable and relevant surrogate studies are provided in References
7 and 8.   Pre-existing data may be appropriate to support the use of a
surrogate as well. 

Charge Question 4:  Please comment on the desirable attributes for
selecting surrogate Bacillus species for Bacillus anthracis in either
qualitative or quantitative sporicidal efficacy tests.

5:00 P.M.	Adjournment

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

	

July 17 - 19, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2007-0186

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington,VA 22202

Guidance on Test Methods for Demonstrating the Efficacy of Antimicrobial
Products for Inactivating Bacillus anthracis Spores on Environmental
Surfaces

Thursday, July 19, 2007

8:30 A.M.	Introduction and Identification of Panel Members - 

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)  

8:40 A.M.	Administrative Procedures by Designated Federal Official - 

		Mr. Joseph E. Bailey, Office of Science Coordination and Policy, EPA

8:45 A.M.	Charge to Panel - Issue 5

Whether gas or vapor products should be subjected to a “simulated use
test.”

The Agency is proposing that gas or vapor sterilants, sporicides and
sporicidal decontaminants be subjected to a “simulated use test” for
gas or vapor products intended for use in large, enclosed spaces.  The
rationale for EPA’s position is that efficacy testing performed in the
laboratory does not necessarily demonstrate that a product will perform
satisfactorily when applied in a large, enclosed space.   Many factors
can reduce the effectiveness of a gas or vapor product, such as
inadequate distribution, breakdown by light, and absorption/breakdown by
porous or reactive surfaces.  Accordingly, EPA believes that a simulated
use test is needed to demonstrate that a gas or vapor product will
perform successfully in a large volume of space (e.g, a typical office).
 In addition, such a test should include monitoring to assure that key
parameters (e.g., temperature, relative humidity, concentration) for an
effective fumigation will be met.

Charge Question 5:  Please comment on the scientific basis for
conducting a “simulated use test” for a gas or vapor product
intended for use in large, enclosed spaces.

10:00 A.M.	Break

10:15 A.M.	Continued Panel Discussion (as needed)

12:00 P.M.	Lunch

1:15 P.M.	Continued Panel Discussion (as needed)

2:45 P.M.	Break

3:00 P.M.	Continued Panel Discussion (as needed)

5:00 P.M.	Adjournment

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin. 
For further information, please contact the Designated Federal Official
for this meeting, Mr. Joseph Bailey, via telephone:  (202) 564-2045;
fax:  (202) 564-8382; or email: bailey.joseph@epa.gov

