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Response to Comments Document 

for the Draft 810.2000 Series Product Performance Guidelines

April 23, 2012

This document summarizes the comments received in response to the draft 

810.2000 Series Product Performance Guidelines for Textiles, Air Sanitizers and Water, 

which were made available for public comment on September 14, 2011, and provides 

the Agency’s responses to those comments. The following groups submitted comments 

to the docket, # EPA-OPP-HQ-2009-0681. They are listed by their assigned docket 

designation.

0020-0028 NSF International

0029 Consumer Specialty Products Association

1. Comments on 810.2400

1.1 Comment (0029):

The commenter deleted the statement “and without prior notice” from the 

sentence “As a guidance document, these guidelines are not binding on either 

EPA or any outside parties, and the EPA may depart from the guidelines where 

circumstances warrant and without prior notice.“ This comment was made for all 

three guidelines.

Agency Response: The Agency disagrees with the deletion. The guidelines are 

non-binding because they are guidelines and not regulations. As such, the 

Agency may choose to depart from the guidelines where circumstances warrant, 

such as in case-by-case situations and without prior notice.

1.2 Comment (0029):

Under the heading “Evaluation of success for limited disinfectant pre-soak 

treatments,” the commenter stated updated criteria should be used for the 

evaluation of success, which is listed as 59 out of each set of 60 carriers.

Agency Response: The commenter provided no other explanation, but the 

Agency believes this comment refers to the EPA’s reassessment of the product 

performance standards for the Use-Dilution Method. These proposed new 

standards would provide a passing result if 57 out of each set of 60 carriers for 

Staphylococcus aureus and 54 out of each set of 60 carriers for Pseudomonas 

aeruginosa are negative for growth The product performance standard for 

Salmonella choleraesuis would remain unchanged This also assumes testing 

each product three times against each test microbe. However, at this time, these 

proposed new standards have not received an independent technical review by 

stakeholders and other federal agencies, and thus are not considered to be 

official changes or final and effective. Therefore, it would be inappropriate to add 

them to the 810.2400 guidelines at this time.

1.3 Comment (0029):
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The commenter has revised the statement “In addition, per the 2009 AOAC 

revisions for the Use-Dilution Method....” to read, “In addition, per the 2009 or the 

latest final versions of the AOAC method for the Use-Dilution Method....” 

Agency Response: The Agency disagrees with the revised language. This 

statement refers to the minimum carrier count that was established in 2009, and 

as such, should remain the way it was written. The Agency will evaluate any 

changes made by the AOAC in the future and will provide additional guidance 

should changes in the guidelines be warranted.

1.4 Comment (0029):

The commenter states that it is important that DIS/TSS 8 be captured in this 810.

Agency Response

 

: The Agency agrees that some of the elements of the 

proposed method for carpet sanitizers (DIS/TSS 8) should be added to the 

810.2400 guidelines. However, the Agency doesn’t believe that the proposed 

method for carpet sanitizers represents the current state-of-the-science for this 

type of application. In addition, in over 30 years, the method has never been 

used to generate data to support a label claim for carpet sanitization. The Agency 

believes applicants should come in for a pre-registration meeting and discuss 

suitable methods to demonstrate label claims for carpet sanitization.

1.5 Comment (0029):

The sections on “Data collection and reporting” and “Data for recommended 

methods” should be removed from 810.2400, 810.2500 and 810.2600 and placed 

in 810.2000.

Agency Response: EPA disagrees with removing the sections on “Data 

collection and reporting” and “Data for recommended methods” from 810.2400, 

810.2500 and 810.2600, and placing the sections in 810.2000. Since each 

guideline is intended for various subjects to be a stand-alone document, it is 

important to retain the sections on “Data collection and reporting” and Data for 

recommended methods” in each individual guideline.

2. Comments on 810.2500 (comments)

2.1 Comment (0029):

The commenter suggested airborne “bacteria” be changed to airborne 

“microorganisms” in the section “Applicability.”

Agency Response: The Agency disagrees with the change. The air sanitizer 

guidelines are for the temporary removal of bacteria, not all microorganisms,

from the air.

2.2 Comment (0029):
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The commenter wants clarification on what is meant by “settle rate.”

Agency Response: The “settle rate” is the rate at which the bacteria, after being 

dispersed into the air, settle to the bottom of the sampling chamber.

2.3 Comment (0029):

The commenter suggested a correction to the statement, “studies to support 

disinfection and sanitization of textiles” to read, “studies to support sanitization of 

air.”

Agency Response: The agency agrees with this comment and the suggested 

change from “studies to support disinfection and sanitization of textiles” to 

“studies to support sanitization of air” will be made.

2.4 Comment (0029):

The commenter suggested changing “methods” to “guidance” in the section 

“Applicability.”

Agency Response: The Agency agrees with the suggested change and will 

revise the wording in the section “Applicability.” There are no methods in 

810.2500; only guidance is provided.

2.5 Comment (0029):

The commenter suggested adding the following text: “For products containing at 

least 5% glycols (triethylene, dipropylene and/or propylene glycols), quantitative 

chemical determinations must be performed, using an air sampling device, to

show the concentration of glycol vapor achieved with the product, used as 

directed, in an enclosed experimental room or chamber.” In addition, under the 

“Evaluation of sanitizer success,” the commenter has suggested adding: For 

products containing at least 5% glycols, the results must show that

adequate vapor concentrations (50% saturation or more) are achieved in the air 

of the test enclosure.

Agency Response: The Agency disagrees with the suggested edits. The Agency 

has historically waived the efficacy data requirements for antimicrobial products 

containing a minimum of 5% glycol as an active ingredient. Historical literature 

from the 1940’s suggests that saturation of enclosed air space with glycol vapors 

could temporarily reduce the number of airborne bacteria when the product was 

used on a continuous basis. The Agency’s 1980 Disinfectant Technical Science 

Section (DIS/TSS) Air Sanitizer guideline makes a note that “Until the proposed 

Product Performance Guidelines are finalized, testing requirements are being 

deferred for products of this type.” Currently, efficacy requirements are satisfied 

by the chemical formula statement showing appropriate glycol content (at least 

5%). 

2.6 Comment (0029):
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The commenter suggested deleting “at least the size of a typical room (e.g., 10ft 

x 10ft x 8ft) from section (d)(1)(A).

Agency Response: The Agency disagrees with the deletion and believes it is 

important to provide the measurements for a typical room or space size for the 

air sanitizer test. 

3. Comments on 810.2600 (Comments)

3.1 Comment (0029):

The commenter requests the following statement be deleted: “The Agency may 

consult with AOAC prior to accepting modifications to their standardized 

methods.” This comment was also made for 810.2400 and 810.2500.

Agency Response: The Agency disagrees with the comment. On a case-by-case 

basis, Agency consultation with a standard setting organization, prior to making 

revisions to their methods, may be warranted. 

3.2 Comment (0029): The commenter suggested addition of “and Sanitizers” to the 

heading “Disinfectants for treating water – efficacy data recommendations.” 

Agency Response: The Agency agrees with the suggested addition and will 

make the change.

3.3 Comment (0029):

What is AD’s authority to review for drinking water?

Agency Response: AD’s authority to review for drinking water comes from the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Disinfection of 

water is a pesticidal claim and therefore drinking water disinfectants are 

regulated as pesticides under FIFRA. The Agency also has the authority to 

regulate drinking water under the Safe Drinking Water Act.

3.4 Comment (0029):

The commenter suggested adding the following text: Evidence must be 

submitted that the chemical intended for use as a drinking water disinfectant is in 

compliance with the EPA’s Office of Drinking Water guidance.

Agency Response: The Agency agrees with the suggested text with one minor 

revision. The text will be revised to read, “Evidence should be submitted that the 

chemical intended for use as a drinking water disinfectant is in compliance with 

EPA’s Office of Drinking Water guidance.” This text will be added to section 

(d)(1) in the 810.2600 guidelines.

3.5 Comment (0029):
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The commenter suggested revising Polio 1 to Poliovirus type 1.

Agency Response: The Agency agrees and will make the suggested revision 

from Polio 1 to Poliovirus type 1.

3.6 Comment (0029):

The commenter suggested adding Rotavirus strain SA-11 (ATCC VR-1565) to 

the recommended strains of Rotavirus.

Agency Response: The Agency agrees with the suggested addition. Rotavirus 

strain SA-11 (ATCC VR-1565) is also an acceptable strain to use for the 

emergency water disinfectant testing.

3.7 Comment (0029):

The commenter makes a note that Poliovirus type 1 (ATCC VR-59) is not an 

attenuated strain of the virus and requires the use of a biosafety level 3 

laboratory. The commenter suggested the use of ATCC VR-1562, the Chat strain 

of Poliovirus, since it is an attenuated strain and only requires the use of a 

biosafety level 2 laboratory. The suggestion was made due to safety concerns.

Agency Response: The Agency agrees with the suggested change to ATCC VR1562 for Poliovirus type 1 due to safety concerns and because VR-59 is currently 

not available from the American Type Culture Collection repository.

3.8 Comment (0029):

The commenter suggested deleting the statement “and should be submitted to 

the Antimicrobials Division for approval prior to initiation of testing” from section 

(d)(3)(i).

Agency Response: The Agency disagrees with deleting the statement. For 

instances when modifications are made to the Guide Standard and Protocol for 

Testing Microbiological Water Purifiers, the Agency believes it is important for the 

applicant to submit these modifications for review to ensure they will support the 

data being generated for a label claim as an emergency drinking water 

disinfectant. 

3.9 Comment (0029):

The commenter suggested adding “and sanitization” to the statement 

“Numerous factors influence the concentrations necessary for disinfection of 

swimming pool water ....” after “disinfection.”

Agency Response: The Agency agrees with the suggested addition of “and 

sanitization” since swimming pool products can be labeled as disinfectants or 

sanitizers.

3.10 Comment (0029):
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The commenter suggested adding the statements “Where a product is shown to 

be slower acting than free chlorine, it may still be acceptable provided that the 

field test results were successful. This is because the field test is more 

representative of the actual application.”

Agency Response: The Agency disagrees with the suggested addition. The 

purpose of this laboratory study is to determine the product’s equivalence to free 

chlorine and the product should act at the same rate as free chlorine. On the 

other hand, the field studies are designed to test the product during actual use

and are intended to represent the product being subjected to potential weather 

conditions and various soils the bathers may introduce into the pool water.

3.11 Comment (0029):

Historically, EPA has allowed (1) efficacy studies on outdoor pools to support 

both indoor and outdoor pool use, and (2) public pool efficacy studies to support 

both residential and public pool use. Alternatively, full size experimental pools 

can be used for field tests. These replicates should share same exposure 

conditions (location, weather, environment, etc.) and simulated bathers use 

should be accomplished by a controlled microbial (Ref. a, b, c) and bather insult 

(Ref d) challenge. Challenge should be made according to bather load capacity 

of the pool and performed in a constant fashion. The test results can be used in 

place of conducting an EUP.

Agency Response: The Agency agrees that (1) efficacy studies conducted on 

outdoor pools can be used to support both indoor and outdoor pool uses, and (2) 

that efficacy studies conducted on public pools can be used to support both

residential and public pool use. Furthermore, full size experimental pools can be 

used for field testing. However, none of these three scenarios negates the need 

for applying for an Experimental Use Permit (EUP). Applicants should apply for 

an EUP prior to conducting the field testing for swimming pool disinfectants and 

sanitizers.

3.12 Comment (0029):

The commenter suggested adding “if needed” to the section which discusses 

bacteriologic monitoring.

Agency Response: The Agency disagrees with the addition of “if needed” to the 

section which discusses bacteriologic monitoring. Bacteriologic monitoring is an 

important parameter in the swimming pool field test.

3.13 Comment (0029):

The commenter suggested revising the statement “A minimum of 144 samples 

should be collected during the test period.” to read, “A minimum of 144 samples 

(72 samples per pool) should be collected during the test period.”

Agency Response: The Agency agrees with the suggested addition and will 

make the change in section (e)(2)(i).
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3.14 Comment (0029):

Under section (e)(2)(ii) of 810.2600, the commenter has changed the statement 

“Field tests should be conducted for an entire swimming season (4 – 12 months)” 

to read, “Field tests should be conducted for an entire swimming season (3 

months).” 

Agency Response: The Agency disagrees with the change. Depending on the 

geographical location of the pool, a swimming season can be 12 months long.

3.15 Comment (0029):

Under section (e)(2)(ii)(E), the commenter suggested adding “or appropriate 

frequency” to the sentence. This is to allow for suspension of testing during 

weekends/holidays. The commenter also suggested adding “considering working 

days” to sections (e)(2)(ii(G) and (e)(2)(ii)(H).

Agency Response: The Agency disagrees with the suggested additions. For field 

testing, monitoring of the pool should occur on a daily basis, and not exclude

weekends when the pool is more likely to have increased use.

3.16 Comment (0020):

The commenter requests further guidance or clarification in section (d)(3) on why 

microbiological water purifiers are included in the guideline if they are exempt 

from registration under the device exemption.

Agency Response: The EPA Guide Standard and Protocol for Testing 

Microbiological Water Purifiers is written to address the testing of three types of 

microbiological water purifiers: ceramic units, halogenated units, and UV units. 

Only the UV units, and the ceramic units if they don’t include a pesticide 

chemical, would be exempt from registration because they are considered to be 

devices. These UV and ceramic units, however, must not be misbranded and are 

subject to the requirements for devices in FIFRA and its regulations.

3.17 Comment (0020): 

The commenter would like the guideline to explicitly state that the appropriate 

procedures in the American National Standards NSF/ANSI 53, NSF/ANSI 55, 

NSF/ANSI 58 and NSF/SNSI 62 are suitable for demonstrating microbiological 

water treatment.

Agency Response: The Agency will add these standards as optional test 

methods in 810.2600 under section (d)(3)(D). 

3.18 Comment (0021):

In addition to the NSF/ANSI standards listed in comment 3.17, the commenter 

has published two certification protocols for microbiological water purifiers –
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protocol P231 and P248. While these two documents are not American National 

Standards, they were created by a consensus process, and they have been 

approved by the same NSF oversight committees that approve the NSF/ANSI 

Standards. NSF P231 uses the EPA Guide Standard for Testing Microbiological 

Water Purifiers for the testing procedure. NSF P248 is for Emergency Military 

Operations Microbiological Water Purifiers, and was developed based on the 

EPA Guide Standard for Testing Microbiological Water Purifiers, in cooperation 

with the US Army Public Health Command. The commenter would like to see 

these two established protocols also included in the 810.2600 guideline as 

appropriate procedures for evaluating microbial treatment efficacy.

Agency Response

 

: Since the EPA Guide Standard and Protocol for Testing 

Microbiological Water Purifiers is the foundation for developing protocols P231 

and P248, the Agency will add them as alternative protocols for evaluating 

microbial treatment efficacy of water purifiers.

3.19 Comment (00150021):

If it is the EPA’s intent to require testing to the EPA Guide Standard for all 

treatment devices currently certified to NSF/ANSI 53 or 58 for Cyst Reduction, or 

to NSF/ANSI 55 for the Class A device claim, then the EPA should consider that 

decision very carefully. It would have a serious impact on the water treatment 

device market.

Agency Response: Devices that only use occlusion (blockage) mechanisms for 

removal of cysts would not require data to be submitted for registration since the 

product, if qualified as a device, would be exempt from registration. 

3.20 Comment (0022):

The commenter would like to see clarification on whether GLP requirements 

would apply to testing of microbiological water purifiers. The testing requirements 

in the EPA Guide Standard for Testing Microbiological Water Purifiers are 

already very expensive, and adding GLP requirements would make the testing 

prohibitively expensive for most purifier vendors.

Agency Response: Yes, the GLP regulations would apply to the testing of 

microbiological water purifiers. According to 40 CFR §160.17(a): “EPA may 

refuse to consider reliable for purposes of supporting an application for a 

research or marketing permit any data from a study which was not conducted in 

accordance with this part.” 40 CFR §160.12 requires with any submitted research 

data “[a] A statement that the study was conducted in accordance with this part; 

[b] A statement describing in detail all differences between the practices used in 

the study and those required by this part; or [c] A statement that the person was 

not a sponsor of the study, did not conduct the study, and does not know whether 

the study was conducted in accordance with this part.” 

3.21 Comment (0023):

The commenter believes that the use of 4-6 micron spheres are not an 

appropriate surrogate for Cryptosporidium and Giardia cysts. During the 
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standards development process for cyst reduction claims, it was found that the 

charge of the surrogate particle, the shape of the particle, the size range of the 

particle, as well as the actual method of sample collection, are critical to the 

accurate and conservative evaluation of the reduction efficiency of size occlusion 

technologies. The commenter strongly recommends that these specifications be 

adopted in the 810.2600 guideline.

Agency Response: The Agency appreciates the work that went into determining 

the described specifications for surrogates for Cryptosporidium and Giardia

cysts. The information regarding cyst reduction claims will be added to section 

(d)(3)(ii)(C) in the 810.2600 guidelines.

3.22 Comment (00150023):

When dealing with size exclusion technologies, Cryptosporidium should be the 

oocyst of choice and not mixed with Giardia.

Agency Response: The Agency disagrees with the comment. The EPA Guide 

Standard and Protocol for Testing Microbiological Water Purifiers does not 

advise mixing Cryptosporidium with Giardia oocysts for size exclusion 

technologies. The Standard states to use both of the above mentioned 

microorganisms separately not as a mixed culture.

3.23 Comment (0023):

The commenter would like to see MS2 coliphage virus allowed as the viral 

challenge organism for size occlusion technologies. MS2 is smaller than 

poliovirus and rotavirus, and much safer and less expensive to work with.

Agency Response: The Agency agrees with the comment and will add MS2 

coliphage virus to be used as an option to using poliovirus and rotavirus. MS2 

coliphage virus is a recognized surrogate for small non-enveloped viruses.

3.24 Comment (0024/0025):

The commenter requests that NSF/ANSI Standard 50-Equipment for Swimming 

Pools, Spas, Hot Tubs and other Recreational Water Facilities be made the 

referenced testing method within OSCPP 810.2600 (e)(1)(i)(2). NSF/ANSI 

Standard 50 certification should replace the requirements within 810.2600 for the 

evaluation of pool/spa products such as: flow through chemical feeder, any 

mechanical or mechanized chemical feeder, any in-line brine/batch type 

electrolytic chemical chlorine (uses NaCl as precursor), bromine (uses BrCl as 

precursor), or other chemical generator of feeding system, as well as process 

equipment such as UV ultraviolet light systems, ozone generation and mixing 

systems, and copper and /pr silver ionizer systems. NSF 50 could also be used 

to evaluate other product technologies such as electro-magnetic and ultra-sonic 

devices.

Agency Response: Although the NSF 50 certification program is very 

comprehensive, the Agency cannot replace the testing methods in 810.2600 with 

NSF Standard 50 because the methods described in (e)(1) and (e)(2) are still 
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appropriate for use in swimming pool and spa water. However, the Agency will 

list the standard as an optional means for determining the disinfection of 

swimming pool and spa water in 810.2600.

3.25 Comment (0026):

The current 810.2600 document appears to lack certain logical and prudent 

evaluation and testing criteria that are a part of NSF 50. Although it does have 

very effective documentation and instructional references for test methods, data 

collection, control, etc. 810.2600 needlessly jeopardizes safety of volunteers 

without confirming product performance, therefore, it misses the mark.

Agency Response: The Agency disagrees with the comment that the swimming 

pool test misses the mark of confirming product performance. The dual purpose 

behind the two part swimming pool tests (AOAC Disinfectants for Swimming 

Pools and the swimming pool field study) is to determine the amount of chemical 

that is equivalent to the amount of available chlorine needed to disinfect a pool 

and to demonstrate the performance of the chemical under actual use. Both 

these studies together confirm the product performance of the chemical.

3.26 Comment (0027/0028):

There are several value added aspects of evaluation and testing from NSF and 

our Certification of products to NSF/ANSI Standard 50, including but not limited 

to, material formulation disclosure and toxicological safety evaluation of materials 

in contact with water; durability and life testing; verification of chemical output or 

output rate and a 3-log kill of microorganisms Enterococcus faecium and 

Pseudomonas aeruginosa. In addition, annual unannounced facility inspections 

to evaluate our NSF Certified manufacturers for changes in product design, 

suppliers, materials and claims as well as a review of the company complaint file 

and other actions taken by NSF during our annual inspections at product 

manufacturing locations. Please strongly consider acceptance of NSF testing and 

certification of products in accordance with NSF/ANSI Standard 50 as well as 

NSF’s policy requirements to meet your goals.

Agency Response: The testing and certification associated with NSF/ANSI 

Standard 50 is very extensive and the Agency believes data generated using this 

standard could adequately support label claims for the disinfection or sanitization 

of swimming pool water. However, the Agency cannot specifically direct an 

applicant to undergo testing and certification by NSF because the Agency does 

not endorse one testing laboratory over another. The Agency will, however, list 

NSF/ANSI Standard 50, in 810.2600, as an optional means to support a label 

claim for the disinfection or sanitization of swimming pool water.