### 1 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 response s to those comments. The following groups submitted comments
to the docket, # EPA

- OPP

- HQ

- 2009

- 0681. They are listed by their assigne d 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 Comme nt ( 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 reassessme nt of the product performance standards for the Use

- Dilution Method. These proposed new standards would provide a passing result if 57 out of e ach 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 t o 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 ) :

### 2 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 min imum 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 gu idelines. 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 documen t , 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. 2 5 00 ( 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 ) :

### 3 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 co mmenter 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 “studie s 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, u sed 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 concent rations (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 a ntimicrobial products

c ontaining a mini mum 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, effica cy requirements are satisfied by the chemical formula statement showing appropriate glycol content (at least 5%).

2.6 Comment (0029):

### 4 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. 2 6 00 (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 wit h 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 “Di sinfectants 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 pesticid al claim and therefore drinking water disinfectants are regulated as pesticid es under FIFRA

. T he Agen cy 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 t he 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 ):

### 5 The commenter suggested revising Polio 1 to Poliovirus type 1.

Agency Response : The Agency agrees and will make the suggest ed revision from Polio 1 to Poliovirus type 1.

3.6 Comm ent ( 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 a ttenuated 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 VR

1562 for Poliovirus type 1 due to safety concerns and be cause 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 t esting” from section (d)(3)(i).

Agency Response : The Agency disagrees with delet ing the statement. For

instances when modifications are made to the Guide Standard and Protocol for Testing Microbiological Water Purifiers, the Agency believes it is importa nt for the applicant to submit these modifications for review to ensure they will support the data being generated for a label claim as a n 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 ):

### 6 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 succe ssful. 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 t he 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 microbi al (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 po ols can be used to support both residential and public pool use. Furthermore, full siz e 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 disinf ectants 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 bacte riologic 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).

### 7 3.14 Comment ( 0029 ):

Under section (e)(2)(ii) of 81 0.2600 , 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 add ition s . 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 bec ause they are considered to be

devices . These UV and ceramic units, however, must not be misbranded and are subject to the requirements for device s 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 option al 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

–

### 8 protocol P231 and P24 8. 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 Testi ng 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 alterna tive protocols for evaluating microbial treatment efficacy of water purifiers

.

3.19 Comment (0015 0021 ):

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 c l aim, 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 th e 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 t o 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 req uired 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

### 9 standards development process for cyst reduction claims, it was found that the charge of the surrogate particle, the shape of the particle, the size ra nge 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 adop ted 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 (0015 0023 ):

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 shou ld 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), b romine (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

### 10 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

co llection, 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 conf irming product performance. The dual purpose behind the two part swimming pool test s (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 nee ded 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 te sting 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 che mical 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 ann ual 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 tes ting 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.