United States Chemical Safety June 2012 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Poly(hexamethylenebiguanide) 

Summary Document: 

Registration Review: Initial Docket 

June 2012 

 
Docket Number: EP A-HQ-OPP-20 12-0341 

www.regulations.gov 

Poly(hexamethy lenebiguanide) 

Summary Document 

Registration Review: Initial Docket 

June 2012 

Case # 3122 

Approved By: 

an Harrigan-Farrelly 

irector, Antimicrobials Division 

Date: 

~ 7 

20f40 
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TABLE OF CONTENTS

Poly(Hexamethylenebiguanide) Registration Review Team ...................................................... 4

I. Preliminary Work Plan -- Poly(Hexamethylenebiguanide) ..................................................... 5

II. Fact Sheet ............................................................................................................................. 13

III. Summary of Anticipated Data Requirements – PHMB ...................................................... 16

IV. Appendix A: Use Patterns – PHMB .................................................................................. 20

________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in 

Support of Registration Review of Poly(hexamethylene-biguanide) hydrochloride. June 

19, 2012. 

2. Poly(hexamethylene-biguanide) hydrochloride. Human Health Scoping Document for the 

Registration Review. June 20, 2012. 

Additional supporting documents for the Poly(hexamethylenebiguanide) Case may be found in 

the registration review docket EPA-HQ-OPP-2012-0341 located on the internet at 

www.regulations.gov. 
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Poly(Hexamethylenebiguanide) Registration Review Team

Human Health & Environmental Effects

William Hazel 

Michelle Centra 

Timothy Dole 

Jonathan Chen 

Srinivas Gowda 

Najm Shamim 

Donna Randall 

Risk Management

Rebecca von dem Hagen 

Lance Wormell 

Office of General Counsel

Philip Ross 
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I. Preliminary Work Plan -- Poly(Hexamethylenebiguanide) 

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the Poly(Hexamethylenebiguanide) Case. 

The Poly(hexamethylenebiguanide) Case, Case Number 3122, contains one active ingredient, 

Poly(hexamethylenebiguanide) (PC Code 111801) (PHMB). The first product containing 

PHMB was registered in 1982 for use in manufacturing swimming pool sanitizers and 

disinfectants for use in commercial, industrial, and residential settings and to formulate sanitizers 

and disinfectants for use in food handling/storage establishments, premises and equipment, 

including food contact surfaces. Currently, there are 25 products containing PHMB as an active 

ingredient registered with EPA. PHMB is a broad spectrum antimicrobial registered for use as a 

fungicide, algicide, and sanitizer in swimming pools, spas and hot tubs; a materials preservative 

in architectural and industrial coatings, textiles and cellulosic material, glues and adhesives, 

leather and fresh animals skins and hides; a microbicide/microbiostat in industrial processes and 

water systems including cooling towers; and as a hard surface, food and non-food contact, 

disinfectant/sanitizer in a variety of residential and public access premises, commercial, 

institutional, industrial premises and equipment, medical and agricultural premises and 

equipment, and food handling storage establishments and equipment. 

In 2008, the Agency established an exemption from a tolerance in 40 CFR 180.1280 for residues 

of PHMB in or on all food commodities when the residues are the result of the lawful application 

of a food contact surface sanitizer containing PHMB at 550 parts per million (ppm). A 

Reregistration Eligibility Decision (RED) for PHMB was completed in 2004 and the Agency 

intends to issue the post-RED DCI in the near future. The Agency intends to incorporate data 
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received in response to the PHMB post-RED DCI into the risk assessments to be performed for 

this registration review. Also, the Agency notes that this registration review will be based on 

updated labels reflecting mitigation measures outlined in Table 13 of the 2004 RED. Labels will 

be updated through the reregistration process. 

Documents associated with the registration review of PHMB can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2012-0341. Below is a summary of the issues 

relevant to this registration review case. 

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for all uses of PHMB. The Agency anticipates 

the need to conduct a human health risk assessment. The Agency anticipates needing additional 

data for use in conducting the registration review for PHMB. 

Ecological Risk: 

 Ecological hazards of PHMB were characterized as part of the 2004 RED assessment; 

however, a quantitative risk assessment was not performed. 

 For registration review, the Agency anticipates conducting a comprehensive 

ecological risk assessment, including an endangered species assessment, for use 

patterns resulting in direct discharge of PHMB to water through uses in industrial 

processes and water systems such as cooling towers and paper mill process water as 

well as indirect discharge of PHMB via consumer, institutional and commercial 

product uses which are disposed of down-the-drain and subsequently discharged to 

receiving waters. 

 The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for PHMB. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether PHMB’s use has 'no 

effect' or 'may affect' federally listed threatened or endangered species (listed species) or 

their designated critical habitats. When an assessment concludes that a pesticide’s use 

'may affect' a listed species or its designated critical habitat, the Agency will consult with 

the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the 

Services), as appropriate. 

 The Agency anticipates the need to require the following additional ecological data for 

use in the registration review of PHMB. 

850.2100 -- Avian acute oral toxicity test, upland game 

850.1010 -- Aquatic invertebrate acute toxicity, freshwater daphnids 

850.1025 -- Oyster acute toxicity test1

850.1055 -- Bivalve acute toxicity larval (embryo/larval)1

 

1

 Results from either GLN 850.1025 or 850.1055 are expected to satisfy both anticipated data requirements. 
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850.1075 -- Fish acute toxicity2

850.1300 -- Daphnid chronic toxicity test 

850.1400 -- Freshwater fish early-life stage toxicity test, using the most acutely 

sensitive fish 

850.1035 -- Estuarine/marine mysid acute toxicity test 

850.4225 -- Seedling emergency and growth Tier II data, rice 

850.4400 -- Aquatic plant toxicology test using Lemna spp., Tier I 

850.5400 -- Algal Toxicity Tier II3

Special Study -- Chronic whole sediment freshwater invertebrate toxicity test, 

amphipod (Hyallela azteca) 

Special Study -- Chronic whole sediment freshwater invertebrate toxicity test, 

midge (Chironomous sp.) 

Special Study -- Chronic whole sediment estuarine/marine invertebrate toxicity 

test, amphipod (Leptochirus plumulosus) 

 The Agency anticipates the need to require the following additional environmental fate 

data for use in the registration review of PHMB. 

835.1230 -- Sediment and soil adsorption/desorption 

 Data are expected to be required for both the 20% and 96.3% technical grade active 

ingredients (TGAI) because available information is unclear on whether or not PHMB – 

which exists as a mixture of polymer chains of different lengths or sizes and mass – will 

have similar polymer characterization; therefore, ecological hazard across products. If 

information is provided to the Agency establishing that polymer characterization is the 

same for both TGAIs, then data are anticipated to be required on the more toxic TGAI 

only. 

 For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of 

Poly(hexamethylene-biguanide) hydrochloride, located in the docket. 

Human Health Risk: 

 The most recent human health risk assessment for PHMB was completed in support of 

the exemption from the requirement of a tolerance established in 2008. 

 The Agency anticipates the need to update or conduct the following human health risk 

assessments based on currently registered use patterns: dietary (food only); residential 

dermal, inhalation and incidental oral including dermal and incidental oral assessments 

for children and toddlers; and occupational dermal and inhalation. In addition, the 

 

2

 GLN 850.1075 is anticipated to be required for both a freshwater warm water fish and an estuarine/marine fish 

species. 

3

The Agency anticipates requiring GLN 850.5400 for the following four species: green algae, freshwater diatom, 

marine diatom and cyanobacterium species 
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Agency anticipates the need to conduct an aggregate assessment on dietary (food) and 

residential sources of PHMB.

 The Agency does not anticipate the need to conduct a drinking water assessment for 

PHMB because the Agency does not expect PHMB or its degradates to reach or pass 

through drinking water treatment plants. 

 Past PHMB risk assessments have relied in part on a human study which involved 

intentional exposure to PHMB. In the course of registration review EPA will reconsider 

this study, as well as any other research involving intentional exposure of human subjects 

to PHMB brought to its attention. If EPA decides to rely on any of this study, EPA will 

ensure that all applicable regulatory requirements are met, including but not limited to the 

requirements for EPA ethics review and Human Studies Review Board review of certain 

research involving intentional exposure of human subjects. 

 The Agency anticipates the need to require the following additional human health data 

for use in the registration review of PHMB. 

870.3465 -- 90-day inhalation toxicity (rat) 

 For more information, please refer to Poly(hexamethylene-biguanide) hydrochloride. 

Human Health Scoping Document for the Registration Review, located in the docket. 

Product Chemistry: 

 The Agency does not anticipate the need to require additional product chemistry data for 

use in this registration review at this time. 

 For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of 

Poly(hexamethylene-biguanide) hydrochloride, located in the docket. 

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of the 2008 exemption from the requirements of a tolerance, EPA 

reviewed these data and selected the most sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 

PHMB is subject to the endocrine screening part of the Endocrine Disruptor Screening Program 

(EDSP). 
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EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. PHMB is not among the 

group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. 

Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, 

requiring the submission of EDSP screening assays for PHMB. For further information on the 

status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test 

guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/. 

Timeline

EPA has created the following estimated timeline for the completion of the PHMB registration 

review: 

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket 

Open Public Comment Period for Docket June 2012

Close Public Comment Period for Docket August 2012 

Phase 2: Case Development 

Develop Final Work Plan (FWP) December 2012 

Issue DCI December 2013 

Data Submission December 2015 

Open Public Comment Period for Preliminary Risk Assessments June 2017 

Close Public Comment Period for Preliminary Risk Assessments July 2017 

Phase 3: Registration Review Decision 

Open Public Comment Period for Proposed Reg. Review Decision December 2017 

Close Public Comment Period for Proposed Reg. Review Decision February 2018 

Final Decision and Begin Post-Decision Follow-up 2018 

Total (years) 6 
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Guidance for Commenters:

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a Final Work Plan for the poly(hexamethylenebiguanide) 

registration review case. 

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality:

PHMB is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for PHMB, based 

on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. 

More information on impaired water bodies and TMDLs can be found at 

http://www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

data can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to PHMB compared to the general population. Please comment 

if you are aware of any sub-populations that may have atypical, unusually high exposure 

compared to the general population. 

Structure Activity Relationships: 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 
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chemical traditionally begins with the applicant’s submission of a set of studies conducted with 

the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, OPP 

has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this time, 

EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements. 

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

PHMB Case, then the Agency invites submission of this information. The submitter would be 

expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged. 

Additional Information:

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information: 

1. Confirmation on the following label information: 
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a. Sites of application 

b. Formulations 

c. Application methods and equipment 

d. Maximum application rates 

e. Frequency of application, application intervals and maximum number of 

applications 

f. Geographic limitations on use 

2. Use or potential use distribution 

3. Use history 

4. Usage/use information for non-agricultural uses (e.g., materials preservation) 

5. Typical application interval 

6. State or local use restrictions 

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency 

8. Monitoring data 

9. Facility information to estimate aquatic exposures from emissions to WWTP and 

directly to water for each emission scenario, specifically those listed below. In the 

absence of information on the number of these facilities that use PHMB and how 

many of these facilities have on-site and/or off-site wastewater treatment, the Agency 

will assume that all such facilities in the United States have the potential to use 

PHMB and have no on-site and/or off-site wastewater treatment. 

(a) The number of pulp and paper mill sites using PHMB or the maximum annual 

production volume of PHMB used in pulp and paper mills in the United States 

and its territories; 

(b) The number of recirculating cooling tower sites using PHMB or the maximum 

annual production volume of PHMB used in cooling towers in the United 

States and its territories; 

(c) The number of oil well development sites using PHMB or the maximum 

annual production volume of PHMB used in oil and gas well development in 

the United States and its territories; 

(d) The number of adhesive industrial or manufacturing sites using PHMB or the 

maximum annual production volume of PHMB used in the adhesive 

formulation industry in the United States and its territories; 

(e) How many of each of these facilities has on-site and/or off-site wastewater 

treatment. 

Next Steps:

After the 60-day comment period closes in August 2012, the Agency will review and respond to 

any comments received in a timely manner, and then issue a Final Work Plan for the 

Poly(Hexamethylenebiguanide) Case. 
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II. Fact Sheet 

Background Information:

 Active Ingredient: Poly(hexamethylenebiguanide) 

 Case number: 3122 

 PC Code: 111801 

 CAS number: 32289-58-0 

 Technical registrant: Arch Chemicals, Inc. 

 First approved for use in a registered product: 1982 

 PHMB is exempt from the requirement of a tolerance in 40 CFR 180.1280 for residues in 

or on all food commodities when the residues are the result of the lawful application of a 

food contact surface sanitizer containing PHMB at 550 parts per million (ppm). 

 Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen, 

vondem-hagen.rebecca@epa.gov

 Antimicrobials Division Product Manager (PM): Jacqueline Campbell-McFarlane, 

campbell-mcfarlane.jacqueline@epa.gov

 Chemical Structure: 

Use & Usage Information:

 PHMB is a broad spectrum antimicrobial registered for use as a fungicide, algicide, and 

sanitizer in swimming pools, spas and hot tubs; a materials preservative in architectural 

and industrial coatings, textiles and cellulosic material, glues and adhesives, leather and 

fresh animals skins and hides; a microbicide/microbiostat in industrial processes and 

water systems including cooling towers; and as a hard surface, food and non-food 

contact, disinfectant/sanitizer in a variety of residential and public access premises, 

commercial, institutional, industrial premises and equipment, medical and agricultural 

premises and equipment, and food handling storage establishments and equipment. 

Ecological Risk Assessment Status:

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping 

Document in Support of Registration Review of Poly(hexamethylene-biguanide) hydrochloride, 

located in the docket, for a detailed discussion of the ecological risk assessments. 

 At the time of the RED, PHMB hazards were characterized as part of the assessment; 

however, a quantitative risk assessment was not performed. 
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 PHMB demonstrates low toxicity to birds and mammals and high toxicity to freshwater 

invertebrates and very high toxicity to fish. There is no major degradate of concern. 

 Labels will be updated through the reregistration process to require discharges from the 

industrial microbiocide uses to aquatic environments to comply with a National Pollutant 

Discharge Elimination System (NPDES) permit in order to regulate risks to the aquatic 

environment. The oil recovery use was identified in the RED as likely to result in 

significant outdoor exposure; therefore, labels will be updated through the reregistration 

process to prohibit use over or near marine/estuarine (e.g., offshore) oil fields. 

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for 

Poly(hexamethylenebiguanide). Please refer to Poly(hexamethylene-biguanide) hydrochloride. 

Human Health Scoping Document for the Registration Review, located in the docket, for a 

detailed discussion of the human health risk assessment. 

 Past PHMB risk assessments have relied in part on a human study which involved 

intentional exposure to PHMB. In the course of registration review EPA will reconsider 

this study, as well as any other research involving intentional exposure of human subjects 

to PHMB brought to its attention. If EPA decides to rely on this study, EPA will ensure 

that all applicable regulatory requirements are met, including but not limited to the 

requirements for EPA ethics review and Human Studies Review Board review of certain 

research involving intentional exposure of human subjects. 

Hazard Characterization: 

 PHMB is of low acute toxicity (Toxicity Category III) via the oral route, dermal route 

and inhalation route. PHMB is a severe eye and skin irritant (Toxicity Category I) and it 

is a moderate skin sensitizer. 

 PHMB was classified in 2003 by OPP’s Cancer Assessment Review Committee as 

“Suggestive Evidence of Carcinogenicity, but Not Sufficient to Assess Human 

Carcinogenic Potential” for inciting vascular tumors in laboratory animals by the oral and 

dermal routes. 

Dietary (Food and Water): 

 A drinking water assessment has not been conducted and is not anticipated because the 

Agency does not expect PHMB to reach or pass through drinking water treatment plants. 

 The most recent dietary (food) risk assessment was conducted in support of the 

exemption from the requirement of a tolerance established in 2008. The tolerance 

exemption was granted because no risks of concern were identified for the use of PHMB 

as a food contact sanitizer at up to 550 ppm. 

Residential: 
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 Residential handler dermal and inhalation exposures to PHMB were assessed in the 2004 

RED for spraying, mopping and wiping with disinfectants and open-pouring addition to 

swimming pools. In 2005, the Agency conducted an assessment of exposure to treated 

textiles using end points derived from a human sensitization patch test. Neither 

assessment identified any risks of concern. Although this human dermal sensitization 

study and its endpoint were used by EPA to assess certain residential risks in 2005, it has 

not been subjected to an ethics review or consideration by the Human Studies Review 

Board (HSRB). See the earlier discussion concerning human studies. 

 Residential dermal and inhalation exposures have not been assessed for PHMB-treated 

paints and will be incorporated into this registration review.

Aggregate: 

 The most recent aggregate assessment of PHMB was conducted in support of the 2004 

RED on dietary and residential exposures and did not identify any risks of concern. 

Occupational: 

 Occupational handler dermal and inhalation exposures to PHMB were assessed in the 

2004 RED for open-pour and meter pump addition scenarios for the various use patterns 

including material preservation, oil production, and swimming pools. The MOEs were 

generally not of concern except when large amounts of PHMB were handled as in the 

case of oil production. To mitigate the risks arising from the oil production use, labels 

will be updated during the reregistration process to require that PHMB be administered in 

a closed system.

 The Agency assessed risks from occupational handler exposures to PHMB for spray, mop 

and wipe cleaning and did not identify any risks of concern. 

Cumulative: 

 EPA does not have, at this time, available data to determine whether PHMB has a 

common mechanism of toxicity with other substances or how to include this pesticide in 

a cumulative risk assessment. For the purposes of this Registration Review, EPA has 

assumed that PHMB does not have a common mechanism of toxicity with other 

substances when used as an antimicrobial as registered. 

Incidents:

Ecological: 

 There are no reported incidents in the Agency's Ecological Incident Information System 

(EIIS) regarding PHMB. 

Human Health: 
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 EPA’s Office of Pesticide Programs has reviewed a total of 118 individual incidents 

involving the use of PHMB-containing products. All of the incident reports reflected 

residential use of PHMB swimming pool products by consumers. Of the 118 incident 

cases, 17 were determined to be the result of misuse. Misuse included failing to follow 

label instructions, accidental ingestion, or splashing the concentrated product onto the 

skin or into the eyes. 

 The reported routes of exposure in the 118 incident cases were dermal, ocular, ingestion, 

inhalation and unknown. In some cases more than one route of exposure was applicable 

to an individual incident case (e.g., both dermal and ocular exposure). The most common 

symptoms reported for each exposure route are as follows: 

o Dermal exposure: skin irritation/burning, rash, hives/welts, itching, skin 

discoloration/redness, allergic reaction, and blistering. 

o Ocular exposure: eye irritation/burning, eye pain, loss of vision, swelling of eyes, 

and allergic reactions. 

o Exposure via ingestion: vomiting/nausea/abdominal pain, irritation to the 

mouth/throat, respiratory irritation including coughing/choking, and diarrhea. 

o Inhalation exposure: respiratory irritation and coughing/choking. 

Tolerances and International Harmonization: 

 In 2008, the Agency established an exemption from a tolerance in 40 CFR 180.1280 for 

residues of PHMB in or on all food commodities when the residues are the result of the 

lawful application of a food contact surface sanitizer containing PHMB at 550 parts per 

million (ppm). 

Data Call-In Status:

 The Agency anticipates issuing a post-RED data call-in (DCI) for PHMB and anticipates 

reviewing any data received in response to the post-RED DCI prior to conducting the 

registration review risk assessments anticipated as being needed in this document. 

Labels: 

Registered products, including EPA registration numbers are provided in Table 1 below. Product 

registration labels may be obtained from the Pesticide Product Label System (PPLS) website at: 

http://oaspub.epa.gov/pestlabl/ppls.home. 

Table 1. Registered Products – PHMB 

Registration 

# Registration Name Company Name Formulation Type % of Active Ingredient 

1258-1252 Vantocil P Arch 

Chemicals, Inc.

Liquid—MUP 20.0 

1258-1253 Vantocil IB 

Microbiocide 

Soluble Concentrate 20.0 

1258-1263 Baquacil Swimming 

Pool Sanitizer and 

Algistat 

Ready-to-Use 

Solution 

20.0 
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

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1258-1265 Baquacil Ultra 

Swimming Pool 

Sanitizer & 

Fungicide 

Ready-to-Use 

Solution 

20.0 

1258-1275 A-Breeze Sanitizer 

Cartridge or ABreeze Sanitizer 

Tablest 

Soluble 

Concentrate/Solid 

96.3 

1258-1277 Vantocil S 

Microbiocide 

Solid—MUP 96.3 

1258-1324 Vantocil NR Soluble Concentrate 20.0 

1258-1335 Vantocil NR 3.8 Soluble Concentrate 1.28 PHMB 

1.28 Didecyl dimethyl ammonium 

chloride 

1.28 alkyl dimethyl benzyl 

ammonium chloride 

3432-83 Pool Elegance or Spa 

Elegance 

N. Jonas & 

Col, Inc. 

Ready-to-Use 

Solution 

20.0 

3573-89 Snipe The Procter & 

Gamble 

Company 

Ready-to-Use 

Solution 

0.1 PHMB 

0.1 Didecyl dimethyl ammonium 

chloride 

48520-19 Biquanide Phoenix 

Products 

Company 

Ready-to-Use 

Solution 

20 

5813-75 Clorox Trapeze The Clorox 

Company 

Ready-to-Use 

Solution 

0.1 

5813-77 CD WII Wet Wipes 0.5 

5813-78 CTW Wet Wipes 0.5 

69461-1 Revacil Mareva, Inc. Soluble Concentrate 20.0 

7124-105 PolyClear 

Maxipolish 

Alden Leeds 

Inc. 

Ready-to-Use 

Solution 

20.0 

71661-1 Surfacine(r) All 

Purpose Cleaner 

Intelligent 

Biocides LLC 

Ready-to-Use 

Solution 

0.0095 silver 

0.56 PHMB 

75512-1 Ebiox Trukleen 

Wipes 

Ebiox Limited Wet Wipes 0.1 PHMB 

0.499 alkyl dimethyl benzyl 

ammonium chloride 

0.451 1-Decanaminium, N-decylN,N-dimethyl-, chloride 

79755-4 F10CL Veterinary 

Disinfectant 

Health and 

Hygiene (PTY) 

Ltd 

Soluble Concentrate 0.08 PHMB 

1.08 alkyl dimethyl benzyl 

ammonium chloride 

79755-5 F10 Veterinary 

Disinfectant (Ready 

to Use) 

Health and 

Hygiene (PTY) 

Ltd 

Ready-to-Use 

Solution 

0.0016 PHMB 

0.0216 alkyl dimethyl benzyl 

ammonium chloride 

79755-6 F10SC Veterinary 

Disinfectant 

Health and 

Hygiene (PTY) 

Ltd 

Soluble Concentrate 0.4 PHMB 

5.4 alkyl dimethyl benzyl 

ammonium chloride 

81002-2 Chlorine Free 

Splashes Sanitizer 

Splashes, Inc. Soluble Concentrate 20.0 

81002-3 Splashes Too 

Swimming Pool 

Sanitizer 

Splashes, Inc. Soluble Concentrate 20.0 

87203-1 AMS Biguanide 20 Active Micro 

Technologies, 

Soluble Concentrate 20.0 
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

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LLC 

III. Summary of Anticipated Data Requirements – PHMB 

The table below summarizes anticipated data needs for the Poly(Hexamethylenebiguanide) Case 

in Section I of this document (Preliminary Work Plan), Product Chemistry, Environmental Fate, 

and Ecological Effects Scoping Document in Support of Registration Review of 

Poly(hexamethylene-biguanide) hydrochloride, and Poly(hexamethylene-biguanide) 

hydrochloride. Human Health Scoping Document for the Registration Review. 

Table 2. Summary of Anticipated Data Requirements – PHMB 

Guideline 

Number Anticipated Data Requirement Test Material 

Estimated Timeframe 

(Measured in months 

from DCI Receipt) 

870.3465 90-Day Rat Inhalation Toxicity TGAI 24 

835.1230 Sediment Sorption/Desorption Study TGAI:20% & 96.3%4 12 

850.2100 Avian acute oral toxicity test, upland game or 

waterfowl species TGAI: 20% & 96.3%4 12 

850.1010 Aquatic invertebrate acute toxicity, freshwater 

daphnids TGAI: 20% & 96.3%4 12 

850.1025 Oyster acute toxicity test5 TGAI: 20% & 96.3%4 12 

850.1055 Bivalve acute toxicity larval (embryo/larval)5 TGAI: 20% & 96.3%4 12 

850.1075 Fish acute toxicity6 TGAI: 20% & 96.3%4 12 

850.1300 Daphnid chronic toxicity test TGAI: 20% & 96.3%4 12 

850.1400 Freshwater Fish early-life stage toxicity test, 

using the most acutely sensitive fish TGAI: 20% & 96.3%4 12 

850.1035 Estuarine/marine mysid acute toxicity test TGAI: 20% & 96.3%4 12 

850.4200 Seedling emergency and growth Tier II data, 

rice TGAI: 20% & 96.3%4 12 

850.4400 Aquatic plant toxicology test using Lemna 

spp., Tier I TGAI: 20% & 96.3%4 12 

850.5400 Algal Toxicity Tier II7 TGAI: 20% & 96.3%4 12 

 

4 Anticipated data are expected to be required on both the 20% and 96.3% technical grade active ingredients (TGAI) 

because available information is unclear on whether or not PHMB – which exists as a mixture of polymer chains of 

different lengths or sizes and mass – will have similar polymer characterization and; therefore, ecological hazard 

across products. If information is provided to the Agency proving that polymer characterization is the same for both 

TGAIs, then data are anticipated to be required on the 96.3% TGAI only.

5

 Results from either GLN 850.1025 or 850.1055 are expected to satisfy both anticipated data requirements. 6

 GLN 850.1075 is anticipated to be required for both a freshwater warm water fish and a estuarine/marine fish 

species. 
Docket Number: EPA-HQ-OPP-2012-0341 

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Special 

Study 

Chronic Whole Sediment Freshwater 

Invertebrate Toxicity Test with the amphipod 

Hyallela azteca

TGAI: 20% & 96.3%4 12 

Special 

Study 

Chronic Whole Sediment Freshwater 

Invertebrate Toxicity Test with the midge 

(Chironomous sp.) 

TGAI: 20% & 96.3%4 12 

Special 

Study 

Chronic Whole Sediment Estuarine/Marine 

Invertebrate Toxicity Test with the amphipod 

Leptochirus plumulosus) 

TGAI: 20% & 96.3%4 12 

 7

The Agency anticipates requiring GLN 850.5400 for the following four species: green algae, freshwater diatom, 

marine diatom and cyanobacterium species 
IV. Appendix A: Use Patterns – PHMB 

EPA Reg # 

Formulation 

% A. I. Use Site Treatment Site/Surfaces Application 

Method 

Min App Rate 

Max App Rate 

Max App Rate Converted 

U

1258-1252 

Liquid 20.00% Formulation Use 

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Household and Consumer Products such as surface cleaners, floor cleaners, disinfectanUsanitizers (nonfood contact, hard surface uses), fabric stain removers, fabric softeners, fabric conditioners, laundry detergents, laundry additives, automotive care silicone emulsions and automotive cleaning products. 

Metered incorporation 

2.5 lb/10,000 lbs product 

25 lbs/10,000 lbs product 

2500ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Janitorial products, chemical toilet deodorants 

Metered incorporation 

3.2 fl. Oz/100 gal of water 

64 fl. Oz/100 gal of water 

5000ppm o

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous based polymer lattices such as polyvinyl acetate and polyvinyl alcohol 

Metered incorporation 

5 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Architectural and industrial coatings including electro coat resins and deposition systems 

Metered incorporation 

10 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb
Docket Number: EPA-HQ-OPP-2012-0341 

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1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous Based Adhesives such as animal glues, latex adhesives based on polyvinyl acetate, PVA, etc., starch, synthetic, dextrin, casein and other glues 

Metered incorporation 

5 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous Mineral Slurries such as calcium carbonate and titanium dioxide 

Metered incorporation 

5 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Fresh Animal Hides and Skins Metered 

incorporation 

1 lb/1,000 lbs product 

2.6 lbs/1,000 lbs product 

2600ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Leather Processing Metered 

incorporation 

1 lb/10,000 lbs product 

30 lbs/10,000 lbs product 

3000ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous Industrial Chemicals such as reagents, oil-in-water emulsions, water-in-oil emulsions, textile spin finish lubricants, wash water and cellulose solutions 

Metered incorporation 

1 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor/Outdoor Nonfood 

Silicone Metered 

incorporation 

1 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb
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1258-1253 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsIndoor Nonfood 

Tunnel Pasteurization Waters Metered 

incorporation 

13 fl. Oz/1000 gal of water 

1 gal/1000 gal of water 

1000ppm o

g

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Cat litter Metered 

incorporation 

2.5 lb/1,000 lbs product 

100 lbs/1,000 lbs product 

10000ppm lb

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Textiles such as household products, for example, upholstery, carpet, curtains, wall coverings, mops, dishcloths, yarns, cords, toweling and blankets. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Cellulosics such as wipes, tissues, sponges, paper products (non-food contact) such as filters and cellulose pulp. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w

1258-1253 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Apparel items such as slacks, shirts, underwear, sweatshirts, sweatpants, socks, oven mitts, slippers, bathrobes, gloves, hats, scarves, jackets, sheets, pillowcases, incontinence pad over stock, washable incontinence briefs and panties. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w
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1258-1253 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsEnvironmentally contained 

Oil recovery systems-oil field injection waters 

Metered incorporation 

19 fl oz/1,000 gal water 

4 gal/1,000 barrels 

95ppm o

gel

1258-1253 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsAquatic/outdoor exposure 

Oil recovery systems- Drilling Muds 

Metered incorporation 

Not listed 126 

gal/1,000 barrels 

3000ppm g

el

1258-1253 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsAquatic/outdoor exposure 

Oil recovery systemsWorkover fluids Metered incorporation Not listed 126 gal/1,000 

barrels 

3000ppm g

el

1258-1253 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsAquatic/outdoor exposure 

Paper mills Metered 

incorporation 

50ppm 1500ppm 1500ppm 

1258-1253 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsAquatic/outdoor exposure 

Cooling Towers Metered 

incorporation 

50ppm 1500ppm 1500ppm 

1258-1263 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(30ppm min) 50ppm 

g
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1258-1263 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Spas and hot tubs Open Pour Not listed 1 oz/150 

gal water 

 o

1258-1263 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Kiddie Pools, Open Pour Not listed 1 oz/150 

gal water 

 o

1258-1265 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(30ppm min) 50ppm 

g

1258-1265 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Spas and hot tubs Open Pour 0.2 oz/150 

gal water 

1 oz/150 gal water 

(30ppm min) 50ppm 

o

1258-1275 

Soluble Concentrate/Solid 

96.30% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Cartridge 1(200g) 

tablet/10000 gal 

2 (200g) tablets/10000 gal 

10ppm 

1258-1277 

 96.30% Formulation Use 

1258-1324 

Soluble Concentrate 

20.00% Food 

handling storage establishments premises and equipmentIce Machines Spray, bruch, sponge, or cloth Not listed Preclean, then 1 fl oz/3 gal water. One minute contact 540ppm o
Docket Number: EPA-HQ-OPP-2012-0341 

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Indirect food contact 

time. Do not rinse. 

1258-1324 

Soluble Concentrate 

20.00% Food 

handling storage establishments premises and equipmentIndirect food contact 

Hard, non-porous surfaces in food processing equipment, food utensils, dishes, silverware, eating utensils, glasses, sink tops, countertops, refrigerated storage and display equipment and other hard, non-porous surfaces in restaurants, and bars, bars, cafeterias, institutional kitchens, fast food operations and food storage areas. 

Spray, bruch, sponge, or cloth 

Not listed Preclean, 

then 1 fl oz/3 gal water. One minute contact time. Do not rinse. 

540ppm o

1258-1324 

Soluble Concentrate 

20.00% Agricultural 

premises and equipmentIndirect food contact 

Fishery, Milk, Citrus, Wine, Fruit, Vegetable, Ice Cream and Potato Processing Plants and beverage plants. 

Spray, bruch, sponge, or cloth 

Not listed Preclean, 

then 1 fl oz/3 gal water. One minute contact time. Do not rinse. 

540ppm o

1258-1324 

Soluble Concentrate 

20.00% Food 

handling storage establishments premises 

Beer and wine processing equipment and holding tanks. 

Spray, bruch, sponge, or cloth 

Not listed Preclean, 

then 1 fl oz/3 gal water. One 

540ppm o
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and equipmentIndirect food contact 

minute contact time. Do not rinse. 

1258-1324 

Soluble Concentrate 

20.00% Agricultural 

premises and equipmentIndirect food contact 

Bottling and beverage equipment and dispensers and final rinse of bottles and cans. 

Spray, bruch, sponge, or cloth 

Not listed Preclean, 

then 1 fl oz/3 gal water. One minute contact time. Do not rinse. 

540ppm o

1258-1324 

Soluble Concentrate 

20.00% Agricultural 

premises and equipmentIndirect food contact 

Hard, non-porous surfaces in dairy farms, hog farms, equine farms, poultry and turkey farms and egg processing plants, meat/poultry processing plants, meat/poultry producing establishments, mushroom farms, rendering plants. 

Spray, bruch, sponge, or cloth 

Not listed Preclean, 

then 1 fl oz/3 gal water. One minute contact time. Do not rinse. 

540ppm o
Docket Number: EPA-HQ-OPP-2012-0341 

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1258-1335 

Soluble Concentrate 

1.28% Food 

handling storage establishments premises and equipmentIndirect food contact 

Ice Machines Spray, bruch, 

sponge, or cloth 

Preclean, then 0.5 fl oz/gal water. One minute contact time. Do not rinse. 

Preclean, then 2 fl oz/gal water. One minute contact time. Do not rinse. 

600ppm o

1258-1335 

Soluble Concentrate 

1.28% Food 

handling storage establishments premises and equipmentIndirect food contact 

Hard, non-porous surfaces in food processing equipment, food utensils, dishes, silverware, eating utensils, glasses, sink tops, countertops, refrigerated storage and display equipment and other hard, non-porous surfaces in restaurants, and bars, bars, cafeterias, institutional kitchens, fast food operations and food storage areas. 

Spray, bruch, sponge, or cloth 

Preclean, then 0.5 fl oz/gal water. One minute contact time. Do not rinse. 

Preclean, then 2 fl oz/gal water. One minute contact time. Do not rinse. 

600ppm o

1258-1335 

Soluble Concentrate 

1.28% Agricultural 

premises and equipmentIndirect food contact 

Fishery, Milk, Citrus, Wine, Fruit, Vegetable, Ice Cream and Potato Processing Plants and beverage plants. 

Spray, bruch, sponge, or cloth 

Preclean, then 0.5 fl oz/gal water. One minute contact time. Do not rinse. 

Preclean, then 2 fl oz/gal water. One minute contact time. Do not rinse. 

600ppm o
Docket Number: EPA-HQ-OPP-2012-0341 

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1258-1335 

Soluble Concentrate 

1.28% Agricultural 

premises and equipmentIndirect food contact 

Beer and wine processing equipment and holding tanks. 

Spray, bruch, sponge, or cloth 

Preclean, then 0.5 fl oz/gal water. One minute contact time. Do not rinse. 

Preclean, then 2 fl oz/gal water. One minute contact time. Do not rinse. 

600ppm o

1258-1335 

Soluble Concentrate 

1.28% Agricultural 

premises and equipmentIndirect food contact 

Bottling and beverage equipment and dispensers and final rinse of bottles and cans. 

Spray, bruch, sponge, or cloth 

Preclean, then 0.5 fl oz/gal water. One minute contact time. Do not rinse. 

Preclean, then 2 fl oz/gal water. One minute contact time. Do not rinse. 

600ppm o

1258-1335 

Soluble Concentrate 

1.28% Agricultural 

premises and equipmentIndirect food contact 

Hard, non-porous surfaces in dairy farms, hog farms, equine farms, poultry and turkey farms and egg processing plants, meat/poultry processing plants, meat/poultry producing 

Spray, bruch, sponge, or cloth 

Preclean, then 0.5 fl oz/gal water. One minute contact 

Preclean, then 2 fl oz/gal water. One minute contact 

600ppm o
Docket Number: EPA-HQ-OPP-2012-0341 

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establishments, mushroom farms, rendering plants. 

time. Do not rinse. 

time. Do not rinse. 

3432-83 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(30ppm min) 50ppm 

g

3432-83 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Spas and hot tubs Open Pour 0.2 oz/150 

gal water 

1 oz/150 gal water 

(30ppm min) 50ppm 

o

3573-89 

Impregnated Materials 

0.10% Residential 

and publc access premisesIndoor Nonfood 

Hard non-porous floors. Spray, mop Not listed Spray 

until wet. 10 minute contact time. Removes excess. Do not rinse. 

5813-75 

Readyto-Use Solution 

0.10% Residential 

and publc access premisesIndoor Nonfood 

Hard non-porous floors. Spray, mop Not listed Spray 

until wet. 5 minute contact time. Removes excess. Do not rinse. 
Docket Number: EPA-HQ-OPP-2012-0341 

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5813-77 

Impregnated Materials 

0.50% Residential 

and publc access premisesIndoor Nonfood 

Hard non-porous surfaces in households, bathrooms and non-food contact kitchen surafces 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

5813-77 

Impregnated Materials 

0.50% Residential 

and publc access premisesIndoor Nonfood 

Diaper changing tables, high chairs 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

5813-77 

Impregnated Materials 

0.50% Residential 

and publc access premisesIndoor/outdoor Nonfood 

Animal kennels/sleeping quarters 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

5813-77 

Impregnated Materials 

0.50% Commercial, 

institutional and industrial premisesIndoor Nonfood 

Hard non-porous surfaces in commercial, institutional and industrial premises 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

5813-78 

Impregnated Materials 

0.50% Residential 

and publc access premisesIndoor Nonfood 

Hard non-porous surfaces in households, bathrooms and non-food contact kitchen surafces 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 
Docket Number: EPA-HQ-OPP-2012-0341 

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5813-78 

Impregnated Materials 

0.50% Residential 

and publc access premisesIndoor Nonfood 

Diaper changing tables, high chairs 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

5813-78 

Impregnated Materials 

0.50% Residential 

and publc access premisesIndoor/outdoor Nonfood 

Animal kennels/sleeping quarters 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

5813-78 

Impregnated Materials 

0.50% Commercial, 

institutional and industrial premisesIndoor Nonfood 

Hard non-porous surfaces in commercial, institutional and industrial premises 

Wipe Not listed Wipe 

until visibly wet. 4 minute contact time. Air dry 

7124-105 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(30ppm min) 50ppm 

g

48520-19 

Readyto-Use Solution 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(30ppm min) 50ppm 

g
Docket Number: EPA-HQ-OPP-2012-0341 

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69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Household and Consumer Products such as surface cleaners, floor cleaners, disinfectanUsanitizers (nonfood contact, hard surface uses), fabric stain removers, fabric softeners, fabric conditioners, laundry detergents, laundry additives, automotive care silicone emulsions and automotive cleaning products. 

Metered incorporation 

2.5 lb/10,000 lbs product 

25 lbs/10,000 lbs product 

2500ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Janitorial products, chemical toilet deodorants 

Metered incorporation 

3.2 fl. Oz/100 gal of water 

64 fl. Oz/100 gal of water 

5000ppm o

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous based polymer lattices such as polyvinyl acetate and polyvinyl alcohol 

Metered incorporation 

5 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Architectural and industrial coatings including electro coat resins and deposition systems 

Metered incorporation 

10 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous Based Adhesives such as animal glues, latex adhesives based on polyvinyl acetate, PVA, etc., starch, synthetic, dextrin, casein and other glues 

Metered incorporation 

5 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb
Docket Number: EPA-HQ-OPP-2012-0341 

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69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous Mineral Slurries such as calcium carbonate and titanium dioxide 

Metered incorporation 

5 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Fresh Animal Hides and Skins Metered 

incorporation 

1 lb/1,000 lbs product 

2.6 lbs/1,000 lbs product 

2600ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Leather Processing Metered 

incorporation 

1 lb/10,000 lbs product 

30 lbs/10,000 lbs product 

3000ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonfood 

Aqueous Industrial Chemicals such as reagents, oil-in-water emulsions, water-in-oil emulsions, textile spin finish lubricants, wash water and cellulose solutions 

Metered incorporation 

1 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor/Outdoor Nonfood 

Silicone Metered 

incorporation 

1 lb/10,000 lbs product 

50 lbs/10,000 lbs product 

5000ppm lb

69461-1 

Soluble Concentrate 

20.00% Industrial 

processes and water systemsIndoor Nonfood 

Tunnel Pasteurization Waters Metered 

incorporation 

13 fl. Oz/1000 gal of water 

1 gal/1000 gal of water 

1000ppm o

g

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Cat litter Metered 

incorporation 

2.5 lb/1,000 lbs product 

100 lbs/1,000 lbs product 

10000ppm lb
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69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Textiles such as household products, for example, upholstery, carpet, curtains, wall coverings, mops, dishcloths, yarns, cords, toweling and blankets. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Cellulosics such as wipes, tissues, sponges, paper products (non-food contact) such as filters and cellulose pulp. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w

69461-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Apparel items such as slacks, shirts, underwear, sweatshirts, sweatpants, socks, oven mitts, slippers, bathrobes, gloves, hats, scarves, jackets, sheets, pillowcases, incontinence pad over stock, washable incontinence briefs and panties. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w

69461-1 

Soluble Concentrate 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(30ppm min) 50ppm 

g

69461-1 

Soluble Concentrate 

20.00% Swimming 

Pools 

Spas and hot tubs Open Pour Not listed 1 oz/150 

gal water 

 o
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

35 of 40 

71661-1 

Readyto-Use Solution 

0.56% Medical 

premises and equipment 

Barber Shops, salons cloth, mop, 

sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 

71661-1 

Readyto-Use Solution 

0.56% Medical 

premises and equipment 

Hard non-porous surfaces in hospitals, dental offices and nursing homes 

cloth, mop, sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 

71661-1 

Readyto-Use Solution 

0.56% Residential 

and publc access premisesIndoor/outdoor Nonfood 

Animal kennels/sleeping quarters/laboratories 

cloth, mop, sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

36 of 40 

71661-1 

Readyto-Use Solution 

0.56% Residential 

and publc access premisesIndoor Nonfood 

Hard non-porous surfaces in households, bathrooms and non-food contact kitchen surafces 

cloth, mop, sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 

 

71661-1 

Readyto-Use Solution 

0.56% Agricultural 

premises and equipmentIndirect food contact 

Hard non-porous surfaces in meat, poultry, shell egg grading and egg products establishments. 

cloth, mop, sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 

 

71661-1 

Readyto-Use Solution 

0.56% Agricultural 

premises and equipmentIndirect food contact 

Hard non-porous surfaces in farm premises, vehicles and enclosures 

cloth, mop, sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 

 
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

37 of 40 

71661-1 

Readyto-Use Solution 

0.56% Agricultural 

premises and equipmentIndirect food contact 

Mushroom farm premises cloth, mop, 

sponge, spray or immersion 

Not listed Saturate 

surfaces. 1 minute to disinfect, 10 minutes to sanitize. Air dry or wipe clean 

 

75512-1 

Impregnated Materials 

0.10% Medical 

premises and equipment 

Hard non-porous surfaces in hospitals, outpatient surgery centers, recovery rooms, radiology treatment areas, medical offices and dental offices, and laboratories. 

Wipe Not listed Wipe 

until visibly wet. 10 minute contact time. Air dry 

75512-1 

Impregnated Materials 

0.10% Medical 

premises and equipment 

Hard non-porous critical or semicritical devices prior to sterilization or high level disinfection. 

Wipe Not listed Wipe 

until visibly wet. 10 minute contact time. Air dry 

75512-1 

Impregnated Materials 

0.10% Residential 

and publc access premisesIndoor Nonfood 

Hard non-porous surfaces in households, bathrooms and non-food contact kitchen surafces 

cloth, mop, sponge, spray or immersion 

Not listed Wipe 

until visibly wet. 10 minute contact time. Air dry 
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

38 of 40 

79755-4 

Soluble Concentrate 

0.08% Agricultural 

premises and equipmentIndirect food contact 

Hard non-porous surfaces in farm premises, vehicles and enclosures 

cloth, mop, sponge, spray or foamer 

Not listed 2.6 

oz/gal of water. 10 minute contact time. Air dry 

79755-4 

Soluble Concentrate 

0.08% Medical 

premises and equipment 

Hard non-porous surfaces in veterinary practice premises 

cloth, mop, sponge, spray or foamer 

Not listed 2.6 

oz/gal of water. 10 minute contact time. Air dry 

79755-4 

Soluble Concentrate 

0.08% Residential 

and publc access premisesIndoor/outdoor Nonfood 

Animal kennels/sleeping quarters/laboratories 

cloth, mop, sponge, spray or foamer 

Not listed 2.6 

oz/gal of water. 10 minute contact time. Air dry 

79755-5 

Readyto-Use Solution 

0.16% Agricultural 

premises and equipmentIndirect food contact 

Hard non-porous surfaces in farm premises, vehicles and enclosures 

cloth, mop, sponge, spray or foamer 

Not listed Apply to 

surface until visibly wet. 10 minute contact time. Air dry 

79755-5 

Readyto-Use Solution 

0.16% Medical 

premises and equipment 

Hard non-porous surfaces in veterinary practice premises 

cloth, mop, sponge, spray or foamer 

Not listed Apply to 

surface until visibly wet. 10 minute contact time. Air dry 
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

39 of 40 

79755-5 

Readyto-Use Solution 

0.16% Residential 

and publc access premisesIndoor/outdoor Nonfood 

Animal kennels/sleeping quarters/laboratories 

cloth, mop, sponge, spray or foamer 

Not listed Apply to 

surface until visibly wet. 10 minute contact time. Air dry 

79755-6 

Soluble Concentrate 

0.40% Agricultural 

premises and equipmentIndirect food contact 

Hard non-porous surfaces in farm premises, vehicles and enclosures 

cloth, mop, sponge, spray or foamer 

Not listed 0.5 

oz/gal of water. 10 minute contact time. Air dry 

79755-6 

Soluble Concentrate 

0.40% Medical 

premises and equipment 

Hard non-porous surfaces in veterinary practice premises 

cloth, mop, sponge, spray or foamer 

Not listed 0.5 

oz/gal of water. 10 minute contact time. Air dry 

79755-6 

Soluble Concentrate 

0.40% Residential 

and publc access premisesIndoor/outdoor Nonfood 

Animal kennels/sleeping quarters/laboratories 

cloth, mop, sponge, spray or foamer 

Not listed 0.5 

oz/gal of water. 10 minute contact time. Air dry 

81002-2 

Soluble Concentrate 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

3/4 gal/15000 gal of water 

(30ppm min) 50ppm 

g
Docket Number: EPA-HQ-OPP-2012-0341 

www.regulations.gov

40 of 40 

81002-3 

Soluble Concentrate 

20.00% Swimming 

Pools 

Freshly filled and dechlorinated pools 

Open Pour 1 

pint/10000 gal of water 

1/2 gal/10000 gal of water 

(50ppm min) 100ppm 

g

81002-3 

Soluble Concentrate 

20.00% Swimming 

Pools 

Spas and hot tubs Open Pour 0.2 oz/150 

gal water 

1 oz/150 gal water 

 o

87203-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Textiles such as household products, for example, upholstery, carpet, curtains, wall coverings, mops, dishcloths, yarns, cords, toweling and blankets. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w

87203-1 

Soluble Concentrate 

20.00% Materials 

preservativeIndoor Nonofood 

Cellulosics such as wipes, tissues, sponges, paper products (non-food contact) such as filters and cellulose pulp. 

Metered incorporation 

0.025%wt/wt 

2.0%wt/wt 

 w