# United States Chemi cal 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

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# TABLE OF CONTENTS

Poly(Hexamethylenebiguanide) Re gistration Review Team ...................................................... 4

I. Preliminary Work Plan -- Po ly(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 su mmarize 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(h examethylene-biguanide) hydrochloride. June

19, 2012.

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

Registration Review. June 20, 2012.

Additional supporting documents fo r the Poly(hexamethylenebigua nide) 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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4 of 40 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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5 of 40 I. Preliminary Work Plan -- Poly(Hexamethylenebiguanide)

Introduction:

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

pesticides distributed or sold in the United St ates 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 ri sks to human health or the environment when

used as directed on product labeling. The regist ration 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 th e statutory standard of no unreas onable 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 marketpl ace can be used safely.

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

.

The Agency is implementing the registration revi ew 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 th e FIFRA standard for

registration. The Agency will consid er 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 whatit knows about the pesticide and what additional

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

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

this initial comment period, the Agency will de velop 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, an d residential settings and to formulate sanitizers

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

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

ingredient registered wi th EPA. PHMB is a broad spectrum an timicrobial registered for use as a

fungicide, algicide, and sa nitizer in swimming pools, spas an d 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 micr obicide/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 reside ntial and public access premises, commercial,

institutional, industrial premises and equipm ent, 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 commod ities when the residues are the re sult of the lawful application

of a food contact surface sani tizer 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 fu ture. The Agency intends to incorporate data

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6 of 40 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 outlin ed in Table 13 of the 2004 RED. Labels will

be updated through the reregistration process.

Documents associated with the registrati on review of PHMB can be viewed at

www.regulations.gov in docket EP A-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 hea lth risk assessment. The Agency anticipates needing additional

data for use in conducting the registration review for PHMB.

Ecological Risk:

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

however, a quantitative risk as sessment 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 PH MB to water through uses in industrial

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

well as indirect discharg e of PHMB via consumer, institutional and commercial

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

receiving waters.

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

species determination for PHMB. The eco logical risk assessment planned during

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

effect' or 'may affect' federall y listed threatened or endange red 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 cr itical 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 toxi city test, upland game

850.1010 -- Aquatic invertebrate acute toxicity, freshwater daphnids

850.1025 -- Oyster acute toxicity test 1



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

1 

# Results from either GLN 850.1025 or 850.1055 are exp ected to satisfy both anticipated data requirements.

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7 of 40 850.1075 -- Fish acute toxicity 2



# 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 gr owth Tier II data, rice

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

850.5400 -- Algal Toxicity Tier II 3



# Special Study -- Chronic whole sediment fr eshwater invertebrate toxicity test,

amphipod ( Hyallela azteca )

Special Study -- Chronic whole sediment fr eshwater invertebrate toxicity test,

midge ( Chironomous sp.)

Special Study -- Chronic whole sediment es tuarine/marine invertebrate toxicity

test, amphipod ( Leptochirus plumulosus )

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

data for use in the regi stration review of PHMB.

835.1230 -- Sediment and soil adsorption/desorption

 Data are expected to be required for bot h the 20% and 96.3% te chnical grade active

ingredients (TGAI) because available informa tion 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; ther efore, ecological hazard across products. If

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

same for both TGAIs, then data are anticipat ed 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 assessm ent 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 followi ng human health risk

assessments based on currently registered us e patterns: dietary (f ood only); residential

dermal, inhalation and incidental oral includ ing 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 85 0.5400 for the following four specie s: green algae, freshwater diatom,

marine diatom and cyanobacterium species

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8 of 40 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 dri nking water assessment for

PHMB because the Agency does not expect PH MB 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 invo lving intentional exposure of human subjects

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

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

requirements for EPA ethics re view 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 registra tion review of PHMB.

870.3465 -- 90-day inhalati on 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 num erous studies to asse ss potential adverse

outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and

chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental,

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

susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology,

organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss,

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

chronic studies that assess gr owth, developmental and reprod uctive effects in different

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

reviewed these data and select ed 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 Endocri ne Disruptor Screening Program

(EDSP).

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9 of 40 EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator

may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal

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

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

will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2

testing is designed to identify a ny adverse endocrine-related eff ects 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 scre en all pesticide chemicals. Between October

2009 and February 2010, EPA issued test orders/dat a call-ins for the firs t group of 67 chemicals,

which contains 58 pesticide activ e ingredients and 9 inert ingred ients. PHMB is not among the

group of 58 pesticide active ingredients on the in itial 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 assa ys 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 scr eening battery, please visit our website: http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated timelin e 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 Pre liminary Risk Assessments July 2017

Phase 3: Registration Review Decision

Open Public Comment Period for Propos ed 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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10 of 40 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 Ag ency intends to solicit information on trade

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

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

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

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

Water Quality:

PHMB is not identified as a cau se of impairment for any wate r bodies listed as impaired under

section 303(d) of the Clean Water Ac t, 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 (T MDL) have been developed for PHMB, based

on information provided at

http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES.

More information on impaired wate r 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 co nform to the quality standards in Appendix A of

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

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

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

data can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all

people, regardless of race, color, national origi n, or income, in the deve lopment, implementation,

and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have

atypical, unusually high exposure to PHMB comp ared to the general pop ulation. 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 qual ity and reliability for each decision made by

the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide

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11 of 40 chemical traditionally begins with the applicant’ s submission of a set of studies conducted with

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

is a logical, scientifically rigorous proce ss 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 alternat ive techniques, i.e., tech niques other than data

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

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

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

that of other chemicals for which data are availabl e. 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 biol ogical properties are a f unction 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 da ta on a single physical, chemical, or biological

property is used to derive a model (an equatio n) to predict the valu e of that property.

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

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

approach to an approach in which the use of pr edicted data, generated us ing validated models, is

considered along with information from open litera ture and studies specifically generated under

Part 161 requirements. All relevant information w ould be considered as pa rt of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain e ndpoints, especially physi cal/chemical and fate

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

for many antimicrobial pesticide chemicals. When considering biological prope rties, 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 predic ted data can fulfill one of the data needs for the

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

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

documentation on the scientific va lidity of the information. The de termination 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 provid e available information a nd data that will assist

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

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

1. Confirmation on the following label information:

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12 of 40 a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, applicatio n 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-agricultura l uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant dama ge 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 scenari o, specifically those listed below. In the

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

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

will assume that all such facilities in th e 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 to wer 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 ma nufacturing sites using PHMB or the

maximum annual production volume of PHMB used in the adhesive

formulation industry in the Unite d States and its territories;

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

treatment.

Next Steps:

After the 60-day comment period closes in A ugust 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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13 of 40 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 (P M): Jacqueline Campbell-McFarlane,

campbell-mcfarlane. jacqueline@epa.gov

 Chemical Structure:

Use & Usage Information:

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

sanitizer in swimming pools, spas and hot t ubs; a materials preserva tive in architectural

and industrial coatings, textiles and cellulosi c material, glues and a dhesives, leather and

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

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

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

commercial, institutional, industrial premis es 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 Fa te, and Ecological Effects Scoping

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

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

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

however, a quantitative risk as sessment was not performed.

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14 of 40  PHMB demonstrates low toxici ty to birds and mammals and high toxicity to freshwater

invertebrates and very high toxicity to fis h. 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 envir onments 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 id entified in the RED as likely to result in

significant outdoor exposure; th erefore, labels will be upda ted 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 hu man 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 invo lving intentional exposure of human subjects

to PHMB brought to its attention. If EPA d ecides 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 re view and Human Studies Review Board review of certain

research involving intentional exposure of human subjects.

Hazard Characterization:

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

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

is a moderate skin sensitizer.

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

“Suggestive Evidence of Carcinogenicit y, but Not Sufficient to Assess Human

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

dermal routes.

Dietary (Food and Water):

 A drinking water assessment has not been c onducted 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 a ssessment 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 c oncern were identified for the use of PHMB

as a food contact sanitiz er at up to 550 ppm.

Residential:

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15 of 40  Residential handler dermal a nd inhalation exposures to PHMB were assessed in the 2004

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

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

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

assessment identified any risks of concern. Although this human de rmal sensitization

study and its endpoint were used by EPA to a ssess 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 di scussion 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 a nd 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 additi on scenarios for the various use patterns

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

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

case of oil production. To mitigate the risks ar ising 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 w ith 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 comm on 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:

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

www.regulations.gov

16 of 40  EPA’s Office of Pesticide Programs has revi ewed a total of 118 individual incidents

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

residential use of PHMB swimming pool pr oducts 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 inci dent cases were derm al, ocular, ingestion,

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

to an individual incident case (e.g., both de rmal and ocular expos ure). The most common

symptoms reported for each e xposure route are as follows:

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

discoloration/redness, allerg ic reaction, and blistering.

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

and allergic reactions.

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

mouth/throat, respiratory irritation in cluding coughing/choking, and diarrhea.

o Inhalation exposure: respirator y irritation and coughing/choking.

Tolerances and International Harmonization:

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

residues of PHMB in or on a ll food commodities when the resi dues are the result of the

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

million (ppm).

Data Call-In Status:

 The Agency anticipates issuing a post-RED da ta 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 anticipat ed as being needed in this document.

Labels:

Registered products, including EP A registration numbers are provi ded in Table 1 below. Product

registration labels may be obtained from the Pe sticide 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

17 of 40 1258-1265 Baquacil Ultra

Swimming Pool

Sanitizer &

Fungicide Ready-to-Use

Solution 20.0

1258-1275 A-Br eeze 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

18 of 40 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 documen t (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 ac ute toxicity, freshwater

daphnids TGAI: 20% & 96.3% 4 

# 12

850.1025 Oyster acute toxicity test 5 

# 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 toxicity 6 

# 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 II 7 

# TGAI: 20% & 96.3% 4 

# 12

4 

# Anticipated data are expected to be required on both the 20% and 96.3% technical gr ade 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 pol ymer characterization and; th erefore, ecological hazard

across products. If information is provided to the Agency proving that polymer characteri zation 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 exp ected 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

www.regulations.gov

19 of 40 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 85 0.5400 for the following four specie s: green algae, freshwater diatom,

marine diatom and cyanobacterium speciesIV. Appendix A: Use Patterns – PHMBEPAReg #Formulation% A. I. Use Site Treatment Site/Surfaces ApplicationMethodMin AppRateMaxAppRateMax AppRateConvertedUnits Use Limitations1258-1252Liquid 20.00% Formulation Use1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodHousehold and ConsumerProducts such as surfacecleaners, floor cleaners,disinfectanUsanitizers (nonfood contact, hard surfaceuses), fabric stain removers,fabric softeners, fabricconditioners, laundrydetergents, laundry additives,automotive care siliconeemulsions and automotivecleaning products.Meteredincorporation2.5lb/10,000lbsproduct25lbs/10,000 lbsproduct2500ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodJanitorial products, chemicaltoilet deodorantsMeteredincorporation3.2 fl.Oz/100gal ofwater64 fl.Oz/100gal ofwater5000ppm oz/gal1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous based polymerlattices such as polyvinylacetate and polyvinyl alcoholMeteredincorporation5lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodArchitectural and industrialcoatings including electro coatresins anddeposition systemsMeteredincorporation10lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs Do not use topreserve latticesused for papercoatingcompositionsDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov21 of 40that may contactfood.1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous Based Adhesivessuch as animal glues, latexadhesives based on polyvinylacetate, PVA, etc., starch,synthetic, dextrin, casein andother gluesMeteredincorporation5lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous Mineral Slurries suchas calcium carbonate andtitanium dioxideMeteredincorporation5lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodFresh Animal Hides and Skins Meteredincorporation1 lb/1,000lbsproduct2.6lbs/1,000lbsproduct2600ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodLeather Processing Meteredincorporation1lb/10,000lbsproduct30lbs/10,000 lbsproduct3000ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous Industrial Chemicalssuch as reagents, oil-in-wateremulsions, water-in-oilemulsions, textile spin finishlubricants, wash water andcellulose solutionsMeteredincorporation1lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoor/Outdoor NonfoodSilicone Meteredincorporation1lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbsDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov22 of 401258-1253SolubleConcentrate20.00% Industrialprocessesand watersystemsIndoorNonfoodTunnel Pasteurization Waters Meteredincorporation13 fl.Oz/1000gal ofwater1gal/1000gal ofwater1000ppm ozgal/gal1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodCat litter Meteredincorporation2.5lb/1,000lbsproduct100lbs/1,000lbsproduct10000ppm lbs/lbs1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodTextiles such as householdproducts, for example,upholstery, carpet, curtains,wall coverings, mops,dishcloths, yarns, cords,toweling and blankets.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodCellulosics such as wipes,tissues, sponges, paperproducts (non-food contact)such as filters and cellulosepulp.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C1258-1253SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodApparel items such as slacks,shirts, underwear, sweatshirts,sweatpants, socks, oven mitts,slippers, bathrobes, gloves,hats, scarves, jackets, sheets,pillowcases, incontinence padover stock, washableincontinence briefs andpanties.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 CDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov23 of 401258-1253SolubleConcentrate20.00% Industrialprocessesand watersystemsEnvironmentallycontainedOil recovery systems-oil fieldinjection watersMeteredincorporation19 floz/1,000gal water4gal/1,000barrels95ppm ozgal/barrels1258-1253SolubleConcentrate20.00% Industrialprocessesand watersystemsAquatic/outdoor exposureOil recovery systems- DrillingMudsMeteredincorporationNot listed 126gal/1,000barrels3000ppm gal/barrels1258-1253SolubleConcentrate20.00% Industrialprocessesand watersystemsAquatic/outdoor exposureOil recovery systemsWorkover fluidsMeteredincorporationNot listed 126gal/1,000barrels3000ppm gal/barrels1258-1253SolubleConcentrate20.00% Industrialprocessesand watersystemsAquatic/outdoor exposurePaper mills Meteredincorporation50ppm 1500ppm 1500ppm1258-1253SolubleConcentrate20.00% Industrialprocessesand watersystemsAquatic/outdoor exposureCooling Towers Meteredincorporation50ppm 1500ppm 1500ppm1258-1263Readyto-UseSolution20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov24 of 401258-1263Readyto-UseSolution20.00% SwimmingPoolsSpas and hot tubs Open Pour Not listed 1 oz/150gal wateroz/gal incompatiblewith chlorinatingchemicalproducts.1258-1263Readyto-UseSolution20.00% SwimmingPoolsKiddie Pools, Open Pour Not listed 1 oz/150gal wateroz/gal1258-1265Readyto-UseSolution20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.1258-1265Readyto-UseSolution20.00% SwimmingPoolsSpas and hot tubs Open Pour 0.2 oz/150gal water1 oz/150gal water(30ppmmin)50ppmoz/gal incompatiblewith chlorinatingchemicalproducts.1258-1275SolubleConcentrate/Solid96.30% SwimmingPoolsFreshly filled anddechlorinated poolsCartridge 1(200g)tablet/10000 gal2 (200g)tablets/10000 gal10ppm adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.1258-127796.30% Formulation Use1258-1324SolubleConcentrate20.00% Foodhandlingstorageestablishments premisesandequipmentIce Machines Spray, bruch,sponge, orclothNot listed Preclean,then 1 floz/3 galwater.Oneminutecontact540ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov25 of 40Indirect foodcontacttime. Donot rinse.equipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.1258-1324SolubleConcentrate20.00% Foodhandlingstorageestablishments premisesandequipmentIndirect foodcontactHard, non-porous surfaces infood processing equipment,food utensils, dishes,silverware, eating utensils,glasses, sink tops, countertops,refrigerated storage anddisplay equipment and otherhard, non-porous surfaces inrestaurants, and bars, bars,cafeterias, institutionalkitchens, fast food operationsand food storage areas.Spray, bruch,sponge, orclothNot listed Preclean,then 1 floz/3 galwater.Oneminutecontacttime. Donot rinse.540ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.1258-1324SolubleConcentrate20.00% Agriculturalpremises andequipmentIndirect foodcontactFishery, Milk, Citrus, Wine,Fruit, Vegetable, Ice Creamand Potato Processing Plantsand beverage plants.Spray, bruch,sponge, orclothNot listed Preclean,then 1 floz/3 galwater.Oneminutecontacttime. Donot rinse.540ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.1258-1324SolubleConcentrate20.00% Foodhandlingstorageestablishments premisesBeer and wine processingequipment and holding tanks.Spray, bruch,sponge, orclothNot listed Preclean,then 1 floz/3 galwater.One540ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) andDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov26 of 40andequipmentIndirect foodcontactminutecontacttime. Donot rinse.(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.1258-1324SolubleConcentrate20.00% Agriculturalpremises andequipmentIndirect foodcontactBottling and beverageequipment and dispensers andfinal rinse of bottles and cans.Spray, bruch,sponge, orclothNot listed Preclean,then 1 floz/3 galwater.Oneminutecontacttime. Donot rinse.540ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.1258-1324SolubleConcentrate20.00% Agriculturalpremises andequipmentIndirect foodcontactHard, non-porous surfaces indairy farms, hog farms, equinefarms, poultry and turkeyfarms and egg processingplants, meat/poultryprocessing plants,meat/poultry producingestablishments, mushroomfarms, rendering plants.Spray, bruch,sponge, orclothNot listed Preclean,then 1 floz/3 galwater.Oneminutecontacttime. Donot rinse.540ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov27 of 401258-1335SolubleConcentrate1.28% Foodhandlingstorageestablishments premisesandequipmentIndirect foodcontactIce Machines Spray, bruch,sponge, orclothPreclean,then 0.5 floz/galwater.Oneminutecontacttime. Donot rinse.Preclean,then 2 floz/galwater.Oneminutecontacttime. Donot rinse.600ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of540 ppm active.1258-1335SolubleConcentrate1.28% Foodhandlingstorageestablishments premisesandequipmentIndirect foodcontactHard, non-porous surfaces infood processing equipment,food utensils, dishes,silverware, eating utensils,glasses, sink tops, countertops,refrigerated storage anddisplay equipment and otherhard, non-porous surfaces inrestaurants, and bars, bars,cafeterias, institutionalkitchens, fast food operationsand food storage areas.Spray, bruch,sponge, orclothPreclean,then 0.5 floz/galwater.Oneminutecontacttime. Donot rinse.Preclean,then 2 floz/galwater.Oneminutecontacttime. Donot rinse.600ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of600 ppm active.1258-1335SolubleConcentrate1.28% Agriculturalpremises andequipmentIndirect foodcontactFishery, Milk, Citrus, Wine,Fruit, Vegetable, Ice Creamand Potato Processing Plantsand beverage plants.Spray, bruch,sponge, orclothPreclean,then 0.5 floz/galwater.Oneminutecontacttime. Donot rinse.Preclean,then 2 floz/galwater.Oneminutecontacttime. Donot rinse.600ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov28 of 40concentration of600 ppm active.1258-1335SolubleConcentrate1.28% Agriculturalpremises andequipmentIndirect foodcontactBeer and wine processingequipment and holding tanks.Spray, bruch,sponge, orclothPreclean,then 0.5 floz/galwater.Oneminutecontacttime. Donot rinse.Preclean,then 2 floz/galwater.Oneminutecontacttime. Donot rinse.600ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of600 ppm active.1258-1335SolubleConcentrate1.28% Agriculturalpremises andequipmentIndirect foodcontactBottling and beverageequipment and dispensers andfinal rinse of bottles and cans.Spray, bruch,sponge, orclothPreclean,then 0.5 floz/galwater.Oneminutecontacttime. Donot rinse.Preclean,then 2 floz/galwater.Oneminutecontacttime. Donot rinse.600ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingequipment,utensils, andother food -contact articlesat aconcentration of600 ppm active.1258-1335SolubleConcentrate1.28% Agriculturalpremises andequipmentIndirect foodcontactHard, non-porous surfaces indairy farms, hog farms, equinefarms, poultry and turkeyfarms and egg processingplants, meat/poultryprocessing plants,meat/poultry producingSpray, bruch,sponge, orclothPreclean,then 0.5 floz/galwater.OneminutecontactPreclean,then 2 floz/galwater.Oneminutecontact600ppm oz/gal This product hasbeen cleared bythe EPA in 40CFR Section180.940(a) and(c) for use onfood processingDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov29 of 40establishments, mushroomfarms, rendering plants.time. Donot rinse.time. Donot rinse.equipment,utensils, andother food -contact articlesat aconcentration of600 ppm active.3432-83Readyto-UseSolution20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.3432-83Readyto-UseSolution20.00% SwimmingPoolsSpas and hot tubs Open Pour 0.2 oz/150gal water1 oz/150gal water(30ppmmin)50ppmoz/gal incompatiblewith chlorinatingchemicalproducts.3573-89ImpregnatedMaterials0.10% Residentialand publcaccesspremisesIndoorNonfoodHard non-porous floors. Spray, mop Not listed Sprayuntil wet.10minutecontacttime.Removesexcess.Do notrinse.5813-75Readyto-UseSolution0.10% Residentialand publcaccesspremisesIndoorNonfoodHard non-porous floors. Spray, mop Not listed Sprayuntil wet.5 minutecontacttime.Removesexcess.Do notrinse.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov30 of 405813-77ImpregnatedMaterials0.50% Residentialand publcaccesspremisesIndoorNonfoodHard non-porous surfaces inhouseholds, bathrooms andnon-food contact kitchensurafcesWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry5813-77ImpregnatedMaterials0.50% Residentialand publcaccesspremisesIndoorNonfoodDiaper changing tables, highchairsWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry5813-77ImpregnatedMaterials0.50% Residentialand publcaccesspremisesIndoor/outdoor NonfoodAnimal kennels/sleepingquartersWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry5813-77ImpregnatedMaterials0.50% Commercial,institutionaland industrialpremisesIndoorNonfoodHard non-porous surfaces incommercial, institutional andindustrial premisesWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry5813-78ImpregnatedMaterials0.50% Residentialand publcaccesspremisesIndoorNonfoodHard non-porous surfaces inhouseholds, bathrooms andnon-food contact kitchensurafcesWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. AirdryDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov31 of 405813-78ImpregnatedMaterials0.50% Residentialand publcaccesspremisesIndoorNonfoodDiaper changing tables, highchairsWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry5813-78ImpregnatedMaterials0.50% Residentialand publcaccesspremisesIndoor/outdoor NonfoodAnimal kennels/sleepingquartersWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry5813-78ImpregnatedMaterials0.50% Commercial,institutionaland industrialpremisesIndoorNonfoodHard non-porous surfaces incommercial, institutional andindustrial premisesWipe Not listed Wipeuntilvisiblywet. 4minutecontacttime. Airdry7124-105Readyto-UseSolution20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.48520-19Readyto-UseSolution20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov32 of 4069461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodHousehold and ConsumerProducts such as surfacecleaners, floor cleaners,disinfectanUsanitizers (nonfood contact, hard surfaceuses), fabric stain removers,fabric softeners, fabricconditioners, laundrydetergents, laundry additives,automotive care siliconeemulsions and automotivecleaning products.Meteredincorporation2.5lb/10,000lbsproduct25lbs/10,000 lbsproduct2500ppm lbs/lbs69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodJanitorial products, chemicaltoilet deodorantsMeteredincorporation3.2 fl.Oz/100gal ofwater64 fl.Oz/100gal ofwater5000ppm oz/gal69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous based polymerlattices such as polyvinylacetate and polyvinyl alcoholMeteredincorporation5lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodArchitectural and industrialcoatings including electro coatresins anddeposition systemsMeteredincorporation10lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs Do not use topreserve latticesused for papercoatingcompositionsthat may contactfood.69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous Based Adhesivessuch as animal glues, latexadhesives based on polyvinylacetate, PVA, etc., starch,synthetic, dextrin, casein andother gluesMeteredincorporation5lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbsDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov33 of 4069461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous Mineral Slurries suchas calcium carbonate andtitanium dioxideMeteredincorporation5lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodFresh Animal Hides and Skins Meteredincorporation1 lb/1,000lbsproduct2.6lbs/1,000lbsproduct2600ppm lbs/lbs69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodLeather Processing Meteredincorporation1lb/10,000lbsproduct30lbs/10,000 lbsproduct3000ppm lbs/lbs69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonfoodAqueous Industrial Chemicalssuch as reagents, oil-in-wateremulsions, water-in-oilemulsions, textile spin finishlubricants, wash water andcellulose solutionsMeteredincorporation1lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs69461-1SolubleConcentrate20.00% MaterialspreservativeIndoor/Outdoor NonfoodSilicone Meteredincorporation1lb/10,000lbsproduct50lbs/10,000 lbsproduct5000ppm lbs/lbs69461-1SolubleConcentrate20.00% Industrialprocessesand watersystemsIndoorNonfoodTunnel Pasteurization Waters Meteredincorporation13 fl.Oz/1000gal ofwater1gal/1000gal ofwater1000ppm ozgal/gal69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodCat litter Meteredincorporation2.5lb/1,000lbsproduct100lbs/1,000lbsproduct10000ppm lbs/lbsDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov34 of 4069461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodTextiles such as householdproducts, for example,upholstery, carpet, curtains,wall coverings, mops,dishcloths, yarns, cords,toweling and blankets.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodCellulosics such as wipes,tissues, sponges, paperproducts (non-food contact)such as filters and cellulosepulp.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C69461-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodApparel items such as slacks,shirts, underwear, sweatshirts,sweatpants, socks, oven mitts,slippers, bathrobes, gloves,hats, scarves, jackets, sheets,pillowcases, incontinence padover stock, washableincontinence briefs andpanties.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C69461-1SolubleConcentrate20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.69461-1SolubleConcentrate20.00% SwimmingPoolsSpas and hot tubs Open Pour Not listed 1 oz/150gal wateroz/gal incompatiblewith chlorinatingchemicalproducts.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov35 of 4071661-1Readyto-UseSolution0.56% Medicalpremises andequipmentBarber Shops, salons cloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipeclean71661-1Readyto-UseSolution0.56% Medicalpremises andequipmentHard non-porous surfaces inhospitals, dental offices andnursing homescloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipeclean71661-1Readyto-UseSolution0.56% Residentialand publcaccesspremisesIndoor/outdoor NonfoodAnimal kennels/sleepingquarters/laboratoriescloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipecleanDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov36 of 4071661-1Readyto-UseSolution0.56% Residentialand publcaccesspremisesIndoorNonfoodHard non-porous surfaces inhouseholds, bathrooms andnon-food contact kitchensurafcescloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipecleansurfaces thatcome in contactwith food,includingequipment usedfor feeding orwatering, shouldbe rinsed withpotable waterbefore reuse.71661-1Readyto-UseSolution0.56% Agriculturalpremises andequipmentIndirect foodcontactHard non-porous surfaces inmeat, poultry, shell egggrading and egg productsestablishments.cloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipecleansurfaces thatcome in contactwith food,includingequipment usedfor feeding orwatering, shouldbe rinsed withpotable waterbefore reuse.71661-1Readyto-UseSolution0.56% Agriculturalpremises andequipmentIndirect foodcontactHard non-porous surfaces infarm premises, vehicles andenclosurescloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipecleansurfaces thatcome in contactwith food,includingequipment usedfor feeding orwatering, shouldbe rinsed withpotable waterbefore reuse.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov37 of 4071661-1Readyto-UseSolution0.56% Agriculturalpremises andequipmentIndirect foodcontactMushroom farm premises cloth, mop,sponge, sprayor immersionNot listed Saturatesurfaces.1 minutetodisinfect,10minutestosanitize.Air dryor wipecleansurfaces thatcome in contactwith food,includingequipment usedfor feeding orwatering, shouldbe rinsed withpotable waterbefore reuse.75512-1ImpregnatedMaterials0.10% Medicalpremises andequipmentHard non-porous surfaces inhospitals, outpatient surgerycenters, recovery rooms,radiology treatment areas,medical offices and dentaloffices, and laboratories.Wipe Not listed Wipeuntilvisiblywet. 10minutecontacttime. Airdry75512-1ImpregnatedMaterials0.10% Medicalpremises andequipmentHard non-porous critical orsemicritical devices prior tosterilization or high leveldisinfection.Wipe Not listed Wipeuntilvisiblywet. 10minutecontacttime. Airdry75512-1ImpregnatedMaterials0.10% Residentialand publcaccesspremisesIndoorNonfoodHard non-porous surfaces inhouseholds, bathrooms andnon-food contact kitchensurafcescloth, mop,sponge, sprayor immersionNot listed Wipeuntilvisiblywet. 10minutecontacttime. AirdryDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov38 of 4079755-4SolubleConcentrate0.08% Agriculturalpremises andequipmentIndirect foodcontactHard non-porous surfaces infarm premises, vehicles andenclosurescloth, mop,sponge, sprayor foamerNot listed 2.6oz/gal ofwater. 10minutecontacttime. Airdry79755-4SolubleConcentrate0.08% Medicalpremises andequipmentHard non-porous surfaces inveterinary practice premisescloth, mop,sponge, sprayor foamerNot listed 2.6oz/gal ofwater. 10minutecontacttime. Airdry79755-4SolubleConcentrate0.08% Residentialand publcaccesspremisesIndoor/outdoor NonfoodAnimal kennels/sleepingquarters/laboratoriescloth, mop,sponge, sprayor foamerNot listed 2.6oz/gal ofwater. 10minutecontacttime. Airdry79755-5Readyto-UseSolution0.16% Agriculturalpremises andequipmentIndirect foodcontactHard non-porous surfaces infarm premises, vehicles andenclosurescloth, mop,sponge, sprayor foamerNot listed Apply tosurfaceuntilvisiblywet. 10minutecontacttime. Airdry79755-5Readyto-UseSolution0.16% Medicalpremises andequipmentHard non-porous surfaces inveterinary practice premisescloth, mop,sponge, sprayor foamerNot listed Apply tosurfaceuntilvisiblywet. 10minutecontacttime. AirdryDocket Number: EPA-HQ-OPP-2012-0341www.regulations.gov39 of 4079755-5Readyto-UseSolution0.16% Residentialand publcaccesspremisesIndoor/outdoor NonfoodAnimal kennels/sleepingquarters/laboratoriescloth, mop,sponge, sprayor foamerNot listed Apply tosurfaceuntilvisiblywet. 10minutecontacttime. Airdry79755-6SolubleConcentrate0.40% Agriculturalpremises andequipmentIndirect foodcontactHard non-porous surfaces infarm premises, vehicles andenclosurescloth, mop,sponge, sprayor foamerNot listed 0.5oz/gal ofwater. 10minutecontacttime. Airdry79755-6SolubleConcentrate0.40% Medicalpremises andequipmentHard non-porous surfaces inveterinary practice premisescloth, mop,sponge, sprayor foamerNot listed 0.5oz/gal ofwater. 10minutecontacttime. Airdry79755-6SolubleConcentrate0.40% Residentialand publcaccesspremisesIndoor/outdoor NonfoodAnimal kennels/sleepingquarters/laboratoriescloth, mop,sponge, sprayor foamerNot listed 0.5oz/gal ofwater. 10minutecontacttime. Airdry81002-2SolubleConcentrate20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater3/4gal/15000 gal ofwater(30ppmmin)50ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.Docket Number: EPA-HQ-OPP-2012-0341www.regulations.gov40 of 4081002-3SolubleConcentrate20.00% SwimmingPoolsFreshly filled anddechlorinated poolsOpen Pour 1pint/10000 gal ofwater1/2gal/10000 gal ofwater(50ppmmin)100ppmgal/gal adjust to 7.2-7.8if necessary.incompatiblewith chlorinatingchemicalproducts.81002-3SolubleConcentrate20.00% SwimmingPoolsSpas and hot tubs Open Pour 0.2 oz/150gal water1 oz/150gal wateroz/gal incompatiblewith chlorinatingchemicalproducts.87203-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodTextiles such as householdproducts, for example,upholstery, carpet, curtains,wall coverings, mops,dishcloths, yarns, cords,toweling and blankets.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C87203-1SolubleConcentrate20.00% MaterialspreservativeIndoorNonofoodCellulosics such as wipes,tissues, sponges, paperproducts (non-food contact)such as filters and cellulosepulp.Meteredincorporation0.025%wt/wt2.0%wt/wtwt/wt optimumconditions forapplication ofthe dilutesolution are pH6.5-8 andtemperature of20-30 C