Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov

United States Preventi on, Pesticides March 2010

Environmental Protection and Toxic Substances Agency (7510P)



# Decyl Isononyl Dimethyl Ammonium

Chloride (DIDAC) Summary Document: Registration ReviewDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 3 of 37 

## TABLE OF CONTENTS

Decyl Isononyl Dimethyl A mmonium Chloride (DIDAC) Registration Review Team ............................................................................................... 4

I. PRELIMINARY WORK PLAN – DIDAC................................................................. 5

II. FACT SHEET ............................................................................................................ 19

III. GLOSSARY of TERMS & ABBREVIATIONS ................................................... 23

IV. APPENDIX A............................................................................................................ 25Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 4 of 37 DIDAC Registration Review Team

Human Health & Environmental Effects

Tim McMahon

Srinivas Gowda

Risk Management

Monisha Harris

Lance Wormell

Office of General Counsel Philip RossDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 5 of 37 I. PRELIMINARY WORK PLAN – Decyl Isononyl Dimethyl Ammonium Chloride (DIDAC)

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated the registration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protec tion 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 di rected on product labe ling. 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, th e Agency periodically reevaluate s pesticides to make sure that as change occurs, products in the mark etplace 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 de termine 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 re gistration 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 registrati on review decision. After reviewing and responding to comments and data received in the docket during th is initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration review of D ecyl Isononyl Dimethyl Amm onium Chloride (DIDAC).

DIDAC (PC Code 069207) is known by the trade name Bardac 2180. Bardac 2180 is also known by the chemical name of isobardac. DIDAC is considered structurally similar to Didecyl Dimet hyl Ammonium Chloride (DDAC) (PC Code 069149) and data developed for DDAC were us ed to support the init ial registration of

DIDAC in 1995. DDAC, as we ll as Alkyl Dimethyl Ethyl Ammonium Bromide, Octyl Decyl Dimethyl Ammonium Chloride, and Di octyl Dimethyl Ammonium Chloride are structurally similar and ar e collectively referred to as the Group I "quaternary compounds" or "quats" as published in PR Notice 88-2 on 2/26/88. Therefore, the Agency will continue to use information fr om the DDAC database to support the DIDAC registration review. Becaus e DIDAC was first registered after November 1, 1984, a reregistration eligibility decision (RED) wa s not issued. A RED was issued in 2006 for

DDAC.

Currently, there are six active products fo r the active ingredient (AI) DIDAC. Registered products contain between 10 a nd 80% AI. Products containing DIDAC are registered for use in/on agricultural prem ises and equipment, food handling/storageDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 6 of 37 establishment premises and equipment, commer cial, institutional and industrial premises and equipment, residential and public access premises, materials and preservatives, medical premises and equipment, industria l processes and water systems, antifouling coatings, wood preservatives, swimming pools, and aquatic areas. DIDAC products are also registered for use as disinfectants, sa nitizers, fungicides, wood preservatives, and

water treatment microbiocides (for cooling towers, pools and spas, oil field flood waters, and pulp and paper mills), and for use in swimming pools and spas as an algaecide, industrial water cooling systems (recircul ating/once-through, evaporative condensers, heat exchange water systems, commercial a nd industrial cooling towe rs, influent systems such as flow-through filters and lagoons, i ndustrial water scrubbing systems and brewery pasteurizers) and pulp/paper mills for control of algae and slime, and as a slimicide in the manufacture of paper and paper board that does not contact food.

Risk Assessment Status & Anticipated Data Needs

Human Health Risk Assessment Status and Anticipated Data Needs

The Agency reviewed the hazard an d exposure databases for the DIDAC registration review case and an ticipates that additional toxi city and exposure studies will be needed for registration review. Th e Agency will need to conduct occupational

inhalation and dermal risk assessments ba sed on exposure to DIDAC through use in antifouling coatings. The Agency will need to conduct a dietary assessment based on indirect dietary exposure. There will also be a need for drinking water assessment of DIDAC based on the materials preservative s, and industrial slimicides use in recirculating cooling water towers and pape r mills that potentia lly pass through waste water treatment plants and may be discharged into terrestr ial and aquatic environments.

Dietary and Drinking Water Assessment

Dietary Exposure

Because DIDAC products are registered fo r use in/on agricultural premises and equipment and food handling/storage establishm ent premises and equipment, there is the potential for dietary exposure to DIDAC through indirect food c ontact. A dietary

assessment was conducted for DDAC for the 2006 DDAC RED. No risk of concern was identified in the RED; however, confirmatory data were required. Based on the review of the confirmatory data, the Agency anticipates reviewing the dietary risk assessment used to support the 2006 DDAC RED and, if necessary , will update the asse ssment to address potential exposure to DIDAC.

Drinking Water Exposure

DIDAC end-use registrations that could pot entially impact wate r are registrations for use as an algaecide and for control of al gal and bacterial slimes in once-through water cooling towers, and pulp and paper mills. The current indoor uses of DIDAC are expected to result in minimal residues in dr inking water supplied by residential wells orDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 7 of 37 municipal sources because re-circulating wate r cooling towers are expected to have infrequent discharges and the effluents from recirculating cooling to wers are regulated by NPDES permits.

Tolerances



### Quaternary ammonium compounds have a tolerance exemption in 40 CFR 180.940 (a) as a food contact sanitizer for use in public eating places, in dairy processing equipment, and in food processing plants on equipment and utensils and (c) as a food contact sanitizer for use in food proce ssing plants on equipment and utensils.

Aggregate and Cumulative Exposure

In examining aggregate exposure, EP A takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non-occupationa l pesticide exposures. Base d on current use patterns, an aggregate risk assessment will be needed for DIDAC for dietary (food and drinking water) and residential exposure.

Section 40(b)(2)(D)(v) of FFDCA requi res that, when considering whether to establish, modify, or revoke a tolerance, th e Agency considers “available information” concerning the cumulative effects of a part icular pesticide’s residues and “other

substances that have a common mechanism of toxicity. The Agency has not made a common mechanism of toxicity determin ation for DIDAC or other quaternary ammonium compounds and DIDAC does not appear to produce a toxic metabolite produced by other substances. For the purposes of this regi stration review, therefore, a cumulative assessment for DIDAC will not be performed at this time.

Occupational and Resi dential Assessment

The Agency reviewed all available data associated with DIDAC and DDAC and has determined that the currently registered uses of DIDAC may result in residential and occupational exposure. Exposure and risk assessments were conducted for DDAC to support the 2006 DDAC RED. The Agency an ticipates updating these assessments as appropriate to include all registered uses of DIDAC including those such as the antifoulant coating use that we re not applicable for DDAC an d, thus, not included in the 2006 assessment. The Agency anticipates n eeding exposure studies to properly assess exposure to DIDAC in antifouling coatings.

Anticipated Human Health Data Needs

The Agency anticipated n eeding the following toxicity and exposure studies to assess the DIDAC registration review case:

Anticipated Human Health Toxicity Data Needs

o (GLN 870.3465) 90-day Inha lation Toxicity StudyDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 8 of 37 Anticipated Occupational/Resid ential Exposure Data Needs

As noted in the DDAC RED, “The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure data available from the Chemical Manufacturers Association (CMA) data base . Therefore, the Agency is requiring confirmatory data to support the uses assessed with the CM A exposure data within this

risk assessment. The risk assessment also noted that many of the use parameters (e.g., amount handled and duration of use) were ba sed on professional judgments. Therefore, descriptions of human activi ties associated with the uses assessed are required as confirmatory.” Based on the review of the confirmatory data, the Agency anticipates reviewing the occupational/r esidential exposure assessmen t used to support the 2006 DDAC RED and, if necessary, will update th e assessment to address potential exposure

to DIDAC.

The Agency anticipates needing the data identified below, for DIDAC.

o (GLN 875.1200) Dermal Exposure

o (GLN 875.1400) Inhalation Exposure

o (GLN 875.1600) Applicator Exposur e Monitoring Data Reporting

o (GLN 875.2300) Fabric Leaching Study

o (GLN 875.2300) Surface Wood Wipe Study

o (GLN 875.2800) Description of Human Activity (all uses)

o (GLN 875.2900) Data Repor ting and Calculations

Anticipated Residue Chemistry Data Needs

o (GLN 860.1460) Food Handling* *Dietary-Residues in Food from Treating Countertops with DIDAC (FDA Wipe Study Methodology) (FDA, 2003a and 2003b)

Further information and detailed justificat ions for the studies that are expected to be required are available in “Summary of Human Health Effects Data for the Decyl Isononyl Dimethyl Ammonium Chloride (D IDAC) Registration Review Decision

Document,” dated March 26, 2010.

Product Chemistry Status and Anticipated Data Needs

The data submitted pertaining to the physical and chemical characteristics of the active ingredient DIDAC are adequate. All product chemistry data requirements have been fulfilled for the active ingredient DIDAC. Therefore, the Agency does not anticipate the need to require additional product chem istry data for DIDAC at this time.

For further information please refer to the Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Decyl Isononyl Dimethyl Ammonium Chloride Registration Review D ecision Document, dated March 29, 2010.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 9 of 37 Environmental Fate and Ecological Risk A ssessment Status and Anticipated Data

Needs

The Agency has evaluated the available e nvironmental fate and ecological effects data on DDAC submitted by the registrant. Wh en DIDAC was first registered in 1995, the Agency concluded that the chemical stru ctures of DDAC and DIDAC are structurally

similar; therefore, the environmental fate and ecological effect s studies developed on DDAC will be used to evaluate DIDAC as part of this registration review. The Agency will complete the environmental fate and ecological hazard risk assessments presented

below.

• Environmental fate

• Ecological hazard

• Endangered species assessment

Further information and detailed justificat ion for the studies that are expected to be required are available in the document titled, Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Decyl Isononyl Dimethyl Ammonium Chloride Registration Review D ecision Document, dated March 29, 2010.

Environmental fate and ecological risk assessments have not been conducted for DIDAC. DIDAC uses that have potentia l for environmental exposure are swimming pools water, material preserva tives, industrial slimicides used in recirculating water cooling towers, and paper mills discharges. The Agency needs to conduct environmental fate and ecological risk assessments for swim ming pools water, material preservatives,

and industrial slimicides used in recirculati ng water cooling towers and paper mills that potentially pass through waste water treatmen t plants (WWTPs) and may be discharged into terrestrial and aquatic environments. Also, the Agency needs to conduct an ecological risk assessment for DIDAC used in once-through water cooling towers for control of microbiologi cal growth and that likely would be discharged into effluents and surface waters. The Agency also needs to conduct an ecological risk assessment for DIDAC used in aquatic areas to control or kill slime-forming b acteria, fungi, or algae. In addition, the Agency needs to conduct an ecol ogical risk assessment for DIDAC used in wood preservatives and antifouling coatings. Th erefore, the Agency anticipates requiring

the identified environmental fate and ecotoxic ity data for DIDAC and/or any of its major degradation products that are of potential c oncern for all registered uses of DIDAC.

Anticipated Environmental Fate Data Needs (Indoor Use)

o (GLN 850.6800) modified activated sludge respiration inhibition

o (GLN 835.1110) activated sl udge sorption isotherm

Anticipated Ecological Da ta Needs (Indoor Use)

o (GLN 850.4225) seedling emergence, Ti er II - dose response study on rice (Oryza sativa)Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 10 of 37 o (GLN 850.4250) vegetative vigor, Ti er II - dose response study on rice (Oryza sativa)

o (GLN 850.4400) aquatic plant growth (a quatic vascular plant toxicity), Tier II - dose response study on floating macrophyte Lemna gibba

o (GLN 850.5400) aquatic plant growth (a lgal toxicity), Tier II - dose response studies on Anabaena flos- aquae (blue-green cyanobacteria), Navicula pelliculosa (freshwater di atom), and Skeletonema costatum (marine diatom)

Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for Antifoulant Coatings Uses of DIDAC

For use in this registration revi ew, the following ecological effects and environmental fate data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number

850.1045: Acute Penaeid; 850.1300: Daphnid chronic toxicity test; 850.1350: Mysid chronic toxicity test - Aquatic invertebrate life cycle 850.1400: Fish early-life stage toxicity studies 850.4225: Seedling emergence 850.4250: Vegetative vigor 850.4400: Aquatic plant growth usi ng floating macrophyte Lemna gibba 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1735: Whole sediment, acute invertebrates (freshwater)

850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailability /biomagnifications, toxicity tests 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Special leaching study (ASTM 6903-07) None: (Special study) Monitoring of repr esentative U. S. waters (residue of

concern)Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 11 of 37 Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for

Outdoor Wood Preservative Uses of DIDAC

For DIDAC registered for treatment of wood products used in outdoor scenarios (e.g., decks, decking materials, aquatic uses ), the Agency antici pates requiring the following data in order to conduct the e nvironmental fate and ecological risk assessments, including an endangered species assessment. However, note that expected data needs may depend on factors such as the quantities of DIDAC (and/or major degradates or metabolites) leaching from w ood; the types of chemical(s) leaching from wood (e.g., parent compound, major degradat es or metabolites); the outdoor use

scenarios in which DIDAC-treat ed wood may be used; and th e Agency's evaluation of leaching data along with the available use, effects, and exposure information for DIDAC:

Anticipated Ecological Effects and Environmental Fate Study Needs 1



### For use in this registration revi ew, the following ecological effects and environmental fate data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.4225: Seedling emergence 850.4250: Vegetative vigor 850.4400: Aquatic plant growth usi ng floating macrophyte Lemna gibba 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1045: Acute Penaeid 850.1300: Daphnid chronic toxicity test 850.1350: Mysid chronic toxicity test 850.1400: Fish early-life stage toxicity studies 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailability /biomagnifications, toxicity tests

850.1735: Whole sediment, acute invertebrates (freshwater)

850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.3020: Honeybee acute contact LD 50 

### 850.3030: Honey Bee Toxicity of Residues on Foliage 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

1 Test material for anticipated studi es would depend in part on what chemicals are leaching from DIDACtreated wood.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 12 of 37 Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number

835.4200: Anaerobic soil metabolism 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Soil leac hing from wood study (AWPA E20-04) None: (Special study) Monitoring of repr esentative U. S. waters (residue of

concern)

Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for Aquatic Areas Use Pattern of DIDAC

For use in this registration revi ew, the following ecological effects and environmental data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.1300 Aquatic invertebrate chronic NOAEC using Daphnia magna 850.1350 Aquatic invertebrate chronic NOAEC using mysid shrimp 850.1400: Fish early-life stage and a quatic invertebrate life-cycle 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.4225: Seedling emergence 850.4250: Vegetative vigor dose response test using rice 850.4400: Aquatic plant growth using floa ting macrophyte Lemna gibba - Tier II 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1045: Acute Penaeid 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailabil ity/biomagnification/toxicity tests

850.1735: Whole sediment, acute invertebrates (freshwater)

850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 835.6200: Aquatic (sediment) Field DissipationDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 13 of 37 None: (Special study) Monitoring of repr esentative U. S. waters (residue of

concern)

Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for Once-Through Cooling Water Systems Use Pattern of DIDAC

DIDAC is intended for use in once-through indus trial cooling water systems in which the

water is not re-used, and is re leased after a single cycle thro ugh the system, and therefore, the Agency anticipates requiring the following data in order to conduct the environmental fate and ecological risk assessments, includ ing an endangered species assessment.

Anticipated Ecological Effects and Environmental Fate Study Needs

For use in this registration review, the following ecological effects and environmental data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.1300 Aquatic invertebrate chronic NOAEC using Daphnia magna 850.1350 Aquatic invertebrate chronic NOAEC using mysid shrimp 850.1400: Fish early-life stage and aquati c invertebrate life-cycle studies 850.4225: Seedling emergence 850.4400: Aquatic plant growth using floa ting macrophyte Lemna gibba - Tier II 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1045: Acute Penaeid 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailabil ity/biomagnification/toxicity tests

850.1735: Whole sediment, acute invertebrates (freshwater)

850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.4250: Vegetative vigor dose response test using rice – Tier II (Oryza sativa) 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 835.1110: Activated sludge sorption isotherm

850.6800: Modified activated slud ge, respiration inhibitionDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 14 of 37 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Monitoring of repr esentative U. S. waters (residue of

concern)

Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species determination. The eco logical risk assessment planned during registration review will allow the Agency to determine whether use of DIDAC has “no effect” or “may affect” federally listed threat ened or endangered sp ecies (listed species) or their designated critical ha bitats. When an assessment c oncludes that a pesticide’s use “may affect” a listed species or its designate d critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

Incidents:

As discussed in the DDAC RED, there were many reported incidents associated with exposure to end-use products containing quats. However, as also noted, for the

available incident information, it was difficult to differentiate the specific members of the quats involved in each incident. Therefor e, all the quats are discussed together.

Most of the incidents are re lated to irritation. Allergic type reactions have also been reported in some incidents. Symptoms associated with eye irritation are the most commonly reported associated with quaternary ammonium e xposure. The most common symptoms reported for cases of ocular e xposure were eye irritation/burning, eye pain, conjunctivitis, swelling eye and swelling of eyelid. The most common symptoms reported for cases of inhalation exposure were respiratory irritati on/burning, irritation to mouth/throat/nose, coughing/c hoking, chest pain, di sorientation, dizziness, shortness of breath. The most common symptoms reported for cases of dermal exposure were skin irritation/burning, rash, itching, and blistering. Allergic type reactions including hives and allergic contact dermatitis, have also been reported. Although oral exposure is considered a minor route of exposure for qua ts use, irritation to mouth/throat/nose, vomiting/nausea/abdominal pain, dizziness, and headache have been reported in the cases of ingestion.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 15 of 37 Timeline:

EPA has created the following estimated timeline for the completion of the DIDAC registration review:

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period fo r DIDAC Docket March 2010

Close Public Comment Period May 2010

Phase 2: Case Development

Develop Final Work Plan (FWP) September 2010

Issue DCI September 2011

Data Submission September 2015

Open Public Comment Period for Preliminary Risk Assessments March 2016

Close Public Comment Period June 2016

Phase 3: Registration Review Decision

Open Public Comment Period for Propos ed Reg. Review Decision September 2016

Close Public Comment Period December 2016

Final Decision and Begin Post-Decision Follow-up 2017

Total (years) 7

Guidance for Respondents:

The public is invited to co mment on EPA’s preliminary registration review work plan and rationale. The Agency will caref ully consider all comments as well as any

additional information or data provided in a timely manner pr ior to issuing a final work plan for the DIDAC regi stration review case.

Trade Irritants

Through the registration review process, th e 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 ma rkets, providing as much specificity as possible regarding the nature of the concern.

Water Quality

DIDAC 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/attain s_nation_cy.cause_detail_303d?p_cause_grou p_id=885 . In addition, no Total Maximum Daily Loads (TMDL) have been developedDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 16 of 37 for [insert pesticide], based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant _detail?p_pollutant_gr oup_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 Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice

EPA seeks to achieve environmental justi ce, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcemen t 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 factor s, may have atypical, unusually high exposure to DIDAC compared to the general populati on. Please comment if you are aware of any sub-populations that may have atypical, unusua lly high exposure compared to the general population.

Structure Activity Relationships

EPA must rely upon information of appropr iate quality and reliability for each decision made by the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide chemical traditionally begins with the appli cant’s submission of a

set of studies conducted with th e 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 environmen tal 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 a lternative techniques, i.e., techniques other than data generation that could significan tly inform the Agency’s decision-making process. Recently, OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory d ecision-making process. In th e SAR process, a chemical's molecular structure is compared to that of other chemicals fo r which data are available.

These structural similarities are then us ed to make predictive judgments about a chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, chemical, and biological propertie s are a function of (o r directly related to) the chemical’s molecular structure. Quantitative SAR is re ferred to as QSAR. To develop a QSAR, a selected set of measured data on a single phys ical, chemical, or bi ological property is used to derive a model (an equation) to predict the valu e of that property.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 17 of 37 Since SAR assessments and QSAR modeli ng 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 appro ach to an approach in which the use of predicted data, generated using validated models, is cons idered along with information from open literature and studies specifi cally generated under Part 161 requirements. All relevant information would be considered as part of a weight-of-the-evidence evaluation.

At this time, EPA believes that for cert ain 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 c onsidering biological properties, at this time, EPA believes that SAR and QSAR can be most effectively

utilized in the evaluation of ch emicals that exhibit lower toxi city 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 screen ing-level assessment pr ocedure rather than multiple tiers of assessments with pr ogressively more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for DIDAC, then the Agency invites s ubmission of this information. The submitter would be expected to supply a rationale desc ribing the utility of the information and provide documentation on the scie ntific validity of the info rmation. The determination that the predicted data fulfills the data require ment would be at the sole discretion of the Agency. Pre-submission consultation with the Agency is encouraged.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p) , EPA has developed the Endocrine Disruptor Screening Program (EDSP) to dete rmine whether certain substances (including pesticide active and other ingred ients) may have an effect in humans or wildlife similar to an effect produced by a “natur ally occurring estrogen, or othe r such endocrine effects as the Administrator may designate.” The ED SP 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 substa nce 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 inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP wher e EPA will determine which, if any, of the Tier 2 tests are necessary based on the avai lable data. Tier 2 te sting is designed to identify any adverse endocrine related eff ects caused by the substance, and establish a dose-response relationship between th e dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which c ontains 58 pesticide ac tive ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 18 of 37 DIDAC is not among the group of 58 pesticid e active ingredients on the initial list

to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticip ates issuing future EDSP test orders/data call-ins for all pesticide active ingredients.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

Additional Information

Stakeholders are also specifically asked to provide available information and data in the following areas:

1. Confirmation on the following label information:

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, app lication 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 mo rtalities) not already reported to the Agency

8. Monitoring data

9. Structure Activity Relationships

Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for

DIDAC.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 19 of 37 II. FACT SHEET

Background Information

• Chemical Name: Decyl Isononyl Dimethyl Ammonium Chloride (DIDAC)

• Common Names: 1-Decanaminium, N- isononyl-N,N-dimethyl-, chloride

• Trade Name: Bardac 2180

• Registration review case number: 5013

• PC Code: 069207

• CAS#: 138698-36-9

• Technical Registrant: Lonza Inc.

• First approved for use in a registered product: 1995

• Six active registrations

• Antimicrobials Division Chemical Revi ew Manager (CRM): Monisha Harris, harris.monisha@epa.gov

• Antimicrobials Division Product Manager (PM): Velma Noble, noble.velma@epa.gov

Chemical Structure:

N +

CH 3 CH 3 R 1

Cl R 2 N +

CH 3 CH 3 R

Cl R

DIDAC DDAC

R1 = C 10 H 21 (decyl) R = C 10 H 21 (decyl)

R2 = Iso-C 9 H 19 (isononyl)Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 20 of 37 Use & Usage Information

• Type of Pesticide: algaecide, disinfectant, f ungicide, fungicide/fungistat,

microbicide/microbistat, molluscicid e and tadpole shrimp and sanitizer

• Antimicrobial Use Sites:

o agricultural premises and equipment

o food handling/storage establishment premises and equipment

o commercial, institutional and i ndustrial premises and equipment

o residential and public access premises

o materials and preservatives

o medical premises and equipment

o industrial processes and water systems

o antifouling coatings

o wood preservatives

o swimming pools and aquatic areas.

o water treatment microbiocides

 for cooling towers, pools and spas , oil field flood waters, pulp and paper mills

Recent Regulatory Actions

There are no recent regulatory actions for DIDAC. Products containing DIDAC was first registered with the EPA on May 11 th 

### 1995. http://www.epa.gov/pesticides /reregistration/status.htm

Human Health Risk Assessment Status

The Agency reviewed the hazard an d exposure databases for the DIDAC registration review case and an ticipates that additional toxi city and exposure studies will be needed for registration review. The EPA anticipates that there is potential occupational inhalation and dermal expos ure through use of DIDAC in antifouling coatings. The Agency will need to conduct a dietary assessment based on indirect dietary exposure. There will also be a need for drinking water assessment of DIDAC based on

the conclusion of the environmental assessment. Further information and detailed justifications for the studies that are expected to be required are available in “Summary of Human Health Effects Data for the Decyl Isononyl Dimethyl Ammonium Chloride (DIDAC) Registration Review Decision Document,” dated March 26, 2010.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 21 of 37 Environmental Fate & Ecologi cal Risk Assessment Status

The Agency has reviewed the environmen tal fate and ecotoxicity databases for the DIDAC registration review case and anticipates requir ing additional environmental fate and ecotoxity data to complete a risk assessment for DIDAC and/or any of its major degradation products that are of potential concern for all re gistered uses of DIDAC.

The Agency has not conducted a risk assessment that supports a complete endangered species determination. The eco logical risk assessment planned during registration review will allow the Agency to determine whether DIDAC’s use has “no effect or “may affect” federall y listed threatened or endange red species (listed species) or their designed critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designate d critical habitat, the Agency will consult

with the U.S. Fish and Wildlife Service and/ or National Marine Fisheries Services (the Services), as appropriate.

Further information and detailed justificat ion for the studies that are expected to be required are available in the document titled, Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Decyl Isononyl Dimethyl Ammonium Chloride Registration Review D ecision Document, dated March 29, 2010.

Tolerances

There are no tolerances or exemptions from tolerances for DIDAC and no registered food uses. DDAC has a toleran ce exemption in 40 CFR 180.940 (a) as a food contact sanitizer for use in public eating pl aces, in dairy processing equipment, and in food processing plants on equipment a nd utensils and 40 CFR 180.940 (c) as a food contact sanitizer for use in food proce ssing plants on equipment and utensils.

Data Call-In Status

The Agency anticipates requiring additional data to complete a risk assessment during the registration re view of this case.

Labels

There are 6 registered products that c ontain DIDAC. The EPA registration numbers are provided in Table 1 below. For future refe rence, during regi stration review a list of product registration numbers will be in cluded in the docket. Product registration labels may be obtained from the Pesticid e Product Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

.Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 22 of 37 Table 1. Registered Active Products of DIDAC

Registration

# Registration

Name Company

Name Formulation Type % of Active Ingredient

6836-209 Bardac 2180 Lonza Inc. Formulation intermediate 80

6836-218 Bardac RW-10 Lonza In c. Ready-to-use solution 10

6836-219 Bardac CW-10 Lonza In c. Ready-to-use solution 10

6836-220 Bardac CW-50 Lonza In c. Ready-to-use solution 50

6836-221 Bardac RW-50 Lonza In c. Ready-to-use solution 50

6836-228 Bardac 2150 LA Lonza Inc. Soluble concentrate for Formulating Uses 50Docket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 23 of 37 III. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient AR Anticipated Residue ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DNT Developmental Neurotoxicity DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation EDWC Estimated Drinking Water Concentration

EEC Estimated Environmental Concentration EPA Environmental Protection Agency

EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery GENEEC Tier I Surface Water Computer Model

IR Index Reservoir

LC 50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD 50 Median Lethal Dose. A statistically deri ved single dose that can be expected to

cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposure

MRID Master Record Identifi cation (number). EPA's system of recording and tracking

submitted studies. MUP Manufacturing-Use Product NA Not Applicable NAWQA USGS National Ambient Water Quality Assessment NPDES National Pollutant Discharge Elimination System NR Not Required

NOAEL No Observed Adverse Effect Level OPP EPA Office of Pesticide Programs

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances PAD Population Adjusted Dose PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area PDP USDA Pesticide Data ProgramDocket Number: EPA-HQ-OPP-2010-0005 www.regulations.gov



### 24 of 37 PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval ppb Parts Per Billion PPE Personal Protective Equipment ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model

Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer

Risk Model RAC Raw Agriculture Commodity RED Reregistration Eligibility Decision REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient SCI-GROW Tier I Ground Water Computer Model SAP Science Advisory Panel SF Safety Factor SLN Special Local Need (Registrati ons Under Section 24©) of FIFRA) TGAI Technical Grade Active Ingredient TEP Typical End-Use Product USDA United States Department of Agriculture UF Uncertainty Factor

WPS Worker Protection StandardDocket Number: EPA-HQ-OPP-2010-0005www.regulations.gov25 of 37IV. APPENDIX AUse Patterns for Decyl Isononyl Dimethyl Ammonium Chloride (DIDAC)Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsAgricultural Premises and EquipmentAgriculture Premises andEquipmentFormulationIntermediate6836-209Not listed on thelabel.Not listed on the label. This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Food Handling/Storage Establishments Premises and EquipmentFood Handling/StorageEstablishments and EquipmentFormulationIntermediate6836-209Not listed on thelabel.Not listed on the label. This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov26 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsCommercial, Institutional and Industrial Premises and EquipmentCommercial, Institutional andIndustrial Premises andEquipmentFormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Residential and Public Access PremisesResidential and Public AccessPremisesFormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov27 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMedical Premises and EquipmentMedical Premises andEquipmentFormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Materials PreservativesMaterials Preservatives FormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov28 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsIndustrial Processes and Water SystemsIndustrial Processes and WaterSystemsFormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Water Treatment Microbiocides SolubleConcentrate6836-228Not listed on thelabel.Not listed on the label. This product is a concentrate for formulating purposesonly. Use only in accordancewith the directions in theTechnical Bulletin from the manufacturer. This productshould not be used or compounded with any reducingor oxidizing agents (such as calcium hypochlorite,solid perchlorate, or nitric acid) since such mixturesmany be explosive. Do not use in conjunction withsoap or any anionic wetting agent.Recirculating Water CoolingSystems, EvaporativeCondensers, Heat ExchangeWater Systems, Commercialand Industrial Cooling Towers,Influent Systems such as FlowThrough Filters and Lagoons,Industrial Water ScrubbingSystems and BreweryPasteurizers, Pulp and PaperMills, Once Through CoolingWaterReady to Use6836-2196836-220Feed Pumps,Meters and Feedlines, Sump Dose,Intermittent/SlugDosing,Continuous FeedRecirculating Water CoolingInitial Treatments: For initialtreatment apply product to avisually clean system or whenalgae or slime is first visible.Add 1.5 to 80 fluid ounces ofthis product for each 1,000gallons of water (5 to 60 ppmactive) in the system to the sumpwater near pump suction. Repeatinitial dose until algae and slimecontrol are evident.Pulp and Paper Mill: Not for use in the manufactureof food-contact paper or paperboard.Once Through Cooling Water: Applications must bein accordance will all environmental regulationsDocket Number: EPA-HQ-OPP-2010-0005www.regulations.gov29 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsRecirculating Water CoolingSystems, EvaporativeCondensers, Heat ExchangeWater Systems, Commercialand Industrial Cooling Towers,Influent Systems such as FlowThrough Filters and Lagoons,Industrial Water ScrubbingSystems and BreweryPasteurizers, Pulp and PaperMills, Once Through CoolingWater(Continued)Ready to use6836-2196836-220Feed Pumps,Meters and Feedlines, Sump Dose,Intermittent/SlugDosing,Continuous FeedBadly fouled systems should becleaned before initiatingtreatment.Maintenance Treatments: Thefrequency at which additionaldosages must be added to controlslime and algal growth can onlybe determined by experience,since each system will vary inwater composition and inamounts and types of organismspresent. After initial control isachieved, maintenance doses 0.5to 65 fluid ounces for each 1,000gallons of water (1.5-50 ppmactive) should be provided daily,weekly, or bimonthly asrequired. The dosage frequencyfor algae control is typically lessthan that required for control ofbacterial slimes. Biweeklytreatment is frequently sufficientto control green algae.Feeding: This product may befed directly from the drum ordiluted with water and fed by asuitable feed system. Dosedirectly into sump or any otherconvenient location providinggood distribution of treatment.Pulp and Paper Mill: Not for use in the manufactureof food-contact paper or paperboard.Once Through Cooling Water: Applications must bein accordance will all environmental regulationsDocket Number: EPA-HQ-OPP-2010-0005www.regulations.gov30 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsRecirculating Water CoolingSystems, EvaporativeCondensers, Heat ExchangeWater Systems, Commercialand Industrial Cooling Towers,Influent Systems such as FlowThrough Filters and Lagoons,Industrial Water ScrubbingSystems and BreweryPasteurizers, Pulp and PaperMills, Once Through CoolingWater(Continued)Ready to use6836-2196836-220Feed Pumps,Meters and Feedlines, Sump Dose,Intermittent/SlugDosing,Continuous FeedPulp and Paper Mills: Thisproduct can be used as aslimicide in the manufacture ofpaper and paperboard that doesnot contact food. Apply 0.05-50gallons of this product per ton ofpaper produced. Alternatively,apply 0.05-100 gallons of thisproduct per 100,000 gallons ofwhite water to be treated, whichcorresponds toa concentrationof 0.5-100 ppm activeingredient. Additions of thisproduct should be made at apoint in the system wheremixing action is good.Once Through Cooling Water:The product may be fed directlyfrom its container, or system.Feed pumps meters and feedlines may be stainless steel,neoprene, glass, plastic orunpigmented fiberglass. Dosedirectly into the sump, near theinlet to the recirculating pump ifpossible, or any other convenientlocation providing gooddistribution. If deactivation isrequired, bentonite clay may beused. A10 ppm clay to 1 ppmactive quaternary ration istypical.Pulp and Paper Mill: Not for use in the manufactureof food-contact paper or paperboard.Once Through Cooling Water: Applications must bein accordance will all environmental regulations.Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov31 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsRecirculating Water CoolingSystems, EvaporativeCondensers, Heat ExchangeWater Systems, Commercialand Industrial Cooling Towers,Influent Systems such as FlowThrough Filters and Lagoons,Industrial Water ScrubbingSystems and BreweryPasteurizers, Pulp and PaperMills, Once Through CoolingWater(Continued)Ready to use6836-2196836-220Feed Pumps,Meters and Feedlines, Sump Dose,Intermittent/SlugDosing,Continuous FeedOnce Through Cooling WaterInitial Treatment: Add 1.4 to130 fluid ounces of this productfor each 10,000 gallons ofsystem cooling water (0.5 to 10ppm active quaternary). Repeatinitial dose until biologicalcontrol is evident.Maintenance TreatmentIntermittent/Slug Dosing: Thefrequency of maintenance dosescan only be determined byexperience, since each coolingsystem will vary in watercomposition and in amounts andtypes of organisms present. Afterinitial control has been achieved,maintenance doses of 1.4 to 65fluid ounces of this product foreach 10,000 gallons of systemcooling water (0.5 to 5 ppmactive quaternary) should beadded daily, weekly or monthlyas required.Continuous Feed: After initialcontrol has been achieved, apply0.5 to 65 fluid ounces of thisproduct for each 10,000 gallonsof system cooling water (0.2 to 5ppm active quaternary) tomaintain biological control.Pulp and Paper Mill: Not for use in the manufactureof food-contact paper or paperboard.Once Through Cooling Water: Applications must bein accordance will all environmental regulationsDocket Number: EPA-HQ-OPP-2010-0005www.regulations.gov32 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsAntifouling CoatingsAntifouling Coatings FormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Wood PreservativesWood Preservatives FormulationIntermediate6836-209Not listed on thelabel.Not listed on the label.This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov33 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsWood Preservatives SolubleConcentrate6836-228Not listed on thelabel.Not listed on the label. This product is a concentrate for formulating purposesonly. Use only in accordancewith the directions in theTechnical Bulletin from the manufacturer. This productshould not be used or compounded with any reducingor oxidizing agents (such as calcium hypochlorite,solid perchlorate, or nitric acid) since such mixturesmany be explosive. Do not use in conjunction withsoap or any anionic wetting agent.Swimming PoolsSwimming Pools and SpasReady to Use6836-218AddPools and Spas: For visiblealgae add 0.5 gallons to each10,000 gallons of water. After 24hours remove dead algae bycleaning algae still present.Repeat doses as necessary.Initial Treatment: Clean poolsand spas. Add 1 quart to each10,000 gallons of water or ratiothereof. Maintenance additionsof 0.25-0.5 quarts per 10,000gallons should be added every7days or more frequentlydepending on water and use.Booster dose of 0.25 quarts per10,000 gallons should beprovided after each rain ofconsequence.Winterization: Test for properbalance of minerals, pH andpresence of metals. Takecorrective action if necessary.Danger: Corrosive. Causes severe eye and skindamage. Do not get in eyes, on skin or clothing. Weargoggles or face shield and rubber gloves whenhandling. May be fatal if swallowed.Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov34 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsSwimming Pools and Spas(Continued)Ready to Use6836-218AddWinterization:Superchlorinatethe pool using recommendedwinter shock treatmentaccording to label directions.Apply when pool is out ofservice and allow pump torecirculate a minimum of onehour, preferably several hoursovernight.Apply this algaecide directly tothe pool water, pouring along theedge of the pool. Use 0.5 gallonsper 10,000 gallons of water andallow to circulate 2-4 hours.Clean the pool water line andfilter. In areas with severefreezing, drain pool equipmentand plumbing lines or useantifreeze recommended forswimming pool plumbing andequipment. Pools without coversor mesh covers may need asecond treatment in mid-winteror just prior to freezing.Danger: Corrosive. Causes severe eye and skindamage. Do not get in eyes, on skin or clothing. Weargoggles or face shield and rubber gloves whenhandling. May be fatal if swallowed.Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov35 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsSwimming Pools and SpasReady to Use6836-221AddPools and Spas: For visiblealgae add 16 fluid ounces toeach 10,000 gallons of water orratio thereof. After 24 hoursremove dead algae by cleaning.If algae is still present, repeatdoses as necessary.Initial Treatment: Clean poolsand spas. Add 8 fluid ounces toeach 10,000 gallons of water orratio thereof. Maintenanceadditions of 1.5-3.0 fluid ouncesper 10,000 gallons should beadded every 7 days or morefrequently depending on waterand use and use factors. Abooster dose of 1.5 fluid ouncesper 10,000 gallons should beprovided after each rain ofconsequence.Winterization: Test for properbalance of minerals, pH andpresence of metals. Takecorrective action if necessary.Superchlorinate the pool usingrecommended winter shocktreatment according to labeldirections. Apply when pool isout of service and allow pump torecirculate a minimum of onehour, preferably several hoursovernight.Danger: Corrosive. Causes severe eye and skindamage. Do not get in eyes, on skin or clothing. Weargoggles or face shield and rubber gloves whenhandling. May be fatal if swallowed.Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov36 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsSwimming Pools and SpasReady to Use6836-221AddWinterization: Apply thisalgaecide directly to the poolwater, pouring along the edge ofthe pool. Use 13 fluid ounces per10,000 gallons of water andallow to circulate 2-4 hours.Clean the pool water line andfilter. In areas with severefreezing, drain pool equipmentand plumbing lines or useantifreeze recommended forswimming pool plumbing andequipment. Pools without coversor mesh covers may need asecond treatment in mid-winteror just prior to freezing.Danger: Corrosive. Causes severe eye and skindamage. Do not get in eyes, on skin or clothing. Weargoggles or face shield and rubber gloves whenhandling. May be fatal if swallowed.Docket Number: EPA-HQ-OPP-2010-0005www.regulations.gov37 of 37Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsSwimming Pools FormulationIntermediate6836-209Not listed on thelabel.Not listed on the label. This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).Aquatic Areas FormulationIntermediate6836-209Not listed on thelabel.Not listed on the label. This product is a concentrate for formulating purposesonly. This product should not be used or compoundedwith any reducing or oxidizing agents (such as calciumhypochlorite, solid perchlorate, or nitric acid) sincesuch mixtures may be explosive. Do not use inconjunction with soap or any anionic wetting agent.Formulators using this product are responsible forproviding data for the EPA registration of theirformulated products. This product may be used toformulate products for specific use(s) not listed o thislabel if the formulator or primary registrant hascompiled with U.S. EPA data requirements regardingthe support of such use(s).