United States Chemical Safety September 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate (DDACB) Summary Document: Registration Review: Initial Docket September 2012Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

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### TABLE OF CONTENTS

Didecyl Dimethyl Ammonium Carbonate a nd Didecyl Dimethyl Ammonium Bicarbonate Registration Review Team ...................................................................................................4 I. Preliminary Work Plan .....................................................................................................5 II. Fact Sheet ................................................................................................................ ......13 III. Summary of Anticipated Data Requirements ..............................................................18 IV. Appendix A ................................................................................................................ ..19

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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 Did ecyl dimethyl ammonium carbonate (DDA Carbonate) and Didecyl dimethyl a mmonium bicarbonate (DDA Bicarbonate). September 13, 2012

2. DIDECYL DIMETHYL AMMONIUM CARBONATE/BICARBONATE (DDACB; BARDAC 22C50): Human Health Assessm ent Scoping Document in Support of Registration Review. September 6, 2012

Additional supporting documents for the Didecyl Dimethyl Ammonium Carbonate And Didecyl Dimethyl Ammonium Bicarbonate Case may be found in the registration review docket EPA-HQOPP-2012-0651 located on the internet at www.regulations.gov

.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

4 of 19 Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate (DDACB)

Registration Review Team

Human Health & Environmental Effects Michelle Centra Nathan Mottl Jonathan Chen William Hazel Srinivas Gowda James Breithaupt

Risk Management Wanda Henson Lance Wormell

Office of General Counsel Philip RossDocket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

5 of 19 I. Preliminary Work Plan -- Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate (DDACB)

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 pe riodically 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 Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate Case (DDACB).

The Didecyl Dimethyl Ammonium Carbonate an d Didecyl Dimethyl Ammonium Bicarbonate - (Case 5014) consist of two chemical moieties (a ca rbonate and a bicarbonat e) combined to make one active ingredient under PC Code 069208.

The first product containing Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate (DDACB) as an active ingredient was regi stered in the United States in 1995. Currently, there are 11 products containing DDACB as an active ingredient registered with EPA. Products containing DDACB are registered for use as hard non porous surface disinfectants and materials pres ervatives for use in/on food handling/storage establishments premises and equipment; industrial process and wa ter systems; medical premises and equipment; residential and public access premises; and as a wood preservative. The are no inert uses and no tolerances.

DDACB is exempt from the requirement for a to lerance per 40 CFR Part 180.940(a) for use: in food-contact surfaces in public eating places, dair y-processing equipment, and food processing equipment and utensils when the end-use con centration does not to ex ceed 400 ppm of active quarternary ammonium compound. The Agency pub lished on August 22, 2012 a final rule that changed the level from 240 ppm to 400 ppm of active quarternary ammonium compound.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

6 of 19 A Reregistration Eligibility Decision (RED) was not completed for DDACB because it was registered after November 1, 1984.

Documents associated with the registration revi ew of Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate ca n be viewed at www.regulations.gov in docket EPA-HQ-OPP-2012-0651. Below is a summ ary of the issues relevant to this registration review

case.

Quaternary Ammonium Compounds DDACB is a part of the Group I cl ass (cluster I grouping) in PR Notice 88-2, i.e. it is a member of the aliphatic dimethyl dialky l quaternary ammonium compounds.

Didecyl dimethyl ammonium chloride (DDAC) whic h is being reevaluated separately under case #3003 is the representative member of the Gr oup I class of quaternar y ammonium compounds and hazard data generated for DDAC is considered to be representative of the hazard associated with all chemicals assigned to this class of quaternary ammonium chemi cals, including DDACB. Consequently, toxicity studies conducted w ith DDAC or other Group I class quaternary ammonium compounds can be bridged into a sing le mammalian toxicity data base. The DDACB risk assessments will be based on studies using the DDAC/DDACB combined database.

A Reregistration Eligibility Decision (RED) document has been issued for DDAC and the Agency intends to incorporate the available RED data as well as any additional data received in response to the DDAC case post-RED Data Call-in (DCI) into the risk assessments to be performed for registration review of DDACB.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessm ent, for all uses of DDACB. The Agency anticipates the need to conduct a human health risk assessment. The Agency anticipates needing additional data for use in conducting the registration review for DDACB.

Ecological Risk:

 No ecological risk assessment has been perf ormed for DDACB. Howe ver, an ecological risk assessment for DDAC was conducted in support of th e 2006 DDAC RED.

 The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for DDACB. The eco logical risk assessment planned during registration review will a llow the Agency to determine whether DDACB 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.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

7 of 19  The Agency anticipates the need to require the following additional ecological data for use in the registration review of DDACB.

850.1730 -- Oyster Bioconcentration study 850.3020 -- Honey bee acute contact study 850.3030 -- Toxicity of re sidues to honeybees 850.3300 -- Activated Sludge Respiration Inhibition

 The Agency does not anticipate the need to re quire additional environmental fate data for this registration review case at this time.

 For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Didecyl dimethyl ammonium carbonate (DDA Car bonate) and Didecyl dimethyl ammonium bicarbonate (DDA Bicarbonate) , located in the docket.

Human Health Risk:

 No human health risk assessment has been performed for DDACB. However, a human health risk assessment was conducted fo r DDAC in support of the 2006 DDAC RED.

 The Agency anticipates the need to require the following additional human health data for use in the registration review of DDACB.

870.3465 -- 90-day inhalati on toxicity (rat) 875.1100 -- Dermal outdoor exposure 875.1200 -- Dermal indoor exposure 875.1300 -- Inhalation outdoor exposure 875.1400 -- Inhalation indoor exposure 875.1600 -- Application exposure data reporting and calculations 875.1700 -- Product use information (Handler) 875.2700 -- Product use informati on (Post application)

 For more information, please refer to DIDECYL DIMETHYL AMMONIUM CARBONATE/BICARBONATE (DDACB; BARDAC 22C50): Human Health Assessment Scoping Document in Support of Registration Review. located in the docket.

Product Chemistry:

 The Agency does not anticipate the need to require additional product chemistry data for this registration review case at this time.

 For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Didecyl dimethyl ammonium carbonate (DDA Car bonate) and Didecyl dimethyl ammonium bicarbonate (DDA Bicarbonate) , located in the docket.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

8 of 19 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 its most recent reregistration decision for DDAC, EPA reviewed these data and selected the most sensitive endpoint s for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), DDACB is subject to the endocrine screeni ng part of the Endocrine Disrup tor Screening Program (EDSP).

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 ingr edients. DDACB 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 DDACB. For furt her 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 Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate (DDACB) registration review:Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

9 of 19 Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Docket and 60-Day Public Comment Period for PWP September 2012 Close Public Comment Period November 2012 Phase 2: Case Development Develop Final Work Plan (FWP) March 2013 Issue DCI March 2014 Data Submission March 2016 Open 30-Day Public Comment Period for Preliminary Risk Assessments September 2017

Close Public Comment Period for Prelim inary Risk Assessments October 2017 Phase 3: Registration Review Decision Open 60-Day Public Comment Period for Proposed Reg. Review Decision March 2018

Close Public Comment Period for Pro posed Reg. Review Decision May 2018 Final Decision and Begin Post-Decision Follow-up September 2018 Total (years) 6

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 Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bi carbonate 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:

DDACB is not identified as a cause of impairment for any water 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 (TMDL) have been developed for DDACB, 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.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

10 of 19 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 DDACB co mpared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to th e general population.

Structure Activity Relationships:

EPA must rely upon information of appropriate qu ality and reliability for each decision made by the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide 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.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

11 of 19 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 Didecyl Dimethyl Ammonium Carbonate And Didecyl Dimethyl Ammonium Bicarbonate (DDACB) 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:

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

Next Steps:

After the 60-day comment period closes in N ovember 2012, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for the Didecyl Dimethyl Ammonium Carbonate And Didecy l Dimethyl Ammonium Bicarbonate (DDACB)

case.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

12 of 19 II. Fact Sheet

Background Information:

 Active Ingredient: Didecyl Dimethyl Amm onium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate (DDACB)

 Case number: 5014

 PC Code: 069208

 CAS numbers: 148788-50-0 and 148812-65-1

 Technical registrants: Lonza

 First approved for use in a registered product: 1995

 There are no inert uses for this chemical and no tolerances. DDACB is exempt from the requirement for a tolerance per 40 CFR Part 180.940(a) for use: in food-contact surfaces in public eating places, dairy-processing e quipment, and food processing equipment and utensils when the end-use concentration does not to exceed 400 ppm of active quarternary ammonium compound. The Agen cy published on August 22, 2012 a final rule that changed the level from 240 ppm to 400 ppm of active quarternary ammonium compound.

 Antimicrobials Division Chemical Re view Manager (CRM): Wanda Henson, Henson.Wanda@epa.gov

 Antimicrobials Division Product Manager (PM): Velma Noble, Noble.Velma@epa.gov

 Chemical Structure:

Use & Usage Information:

 Products containing didecyl dimethyl am monium carbonate and didecyl dimethyl ammonium bicarbonate (DDACB) are registered for use as a hard non porous surface disinfectant and a material preservative: in/on food hand ling/storage establishments premises and equipment; industrial process and water systems; medical premise and equipment; residential and public acce ss premises; as a wood preservative.

Recent/Pending Regulatory Actions:

 There are currently three (3) pending registrations for this chemical.

Ecological Risk Assessment Status:Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

13 of 19  The Agency has not conducted a risk assessment that supports a complete endangered species determination for DDACB. The ecological risk assessment planned during registration review will allow the Agency to determine whether DDACB’s use has 'no effect' or 'may affect' federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

 The most recent ecological risk assessment for D DAC was conducted in support of the 2006 DDAC RED. In the RED, EPA specified la beling language to reduce environmental exposure and risk resulting from DDAC use in once-through cooling water towers and anti-sapstain wood.

 For registration review, a n ecological risk assessment will be conducted for uses that have the potential to discharge to waste water treatm ent plants with releas es to surface water.

 The Agency anticipates the need to require the following additional ecological data for use in the registration review of DDACB.

850.1730 -- Oyster Bioconcentration study 850.3020 -- Honey bee acute contact study 850.3030 -- Toxicity of residues to honeybees 850.3300 -- Activated Sludge Respiration Inhibition

 Please refer to Product Chemistry, Environmental Fa te, and Ecological Effects Scoping Document in Support of Registration Review of Didecyl dimethyl ammonium carbonate (DDA Carbonate) and Didecyl dimethyl ammonium bicarbonate (DDA Bicarbonate)

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

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonat e. Please refer to DIDECYL DIMETHYL AMMONIUM CARBO NATE/BICARBONATE (DDACB; BARDAC 22C50): Human Health Assessment Scoping Docu ment in Support of Registration Review. located in the docket, for a detailed discus sion of the human health risk assessment.

Hazard Characterization:

 DDACB was assigned a Toxicity Ca tegory II in an acute oral t oxicity study in rats and assigned a Toxicity Category I in a primary dermal irritation study in rabbits. A photo allergyl sensitization study (w ith and without UV irradiati on) in guinea pigs conducted with the product, BARDAC 22C50 (50% a.i.), is negative for dermal sensitization; however the photoallergic response results fo r this study were equivocal. The Agency has granted data waivers for acute dermal toxicity, primary eye irritation and acute inhalation toxicity b ecause of the corrosive nature of the active ingredient, DDACB. Based on the results of the primary skin ir ritation study in rabbits, the BARDAC 22C50Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

14 of 19 product and other products cont aining 50% DDACB active ingr edient were assigned an overall Toxicity Category I (corrosive).

 There is no available repeat e xposure inhalation toxicity study to demonstrate the types of adverse effects that may be manifested via th is route of exposure or the dose(s) at which respiratory-specific adverse effects may occur.

 DDAC is not likely to be a human carcinoge n based on (1) negative results for all DDAC mutagenicity testing and (2) lack of eviden ce of carcinogenicity in the rat and mouse carcinogenic studies

Dietary (Food and Water):

 DDACB residues can migrate to food coming in to contact with the treated surfaces.

 EPA considered dietary exposure to the higher proposed DDACB use dilution (400 ppm) as well as to all existing a liphatic dialkyl dimethyl quate rnary ammonium salts (DDAC, etc.) uses. The Agency assessed acute and chronic dietary exposures from the use of DDACB as a disinfectant a nd food-contact sanitizer on utensils, countertops, and food/beverage processing equipment using F DA models and the Indi rect Dietary Residue Exposure Assessment Model (IDREAM). A 100% residue transfer rate was assumed for the food bottling/packaging use because of the potentially lo ng contact time of food with treated surfaces. Acute and chronic dietary ri sks were estimated to be 11% (adult males (13+ yr)), 12% (adult females (13-49 yr)), and 70% (children (1-2 yr)) of the aPAD and cPAD both of which are 0.1 mg/kg/day.

 DDACB is classified as a surfactant possessi ng a charged moiety (N+) and components that are nonpolar/lipophilic (t he two 10-carbon alkyl groups). These components provide DDACB with properties allowing it to adsorb bot h to clay particles (via cation exchange) and organic matter (via hydrophobic attraction of the two alkyl groups). It adsorbs rapidly to soil and sediments but is not readily desorbed. It also binds to cellulose and lignin (organic matter) thus permitting its use as a wood preservative. Because of its strong adsorption to soils, DDACB is not expected to contaminate surface and ground waters or to reach waste water treatment plants if it were discharged from industrial water systems. As a result, contamination of drinking wate r with DDACB residues is expected to be negligible.

Residential:

 Residential exposure and risk to DDAC was assessed in the 2006 DDAC RED. Many of the uses of DDAC are similar to DDACB. The residential-use products include disinfectants, sanitizers, fungi cide, mildewstats, and deodorizers. DDACB is also used as a material preservative in pa ints and laundry detergents. Unit exposure data for liquid pour, mopping, wiping, aerosol spray, airless sprayer, and brush/roller are needed before new handler risk assessments can be conducted.Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

15 of 19  The residential post-application scenario that will be considered for the registration review include exposure to residue from hard surfaces (i.e., floors) and carpets that have been mopped, sprayed or cleaned with a product containing DDACB; incidental ingestion from hand-to-mouth exposure from countertops and pressure treated decks; mouthing of laundered clothes; and dermal exposure from tr eated decks, playsets and floors. DDACB has a low vapor pressure; ther efore, there is no c oncern for potential vapor inhalation exposure.

 There are also uncertainties associated with the assumptions used in the post-application assessment in support of the DDAC RED (i.e. pe rcent transfer of residues from cleaned floor, leaching of residues from the laundered textiles, etc) that will also need to be addressed as they relate to DDACB. Upon a submission of the necessary information, a post application exposure assessment will be completed for registration review, as appropriate, additional scenarios will be in corporated into the revised aggregate
assessment.

Aggregate:

 In examining aggregate exposure, EPA take s into account the available and reliable information concerning exposures to pesticid e residues in food and drinking water, as well as non-occupational pesticide exposures . Upon a reevaluation and selection of toxicological endpoints, combined with th e revised dietary and residential exposure assessment expected as a part of this regi stration review case, an aggregate assessment will need to be conducted for DDACB.

Occupational:

 Worker exposure to DDACB is expected to occur through the use of DDACB-containing products in several industrial and commercial settings. Short-term and intermediate-term from contact will be assessed. A recent risk assessment has reassessed the uses for agricultural premises; commercial, institu tional, and industrial premises; medical premises; and food handling (D400391, D340425). The DDAC RED also covered these use patterns as well as industrial proce sses and water systems and wood treatment (USEPA, 2006). Recent registration occupati onal and residential exposure assessments have also assessed wood preservati ve uses and paints (D321231, D24130).

 The Agency intends to review and consider data received in response to the DDAC postRED DCI (anticipated issuance in FY 2012) a nd incorporate the new data into the risk assessments. The Agency anticipates needing additional data for some use patterns that were not covered in the DDAC RE D. These uses include material preservatives such as paint, metal working fluids and the Agency e xpects to issue a separa te registration review DCI for these studies. During reregistration the Agency received several exposure studies from the registrant and intends to review th ese studies during regi stration review (see reference section for some of the existing data submissions).

 The occupational exposure assessment uti lized surrogate databases, for which uncertainties have been identified. A review of the registered labels identifed additionalDocket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

16 of 19 occupational exposure scenarios that will need to be assessed. Based on these additional scenarios, occupational risk assessments will be required to support re gistration review of DDACB.

Cumulative:

 EPA does not have, at this time, available data to determine whether DDACB has a common mechanism of toxicity w ith other substances or how to include this pesticide in a cumulative risk assessment. This Regist ration Review assumes that DDACB does not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.

Incidents:

Ecological:

 No DDACB ecological incidents have been reported in the Ecological Incident Information System (EIIS) database.

Human Health:

 EPA reviewed available incident informati on for all quarternary ammonium compounds, including DDACB, for the human incidents asso ciated with exposure to end-use products containing these chemicals reported in the OPP Incident Data System (IDS), California Department of Pesticide Regulation (1982- 2004), National Pesticide Telecommunications Network (NPTN) and Published Incident Repor ts. Dermal, ocular and inhalation are the primary routes of exposure. Most of the incidences are relate d to irritation. The symptoms associated with eye are comm only reported for quaternary ammonium compound exposures. Allergic type reactions have also been reported in some incidents.

Tolerances and International Harmonization:

 DDACB is exempt from the requirement for a tolerance per 40 CFR Part 180.940(a) for use: in food-contact surfaces in public eati ng places, dairy-processing equipment, and food processing equipment and utensils when the end-use concentration does not to exceed 400 ppm of active quarternary amm onium compound. The Agency published on August 22, 2012 a final rule that changed the level from 240 ppm to 400 ppm of active quarternary ammonium compound.

Data Call-In Status:

 There are currently no outsta nding Data Call-In require ments for this chemical.

Labels:

Registered products, including EP A registration numbers are provi ded in Table 1 below. For future reference, during registra tion review a list of product regi stration numbers will be includedDocket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

17 of 19 in the docket. Product registration labels may be obtained from the Pesticide Product Label System (PPLS) website at: http ://oaspub.epa.gov/pestlabl/ppls.home

. Table 1. Registered Products (DDACB)

Registration # Registration Name Company Name Formulation Type % A.I.

1677-231 Ster-Bac Ecolab, Inc. Soluble Concentrate 7.5

3008-90 ORD-X732 Osmose Inc. Ready-To-Use 12.8

3008-94 ORD-X280 Osmose Inc. Soluble Concentrate 16.66

3008-104 Sustain 20CQ Osmose Inc. Flowable Concentrate 12.8

6836-236 Bardac 22C50 Lonza Inc. Formulation Intermediate 50

6836-304 Carboquat WP-50 Lonza Inc. Soluble Concentrate 50

6836-323 Carboserve Lonza Inc. Soluble Concentrate 50

6836-327 Carbosan Lonza Inc. Soluble Concentrate 50

6836-330 Carboquat CM-50 Lonza Inc. Soluble Concentrate 50

6836-331 Carbosan 20 Lonza Inc. Soluble Concentrate 20

6836-332 Carbosan 7.5 Lonza Inc. Soluble Concentrate 7.5Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

18 of 19 III. Summary of Anticipated Data Requirements – Didecyl Dimethyl Ammonium Carbonate And Didecyl Dimethyl Ammonium Bicarbonate (DDACB)

The table below summarizes anticipated data needs for the Didecyl Dimethyl Ammonium Carbonate And Didecyl Dimethyl Ammonium Bicar bonate Case in Section I of this document (Preliminary Work Plan), Product Chemistry, Environmenta l Fate, and Ecological Effects Scoping Document in Support of Registration Revi ew of Didecyl dimethyl ammonium carbonate (DDA Carbonate) and Didecyl dimethyl ammonium bicarbonate (DDA Bicarbonate) , and DIDECYL DIMETHYL AMMONIUM CARBO NATE/BICARBONATE (DDACB; BARDAC 22C50): Human Health Assessment Scoping Docu ment in Support of Registration Review.

. Table 2. Summary of Anticipated Data Requirements – DIDECYL DIMETHYL AMMONIUM CARBONATE And DIDE CYL DIMETHYL AMMONIUM BICARBONATE (DDACB)

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months from DCI Receipt)

850.1730 Oyster bioconcentration study TGAI 24
850.3020 Honey bee acute contact study TGAI 12
850.3030 Toxicity of residues to honeybees TGAI 12
850.3300 Activated Sludge Respiration Inhibition TGAI 24
870.3465 90-day inhalation toxicity(rat) TGAI 24
875.1100 Dermal outdoor exposure TGAI 24
875.1200 Dermal indoor exposure TGAI 24
875.1300 Inhalation outdoor exposure TGAI 24
875.1400 Inhalation indoor exposure TGAI 24

875.1600 Application exposure data reporting and calculations TGAI 12

875.1700 Product use information (Handler) TGAI 12

875.2700 Product use information (Post Application) TGAI 12Docket Number: EPA-HQ-OPP-2012-0651 www.regulations.gov

19 of 19 IV. Appendix A

Food Handling/storage establishm ents premises and equipment Beer fermentation and storage tanks Dairy processing equipment Egg washing treatments Entryway sanitizing systems Food processing equipment, Conveyors Hard non-porous surfaces in restaurants Sanitary filling equipment, ice machines, soft serve and frozen beverage dispensing equipment Waterproof gloves, shoe baths

Industrial processes and water systems Gas/oil recovery systems Hydrotesting pipelines or vessels Pipeline pigging and scraping operations

Materials Preservatives Aerosol cans, petroleum products, cleani ng products, and cleaning, sanitizing, and disinfecting wipes for use on hard non-porous, surfaces Paints and decorative coatings Metalworking fluids Paper and Paperboard Metalworking Cutting Fluids

Medical premises and equipment Hard non-porous surfaces in Hospitals, nursing homes and dentist offices, etc. Salon / barber tools and instruments Ultrasound transducers, probes, mammography compressor plates

Residential and public access premises Air freshener Hard non-porous surfaces in household/domestic dwellings Laundry Holding tanks, gray water tanks.

Wood Preservatives Pressure treatment