United States Chemi cal Safety June 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Dibromodicyanobutane Summary Document: Registration Review: Initial Docket June 2012Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

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### TABLE OF CONTENTS

Dibromodicyanobutane Regist ration Review Team ............................................................4 I. Preliminary Work Plan .....................................................................................................5 II. Fact Sheet ................................................................................................................ ......13 III. Summary of Anticipated Data Requirements ..............................................................17 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 Dibromodicyanobutane. May 31, 2012

2. 1,2-Dibromo-2,4-dicyanobutane (DBDCB): Huma n Health Registra tion Review Scoping Document. May 3, 2012

Additional supporting documents for the Dibr omodicyanobutane Case may be found in the registration review docket EPA-HQ-OPP-2012-0342 located on the internet at www.regulations.gov

.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

4 of 23 Dibromodicyanobutane Regi stration Review Team

Human Health & Environmental Effects Timothy Dole Jenny Tao Jonathan Chen Talia Lindheimer Srinivas Gowda David Bays James Breithaupt

Risk Management Seiichi Murasaki Lance Wormell

Office of General Counsel Philip RossDocket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

5 of 23 I. Preliminary Work Plan -- Dibromodicyanobutane

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a regi stration review program. All pesticides distributed or sold in the United St ates generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency ) based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The regist ration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet th e statutory standard of no unreas onable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs , products in the marketpl ace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consid er benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state whatit knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the Dibromodicyanobutane Case.

The first product containing 1-Bromo-1 -(bromomethyl)-1,3-propanedicarbonitrile (Dibromodicyanobutane or DBDCB) (PC Code 111001) as an active ingredient was registered in the United States in 1980. Currently, there ar e 16 products containing DBDCB as an active ingredient registered with EP A. Dibromodicyanobutane is registered for use in materials preservation, industrial recirculating cooling water treatment, oil production, and paper mill water treatment. The material preservation us es include adhesives, caulks, household cleaning solution, paints and coatings, metal working flui ds and non-apparel textil es. DBDCB is regulated by the FDA as an indirect food additive. Tole rances have been established for DBDCB as a preservative in food grade adhesives (see 21 CFR § 175.105) and as a slimicide in the manufacture in food grade paper and paperboard at a maximum level of 0.005% of dry weight fiber (see 21 CFR § 176.300).

The Agency completed a Reregistration Eligib ility Decision (RED) for Dibromodicyanobutane in 1996.

Documents associated with the registration revi ew of Dibromodicyanobutane can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2012- 0342. Below is a summary of the issues relevant to this registration review case.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

6 of 23 Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessmen t, for all uses of Dibromodicyanobutane. If endpoints of concern are identified from toxicolo gical studies expected to be required for the registration review of DBDCB, th e Agency anticipates the need to conduct quantitative dietary, residential, occupational, and, if appropriate, aggregate assess ments. The Agency anticipates needing additional data for use in conducting the registration review for Dibromodicyanobutane.

Ecological Risk:

• The most recent ecological risk assessmen t for DBDCB was performed to support the 1996 RED.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for Dibromodicya nobutane. The ecological risk assessment planned during registration review will a llow the Agency to determine whether DBDCB’s use has 'no effect' or 'may affect ' federally listed thr eatened or endangered species (listed species) or their designate d critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical habitat, the Agency will consult with the U. S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

• The Agency anticipates the need to require the following additional ecological data for use in the registration revi ew of Dibromodicyanobutane.

850.4400 -- Aquatic plant toxicolo gy test using Lemna spp. 1 850.5400 -- Algal Toxicity (Tier II) 2

• The Agency anticipates the need to require the following additional environmental fate data for use in the registration review of Dibromodicyanobutane.

850.6800 -- Modified activated sludge , respiration inhibition test 3

1 If data indicate the IC 50 for Selenastrum capricornutum is greater than 1000 ppb, the Agency will consider waiver requests for the Aquatic vascular plant toxicology test (850.4400).
2 Algal Toxicity Tier II data using Selenastrum capricornutum (Green Algae), Anabaena flos-aquae (Blue-Green Cyanobacteria), Navicula pelliculosa (Freshwater Diatom), and Skeletonema costatum (Marine Diatom) are expected to be required. If data indicate the IC 50 for Selenastrum capricornutum is greater than 1000 ppb, the Agency will consider waiver requests for studies conducted with the other three algal species.
3 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the DCI expected to be issued would provide that the registrant would choose to conduct either: (i) Ready Biodegradability or (ii) a) Biode gradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the antimicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or SimulationDocket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

7 of 23 835.3110 -- Ready Biodegradability 3
835.3220 -- Porous Pot Test 3 835.3280 -- Simulation Tests to Assess the Biodeg radability of Chemicals Discharged to Wastewater 3 835.3240 -- Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units 3

• For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Dibromodicyanobutane , located in the docket.

Human Health Risk:

• The most recent qualitative human health ri sk assessment for DBDCB was performed to support the 1996 RED.

• Toxicological endpoints of concern were not identified at the time of the RED. If endpoints of concern are identified from toxico logical studies expected to be required for the registration review of DBDCB, the Ag ency anticipates the need to conduct quantitative dietary, residentia l, occupational, and, if appr opriate, aggregate assessments.

• The Agency may need to conduct a dietar y risk assessment based on indirect food exposure from DBDCB for use as a slimicid e in food contact paper and paperboard production and to preserve paper-making chemicals.

• The Agency may need to conduct a resident ial risk assessment based on exposure from DBDCB during use of treated pa ints and household cleaners.

• The Agency may need to conduct an occ upational risk assessment based on exposure from DBDCB during open pouring of liquids and wettable powders for material preservation and during the us e of treated paints, metal working fluids, and cleaning solutions.

• The Agency may need to conduct an aggr egate assessment based on residential and dietary exposures.

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

870.3465 -- 90-day inhalation toxicity 4 870.3800 – Two-Generation Reproduction 5 875.1200 -- Dermal indoor exposure 6

Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.
4 Study is anticipated as being needed for following scenarios: open-pour liquids; open-pour wettable powders; application of preserved paints using brush/roller or airle ss sprayer; use of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners.
5 Study is anticipated as being needed for all uses th at can result in dietary and drinking water exposures.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

8 of 23 875.1400 -- Inhalation indoor exposure 6 875.1600 -- Application exposure da ta reporting and calculations 6 875.1700 -- Product use information 875.2300 -- Indoor surface residue dissipation 7 Special Study -- Nature of Residue on Surfaces 8 Special Study -- Migration Study 8

• For more information, please refer to 1,2-Dibromo-2,4-dicyanobutane (DBDCB): Human Health Registration Review Scoping Document , located in the docket.

Product Chemistry:

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

• For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Dibromodicyanobutane, located in the docket.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of the re-registr ation eligibility decision in 1996 for dibromodicyanobutane , EPA reviewed the availabl e toxicology data and determined that there were no endpoints of concern for the existing use patterns. However, as required by FFDCA

6 Exposure studies are anticipated as being needed for following scenarios: open-pour liquids; open-pour wettable powders; application of preserved paints using brush/roller or airless sprayer; use of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners. If labels are amended to require closed mixing/loading, then any required exposure study for open-pour liquid scenarios can likely be waived. If labels are amended to require water soluble packaging, then any required exposure study for open-pour wettable powder scenarios can likely be waived. It may be possible to use proprietary surrogate exposure data if data compensation issues are adequately addressed.
7 Study is anticipated as being needed for following scenario: residential post application dermal and incidental oral exposure to floors cleaned with preserved household cleaning solutions. The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study.
8 Study is anticipated as being needed for following scenarios: dietary exposures from countertops cleaned with preserved household cleaning solution; and dietary exposures from DBDCB treated paper products used in food packaging. The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study. In the absence of ad ditional data, a default transfer factor of 100% would be expected to be used.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

9 of 23 section 408(p), Dibromodicyanobutane is subject to the endocrine scre ening part of the Endocrine Disruptor 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 ingred ients. Dibromodicyanobutane is not among the group of 58 pesticide active ingredient s on the initial list to be screened under the EDSP. Accordingly, as part of registration revi ew, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for Dibromodicyanobutane. For further information on the status of the EDSP, the polic ies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, pl ease visit our website: http://www.epa.gov/endo/.

Timeline

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

Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket June 2012 Close Public Comment Period for Docket August 2012 Phase 2: Case Development Develop Final Work Plan (FWP) December 2012 Issue DCI December 2013 Data Submission December 2017 Open Public Comment Period for Preliminary Risk Assessments June 2019
Close Public Comment Period for Pre liminary Risk Assessments July 2019 Phase 3: Registration Review Decision Open Public Comment Period for Propos ed Reg. Review Decision December 2019 Close Public Comment Period for Proposed Reg. Review Decision February 2020Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

10 of 23 Final Decision and Begin Post-Decision Follow-up 2020 Total (years) 8

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 Dibromodicyanobutane 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:

Dibromodicyanobutane is not identi fied as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=88 5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Dibromodicyanobutane, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES.

More information on impaired wate r bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should co nform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Revi ew Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to ensure the data can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to Dibromodi cyanobutane compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to th e general population.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

11 of 23 Structure Activity Relationships:

EPA must rely upon information of appropriate qual ity and reliability for each decision made by the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide chemical traditionally begins with the applicant’ s submission of a set of studies conducted with the specific pesticide chemical of interest. The us e of the results of such testing (measured data) is a logical, scientifically rigorous proce ss that identifies the physical, chemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in alternat ive techniques, i.e., tech niques other than data generation that could significantly inform the Agency’s decision-making process. Recently, OPP has made increasing use of stru cture activity relationship (SAR ) as part of its regulatory decision-making process. In the SAR process, a ch emical's molecular structure is compared to that of other chemicals for which data are availabl e. These structural similarities are then used to make predictive judgments about a chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, chemical, and biol ogical properties are a f unction of (or directly related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a selected set of measured da ta on a single physical, chemical, or biological property is used to derive a model (an equatio n) to predict the valu e of that property.

Since SAR assessments and QSAR modeling are anothe r set of tools that are available to Agency scientists, OPP has begun a proce ss shift that envisions shifting from the current study-by-study approach to an approach in which the use of pr edicted data, generated us ing validated models, is considered along with information from open litera ture and studies specifically generated under Part 161 requirements. All relevant information w ould be considered as pa rt of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain e ndpoints, especially physi cal/chemical and fate properties, that SAR and QSAR might be effect ively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals. When considering biological prope rties, at this time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of predic ted data can fulfill one of the data needs for the Dibromodicyanobutane case, then the Agency in vites submission of this information. The submitter would be expected to supply a rationale describing the utility of the information and provide documentation on the scient ific validity of the informa tion. The determination that the predicted data fulfills the data requirement woul d be at the sole discretion of the Agency. Presubmission consultation with the Agency is encouraged.

Additional Information:Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

12 of 23 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 A ugust 2012, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for the Dibromodicyanobutane case.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

13 of 23 II. Fact Sheet

Background Information:

• Active Ingredient: 1-Bromo-1-(bro momethyl)-1,3-propanedicarbonitrile (Dibromodicyanobutane)

• Case number: 2780

• PC Code: 111001

• CAS number: 35691-65-7

• Technical registrants: Lanxess Corporation

• First approved for use in a registered product: 1980

• DBDCB is regulated by the FDA as an indir ect food additive. Tolerances have been established for DBDCB as a preservativ e in food grade adhesives (see 21 CFR § 175.105) and as a slimicide in the manufacture in food grade paper and paperboard at a maximum level of 0.005% of dry we ight fiber (see 21 CFR § 176.300).

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, murasaki.seiichi@epa.gov

• Antimicrobials Division Product Manager (P M): Jacqueline Campbell-McFarlane, campbell-mcfarlan e.jacqueline@epa.gov

• Chemical Structure:

Use & Usage Information:

• Dibromodicyanobutane (DBDCB) is register ed for use in materials preservation, industrial recirculating coo ling water treatment, oil production, and paper mill water treatment. The material preservation uses include adhesives, caulks, household cleaning solution, paints and coatings, metal wo rking fluids and non-apparel textiles.

Recent/Pending Regulatory Actions:

• There are no pending regula tory actions for DBDCB.

Ecological Risk Assessment Status:

Please refer to Product Chemistry, Environmental Fa te, and Ecological Effects Scoping Document in Support of Registratio n Review of Dibromodicyanobutane, located in the docket, for a detailed discussion of the ecological risk assessments.

• DBDCB is moderately toxic to freshwater and estuarine/marine animals and slightly toxic to birds and mammals. For use in conducting an ecological risk assessment, including an endangered species assessment for all uses, the Agency anticipates requiringDocket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

14 of 23 an algal (Tier II) toxici ty study using freshwater green alga. No toxicity data is available for the MGN degradate, toxicity of this degradate will be assumed to be as toxic as the parent.

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Dibromodicyanobutane. Please refer to 1,2-Dibromo-2,4-dicyanobutane (DBDCB): Human Health Registration Review Scoping Document , located in the docket, for a detailed discussion of the human health risk assessment.

Hazard Characterization:

• Toxicological endpoints of concern were not identified at the time of the RED.

• Based on acute toxicity data, DBDCB is of lo w oral toxicity (Toxici ty Category III), low dermal toxicity (Toxicity Category IV), a nd low inhalation toxici ty (Toxicity Category IV). DBDCB is a severe dermal and eye ir ritant (Toxicity Categor y I). It is not a sensitizer in animals but is a dermal sensitizer in humans.

Dietary (Food and Water):

• Dietary (food) exposure to DBDC B is possible since it is us ed as a slimicide in food contact paper and paperboard production and to preserve paper-making chemicals and migration of DBDCB from paper packag ing to the food contents may occur.

• Material preservative uses of DBDCB may lead to contamination of human and livestock drinking water through the discharge of waste water. DBDCB and/or its degradates could potentially pass through wastewater treatme nt plants (WWTPs). The Agency will determine the need for a dietary drinking wa ter risk assessment following the submission and review of environmental fate data that are anticipated to be required

Residential:

• Residential dermal and inhalation exposures to DBDCB could occur during use of treated paints and household cleaners. Residential incidental oral exposures could occur for toddlers playing on floors cleaned with treated cleaning solutions.

Aggregate:

• EPA has not conducted an aggregate risk assessment for DBDCB. In examining aggregate exposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as nonoccupational pesticide exposures. The Agen cy may need to conduct an aggregate assessment based on residentia l and dietary exposures.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

15 of 23 Occupational:

• Occupational dermal and inhalation expos ures to DBDCB could occur during open pouring of liquids and wettable powders for ma terial preservation and during the use of treated paints, metal working fluids, and cleaning solutions.

Cumulative:

• EPA does not have, at this time, available data to determine whether Dibromodicyanobutane has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this Registration Review, EPA has assumed th at Dibromodicyanobutane does not have a common mechanism of toxicity with other subs tances when used as an antimicrobial as registered.

Incidents:

Ecological:

• No Dibromodicyanobutane incidents have b een reported in the Agency’s Ecological Incident Information System (EIIS).

Human Health:

• No Dibromodicyanobutane human poisoning incide nts have been reported in the OPP’s Incident Data System (IDS).

Tolerances and International Harmonization:

• DBDCB is regulated by the FDA as an indir ect food additive. Tolerances have been established for DBDCB as a preservativ e in food grade adhesives (see 21 CFR § 175.105) and as a slimicide in the manufacture in food grade paper and paperboard at a maximum level of 0.005% of dry we ight fiber (see 21 CFR § 176.300).

Data Call-In Status:

• There are no outstanding data call -in (DCI) requirements for DBDCB.

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 included 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

.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

16 of 23 Table 1. Registered Products – Dibromodicyanobutane

Registration # Registration Name Company Name Formulation Type % A.I.
39967-28 BIOCHEK 721M Lanxess Corporation Ready-to-Use Solution 12

39967-29 TEKTAMER 38 LIQUID CONCENTRATE Lanxess Corporation Ready-to-Use Solution 25

39967-32 TEKTAMER 38 Lanxess Corporation Formulation Intermediate 99.9

39967-34 TEKTAMER 38 A.D. Lanxess Corporation Ready-to-Use Solution 25.5
39967-36 METASOL CB 225-AD Lanxess Corporation Ready-to-Use Solution 25
39967-37 METASOL CB 225-LC Lanxess Corporation Ready-to-Use Solution 25
39967-38 BIOCHEK 430 Lanxess Corporation Ready-to-Use Solution 23.73
39967-39 BIOCHEK 410 Lanxess Corporation Ready-to-Use Solution 19
39967-40 METASOL CB-220 Lanxess Corporation Ready-to-Use Solution 20

39967-41 TEKTAMER 38 WET CAKE Lanxess Corporation Formulation Intermediate 85

39967-62 TEKTAMER 38 MU Lanxess Corporation Technical Chemical 99.9
39967-110 DBDCB AD Lanxess Corporation Ready-to-Use Solution 25

39967-111 DBDCB Lanxess Corporation Emulsifiable Concentrate 98

39967-117 VERIGUARD 3003 Lanxess Corporation Soluble Concentrate 10

59106-2 BIOCLEAR 750 Clearwater International, LLC Wettable Powder 78.4

59106-3 BIOCLEAR 550 FIZZY TABS Clearwater International, LLC Pelleted/Tableted 25Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

17 of 23 III. Summary of Anticipated Data Requirements – DBDCB

The table below summarizes anticipated data needs for the Dibromodicyanobutane Case in Section I of this document (Preliminary Work Plan), Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Dibromodicyanobutane, and 1,2-Dibromo-2,4-dicyanobutane (D BDCB): Human Health Registration Review Scoping Document

. Table 2. Summary of Anticipated Data Requirements – Dibromodicyanobutane

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months from DCI Receipt)
850.4400 Aquatic plant toxicology test using Lemna spp. 9 TGAI 12
850.5400 Algal Toxicity (Tier II) 10 TGAI 12
850.6800 Modified activated sludge, respiration inhibition test 11 TGAI 12
835.3110 Ready Biodegradability 11 TGAI 12

835.3220 Porous Pot Test 11 TGAI 12

835.3280 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 11 TGAI 12

835.3240 Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units 11 TGAI 12

870.3465 90-day inhalation toxicity 12 TGAI 24

9 If data indicate the IC 50 for Selenastrum capricornutum is greater than 1000 ppb, the Agency will consider waiver requests for the Aquatic vascular plant toxicology test (850.4400).
10 Algal Toxicity Tier II data using Selenastrum capricornutum (Green Algae), Anabaena flos-aquae (Blue-Green Cyanobacteria), Navicula pelliculosa (Freshwater Diatom), and Skeletonema costatum (Marine Diatom) are expected to be required. If data indicate the IC 50 for Selenastrum capricornutum is greater than 1000 ppb, the Agency will consider waiver requests for studies conducted with the other three algal species.
11 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the DCI expected to be issued would provide that the registrant would choose to conduct either: (i) Ready Biodegradability or (ii) a) Biode gradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the antimicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.
12 Study is anticipated as being needed for following scenarios: open-pour liquids; open-pour wettable powders; application of preserved paints using brush/roller or airle ss sprayer; use of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

18 of 23 870.3800 Two-Generation Reproduction 13 TGAI 48
875.1200 Dermal indoor exposure 14 TGAI 12
875.1400 Inhalation indoor exposure 14 TGAI 12
875.1600 Application exposure da ta reporting and calculations 14 TGAI 12

875.1700 Product use information TGAI 12
875.2300 Indoor surface residue dissipation 15 TGAI 24
Special Study Nature of Residue on Surfaces 16 TGAI 24

Special Study Migration Study 16 TGAI 24

13 Study is anticipated as being needed for all uses th at can result in dietary and drinking water exposures.
14 Exposure studies are anticipated as being needed for following scenarios: open-pour liquids; open-pour wettable powders; application of preserved paints using brush/roller or airless sprayer; use of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners. If labels are amended to require closed mixing/loading, then any required exposure study for open-pour liquid scenarios can likely be waived. If labels are amended to require water soluble packaging, then any required exposure study for open-pour wettable powder scenarios can likely be waived. It may be possible to use proprietary surrogate exposure data if data compensation issues are adequately addressed.
15 Study is anticipated as being needed for following scenario: residential post application dermal and incidental oral exposure to floors cleaned with preserved household cleaning solutions. The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study.
16 Study is anticipated as being needed for following scenarios: dietary exposures from countertops cleaned with preserved household cleaning solution; and dietary exposures from DBDCB treated paper products used in food packaging. The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study. In the absence of ad ditional data, a default transfer factor of 100% would be expected to be used.Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

19 of 23 IV. Appendix A: Use Patterns – Dibromodicyanobutane

Use Site Formulation/ EPA Reg.

no. Method of Application Max. Application Rate Materials preservative Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic, polyvinyl alcohol & hydroxyethyl cellulose, epoxy, polyester, dextrine based adhesives, casein based adhesives. 39967-28 metered injection 0.10-0.60% by weight

Dispersed Pigments 39967-28 metered injection 0.04-0.10% by weight Fiber Processing fluids 39967-28 metered injection 0.20-1.20% by weight Joint cement 39967-28 metered injection 0.20-0.40% by weight Latex emulsions 39967-28 metered injection 0.04-0.20% by weight Metalworking fluids 39967-28 metered injection 0.10-0.40% by weight Aqueous paints (including heating and air conditioning systems) 39967-28 metered injection 0.10-0.30% by weight Waxes, polishes and inks 39967-28 metered injection 0.01-0.10% by weight Aqueous paints 39967-29 metered injection 0.1-0.3% by weight Latex emulsions 39967-29 metered injection 0.04-0.2% by weight Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic Polyvinyl alcohol & hydroxyethyl cellulose. Epoxy, polyester. Dextrin. Casein 39967-29 metered injection 0.1-0.6% by weight

Dispersed Pigments 39967-29 metered injection 0.04-0.1% by weight Metalworking fluids 39967-29 metered injection 0.1-0.4% by weight Waxes, polishes and inks 39967-29 metered injection 0.01-0.1% by weight Joint cement 39967-29 metered injection 0.2-0.4% by weight Fiber Processing fluids 39967-29 metered injection 0.2-1.2% by weight Aqueous paints 39967-32 metered injection 0.025-0.075% by weight Latex emulsions 39967-32 metered injection 0.01-0.05% by weight Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic Polyvinyl alcohol & hydroxyethyl cellulose. Epoxy, polyester. Dextrin. Casein 39967-32 metered injection 0.01-0.1$ by weight

Titanium dioxide, calcium carbonate & clay 39967-32 metered injection 0.01-0.025% by weight Metalworking fluids 39967-32 metered injection 0.025-0.4% by weight Waxes, polishes and inks 39967-32 metered 0.01-0.1% byDocket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

20 of 23 Use Site Formulation/ EPA Reg.

no. Method of Application Max. Application Rate injection weight Paste type, vinyl latex & protein Reconstituted powder type, vinyl latex & protein 39967-32 metered injection 0.05-0.2% by weight Aqueous paints 39967-34 metered injection 0.1-0.3% by weight Latex emulsions 39967-34 metered injection 0.04-0.2% by weight Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic Polyvinyl alcohol & hydroxyethyl cellulose. Epoxy, polyester. Dextrin. Casein 39967-34 metered injection 0.1-0.6% by weight

Dispersed Pigments 39967-34 metered injection 0.04-0.1% by weight Metalworking fluids 39967-34 metered injection 0.1-0.4% by weight Waxes, polishes and inks 39967-34 metered injection 0.01-0.1% by weight Joint cement 39967-34 metered injection 0.2-0.4% by weight Fiber Processing fluids 39967-34 metered injection 0.2-1.2% by weight Starch, clay, calcium carbonate, titanium dioxide; paper coatings, high viscosity suspensions; e.g., polymers, sizing solutions; adhesives such as polyvinyl alcohol/polyvinyl acetate based adhesives; starch based adhesives; dextrin based adhesives. 39967-36 metered injection 0.04-1.0% by weight

Starch, clay, calcium carbonate, titanium dioxide; paper coatings, high viscosity suspensions; e.g., polymers, sizing solutions; adhesives such as polyvinyl alcohol/polyvinyl acetate based adhesives; starch based adhesives; dextrin based adhesives. 39967-37 metered injection 0.04-1.0% by weight

Aqueous paints and Coatings (including heating and air conditioning systems) 39967-38 metered injection 800-3000ppm

Dishwashing liquids, furniture and floor waxes and polishes, cleaners and treatment products and over-the counter inks. 39967-38 metered injection 500-8000ppm

Starch, epoxy, polyester, polyvi nyl acetate, styrene butadiene, methyl cellulose, acrylic, polyvinyl alcohol, hydroxyethyl cellulose, dextrin and casein. 39967-38 metered injection 500-8000ppm

Joint cement 39967-38 metered injection 2000-8000ppm

Paints and coatings, adhesives and plastics. Starch, clay, calcium carbonate or titanium dioxide; paper coatings, high viscosity suspensions, polymers , sizing solutions. 39967-38 metered injection 400-9000ppm

Metalworking fluids 39967-38 metered injection 500-4000ppm

Dishwashing liquids, furniture and floor waxes and polishes, cleaners and treatment products and over-the counter inks. 39967-38 metered injection 500-4000ppm

Non-apparel fiber applications and canvas

39967-38 metered injection 0.2-1.2% by weight (2000- 12000ppm)Docket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

21 of 23 Use Site Formulation/ EPA Reg.

no. Method of Application Max. Application Rate Aqueous paints and Coatings. 39967-39 metered injection 500-4000ppm

Polyvinyl acetate, acrylic, vinyl acrylic and styrene butadiene. 39967-39 metered injection 500-8000ppm

Dispersed Pigments 39967-39 metered injection 500-2000ppm

Dishwashing liquids, furniture and floor waxes and polishes, cleaners and treatment products and over-the counter inks. 39967-39 metered injection 500-8000ppm

Joint cement 39967-39 metered injection 2000-8000ppm

Metalworking fluids 39967-39 metered injection 500-4000ppm

Printer, copier and computer printer inks 39967-39 metered injection 10-2000ppm

Polyvinyl acetate, acrylic, vinyl acrylic, alkyd modified acrylic & alkyl modified vinyl acrylic 39967-40 metered injection 0.125-0.375% by weight Polyvinyl acetate, acrylic, viny l acrylic & styrene-butadiene 39967-40 metered injection 0.05-0.25% by weight Potyvinyl acetate, Styrene-but adiene, methyl cellulose & acrylic, hydroxyethyl cellulose, Epoxy, polyester, Dextrin, Casein 39967-40 metered injection 0.05-0.375% by weight

Clay, titanium dioxide & calcium carbonate 39967-40 metered injection 0.05-0.125% by weight Metalworking fluids 39967-40 metered injection 0.125-0.5% by weight Waxes, polishes and inks 39967-40 metered injection 0.05-0.5% by weight Joint cement 39967-40 metered injection 0.25-0.5% by weight Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic, polyvinyl alcohol & hydroxyethyl cellulose, epoxy, polyester, dextrine based adhesives, casein based adhesives. 39967-110 metered injection 0.10-0.60% by weight

Dispersed Pigments 39967-110 metered injection 0.04-0.10% by weight Fiber Processing fluids 39967-110 metered injection 0.20-1.20% by weight Joint cement 39967-110 metered injection 0.20-0.40% by weight Latex emulsions 39967-110 metered injection 0.04-0.20% by weight Metalworking fluids 39967-110 metered injection 0.10-0.40% by weight Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic, polyvinyl alcohol & hydroxyethyl cellulose, epoxy, polyester, dextrine based adhesives, casein based adhesives. 39967-111 metered injection 0.10-0.60% by weight

Dispersed Pigments 39967-111 metered injection 0.04-0.10% by weight Fiber Processing fluids 39967-111 metered injection 0.20-1.20% by weight Joint cement 39967-111 metered injection 0.20-0.40% by weightDocket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

22 of 23 Use Site Formulation/ EPA Reg.

no. Method of Application Max. Application Rate Latex emulsions 39967-111 metered injection 0.04-0.20% by weight Metalworking fluids 39967-111 metered injection 0.10-0.40% by weight Paints, coatings and stains 39967-111 metered injection 0.10-0.30% by weight Waxes, polishes and inks 39967-111 metered injection 0.01-0.10% by weight Paper Auxiliaries/Additives Paper Slurries Fiber Processing Fluids 39967-117 metered injection 0.20-1.7% by weight

Polyvinyl acetate, styrene-but adiene, methyl cellulose & acrylic, polyvinyl alcohol & hydroxyethyl cellulose, epoxy, polyester, dextrine based adhesives, casein based adhesives. 39967-117 metered injection 0.0125-0.6% by weight (125- 6000ppm) Biopolymers (e.g. Xanthan), Caulking Materials, Mastics, Ceramic Glazes Chemical Cleaning Solutions, Cleaning Solutions, Concrete and Masonry, Additives, Concrete, Fire Extinguishing Medium, Photographic Gelatins, Plasters, Polishes, Rubber Systems, Tints, Wax Emulsion s, Joint cements 39967-117 metered injection

Metalworking fluids concentrates 39967-117 metered injection 0.2-0.5 gallons per 1000 gallons Alkyd Resin-Based Systems, Casein-Systems, Latex-Based Systems, Oil-Containing Systems, Synthetic Resin Dispersions 39967-117 metered injection 0.0125-0.6% by weight (125- 6000ppm) Calcium Carbonate Slurries, Ca rbon Black Pigment Slurries, Clay Slurries Iron Oxide Pigment Slurries, Ka olin Slurries, Organic Dyes and Pigment Slurries, Other Filler Suspensions Starch Slurries, Inks 39967-117 metered injection 0.0125-0.6% by weight (125- 6000ppm)

Acrylic-Systems, Other Polymer Dispersions, PolyesterBased Systems, Polyurethane-Based Systems, Polyvinyl acetate (PVA) Systems, Styrene Butadiene Systems, Vinyl Acrylic-Based Systems, Latex Emulsions 39967-117 metered injection 0.0125-0.6% by weight (125- 6000ppm)

Industrial processes and water systems Pulp, paper and paperboard systems 39967-36 metered injection 0.08-0.4lbs/ton.

Pulp, paper and paperboard systems 39967-37 metered injection 0.08-0.4lbs/ton.

Cooling water tower systems 39967-38 metered injection 500-8000ppm

Pulp, paper and paperboard systems 39967-38 metered injection 0.05-0.4 lbs/ton

Pulp, paper and paperboard systems 39967-40 metered injection 0.02-0.1% by weight Non-marine enhanced oil recovery systems, oil field water, polymer of micellar floods, water-disposal systems or other oil field water systems 59106-2 metered injection 3-27lbs per 20,000 gal water, 1-4 times per week Drilling muds

59106-2 metered injection 3-27lbs per 20,000 gal water, 1-4 times perDocket Number: EPA-HQ-OPP-2012-0342 www.regulations.gov

23 of 23 Use Site Formulation/ EPA Reg.

no. Method of Application Max. Application Rate week Water floods

59106-2 metered injection 3-27lbs per 20,000 gal water, 1-4 times per week Non-marine enhanced oil recovery systems, oil field water, polymer of micellar floods, water-disposal systems or other oil field water systems 59106-3 metered injection 0.8-7.6 lbs per 100 barrels of
water Completion and workover fluids

59106-3 metered injection 0.8-7.6 lbs per 100 barrels of
waterDrilling muds/packer fluids59106-3 metered injection 0.8-7.6 lbs per 100 barrels of
water Water floods

59106-3 metered injection 0.8-7.6 lbs per 100 barrels of
water Industrial processes and water systems

39967-117 metered injection 0.00095-0.095 gallons per 1000 gallons of water Cooling water tower systems

39967-117 metered injection 0.00095-0.095 gallons per 1000 gallons of water Pulp, paper and paperboard systems

39967-117 metered injection 0.15-0.50 lbs per ton of pulp or
paper Oil field water, polymer of micellar floods, water-disposal systems or other oil field water systems

39967-117 metered injection 0.1-6.4 gallons per 2400 barrels of water (1-80 ppm) Formulation Use Only for formulation into a microbiocide / microbiostat / bacteriostat for use as an additive for latex and oil paints, emulsions, metalworking cutting fluids, secondary oil recovery injection waters, drilling muds, industrial adhesives, dispersed pigments, metalworking fluids, waxes & polishes, inks, and joint cements. 39967-41 Only for formulation into a microbiocide / microbiostat / bacteriostat for use as an additive for latex and oil paints, emulsions, industrial adhesives, dispersed pigments, metalworking fluids, waxes & polishes, inks, and joint cements. 39967-62