United States Chemical Safety December 2011 Environmental Protection and Pollution Prevention Agency (7510P)



# Sodium Omadine Summary Document: Registration Review : Initial Docket December 2011Docket Number: EPA

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### TABLE OF CONTENTS

Sodium Omadine Registration Review Team

................................ ................................ ........ 4 I. Preliminary Work Plan

................................ ................................ ................................ ........ 5 II. Fact Sheet

................................ ................................ ................................ .......................... 12 III. Summary of Anticipated Data Requirements

................................ ................................ 18 IV. Appendix A

................................ ................................ ................................ ...................... 19

________________________________________
Please Note

This Preliminary Work Pla n and Fact Sheet summarize the Environmental Protection Agency's current position based on the following documents:

1. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Sodium omadine

. October 14, 2011

2. Sodium Omadine: Human Health Risk Assessment Scoping Document in Support of Registration Review

. September 26, 2011

Additional supporting documents for the Sodium Omadine Case may be found in the registration review docket EPA

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4 of 18 Sodium Omadine Registration Review Team

Timothy Dole Human Health & Environmental Effects

Srinivas Gowda

Eliza Blair Risk Management

Lance Wormell

Philip Ross Office of General CounselDocket Number: EPA

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5 of 18 I. Preliminary Work Plan

-- Sodium Omadine

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

. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling

. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory stan dard of no unreasonable adverse effects to human health or the environment

. Changes in science, public policy, and pesticide use practices will occur over time

. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely

. Information on this program is provided at Introduction:

http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implement ing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for regist ration

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

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

. The docket is the Agency’s opportunity to state what it knows about the pes ticide and what additional risk analyses and data or information it believes are needed to make a registration review decision

. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will d evelop and commit to a final work plan and schedule for the Sodium Omadine C ase.
The first product containing Sodium Omadine ( Sodium Omadine ) (PC Code 088004 ) as an active ingredient was registered in the United States in 1968

. Currently

, there are 12 product s registered with EPA. They are registered for use in metalworking cutting fluids, cooling and lubricating fluids, adhesives, caulks, patching compounds, sealants, pastes and grouts, paints (in

can), inks, sponges, janitorial products (in

- container ), hides/leather /leather products (surfaces), aqueous analytical and diagnostic reagents used in chemical and clinical analysis, aqueous synthetic fiber lubricating (spin finishes), carrageenan based gels used in solid air fresheners, dry wall and gypsum, pearlite, plaster

- like, mineral used in manufacture of tile, chrome or vegetable tanned leather, for the dry film preservation of natural, and synthetic adhesives, latexes, urethane foams, caulks, patching compounds, sealants, architectural paints, indust rial paints and coatings (including wood coatings), glues, in

- can preservation of latex emulsions used in adhesives, laundry rinse additives, laundry detergents, carpet cleaners, surface cleaners, floor cleaners, pigment slurries, building materials such a s joint cements and concrete additives, materials in the textile, paper, polishes waxes, protein solutions, ceramic glazes, fire extinguishing materials, cleaning solutions and detergents as a materials preservative. There are no tolerances or exemptions f rom tolerances established by the EPA for sodium omadine. Sodium omadine is approved by FDA as a preservative of adhesives in food contact packaging (21 CFR 175.105).

The Agency completed a Reregistration Eligibility Decision (RED) for Sodium Omadine in 1 996

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6 of 18 Documents associated with the registration review of Sodium omadine can be viewed at www.regulations.gov in docket EPA

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. Below is a summary of the issues relevant to th is registration review ca se.

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of Sodium Omadine. 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 Sodium Omadine. Anticipated Risk Assessment and Data Needs:

Ecological Risk:

**•** No recent ecological risk assessment has been performed for Sodium Omadine

.

**•** The Agen cy has not conducted a risk assessment that supports a complete endangered species determination for Sodium Omadine

. The ecological risk assessment planned during registration review will allow the Agency to determine whether Sodium Omadine ’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 Agen cy will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

**•** The Agency anticipates the need to require the following additional ecological data for use in the registration review of Sodi um Omadine.

o (GLN 850.5400) Algal toxicity (Tier II) using freshwater green alga, Selenastrum capricornutum.

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

o ( GLN 850. 835.2240 ) Photodegradation in water

o (GLN 850.6800) Modified Activated Sludge Respiration Inhibition

o (GLN 835.3110) Ready biodegradability

o (GLN 835.3220) Porous Pot Test 1

o (GLN 835.3280) Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 1

1

o (GLN 835.3240) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units 1

1 The results of the Activated Sludge Respiration Inhibition Test (ASRI) that is expected to be required would 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 applicant would choose to conduct either: (i) Ready Biodegradability or (ii) Biodegradation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A.Docket Number: EPA

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7 of 18 **•** F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Sodium omadine , located in the docket

.
Human Health Risk:

**•** No recent human health risk assessment has been performed for Sodium Omadine

.

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

o 875.1100

- Indoor Exposure, Dermal

o 875.1300

- Indoor Exposure, Inhalation

o 875.1600

- Data Reporting/Calculations

o 875.2300

- Surface Residue Dissipation

o 875.1700

- Product Use Information

**•** F or more info rmation

, please refer to Sodium Omadine: Human Health Risk 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 thi s registration review case at this time.

**•** F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Sodium omadine

, located in the docket

.

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals

. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogeni city, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity , sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring

. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different
taxono mic groups

. As part of its reregistration decision for Sodium Omadine , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from Endocrine Disruptor Screening Program

Activated Sludge Units or the Porou s Pot Test. If the antimicrobial passes the ready biodegradability study, 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 Simu lation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.Docket Number: EPA

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8 of 18 the existing hazard database

. However, as required by FFDCA section 408(p), Sodium Omadine is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in hum ans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems

. Chemicals that go through Tier 1 screening and are found to have the potential to inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related 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 screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/ data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Sodium Omadine is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. According ly, as part of registration review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP screening assays for Sodium Omadine

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

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9 of 18 Timeline EPA has created the following estimated timeline for the completion of the Sodium O madine registration review:

Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket December 2011 Close Public Comment Period for Docket February 2012 Phase 2: Case Development Develop Final Work Plan (FWP) June 2012 Issue DCI June 2013 Data Submission June 2014 Open Public Comment Period for Preliminary Risk Assessments December 2015 Close Public Comment Period for Preliminary Risk Assessments February 2016 Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision June 2016 Close Public Comment Period for Proposed Reg. Review Decision August 2016 Final Decision and Begin Post

- Decision Follow

- up 2016 Total (years) 5

Guidance for Commenters:

The public is invited to comment on EPA’s P reliminary W ork P lan 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 Sodium O madi ne registration review

case.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution

. Growers and other stakehold ers are asked to comment on any trade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

Sodium Omadine is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_det ail_303d?p_cause_group_id=88 5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Sodium Omadine , based on information provided atDocket Number: EPA

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10 of 18 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id =885&p_pol lutant_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 exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm ), in order to ensure the data can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws , regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusu ally high exposure to Sodium Omadine compare d to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

Structure Activity Relationships:

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

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

. The use of the results of such testing (measured data) is a logical, scientifically rigorous process that identifies the physical, chemical, and environmental fate properties of the pestici de, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in alternative techniques, i.e., techniques other than data generation that could significantly inform the Agency’s decision

- making process

. Recently, OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory decision

- making process

. In the SAR process, a chemical's molecular structure is compared to that of other chemicals for which data are available

. These structural similarities are then used to make predictive judgments about a chemical’s physical, chemical, and biological properties

. Thus, the chemical’s physical, chemical, and biological properties are a function of (or directl y related to) the chemical’s molecular structure

. Quantitative SAR is referred to as QSAR

. To develop a QSAR, a selected set of measured data on a single physical, chemical, or biological property is used to derive a model (an equation) to predict the valu e of that property

. Since SAR assessments and QSAR modeling are another set of tools that are available to Agency scientists, OPP has begun a process shift that envisions shifting from the current study

- by

- study approach to an approach in which the use of predicted data, generated using validated models, is considered along with information from open literature and studies specifically generated underDocket Number: EPA

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11 of 18 Part 161 requirements

. All relevant information would be considered as part of a weight

- of

- the

evidence ev aluation

. At this time, EPA believes that for certain endpoints, especially physical/chemical and fate properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals

. When consider ing biological properties, at this time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters

. This is appropriate because the risk assessm ent for lower toxicity chemicals can be stream

- lined, i.e., a screening

- level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of predicted data can fulfill on e of the data needs for the Sodium Omadine c ase, then the Agency invites submission of this information

. The submitter would be expected to supply a rationale describing the utility of the information and provide documentation on the scientific validity of the information

. The determination that the predicted data fulfills the data requirement would be at the sole discretion of the Agency

. Pre

- submission consultation with the Agency is encouraged.

Additional Information:

Stakeholders are also specifically a sked to provide available information and data that will assist the Agency in refining its risk assessments , including any species

- specific ecological effects determinations. The Agency is interested in receiving the following information:

1. Confirmation on the following label information:

a. Sites of application b. Formulations

c. Application methods and equipment d. Maximum application rates

e. Frequency of application, application intervals and maximum number of applications f. Geographic limitations on use 2. Use or potential use distribution 3. Use history 4. Usage/use information for non

- agricultural uses (e.g., materials preservation) 5. Typical application interval 6. State or local use restrictions 7. Ecological incidents (non

- target plant damage and avian, fish, reptilian, amphibian

an d mammalian mortalities) not already reported to the Agency 8. Monitoring data

Next Steps:

After the 60

- day comment period closes in February 2012 , the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work P lan for the Sodium Omadine c ase

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12 of 18 II. Fact Sheet

Background Information:

**•** Active Ingredient: Sodium Omadine

**•** C ase number: 0209

**•** PC Code: 088004

**•** CAS number : 15922

- 78

- 8

**•** Technical registrants: Arch Chemicals, Inc., Phichem USA, 3M, Lanxess Corp., Janssen PMP, API Corp.

**•** First approved for use in a registered product: 1968

**•** There are no tolerances or exemptions from tolerances established by the EPA for sodium omadine. Sodium omadine is approved by FDA as a preservative of adhesives in food contact packaging (21 CFR 175.105).

**•** Antimicrobials Division Chemical Review Manager (CRM): Eliza Blair

, blair.eliza@epa.gov

**•** Antimicrobials Division Product Manager (PM): Marshall Swindell

, swindell.marshall@epa.gov

**•** Chemical Structure:

Use & Usage Information:

**•** Products contai ning Sodium Omadine are registered for use in metalworking cutting fluids, cooling and lubricating fluids, adhesives, caulks, patching compounds, sealants, pastes and grouts, paints (in

- can), inks, sponges, janitorial products (in

- container), hides/leather /leather products (surfaces), aqueous analytical and diagnostic reagents used in chemical and clinical analysis, aqueous synthetic fiber lubricating (spin finishes), carrageenan based gels used in solid air fresheners, dry wall and gypsum, pearlite, plast er

- like, mineral used in manufacture of tile, chrome or vegetable tanned leather, for the dry film preservation of natural, and synthetic adhesives, latexes, urethane foams, caulks, patching compounds, sealants, architectural paints, industrial paints and coatings (including wood coatings), glues, in

- can preservation of latex emulsions used in adhesives, laundry rinse additives, laundry detergents, carpet cleaners, surface cleaners, floor cleaners, pigment slurries, building materials such as joint cements and concrete additives, materials in the textile, paper, polishes waxes, protein solutions, ceramic glazes, fire extinguishing materials, cleaning solutions and detergents as a materials preservative.Docket Number: EPA

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13 of 18 Recent/Pending Regulatory Actions:

**•** No recent or pending regulatory actions exist for sodium omadine.

Ecological Risk Assessment Status:

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Sodium omadine , located in the docket, for a detailed discussion of the ecological risk assessments.

**•** No ecological risk assessment was performed for sodium omadine at the time of the registration. The Agency's conclusions f or previously

- submitted terrestrial and aquatic effects studies are as follows.

**•** Birds, Acute and Subacute

Sodium omadine is moderately toxic to avian species on an acute oral basis and slightly toxic to avian species on subacute dietary basis.

**•** Mammals

Acute Oral: Sodium omadine is slightly toxic to mammals on an acute oral basis.

2

- generation rat reproduction study: Slightly decreased number of pups per litter born in both generations (possibly a consequence of reduced mating success due to hind limb atrophy), delayed developme nt in pups from both generations (including open ears and eyes and startle response), and decreased pup body weight and weight gain in both sexes.

**•** Freshwater Fish and Invertebrates

Sodium omadine was found to be very highly toxic to rainbow trout, bluegi ll sunfish and daphnia.

**•** Freshwater Algae

No algal toxicity data have been submitted. For use in the ecological risk assessment, including an endangered species assessment for all uses, t he Agency anticipates needing the algal toxicity data identified ea rlier in this document

.

**•** The Agency needs to conduct environmental fate and ecological risk assessments for material preservatives that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic environments. Therefore, the Ag ency anticipates needing the environmental fate and ecotoxicity data identified earlier in this document for sodium omadine and/or any of its major degradation products that are of potential concern for all registered uses of S odium O madine.Docket Number: EPA

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14 of 18 Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Sodium O madine . Please refer to Sodium Omadine: Human Health Risk Assessment Scoping Document in Support of Registration Review

, located in the docket, for a detailed discussion of the human health risk assessment.

Hazard Characterization:

**•** The RED for S odium O madine was completed in 1996 and all of existing uses were found to be eligible for registration. Some additional uses such as leather preservation, paper and sponges were added after the completion of the RED. The sponge use was evaluated in a risk assessment (EPA, 1999) and it was determined that the risks were not of concern for either workers involved in the sponge treatm ent or residential users of the treated sponges. The leather and paper uses have not been evaluated.

**•** No additional toxicology data were required in the RED and no additional toxicology data are expected to be needed for this registration review. Addition al physics

- based pharmacokinetics (PBPK) data are currently being reviewed for a related chemical, zinc omadine, and if appropriate, will be used for S odium O madine as well

. Dietary (Food and Water):

**•** No dietary or drinking water assessment was conducted fo r the S odium O madine RED because no dietary exposure was expected according to registered uses at the time.

**•** Sodium Omadine is also approved by FDA as a preservative of adhesives in food contact packaging (21 CFR 175.105). Most Sodium Omadine product labels have the statement “Do not use for applications involving direct or indirect food/drinking water contact.” Three labels (#1258

- 990, #1258

- 1205 and #39967

- 26) do not have this statement

, however, and label #39967

- 26 is approved for uses such as pape r, cleaning solutions and detergents that might involve food contact. Therefore , it will be necessary to assess indirect food contact exposures from these uses and additional residue data are expected
to be needed.

**•** The registered uses of sodium omadine might result in contamination of surface and ground water as a result of discharges of treated water from industries using this antimicrobial as a material preservative. Therefore, drinking water exposure might occur. Additional data anticipated to be req uired through registration review will be used to determine if sodium omadine can pass through wastewater treatment plants into drinking water. Therefore, the need for a drinking water assessment will be revisited upon submission and review of the environ mental fate data anticipated to be required for this registration review

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15 of 18 Residential:

**•** The most recent residential risk assessment was completed in 1996 in support of the S odium O madine RED.

**•** Sodium O madine residential exposure may occur during the use of treated products such as paints and coatings, surface cleaners, floor cleaners, carpet cleaners, textiles and leather. It should be noted that in the risk assessment for the RED, the worker risks were assessed for S odium O madine while the sponge

- related r esidential risks were assessed for zinc omadine because S odium O madine reacts with zinc that is impregnated within the sponge and forms zinc omadine.

**•** Residential exposures apart from treated sponges were not assessed in the RED because it was believed at the time that the exposures would be very low due to dilution. However, based on additional review of the toxicological endpoints established in the RED, the Agency believes it will be necessary to assess further residential exposures , such as S odium O ma dine

- preserved dish detergents and household cleaners, during registration review.

Aggregate:

**•** No aggregate assessment has been completed for S odium O madine.

**•** 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 non

- occupational pesticide exposures. Potential human exposures to Sodium Omadine include dietary, r esidential and occupational use sites

. The Agency anticipates that it will perform an aggregate risk assessment for Sodium Omadine during the risk assessment phase of registration review.

Occupational:

**•** The most recent occupational exposure assessment was completed in 1996 in support of the S odium O madine RED.

**•** Occupational post application exposures that occur during the use of treated materials were not assessed for the RED because it was believed at the time that these exposures would be minimal because of low application rates and because S odium O m adine has low vapor pressure. Although it is true that vapor exposures to S odium O madine will be minimal as stated in the RED, there is the potential for dermal and inhalation exposures to aerosols during the use of materials such as paints, metal working fluids, surface cleaners and f loor cleaners treated with S odium O madine. Additionally

, it will be necessary to reassess the general preservative uses because some materials have application rates of up to 5000 ppm

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16 of 18 Cumulative:

**•** EPA does not have, at this time, available data to determine whether Sodium Omadine has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Sodium Omadine is toxicologica lly similar to Zinc Omadine (zinc pyrithione); thus, a cumulative assessment may be necessary. The Agency will revisit the need for a cumulative assessment for this chemical during the risk assessment phase of registration review.

Incidents:

Ecological:

**•** No Sodium Omadine ecological incidents have been reported in the OPP incident database.

Human Health:

**•** There are no human incidents reported in the OPP incident database that are associated with S odium O madine exposure

. However, there are literature reports of allergic contact dermatitis and contact dermatitis associated with occupational exposure to S odium O madine in metal working fluids. Please see Sodium Omadine : Human Health Scoping Document in Support of Registration Review for more information.

Tolerances and International Harmonization:

**•** There are no tolerances or exemptions from tolerances established by the EPA for S odium O madine. Sodium O madine is approved by FDA as a preservative of adhesives in food contact packaging (21 CFR 175.105).

Data Call

- In Status:

**•** A Data Call

- In (DCI) was issued for S odium O madine in 1996.

Labels:

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

. For future reference, during registration review a list of product registration num bers 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

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17 of 18 Table 1

. Registered Products

– Sodium Omadine

Registration # Registration Name Company Name Formulation Type % of Active Ingredient

1258

- 843 Sodium Omadine 40% Aqueous Solution Arch Chemicals, Inc. Ready

- to

- Use Solution 40

1258

- 990 Triadine 10 Arch Chemicals, Inc. Ready

- to

- Use Solution 6.56

1258

- 1205 Triadine 20 Industrial Microbiostat Arch Chemicals, Inc. Ready

- to

- Use Solution 3.69

1258

- 1213 Sodium Omadine 10% Aqueous Solution Arch Chemicals, Inc. Ready

- to

- Use Solution 10

1258

- 1238 Sodium Omadine

- E 10% Aqueous Solution Arch Chemicals, Inc. Soluble Concentrate 10

10350

- 56 Sodium Pyrithione 3M Soluble Concentrate 41

39967

- 26 Preventol WB Plus Lanxess Corporation Soluble Concentrate 1.2

43813

- 48 Sodium Pyrion 40% Aqueous Solution Janssen PMP Soluble Concentrate 40

43813

- 49 Sodium Pyrion 40% MP Janssen PMP Technical Chemical 40

63898

- 2 Tomicide S API Corporation Soluble Concentrate 41

87772

- 1 Phicide Sodium Manufacturing Concentrate Dublinchem, Inc Formulation Intermediate 41.57

87772

- 2 Phicide Sodium (Sodium Pyrithione 41% Aqueous Solution) Dublinchem, Inc Soluble Concentrate 41Docket Number: EPA

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18 of 18 III. Summary of Anticipated Data Requirements

– Sodium Omadine

The table below summarizes anticipated data needs for the Sodium Omadine 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 Sodium O madine

, and Sodium Omadine: Human Health Risk Assessment Scoping Document in Support of Registration Review

.
Table 2. Summary of Anticipated Data Requirements

– Sodium Omadine

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

875.1100 Indoor Exposure, Dermal TGAI 24

875.1300 Indoor Exposure, Inhalation TGAI 24

875.1600 Data Reporting/Calculations TGAI 24

875.2300 Surface Residue Dissipation TGAI 24

875.1700 Product Use Information TGAI 24

835.2240 Photodegradation in water TGAI 12

850.6800 Modified Activated Sludge Respiration Inhibition TGAI 12

835.3110 Ready biodegradability 2 TGAI 12

835.3220 Porous Pot Test TGAI 2 12

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

2 12

835.3240 Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units TGAI
2 12

850.5400 Algal toxicity (Tier II) using freshwater green alga, Selenastrum capricornutum TGAI 12

2 The results of the Activated Sludge Respiration Inhibition Test (ASRI) that is expected to be required would determine which of t hese three biodegradation tests are 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 applicant would choose to conduct either: (i) Ready Biodegradability or (ii) Biodegradation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test. If the antimicrobial passes the ready biodegradability study, then no further testing would be expected to be required. If, however, the antimicrobial fails the ready biodegradability study, then the Biodegr adation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.Appendix A: Tri-n butyl tetradecyl phosphonium chloride (TTPC)EPA Reg # Formulation % A. I. Use Site Treatment Site/Surfaces Application Method Min App Rate Max App RateMax App RateConverted Units Use Limitations83451-15SolubleConcentrate 50Industrialprocesses andwater systemscommercial and industrial cooling towers,evaporative condensers, heat exchangewater systems, evaporative coolers, dairysweetwater systems, industrial processwater systems, brewery pasteurizers, canwarmers, hydrostatic sterilizers and retorts,air washing systems equipped with a misteliminator, and industrial air scrubbingsystems. Metered1.3-2.6 oz per 1000gallons3.8-7.7 oz per 1000gallons oz per galdairy sweetwater systems, brewerypasteurizers, can warmers, hydrostaticsterilizers and retorts, air washingsystems equipped with a mist eliminator,and industrial air scrubbing system usesare not registered for use in CA.83451-15SolubleConcentrate 50Industrialprocesses andwater systemspulp, paper, and paperboard mill processwater systems Metered0.3-0.5 lbs per tonof pulp or paper (drybasis)2.0-3.0 lbs per tonof pulp or paper(dry basis) LBS per TONOnly for Paperboard not intended forfood contact uses.83451-15SolubleConcentrate 50MaterialpreservativeWater based coatings, starches, pigmentsand filler slurries. Metered 200ppm 1000ppmOnly for Paperboard and adhesives notintended for food contact uses.83451-15SolubleConcentrate 50Industrialprocesses andwater systems Enhanced Oil Recovery Systems Metered4.2 gallons per 1000barrels42 gallons per 1000barrelsGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systems Gas Storage Wells and Systems Metered 100ppm 1000ppmGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systems Hydrotesting Metered 100ppm 1000ppmGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systems Pipeline pigging and scraping Metered 100ppm 1000ppmGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systemsDrilling, packer, completion, workover andfracturing fluids Metered 100ppm 1000ppmGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systemscommercial and industrial cooling towers,evaporative condensers, heat exchangewater systems, evaporative coolers, dairysweetwater systems, industrial processwater systems, brewery pasteurizers, canwarmers, hydrostatic sterilizers and retorts,air washing systems equipped with a misteliminator, and industrial air scrubbingsystems. Metered13-26 oz per 1000gallons38-77 oz per 1000gallons oz per galdairy sweetwater systems, brewerypasteurizers, can warmers, hydrostaticsterilizers and retorts, air washingsystems equipped with a mist eliminator,and industrial air scrubbing system usesare not registered for use in CA.83451-16SolubleConcentrate 5Industrialprocesses andwater systemspulp, paper, and paperboard mill processwater systems Metered3.0-5.0 lbs per tonof pulp or paper (drybasis)20-30 lbs per ton ofpulp or paper (drybasis) LBS per TONOnly for Paperboard not intended forfood contact uses.83451-16SolubleConcentrate 5MaterialpreservativeWater based coatings, starches, pigmentsand filler slurries. Metered 200ppm 1000ppmOnly for Paperboard and adhesives notintended for food contact uses.83451-16SolubleConcentrate 5Industrialprocesses andwater systems Enhanced Oil Recovery Systems Metered42 gallons per 1000barrels420 gallons per1000 barrelsGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systems Gas Storage Wells and Systems Metered 1000ppm 10000ppmGallons perBarrelAppendix A: Tri-n butyl tetradecyl phosphonium chloride (TTPC)EPA Reg # Formulation % A. I. Use Site Treatment Site/Surfaces Application Method Min App Rate Max App RateMax App RateConverted Units Use Limitations83451-16SolubleConcentrate 5Industrialprocesses andwater systems Hydrotesting Metered 1000ppm 10000ppmGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systems Pipeline pigging and scraping Metered 1000ppm 10000ppmGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systemsDrilling, packer, completion, workover andfracturing fluids Metered 1000ppm 10000ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systemscommercial and industrial cooling towers,evaporative condensers, evaporativecoolers, closed loop heating and· coolingsystems and industrial process watersystems. Metered1.9-6.4oz per 1000gallons9.6-19.2 oz per1000 gallons oz per gal83451-20FlowableConcentrate 15Industrialprocesses andwater systemsair washing systems equipped with a misteliminator and industrial air scrubbingsystems. Metered1.9-6.4oz per 1000gallons9.6-19.2 oz per1000 gallons oz per gal83451-20FlowableConcentrate 15Industrialprocesses andwater systemsbrewery pasteurizers, bottle and canwarmers and hydrostatic sterilizers andretorts. Metered1.9-6.4oz per 1000gallons9.6-19.2 oz per1000 gallons oz per gal83451-20FlowableConcentrate 15Industrialprocesses andwater systemspulp, paper, and paperboard millprocess water systems including white watersystems Metered0.3-0.5 lbs per tonof pulp or paper (drybasis)2.0-3.0 lbs per tonof pulp or paper(dry basis) LBS per TONOnly for Paperboard not intended forfood contact uses.83451-20FlowableConcentrate 15Industrialprocesses andwater systems Enhanced Oil Recovery Systems Metered4.2 gallons per 1000barrels63 gallons per 1000barrelsGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systems Gas Storage Wells and Systems Metered 100ppm 1500ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systems Hydrotesting Metered 100ppm 1500ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systems Pipeline pigging and scraping Metered 100ppm 1500ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systemsDrilling, packer, completion, workover andfracturing fluids Metered 100ppm 1500ppmGallons perBarrel