United States Chemical Safety December 2011

Environmental Protection and Pollution Prevention

Agency (7510P)

Sodium Omadine

Summary Document:

Registration Review: Initial Docket

December 2011

Docket Number: EPA-HQ-OPP-2011-0611

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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 Plan 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-HQ-OPP-2011-0611 located on the internet at www.regulations.gov.
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Sodium Omadine Registration Review Team

Timothy Dole

Human Health & Environmental Effects

Srinivas Gowda

Eliza Blair

Risk Management

Lance Wormell

Philip Ross

Office of General Counsel
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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 standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, 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 implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

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

public phase of 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 pesticide 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 develop and commit to a final work plan and 

schedule for the Sodium Omadine Case.

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 products

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 (incan), 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, 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. 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).

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

1996. 
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Documents associated with the registration review of Sodium omadine can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2011-0611. Below is a summary of the issues 

relevant to this registration review case.

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 Agency 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 Agency will consult with the U.S. Fish and Wildlife Service and/or National 

Marine Fisheries Services (the Services), as appropriate.

• The Agency anticipates the need to require the following additional ecological data for 

use in the registration review of Sodium 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 EC50 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 EC50 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. 
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• For 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

• For more information, 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 

this registration review case at this time.

• For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of 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 carcinogenicity, 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 

taxonomic 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 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 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.
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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 humans 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 

interact 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 effects 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. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, 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 chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.
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Timeline

EPA has created the following estimated timeline for the completion of the Sodium Omadine

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 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 Sodium Omadine 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 stakeholders are asked to comment on any trade irritant issues resulting from lack of 

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

export 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_detail_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 at 
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http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES.

More information on impaired water bodies and TMDLs can be found at 

http://www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of 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, unusually high exposure to Sodium Omadine compared 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 studies 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 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 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 directly 

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 value 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 under 
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Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

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 considering 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 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 predicted data can fulfill one of the data needs for the 

Sodium Omadine case, 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 asked 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 

and 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 Plan for the Sodium 

Omadine case. 
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II. Fact Sheet

Background Information:

• Active Ingredient: Sodium Omadine

• Case 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 containing 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, 

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, 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.
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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 for 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 development 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, bluegill 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, the Agency anticipates needing 

the algal toxicity data identified earlier 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 Agency 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 Sodium Omadine.
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Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Sodium 

Omadine. 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 Sodium Omadine 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 treatment 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. Additional physics-based 

pharmacokinetics (PBPK) data are currently being reviewed for a related chemical, zinc 

omadine, and if appropriate, will be used for Sodium Omadine as well.

Dietary (Food and Water):

• No dietary or drinking water assessment was conducted for the Sodium Omadine 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 paper, 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 required 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 environmental fate data anticipated to be required for this 

registration review.
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Residential:

• The most recent residential risk assessment was completed in 1996 in support of the 

Sodium Omadine RED.

• Sodium Omadine 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 Sodium Omadine while the sponge-related residential risks were assessed for 

zinc omadine because Sodium Omadine 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 

Sodium Omadine-preserved dish detergents and household cleaners, during registration 

review.

Aggregate:

• No aggregate assessment has been completed for Sodium Omadine.

• 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, residential 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 Sodium Omadine RED.

• Occupational postapplication 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 Sodium Omadine has 

low vapor pressure. Although it is true that vapor exposures to Sodium Omadine 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, metalworking fluids, surface 

cleaners and floor cleaners treated with Sodium Omadine. Additionally, it will be 

necessary to reassess the general preservative uses because some materials have 

application rates of up to 5000 ppm, which is much greater than the rate of 46 ppm that 

was assessed in the RED.
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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 toxicologically 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 Sodium Omadine exposure. However, there are literature reports of allergic contact 

dermatitis and contact dermatitis associated with occupational exposure to Sodium 

Omadine in metalworking 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 

Sodium Omadine. Sodium Omadine 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 Sodium Omadine 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 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.
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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 41
Docket Number: EPA-HQ-OPP-2011-0611

www.regulations.gov

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 Omadine, 

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 biodegradability2 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 these three biodegradation tests are required. If the ASRI test EC50 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 EC50 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 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.
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 Rate

Max App Rate Converted Units Use Limitatio

83451-15

Soluble Concentrate 50

Industrial processes and water systems

commercial and industrial cooling towers, evaporative condensers, heat exchange water systems, evaporative coolers, dairy sweetwater systems, industrial process water systems, brewery pasteurizers, can warmers, hydrostatic sterilizers and retorts, air washing systems equipped with a mist eliminator, and industrial air scrubbing systems. Metered

1.3-2.6 oz per 1000 gallons

3.8-7.7 oz per 1000 gallons oz per gal

dairy sweetwapasteurizers, csterilizers and systems equipand industrial are not registe

83451-15

Soluble Concentrate 50

Industrial processes and water systems

pulp, paper, and paperboard mill process water systems Metered

0.3-0.5 lbs per ton of pulp or paper (dry basis)

2.0-3.0 lbs per ton of pulp or paper (dry basis) LBS per TON

Only for Papefood contact u

83451-15

Soluble Concentrate 50

Material preservative

Water based coatings, starches, pigments and filler slurries. Metered 200ppm 1000ppm

Only for Papeintended for fo

83451-15

Soluble Concentrate 50

Industrial processes and water systems Enhanced Oil Recovery Systems Metered

4.2 gallons per 1000 barrels

42 gallons per 1000 barrels

Gallons per Barrel

83451-15

Soluble Concentrate 50

Industrial processes and water systems Gas Storage Wells and Systems Metered 100ppm 1000ppm

Gallons per Barrel

83451-15

Soluble Concentrate 50

Industrial processes and water systems Hydrotesting Metered 100ppm 1000ppm

Gallons per Barrel

83451-15

Soluble Concentrate 50

Industrial processes and water systems Pipeline pigging and scraping Metered 100ppm 1000ppm

Gallons per Barrel

83451-15

Soluble Concentrate 50

Industrial processes and water systems

Drilling, packer, completion, workover and fracturing fluids Metered 100ppm 1000ppm

Gallons per Barrel

83451-16

Soluble Concentrate 5

Industrial processes and water systems

commercial and industrial cooling towers, evaporative condensers, heat exchange water systems, evaporative coolers, dairy sweetwater systems, industrial process water systems, brewery pasteurizers, can warmers, hydrostatic sterilizers and retorts, air washing systems equipped with a mist eliminator, and industrial air scrubbing systems. Metered

13-26 oz per 1000 gallons

38-77 oz per 1000 gallons oz per gal

dairy sweetwapasteurizers, csterilizers and systems equipand industrial are not registe

83451-16

Soluble Concentrate 5

Industrial processes and water systems

pulp, paper, and paperboard mill process water systems Metered

3.0-5.0 lbs per ton of pulp or paper (dry 

basis)

20-30 lbs per ton of pulp or paper (dry basis) LBS per TON

Only for Papefood contact u

83451-16

Soluble Concentrate 5

Material preservative

Water based coatings, starches, pigments and filler slurries. Metered 200ppm 1000ppm

Only for Papeintended for fo

83451-16

Soluble Concentrate 5

Industrial processes and water systems Enhanced Oil Recovery Systems Metered

42 gallons per 1000 barrels

420 gallons per 1000 barrels

Gallons per Barrel

83451-16

Soluble Concentrate 5

Industrial processes and water systems Gas Storage Wells and Systems Metered 1000ppm 10000ppm

Gallons per Barrel
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 Rate

Max App Rate Converted Units Use Limitatio

83451-16

Soluble Concentrate 5

Industrial processes and water systems Hydrotesting Metered 1000ppm 10000ppm

Gallons per Barrel

83451-16

Soluble Concentrate 5

Industrial processes and water systems Pipeline pigging and scraping Metered 1000ppm 10000ppm

Gallons per Barrel

83451-16

Soluble Concentrate 5

Industrial processes and water systems

Drilling, packer, completion, workover and fracturing fluids Metered 1000ppm 10000ppm

Gallons per Barrel

83451-20

Flowable Concentrate 15

Industrial processes and water systems

commercial and industrial cooling towers, evaporative condensers, evaporative coolers, closed loop heating and· cooling systems and industrial process water systems. Metered

1.9-6.4oz per 1000 gallons

9.6-19.2 oz per 1000 gallons oz per gal

83451-20

Flowable Concentrate 15

Industrial processes and water systems

air washing systems equipped with a mist eliminator and industrial air scrubbingsystems. Metered

1.9-6.4oz per 1000 gallons

9.6-19.2 oz per 1000 gallons oz per gal

83451-20

Flowable Concentrate 15

Industrial processes and water systems

brewery pasteurizers, bottle and can warmers and hydrostatic sterilizers and retorts. Metered

1.9-6.4oz per 1000 gallons

9.6-19.2 oz per 1000 gallons oz per gal

83451-20

Flowable Concentrate 15

Industrial processes and water systems

pulp, paper, and paperboard millprocess water systems including white water systems Metered

0.3-0.5 lbs per ton of pulp or paper (dry basis)

2.0-3.0 lbs per ton of pulp or paper (dry basis) LBS per TON

Only for Papefood contact u

83451-20

Flowable Concentrate 15

Industrial processes and water systems Enhanced Oil Recovery Systems Metered

4.2 gallons per 1000 barrels

63 gallons per 1000 barrels

Gallons per Barrel

83451-20

Flowable Concentrate 15

Industrial processes and water systems Gas Storage Wells and Systems Metered 100ppm 1500ppm

Gallons per Barrel

83451-20

Flowable Concentrate 15

Industrial processes and water systems Hydrotesting Metered 100ppm 1500ppm

Gallons per Barrel

83451-20

Flowable Concentrate 15

Industrial processes and water systems Pipeline pigging and scraping Metered 100ppm 1500ppm

Gallons per Barrel

83451-20

Flowable Concentrate 15

Industrial processes and water systems

Drilling, packer, completion, workover and fracturing fluids Metered 100ppm 1500ppm

Gallons per Barrel