United States Chemical Safety June 2012 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Nanosilver 

Summary Document 

Registration Review: Initial Docket 

June 2012 

 

Docket Number: EPA-HQ-OPP-2011-0370 

www.regulations.gov

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TABLE OF CONTENTS 

Nanosilver Registration Review Team ................................................................................4 

I. Preliminary Work Plan .....................................................................................................5

II. Fact Sheet ......................................................................................................................13 

III. Summary of Anticipated Data Requirements ..............................................................17 

IV. Appendix A ..................................................................................................................22 

________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Nanosilver: Summary of Product Chemistry, Environmental Fate, and Ecotoxocity 

Effects in Support of Registration Review. June 22, 2012 

2. Nanosilver: Summary of Human Health Effects in Support of Registration Review. June 

22, 2012 

Additional supporting documents for the nanosilver case may be found in the registration review 

docket EPA-HQ-OPP-2011-0370 located on the internet at www.regulations.gov. 
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Nanosilver Registration Review Team

Human Health & Environmental Effects

Jed Costanza 

Risk Management

Wanda Henson 

Lance Wormell 

Office of General Counsel

Amber Aranda 

Philip J. Ross 
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I. Preliminary Work Plan -- Nanosilver 

Introduction:

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 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 nanosilver case. 

Concerning the pesticide products that will be covered by this nanosilver registration review 

case, EPA has information that there are silver-based pesticide products currently in the market 

place that were registered without the registrant disclosing to the Agency, at the time of initial 

registration, the presence or characteristics of the nanosilver in their products. In light of this 

information, EPA sent a letter in August of 2009 to each registrant with silver-based products 

requesting a statement as to whether or not their products contained any amount of silver in any 

form having a dimension that measures between 1 and approximately 100 nanometers, referred 

to as “nanosilver.” In response to this letter, four registrants stated that their products, which 

were registered using data for conventional silver (PC Code 072501), contain nanosilver, 

including: 

1. Nanohorizons (Additive SSB, EPA Reg. No. 83587-3) 

2. Garrison Dental (H2PRO, EPA Reg. No. 75829-1) 

3. American Biotech Labs (ASAP-AGX, EPA Reg. No. 73499-1 and ASAP-AGX-32, EPA 

Reg. No. 73499-2) 

4. Pool Products Packaging (Algaedyn, EPA Reg. 68161-1) 

In addition, EPA is identifying the following products that were registered using data for silver 

chloride (PC Code 072506) as potentially containing nanosilver: 
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5. Clariant (JMAC Composite PG, EPA Reg. No. 49403-34; JMAC LP10A, EPA Reg. No. 

49403-36; Nipacide JLP10, EPA Reg. No. 49403-38). 

EPA is proposing to reclassify the products identified above as containing nanosilver (PC Code 

072599) and include these products in this Nanosilver Registration Review case (Case No. 

5042). 

In addition, on December 1, 2011, EPA registered two nanosilver containing products: HeiQ 

AGS-20 (EPA Reg. No. 85249-1) and HeiQ AGS-20 U (EPA Reg. No. 85249-2). Both of these 

products are included in this registration review case. 

The Agency believes that additional data are needed to determine whether the FIFRA standard 

for maintaining these registrations is met due to nanosilver’s unique physical and chemical 

properties, and thus nanosilver’s potentially different health and safety properties as compared to 

silver. The Agency is establishing this Nanosilver Registration Review case pursuant to 40 CFR 

Part 155.42, including, but not limited to, 40 CFR 155.42(b)(2). 

With the exception of the HeiQ products, EPA does not have information on the composition of 

the nanosilver or potential nanosilver in the products listed above. Thus, EPA is proposing that 

the first phase of data submission be focused on determining the characteristics of the silver 

present in these products. If nanosilver is identified during the first phase of data submission then 

the next phase of proposed data submission would be determining the form and concentration of 

silver released from the products identified to contain nanosilver. If nanosilver is found to be 

released from the products identified to contain nanosilverthen the final phases of data 

submission will concern health effects, ecological effects, and environmental fate. 

The registration review of nanosilver is being initiated separately from the Silver and 

Compounds Registration Review case (Case No. 4082, docket EPA-HQ-OPP-2009-0334) 

because EPA has determined that the information required to assess the safety of nanosilver is 

different from that of silver. This determination is a presumption that is, of course, is rebuttable 

on a case-by-case basis. On February 29, 2012, EPA sent Data Call-In Notices (DCI) to 

registrants with products included in the Silver and Compounds Registration Review case (Case 

No. 4082) requesting information on particle size. EPA is currently reviewing responses to the 

DCI Notice and may determine that some of the products covered by that case and DCI should 

also be included in this Nanosilver Registration Review case (Case No. 5042). Should the 

Agency determine that any of these products need to be included in this Nanosilver Registration 

Review case (Case No. 5042), it will include a statement in the docket, and reflect that 

determination in the Nanosilver (Case No. 5042) Final Work Plan and in an amendment to the 

Silver (Case No. 4082) Final Work Plan. Should the Agency subsequently determine that 

products listed in the Nanosilver Registration Review case belong only in the Silver and 

Compounds Registration Review case, it will include a statement in the Nanosilver Registration 

Review docket and reflect that determination in an amendment to the Nanosilver (Case No. 

5042) Final Work Plan and in an amendment to the Silver (Case No. 4082) Final Work Plan. 

Documents associated with the registration review of nanosilver can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2011-0370. 
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Anticipated Risk Assessment and Data Needs:

In November, 2009 the Agency convened a meeting of the FIFRA Scientific Advisory Panel 

(SAP) to address a number of questions associated with assessing the hazard of and exposure to 

nanosilver and other nanoscale metal-based pesticides (FIFRA SAP, 2009). In general, the SAP 

advised that the toxicity of nanosilver could differ from and might be higher than other forms of 

silver (e.g., silver ions). 

The SAP was generally unsupportive of bridging among silver-based materials with different 

properties. However, the SAP indicated that bridging would be appropriate for materials of 

similar size and essentially identical physical properties and that bridging between silver ions 

released from nanosilver and the existing database for silver ions is feasible (FIFRA SAP, 2009). 

The SAP cautioned about extrapolating from one nanosilver formulation to another when 

assessing hazards because differences in particle formulation (e.g., coating and inert ingredients) 

are likely to affect biological activity, among other things. 

The SAP commented that not enough literature is available to draw any firm conclusions 

regarding human (occupational or consumer) and environmental exposures to nanosilver under 

realistic use scenarios. Potentially, three major routes exist for human exposure to nanoparticles: 

oral, inhalation, and dermal. Only a few studies in rodents are known that investigate the toxicity

of nanosilver from exposure by these routes. Nor is there much information on the level of 

human exposure to nanosilver by these routes, for either workers or consumers using products 

containing nanosilver. The same situation exists for the environmental fate and transport of 

nanosilver. The ability to measure concentrations of nanosilver in the environment along with the 

environmental exposure pathways, bioavailability, toxicity, and potential impact of nanosilver on 

ecological systems is not well developed. Furthermore, little or no information on the fate of 

nanosilver in soils and sediments was found. As a result, the SAP recommended a case-by-case 

approach to hazard and exposure assessment (i.e., product-by-product). The SAP also advised 

that existing data requirements may have to be adjusted to obtain data appropriate to assess the 

fate, degradation, metabolism, mobility, dissipation, and accumulation of nanomaterials. 

The SAP report further suggested that existing information on conventional silver could be 

useful but would not necessarily be sufficient in assessing potential nanosilver risks. The SAP 

recommended that the Agency treat nanosilver differently from its conventional silver 

counterpart in evaluating proposed nanosilver product applications (in terms of both data 

requirements and the conduct of risk assessments). Moreover, the Panel recommended that EPA 

require additional data on the physical chemistry, exposure potential, and the potential hazard of 

nanosilver to human health and the environment. 

Based on the SAP findings, the Agency anticipates the need to conduct a human health and 

ecological risk assessment if exposure to nanosilver is anticipated to or determined to occur. As 

noted later in this document, EPA anticipates that any required data would be developed in a 

phased approach where product characterization data would be generated prior to developing 

protocols for subsequent effects testing (See Table 2). 

Product Chemistry: 
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 The Agency anticipates requiring the following additional product chemistry data for the 

registration review of nanosilver. 

830.1620/1650 – Description of Production and Formulation including specifics on 

milling, separation procedures, use of reductants or reducing atmospheres, and heating 

conditions. Information regarding the particulate size of ingredients must be stated for 

each formulation step. 

830.1800 -- Enforcement analytical method 

830.7050 -- UV/visible light absorption 

Non-Guideline–Special Study: Particle Size and Diameter (size) Distribution 

Non-Guideline–Special Study: Surface Area Determination 

Non-Guideline–Special Study: Zeta Potential 

Non-Guideline–Special Study: Stability to sunlight, detergents, temperature, and 

salinity 

Non-Guideline–Special Study: Chemical Speciation 

Non-Guideline–Special Study: Rate of Deposition 

Non-Guideline–Special Study: Dissolution Kinetics 

 For more information, please refer to Nanosilver: Summary of Product Chemistry, 

Environmental Fate, and Ecotoxocity Effects in Support of Registration Review, located 

in the docket. 

Human Health Risk: 

 The Agency anticipates conducting residential and occupational exposure risk 

assessments for the registration review of nanosilver. 

 Aggregating exposures and risks from the same pesticide requires information. Currently, 

there is insufficient information to aggregate exposures to other nanosilvers in the market 

place because the Agency does not have information on the composition of the other 

nanosilvers, their distribution in the market place, or use by consumers to determine 

which exposure scenarios are likely to occur together. The Agency will again examine 

whether sufficient information to conduct an aggregate assessment is available at the risk 

assessment stage of registration review for nanosilver. 

 

 EPA does not have, at this time, adequate data to determine whether nanosilvers have 

common mechanisms of toxicity with each other or with other substances, or how to 

include these pesticides in a cumulative risk assessment. 

 The Agency anticipates requiring the following additional human health data for the 

registration review of nanosilver. 

870.3100 – 90-day oral toxicity (rat) 

870.3465 -- 90-day inhalation toxicity (rat) 

870.3250 -- 90-day dermal toxicity 

870.3550 -- Modified Reproduction and developmental toxicity screening tests in rats 
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Non-Guideline–Special Study: An in-vitro micronucleus assay for mutations in 

genetic material 

875.1200 -- Dermal indoor exposure 

875.1400 -- Inhalation indoor exposure 

Non-Guideline–Special Study: Textile Leaching Study 

Non-Guideline–Special Study: Plastics Leaching Study 

Non-Guideline–Special Study: Textile Attrition Study 

Non-Guideline–Special Study: Pool Water Residues 

 For more information, please refer to Nanosilver: Summary of Human Health Effects in 

Support of Registration Review, located in the docket. 

Ecological Risk: 

 The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for nanosilver. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether nanosilver’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 requiring the following additional ecological data for the 

registration review of nanosilver. 

850.1850 -- Modified Aquatic Food Chain Transfer 

850.4100 -- Terrestrial plant toxicity (seedling emergence, Tier I) 

850.4400 -- Aquatic Plant Toxicity, Tier II 

850.5400 -- Algal Toxicity Tier I and Tier II 

Non-Guideline–Special Study: Measuring the Chronic Effects of Freshwater 

Sediment-Associated Contaminants on Chironomus dilutes

Non-Guideline–Special Study: Measuring the Chronic Effects of Freshwater 

Sediment-Associated Contaminants on Hyalella azteca 

Non-Guideline–Special Study: Measuring the Chronic Effects of Marine and Estuarine 

Sediment-Associated Contaminants on Leptocheirus plumulosus

 The Agency anticipates requiring the following additional environmental fate data for 

the registration review of nanosilver. 

835.1110 -- Activated Sludge Sorption Isotherm 

850.6800 -- Modified activated sludge, respiration inhibition test 

835.1230 -- Sediment and soil adsorption/desorption 

835.1240 -- Leaching and adsorption/desorption 

Non-Guideline–Special Study: Dissolution Kinetics Study 

Non-Guideline–Special Study: Rate of Deposition 
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 For more information, please refer to Nanosilver: Summary of Product Chemistry, 

Environmental Fate, and Ecotoxocity Effects in Support of Registration Review, located 

in the docket. 

Timeline

EPA has created the following estimated timeline for the completion of the nanosilver 

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) August 2012 

Issue DCI August 2012 

DCI 90-day responses due1 November 2012 

Data Submission – All data2 August 2015 

Open Public Comment Period for Preliminary Risk Assessments January 2016 

Close Public Comment Period February 2016 

Phase 3: Registration Review Decision 

Open Public Comment Period for Proposed Reg. Review Decision September 2016 

Close Public Comment Period for Proposed Reg. Review Decision November 2016 

Final Decision and Begin Post-Decision Follow-up March 2017 

Total (years) 5 1

The 90‐day responses will be due to the Agency based on the date the affected registrant receives the

DCI that the Agency anticipates issuing.  

2

This date reflects the last date on which required data are due, based on the schedule expected to be

included in the anticipated DCI.  Earlier deadlines for submission will be included in the DCI for various

data requirements due earlier.

Registrants will have the option of using protocols developed as part of the HeiQ AGS-20 

registration or developing their own protocols. 

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 nanosilver registration review case. 

Trade Irritants:
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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:

Nanosilver 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 nanosilver, 

based on information provided at 

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 nanosilver 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 
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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 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 

Part 161 requirements (i.e., Data Requirements for Antimicrobial Pesticides). All relevant 

information would be considered as part of a weight-of-the-evidence evaluation. 

At this time, EPA believes that for certain endpoints and for many chemicals, especially 

physical/chemical and fate properties, 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 

nanosilver 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. 

With respect to nanosilver, EPA notes for nanoscale materials that most SAP members were 

generally “unsupportive of bridging among silver-based materials with different properties.” 

EPA asked the SAP about the applicability of SAR/QSARs for nanoscale materials and the Panel 

stated that “[a]s more research data become available, it might become possible to develop 

predictive Quantitative Structure Activity Relationship-like models for nanomaterials. However, 

such models do not exist at this time.” EPA will take the SAP statements into consideration 

when reviewing any arguments or data supporting the possible use of SAR/QSAR for nanosilver 

products. 

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: 
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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 August 2012, the Agency will review and respond to 

any comments received in a timely manner, and then issue a Final Work Plan for the nanosilver 

case. Additionally, the Agency plans to issue a DCI for the data at the same time it issues the 

Final Work Plan. 
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II. Fact Sheet 

Background Information:

 Active Ingredient: Nanosilver 

 Case number: 5042 

 PC Code: 072599 There are no tolerances or exemptions from requirements of a tolerance 

established for nanosilver used as a pesticide. 

 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: Ag(0)

Recent/Pending Regulatory Actions:

On December 1, 2011 EPA issued conditional registrations for two pesticide products containing 

nanosilver as an active ingredient. The registrations were issued to HeiQ Materials Ag (“HeiQ”) 

for the product HeiQ AGS-20 intended for use as a preservative in textile products (EPA Reg. 

Nos. 85249-1 and 85249-2). HeiQ AGS-20 contains an active ingredient, silver nanoparticles 

also known as nanosilver. The AGS-20 nanosilver is not an active ingredient in any currently 

registered pesticide (i.e., it is a “new” active ingredient). As part of the conditional registrations, 

HeiQ is required through the terms of its conditional registrations to provide the types of data 

identified in Section I: Anticipated Risk Assessment and Data Needs of this document.

Use & Usage Information:

As detailed earlier in this document, in addition to the two HeiQ registrations that the Agency 

recently granted for products containing nanosilver as an active ingredient, EPA has also learned 

that it previously registered several silver-based pesticide products without the registrant 

disclosing to the Agency, at the time of the registration, the presence or characteristics of 

nanosilver in the products. At present, therefore, EPA is aware that nanosilver products have 

been registered for the following uses: material preservatives, algaecide in swimming pools, 

dental unit water-line treatment, and hard surface disinfectants. 

 

Ecological Risk Assessment Status:

The following are key findings from studies available in the scientific literature for nanosilver 

with certain size ranges and specified properties. This information provides a general 

understanding of the ecological risk for nanosilver; however, this information may not apply to 

the nanosilver in the products identified herein. Please refer to Nanosilver: Summary of Product 

Chemistry, Environmental Fate, and Ecotoxocity Effects in Support of Registration Review, 

located in the docket, for a detailed discussion of the anticipated ecological risk assessments and 

data needs. 

Environmental Fate 
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 There is a potential for nanosilver to reside or persist in the environment for a significant 

period of time where these particles are most likely to be associated with sediments. 

There is also the potential for nanosilver to reach publically owned wastewater treatment 

and privately owned septic systems where they will most likely complex with sulfide and 

partition to biosolids. Once entrained in the biosolids, the nanosilver could serve as a long 

term source of ionic silver which may adversely affect microorganisms that are vital to 

the wastewater treatment process. Because there are contradictory reports in the 

scientific literature on the potential for nanosilver to impact wastewater treatment 

operations, EPA anticipates requiring data about the environmental fate of nanosilver and 

the impact to wastewater treatment processes. 

Ecotoxicity 

 The ecotoxicity information available to assess the potential hazards of nanosilver to 

aquatic life is limited. There are studies in the scientific literature covering the toxicity of 

nanosilver to aquatic organisms. These studies indicate to the Agency that, if sufficient 

quantities of nanosilver reach surface water, then exposure to nanosilver may result in 

adverse effects to aquatic species. Although these studies are useful for indicating the 

concentration of nanosilver that might lead to effects in aquatic species, they represent 

short-term (e.g., 96 hr) acute exposures and do not characterize the effects from longerterm exposure to nanosilver. Given this limitation, the Agency anticipates requiring 

additional data about the long-term or chronic ecotoxicity effects of nanosilver. 

Human Health Risk Assessment Status:

The following are key findings from studies available in the scientific literature for nanosilver 

with certain size ranges and specified properties. This information provides a general 

understanding of the ecological risk for nanosilver; however, this information may not apply to 

the nanosilver in the products identified herein. Please refer to Nanosilver: Summary of Human 

Health Effects in Support of Registration Review, located in the docket, for a detailed discussion 

of the anticipated human health risk assessment and data needs. 

Hazard Characterization: 

 There is little indication that nanosilver poses an acute risk to human health. While 

nanosilver is not anticipated to be acutely toxic, little information is available on the 

effects from long-term exposure to nanosilver as well as potential reproductive and 

developmental effects. One study showed toxic effects in the liver and lungs of rats after 

inhalation of nanosilver. The Agency considers these effects adverse. Significant 

increases in the amount of nanosilver in tissues, such as olfactory bulb, brain, kidneys, 

and blood, were reported. Females had two to three times more silver accumulation in 

their kidneys than males. This study indicates to the Agency that, if sufficient quantities 

of nanosilver become airborne, and if such nanoparticles display toxicity similar to the 

nanoparticles used in the Sung et al. (2009) study, then inhalation of nanosilver may 

result in adverse health effects. As a result, the Agency anticipates requiring additional 

data about what, if any, material is released from treated textiles, and what, if any, effects 

are observed from longer term exposures. 
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Dietary (Food and Water): 

 A dietary risk assessment has not been conducted because none of the products 

mentioned in this workplan are registered for food contact use. However, there is a 

potential for drinking water exposure from discharges due to use as a materials 

preservative, and swimming pool and dental-line treatment. The Agency expects that the 

environmental fate data that are anticipated to be required will be useful to evaluate this 

potential. Therefore, the need for a drinking water assessment will be determined after 

any required environmental fate data are received and reviewed. 

Residential: 

 Residential exposures are expected during use of nanosilver-containing pesticide 

products intended for use as or in hard surface cleaners, swimming pools, paint, and 

treated articles. There is also a potential for exposure during dental treatment. Infants and 

children as well as older individuals are also a potential subpopulation of exposure, based 

on residential use sites as well as registered uses in day care facilities, during dental 

treatments, and hospitals. Durations of exposure could involve short, intermediate, and 

long-term. Therefore, exposure data are anticipated to be needed to assess these 

residential exposure scenarios.

Aggregate Exposure Assessment: 

 There is insufficient information to aggregate exposures to other nanosilvers currently in 

the market place because the Agency does not have information on the composition of 

the other nanosilvers, their distribution in the market place, or use by consumers to 

determine which exposure scenarios are likely to occur together. 

Occupational: 

 Occupational exposure would be expected when handling nanosilver powder, 

manufacturing and processing treated articles, applying hard-surface cleaners or paints by 

spray, mop, sponge, cloth, or brush, or during maintenance of dental treatment lines. This 

exposure could involve both dermal and inhalation exposures; therefore dermal and 

inhalation exposure assessments are needed for short, intermediate, and long-term 

exposure scenarios. 

Cumulative: 

 EPA does not have, at this time, adequate data to determine whether nanosilvers have 

common mechanisms of toxicity with each other or with other substances, or how to 

include these pesticides in a cumulative risk assessment. 

Incidents:

Ecological: 
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 No nanosilver ecological incidents have been reported in the OPP incident database. 

Human Health: 

 One human health incident was identified in the OPP incident database. Nanosilver is 

used medically in wound dressings for patients suffering from burns. There is only one 

published report available for use by the Agency. In this report, a burn patient with 

nanosilver-coated wound dressing developed clinical signs of argyria and elevated serum 

liver enzymes indicative of liver toxicity along with elevated silver concentrations in 

blood and urine (Trop, 2006). 

Tolerances and International Harmonization: 

There are no tolerances or exemptions from tolerances for nanosilver. Nanosilver is not 

approved for food contact use. 

Data Call-In Status:

 There are currently no outstanding Data Call-In data requirements for the nanosilver case. 

[Note: The anticipated data needs listed in this work plan are similar to those required for the 

conditional registrations of HeiQ AGS-20.]

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. 

Table 1. Registered Products – Nanosilver 

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

68161-1 Silver Algaedyn Pool Products Packaging Corp Nanosilver suspension 0.8 

73499-1 ASAP-AGX American Biotech Labs Nanosilver suspension 0.001 

73499-2 ASAP-AGX-32 American Biotech Labs Nanosilver suspension 0.0032 

75829-1 

H2PRO 

MAINTENANCE 

TREATMENT 

GARRISON DENTAL 

SOLUTIONS Nanosilver suspension 0.0015 

83587-3 ADDITIVE SSB NANOHORIZONS, INC. Nanosilver Powder 99.9 
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85249-1 HeiQ AGS-20 HeiQ Materials AG Silica-Nanosilver 

Composite 19.3 

85249-2 HeiQ AGS-20 U HeiQ Materials AG Silica-Nanosilver 

Composite 19.3 

Table 2. Registration Products – Products Believed to Contain Nanosilver 

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

49403-34 

JMAC Composite PG 

-orNipacide JCPG Clariant Corp Silver Chloride Powder 20 

49403-36 JMAC LP10A Clariant Corp Silver Chloride 

suspension 2 

49403-38 Nipacide JLP10 Clariant Corp Silver Chloride 

suspension 2 

III. Summary of Anticipated Data Requirements – Nanosilver 

The table below summarizes anticipated data needs for the nanosilver case in Section I of this 

document (Preliminary Work Plan), Nanosilver: Summary of Product Chemistry, Environmental 

Fate, and Ecotoxocity Effects in Support of Registration Review, and Nanosilver: Summary of 

Human Health Effects in Support of Registration Review. 

The current EPA Office of Chemical Safety and Pollution Prevention (OSCPP) and Organisation 

for Economic Co-operation and Development (OECD) test guidelines are based on conventional 

chemicals and only provide general guidance on study design issues that might arise when 

testing nanomaterials. Due to the unique properties of nanomaterials, the Agency is initiating 

efforts to revise OCSPP and OECD guidelines so that they are applicable for nanomaterials. 

However, in the interim, in responding to any data requirement, whether in response to a DCI or 

to obtain registration, or to meet conditional registration requirements, registrants/applicants are 

encouraged to submit a protocol for each test prior to commencing any of the studies listed in 

Table 2. EPA will review these test protocols and make suggestions regarding details of the 

testing procedures. Results from any test submitted without prior EPA protocol review run the 

risk of being graded as unacceptable if found not to, among other things, satisfy the objectives of 

the required testing. 

EPA anticipates that any required data would be developed in a phased approach. Thus, the 

summary of anticipated data requirements is separated into phases where the first phase (Phase 1 
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– Product Characteristics) is to be completed prior to the second phase (Phase 2 –Release 

Characteristics/Exposure) and third phase (Phase 3 – Health Effects), the fourth phase (Phase 4 – 

Product Characteristics of Nanosilver Released from Treated Article), and the final fifth phase 

(Phase 5 – Effects and Fate) commenced after the first four phases are complete

Table 2. Summary of Anticipated Data Requirements – Nanosilver 

Guideline 

Number Anticipated Data Requirement Test Material 

Estimated Timeframe for 

Data Submission (Measured 

in months from DCI 

Receipt) 

Phase 1: Product Characteristics TGAI 

EP 7 months 

Phase 2: Release Characteristics/Exposure EP 16 months

Phase 3: Product Characteristics of Nanosilver 

Released from Treated Article AIRTA* 25 months 

Phase 4: Human Health Data TGAI 

AIRTA* 36 months 

Phase 5: Ecological and Environmental Fate Data AIRTA* 36 months 

*AIRTA: Active Ingredient Release from the Treated Article determined during Phase 2 testing.

References 

FIFRA SAP, 2009. FIFRA Scientific Advisory Panel Meeting held November 3 - 5, 2009 on the 

Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Pesticide 

Products Available at:

http://www.epa.gov/scipoly/sap/meetings/2009/november/110309ameetingminutes.pdf
Docket Number: EPA-HQ-OPP-2011-0370 

www.regulations.govIV. Appendix A: Use and Usage Information for Nanosilver Case 5042 

EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

68161-1 Nanosilver 

suspension 

Swimming Pools 

Pool water systems Swimming pool water 

algae 

open pour 4-16 oz. per 

10,000 gallons at the rate of 8 oz per 10 minutes 

Adjust pCl to 3padding use prodnot Intepools. 

73499-1 Nanosilver 

suspension 

Commercial, institutional and industrial equipment and premises 

Walls, urinals, floors, tables, chairs, light fixtures, and bathroom surfaces including those made of glass, porcelain, ceramic, enameled, painted, plastic, rubber, metal, and wood. 

Hard Non-porous surfaces of inanimate objects 

Mop, sponge, or cloth 

Thoroughly wet pre-cleaned surface. 10 minute contact time at 68 F. Wipe surface with clean towel. 

This profood coIn medifacilitie

73499-1 Nanosilver 

suspension 

Residential and public access premises 

Walls, urinals, floors, tables, chairs, light fixtures, and bathroom surfaces including those made of glass, porcelain, ceramic, enameled, painted, plastic, rubber, metal, and wood. 

Hard Non-porous surfaces of inanimate objects 

Mop, sponge, or cloth 

Thoroughly wet pre-cleaned surface. 10 minute contact time at 68 F. Wipe surface with clean towel. 

This profood coIn medifacilitie
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

73499-2 Nanosilver 

suspension 

Commercial, institutional and industrial equipment and premises 

Walls, urinals, floors, tables, chairs, light fixtures, and bathroom surfaces made of glass, porcelain, metal, glazed ceramic, enameled, and painted surfaces. 

Hard Non-porous surfaces of inanimate objects 

Mop, sponge, or cloth 

Thoroughly wet pre-cleaned surface. 10 minute contact time at 68 F. Wipe surface with clean towel. 

This profood co

73499-2 Nanosilver 

suspension 

Residential and public access premises 

Walls, urinals, floors, tables, chairs, light fixtures, and bathroom surfaces made of glass, porcelain, metal, glazed ceramic, enameled, and painted surfaces. 

Hard Non-porous surfaces of inanimate objects 

Mop, sponge, or cloth 

Thoroughly wet pre-cleaned surface. 10 minute contact time at 68 F. Wipe surface with clean towel. 

This profood co

73499-2 Nanosilver 

suspension 

Medical premises and equipment 

Walls, urinals, floors, tables, chairs, light fixtures, and bathroom surfaces made of glass, porcelain, metal, glazed ceramic, enameled, and painted surfaces. 

Hard Non-porous surfaces of inanimate objects 

Mop, sponge, or cloth 

Thoroughly wet pre-cleaned surface. 10 minute contact time at 68 F. Wipe surface with clean towel. 

This profood co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

73499-2 Nanosilver 

suspension 

Medical premises and equipment 

Dental Units Dental Unit water lines Circulation Disinfection: 8 

oz. end use product to 4 oz distilled/deionized water. (22 ppm) Run dental unit for 5 minutes. Allow product to remain in unit for 12 hours. Completely drain before use and refill with maintenance treatment. 

Maintenof end udistilled(0.5pppdental u

75829-1 Nanosilver 

suspension 

Medical premises and equipment 

Dental Units Dental Unit water lines Circulation Disinfection: add 

four (1 oz) pumps of both bottles A and B into dental unit. Run until red coloration appears in supply lines. Allow product to remain in unit for 12 hours. Completely drain before use and refill with maintenance treatment. 

Maintenoz of engallons water. Mdental uuntil bluin supplNOTE: covers opart disi
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

83587-3 Nanosilver 

Powder 

Materials preservative 

Vitreous china, ceramics, glazes, earthenware, stoneware, dental glasses, borosilicate glasses, lead glasses, soda lime glasses, special glasses, porcelains, porcelain enamels, clays, concretes, and grouts. 

Toilets, sinks, urinals, bidets, lavatories, bathtubs, tile, flooring, windows, shower doors, shower walls, shower trays, bath and kitchen accessions, countertops, handles, and knobs. 

Metered, open pour, incorporation 

1% by weight This pro

food co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

83587-3 Nanosilver 

Powder 

Materials preservative 

Plastics and plastic composite materials including alkyds, amino resins, (melamine formaldehyde and urea formaldehyde), polyester (PET, PBT, and PEN), polyamide (Nylon), polyimide, polypropylene (PP), polyethylene (PE), polybutylene, polymethylpentene (PMP), polysiloxane, polyvinyl alcohol (PVOH), polyvinyl acetate (PVA), ethylene vinyl acetate (EVA), 

polyethylene copolymer, 

polyvinyl chloride (PVC). epoxies, phenolic, polycarbonate, cellulosics, cellulose acetate, polystyrene, polyeurethane, acrylic, polymethyl methacrylate, acrylonitrile-butadienestyrene copolymer (ABS), acrylonitrilestyrene-acrylic copolyiner (ASA), acetals, polyketones, polyphelyene, 

Toilet seats, toilets, sinks, urinals, bidets, lavatories, bathtubs, spas, tile, flooring, shower doors, shower walls, shower trays, bath and kitchen accessories, plumbing supplies and fixtures, countertops, handles, knobs, automobile parts, shower curtains, mats, protective covers, waste containers, general purpose containers, shower heads, mops, brooms, tapes, packaging, gaskets, pipes, tubing, pipe fittings, whirlpool tub and spa components, structural reinforcement composites (e.g., fiber reinforced resin backings), furniture, HVAC parts and equipment, window blinds, tools, keyboards, personal grooming equipment, footwear including boots, sports 

Metered, open pour, incorporation 

1% by weight This pro

food co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

polyphenylene, polyphenylene sulfide, polyphenylene oxide, polysulfones, liquid crystal polymer and flouropolymers, amino resins, thermoplastic elastomer, rubber (including styrene, butadyene, common acrylonitrile rubber, CR) polyacetal (polyoxymethylene), and blends and copolymers therof. 

equipment, telephones, and computer equipment. 
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

83587-3 Nanosilver 

Powder 

Materials preservative 

Coatings including alkyds, amino resins, (melamine formaldehyde and urea formaldehyde), polyester (PET, PBT, and PEN), polyamide (Nylon), polyimide, polypropylene (PP), polyethylene (PE); polybutylene, polymethylpentene (PMP), polysiloxane, polyvinyl alcohol (PVOH), polyvinyl acetate (PVA), ethylene vinyl acetate (EVA), 

polyethylene copolymer, 

polyvinyl chloride (PVC), epoxies, phenolic, polycarbonate, cellulosics, cellulose acetate, polystyrene, polyeurethane, acrylic, polymethyl methacrylate, acrylonitrile-butadienestyrene copolymer (ABS), acrylonitrilestyrene-acrylic copolymer (ASA), acetals, polyketones, polyphelylene, polyphenylene sulfide, 

Toilet seats, toilets, sinks, urinals, bidets, lavatories, bathtubs, spas, tile, flooring, shower doors, shower walls, shower trays, bath and kitchen accessories, plumbing supplies and fixtures, countertops, handles, knobs, automobile parts, shower curtains, mats, protective covers, waste containers, general purpose containers, shower heads, mops, brooms, tapes, packaging, gaskets, pipes, tubing, tube fittings, whirlpool tub and spa components, structural reinforcement composites (e.g., fiber reinforced resin backings), furniture, HVAC parts and equipment, window blinds, tools, keyboards, personal grooming equipment, footwear including boots, sports 

Metered, open pour, incorporation 

1% by weight This pro

food co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

polyphenylene oxide, polysulfones, liquid crystal polymer and flouropolymers, amino resins, thermoplastic elastomer, rubber (including styrene, butadyene; common acrylonitrile rubber, CR) polyacetal (polyoxymethylene), and blends and copolymers thereof. 

equipment, telephones, and computer equipment. 
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

83587-3 Nanosilver 

Powder 

Materials preservative 

Fibers including polyester (“Dacron” PET, and PTT), acetate, polyolefins, polyamides (Nylon), polypropylene (PP), polyethylene (PE), polypeptides, acrylics, cellulosics, viscose, polyurethane, “Rayon”, polyvinyl alcohol (PVOH), polyvinyl chloride (PVC), polyvinylidene chloride, polysaccharides, and blends and copolymers thereof. 

Fabrics for household applications such as drapes, carpets, table clothes and towels; home furnishings such as chairs and bedding; automotive fabrics such as upholstery and carpeting; and apparel such as socks, shins, outwear, gloves and hats. 

Metered, open pour, incorporation 

1% by weight This pro

food co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

83587-3 Nanosilver 

Powder 

Materials preservative 

Adhesives and Sealants including alkyds, amino resins, (melamine formaldehyde and urea formaldehyde), polyester (PET, PBT, and PEN), polyamide (Nylon), polyimide, polypropylene (PP), polyethylene (PE), polybutylene, polymethylpentene (PMP), polysiloxane, polyvinyl alcohol (PVOH), polyvinyl acetate (PVA), ethylene vinyl acetate (EVA), 

polyethylene copolymer, 

polyvinyl chloride (PVC), phenolic, polycarbonate, cellulosics, cellulose acetate, polystyrene, polyeurethane, acrylic, polymethyl methacrylate, acrylonitrile-butadienestyrene copolymer (ABS), acrylonitrilestyrene-acrylic copolymer (ASA), acetals, polyketones, polyphelylene, polyphenylene sulfide, 

Toilet seats, toilets, sinks, urinals, bidets, lavatories, bathtubs, spas, tile, flooring, shower doors, shower walls, shower trays, bath and kitchen accessories, plumbing supplies and fixtures, countertops, handles, knobs, automobile parts, shower curtains, mats, protective covers, waste containers, general purpose containers, shower heads, mops, brooms, tapes, packaging, gaskets, pipes, tubing, pipe fittings, whirlpool tub and spa components, structural reinforcement composites (e.g., fiber reinforced resin backings), furniture, HVAC parts and equipment, window blinds, tools, keyboards, personal grooming equipment, footwear including boots, sports 

Metered, open pour, incorporation 

1% by weight This pro

food co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

polyphenylene oxide, polysulfones, liquid crystal polymer and flouropolymers, amino resins, thermoplastic elastomer, rubber (including styrene, butadyene; common acrylonitrile rubber, CR) polyacetal (polyoxymethylene), and blends and copolymers thereof. 

equipment, telephones, and computer equipment. 

85249-1 Silicananosilver 

composite 

Materials preservative 

Textiles Apparel, carpeting, 

industrial textile products, household textile products, outdoor textiles, automotive textiles and upholstery. 

Metered, open pour, incorporation 

0.001-0.010% by weight. 

This profood co
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

85249-2 Silicananosilver 

composite 

Materials preservative 

Textiles Apparel, carpeting, 

industrial textile products, household textile products, outdoor textiles, automotive textiles and upholstery. 

Metered, open pour, incorporation 

0.001-0.010% by weight. 

This profood co

49403-34 Silver 

chloride and inert ingredient composite 

Materials preservative 

Fibers and textiles Napkins; wiping cloths; mops; towels; bags; brush bristles; filters; sponges; packaging including bags, sacks, wraps, cushion and absorbent materials, containers; conveyor belts (non food contact); apparel; commercial and industrial wipes and fabrics; Mattress cover pads and filling; pillow covers; sheets; blankets; fiberfill for quilts and pillows; curtains; draperies; carpet and carpet underlay; rugs; upholstery; wall covering fabrics; cushion pads; sleeping bags; automotive and truck upholstery; carpeting; rear decks; 
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EPA Reg Number 

Formulation Use 

Category 

Use Site Treatment 

Site/surfaces 

Method of Application 

Max Application/Use Rate 

Use Lim

trunk liners; convertible tops; interior liners; umbrellas; outerwear; apparel: sportswear; sleepwear; trim for outerwear and garments; stockings; socks; hosiery; caps; undergarments; inner liners for jackets; shoes; gloves and helmets; curtains, draperies, upholstery, wall covering fabrics, artificial leather; book covers; sails; ropes; tents and other outdoor equipment; tarps; awnings.