United States Chemical Safety March 2012

Environmental Protection and Pollution Prevention

Agency (7510P)

Perboric Acid, (HBO(O2)), Sodium Salt, 

Monohydrate

Summary Document:

Registration Review: Initial Docket

March 2012
Docket Number: EPA-HQ-OPP-2012-0006 

www.regulations.gov 

Perboric Acid, (HBO(02)), Sodium Salt, Monohydrate 

Summary Document 

Registration Review: Initial Docket 

March 2012 

Case # 5007 

Approved By: 

Date: 

J ) 

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Docket Number: EPA-HQ-OPP-2012-0006

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TABLE OF CONTENTS

Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate Registration Review Team .........4

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

II. Fact Sheet ......................................................................................................................11

III. Summary of Anticipated Data Requirements..............................................................14

IV. Appendix A..................................................................................................................15

________________________________________

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 Perboric acid, sodium salt, monohydrate (PBSM). 

February 15, 2012

2. Perboric Acid, Sodium Salt Monohydrate (PBSM) Human Health Risk Assessment 

Scoping Document in Support of Registration Review. February 2, 2012

3. HERA. Draft Human and Environmental Risk Assessment on ingredients of European 

cleaning products -- Perboric acid, sodium salt, mono and tetrahydrate. August 4, 2002.

Additional supporting documents for the Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate

Case may be found in the registration review docket EPA-HQ-OPP-2012-0006 located on the 

internet at www.regulations.gov.
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Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate Registration Review Team

Nathan Mottl

Human Health & Environmental Effects

William Hazel

Srinivas Gowda

David Bays

Seiichi Murasaki

Risk Management

Lance Wormell

Philip Ross

Office of General Counsel
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I. Preliminary Work Plan -- Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate

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 Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate Case.

The first product containing perboric acid, (HBO(O2)), sodium salt, monohydrate (perboric acid 

or PBSM) (PC Code 011105) as an active ingredient was registered in the United States in 1998. 

Currently, there are two products registered with EPA. The only registered use of PBSM is in 

laundry detergents used in combination with nonanoyloxybenzenesulfate (NOBS) (PC Code 

089053) as a sanitizer to kill odor-causing germs and bacteria on clothes. NOBS is being 

evaluated separately under registration review Case # 6077, Pelargonic Acid, Salts, and Esters. 

Products containing PBSM are only registered for non-food use and there are no tolerances or 

exemptions from tolerances established for PBSM.

There was no RED issued for perboric acid because PBSM was registered after November 1, 

1984.

Documents associated with the registration review of perboric acid, (HBO(O2)), sodium salt, 

monohydrate can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2012-0006. Below 

is a summary of the issues relevant to this registration review case.

The Agency does not anticipate the need to conduct an ecological risk assessment. 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 perboric acid.

Anticipated Risk Assessment and Data Needs:
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Ecological Risk:

• No ecological risk assessment has been performed for perboric acid. 

• Based on the low hazard and exposure, the Agency intends to conclude that the registered 

uses of perboric acid will have 'no effect' (NE) on endangered or threatened terrestrial or 

aquatic species, or their designated critical habitats, as listed by the U.S. Fish and 

Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration's 

(NOAA) National Marine Fisheries Service (NMFS). EPA anticipates conducting no 

further analysis of potential risks to endangered or threatened species unless public 

comment or other submissions provide data or information that would otherwise inform 

the Agency's determination.

• The Agency does not anticipate the need to require additional ecological data for this

registration review case at this time.

• The Agency does not anticipate the need to require additional environmental fate data for 

this registration review case at this time.

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

Ecological Effects Scoping Document in Support of Registration Review of Perboric acid, 

sodium salt, monohydrate (PBSM), located in the docket.

Human Health Risk: 

• No human health risk assessment has been performed for perboric acid.

• The Agency anticipates the need to require the following additional human health data 

for use in the registration review of perboric acid.

870.1300 -- Acute inhalation toxicity (rat)

870.3465 -- 90-day inhalation toxicity (rat)

870.3700 -- Prenatal developmental toxicity study (rat and rabbit, preferred)

875.1400 -- Inhalation indoor exposure

875.1600 -- Application exposure data reporting and calculations

• For more information, please refer to Perboric Acid, Sodium Salt Monohydrate (PBSM) 

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.
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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 Perboric acid, 

sodium salt, monohydrate (PBSM), 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. A human health risk assessment identifying the most sensitive endpoints has 

not been conducted for PBSM. However, as required by FFDCA section 408(p), perboric acid is 

subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

Endocrine Disruptor Screening Program

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. Perboric acid 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 call-ins, 

requiring the submission of EDSP screening assays for perboric acid. 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 Perboric acid, 

(HBO(O2)), sodium salt, monohydrate registration review:

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Docket March 2012

Close Public Comment Period for Docket May 2012

Phase 2: Case Development

Develop Final Work Plan (FWP) September 2012

Issue DCI September 2013

Data Submission September 2015

Open Public Comment Period for Preliminary Risk Assessments March 2017

Close Public Comment Period for Preliminary Risk Assessments April 2017

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision September 2017

Close Public Comment Period for Proposed Reg. Review Decision November 2017

Final Decision and Begin Post-Decision Follow-up 2018

Total (years) 6

Guidance for Commenters:

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the Perboric acid, (HBO(O2)), sodium salt, 

monohydrate 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:

Perboric acid 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 perboric acid, 

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 perboric acid 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 

Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate 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 May 2012, the Agency will review and respond to 

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

Acid, (HBO(O2)), Sodium Salt, Monohydrate case. 
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II. Fact Sheet

Background Information:

• Active Ingredient: Perboric acid, (HBO(O2)), sodium salt, monohydrate (perboric acid)

• Case number: 5007

• PC Code: 011105

• CAS number: 10332-33-9

• Technical registrants: The Procter & Gamble Company

• First approved for use in a registered product: 1998

• Products containing PBSM are only registered for non-food uses and there are no 

tolerances or exemptions from tolerances established for PBSM.

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, 

murasaki.seiichi@epa.gov

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

swindell.marshall@epa.gov

• Chemical Structure:

Use & Usage Information:

• The only registered use of PBSM is in laundry detergents used in combination with 

nonanoyloxybenzenesulfate (NOBS) as a sanitizer to kill odor-causing germs and 

bacteria on clothes.

Recent/Pending Regulatory Actions:

• There are no pending regulatory actions for PBSM.

Ecological Risk Assessment Status:

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping 

Document in Support of Registration Review of Perboric acid, sodium salt, monohydrate 

(PBSM), located in the docket, for a detailed discussion of the ecological risk assessments.

• The Agency expects no exposure of nontarget organisms to PBSM to occur in the 

environment from the laundry sanitizing use of PBSM because of its rapid reactivity and 

decomposition to oxygen, water, borates and boric acid. Water and oxygen are nontoxic 

degradates and sodium, boric acid, and boron-containing salts are ubiquitous in the 

environment. Sodium and boron occur naturally in soils, water, fruits, vegetables, and 

forage crops. Boron is an essential nutrient for plants as well as an essential element for 

many organisms and sodium is an essential element for animals. There are sufficient 

ecological effects data for boric acid and its sodium salts documenting that boron is 

practically nontoxic to birds, fish and aquatic invertebrates.
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Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for perboric acid, 

(HBO(O2)), sodium salt, monohydrate. Please refer to Perboric Acid, Sodium Salt Monohydrate 

(PBSM) 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:

• PBSM exhibits low to moderate toxicity based on acute oral and dermal studies in 

animals and was identified as a mild skin irritant and corrosive to the eye. Inhalation 

studies are not available. The draft HERA Risk Assessment indicates sodium perborate 

may cause developmental concerns, including reduced fetal body weight and skeletal and 

visceral variants.

Dietary (Food and Water):

• For the laundry sanitizing use of PBSM, there is no opportunity for residues of this active 

ingredient to result in human dietary exposure via contaminated food. Although 

discharges of washing machine waste water is expected, human dietary exposure via 

contaminated drinking water is not likely to occur, based on high reactivity and rapid 

biodegradability.

Residential:

• The Agency will identify and select toxicological endpoints once toxicity data have been 

submitted, reviewed, and accepted. Based on available use information, assessments of 

residential dermal and inhalation risk may be necessary because there is potential 

exposure when pouring the dry flowable detergent.

Aggregate:

• 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. An aggregate risk assessment has not been 

deemed necessary for perboric acid because dietary exposures of concern are not 

anticipated.

Occupational:

• The Agency will identify and select toxicological endpoints once toxicity data have been 

submitted, reviewed, and accepted. Based on available use information, assessments of 

occupational dermal and inhalation risk may be necessary because there is potential 

exposure when pouring the dry flowable detergent.
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Cumulative:

• EPA does not have, at this time, available data to determine whether perboric acid has a 

common mechanism of toxicity with other substances or how to include this pesticide in 

a cumulative risk assessment. For the purposes of this Registration Review, EPA has 

assumed that perboric acid does not have a common mechanism of toxicity with other 

substances when used as an antimicrobial as registered.

Incidents:

Ecological:

• No perboric acid ecological incidents have been reported in the Ecological Incident 

Information System (EIIS), maintained by the Environmental Fate and Effects Division 

(EFED) of the Agency.

Human Health:

• No perboric acid human poisoning incidents have been reported in the OPP Incident Data 

System (IDS).

Tolerances and International Harmonization:

• Since the only registered uses are for non-food uses and no dietary assessment is needed, 

no tolerances or exemptions from tolerances are needed to support the existing registered 

use of PBSM.

Data Call-In Status:

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

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 – Perboric Acid

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

3573-56 Tide With Bleach II The Procter & Gamble Company Soluble Concentrate (EP) 5.28

3573-58 Gain With Bleach II The Procter & Gamble Company Soluble Concentrate (EP) 4.74
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III. Summary of Anticipated Data Requirements – Perboric Acid, (HBO(O2)), Sodium 

Salt, Monohydrate

The table below summarizes anticipated data needs for the Perboric Acid, (HBO(O2)), Sodium 

Salt, Monohydrate 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 Perboric acid, sodium salt, monohydrate (PBSM), and Perboric Acid, 

Sodium Salt Monohydrate (PBSM) Human Health Risk Assessment Scoping Document in 

Support of Registration Review..

Table 2. Summary of Anticipated Data Requirements – Perboric Acid

Guideline

Number Anticipated Data Requirement Test Material

Estimated Timeframe (Measured 

in months from DCI Receipt)

870.1300 Acute inhalation toxicity (rat) TGAI 8

870.3465 90-day inhalation toxicity (rat) TGAI 24

870.3700 Prenatal developmental toxicity study (rat) TGAI 24

875.1400 Inhalation indoor exposure TGAI 24

875.1600 Application exposure data reporting and calculations TGAI 12
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IV. Appendix A: Use Patterns – Perboric acid, (HBO(O2)), sodium salt, monohydrate

Use Site Formulation/

EPA Reg. no.

Method of Application Application Rate/ No. of applications % AI

Residential and public access premises / Household and domestic dwellings

Laundry 3573-56 Open pour 1/2 to 7/8 cup per load of laundry 5.25

Laundry 3573-58 Open pour 1/2 to 7/8 cup per load of laundry 4.74