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 2012Docket 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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### 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, Envir onmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Perboric acid, sodium salt, monohydrate (PBSM)

. February 1 5 , 2012
2. Perboric Acid, Sodium Salt Monohydrate (PBSM) Human Health Risk Assessment Scoping Document in Support of Registrat ion 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

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4 of 15 Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate Regist ration 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 CounselDocket Number: EPA

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5 of 15 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 abil ity 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 p ractices 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) an d 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 begin s 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

. Af ter 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 C ase. The first pro duct containing p erboric acid, (HBO(O2)), sodium salt, monohydrate ( p erboric acid or PBSM) (PC Code 011105 ) as an active ingredient was registered in the United States in 1998

. Currently , there are two product s 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 rev iew 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 r egistered after November 1, 1984. Documents associated with the registration review of p erboric acid, (HBO(O2)), sodium salt, monohydrate can be viewed at www.regulations.gov in docket EPA

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. Below is a summary of the issues relevant to th is registration review 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 p erboric acid. Anticipated Risk Assessment and Data Needs:Docket Number: EPA

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6 of 15 Ecological Risk:

**•** No ecological risk assessment has been performed for p erboric acid

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**•** Based on the low hazard a nd exposure, the Agency intends to conclude that the registered uses of p erboric 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 Serv ice (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 sub missions 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 th is registration review case at this time.

**•** The Agency does not anticipate the n eed to require additional environmental fate data for th is registration review case at this time.

**•** F or more information , please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Perb oric acid, sodium salt, monohydrate (PBSM) , located in the docket

. Human Health Risk:

**•** No human health risk assessment has been performed for p erboric acid

.

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

**•** F or 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 Che mistry:

**•** The Agency does not anticipate the need to require additional product chemistry data for this registration review case at this time.Docket Number: EPA

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7 of 15 **•** F or more information , please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Documen t 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 expos ure 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 evaluate s 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 FFD CA section 408(p), p erboric 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 endo crine

- 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 is sued 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 p erboric acid

. For further information on the status of the EDSP, the policies and procedures, the li st 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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8 of 15 Timeline EPA has created the following estimated timeline for the completion of the Perboric acid, (HBO(O2)), sod ium 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 P reliminary W ork P lan and rationale

. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manner prior to issuing a final work plan for the Perboric acid, (HBO(O2)), sodium salt, monohydrate registration review case.
Trade Irritant s: 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 irrit ant 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 ident ified 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 p erboric acid , based on information provided atDocket Number: EPA

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9 of 15 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES.
More informatio n 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 quali ty 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 envir onmental 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 pote ntial 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 p erboric acid compare d to t he 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 chem ical 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 similariti es 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 Q SAR 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 model s, is considered along with information from open literature and studies specifically generated underDocket Number: EPA

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10 of 15 Part 161 requirements

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

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evidence evaluation

. At this time, EPA believes that for c ertain 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 bel ieves 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

- l ined, 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 c ase, then the Agency invites submission of this information

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

. 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 prov ide 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 followin g 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 distrib ution 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 c ase

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11 of 15 II. Fact Sheet Background Information:

**•** Active Ingredient: Perboric acid, (HBO(O2)), sodium salt, monohydrate ( p erboric acid)

**•** C ase number: 5007

**•** PC Code: 011105

**•** CAS number : 10332

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**•** Technical regi strants: 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 nutr ient 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, fis h and aquatic invertebrates.Docket Number: EPA

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12 of 15 Human Health Risk Assessment Status: The following are key findings of the recent human health risk assessments for p erboric acid, (HBO(O2)), sodium salt, monohydrate . Please refer to Perboric Acid, Sodium Salt Monohydrate (PBS M) Human Health Risk Assessment Scoping Document i n 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 an d 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 bod y 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 toxi city 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 ex amining 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 ha s not been deem ed necessary for p erboric 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.Docket Number: EPA

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13 of 15 Cumulative:

**•** EPA does not have, at this time, available data to determine whether p erboric ac id 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 p erboric acid does not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.
Incidents: Ecological:

**•** No p erboric acid ecological incidents have been reported in the Ecological Incident Information System (EIIS), maintaine d by the Environmental Fate and Effects Division (EFED) of the Agency

. Human Health:

**•** No p erboric 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 obtai ned 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 ) 4.74Docket Number: EPA

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14 of 15 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 Re view.

. 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 12Docket Number: EPA

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15 of 15 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