United States Chemical Safety September 2012

Environmental Protection and Pollution Prevention

Agency (7510P)

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

Monohydrate

Registration Review:

Final Work Plan

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

www.regulations.gov 

Perboric Acid, (HB0(02)), Sodium Salt, Monohydrate 

Registration Review: 

Final Work Plan 

September 2012 

Case# 5007 

Approved By: 

oan Harrigan- arrelly 

Director, Antimicrobials Division 

Date: 

I t 

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

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

Human Health & Environmental Effects

Nathan Mottl

William Hazel

Jonathan Chen

Srinivas Gowda

David Bays

Pat Jennings

Risk Management

Seiichi Murasaki

Lance Wormell

Office of General Counsel

Philip Ross

________________________________________

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

www.regulations.gov

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Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the 

Agency”) for the registration review of Perboric acid, (HBO(O2)), sodium salt, monohydrate

(Case 5007). The work plan includes the expected registration review timeline. The work plan 

also addresses public comments received concerning the Preliminary Work Plan (PWP) in the 

Summary Document which was posted in the Perboric acid, (HBO(O2)), sodium salt, 

monohydrate registration review docket, and any other comments concerning the initial docket 

postings. The Summary Document provided information on what EPA knows about the pesticide 

and what additional risk analyses and data or information the Agency believes are needed to 

make a registration review decision.

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

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 that 

statutory standard. The public phase of registration review begins when the initial docket is 

opened for each case. Information on this program is provided at: 

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

The Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate Preliminary Work Plan (PWP) (PC 

Code 011105) was published on March 28, 2012 and the 60-day comment period ended on May 

29, 2012. The Preliminary Work Plan document is available on www.regulations.gov docket 

number EPA-HQ-OPP-2012-0006.

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.

Comments Received on the Preliminary Work Plan

The Agency received one comment during the public comment period on the initial docket. In 

the PWP, the Agency solicited comments on specific topics: environmental justice, water body 

impairment, trade irritants, and structure activity relationships. The comment received during the 

public comment period concerned these issues and is summarized below. More details of the 

comments and agency responses are provided in “Responses to Central Valley Regional Water 

Quality Control Board’s 60-Day Public Comments on the Registration Review Preliminary 

Work Plan for PBSM.”, located in the docket.
Docket Number: EPA-HQ-OPP-2012-0006

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The Central Valley Regional Water Quality Control Board (Central Valley Water Board) 

identified impaired water bodies in California that exceed water quality standards for boron and 

sodium, two degradates of PBSM, and requested the Agency conduct an environmental risk 

assessment for the following degradates of PBSM: hydrogen peroxide, borate, boric acid, and 

sodium.

Based on the concerns identified by the Central Valley Water Board, the Agency has revisited 

the need to perform an ecological risk assessment for this registration review and will perform an 

ecological risk assessment of PBSM degradates persistent enough to have the potential to enter 

surface water as a result of PBSM’s use as a laundry sanitizer. Because studies on the effects of 

these degradates to freshwater organisms are available in the public literature, the Agency will 

review these studies during registration review to derive measurement endpoints that will be

used in the ecological risk assessment. Also, since the environmental fate of PBSM and its 

degradates is well understood, the Agency does not anticipate the need to require additional

ecological or environmental fate data for this registration review at this time. The timeline 

described in the PWP remains as presented initially. Further, this document makes final the work 

plan for the Perboric acid, sodium salt, monohydrate registration review process.

Risk Assessments and Anticipated Data Needs

The Agency will conduct a comprehensive ecological risk assessment, including an endangered 

species risk assessment, for all uses of perboric acid. The Agency will conduct a human health 

risk assessment. The Agency expects to require additional data for use in conducting the 

registration review for perboric acid.

Ecological Risk Assessment Status and Anticipated Data Needs

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

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

conducting the registration review of boric acid at this time.

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

in conducting the registration review of boric acid at this time.

• For more information, please refer to Revised 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 Assessment Status and Anticipated Data Needs

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

Dietary Assessment

• 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.

Tolerances and International Harmonization

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

or exemptions from tolerances established for PBSM.
Docket Number: EPA-HQ-OPP-2012-0006

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Occupational and Residential Assessment and Risk

• 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.

• 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 and Cumulative Exposure and Risk

• 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.

• 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. 

Human Health Anticipated Data Needs

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

use in conducting 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 Anticipated Data Needs

• The Agency does not anticipate the need to require additional product chemistry data for the 

registration review at this time.

• For more information, please refer to Revised 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.
Docket Number: EPA-HQ-OPP-2012-0006

www.regulations.gov

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Incidents:

Ecological:

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

Information System (EIIS).

Human Health:

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

System (IDS).

Endangered Species

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

determination for perboric acid. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether perboric acid’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.

Endocrine Disruptor Screening Program

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).

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

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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/.

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 Completed

March 2012

Close Public Comment Period for Docket Completed

May 2012

Phase 2: Case Development

Develop Final Work Plan (FWP) Completed 

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 March 2018

Total (years) 6

Next Steps

A DCI will be developed regarding the data needs listed under the “Risk Assessments and 

Anticipated Data Needs” section of this document. The Agency expects to issue the DCI in 

September 2013. Human health and environmental fate and ecological hazard assessments will 

be conducted for all uses.
Docket Number: EPA-HQ-OPP-2012-0006

www.regulations.gov

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Summary of Anticipated Data Requirements – Perboric acid

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

Salt, Monohydrate Case in this document (Final Work Plan), Revised 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.

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