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 2012Docket 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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3 of 9 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

________________________________________

S upporting documents for the Perboric Acid, (HBO(O2)), Sodium Salt, Monohydrate Case may be found in the registration review docket EPA

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- 0006 located on the internet at www.regulations.gov

.Docket Number: EPA

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4 of 9 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 analy ses 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 w ill 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 intend ed 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 6 0

- day comment p eriod ended on May 29, 2012 . The Preliminary Work Plan document is available on www.regulations.gov docket
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. 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

T he Agency received one comment during the public comment period on the initial docket. In the PWP, the Agency solicited comments on specifi c topics: environmental justice, water body impairment

, trade irritants , and structure activity relationships

. The co mment 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

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5 of 9 The Central Valley Regional Water Quality Control Board (Central Valley Water Board) identified impaired water bodies in California that exceed water quality standards for bor on 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 B oard , t he 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 PB SM’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 t he 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 t his time. The timeline
described in the PWP remain s 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 Agenc y 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 cond ucting 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 t ime

.

• F or 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 Inte rnational 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

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6 of 9 Occupational and Residential Assessment and Risk

• The Agency will identify and select toxic ological 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 dete rmine 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 m echanism 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
875.160 0

-- 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.

• F or more information

, please refer to Revised Product Chemistry, Environmental Fate, and Ecologi cal Effects Scoping Document in Support of Registration Review of Perboric acid, sodium salt, monohydrate (PBSM)

, located in the docket

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7 of 9 Incidents:

Ecological:

• No perboric acid ecological incidents have been reported in the Ecological Inc ident 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
dete rmination 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 S ervices (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, subchroni c 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), p erboric acid is subject to the e ndocrine 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 effec t 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 assay s 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 syste ms 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

e stablish a dose

- response relationship between the dose and the E, A, or T effect.Docket Number: EPA

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8 of 9 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 guidelin es 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

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9 of 9 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 P lan), 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