Sodium Percarbonate PC Code: 128860

Docket Number EPA-HQ-OPP-2017-0354 www.regulations.gov

Sodium percarbonate PC Code: 128860

Registration Review Final Work Plan

Case 6059

Approved by: Approved by:

.f·•·f'··· .. ~~'----· V Robert McNally, D rector Anita Pease. Director Biopesticides and Antimicrobial Division Po1Iution Prevention Division

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INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of sodium percarbonate. This work plan addresses any public comments received during the 60-day comment period for the Preliminary Work Plan (PWP), which was posted to www.regulations.gov in the registration review docket (EPA-HQ-OPP-2017-0354) on December 26, 2017. Sodium percarbonate is formed by mixing sodium carbonate and hydrogen peroxide. Products containing sodium percarbonate are registered for antimicrobial and biopesticide use as sanitizers for a variety of use sites including: laundry, farms, food processing and preparation facilities, residential areas (floors and toilets), animal premises, footwear, water bodies (e.g., swimming pools, ponds, lakes, etc.), non-painted surfaces, dental tools, storage areas, nurseries, green houses, turf, hard surfaces and on various agricultural foods. Products containing sodium percarbonate are generally used to control fungi, bacteria, algae, and viruses. There are 21 products containing sodium percarbonate (sodium carbonate peroxyhydrate) currently registered with EPA. Because of the dual biopesticide and antimicrobial uses, the registration review of sodium percarbonate is being conducted jointly by the Biopesticides and Pollution Prevention Division and the Antimicrobials Division.

EPA 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 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 the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this program is provided on the Agency’s website.1

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive comments received, if any, during the public comment period for the PWP and a summary of the Agency’s responses to those comments. That section is followed by registration review anticipated data needs, risk assessments expected to be conducted, and the projected registration review timeline for sodium percarbonate. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

Since the issuance of the PWP in December 2017, there have been no changes to the registrations of the 21 pesticide products containing sodium percarbonate.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

The 60-day public comment period for the sodium percarbonate PWP opened on December 26, 2017, and closed on February 26, 2018. The Agency did not receive any comments concerning this case during the comment period.

1 https://www.epa.gov/pesticide-reevaluation

2 Sodium Percarbonate EPA-HQ-OPP-2017-0354 www.regulations.gov

PLANNED DATA NEEDS

In the December 2017 PWP, the Agency provided detailed tables regarding how the data requirements have been fulfilled, unmet or waived for sodium percarbonate. It was noted in the PWP that EPA’s database for sodium percarbonate continues to support the biopesticide registrations; and there are no data gaps relative to this registration review for those biopesticide registrations. However, some data needs were identified for sodium percarbonate relative to its antimicrobial registrations. Those antimicrobial data needs remain unchanged since the PWP, and are restated below.

For the registration review of sodium percarbonate, the Agency anticipates conducting a human health risk assessment for the antimicrobial uses. In particular, the Agency anticipates assessing inhalation exposure to hydrogen peroxide for the antimicrobial uses of sodium percarbonate. The Agency currently has a registration review case for peroxy compounds (Case 4072), which includes hydrogen peroxide.2 Pursuant to 40 CFR Part 155.42(b)(3), the sodium percarbonate case will be combined with the peroxy compounds case (Case 4072) for the Draft Risk Assessment, Proposed Interim Decision, and Interim Decision. Anticipated data requirements related to sodium percarbonate are presented in Table 1 below.

Table 1. Data Anticipated as Needed for Antimicrobial Registrations* Harmonized Data Requirement Time Risk Assessment Data Applicable Exposure Guideline # Frame Will Support Scenario 875.1700 Product Use 12 months Occupational and Inhalation exposure to Information Residential Exposure hydrogen peroxide from residential uses 870.3465 Inhalation Toxicity 24 months Occupational and Inhalation exposure to Residential Exposure hydrogen peroxide from residential uses 875.1400 Inhalation 24 months Occupational and Inhalation exposure to Exposure—Indoor Residential Exposure hydrogen peroxide from residential uses * There are no biochemical data gaps

RISK ASSESSMENTS FOR REGISTRATION REVIEW

EPA plans to conduct a human health risk assessment for the antimicrobial uses of sodium percarbonate as part of the peroxy compounds case (Case 4072). In particular, EPA intends to conduct an occupational and residential exposure (ORE) assessment to better characterize the risks associated with inhalation exposures resulting from the use of antimicrobial pesticide products containing sodium percarbonate.

As stated in the PWP, the most recent comprehensive risk assessment for sodium percarbonate was completed in 2002. This assessment included a "No Effect" determination under the Endangered Species Act for direct and indirect effects to listed species and their designated critical habitat.

2 All documents supporting peroxy compounds registration review can be found in docket: EPA-HQ-OPP-2009-0546, accessible at http://www.regulations.gov.

3 Sodium Percarbonate EPA-HQ-OPP-2017-0354 www.regulations.gov

In addition, the Agency has determined that no adverse effects will occur to bees or other nontarget insects as a result of the labeled applications of sodium percarbonate. Therefore, risk to pollinators is not expected as a result of the uses of sodium percarbonate, as labeled.

The Agency will determine whether, pursuant to section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), sodium percarbonate qualifies for exemption from the Endocrine Disruptor Screening Program (EDSP). EPA believes that sodium percarbonate is likely not an endocrine disruptor; as such, the Agency may exempt it from EDSP. If it is exempted, then EPA will issue an order.

The Agency does not anticipate conducting any additional risk assessments for the biopesticides registrations. There are no other data gaps for biopesticide products. A 2002 comprehensive risk assessment continues to support the registration of biopesticide products containing sodium percarbonate (US EPA, 2002). Further, the use patterns have not changed and the literature review revealed no significant human health science findings.

TIMELINE

EPA has created the following estimated timeline for the completion of the sodium percarbonate registration review in Table 2, below.

Table 2. Estimated Timeline for the Sodium Percarbonate Registration Review Activities Estimated Month/Year Opening the Docket Open Docket and 60-Day Public Comment Period for December 2017 Close Public Comment Period February 2018 Case Development Issue Final Work Plan June 2018 Issue Data Call-in (DCI) August 2018 Data Submission August 2020 Open 30-Day Public Comment Period for Draft Risk Assessment May 2021 Close Public Comment Period June 2021 Registration Review Decision Open 60-Day Public Comment Period for Proposed Registration Review Decision November 2021 Close Public Comment Period January 2022 Final Decision TBD *Estimated Total (years) TBD * This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, an amended Final Work Plan will be issued at that time that will set forth a new timeline and, if applicable, any new data requirements will be included in the amended document and a Data Call-In Notice will be issued. This schedule is also subject to change based on the progress and timing of the peroxy compounds case (Case 4072).

NEXT STEPS

The Agency plans to issue a DCI for this case in August 2018. The resulting data submission is anticipated to be received by EPA in August 2020; and a Draft Risk Assessment is expected to be completed by May 2021. A 30-day comment period will be opened for the Draft Risk Assessment.

4 Sodium Percarbonate EPA-HQ-OPP-2017-0354 www.regulations.gov

REFERENCES

EU, 2003. European Union Risk Assessment Report: Hydrogen Peroxide CAS No. 7722-84-1; EINECS No:231-765-0, Volume:38. European Chemicals Bureau, Institute for Health and Consumer Protection. http://ecb.jrc.it/esis/

Hartwig, A. 2012. Hydrogen peroxide [MAK Value Documentation, 2010]. The MAK Collection for Occupational Health and Safety. 192–214. http://onlinelibrary.wiley.com/doi/10.1002/3527600418.mb772284e0026/pdf

HERA, 2002. Human and Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Sodium Percarbonate (CAS No. 15630-89-4). August 2002.

IARC, 1987. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Hydrogen Peroxide. IARC Supplements Supplement 7. https://monographs.iarc.fr/ENG/Monographs/vol71/mono71-29.pdf

Olgun, S., 2011. Immunotoxicity of Pesticide Mixtures and the Role of Oxidative Stress. (Doctoral dissertation). Retrieved from http://hdl.handle.net/10919/26308.

US EPA, 2002. Biopesticide Registration Action Document (BRAD) Sodium Carbonate Peroxyhydrate (PC Code 128860). U.S. Environmental Protection Agency (U.S. EPA), September 16, 2002. Available at: https://www3.epa.gov/pesticides/chem_search/reg_actions/registration/decision_PC-128860_16- Sep-02.pdf

US EPA, Chemistry Dashboard. ACD/Lab percepta platform: Sodium Percarbonate. http://comptox.zn.epa.gov/dashboard/