I. Preliminary Work Plan……………………………………………………………………….4 A. Overview ...... 4 B. Statutory and Regulatory Authority ...... 5 C. Background and Regulatory Information ...... 5 D. Anticipated Data Needs and Risk Assessments ...... 12 E. Risk to Threatened and Endangered Species ...... 20 F. Endocrine Effects ...... 20 G. Incidents ...... 21 H. Timeline ...... 21 I. Guidance for Commenters ...... 21 J. Next Steps ...... 23 II. Bibliography………………………………………………………………………………….24 A. Studies Supporting Registration Review of Sodium Percarbonate ...... 24 B. U.S. Environmental Protection Agency Regulatory Documents and Risk Assessment Memoranda ...... 24

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ACRONYMS AND ABBREVIATIONS

AI or a.i. Active Ingredient AD The EPA’s Antimicrobials Division BPPD The EPA’s Biopesticides and Pollution Prevention Division C.F.R. Code of Federal Regulations DCI Data Call-In EDSP Endocrine Disruptor Screening Program EPA U.S. Environmental Protection Agency FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FR Federal Register FWP Final Work Plan IDS Incident Data System MRID No. Master Record Identification Number: The EPA's system of recording and tracking studies submitted to the Office of Pesticide Programs. MRL Maximum Residue Limit OPP The EPA’s Office of Pesticide Programs PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals. PWP Preliminary Work Plan TGAI Technical grade of the active ingredient TMDL Total Maximum Daily Load US United States

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I. PRELIMINARY WORK PLAN

A. Overview

The docket (EPA-HQ-OPP-2017-0354) for sodium percarbonate is now open, initiating the first public comment period for this registration review case (case number 6059). Twenty-one products containing sodium percarbonate (sodium carbonate peroxyhydrate) are currently registered. Sixteen of the active products are classified as biopesticides, while five are classified as antimicrobials. Products containing sodium percarbonate are registered for both antimicrobial and biopesticide use as cleaners and sanitizers in residential, storage and commercial areas, animal premises, food processing facilities, and on hard surfaces. Sodium percarbonate antimicrobial products are used in dental water lines and laundry detergents, while the biopesticide products are registered for use on agricultural food, turf, outdoor water bodies, and in plant nurseries.

This Preliminary Work Plan (PWP) explains what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) knows about sodium percarbonate, highlights its anticipated data and assessment needs, identifies types of information that would be especially useful in conducting the review, and provides an anticipated timeline for completing the registration review process for sodium percarbonate.

The registration review process was designed to include a public participation component and, by sharing this information in the docket, EPA intends to inform the public of what it knows about sodium percarbonate and what types of new data or other information would be helpful to receive as it moves toward a decision on sodium percarbonate. The EPA encourages all interested stakeholders to review the PWP and to provide comments and additional information that will help the EPA’s decision-making process for this biochemical pesticide. Interested stakeholders could include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP about which the EPA specifically seeks comments and information.

The PWP begins by describing the statutory and regulatory authorities for Registration Review. Next, it provides background on sodium percarbonate, which includes a description of its mode of action, the currently registered pesticide products, application rates and methods, use sites, and tolerance exemption information. Then, it lists the anticipated data needs, risk assessments, and a projected Registration Review timeline for this case. Finally, the PWP provides guidance for commenters, explains the next steps EPA will be taking, summarizes background information, and lists supporting studies, risk assessments, and other documents available for the registration review of sodium percarbonate.

Further information about this case, including background and supporting documents, is available at http://www.regulations.gov (under “SEARCH for: Rules, Comments, Adjudications or Supporting Documents,” enter the docket identification number, which is indicated above).

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B. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States (US) must generally be registered by the EPA, based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on the 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 EPA periodically reevaluates pesticides to make sure that, as change occurs, products in the marketplace can continue to be used safely. Information on this program is provided on the EPA’s website.1

The EPA is implementing the registration review program pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 C.F.R. § 155.40. The EPA 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 EPA’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 EPA will develop a Final Work Plan (FWP) and the anticipated schedule for the registration review of sodium percarbonate.

C. Background and Regulatory Information

i. Summary of the Active Ingredient, Usage and Associated Pesticide Products

Sodium percarbonate is formed by mixing sodium carbonate and hydrogen peroxide. Its products are registered for antimicrobial and biopesticide use as cleaners and 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, and 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. Both technical and end-use products are formulated as a white free flowing granular, pelleted powder. One end-use product is formulated as a solid tablet.

On January 30, 2002, EPA received two applications from Solvay Interox, Inc. One registration for the sodium percarbonate Technical Grade Active Ingredient (TGAI), and one for the end use product “Terracyte”. The sodium percarbonate TGAI “Technical Sodium Carbonate Peroxyhydrate” and “Terracyte”, the end use product, were the first biopesticide products containing the active ingredient and were unconditionally registered on September 20, 2002. The notice announcing approval of the end- use and technical registrations was published on November 20, 2002 (OPP-2002-0293; FRL-7278-9).

1 See http://www2.epa.gov/pesticide-reevaluation. 5

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The following table provides a summary of the chemical facts for sodium percarbonate:

Table 1. Chemical Facts for Sodium Percarbonate PC code 128860 Case Number 6059 CAS Number 15630-89-4 Year first registered 2002 Pesticide Type Biopesticide and Antimicrobial Chemical class Biopesticide and Antimicrobial Reregistration Eligibility Not applicable. Because it was registered after November 1984, sodium Decision (RED) percarbonate was not subject to reregistration. Tolerance Reassessment None Eligibility Decision (TRED) Cumulative group None 40 CFR Citation 40 CFR 180.1197 and 40 CFR 180.1234 (sodium percarbonate is an adduct of hydrogen peroxide and sodium carbonate). 40 CFR §180.1197: An exemption from the requirement of a tolerance is established for residues of hydrogen peroxide in or on all food commodities at the rate of ≤ 1% hydrogen peroxide per application on growing and postharvest crops. 40 CFR§ 180.1234: An exemption from the requirement of a tolerance is established for residues of sodium carbonate Non-pesticidal uses Glass manufacturing, water softener, paper products

The following table summarizes the use and usage information for sodium percarbonate:

Table 2. Sodium Percarbonate Use and Usage Information Animal premises, farms, non-painted surfaces, surface water (e.g., ponds, lakes), Summary of Biopesticide Use floors, green houses, turf, swimming pools, and mildew, mold and algae Sites remediation Animal premises, farms, residential and commercial laundry detergents, hard Summary of Antimicrobial Use surfaces (e.g., tools), soft surfaces (e.g., fabric), dental water lines, floors, and Sites boot sanitizer, Disinfectant, sanitizer, bactericide, algaecide, fungicide and virucide Summary of Usage

Formulation Types Flowable granular/pellets, soluble concentrate/solid

Application Method Pour, wipe, brush, foam, mop, spray, immersion, sponge, trigger sprayer The Pond Guy Services, Agri-neo, Biosafe Systems, and Solvay Chemicals Technical Registrant 21 No. of Registrations None Restricted Use

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The following table lists the currently registered products containing sodium percarbonate as an active ingredient.

Table 3. Information About the Currently Registered Sodium Percarbonate Pesticide Products EPA Product Name Registrati (% Active Date Application on Application Rates Use Sites Ingredient; Registered Methods Number Formulation Type)

68660-8 Technical Sodium 09/20/02 Not Applicable Not Applicable Formulation Carbonate Intermediate Peroxyhydrate (85%) General Treatment (low vs high growth): 1 teaspoon - 500 lbs. of product per 1,000 - 1,000,000 gallons of water

String Algae Treatment: 1 tablespoon - 10 cups product per 50 - 10,000 gallons of water

Green Water Algae Treatment: .05 teaspoons - 2 cups product per 50 -10,000 gallons of water GREENCLEAN Water bodies, non- 70299-4 Granular 06/03/03 Non-painted Broadcast, spray painted surfaces, (42.5%; granular) Surface, Pond & or foam residential, turf and Surface Cleaning treatment. Dumpsters/trash Treatment: cans. 2 - 6 cups of product per 1,000 sq. feet surface water

Ground/Surface Treatment: 0.5 teaspoon - 3 lbs of product per 2.5 - 1,000 sq. ft surface water.

Hardscapes & Animal Premises Treatment:

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(Liquid) 0.5 lbs of product per gallon of water

(Granular) 1 - 2 lbs of product per 1,000 sq. ft.

Dumpster Treatment: 0.5 - 1 lb. of product per 125 sq. ft.

Lawn Moss Treatment: (Liquid) 1 cup of product per 1 gallon of water

(Granular) 1 to 2 lbs. of product per 1,000 sq. ft. of turf Agricultural Spray Irrigation & Livestock Water Tank Treatment: 2 – 10 tablespoons of product per 1,000 Greenclean Pro gallons of water Broadcast and Water surfaces, Granular aerial spread by Non-painted 70299-6 Algaecide/fungicide 06/04/04 Sewage Water plane or other surfaces, food (85% granular) Treatment: professional processing facilities, 50 – 250 lbs of device. and Agricultural/ product per Horticultural use 1,000,000 gallons of sites. water

Algae control in rice fields & paddies: 10 – 25 lbs of product per acre as a

Solid floors, food Pour, wipe, brush, processing facilities, Sterilex Ultra scrub, spray, animal premises, 63761-5 Powder (29.75%; 02/04/05 4650-18,550 ppm sponge, foam foot pans, dental soluble concentrate) water lines, beverage manufacturing

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facilities, zoos, farms, labs, refrigerated trucks, non-food contact surfaces, and general disinfectant/cleaner. Wash N Bleach Industrial and Extra 2 (22.53%; 16930-5 10/24/05 150-260 ppm institutional laundry soluble Open pour detergent. concentrate/solid)

90185-1 Algae-Off Tech 07/10/06 Not Applicable Not Applicable Formulation (85%) Intermediate Ground/surface Treatment: Apply 2-3 lbs/per 1000 square feet of 90185-2 Algae-Off AG PRO 07/10/06 area Broadcast Hard surfaces, water (85%; granular) spreader bodies and turf Surface Water Treatment: 0.005 – 0.025 lbs/per 100 gallons of water Ground/surface Treatment: Apply 2-3 lbs/per 90185-3 Algae-Off 07/10/06 1000 square feet of Broadcast Water bodies (50%; granular) area spreader

Water Treatment: 0.005 - 0.025 lbs/per 100 gallons of water Surface Water 70299-10 GreenClean Tablets 11/14/07 Treatment: Broadcast Water bodies (42.5 %; 3 Tablespoons per spreader pelleted/tableted) 200 gallons of water

ICX (6.96%; 79662-1 9/19/08 8 ppm Solid tablet Dental water lines pelleted/tableted)

Sodium Carbonate 70299-14 Peroxyhydrate 08/14/09 N/A N/A N/A Technical (85%)

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Surface Water Treatment: 0.1 lbs. product for GC Pro every 100 gallons Aquatic and 70299-15 (85%; granular) 08/14/09 of water Broadcast agricultural spreader (including crop) uses Lawn/Turf Treatment: 10 - 25 lbs. of product per acre

Surface Water Treatment: 4 lbs. product per 1,000 sq. ft. applied Greenhouses, 70299-3 Terracyte 10/25/11 to a wet surface Broadcast storage areas, and (34%; granular) spreader nursery yards (For preventative treatments: 2 – 4 lbs. of product every 5 to 7 days)

Sodium Formulation 88306-2 Percarbonate 07/03/12 Not Applicable Not Applicable Intermediate Technical (85%) Surface Water Treatment: 3 - 170 lbs per acre- foot of water (large Peroxy Tech bodies of water) Broadcast Water bodies and 88999-4 Granular 01/13/14 spreader turf (42.5%; granular) 1-16 tablespoons per 1000 gallons of water

ATO Cide Granular Greenhouse, 88306-3 (42.50%; soluble 09/18/14 2 - 6 lbs. of product Foliar spray nursery, and field concentrate) (tank mix) (e.g. crop) uses

Surface Water Treatment: 68660-9 PAK 27 Algaecide 12/22/14 34g - 100 lbs Broadcast In or around (85%; granule) product per 200 - spreader residential and 325,851 gallons of commercial water water bodies

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Surface Water SePRO PAK27 Treatment: 67690-76 Algaecide 08/13/15 13 - 1,393 lbs Broadcast In or around water (.85%; granule) product per 100 - spreader bodies 10,000 gallons of water Plant Treatment: 88306-4 NEO-BOOST 09/10/15 1 - 4 lbs/acre for Spray Greenhouse, (51%; soluble crops nursery, and field concentrate) uses 0.2 - 2.6 lbs/acre for turf Animal premises, food processing Pour, foam, mop, facilities, footwear, sprayer, Sterilex Ultra Step hard nonporous immersion, 63761-10 (12.1%; soluble 07/11/16 160-35,825 ppm surfaces, floors sponge, coarse concentrate) pump, trigger Label states it is sprayer. not for food contact surfaces.

Laundry, hard/soft surface, fabrics, Capricorn (18.5%; disinfectant, 10772-23 soluble 08/26/16 18,560-62,400 ppm Open pour commercial, concentrate/solid) residential, transportation, and etc.

ii. Tolerance Actions

Food Tolerances

40 CFR §180.1234 Sodium carbonate; exemption from the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for residues of sodium carbonate. [70 FR 33363, June 8, 2005]

40 CFR §180.1197 Hydrogen peroxide; exemption from the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for residues of hydrogen peroxide in or on all food commodities at the rate of ≤ 1% hydrogen peroxide per application on growing and postharvest crops. [67 FR 41844, June 20, 2002]

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D. Anticipated Data Needs and Risk Assessments

For the registration review of sodium percarbonate, the Agency anticipates conducting a human health risk assessment for antimicrobial uses, and does not anticipate conducting an ecological risk assessment. Shown below are tables of the current data requirements for biochemical pesticides as set forth in 40 C.F.R. § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health assessment, and non-target organisms) and descriptions are included regarding how the data requirements have been fulfilled or where data have been waived. The most recent risk assessment for sodium percarbonate was completed in September 2002 in support of the registration of Sodium Percarbonate, TGAI as a new active ingredient. The complete risk assessment and other regulatory information pertaining to the biopesticide action can be found in the Biopesticides Registration Action Document (BRAD).

The Agency anticipates assessing inhalation exposure to hydrogen peroxide for antimicrobial uses of sodium percarbonate. The Agency currently has a registration review case for peroxy compounds (Case 4072),2 which includes hydrogen peroxide. EPA anticipates calling in the same data as that risk assessment, given its relevance and it being a metabolite of sodium percarbonate. Anticipated data requirements related to this are presented in Table 7 below.

i. Product Chemistry (40 C.F.R. § 158.2030)

The Product Chemistry data requirements for sodium percarbonate have all been fulfilled. Table 4 and Table 5 below capture the current status of the data requirements and provide summary product chemistry information for sodium percarbonate:

Table 4. Summary of Product Analysis Data for Sodium Percarbonate Harmonized Has Data Requirement MRID No. or Other Guideline Data Requirement Been Addressed? How? Source Number 880.1100 Product Identity and Composition Yes – Study 46667301 Description of Staring Materials, Production, 880.1200 Yes – Study 46667301 and Formulation Process 880.1400 Discussion of Formation of Impurities Yes – Study 46667301 830.1700 Preliminary Analysis Yes – Study 46667301 830.1750 Certified Limits Yes – Study 46667301 830.1800 Enforcement Analytical Method Yes – Study 46667301

2 All documents supporting Peroxy Compounds registration review can be found in docket: EPA-HQ-OPP-2009-0546, accessible at http://www.regulations.gov. 12

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Table 5. Summary of Physical and Chemical Characteristics for Sodium Percarbonate Harmonized Has Data Requirement Been MRID No. or Guideline Data Requirement Addressed? How? Other Source Number 830.6303 Physical State Study – Granular solid 46667301 830.6304 Odor Study – Odorless 46667301 Study – Stable at normal temperatures; Active Stability to Normal and Elevated 830.6313 ingredient not expected to 46667301 Temperatures, Metals and Metal Ions come into contact with metals or metal ions N/A – Ingredient is a solid and 830.6315 Flammability does not contain a combustible 46667301 liquid

830.6317 Storage Stability Stable N/A

The metabolite hydrogen peroxide is not corrosive to 830.6320 Corrosion Characteristics 44824404 aluminum, and slightly corrosive to stainless steel. 830.7000 pH 10.42+0.01 46667301 N/A – Not required for TGAI Sodium percarbonate major 830.7050 UV/Visible Light Absorption 46667301 metabolite, hydrogen peroxide is not stable to sunlight

830.7100 Viscosity N/A – Technical is a solid 46667301

830.7200 Melting Point/Melting Range Study – >300º C 46667301

Boiling Point/Boiling Range N/A – Ingredient is a solid at 830.7220 46667301 room temperature Density/Relative Density/Bulk Density 830.7300 Study – 900 – 1200 g/L 46667301 (Specific Gravity)

Particle Size, Fiber Length, and Diameter N/A -Ingredient is not water 830.7520 N/A Distribution insoluble or fibrous 830.7550 N/A – Ingredient is soluble in 830.7560 Partition Coefficient (n-Octanol Water) 46667301 water 830.7570 830.7840 Water Solubility Study – 145 g/L @20º C 46667301 U.S. EPA Chemistry Public literature – 2.5e-5 Dashboard 830.7950 Vapor Pressure mmHg (ACD/Labs Percepta Platform)

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ii. Human Health Assessment (40 C.F.R. § 158.2050)

Hazard Characterization and Risk

Mammalian toxicology information from the open scientific literature and data were submitted to adequately satisfy data requirements to support biopesticide and antimicrobial registrations. The mode of action of the pesticide, sodium percarbonate, is to kill the target organisms by oxidizing critical components, such as the cellular structure of the target organism. It is currently classified as both an antimicrobial and biochemical pesticide that is eligible for reduced data requirements. Sodium percarbonate is a non-complex chemical and its physical and chemical characteristics are well understood (U.S. EPA, 2002). In the presence of water, the granules or crystals of sodium percarbonate are dissolved and transformed into hydrogen peroxide and sodium carbonate. Upon contact, the hydrogen peroxide oxidizes its target while breaking down into water and oxygen, neither of which is of toxicological concern. Hydrogen peroxide is an endogenous product by oxygen reduction in the aerobic cell that is degraded in tissues and blood by the enzymes catalase, and by glutathione peroxidase. The high degradation capacity for hydrogen peroxide in the blood makes it unlikely that the substance will systemically distribute following exposure.

The Agency has considered sodium percarbonate in light of the mode of action of the chemical, residues of concern and the relevant safety factors in FQPA and FIFRA. For the biopesticide uses, a determination has been made that no unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, will result from the use of sodium percarbonate when label instructions are followed (U.S. EPA, 2002). For the antimicrobial uses, the Agency is currently in the process of conducting a comprehensive risk assessment on hydrogen peroxide the active metabolite of sodium percarbonate. Prior to conducting a risk assessment, the Agency anticipates requiring additional data (see Table 7 for details). Once the risk assessment is completed, the Agency will reevaluate the risk and develop risk mitigation measures where needed, which will be discussed in the Proposed Interim Decision document.

The Agency has granted data waivers for subchronic toxicity studies (90- day oral, 90-day dermal, 90- day inhalation) for sodium percarbonate for the antimicrobial and biopesticide uses. However, the previously granted waiver for the 90-day inhalation on the parent a.i. is not appropriate for antimicrobial use patterns where people are potentially exposed to hydrogen peroxide. The subchronic studies were waived based on (1) the lack of systemic effect from hydrogen peroxide exposure in 90-day oral studies performed in rats and in sensitive catalase- deficient mice (HERA, 2002); (2) significant or prolonged dermal exposure to hydrogen peroxide from use of sodium percarbonate in not anticipated based on the label use instructions; and (3) the product is a granular formulation that is too large to be inhaled (350- 550 µm) (HERA, 2002).

Available acute toxicity information indicates that sodium percarbonate is of low oral and dermal toxicity (Toxicity Category III & IV, respectively). Sodium percarbonate dermal irritation and skin sensitization studies revealed slight dermal irritation in rabbits (Toxicity Category IV), however no dermal sensitization was identified in guinea pigs (Toxicity Category IV). A data waiver for the acute inhalation study was granted by the Agency on the basis that the active ingredient is a solid and not respirable. However, for the antimicrobial uses, this data waiver is no longer supported given the use patterns currently registered. Eye irritation studies demonstrated severe irritation to the eyes of rabbits (Toxicity Category I). 14

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Dietary Exposure and Risk Assessment

Dietary (food and drinking water) risk assessments were not conducted for the following reasons: (1) residues of sodium percarbonate in drinking water are anticipated to be negligible; (2) sodium percarbonate readily transforms into sodium carbonate and hydrogen peroxide (which is broken down into water and oxygen upon contact with organic matter); and (3) there is negligible risk that food, municipal drinking water and runoff to surface or groundwater or water will be affected because of the instability of the sodium percarbonate molecule in the presence of water (U.S. EPA, 2002). Based on the above mentioned reasons, dietary exposure from the pesticidal use of sodium percarbonate is expected to be minimal.

Residential and Occupational Exposure and Risk

Sodium percarbonate is registered for use as both an antimicrobial and biopesticide. Sodium percarbonate is used to control bacteria, algae, moss, and slime molds in and around farms, food processing and preparation facilities, residential areas (laundry, floors and toilets), animal premises, footwear, water bodies (e.g., swimming pools, ponds, lakes, and etc.), non-painted surfaces, dental tools, storage areas, nurseries, green houses, turf and hard surfaces.

For biopesticide products containing sodium percarbonate, exposure to individuals other than the pesticide applicators is anticipated to be negligible due to the instability of sodium percarbonate molecule in the presence of water (U.S. EPA, 2002). Likewise, significant occupational exposures to the active ingredient sodium percarbonate in biopesticide products are not anticipated. Negligible repeated inhalation and dermal exposures to sodium percarbonate are anticipated as the product is too large to be inhaled (350-550 µm) (HERA, 2005). In addition, agricultural use of sodium percarbonate is subject to the Worker Protection Standards (WPS) requiring Personal Protective Equipment (PPE), which are: protective eyewear (goggles or face shield), rubber gloves, coveralls over long-sleeved shirt, long pants, and chemical resistant footwear plus socks. These PPE will mitigate worker exposure and risk to occupational handlers so long as the label instructions are followed.

For the antimicrobial products, the residential uses of sodium percarbonate as a disinfectant could result in inhalation exposure to hydrogen peroxide when the active ingredient degrades. According to the Peroxy Compounds Human Health Scoping Document,3 hydrogen peroxide exposure through the inhalation route is moderately irritating to lungs (toxicity category II). A Data Call-In (DCI) was issued for hydrogen peroxide in February 2012, after the Agency’s original granting of the waiver for a 90- day inhalation study for sodium percarbonate. The hydrogen peroxide DCI required registrants to submit a 90-day inhalation toxicity study (GLN 870.3465) and indoor inhalation exposure (GLN 875.1400) (both studies on hydrogen peroxide) in order to assess residential exposures to the peroxy compound. Based on the antimicrobial use patterns for sodium percarbonate, the inability to require PPE for residential uses, and the data call-in for its byproduct, hydrogen peroxide, the Agency anticipates requiring inhalation data to assess the risk of exposure from antimicrobial uses of sodium percarbonate. Further, the Agency anticipates requiring these data since the basis for the 90-day inhalation waiver on sodium bicarbonate as, previously granted, no longer supports the data requirement since exposure to the degradate, hydrogen peroxide, is what is expected. Additionally, the Agency anticipates calling in

3 All documents supporting Peroxy Compounds registration review can be found in docket: EPA-HQ-OPP-2009-0546, accessible at http://www.regulations.gov. 15

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Product Use Information (GLN 875.1700) to accurately characterize the major use sites, application methods, and other information regarding the use of the end-use products that are pertinent to the risk assessment. A Data Call-In for the residential antimicrobial uses is anticipated to be issued in fiscal year 2018. The registrants will have the option of conducting their own studies or citing the hydrogen peroxide study below.

The Agency has since received 90-day inhalation toxicity (GLN 870.3465) and indoor inhalation exposure (GLN 875.1400) data on hydrogen peroxide from previous DCIs that were issued in February 2012. Those data are currently undergoing review and will be included in the comprehensive risk assessment on hydrogen peroxide (the active metabolite of sodium percarbonate).

Table 6. Summary of Human Health Assessment Data for Sodium Percarbonate Harmonized MRID No. or Other Guideline Data Requirement Results (and Toxicity Category) Source Number

870.1100 Acute Oral Toxicity - Rat LD50 > 1526 mg/kg; Toxicity Category III 46667303

870.1200 Acute Dermal Toxicity LD50 > 5,000 mg/kg; Toxicity Category IV 46667304

Waived for the biochemical products based 46667305 on non-respirable large particle size (350- Acute Inhalation Toxicity – 870.1300 550 µm) in granular formulation. Rat

Antimicrobial Data Gap4

870.2400 Primary Eye Irritation Severely irritating; Toxicity Category I 46667306

870.2500 Primary Dermal Irritation Slightly irritating; Toxicity Category IV 46667307

870.2600 Dermal Sensitization Not a skin sensitizer. 46667308

Waived based on the lack of systemic effect 47499502 of hydrogen peroxide in 90 day oral studies HERA, 2002 880.3550 Immunotoxicity performed in rats and in sensitive catalase- deficient mice.

Waived based on the lack of systemic effect 47499502 of hydrogen peroxide in 90 day oral studies HERA, 2002 870.3100 90-Day Oral (one species) performed in rats and in sensitive catalase- deficient mice.

870.3250 90-Day Dermal – Rat

4 The acute inhalation toxicity study is identified as a data gap, but is not needed for the registration review risk assessment. 16

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Table 6. Summary of Human Health Assessment Data for Sodium Percarbonate Harmonized MRID No. or Other Guideline Data Requirement Results (and Toxicity Category) Source Number Waived as significant or prolonged human 47499502 exposure to sodium carbonate by the dermal route is not anticipated based on the label use instructions.

Waived due to the fact that the parent a.i. is a granular formulation too large (350-550 µm) to be inhaled and no repeated inhalation 47499502 exposures are expected for biopesticide/agricultural uses.

870.3465 90-Day Inhalation – Rat Previously granted waiver on parent a.i. is not appropriate for antimicrobial use patterns where people are potentially exposed to hydrogen peroxide.

Antimicrobial Data Gap

Waived due the fact that hydrogen peroxide Prenatal Developmental – (active metabolite formed on contact with 870.3700 Rat Preferably moisture) is degraded enzymatically upon 47499502 absorption and is not systemically available.

N/A – 90-day studies waived & chronic 870.4100 Chronic Toxicity toxicity of hydrogen peroxide (active metabolite of a.i.) known in public literature5

N/A – Potential for carcinogenicity of 870.4200 Carcinogenicity hydrogen peroxide (active metabolite of a.i.) known in public literature6

Waived as hydrogen peroxide (active metabolite) is not genotoxic in vivo based on Bacterial Reverse Mutation 870.5100 studies evaluated by the EU and the known 47499502 Assay rapid metabolism of hydrogen peroxide in EU, 2002 the body.

Waived due to the fact that hydrogen peroxide (active metabolite of sodium 870.5300 In vitro Mammalian Cell percarbonate) is genotoxic in vitro, but not in 47499502 870.5375 Assay vivo based on studies evaluated by the EU and the known rapid metabolism of hydrogen peroxide in the body

5 2012. Hydrogen peroxide [MAK Value Documentation, 2010]. The MAK Collection for Occupational Health and Safety. 192–214. 6 1987. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Hydrogen Peroxide. IARC Supplements Supplement 7. 17

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Table 7. Data Anticipated as Needed for Antimicrobial Registrations* Harmonized Risk Assessment Time Guideline Data Requirement Data Will Applicable Exposure Scenario Frame Number Support Occupational and Inhalation exposure to hydrogen 875.1700 Product Use Information 12 months Residential peroxide from residential uses Exposure Occupational and Inhalation exposure to hydrogen 870.3465 Inhalation Toxicity 24 months Residential peroxide from residential uses Exposure Occupational and Inhalation exposure to hydrogen 875.1400 Inhalation Exposure—Indoor 24 months Residential peroxide from residential uses Exposure * There are no biochemical data gaps

iii. Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060)

Environmental Assessment

An environmental risk assessment is not anticipated to be needed for biopesticide or antimicrobial uses. The end-use products are mainly used to control bacteria, algae, moss, and slime molds and are sold for indoor and outdoor horticultural, agricultural, residential, and commercial use sites, in addition to use in and around water bodies. When applied in accordance with label, directions, the unstable nature of the chemical accounts for the use of the product without expected harm to birds and other terrestrial animal species. In the presence of water, the active ingredient rapidly breaks down to hydrogen peroxide and sodium carbonate, and hydrogen peroxide rapidly breaks down, on contact, to water and oxygen, neither of which presents toxicological concern. When considering the uses for associated with sodium percarbonate, harm to aquatic species, freshwater fish and freshwater aquatic invertebrates is not foreseen. For non-target plants, submitted data from the open literature allowed EPA to grant waivers for required studies as specified in OPP Guideline 154.10, provided the label directs that any treated turf grasses be tested for phytotoxicity prior to application, and that repeated applications may cause the possible elevation of the pH of the soil that may adversely affect plant growth. A waiver for studies testing non-target insects and honey bee acute contact toxicities was also granted, provided that precautionary statements or mitigating language is present on the labels.

The antimicrobial uses of sodium percarbonate are not anticipated to result in significant exposure to non-target organisms, due to the rapid breakdown into hydrogen peroxide and sodium carbonate.

Table 8. Summary of Nontarget Organism Data for Sodium Percarbonate

MRID or Harmonized Other Guideline Data Requirement Has Data Requirement Been Addressed? How? Source Number

Avian Acute Oral Waived due to unstable nature of chemical in water (label 850.2100 47499502 Toxicity requires a.i. to be applied with water to ensure birds do not contact granular product) and presence of appropriate environmental hazard statements for birds on label. 18

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

Table 8. Summary of Nontarget Organism Data for Sodium Percarbonate

MRID or Harmonized Other Guideline Data Requirement Has Data Requirement Been Addressed? How? Source Number

Waived due to unstable nature of chemical in water (label Avian Dietary requires a.i. to be applied with water to ensure birds do not 850.2200 Toxicity contact granular product) and presence of appropriate 47499502 environmental hazard statements for birds on label.

Waived due to unstable nature of chemical in water (label Fish Acute Toxicity, requires a.i. to be applied with water to ensure birds do not 850.1075 Freshwater contact granular product) and presence of appropriate U.S. EPA, environmental hazard statements for fish on label. 20027

Waived due to unstable nature of chemical in water (label Aquatic Invertebrate requires a.i. to be applied with water to ensure birds do not 850.1010 Acute Toxicity, contact granular product) and presence of appropriate U.S. EPA, Freshwater environmental hazard statements for fish on label. 2002

Waived based on the information that the sodium percarbonate has been tested on turf and other non-target plants with no Terrestrial Plant significant phytotoxicity reported, in the presence of water (as 47499502 850.4100 Toxicity, Seedling required per label instructions). Sodium percarbonate breaks Emergence down to form hydrogen peroxide which rapidly breaks down to water and oxygen which are not phytotoxic.

Waived based on the information that the sodium percarbonate has been tested on turf and other non-target plants with no Terrestrial Plant significant phytotoxicity reported, in the presence of water (as 47499502 850.4150 Toxicity, Vegetative required per label instructions). Sodium percarbonate breaks Vigor down to form hydrogen peroxide which rapidly breaks down to water and oxygen which are not phytotoxic.

Waived due to unstable nature of chemical in water (label Nontarget Insect requires a.i. to be applied with water to ensure insects do not 880.4350 Testing contact granular product) and presence of appropriate 47499502 environmental hazard statements for non-target insects on label.

7 U.S. EPA, September 2002. Sodium Carbonate Peroxyhydrate Biopesticides Registration Action Document. 19

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

E. Risk to Threatened and Endangered Species

Risks to non-target species from pesticidal use of sodium percarbonate are expected to be minimal. Waivers for all Tier I ecological effects data were granted based on the proposed use pattern and the active ingredient’s instability in water (label requires active ingredient to be applied with water, thus breaking down the sodium percarbonate immediately into sodium carbonate and hydrogen peroxide, neither of which are of concern for toxicity to threatened/endangered species). A search of OPP’s Ecological Incident Information System (EIIS) version 2.1.1 conducted on August 31 2017, revealed no incidents associated with sodium percarbonate; this database contains information dating back to the 1970s and was most recently updated March 1, 2016. EPA anticipates conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the Registration Review process that would indicate such an assessment would be needed to inform the Agency’s final decision concerning this case, or if future registrations for products containing sodium percarbonate as the active ingredient are formulated in a manner that would result in toxic risk from increase exposures to non-target organisms.

F. Endocrine Effects

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order 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.” FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determination is made that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013, and includes some pesticides scheduled for registration review and chemicals found in water. Sodium percarbonate is not among the group of pesticide active ingredients on the lists to be screened under the EDSP. The EPA, as part of this Preliminary Work Plan, believes that sodium percarbonate is a substance that would not likely produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. As such, pursuant to Section 408(p)(4), the EPA will determine in the future whether it can exempt sodium percarbonate from the requirements of the Section 408(p) EDSP. In the event the EPA does determine to exempt this substance from the EDSP, an order will be issued. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website at http://www.epa.gov/endo/.

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

G. Incidents

From 1992 (initial date for the OPP Incident Data System), through May 16, 2017, OPP’s Incident Data System (IDS) contains no reported human incidents by applicators while using pesticide products containing sodium percarbonate as the active ingredient.

A search of OPP’s Environmental Incident Information System (EIIS) conducted on August 31, 2017, revealed no incidents associated with sodium percarbonate; this database contains information dating back to the 1970s. The EPA will consider any incident data or comments submitted in response to this Preliminary Work Plan.

H. Timeline

Below is the projected timeline for Registration Review case 6059, sodium percarbonate: Activities Estimated Month/Year Opening the Docket Open Docket and 60-Day Public Comment Period for September 2017 Close Public Comment Period November 2017 Case Development Issue Final Work Plan March 2018 Issue Data Call-in June 2018 Data Submission June 2020 Open 30-Day Public Comment Period for Draft Risk Assessments December 2021 Close Public Comment Period January 2022 Registration Review Decision Open 60-Day Public Comment Period for Proposed Registration Review June 2022 Decision Close Public Comment Period August 2022 Final Decision September 2022 *Estimated Total (years) 5 years * This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, 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.

I. Guidance for Commenters

The public is invited to comment on the EPA’s PWP for sodium percarbonate and rationale. The areas below highlight topics of special interest to the EPA where comments, information and data, or reference to sources of additional information could be of particular use. The EPA will consider all comments, as well as any additional information or data provided in a timely manner, prior to issuing a Final Work Plan for this case.

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

i. Environmental Justice

The 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 EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have unusually high exposure to the pesticidal use of sodium percarbonate, compared to the general population. Please comment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general population.

ii. Water Quality

Sodium percarbonate is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act.8 In addition, no Total Maximum Daily Loads (TMDLs) have been developed for sodium percarbonate.9 More information on impaired water bodies and TMDLs can be found on EPA’s website.10 The EPA 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 Office of Pesticide Program’s (OPP) Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in Registration Review Risk Assessment and Management Process11 to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

iii. Trade Irritants

Through the Registration Review process, the EPA intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize tolerance and international Maximum Residue Limits (MRLs), and, if necessary, may modify tolerance levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of 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. There are no known MRLs for sodium percarbonate. Therefore, the EPA does not anticipate that current uses of sodium percarbonate will pose concerns as trade irritants.

iv. Additional Information

Stakeholders are also specifically asked to provide information and data that will assist the EPA in refining the risk assessments. The EPA is interested in obtaining the following information regarding sodium percarbonate:  Confirmation on the following label information: - Sites of application - Formulations - Application methods and equipment - Maximum application rates

8 Based on information provided at http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/index.cfm. 9 Based on information provided at http://iaspub.epa.gov/apex/waters/f?p=ASKWATERS:DOC_SEARCH:0::::: 10 See http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/index.cfm. 11 This document can be found at http://www.epa.gov/pesticides/registration-review2/water_quality_sop.htm. 22

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

- Frequency of application, application intervals, and maximum number of applications - Geographic limitations on use  Use or potential use distribution (e.g., acreage and geographical distribution of relevant use sites)  Median and 90th percentile reported use rates (lbs active ingredient/1,000 square feet) from usage data – national, state, and county  Application timing (date of first application and application intervals) – national, state, and county  Usage/use information for nonagricultural uses  Typical application interval (days)  State or local use restrictions  Monitoring data Foreign technical registrants not listed above who supply technical sodium percarbonate to the US market

J. Next Steps

After the 60-day comment period closes, the EPA will review and respond to any comments received in a timely manner, then issue a Final Work Plan for sodium percarbonate.

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

II. BIBLIOGRAPHY

A. Studies Supporting Registration Review of Sodium Percarbonate Pither, K. (2005) Product Chemistry of Algae-Off Tech 85%. Project Number: WCO/00001, 17125, 11-Oct- 46667301 P801. Unpublished study prepared by Product Safety Laboratories. 97 p. 2005 Sinning, D. (2005) Physical Characteristics of 85% Granular Sodium Percarbonate: Final Report. 11-Oct- 46667302 Project Number: 3390/01, WCO/00009. Unpublished study prepared by Case Consulting 2005 Laboratories, Inc. 15 p. Merkel, D. (2005) Sodium percarbonate, Coated: Acute Oral Toxicity Up and Down Procedure in 11-Oct- 46667303 Rats. Project Number: WCO/00003, 17126, P320/UDP. Unpublished study prepared by Product 2005 Safety Laboratories. 16 p. Merkel, D. (2005) Sodium percarbonate, Coated: Acute Dermal Toxicity Study in Rats - Limit Test. 11-Oct- 46667304 Project Number: WCO/00004, 17127, P322. Unpublished study prepared by Product Safety 2005 Laboratories. 15 p. Ollinger, J. (2005) Request for Waiver from Acute Inhalation Toxicity Testing with 85% Sodium 11-Oct- 46667305 Percarbonate. Project Number: WCO/00008, 3390/01. Unpublished study prepared by Ollinger 2005 Consulting LLC and Case Consulting Laboratories, Inc. 22 p. Ollinger, J. (2005) Request for Waiver from Eye Irritation Toxicity Testing with Sodium 11-Oct- 46667306 Percarbonate, Coated. Project Number: WCO/00007. Unpublished study prepared by Ollinger 2005 Consulting LLC. 6 p. Merkel, D. (2005) Sodium percarbonate, Coated: Primary Skin Irritation Study in Rabbits. Project 11-Oct- 46667307 Number: WCO/00005, 17128, P326. Unpublished study prepared by Product Safety Laboratories. 16 2005 p. Merkel, D. (2005) Sodium percarbonate, Coated: Dermal Sensitization Study in Guinea Pigs (Buehler 11-Oct- 46667308 Method). Project Number: WCO/00006, 17129, P328. Unpublished study prepared by Product Safety 2005 Laboratories. 24 p. Mileson, B. (2008) Response to Tier 1 Biochemical Pesticide Data Requirements for Sodium 01- 47499502 Carbonate Peroxyhydrate Technical. Project Number: 242/07. Unpublished study prepared by Aug- Technology Sciences Group, Inc. 443 p. 2008

B. U.S. Environmental Protection Agency Regulatory Documents and Risk Assessment Memoranda

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/

U.S. 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

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

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

References: 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

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

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

U.S. EPA, September 2002. Sodium carbonate peroxyhydrate Biopesticides Registration Action Document. https://www3.epa.gov/pesticides/chem_search/reg_actions/registration/decision_PC- 128860_16-Sep-02.pdf

U.S. EPA, Chemistry Dashboard. ACD/Lab percepta platform: Sodium percarbonate. http://comptox.zn.epa.gov/dashboard/