United States Chemical Safety September 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Na & Ca Hypochlorite

Registration Review : Final Work Plan September 2012Docket Number: EPA

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3 of 12 Na & Ca Hypochlorite Registration Review Team

Human Health & Environmental Effects Nathan Mottl Talia Lindheimer Steven Malish Srinivas Gowda David Bays Najm Shamim

Risk Management Wanda Henson Lance Wormell

Office of General Counsel Philip Ross

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S upporting documents for the Na & Ca Hypochlorite Case may be found in the registration review docket EPA

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.Docket Number: EPA

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4 of 12 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of Na & Ca Hypochlorite (Case 0029 )

. 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 Na & Ca Hypochlorite registration review docket , and any other comments concerning the initial docket posting s. 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 s cience, 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 th at 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 Na & Ca Hypochlorite Preliminary Work P lan (PWP) (PC Code 014701 ) was published on March 28 , 2012 and the 6 0

- day comment period ended on May 29, 2012 . The Preliminary Work Plan document for Na & Ca Hypochlorite is available on www.regulations.gov docket number
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The Na & Ca Hypochlorites Case (Case 0029) contains two active ingredients, calcium hypochlorite (PC Code 014701) and sodium hypochlorite (PC Code 014703).

The first pesticide product containing c alcium hypochlorite (Ca Hypoch lorite) (PC Code 014701 ) as an active ingredient was registered in the United States in 1957

. Currently, there are 120 products containing calcium hypochlorite as an active ingredient registered with EPA for use

as a d isinfectant (swimming pools, hubbard/i mmersion tank water, spa/hot tubs, hydrotherapy pools, surfaces

- food and non

- food, drinking water

- emergency

- public

- indivdual and poultry drinking water), sanitizer (laundry

- commercial and residential, surfaces

- food and non

- food, toilet bowls, dialysis machines) algaecide/slimicide (cooling towers, evaporative condenser, boat bottom) control microorganisms (sewage, wastewater, eggs for human consumption, industrial and pulp and paper) control algae/bacteria (fish, lobster ponds/tanks and conditioning oys ters) wash or lye peeling (fruits and vegetables) kills (scavenger fish). Calcium hypochlorite is exempt from the requirement of a tolerance under FFDCA sec. 408 (40 CFR 180.1054) under the following circumstances: (a) when used preharvest or postharvest i n a solution on all raw agricultural commodities, and (b) in or on grapes when used as a fumigant postharvest by means of a chlorine generator pad.Docket Number: EPA

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5 of 12 The first pesticide product containing sodium hypochlorite (Na Hypochlorite) (PC Code 014703 ) as an active ingredient was registered in the United States in 1957

. Currently, there are 425 products containing s odium hypochlorite as an active ingredient registered with EPA for use as a d isinfectant (swimming pools, hubbard/immersion tank water, spa /hot tubs, hydrotherapy pools, surfaces

- food and non

- food, drinking water

- emergency

- public

- indivdual and poultry drinking water), sanitizer (laundry

- commercial and residential, surfaces

- food and non

- food, toilet bowls, dialysis machines) algaecide/slim icide (cooling towers, evaporative condenser, boat bottom) control microorganisms (sewage, wastewater, eggs for human consumption, industrial and pulp and paper) control algae/bacteria (fish, lobster ponds/tanks and conditioning oysters) wash or lye peelin g (fruits and vegetables) kills (scavenger fish). Disinfectant (fish and lobster ponds equipment) Control pathogens (water used for forest dust abatement, nursery/farm seeds, roots, and equipment) Oyster conditioning. Products containing calcium and /or so dium hypochlorite are often referred to as “bleach.” There is currently an exemption from the requirement of a tolerance for sodium hypochlorite (40 CFR 180.1235). A food additive regulation permitting the use of sodium hypochlorite in washing or assisting in lye peeling of fruits and vegetables has been established (21 CFR 173.315).

Additionally, sodium hypochlorite can be used as a component in paper in contact with aqueous and fatty foods (21 CFR 176.170), and in textiles fibers used for packing food (2 1 CFR 177.2800).

The Agency completed a Reregistration Eligibility Decision (RED) for sodium and calcium hypochlorite in 1992.

Documents associated with the registration review of Na & Ca Hypochlorite can be viewed at www.regulations.gov in docket EPA

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Comments Received on the Preliminary Work Plan

The Agency received comment s from one respondent during the public comme nt period on the initial docket, described below. In the PWP, the Agency solicited comments on specifi c topics: environmental justice, water body impairment

, trade irritants , and structure activity relationships

. No comments or information were received du ring the public comment period concerning these issues.

Comment: Clorox recommends the following EPA

- approved uses of sodium hypochlorite be included in EPA’s review.

Disinfectant (fish and lobster ponds equipment) Control pathogens (water used for forest dust abatement, nursery/farm seeds, roots, and equipment) Oyster conditioning.

Response : The Agency concurs and the uses have been included:

Disinfectant (Swimming Pools, Hubbard/Immersion Tank Water, Spa/Hot Tub s, Hydrotherapy Pools, Surfaces

- Food and Non

- Food, Drinking Water

- Emergency

- Public

Individual and Poultry Drinking Water); Sanitizer (Laundry

- Commercial and Residential, Surfaces

- Food and Non

- Food, Toilet Bowls, Dialysis Machines);Docket Number: EPA

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6 of 12 Algaecide/Slimic ide (Cooling Towers, Evaporative Condenser, Boat Bottom); Control Microorganisms (Sewage, Wastewater, Eggs for Human Consumption, Industrial and Pulp and Paper); Control Algae/Bacteria (Fish, Lobster Ponds/Tanks and Conditioning Oysters); Wash or Lye Pe eling (Fruits and Vegetables); Kills (Scavenger Fish); Disinfectant (fish and lobster ponds equipment); Control pathogens (water used for forest dust abatement, nursery/farm seeds, roots, and equipment); Oyster conditioning.

Comment: Clorox suggests ren aming th e section " Use Patterns/Use Sites ( Aquatic areas) " to "Aquatic and outdoor environmental areas." Clorox recommends adding a use to this section titled “T reatment for water used in forest dust abatement." The use of sodium hypochlorite for control o f phytophthora species spread via dust abatement in forests has been previously approved by EPA.

Response: “ Aquatic areas” will be changed to “ Aquatic outdoor environmental areas ” and the

use "Treatment for water used in forest dust abatement” will be add ed to the section.

Comment: Clorox recommends the removal of Southern Seaoat seeds from this section. Uniola paniculata (Southern Seaoats) is the dominant foredune

- building grass along the southeastern

coast.

Response: Under Direct Food Contact, Southern Seaoat seeds will be deleted.

The comment received during the initial public comment period did not affect the data needs, work plan and timeline described in the PWP and they remain as they were presented initially in the PWP. Further, this document make s final the work plan for the Na & Ca Hypochlorite registration review process.

Risk Assessments and Anticipated Data Needs

The Agency will not conduct ecological risk assessment s for Na & Ca Hypochlorite

. The Agency will not conduct human health risk assessment s for Na & Ca Hypochlorite

. The Agency will not require additional data for use in conducting the registration review for Na & Ca Hypochlorite.

Ecological Risk Assessment Status and Anticipated Data Needs

• The most recent ecological risk assess ments for Na & Ca Hypochlorite were completed in 1992 , in support of reregistration

.

• The Agency does not anticipate the need to require additional ecological data for the registration review at this time for Na & Ca Hypochlorite

.

• The Agency does not anticipate the need to require additional environmental fate data for the registration review at this time for Na & Ca Hypochlorite

.

• F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Sco ping Document in Support of Registration Review of Sodium and Calcium Hypochlorite Salts , located in the docket

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7 of 12 Human Health Risk Assessment Status and Anticipated Data Needs

• The most recent human health risk assessments for sodium and calcium hypochlorit es were completed in 1992, in support of the Reregistration Eligibility Decision.

• The Agency does not anticipate the need to require additional human health data for this registration review case at this time.

• For more information, please refer to Sodium H ypochlorite and Calcium Hypochlorite: Human Health Risk Assessment Scoping Document in Support of Registration Review, located in the docket.

Product Chemistry

The Agency does not anticipate the need to require additional product chemistry data for the registration review at this time for Na & Ca Hypochlorite

.

• F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Sodium and Calcium Hypochlorite Salts

, loca ted in the docket

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Endangered Species for Na & Ca Hypochlorite

Based on the low likelihood of exposure, the Agency intends to conclude that the registered uses for Na & Ca Hypochlorite will have 'no effect' (NE) on endangered or threatened terrestrial or aquatic species, or their designated critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS). EPA anticipates conducting no furthe r analysis of potential risks to endangered or threatened species unless public comment or other submissions provide data or information that would otherwise inform the Agency's determination.

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, reprodu ctive, 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 r ates, 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. As part of its reregistration decision for Na & Ca Hypochlorite , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), Na & Ca Hypochlorite subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).Docket Number: EPA

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8 of 12 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 eff ect 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 ass ays 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 sys tems 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.

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. Calcium Hypochlorite 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 Na & Ca Hypochlorite

. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, t he test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

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Timeline

EPA has created the following estimated timeline for the completion of the Na & Ca Hypochlorite registration review:

Anticipated Schedule
Acti vities 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 N/A 1

Data Submission N/A 1
Open Public Comment Period for Preliminary Risk Assessments N/A 1
Close Public Comment Period for Preliminary Risk Assessments N/A 1

Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision September 2013 1
Close Public Comment Period for Proposed Reg. Review Decision November 2013 1Docket Number: EPA

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9 of 12 Final Decision and Begin Post

- Decision Follow

- up March 2014 1 Total (years) 2 1

1 The anticipated schedule will be revised as necessary based, for example; on any need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case

Next Steps

EPA will complete a proposed registration review decision for the Na & Ca Hypochlorite case.Docket Number: EPA

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10 of 12 Table 3

. ANTIMICROBIAL USE PATTERNS/USE SITES OF SODIUM AND CALCIUM HYPOCHLORITES

Use Patterns/Use sites

Agricultural premises and equipment Food area premises and equipment

- indirect food contact

Barns, stables, hutches Farm premises, halters, ropes as well as forks, shovels, and scrapers Meat and poultry plant processing water, poultry chiller intake water Meat and poultry plant processing water, carcass wash water Leaf cutting bee cells and bee boards, Bee domiciles Dairy and creamery equipment, teat cups and tubes, CIP pipeline, transfers stations and tanks. Milking machines and utensils. Milk bottles Poultry equipment and premises, houses brooders, hatcheri es. Incubators, feeders, poultry drinking water, fabrics Swine equipment and premises, hog and farrowing houses. Watering troughs and feeders, swine/hog drinking water, fabrics

Antifoulant coatings and treatments

Boat Bottoms

Aquatic and outdoor environmental areas

a. Commercial fishery water systems Maine Lobster ponds Conditioning live oysters Scavenger control in fish hatchery ponds

b. Lakes, ponds, reservoirs Fish Ponds Fish Pond equipment

c. Treatment for water used in forest dust abatement

Commercial, institutional and industrial premises

a. Indoor Commercial l aundry

Food handling/storage establishments, premises and equipment

a. Food area premises and equipment

- indirect food contact Porous and non

- porous food contact surfaces in agricultural/farm structures/buildings and equipment surfaces Cutting boards, work surfaces Dishes, glassware, utensils Cleaning sponges and clothsDocket Number: EPA

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11 of 12 Garbage cans and pails Cleaning equipment, mops, brooms, etc
b. Direct food contact Food egg sanitization Fruit and vegetable washing Post harvest protection

- Potatoes Asparagus Seeds, Pepper Seeds, Tomato Seeds, Rice Seeds

Human drinking water systems

a. E mergency water systems Emergency Disinfection

- personal drinking water Emergency disinfection of wells and casings Emergency disinfection of basins, tanks, flumes, etc. Emergency disinfection of reservoirs Emergency disinfection of Filters Emergency disinfection of distribution systems Emergency disinfection of cross connections or emergency connec tions Emergency disinfection of supplementary water supplies Emergency disinfection of water shipped in by vehicle Emergency disinfection of mains
b. Public water systems Public systems Mains New tanks, basins, etc. New Filter sand New wells Existing equipment

c. Individual water systems Dug, drilled, driven, and bored wells; casings, linings, pipelines, pipe sleeves, pumps and exteriors

Industrial processes and water systems

a. Aquatic/outdoor exposure Cooling tower/evaporative condenser water Pulp and paper mill process water systems Sewage and wastewater treatment, effluents Sewage and wastewater treatment, filter beds

Medical premises and equipment

Hard nonporous surfaces in hospitals, nursing homes and dental offices Dialysis Machines, Single and multi

- patient hemodialysate systems.

Residential and public access premises

a. Nonfood indoorDocket Number: EPA

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12 of 12 Household Laundry Hard nonporous kitchen surfaces Hard nonporous bathroom surfaces Nursery surfaces, baby toys Sports equipment Garbage cans/pails Amphibian care
b. Nonfood indoor/outdoor As phalt or wood roofs and sidings Artificial sand beaches Pet items, kennels, litter boxes Coolers Driveways, sidewalks, patios Bird baths Finished woodwork

c. Indirect foo d contact Household/domestic d wellings, indoor food handling areas Cutting boards, work surfaces Dishes, glassware, utensils Baby bottles Kitchen sponges and cloths

Swimming pools

Swimming pool water systems Pool Water, startup and maintenance Pool Water, winterization Spas/hot tubs Spas/hot tubs, shock treatment Hubbard/immersion tanks Hydrotherapy Tanks