United States Chemical Safety September 2012

Environmental Protection and Pollution Prevention

Agency (7510P)

Na & Ca Hypochlorite

Registration Review:

Final Work Plan

September 2012

Docket Number: EPA-HQ-OPP-2012-0004

www.regulations.gov

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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

________________________________________

Supporting documents for the Na & Ca Hypochlorite Case may be found in the registration 

review docket EPA-HQ-OPP-2012-0004 located on the internet at www.regulations.gov.
Docket Number: EPA-HQ-OPP-2012-0004

www.regulations.gov

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Introduction

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

Agency”) for the registration review of 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 postings. The Summary Document provided information 

on what EPA knows about the pesticide and what additional risk analyses and data or 

information the Agency believes are needed to make a registration review decision.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

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

The registration review program is intended to make sure that, as the ability to assess risk 

evolves and as policies and practices change, all registered pesticides continue to meet that 

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

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

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

The Na & Ca Hypochlorite Preliminary Work Plan (PWP) (PC Code 014701) was published on

March 28, 2012 and the 60-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 

EPA-HQ-OPP-2012-0004.

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 calcium hypochlorite (Ca Hypochlorite) (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 disinfectant (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/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 oysters) 

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 in 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-HQ-OPP-2012-0004

www.regulations.gov

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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 sodium hypochlorite as an active ingredient registered with EPA for use as a

disinfectant (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/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 oysters) wash or lye 

peeling (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 sodium 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 (21 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-HQ-OPP-2012-0004. Below is a summary of the issues 

relevant to this registration review case. 

Comments Received on the Preliminary Work Plan

The Agency received comments from one respondent during the public comment period on the 

initial docket, described below. In the PWP, the Agency solicited comments on specific topics: 

environmental justice, water body impairment, trade irritants, and structure activity relationships.

No comments or information were received during 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 Tubs, 

Hydrotherapy Pools, Surfaces -Food and Non-Food, Drinking Water -Emergency-PublicIndividual and Poultry Drinking Water); Sanitizer (Laundry -Commercial and 

Residential, Surfaces -Food and Non-Food, Toilet Bowls, Dialysis Machines); 
Docket Number: EPA-HQ-OPP-2012-0004

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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 

Oysters); Wash or Lye Peeling (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 renaming the section "Use Patterns/Use Sites (Aquatic areas)" to 

"Aquatic and outdoor environmental areas." Clorox recommends adding a use to this section 

titled “Treatment for water used in forest dust abatement." The use of sodium hypochlorite for 

control of 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 added 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 makes 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 assessments for Na & Ca Hypochlorite. The 

Agency will not conduct human health risk assessments 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 assessments 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.

• For 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, located in the docket.
Docket Number: EPA-HQ-OPP-2012-0004

www.regulations.gov

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Human Health Risk Assessment Status and Anticipated Data Needs

• The most recent human health risk assessments for sodium and calcium hypochlorites 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 Hypochlorite 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.

• For 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, located in the docket.

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 further 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, 

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. 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-HQ-OPP-2012-0004

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EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and

establish a dose-response relationship between the dose and the E, A, or T effect.

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 callins, 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, the test guidelines and the Tier 1 screening battery, please visit our website:

http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated timeline for the completion of the Na & Ca 

Hypochlorite 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 N/A1

Data Submission N/A1

Open Public Comment Period for Preliminary Risk Assessments N/A1

Close Public Comment Period for Preliminary Risk Assessments N/A1

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision September 20131

Close Public Comment Period for Proposed Reg. Review Decision November 20131
Docket Number: EPA-HQ-OPP-2012-0004

www.regulations.gov

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Final Decision and Begin Post-Decision Follow-up March 20141

Total (years) 21

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-HQ-OPP-2012-0004

www.regulations.gov

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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, hatcheries. 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 laundry

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 cloths
Docket Number: EPA-HQ-OPP-2012-0004

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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 systemsa. Emergency 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 connections

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 indoor
Docket Number: EPA-HQ-OPP-2012-0004

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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

Asphalt or wood roofs and sidings

Artificial sand beaches

Pet items, kennels, litter boxes

Coolers

Driveways, sidewalks, patios

Bird baths

Finished woodwork

c. Indirect food contact

Household/domestic dwellings, 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