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## Calcium Oxide Summary Document Registration Review: Initial Docket December 2010Docket Number: E PA-HQ-OPP-20 I 0

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## Calcium Oxide Summary Document Registration Review: Initial Docket December 2010

Case No. 5104

Approved By:



### Date 

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### TABLE OF CONTENTS

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I. Preliminary Work Plan (PWP) 5

II. Fact Sheet 13

________________________________________ Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's current position bas ed on the following documents:

1. Preliminary Plan for Registration Review of: Calcium Hydroxide/Calcium Oxide. October 14, 2010.

2. Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health Assessment Scoping Document in Support of Registration Review. October 27, 2010.

Additional supporting documents for calcium oxide may be found in the registration review docket EPA

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.Docket Number: EPA

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4 Calcium Oxide R egistration Review Team

Human Health & Environmental Effects Michelle Centra A. Najm Shamim

Risk Management Rebecca von dem Hagen Lance Wormell

Office of General Counsel Philip RossDocket Number: EPA

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5 I. Preliminary Work Plan

– Calcium Oxide

Introduction:

The Food Quality Protection Act of 1996 mandated a registration review program . All pesticides sold or distributed in the United States generally must be registered by the Environ mental Protection Agency (EPA), based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration r eview 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 Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used saf ely. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), an d will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begi ns when the initial docket is opened for each case. The docket is the Agency’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 Agency will develop and commit to a final work plan and schedule for the registration review of calcium oxide.

The calcium oxide case (Case Number 5104) currently includes two active ingredients, calcium oxide (PC Code 075601) and calcium hydroxide (PC Code 075604) . Calcium oxide is a baceteriocide/bacteriostat contained in a product registered for use in the treatment of medical waste. C alcium hydroxide, created by the mixing of calcium oxide and water, is a baceteriocide/bacteriostat contained in a manufacturing use product (MUP) registered for use for the manufacture of or fabrication into antimicrobial products to be used as coatings on or components of the following hard, inanimate surfaces and products: walls, floors, ceilings, tile, fixtures, tools, appliance exteriors, pipe exteriors, heating cooling ventilation (HVAC) equipment, duct work and related equipment (other than motors, fans and similar mechanical moving parts) interiors and exteriors

, and concrete, stone, ceramic, plaster, wood, drywall substrates in residential dwellings , schools, day care centers, professional offices, commercial and industrial buildings, factories, an imal housing facilities (barns, corrals, fences) and healthcare facilities (hospitals, medical office, nursing homes).

Both calcium oxide and calcium hydroxide were new active ingredients in products registered in 1976. In 1989 all of the then

- existin g registered products containing calcium oxide or calciumDocket Number: EPA

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6 hydroxide were voluntarily cancelled; therefore, these active ingredients were not evaluated under reregistration. In 2002 and 2004 EPA registered new products containing calcium oxide and calcium hydroxide, respectively. The existing registrations are presented in Table 1.

Documents associated with the registration review of the calcium oxide case can be viewed at www.regulations.gov in docket EPA

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- 0693. Below is a summary of the issues relevant to the registration review of calcium oxide.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of calcium oxide and calcium hydroxide. The Agency also anticipates the need to conduct comprehensive human health risk

assessments. The Agency anticipates needing additional data to conduct the registrat ion review of calcium oxide and calcium hydroxide.

Ecological Risk:

**•** No ecological risk assessment has been performed for the calcium oxide case.

**•** The Agency does not anticipate the need to complete an environmental fate risk

assessment. Based on current use patterns no long term environmental impact is expected from calcium oxide or calcium hydroxide because once calcium enters the environment, it is expected to quickly reach backgrou nd levels. No environmental fate data gaps exist for the present uses of these chemicals.

**•** The Agency has not conducted a risk assessment that supports a complete endan gered species determination for the calcium oxide case . The ecological risk assessment planned during registration review will allow the Agency to d etermine whether calcium oxide or calcium hydroxide’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats . When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriat e.

**•** The current database on ecological effects for the calcium oxide case is composed of studies from open literature and submitted studies that have not been fully reviewed. Because the existing data were generated on non

- guideline studies and also on sp ecies not found in the United States, t he Agency anticipates requiring the following ecotoxicity studies

.Docket Number: EPA

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7 o GDLN 850.1075

– Acute Freshwater Fish Toxicity

o GDLN 850.5400

– Aquatic Growth, Tier II Green Algae

**•** Please refer to Preliminary Plan for Registra tion Review of: Calcium Hydroxide/Calcium Oxide located in the docket, for a detailed discussion of these anticipated risk assessment s and data needs.

Human Health Risk:

**•** No human health risk assessment has been performed for the registered antimicrobial uses of calcium oxide and calcium hydroxide.

**•** The Agency intends to conduct residential and occupational exposure risk assessments based on current use patterns.

**•** Dietary (food and water) exposure is not expected from the registered use of calcium oxide be cause the chemical is applied in a closed system and must be disposed of in a sanitary landfill. Dietary exposure (food and water) is not expected from the registered calcium hydroxide manufacturing use product because it is not for use in or on coating or other antimicrobial pesticides that will be used on food contact, food preparation or food processing surfaces

. The U.S. Food a nd Drug Administration considers calcium oxide and calcium hydroxide Generally Recognized as Safe (GRAS) for use in foods wi th no limitations except good manufacturing practices. Therefore, because non

- occupational exposure and hazard are expected to be minimal, the Agency does not anticipate conducting dietary or aggregate risk assessments for the calcium oxide case.

**•** The Agency anticipates requiring the following data in order to conduct a n occupational risk assessment for calcium oxide and occupational and residential risk assessments for calcium hydroxide. The Agency intends to reevaluate the existing submitted, cit ed and published data and evaluate anticipated toxicology data for calcium oxide and calcium hydroxide during the registration review risk assessment in order to better characte rize hazard and potential human health risks. The following Tier 1 toxicology s tudies have been identified as data gaps for the calcium oxide case.

Toxicology Data for Calcium Hydroxide or Calcium Oxide

o 870.3200 21/28

- day Dermal Toxicity

o 870.3465 28

- day Inhalation Toxicity

o 870.5100 Bacterial Reverse Mutation Test

o 870.5300 In vitro Mammalian Cell Gene Mutation Test or 870.5375 In vitro Mammalian Chromosome Aberration Test

o 870.5385 Mammalian Bone Marrow Chromosomal Aberration Test or 870.5395 Mammalian Erythrocyte Micronucleus TestDocket Number: EPA

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8 Exposure Data for Calcium Oxide (Occupational Applic ator

– Medical Waste; Loading; Open Pour)

o 875.1300 Inhalation Exposure

- Outdoor

o 875.1400 Inhalation Exposure

- Indoor

o 875.1600 Data Reporting and Calculations

o 875.1700 Product Use Information

Exposure Data for Calcium Hydroxide (Occupational/Residential Applicator

– Paints/Coatings; Brush, Roller, Spray

- on)

o 875.1100 Dermal Exposure

- Outdoor

o 875.1200 Dermal Exposure

- Indoor

o 875.1300 Inhalation Exposure

- Outdoor

o 875.1400 Inhalation Exposure

- Indoor

o 875.1600 Data Reporting and Calculations

o 875.1700 Product U se Information

**•** Please refer to Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health Assessment Scoping Document in Support of Registration Review, located in the docket, for a detailed discussion of the anticipated human health risk assessmen t and data needs for the calcium oxide case

.
Product Chemistry :

**•** The Agency has reviewed the product chemistry database for the calcium oxide case and anticipates that no additional product chemistry data will be needed for registration review.

**•** Please refer to Preliminary Plan for Registration Review of: Calcium Hydroxide/Calcium Oxide located in the docket, for more information on the calcium oxide case.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (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, andDocket Number: EPA

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9 establish a quantitative relationship between the dose and the E, A, or T effect.

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. This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post

- application agricultural scenarios. This list should not be construed as a list of k nown or likely endocrine disruptors.

Calcium Oxide and calcium hydroxide were not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals . Accordingly, EPA anticipates issuing future EDSP orders/data call

- ins for all Registration Review cases, including those for which EPA has already opened a Registration Review docket for a pesticide active ingredient.

For further information on the st atus of the EDSP, the policies and procedures, the list of 67 chemicals, 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 completi on of the calcium oxide case registration review.

Registration Review for Calcium Oxide

– Projected Registration Review Timeline
Activities Estimated Date Opening the Docket Open Docket and Public Comment Period December 2010 Close Public Comment February 2011 Case Development Final Work Plan May 2011 Issue DCI May 2012 Data Submission May 2 01 4 Open Public Comment Period for Draft Risk Assessments September 201 5 Close Public Comment Period December 201 5 Registration Review Decision Open Public Comment Period for Proposed Registration Review Decision March 201 6

Close Public Comment Period June 201 6 Registration Review Decision and Begin Post

- Decision Follow

- up 201 6 Total (years) 6Docket Number: EPA

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10 Guidance for Commenters :

The public is invited to comment on EPA’s preliminary registration review work plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manner prior to issuing a final work plan for the calcium oxide registration review case.

Trade Irritants

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growe rs and other stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum Residue Limits (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.

Water Quality

Calcium oxide is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88 5 . In addition, no Total Maximum Daily Loads (TMDL) have be en developed for calcium oxide

, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_n ation.tmdl_pollutant_detail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites subm ission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registratio n Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm ) in order to ensure they can be used quantitativ ely or qualitatively in pesticide risk assessments.

Environmental Justice

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 Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to calcium oxide compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general po pulation.Docket Number: EPA

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11 Structure Activity Relationships

EPA must rely upon information of appropriate quality and reliability for each decision made by the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide chemical traditiona lly begins with the applicant’s submission of a set of studies conducted with the specific pesticide chemical of interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous process that identifies the physical, c hemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in alternative techniques, i.e., techniques other than data generation that could significantly inform the Agency’s decision

- making process. Recently, OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory decision

- making process. In the SAR process, a chemical's molecular structure is compared to that of other chemicals for which data are available. These structural similarities are then used to make predictive judgments about a chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, chem ical, and biological properties are a function of (or directly related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a selected set of measured data on a single physical, chemical, or biological
prope rty is used to derive a model (an equation) to predict the value of that property.

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency scientists, OPP has begun a process shift that envisions shifting from the cur rent study

- by

- study approach to an approach in which the use of predicted data, generated using validated models, is considered along with information from open literature and studies specifically generated under Part 161 requirements. All relevant inform ation would be considered as part of a weight

- of

- the

evidence evaluation.

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate properties, that SAR and QSAR might be effectively utilized to fulfill these data require ments for many antimicrobial pesticide chemicals. When considering biological properties, at this time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human health and/or ecot oxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream

- lined, i.e., a screening

- level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stak eholders believe that submission of predicted data can fulfill one of the data needs for calcium oxide , then the Agency invites submission of this information. The submitter would be expected to supply a rationale describing the utility of the information and provide documentation on the scientific validity of the information. The determination that the predicted data fulfills the data requirement would be at the sole discretion of the Agency. Pre

- submission consultation with the Agency is encouraged.Docket Number: EPA

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12 Ad ditional Information

Stakeholders are also specifically asked to provide available information and data that will assist the Agency in refining the risk assessments. The Agency is interested in receiving the following information.

1. Confirmation on the following label information:

a. Sites of application b. Formulations

c. Application methods and equipment d. Maximum application rates

e. Frequency of application, application intervals and maximum number of applications f. Geographic limitations on use 2. Use or potential us e distribution 3. Use history 4. Usage/use information for non

- agricultural uses (e.g., materials preservation) 5. Typical application interval 6. State or local use restrictions 7. Ecological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency 8. Monitoring data 9. Structure Activity Relationships

Next Steps:

After the 60

- day comment period closes, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for the calcium oxide case

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13 II. FACT SHEET

Background Information:

**•** Active ingredients: Calcium Oxide and Calcium Hydroxide

**•** Trade and Other Names: Hydrated Lime

**•** Registration Review Case N umber: 5104

**•** PC Code: 075604 & 075601

**•** CAS#: 1305

- 78

- 8 & 1305

- 62

- 0

**•** Technical Registrant s : Alistagen Corporation

**•** First approved for use in a registered product: 1976

**•** There are 2 registered products that contain calcium oxide & calcium hydroxide as active ingredients: 1 end use product (calcium oxide) and 1 manufacturing use product (calcium hydroxide)

**•** Calcium hydroxide is exempt from the requirement of a tolerance when used as an inert ingredient as a solid diluent or carrier in pesticide formulations applied to growing crops or to raw agricultural com modities (40 CFR 180.1001(c)).

**•** Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen; Vondem

- Hagen.Rebecca@epa.gov

**•** Antimicrobials Division Product Manager (PM): Velma Noble; Noble.Velma@epa.gov

Use & Usage Information: (For additional details, please refer to the Appendix A: Registered Antimicrobial Uses of Calcium Oxide and Calcium Hydroxide)

**•** There is one end

- use product (EUP) and one manufacturing use product (MUP)

**•** Calcium oxide and calcium hydroxide are registered as microbiocide/microbiostat

**•** Antimicrobial Use Sites :

o Medical waste treatment facilities

o Manufacturing use product that can be used for the manufacture of or fabrication i nto antimicrobial pesticides to be used a s coatings on, or components of the following hard, inanimate surfaces and products: walls, floors, ceiling, tile, fixtures, tools appliance exteriors, pipe exteriors HVAC equipment, ductwork and related equipment ( other than motors, fans and similar mechanical moving parts) interiors and exteriors, and concrete, stone, cera mic, plaster wood, and drywall substrates

Recent and Pending Actions:

**•** There are no recent or pending actions involving calcium oxide or calcium hydroxide.Docket Number: EPA

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14 Ecological Risk Assessment Status :

The Agency has not conducted an ecological risk assessment for the calcium oxide case. Please refer to Preliminary Plan for Registration Review of: Calcium Hydroxide/Oxide located in the docket, for a detailed discussion of the anticipated ecological risk assessments.

**•** N o long term environmental impact is expected from calcium hydroxide or calcium oxide b ased on current use patterns. No long term environmental impact is exp ected because

once calcium enters the environment, it is expected to quickly reach background levels.

**•** Based on ecotoxicity studies in the Agency’s database and collected from open literature

, calcium oxide and calcium hydroxide appear to be nontoxic to western mosquito fish and invertebrates such as scud and midge; slightly toxic to African catfish (not native of USA); and moderately toxic to red

- winged blackbird. For aquatic plant s like blue

- green algae only inhibition of nitr ogen fixation has been observed.

Human Health Risk Assessment Status:

The Agency has not conducted a human health risk assessment for the calcium oxides case. At the time of registration, the Agency concluded that there were no significant risks expected from the proposed uses of calcium hydroxide as the active ingredient (96.6%) in the MUP . D espite the limited toxicology database and the deficiencies of the submitted data, the Agency recognized that calcium hydroxide had a long history of use as a direct food additive, is Generally Recognized as Safe by the U.S. Food and Drug Administration (21 CFR 582.1205) and the potential exposures to calcium hydroxide fr om uses identified on the MUP label were considered minimal in comparison to direct exposure to the active ingredient in the diet . Please refer to Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health Assessment Scoping Document in Support of Registration Review , located in the docket, for a detailed discussion of the anticipated human health risk assessment.

Hazard Characterization:

**•** Calcium oxide and calcium hydroxide are corrosive and severe irritants.

**•** Due to the corrosive and severely irritating nature of calcium oxide and calcium hydroxide, acute dermal and inhalation studies were waived in accordance with 40 CFR § 158.340 and the chemicals were de termined to be Toxicity Categories II and I, respective ly.

Dietary (Food and Water):

**•** The U.S. FDA considers calcium oxide and calcium hydroxide Generally Recognized as Safe (GRAS) for use in foods with no limitations except good manufacturing practices.Docket Number: EPA

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15 **•** Because calcium oxide is registered solely to treat m edical waste and calcium hydroxide is required to state on the label “not for use in or on coating or other antimicrobial pesticides that will be used on food contact, food preparation or food processing surfaces,” dietary (food and water) exposure is not expected. T herefor e, a dietary risk assessment has not been performed.

Residential:

**•** A residential risk assessment has not been conducted for calcium oxide or calcium hydroxide

. Aggregate:

**•** Because dietary exposure to calcium oxide is not of concern and a residential assessment

was not performed

, the Agency did not conduct an aggregate exposure assessment.
Occupational :

**•** An occupational risk assessment has not been conducted for calcium oxide or calcium hydroxide

.
Cumulative:

**•** EPA does not have, at this t ime, available data to determine whether calcium oxide or calcium hydroxide have a common mechanism of toxicity with other substances or how to include these pesticides in a cumulative risk assessment. For the purposes of this Registration Review, EPA has assumed that calcium oxide and calcium hydroxide do not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered

.

Incidents:

**•** The Agency has reviewed the OPP Incident Data Systems (IDS) and one incident associated with calcium hydroxide exposure was reported in which dermal and eye irritation were the associated symptoms. No incidents associated with calcium oxide exposure have been reported.

Tolerances and International Harmonization:

**•** Calcium oxide is Generally Recognized as S afe (GRAS) as a direct food additive by the U.S. FDA (21 CFR 582.1210) and calcium hydroxide is G enerally Recognized as S afe (GRAS) as a direct food a dditive by the U.S. FDA (21 CFR 582.1205) with “noDocket Number: EPA

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16 limitation other than current good manufacturing practice.”

**•** Calcium hydroxide is exempt from the requirement of a tolerance when used as an inert ingredient as a solid diluent or carrier in pesticide formulations applied to growing crops or to raw agricultural commodities (40 CFR 180.1001(c)). Calcium hydroxide is currently on EPA’s 4B list of Minimal Risk Inert Ingredients (those inert ingredients which have sufficient data to substantiate they can b e used safely in pesticide prod ucts) while calcium oxide is on EPA’s 4A List of Inert Ingredients (inert ingredients generally regarded as safe).

**•** Calcium hydroxide is listed as an approved synthetic nonagricultural substance allowed as an ingredient in o rganic processed food by the USDA (205.605(b)(6)).

Data Call

- In Status

**•** There are currently no outstanding Data Call

- In data requirements for the calcium oxides

case.

Labels :

Registered active products, including EPA registration numbers

, are provided in Table 1 below. For future reference, during registration review a list of product registration numbers will be included in the docket. Calcium oxide and calcium hydroxide product labels can be obtained from the Pesticide Product Label Sys tem (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

Table 1: Registered Active Products for Calcium Oxide and Calcium Hydroxide
EPA Reg. Number Product Name Formulation Type % Active Ingredient Registrant

73696

- 2 Hydrated Lime Technical Chemical 96.6 Alistagen Corporation

75661

- 1 Cold

- Ster Soluble Concentrate 86.8 Positive Impact Waste Solutions, LLCDocket Number: EPA

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17 I II. S ummary of Anticipated Data Requirements

– Calcium Oxide and Calcium Hydroxide

The table below summarizes a nticipated data needs for calcium oxide and calcium hydroxide listed in Section I of this document (Preliminary Work Plan), the Preliminary Plan for Registration Review of: Calcium Hydroxide/Oxide dated October 14, 20 10, and Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health Assessment Scoping Document in Support of Registration Review dated October 27, 2010

.

Active Ingredient Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured from DCI Receipt)

075604 850.1075 Acute freshwater fish toxicity TGAI 12 months

075604 850.5400 Aquatic growth, Tier II green algae TGAI 12 months

075601 or

075604 870.3200 21/28

- day Dermal Toxicity TGAI 24 months

075601 or

075604 870.3465 28

- day Inhalation Toxicity TGAI 24 months

075601 or

075604 870.5100 Bacterial Reverse Mutation Test TGAI 8 months

075601 or

075604 870.5300

and/or

870.5375 In vitro Mammalian Cell Gene Mutation Test

or

In vitro Mammalian Chromosome Aberration Test TGAI 8 months

075601 or

075604 870.5385

or

870.5395 Mammalian Bone Marrow Chromosomal

Aberration Test

or Mammalian Erythrocyte Micronucleus Test TGAI 8 months

075601 875.1300 Inhalation Exposure

- Outdoor TGAI 24 months

075601 875.1400 Inhalation Exposure

- Indoor TGAI 24 months

075601 875.1600 Data Reporting and Calculations TGAI 24 months

075601 875.1700 Product Use Information TGAI 12 months

075604 875.1100 Dermal Exposure

- Outdoor TGAI 24 monthsDocket Number: EPA

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18 Active Ingredient Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured from DCI Receipt)

075604 875.1200 Dermal Exposure

- Indoor TGAI 24 months

075604 875.1300 Inhalation Exposure

- Outdoor TGAI 24 months

075604 875.1400 Inhalation Exposure

- Indoor TGAI 24 months

075604 875.1600 Data Reporting and Calculations TGAI 24 months

075604 875.1700 Product Use Information TGAI 12 monthsDocket Number: EPA

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19 IV. Appendix A: Registered Antimicrobial Uses of Calcium Oxide and Calcium Hydroxide
PC Code EPA Reg Number used for Max. Appl. Rate Formulation % Active Ingredi ent in End Use Formul ation Use Category Use Site Treatment Site/Surfaces Metho d of Appli cation Max Application/ Use Rate Use Limitations

075601 73696

- 2 Technical Chemical 96.6 Use only for manufacture of or fabrication into antimicrobial pesticides to be used as coatings on, or components of, the following hard, inanimate surfaces and products: walls, floors, ceiling, tile, fixtures, tools appliance exteriors, pipe exteriors HVA C equipment, ductwork and related equipment (other than motors, fans and similar mechanical moving parts) interiors and exteriors, and concrete, stone, ceramic, plaster wood, and drywall substrates. Formulations and antimicrobial coating products that i ncorporate hydrated lime are to be formulated to include 15

- 25% of this product.

075604 75661

- 1 Soluble Concentrate 86.8 Medical Premises and Equipment Regulated Medical Waste Cultures and stocks, human pathological waste, human blood and blood products, used and unused sharps and Isolation waste. Open
pour 7.5% by weight of the material treated End use product is designed for use only in the PIWS

- 3000 Treatment System.