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



# Aliphatic Alcohols, C1

- C5 Ethanol and Isopropyl Alcohol Summary Document Registration Review : Initial Docket

June 2012Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

3 of 23 

### TABLE OF CONTENTS

Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alchol) Registration Review Team

.... 4 I. Preliminary Work Plan

................................ ................................ ................................ ..... 5 II. Fact Sheet

................................ ................................ ................................ ...................... 12 III. Summary of Anticipated Data Requirements

................................ .............................. 21 IV. Appendix A

................................ ................................ ................................ .................. 22

________________________________________
Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's current position based on the following doc uments :

1. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol). May 31, 2012

2. Aliphatic Alcohols, C1

- C5: Human Health Effects Scoping Document for the Registration Review Decision

. April 16, 2012

Additional supporting documents for the Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol) Case may be found in the registration review docket EPA

- HQ

- OPP

- 2012

- 0340 located on the internet at www.regulations.gov

.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

4 of 23 Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol) Registration Review Team

Human Health & Environmental Effects Talia Lindheimer Jonathan Chen Steven Malish Srinivas Gowda James Breithaupt David Bays

Risk Management Wanda Henson Lance Wormell

Office of General Counsel Philip RossDocket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

5 of 23 I. Preliminary Work Plan

-- Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol)

Introduction :
The Food Quality Protection Act (FQPA) of 1996 ma ndated a registration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data showing that they will not cause unr easonable risks to human health or the environment when used as directed on 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 pesticid es 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 perio dically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. 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) and 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 begins when the initial docket is opened for each case. The doc ket 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 Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alc o hol) C ase.
The Aliphatic Alcohol Case (Case 4003) contains two active ingre dients: ethanol (PC Code 001501) and isopropyl alcohol (PC Code 047501)

T he first product containing ethanol was registered in the United States on April 21, 1948

, and is registered for use as a glassware sanitizer in eating establishments and hard non

- po rous surface disinfectant and bacteriocide in eating establishments and institutional premises. There are currently 50 registered active products containing the active ingredient ethanol. End use products containing the chemical ethanol are registered for use as surface disinfectant s in use sites such as

a gricultural premises and equipment , medical premises and equipment, industrial areas and residential and public access areas. Ethanol is also registered for use in antifouling paints for use on boats botto ms and boat running gear below the water line. End use products are also registered for use in aquatic industrial processes and water systems such as cooling towers as well as pulp and paper mill process water systems. In addition to being registered for use in human drinking water systems, ethanol is also registered for use as an ingredient in products used in pools, hot tubs and spas. In addition, ethanol containing products are also used in aquatic areas such as commercial fishery water systems and fish containing lakes, ponds and reservoirs. There are two registered food contact uses for this chemical. One is for the sanitization of food eggs and the other is as a post harvest treatment for specific fruits and vegetables.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

6 of 23 Ethanol also is registered f or use as a plant growth regulator (a ripener). There is also a registered use of ethanol with ARCO Ethylene Generators (catalytic generation of ethylene gas) involving EPA Reg. No. # 58502

- 1, a product that is registered for use as a ripening agent for citrus fruits, pear, avocado, banana, papaya, melons, tomato, flue

- cured tobacco/cigar/cigar wrapping. The receptors in fruits and vegetables absorb free atmospheric ethylene molecules, and this in turn accelerates the ripening process. Due to the product based conversion of ethanol to ethylene gas, there are no expected exposures to ethanol on the raw agricultural commodity, ( RAC ) and residual ethylene gas is not expected . Fruits and vegetables produce ethylene gas naturally, and reabsorb the gas to stim ulate the production of more ; as this is the process by which ripening occurs. E thanol is converted to ethylene gas, and the gas is pumped into ripening rooms.

The first product containing i sopropyl alcohol was registered on March 5, 1948 and is registered for use as a glassware sanitizer in eating establishments and hard non

- porous surface disinfectant and bacteriocide in household, commercial and institutional premises. There are currently 31 registered products containing the active ingredient isopropyl alcohol. Products containing isopropyl alcohol are also registered for use in spray, ready to use solution and impregnated wipe forms. End use products containing the chemical isopropyl alcohol are registered for use as porous (fabrics, mattresses, etc.) a nd non

- porous surface disinfectant in use sites such as agricultural premises and equipment, industrial areas and residential and public access areas. Products containing isopropyl alcohol are also registered for use in/on medical premises and equipment an d veterinary premises as well as in/ on salon and barber shop areas and utensils as well as ultra sonic cleaners and for precleaning of medical instruments prior to disinfection. In addition, isopropyl alcohol containing products are also used in non

- pestic idal products as a deodorizer in air fresheners. It is also registered for use in retail and institutional food establishments, food processing plants and other health department regulated food facilities.

There are no EPA established tolera nces or exemptions from tolerances identified for isopropanol; however, there are several FDA established tolerances for isopropanol in modified hop extract (21 CFR 172.560) and in foods for human consumption (21 CFR 173.240) . Ethanol has three inert exem ptions from the requirement of a tolerance in 40 CFR 180.910,

- .930, and

- .940. Both ethanol and isopropanol also have a wide range of non

- pesticidal uses. For example, ethanol is contained in some beverages, and isopropanol is the major ingredient in rubb ing alcohol.

The Agency completed a Reregistration Eligibility Decision (RED) for Aliphatic Alcohols, C1

- C5 ( Ethanol and Isopropyl A lcohol ) in 1995

. When the aliphatic alcohols, C1

- C5 ( ethanol and isopropyl alcohol) registration review case was establi shed

, it was considered that C1

- 5 alcohols are all very water

- soluble and are expected to be similar. The remaining alcohol groups, C6

- 16, which were in reregistration case 4004 for which a RED was completed in 2007

, will be addressed under a separate regi stration review case.

Documents associated with the registration review of A liphatic A lcohols, C1

- C5 can be viewed
at www.regulations.gov in docket EPA

- HQ

- OPP

- 2012

- 0340

. Below is a summary of the issues relevant to th is registration review case.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

7 of 23 Anticipated Risk Assessment and Data Needs :
The Agency does not anticipate the need to conduct an ecological risk assessment. The Agency does not anticipate the need to conduct a human health risk assessment. The Agency d oes not anticipate needing additional data for use in conducting the registration review for aliphatic alcohols, C1

- C5 ( e thanol and i sopropyl alcohol )

. Ecological Risk :

The most recent qualitative ecological risk assessment was performed for aliphatic alcohols, C1

- C5 ( e thanol and i sopropyl alcohol ) in support of the 1995 RED

.

Based on ethanol and isopropyl alcohol’s use patterns, volatility, ready biodegradability

, and low toxicity, and the use of these compounds as a nutrient source by microbes, the Agency intends to conclude that the registered uses of ethanol and isopropyl alcohol 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 Servi ce (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 subm issions provide data or information that would otherwise inform the Agency's determination

. The Agency does not anticipate the need to require additional ecological data for use in registration review for A liphatic A lcohols, C1

- C5 ( ethanol and isopropyl alcohol) C ase at this time. The use pattern is restricted to indoor uses (listed above), and its use will lead to little, if any, exposure to non

- target organisms.

The Agency does not anticipate the need to require additional environmental fate data fo r use in the aliphatic alcohols, C1

- C5 ( ethanol and isopropyl alcohol) registration review

case at this time. There is sufficient information in the public literature on the fate of aliphatic alcohols in the environment. Aliphatic alcohols chemistry is well known and well documented in the open literature. Although the aliphatic alcohols are expected to be stabl e in water under typical use conditions, the compounds are not hazardous to the environment because they are readily biodegradable, a nutrient for microbes, and a metabolite of microbes.

F or more information

, please refer to Product Chemistry, Environme ntal Fate, and Ecological Effects Scoping Document in Support of Registration Review of Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol). , located in the docket

.
Human Health Risk :

No human health risk assessment has been performed for aliphatic alcohols, C1

- C5 ( ethanol and isopropyl alcohol)

. H uman health risk assessments were not need ed a t the time of the RED, because the Agency determined that toxicological criteria were not triggered and that the exposure and risk from the active ingredients were not significantDocket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

8 of 23 when compared to the frequent intentional human exposures resulting from non

pesticidal uses

. The Agency does not anticipate the need to require additional human health data for use in th is registration r eview for aliphatic alcohols, C1

- C5 ( ethanol and isopropyl alcohol) at this time.

F or more information

, please refer to Aliphatic Alcohols, C1

- C5: Human Health Effects Scoping Document for the Registration Review Decision

, located in the docket

.
Product Chemistry :
The Agency does not anticipate the need to require additional product chemistry data for use in th is registration review for e thanol and i sopropyl alcohol at this time.

F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol)

, located in the docket

. 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 system ic 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. A human health risk assessment identifying the most sensiti ve endpoints has not been conducted for the Aliphatic Alcohols, C1

- C5 (ethanol and isopropyl alcohol) registration review case. However, as required by FFDCA section 408(p), e thanol and i sopropyl alcohol are subject to the endocrine screening part of the E ndocrine Disruptor Screening Program (EDSP).

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 occur ring 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 stag e 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 relatio nship between the dose and the E, A, or T effect.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

9 of 23 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. E thanol and i sopropyl alcohol are 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 iss ue future EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for e thanol and i sopropyl alcohol

. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guid elines 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 Aliphatic alcohols, C1

- C5 registration review :
Anticipated Schedule 1
Activities Estimated Month/Year Phase 1 : Opening the docket Open Public Comment Period for Docket June 2012 Close Public Comment Period for Docket August 2012 Phase 2 : Case Development Develop Final Work Plan (FWP) December 2012 Issue DCI N/A Data Submission N/A Open Public Comment Period for Preliminary Risk Assessments N/A Close Public Comment Period for Preliminary Risk Assessments N/A
Phase 3 : Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision December 2012 Close Public Comment Period for Proposed Reg. Review Decision February 2013 Final Decision and Begin Post

- Decision Follow

- up 2013 Total (years) 1

Guidance for Commenters :
The public is invited to comment on EPA’s P reliminary W ork P lan 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 aliphatic alcohols, C1

- C5 ( ethanol and isopropyl alcohol) registration review case.

1 The schedule will be updated as appropriate based on the need to issue test orders under the Endocrine Disruptor Screening Program.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

10 of 23 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. Growers 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 Qualit y :
Aliphatic Alcohols, C1

- C5 ( Ethanol and Isopropyl Acohol) are 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_waters 10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88 5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Aliphatic A lcohol s, C1

- C5 (Ethanol and Isopopyl Alcohol) , based on information provided at http://iaspub.epa.gov/tmdl_wat ers10/attains_nation.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 Agenc y 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 OPP Standard Operating Procedure : Inclusion of Impaired Water Body and Other Water Quality Data in OPP ’s Registration Review Risk Assessment and Management Process (see : http : //www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm ), in order to ensure the data can be used quantitatively 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 incom e, 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 th eir location, cultural practices, or other factors, may have atypical, unusually high exposure to aliphatic alcohols, C1

- C5 ( ethanol and isopropyl alcohol) compared to the general population. Please comment if you are aware of any sub

- populations that ma y have atypical, unusually high exposure compared to the general population.

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 traditionally 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, chemical, 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.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

11 of 23 Today, there is significant int erest 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 deci sion

- 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, a nd biological properties. Thus, the chemical’s physical, chemical, 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 measur ed data on a single physical, chemical, or biological property 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 current 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 information 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 requirements 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 chemical s that exhibit lower toxicity for human health and/or ecotoxicity 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 asses sments with progressively more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl alcohol) c ase, 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 w ould be at the sole discretion of the Agency. Pre

- submission consultation with the Agency is encouraged.

Additional Information :
Stakeholders are also specifically asked to provide available information and data that will assist the Agency in refining its risk assessments , including any species

- specific ecological effects determinations

. 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 applicationsDocket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

12 of 23

f. Geographic limitations on use 2. Use or potential use distribution 3. Use history 4. Usage/use information for non

- agricultural uses (e.g., ma terials 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

Next Steps :

After the 60

- da y comment period

, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for the A liphatic A lcohols, C1

- C5 ( e thanol and i sopropyl alcohol) c ase.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

13 of 23 II. Fact Sheet

Background Infor mation : Active Ingredient : Isopropyl alcohol C ase number : 4003 PC Code : 047501 CAS number: 67

- 63

- 0 Technical registrants : There are no technical registrants for isopropyl alcohol First approved for use in a registered product : 1948 There are no EPA established tolerances or exemptions from tolerances for isopropanol; however, there are several FDA established tolerances for isopropanol in modified hop extract (21 CFR 172.560) and in foods for human consumption (21 CFR 173.240)

. Isopr opanol is currently not used as an inert, and does not have any inert based exemptions from the requirement of a tolerance. Antimicrobials Division Chemical Review Manager (CRM) : Wanda Henson

, Henson.Wanda@epa.go v Antimicrobials Division Product Manager (PM) : Marshall Swindell

, Swindell.Marshall@epa.gov Chemical Structure:

Active Ingredient : Ethanol C ase number : 4003 PC Code : 001501 CAS number: 64

- 17

- 5 Technical registrants : H & S Chemicals Division First approved for use in a registered product : 1948 There are EPA established tolerances for ethanol. Ethanol has three inert exemptions from the requirement of a tolerance in 40 CFR 180.910,

- .930, and

- . 940, (USEPA, 2006). Ethanol is listed in 21 CFR 184.1293 as generally recognized as safe (GRAS). Additionally, as defined in 21 CFR 170.3(o)(2), it may be used as an antimicrobial agent on pizza crusts prior to final baking at levels not to exceed 2.0% active by product

. Antimicrobials Division Chemical Review Manager (CRM) : Wanda Henson

, Henson.Wanda@epa.gov Antimicrobials Division Product Manager s (PM ’s ) : Jacqueline Campbell

- Mcfarlane

, Campbell

- McFarlane.Jacqueline@epa.gov and Velman Noble, Noble.Velma@epa.gov Chemical StructureDocket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

14 of 23 Use & Usage Information :
Products containing ethanol are registered for use as a glassware sanitizer in eating establishments and hard non

- porous surface disinfectant and bacteriocide in eating establishments and institutional premises. There are currently 50 registered products containing the active ingredi ent ethanol. End use products containing the chemical ethanol are registered for use as surface disinfectant in use sites such as a gricultural premises and equipment , medical premises and equipment, industrial areas and residential and public access areas. Ethanol is also registered for use in antifouling paints for use on boats bottoms and boat running gear below the water line. End use products

are registered for use in aquatic industrial processes and water systems such as cooling towers as well as pulp and paper mill process water systems. In addition to being registered for use in human drinking water systems, ethanol is also registered for use as an ingredient in products used in pools, hot tubs and spas. In addition, ethanol containing products are a lso registered for use in aquatic areas such as commercial fishery water systems and fish containing lakes, ponds and reservoirs. There are two registered food contact uses for this chemical. One is for the sanitization of food eggs and the other is as

a post harvest treatment for specific fruits and vegetables.

Ethanol also is registered for use as a plant growth regulator (a ripener). There is also a registered use of ethanol with ARCO Ethylene Generators (catalytic generation of ethylene gas) involving , EPA Reg. No. # 58502

- 1, a product that is registered for use as a ripening agent for citrus fruits, pear, avocado, banana, papaya, melons, tomato, flue

- cured tobacco/cigar/cigar wrapping. The receptors in fruits and vegetables absorb free atmosp heric ethylene molecules, and this in turn accelerates the ripening process. Due to the product based conversion of ethanol to ethylene gas, there are no expected exposures to ethanol on the raw agricultural commodity, RAC. It is also conclusive that ther e will not be any residual ethylene gas. Fruits and vegetables produce ethylene gas naturally, and reabsorb the gas to stimulate the production of more ; as this is the process by which ripening occurs. E thanol is converted to ethylene gas, and the gas is pumped into ripening

rooms.
Products containing isopropyl alcohol are registered for use as a glassware sanitizer in eating establishments and hard non

- porous surface disinfectant and bacteriocide in household, commercial and institutional premises. There are currently 31 registered for use active products containing the active ingredient isopropyl alcohol. It is registered for

use in spray, ready to use solution and impregnated wipe forms. End use products containing the chemical isopropyl alcohol are regi stered for use as porous (fabrics, mattresses, etc.) and non

- porous surface disinfectant in use sites such as agricultural premises and equipment, industrial areas and residential and public access areas. It is registered for use in/on medical premises and equipment and veterinary premises as well

as in/ on salon and barber shop areas and utensils. It is registered for use in ultra sonic cleaners and for precleaning of medical instruments prior to disinfection. In addition, isopropyl alcohol containing produ cts are also as a deodorizer in air fresheners. It is also registered for use in retail and institutional food establishments, food processing plants and other health department regulated food facilities.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

15 of 23 Recent/Pending Regulatory Actions :

There are curr ently no pending regulatory actions for isopropyl alcohol.

There are currently 3 new product registration applications pending for ethanol.

Ecological Risk Assessment Status :

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Aliphatic Alcohols, C1

- C5 (Ethanol and Isopropyl Alcohol). , located in the docket, for a detailed discussion of the ecological risk
assessments.

The Aliphatic Alcohols RED and the public literature foun d in the H igh P roduction V olume (HPV) S creening I nformation D ata Set (SIDS) database, state that ethanol and isopropanol are practically non

- toxic to mammals, fish, and aquatic invertebrates. No additional ecological effects studies are anticipated to be needed for these chemicals. The use pattern is restricted to indoor uses, and its use will lead to little, if any, exposure to nontarget organisms. In addition, both alcohols are highly volatile, which supports the conclusion that exposure to terrestrial and aquatic nontarget organisms would be extremely minimal.

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Aliphatic alcohols, C1

- C5 . Please refer to Aliphatic Alcohols, C1

- C5: Human Health Effects Scoping Document for the Registration Review Decision

, located in the docket, for a detailed discussion of the human health risk assessment.

Hazard Characterization :
Ethanol and isopropanol have low acute toxicity (Toxicity Category III or IV).

H uman health risk assessments were not need ed a t the time of the RED because the Agency determined that the toxicological criteria were not triggered and that the exposure and risk from the active ingredients were not significant when compared to the frequent intentional human exposures resulting from non

- pesticidal uses

. Dietary (Food and Water) :
The registered uses of the aliphatic alcohols are not expected to result in contamination of

s urface water or ground water b ased on the antimicrobial use p atterns as well as the rapid volatilization from the treated surface. R esidues of ethanol and isopropyl alcohol, along with byproducts resulting from degradation, are not expected to migrate through wastewater treatment facilities into drinking water or mi grate into residential groundwater wells. In the event that the treated surface is rinsed after pesticidal application and subsequently, the rapid volatilization supports that ethanol and isopropyl alcohol are not expected to be present in the drinking wat er.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

16 of 23 Residential :
Based on frequent intentional human exposures to ethanol and isopropyl alcohol along with the rapid volatilization of the active ingredient s from the treated surfaces, it is not expected that there will be measurable residues available to trigger the need for a residential exposure assessment.

Aggregate :
In examining aggregate exposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non

- occupa tional pesticide exposures. A human health risk assessment is not expected to be necessary for ethanol and isopropyl alcohol registration review; therefore an aggregate assessment would not be appropriate.

Occupational :
Based on frequent intentional human exposures to ethanol and isopropyl alcohol along with the rapid volatilization of the active ingredient from the treated surfaces, it is not expected that there will be measurable residues available to trigger the need for a residential exposure asse ssment.

Cumulative :

EPA does not have, at this time, available data to determine whether ethanol and i sopropyl alcohol ha ve a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purp oses of this Registration Review, EPA has assumed that ethanol and i sopropyl alcohol does not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.

Human Studies:

There has not been any historical reliance on human studies when assessing exposure and risk to the aliphatic alcohols. In the course of registration review, EPA is considering a 21

- day dermal study, Phillips et al. , 1972, in which human volunteers were i nvolved, and results concluded no dermal irritation. EPA will also consider any other research involving intentional exposure of human subjects brought to its attention. If EPA determines that the above intentional exposure human study (or any additional intentional exposure human studies brought to EPA’s attention) are sufficiently sound from a scientific perspective to warrant inclusion in future risk management decisions, EPA will consider the ethical acceptability of the study. Before reaching a final decision to rely on this study, EPA will ensure that all applicable regulatory requirements are met, including but not limited to the requirements for EPA ethics review and Human Studies Review Board review of certain research involving intentional exposur e of human subjects.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

17 of 23 Incidents :
Ecological :

No ethanol ecological incidents have been reported in the Agency’s Ecological Incident Information System (EIIS).

No isopropyl alcohol ecological incidents have been reported in the Agency’s Ecological Incident Information System (EIIS).

Human Health :

No ethanol alcohol human poisoning incidents have been reported in the OPP I ncident Data System (IDS)

.

No isopropyl alcohol human poisoning incidents have been reported in the OPP I n cident Data System (IDS)

.
Tolerances and International Harmonization :
There are no EPA established tolerances or exemptions from tolerances for isopropanol; however, there are several FDA established tolerances for isopropanol in modified hop
extract (21 CFR 172.560) and in foods for human consumption (21 CFR 173.240)

. There are EPA established tolerances for ethanol. Ethanol has three inert exemptions from the requirement of a tolerance in 40 CFR 180.910,

- .930, and

- .940, (USEPA, 2006). Isopropanol is currently not used as an inert, and does not have any inert based exemptions from the requirement of a tolerance.

Ethanol is listed in 21 CFR 184.1293 as generally recognized as safe (GRAS). Additionally, as defined in 21 CFR 170.3(o)(2), it may be used as an antimicrobial agent on pizza crusts prior to final baking at levels not to exceed 2.0% active by product

Data Call

- In Status :

There are currently no Data Call

- Ins for either ethanol or isopropyl alcohol.

Labels :
Registered 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. Product registration labels may be obtained from the Pesticide Product Label System (PPLS) website at : http : //oaspub.epa.gov/pestlabl/ppls.home

.Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

18 of 23 Table 1. Registered Products

– Ethanol

Registration # Registration Name Company Name % of Active Ingredient

211

- 32 PHENO

- CEN SPRAY

DISINFECTANT/DEODORANT CENTRAL SOLUTIONS, INC. 69.623

498

- 134 SPRAYPAK SPRAY

DISINFECTANT FORMULA 2 CHASE PRODUCTS CO 63.2

498

- 179 CHAMPION SPRAYON SPRAY

DISINFECTANT FORMULA 3 CHASE PRODUCTS CO 30.8

498

- 194 SPRAYPAK SPRAY

DISINFECTANT/LUBRICANT CHASE PRODUCTS CO 63.2

498

- 197 SPRAY DISINFECTANT CHASE PRODUCTS CO 63.2

706

- 69 CLAIRE DISINFECTANT

SPRAY CLAIRE MANUFACTURING COMPANY 49.95

777

- 99 BRACE RECKITT BENCKISER LLC. 58

777

- 105 LYSOL BRAND IV I.C.

DISINFECTANT RECKITT BENCKISER LLC. 60.825

1043

- 19 STAPHENE DISINFECTANT

SPRAY AND DEODORIZER STERIS CORPORATION 53.096

1270

- 237 ZEP REFRESH II ZEP INC. 66.825

4313

- 93 OCIDE PLUS CARROLL COMPANY 37

5741

- 22 STERIPHENE II BRAND

DISINFECTANT DEODORANT SPARTAN CHEMICAL COMPANY, INC. 64

5813

- 59 CLOROX DISINFECTING

SPRAY III CLOROX CO., THE 53.088

5813

- 67 CLOROX 409

- R CLOROX CO., THE 65

5813

- 97 BRAC CLOROX CO., THE 58.06

7405

- 51 CHEMI

- CAP HOSP

- I

- SEPTIC G

SURFACE DISINFECTANT DEODORANT CPC AEROSCIENCE, INC. 53.72Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

19 of 23 8284

- 6 BISSELL DISINFECTANT

SPRAY PENN CHAMP 68.5

10088

- 104 MIS

- TERY HOUSEHOLD

DISINFECTANT AND DEODORIZER SPRAY ATHEA LABORATORIES INC 53.46

10088

- 105 C

- SPRAY DISINFECTANT

DEODORANT ATHEA LABORATORIES INC 66

10807

- 177 MISTY II DISINFECTANT &

DEODORANT AMREP, INC 61.348

11525

- 30 DISINFECTANT SPRAY "G" KIK CUSTOM PRODUCTS, INC. 53.088

11694

- 98 MEDAPHENE PLUS

DISINFECTANT DEODORANT ILLINOIS TOOL WORKS, INC. 68

11694

- 99 MEDAPHENE PLUS

DISINFECTANT SPRAY ILLINOIS TOOL WORKS, INC. 68

15136

- 9 WAVICIDE

- 06 PLUS MEDICAL CHEMICAL CORP. 50

33176

- 5 AIRYSOL BRAND SURFACE

DISINFECTANT AMREP, INC. 44.25

33176

- 24 AIRYSOL BRAND SURFACE

DISINFECTANT SPRAY AMREP, INC. 53

37433

- 1 ETHY

- GEN(R) II

CONCENTRATE CATALYTIC GENERATORS, LLC 90

42964

- 17 ASEPTICARE AIRKEM PROFESSIONAL PRODUCTS 62.74

44446

- 67 CONCEPT HOSPITAL

DISINFECTANT DEODORANT QUESTVAPCO CORPORATION 53

46781

- 12 CAVICIDE 1 METREX RESEARCH 7.5

46781

- 13 CAVIWIPES 1 METREX RESEARCH 7.5

47371

- 13 FMB 6075

- 8 QUAT

CONCENTRATED GERMICIDE H & S CHEMICALS DIVISION 12.5

47371

- 16 FMB 4500

- 5 QUAT

CONCENTRATED H & S CHEMICALS DIVISION 10Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

20 of 23

GERMICIDE

47371

- 22 FMB 4500

- 28 QUAT H & S CHEMICALS DIVISION 20

56392

- 2 CITRACE HOSPITAL

GERMICIDAL DEODORIZER CLOROX PROFESSIONAL PRODUCTS COMPANY 66.34

56392

- 4 CITREX HOSPITAL SPRAY

DISINFECTANT CLOROX PROFESSIONAL PRODUCTS COMPANY 69.1

58502

- 1 RIPENER 1 CONCENTRATE AMERICAN RIPENER, LLC 90

67346

- 1 ETHYLENE FLUID PRECISION GENERATORS, LLC 90

67603

- 4 SPRAY DISINFECTANT SHERWIN

- WILLIAMS DIVERSIFIED BRANDS 37

67619

- 3 CPPC SPRAY 1 CLOROX PROFESSIONAL PRODUCTS CO 65

67619

- 21 CARB CLOROX PROFESSIONAL PRODUCTS CO 58.06

68959

- 1 STER

- AHOL VELTEK ASSOCIATES INC. 70

68959

- 3 STER

- AHOL AEROSOL VELTEK ASSOCIATES INC. 70

69658

- 3 NOVIGARD (QUICK DRY) WORLD PHARMACETICALS CORPORATION 98

70467

- 3 BioSURF MICRYLIUM LABORATORIES 70.5

70627

- 1 SPRAY DISINFECTANT HG DIVERSEY, INC. 53.088

70627

- 12 JOHNSON END BAC

PRESSURIZED DISINFECTANT SPRAY DIVERSEY, INC. 62.56

83831

- 1 SURFACE DISINFECTANT

PLUS GERM PRO PRODUCTS 60Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

21 of 23 84368

- 1 URTH PRO URTHTECH, LLC 29.4

87819

- 1 ABLUERE DISINFECTANT

SPRAY JDBJ ASSOCIATES 60

Table 2

. Registered Products

– Isopropyl Alcohol

Registration # Registration Name Company Name % of Active Ingredient

397

- 13 STERI

- FAB NOBLE PINE PRODUCTS CO 60.39

498

- 97 SPATPAK SPRAY

DISINFECTANT FORMULA 1 CHASE PRODUCTS CO 30.8

498

- 180 CHAMPION SPRAYON

DISINFECTANT FORMULA 4 CHASE PRODUCTS CO 55

833

- 3 WYANDOTTE SANIFECT D2 ALEX C. FERGUSSON, INC 50

954

- 10 CLIPPERCIDE SPRAY KING RESEARCH, INC. 45.6

1130

- 15 WEIMAN GERMICIDAL

SOLUTION WEIMAN PRODUCTS, LLC. 21

1130

- 19 WEIMAN DISINFECTING

WIPES WEIMAN PRODUCTS, LLC. 21

1677

- 208 SPIRICLENS SPRAY ECOLAB INC. 70

1677

- 224 PREMIER 70/30 STERILE IPA

SPRAY ECOLAB INC. 70

1839

- 85 AEROSOL SURFACE

DISINFECTANT STEPAN COMPANY 53

1839

- 188 AEROSOL SDAS STEPAN COMPANY 53

5813

- 81 CGW CLOROX CO., THE 1

9480

- 7 SANI

- WIPE PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. 5.48

9688

- 135 CHEMSICO SURFACE

DISINFECTANT CHEMSICO 53

10492

- 4 DISCIDE ULTRA PALMERO HEALTH 63.25Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

22 of 23

DISINFECTING TOWELETTES CARE

10492

- 5 DISCIDE ULTRA

DISINFECTING SPRAY PALMERO HEALTH CARE 63.25

11623

- 24 ENVICIDE II APOLLO INDUSTRIES INCORPORATED 53

46781

- 6 CAVICIDE METREX RESEARCH 17.2

46781

- 8 CAVIWIPES METREX RESEARCH 17.2

46781

- 12 CAVICIDE 1 METREX RESEARCH 15

46781

- 13 CAVIWIPES 1 METREX RESEARCH 15

59894

- 9 KWIKKILL

DISINFECTING/DEODORIZIN G SPRAY/SOLUTION M & S RESEARCH, INC. 41.58

59894

- 10 KWIKKILL DISINFECTANT

DEODORIZING CLEANING WIPES M & S RESEARCH, INC. 41.58

60142

- 1 VIRAHOL VERIDIEN CORPORATION 70

60142

- 3 VIRAHOL HOSPITAL

SURFACE DISINFECTANT TOWELETTE VERIDIEN CORPORATION 70

68959

- 2 DECON

- AHOL VELTEK ASSOCIATES INC. 70

68959

- 4 DECON

- AHOL AEROSOL VELTEK ASSOCIATES INC. 70

70144

- 1 OPTI

- CIDE 3 MICRO

- SCIENTIFIC INDUSTRIES, INC. 21

73232

- 1 ALPET D2 BEST SANITIZERS, INC. 58.6

73232

- 2 ALPET D2 SURFACE

SANITIZING WIPES BEST SANITIZERS, INC. 58.6

73232

- 3 SMART

- SAN D2 BEST SANITIZERS, INC. 58.6Docket Number : EPA

- HQ

- OPP

- 2012

- 0340

www.regulations.gov

23 of 23 III. Summary of Anticipated Data Requirements

– Aliphatic Alcohols, C1

- C5

The Agency does not anticipate needing additional data for use in conducting the registration review for Aliphatic Alcohols, C1

- C5 (ethanol and isopropyl alcohol).