United States Chemical Safety December 2012 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Aliphatic Alcohols, C1-C5 

Registration Review: 

Final Work Plan 

December 2012 

 

Docket Number: EPA-HQ-OPP-2012-0340 

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Aliphatic Alcohols, C1-C5 Registration Review Team

Human Health & Environmental Effects

Jonathan Chen 

Steven Malish 

Srinivas Gowda 

David Bays 

James Breithaupt 

Risk Management

Wanda Henson 

Lance Wormell 

Office of General Counsel

Philip Ross 

________________________________________ 

Supporting documents for the Aliphatic Alcohols, C1-C5 Case may be found in the registration 

review docket EPA-HQ-OPP-2012-0340 located on the internet at 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 Aliphatic alcohols, C1-C5 (Case 4003). 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 Aliphatic alcohols, C1-C5 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 Aliphatic Alcohols, C1-C5 Case contains two active ingredients: ethanol (PC Code 001501) 

and isopropyl alcohol (PC Code 047501). The Preliminary Work Plan was published on July 6, 

2012 and the 60-day comment period ended on September 10, 2012. The Preliminary Work Plan 

document is available on www.regulations.gov docket number EPA-HQ-OPP-2012-0340. 

The 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-porous surface 

disinfectant and bacteriocide in eating establishments and institutional premises. There are 

currently 51 registered active products containing the active ingredient ethanol. End use products 

containing the chemical ethanol are registered for use as surface disinfectants in use sites such as 

agricultural 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 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. 

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 atmospheric ethylene molecules, and this in turn 
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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 stimulate the production of more; as this is the process by which ripening 

occurs. Ethanol is converted to ethylene gas, and the gas is pumped into ripening rooms. 

The first product containing isopropyl alcohol (isopropanol) 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 32 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.) and 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 and veterinary premises as well as in/on salon and barber shop areas and 

utensils as well as ultra sonic cleaners and for pre-cleaning of medical instruments prior to 

disinfection. In addition, isopropyl alcohol containing products are also used in non-pesticidal 

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 tolerances 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 exemptions 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 rubbing 

alcohol. 

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 weight. 

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

C5, in 1995. When the aliphatic alcohols, C1-C5 (ethanol andisopropyl alcohol) registration 

review case was established, 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 

registration review case. 

Comments Received on the Preliminary Work Plan

The Agency received one comment 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. 
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Comment: 

Delta Analytical believes that EPA has approved isopropyl alcohol (IPA) as an inert ingredient in 

products at percentages much higher than the 30% and 5% (for quat products) and requests that 

EPA review and provide an explanation of the percentages in this paragraph. Delta Analytical 

questions whether the percentages listed for IPA as an active ingredient or an inert ingredient are 

current and requests information on the supporting scientific rationale. Information received 

from an EPA reviewer stated that below 50% isopropanol in quaternary ammonium compound 

products is an inert ingredient. Therefore, are ethanol and isopropyl alcohol when present in 

quaternary ammonium compound products at percentages greater than 50% are considered to be 

active ingredients? 

Response: 

The percentages listed for isopropyl alcohol as an active or an inert ingredient are current as 

written in the Preliminary Work Plan and support documents. As stated in the 1995 aliphatic 

alcohols RED, inert ingredient determinations are made on a case-by-case basis. While the 1995 

RED provides some general information on aliphatic alcohols, each product is individually 

assessed. Normally the applicant submitting the registration application will make the initial 

determination on whether an ingredient in the product is active or inert. The Agency, as a part of 

its review, will then determine whether the ingredient by itself has the capability to function as a 

pesticide, whether the ingredient has the ability to enhance a pesticide effect in another 

compound whose pesticidal activity may be substantiality increased due to the interaction of the 

compounds, or whether the substance is indeed an inert ingredient. Additional factors including 

the concentration (dosage, intensity) of the agent, the mode of action of the agent, contact time, 

the number of microorganisms, the nature of the microorganisms in the population, the presence 

of solvents, interfering organic matter and inhibition may also factor into EPA’s determination. 

If the Agency’s initial evaluation is inconclusive as to whether an ingredient is active or inert, the 

Agency will ask the company to submit efficacy data with and without the ingredient in question. 

At that point, the efficacy data will determine the classification of the ingredient. The Agency is 

open to answering additional questions regarding classification of active ingredients and inerts 

and encourages the registrant to contact the EPA Product Manager with additional questions as 

appropriate. 

The comments 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 Aliphatic alcohols, C1-C5 

registration review process. 

Risk Assessments and Anticipated Data Needs

The Agency will not conduct an ecological risk assessment. The Agency will not conduct a 

human health risk assessment. The Agency will not require additional data for use in conducting 

the registration review for Ethanol and Isopropanol. 
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Ecological Risk Assessment Status and Anticipated Data Needs

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

C1-C5 (ethanol and isopropyl alcohol) in support of the 1995 RED. 

 The Agency does not anticipate the need to require additional ecological data for use in 

registration review for aliphatic alcohols, C1-C5 (ethanol and isopropyl alcohol) Case 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 for 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 stable 

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. 

For 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). EPA-HQ-OPP-2012-0340, located in the docket. 

Human Health Risk Assessment Status and Anticipated Data Needs

 No human health risk assessment has been performed for aliphatic alcohols, C1-C5 (ethanol 

and isopropyl alcohol). Human health risk assessments were not needed at 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 significant 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 

this registration review for aliphatic alcohols, C1-C5 (ethanol and isopropyl alcohol) at this 

time. 

 Dietary Assessment

 The registered uses of the aliphatic alcohols, C1-C5, are not expected to result in 

contamination of surface water or ground water. Based on the antimicrobial use patterns of 

these chemicals as well as the fate property of rapid volatilization from the treated surface. It 

has been determined that residues of ethanol, along with byproducts resulting from 

degradation, are not expected to migrate through wastewater treatment facilities into drinking 

water or migrate into residential groundwater wells. In the event that the treated surface is 

rinsed after pesticidal application and subsequently, the rapid volatilization supports that 

ethanol is not expected to be present in the drinking water. 
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Tolerances and International Harmonization

 There are no EPA established tolerances 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 exemptions from the requirement of a tolerance in 40 CFR 

180.910, -.930, and -.940. Both ethanol and isopropanol also have a wide range of nonpesticidal uses. For example, ethanol is contained in some beverages, and isopropanol is the 

major ingredient in rubbing alcohol. 

 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 weight. 

Occupational and Residential Assessment and Risk

 Based on frequent intentional human exposures to ethanol 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 assessment. 

 Based on frequent intentional human exposures to 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 

assessment. 

Aggregate and Cumulative Exposure and Risk

 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-occupational pesticide exposures. An aggregate risk assessment has not been deemed 

necessary for ethanol and isopropyl alcohol because a human health risk assessment is not 

required. 

EPA does not have, at this time, available data to determine whether ethanol has a common 

mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk 

assessment. 

 For the purposes of this Registration Review, EPA has assumed that isopropyl alcohol does 

not have a common mechanism of toxicity with other substances when used as an 

antimicrobial as registered. 

Human Health Anticipated Data Needs

 The Agency does not anticipate the need to require additional human health data for the 

registration review at this time. 

For more information, please refer to Aliphatic Alcohols, C1-C5: Human Health Effects Scoping 

Document for the Registration Review Decision, located in the docket. 
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Product Chemistry Anticipated Data Needs

 The Agency does not anticipate the need to require additional product chemistry data for the 

registration review at this time. 

For 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. 

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 Incident Data 

System (IDS). 

 No isopropyl alcohol human poisoning incidents have been reported in the OPP Incident 

Data System (IDS).

Endangered Species 

EPA has made a “No Effect” determination for endangered species for ethanol and isopropyl 

alcohol and further environmental risk assessments will not be conducted unless public 

comments or other submissions provide new information or data that warrant such assessment. 

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 has 

determined 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 Service (USFWS) and the National Oceanic and 

Atmospheric Administration (NOAA). As a result, no further risk assessment is anticipated 

unless new information warrants such action. 

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, 
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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 sensitive 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), aliphatic alcohols, C1-C5 (ethanol 

and isopropyl alcohol) are subject to the endocrine screening part of the Endocrine 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 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. Ethanol was included on 

that list and has been issued an order to conduct the Tier 1 testing. Once all required Tier 1 and 

Tier 2 data have been received and reviewed, the endpoints and safety factors used for risk 

assessment purposes will be examined and a new risk assessment performed if necessary. 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 Aliphatic alcohols, 

C1-C5 registration review: 

Anticipated Schedule1

Activities Estimated Month/Year

Phase 1: Opening the docket 

Open Public Comment Period for Docket Completed 

July 2012

Close Public Comment Period for Docket Completed 

September 2012 

Phase 2: Case Development 

Develop Final Work Plan (FWP) Completed 

December 2012 

Issue DCI N/A 
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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 2013 

Close Public Comment Period for Proposed Reg. Review Decision February 2013 

Final Decision and Begin Post-Decision Follow-up June 2014 

Total (years) 2 

Next Steps

EPA will complete a proposed registration review decision for - Aliphatic Alcohols, C1-C5 

(Case 4003), to be issued in Fiscal Year 2013.

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.