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Docket Number EPA-HQ-OPP-2012-0340

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Table of Contents

Contents

Aliphatic Alcohols, C1-C5.............................................................................................................. 1

I. Introduction.......................................................................................................................... 4

II. Scientific Assessment .......................................................................................................... 6

A. Human Health Assessment .................................................................................................. 6

1. Risk Conclusions ................................................................................................................. 6

2. Human Incidents.................................................................................................................. 6

3. Tolerances............................................................................................................................ 7

4. EPA Not Relying on Human Studies................................................................................... 7

B. Environmental Assessment ....................................................................................................... 7

1. Risk Conclusions ................................................................................................................. 7

2. Ecological Incidents............................................................................................................. 8

C. Endangered Species Assessment................................................................................................ 8

D. Endocrine Disruptor Screening Program................................................................................... 8

III. Proposed Interim Decision................................................................................................... 9

A. Proposed Interim Registration Review Decision................................................................. 9

IV. Next Steps and Timeline...................................................................................................... 9

A. Interim Registration Review Decision................................................................................. 9

B. Implementation of Mitigation Measures............................................................................ 10

C. Recommended Labeling Changes...................................................................................... 10
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I. Introduction

This document is the Environmental Protection Agency’s (EPA or the agency) Proposed Interim 

Registration Review Decision (PID) for aliphatic alcohols, C1-C5 (case 4003, PC codes 001501 

and 047501) and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration 

review decision is the agency's determination whether a pesticide meets, or does not meet, the 

standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The 

agency may issue, when it determines it to be appropriate, an interim registration review decision 

before completing a registration review. Among other things, the interim registration review 

decision may: 1) require new risk mitigation measures, 2) impose interim risk mitigation 

measures, 3) identify data or information required to complete the review, and 4) include 

schedules for submitting the required data, conducting the new risk assessment, and completing 

the registration review. Further information and additional documents on aliphatic alcohols, C1-

C5 can be found in EPA’s public docket (EPA-HQ-OPP-2012-0340) at www.regulations.gov.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the 

continuous review of existing pesticides. All pesticides distributed or sold in the United States

(U.S.) generally must be registered by the EPA based on scientific data showing that they will 

not cause unreasonable risks to human health or to the environment when used as directed on 

product labeling. The registration review program is intended to make sure that, as the ability to 

assess and reduce risk evolves and as policies and practices change, all registered pesticides 

continue to meet the statutory standard of no unreasonable adverse effects. 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 these changes occur, 

products in the marketplace can continue to be used safely. Information on this program is 

provided at http://www2.epa.gov/pesticide-reevaluation. In 2006, the agency implemented the 

registration review program pursuant to FIFRA section 3(g) and will review each registered 

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

registration.

The aliphatic alcohols, C1-C5 case contains two active ingredients: ethanol (PC Code 001501) 

and isopropyl alcohol (PC Code 047501). The Reregistration Eligibility Decision (RED) for 

aliphatic alcohols, C1- C5, was published in 1995. When the aliphatic alcohols, C1-C5,

registration review case was established, it was considered that C1-C5 alcohols were all very 

water-soluble and they were expected to be similar. The remaining alcohol groups, C6-16, 

reregistration case 4004 for which a RED was completed in 2007, will continue to be addressed 

under a separate registration review case, which is anticipated to begin later in 2016.

The first pesticide product containing ethanol was registered in the United States on April 21, 

1948, and it is registered for use as a glassware sanitizer in eating establishments and as a 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 
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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 in products 

used in pools, hot tubs and spas. Ethanol containing products are also 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. 

Products containing ethanol also are 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 avocados, bananas, citrus fruits, kiwifruit, mangoes, melons, papayas, pears, 

persimmons, pineapples, stone fruits (nectarine, peach, and plum), tomatoes, walnuts, and fluecured tobacco/cigar/cigar wrapping. The receptors in fruits and vegetables absorb free 

atmospheric ethylene molecules, and this in turn accelerates the ripening process. 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. 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.

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 as a hard nonporous 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 disinfectants 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 

application as a deodorizer in air fresheners. Products containing it are also registered for use in 

retail and institutional food establishments, food processing plants and other health department 

regulated food facilities.

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for aliphatic 

alcohols, C1-C5 (case 4003). The following timeline highlights significant events that have 

occurred during the registration review of this case:

- July 6, 2012 – Publication of aliphatic alcohols, C1- C5 Summary document, including

the Preliminary Work Plan (PWP), was issued for a 60-day public comment period. 

- December 27, 2012 – Final Work Plan (FWP) for aliphatic alcohols, C1-C5 was posted.

The comments received during the initial public comment period did not affect the data 

needs, work plan and timeline described in the PWP.
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- The FWP noted that no additional data were anticipated to be needed for the aliphatic 

alcohols, C1-C5 registration review because sufficient information was available to 

support a proposed registration review decision. Therefore, no Generic Data Call-In

(GDCI) was needed for this case. 

- Risk Assessment – the agency did not conduct ecological or human health risk 

assessments for aliphatic alcohols, C1-C5. 

- March 2016 – The agency is now publishing the aliphatic alcohols, C1-C5 Proposed 

Interim Registration Review Decision in the docket (EPA-HQ-OPP-2012-0340) for a 60-

day public comment period.

II. Scientific Assessment 

A. Human Health Assessment

A summary of the agency’s human health assessment is presented below. For a

detailed discussion of the human health assessment for aliphatic alcohols, C1-C5, see Aliphatic 

Alcohols, C1-C5: Human Health Effects Scoping Document for the Registration Review Decision

dated April 16, 2012, available in the public docket EPA-HQ-OPP-2012-0340, at 

http://www.regulations.gov/.

1. Risk Conclusions

No human health risk assessment has been performed for aliphatic alcohols, C1-C5. Human 

health risk assessments were not required at the time of the RED in 1995 and registration review 

in 2012 because the agency determined that toxicological criteria were not triggered and that the 

exposure and risk from the active ingredients were not significant when compare to the frequent 

intentional human exposures resulting from non-pesticidal uses. 

The agency does not need to require additional human health data for use in this registration 

review for aliphatic alcohols, C1-C5. 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 and isopropyl alcohol, along with 

byproducts resulting from degradation, are not expected to migrate through wastewater treatment 

facilities into drinking water or residential groundwater wells or to be present in measurable 

amounts in an occupational or residential setting.

2. Human Incidents

There is no human incident information in the agency’s incident data system (IDS) from 1993 to 

February 16, 2016.
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3. Tolerances

There are no EPA established tolerances or exemptions from tolerances identified for isopropyl 

alcohol. Ethanol has three inert exemptions from the requirement of a tolerance in 40 CFR 

180.910, -.930, and -.940. Because of these chemicals’ use patterns, volatility, ready 

biodegradability, and low toxicity, residues are not expected, and therefore, no tolerances or 

exemptions from tolerances for registered uses of ethanol and isopropyl alcohol are necessary.

4. EPA Not Relying on Human Studies

The Human Health Scoping Document noted that EPA was considering a 21-day dermal 

irritation study by Phillips et al.,1972,1 which compares rabbit and human skin response to 

certain irritants and concluded no dermal irritation. However, EPA has decided that this study is 

not needed to make a determination for registration review, and EPA is not relying on this study 

or its resulting data in any regulatory action or determination under FIFRA. Because the agency 

is not relying on the data, EPA is not required to submit this study to the Human Studies Review 

Board (HSRB) for review.

B. Environmental Assessment

A summary of the agency’s environmental fate assessment is presented below. For a detailed 

discussion of the environmental assessment for aliphatic alcohols, C1-C5, see Product 

Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of 

Registration Review of Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl Alcohol) dated May 

31, 2012, available in the public docket EPA-HQ-OPP-2012-0340, at 

http://www.regulations.gov/.

1. Risk Conclusions

Environmental Fate and Exposures. The agency does not need to require additional 

environmental fate data for use in the aliphatic alcohols, C1-C5 registration review case. There is 

sufficient information in the public literature on the fate of aliphatic alcohols in the environment. 

Aliphatic alcohols chemistry is 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.

 

Ecological Assessment. The most recent qualitative ecological risk assessment was performed for 

aliphatic alcohols, C1-C5 in support of the 1995 RED. The agency does not need to require 

additional ecological data and no additional ecological risk assessment was necessary for the 

registration review of aliphatic alcohols, C1-C5. The use patterns (listed above) will lead to little, 

if any, exposure to non-target organisms. In addition, both alcohols are highly volatile, which 

supports the conclusion that exposure to terrestrial and aquatic nontarget organisms would be 

minimal.

 1

Phillips, L., Steinberg, M., Laibach, H.I., Akers, W.A., A comparison of rabbit and human skin response tocertain irritants. Tox. Appl. Pharm. 

1972;21(3):369-382.
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2. Ecological Incidents

For the period from 1993 to February 16, 2016, there is no ecological incident information on the 

aliphatic alcohols, C1-C5, case in the agency’s incident database.

C. Endangered Species Assessment

There is no reasonable expectation for any registered use of aliphatic alcohols, C1-C5 to cause 

direct or indirect adverse effects to threatened and endangered species. No adverse modification 

of critical habitat is expected from the use of aliphatic alcohols, C1-C5. 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, EPA has made a “no effect” determination 

under the Endangered Species Act (ESA) for all listed species and designated critical habitat for 

such species and has therefore concluded that consultation with the Fish and Wildlife Service 

and the National Marine Fisheries Service under ESA section 7(a)(2) is not required.

D. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As required by FFDCA section 408(p), aliphatic alcohols, C1-C5 is 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 and isopropyl 

alcohol are not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. 
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A second list of chemicals identified for EDSP screening was published on June 14, 20132 and 

includes some pesticides scheduled for registration review and chemicals found in water. For 

further information on the status of the EDSP, the policies and procedures, the lists of chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website.3

In this proposed interim decision, EPA is making no human health or environmental safety 

findings associated with the EDSP screening of aliphatic alcohols, C1-C5. Before completing 

this registration review, the agency will make an EDSP FFDCA section 408(p) determination.

III. Proposed Interim Decision

A. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the agency is issuing this proposed 

interim decision document for aliphatic alcohols, C1-C5. EPA’s proposed Registration Review 

Decision determination for aliphatic alcohols, C1-C5, is that the pesticide meets the standard for 

registration under FIFRA. Also, as discussed in the Human Health Scoping Document and 

further in Section IV.C. below, EPA determined that based on the use patterns and chemical 

characteristics, the restrictions on hard surfaces that will contact food are no longer appropriate. 

EPA recommends that any labels that contain this language be amended to delete this language. 

In addition, EPA does not expect aliphatic alcohols, C1-C5, to have direct or indirect adverse 

effects to non-listed and listed species or to adversely modify any designated critical habitat for 

such species and has made a “no effect” determination under the Endangered Species Act (ESA) 

for all listed species and designated critical habitat for such species. This proposed interim 

decision does not cover the EDSP component of the aliphatic alcohols, C1-C5, registration 

review case. The agency is issuing a proposed interim registration pending the evaluation of 

potential endocrine disruptor risk.

IV. Next Steps and Timeline

A. Interim Registration Review Decision

A Federal Register Notice will announce the availability of this proposed decision for aliphatic 

alcohols, C1-C5 and allow a 60-day comment period. If there are no significant comments or 

additional information submitted to the docket during the comment period that leads the agency 

to change its proposed decision, EPA may issue an interim decision for this case. However, a

final decision for aliphatic alcohols, C1-C5 may be issued without having previously issued an 

interim decision. A final registration review decision for the aliphatic alcohols, C1-C5 case will

depend upon the result of an EDSP FFDCA section 408(p) determination. 

 2 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.

3 http://www.epa.gov/endocrine-disruption
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B. Implementation of Mitigation Measures

There are no mitigation measures or required label amendments associated with this Proposed 

Interim Decision.

C. Recommended Labeling Changes

In the RED, the use limitations included:

"Not to allow the product to result in contact with foods/drinks/feeds or surfaces

that they may contact; and to protect foods/drinks/feeds or surfaces during

treatment by removing or covering them. Any contaminated food/drink/feed

contact surfaces should be washed with a suitable cleaning product and rinsed

with potable (drinking) water before using. Treat food/drink/feed processing areas

only when the facility is not in operation."

These use limitations are conflicting as products containing ethanol and isopropyl alcohol are 

registered for use to sanitize or disinfect hard surfaces that will contact food items. Based on 

ethanol and isopropyl alcohol’s use patterns and chemical characteristics, the restrictions are no 

longer appropriate. EPA recommends that any labels that contain this language be amended to 

delete this language.