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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

................................ ................................ ...................... 10Docket Number EPA

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### I. Introduction

This document is the Environmental Protection Agency’s (EPA or the a gency ) Proposed Interim Registration Review Decision (PID) for a liphatic 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 a gency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Inse cticide, Fungicide, and Rodenticide Act (FIFRA). The

a gency may issue, when it determines it to be appropriate, a n interim registration review decision before completing a registration review. Among other things, the interim registration review decision ma y : 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 a liphatic alcohols, C1

- C5 can be found in EPA’s public docket (EPA

- HQ

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- 2012

- 0340 ) at www.regulations.gov

.
FIFRA, as ame nded 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 practice s 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 a gency periodi cally 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 a t http://www2.epa.gov/pes ticide

- reevaluation

. In 2006, the a gency 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 a liphatic a lcohols, C1

- C5 c ase contains two active ingredients: ethanol (PC Code 001501) and isopropyl alcohol (PC Code 047501). The Reregistration Eligibility Decision (R ED) 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

- C 5 alcohols were all very
water

- soluble and they we re expected to be similar. The remaining a lcohol 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 ins titutional 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 re gistered for use in aquatic industrial processes and water systemsDocket Number EPA

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5 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 p roducts 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 e thanol also are registered for use as a plant growth regulator (a ripener). There is also a regist ered 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, pe ar s , persimmons, pineapples, stone fruits (nectarine, peach, and plum), tomato es , walnuts, and 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. Fruits and vegetables produce ethylene gas naturally, and reabsorb the gas to sti mulate 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 estab lishments and as a 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 alcoh ol 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 s in use

s ites 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 salo n 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 fr esheners. 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 registrat ion review for a liphatic 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 a liphatic alcohols, C1

- C5 Summary d ocument , including the Preliminary Work Plan (PWP)

, was issued for a 60

- day public comment period.

- December 27 , 20 12

– Final Work Plan (FWP) for a lipha tic 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.Docket Number EPA

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6 - The FWP noted that no additional data were anticipated to be needed for the aliphatic alcohols

, C1

- C5 registration review because sufficie nt 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 d id not conduct ecological or human health risk
assessment s for a liphatic alcohols

, C1

- C5.

- March 2016

– The agency is now publishing the a liphatic alcohols

, C1

- C5 Proposed Interim Registration Review Decision in the docket ( EPA

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- 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, 201 2 , available in the public docket EPA

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1. Risk Conclusions
No human health risk assessment has been performed for ali phatic alcohols, C1

- C5. Human health risk assessme nts 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 t o 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 alcoho ls, 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

, i t 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 a n 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, 201 6.Docket Number EPA

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7 3. Tolerances There are no EPA established tolerances or exemptions from tolerances ide ntified for isoprop yl 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 expe cted, 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 S coping Document noted that EPA was considering a 21

- day dermal irritatio n 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 a gency 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 a gency’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 Ef fects 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

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1. Risk Conclusions
Envi r onmental 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 w ater 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 asse ssment 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

- C 5. The use pattern s (listed above) will lead to little, if any, exposu re 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.Docket Number EPA

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8 2. Ecological Incident s For the period from 1993 to Februar y 16, 2016 , t here is no ecological incident information on the

a liphatic alcohols, C1

- C5

, case in the agency ’s incident database

.


### C . Endangered Species Assessment

T here 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 et hanol 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 liste d 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 s ection 7(a)(2) is not required.



### D . Endocrine Disruptor Screeni ng 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, sexu al 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 gr oups. 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

a ctive 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 th e 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.Docket Number EPA

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9 A second list of chemicals identified for EDSP screening was published on June 14, 2013 2 and includes some pesticides scheduled for registration review and chemicals found in water. For furt her 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 i n terim 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 Inte rim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the a gency 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 S coping Document and further in Section IV.C. below, EPA determined that b ased 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 dire ct 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 cr itical habitat for such species. This proposed interim decision does not cover the EDSP component of the aliphatic alcohols, C1

- C5

, registration review case. The a gency is issuing a proposed interim registration pending the evaluation of potential endocrin e disruptor risk.



### I V. Next Steps and Timeline

A. Interim Registration Review Decision

A Federal Register N otice will announce the availability of this proposed decision for a liphatic alcohol s , 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 a gency 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 al iphatic 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=E PA

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- 2009

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- 0074 for the final second list of chemicals.

3 http://www.epa.gov/endocrine

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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 include d :

"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 san itize 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 ame nded to delete this language

.