Registration Decision for First Food pse of 1-0ctanol 

Update to the Aliphatic Alcohols 

Reregistration Eligibility Decision (RED), Case 4004 

Approved by: 

Robert McNally, Director 

Biopesticides and 

Pollution Prevention Division 

Date: 

APR 0 1 2015 
1. Background 

On August 16, 2013, the U.S. Environmental Protection Agency ("EPA") received an application 

from D-I-1-4, Inc., a division of 1 ,4-Group, Inc., for the registration of a first food use of 1-

octanol (CAS Number 111-87-5), an old biochemical active ingredient first registered on April2, 

1980, and reregistered in March, 2007. There will be three new pr0duct sold under the trade 

names "1,4PEEP," "1,4ZAP Technical," and " 1,4ZAP." 1-0ctanol, or octyl alcohol, is classified 

as a biochemical pesticide 1 based on its history of exposure to humans and the environment 

demonstrating minimal toxicity and its non-toxic mode of action to the target pest(s). It is a 

linear saturated aliphatic alcohol containing eight carbons and has been previously summarized 

in the Reregistration Eligibility Decision (RED) for Aliphatic Alcohols, List D, Case No. 4004, 

available at: http://www.epa.gov/pesticides/reregistration!REDslaliphatic alcohols red.pdf. Case 

4004 consists of four active ingredients, all classified as straight1:hain aliPhatic alcohols with 6 

to 16 carbon atoms in the chain. Three ofthese active ingredients, "1-octanol, 1-decanol and a 

mixture of aliphatic alcohols described as "fatty alcohols," are l,lsed as plant growth regulators on 

tobacco. The fourth, 1-dodecanol (also known as lauryl alcohol), is egistered as a :Cepidopteran 

pheromone/sex attractant in pear and apple orchards. 

1-0ctanol functions as a plant growth regulator (PGR) by counteracting the effects of ethylene 

(ripening) and thus decreasing suckers in tobacco and sprouting in root and tuber crops. The 

three new products put forth by D-I-1-4, Inc., intended for use to inhibit sprouting on stored root 

and tuber vegetables post-harvest, signify the frrst pesticide active r"ligredient food-use for an 

aliphatic alcohol. D-I-1-4, Inc., has requested that 40 CFR part 180 be amended by establishing 

an exemption from the requirement of a tolerance for residues of 1-octanol applied post-harvest 

to stored potatoes and other sprouting root and tuber crops. A copy of the petition is available in 

Docket ID EPA-HQ-OPP-2014-0353 via http://www.regulations.gov. 

2. Evaluation 

- In evaluating a pesticide registration application, the EPA assesses a wide variety of 

environmental fate (i.e., how the chemical will move in the environment) and toxicity studies 

(i.e., effects on non-target organisms) to determine the likelihood of adverse effects (i.e., risk) 

from exposures associated with the proposed use of the product. Risk assessments are developed 

to evaluate the environmental fate of the compound as well as how it might affect a wide range 

of non-target organisms including humans, terrestrial and aquatic wildlife (plants and animals), 

On the basis of these assessments, EPA evaluates and approves language for each pesticide label 

to ensure the directions for use and safety measures are appropriate to mitigate any potential risk. 

In this way, the pesticide's label helps to communicate essential limitations and mitigations that 

are necessary for public safety. In fact, the pesticide law has a provision which indicates that it is 

a violation to use a pesticide in a way that conflicts with the label. 

1 1-0ctanol was classified as a biochemical pesticide by EPA's Office ofPesticide Programs (OPP) Biochemical 

Classification Committee (BCC) on July 3, 2012. 

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2.1 Assessment of Risk to Human Health 

EPA requires a wide range of studies in order to assess a pesticide. For 6 to 16 carbon aliphatic 

alcohols (case 4004 ), the database of studies required to support the assessment of risk to human 

health from pesticidal non-food use is complete. For 1-octanol in particular, adequate 

data/information has been received by the Agency to support the assessment of risk to human 

health for the use of this active ingredient on root and tuber vegetables post-harvest (first fooduse). 

The acute toxicity for 1-octanol is low for all routes of exposure (oral, dermal, inhalation), with 

the exception of eye irritation (moderately to severely irritating). The labeling precautionary 

signal word is "CAUTION." . 

The evaluation of the data and information submitted indicate that 1-octanol is not genotoxic. A 

developmental toxicity study (subchronic) revealed increased salivation (maternal) at 1,000 

milligrams 1-octanol per kilogram body weight (mg{kg); however, the Agency does not consider 

this to be an adverse effect because the effect occurs at a very high dose, a much higher dose 

than the level at which humans are likely to be exposed, given-the 1ihlf-life of this substance and 

the classification of the pesticide: a plant growth regulator intended for use before long-term 

storage. EPA concludes that l-octanol has no subchronic toxic effects and is not a 

developmental toxicant. There are no known effects of 1-octanol on endocrine systems via oral, 

dermal, or inhalation routes of exposure. Furthermore, EPA has not found 1-octanol to share a 

common mechanism of toxicity with any other substances, and 1-octanol does not appear to 

produce a toxic metabolite produced by other substances. 

Given the low likelihoed of adverse effects on humans, more refined estimates of acute and 

chronic dietary risk were not ~ecessary for 1-octanol. Humans are currently exposed to 1-octanol 

through its natural occurrence in certain foods, its use as a food additive, its use as a pesticide 

inert ingredient~ .. and from its use as a pesticide active ingredient on tobacco. Furthermore, human 

exposure to 1-octanol via dietary exposure to pesticide-treated commodities, such as root and 

tuber vegetables, is unlikely. Residues. on food commodities are not anticipated as the half-life of 

1-octanol is estimated to be from 3.5 minutes to 1.3 days. The chemical is volatile and is 

expected to degrade in the atmosphere by reaction with photochemically-produced hydroxyl 

radicals. Exposure of humans to 1-octanol in drinking water is not expected because use of 1-

octanol as an active ingredient will be approved for application indoors only (root and tuber 

vegetables in storage facilities). 

For more information, please refer to the document entitled, "Federal Food, Drug, and Cosmetic 

Act (FFDCA) Considerations for 1-0ctanol (March 13, 2015)," which can be found in Docket 

ID EPA-HQ-OPP-2014-0353 ·(Document ID: EPA-HQ-OPP-2014-0353-0003). 

2.2 Assessment of Ecological Risk 

The battery of tests required to assess the environmental fate and ecological effects of 1-octanol 

is complete. 1-0ctanol is volatile and is expected to degrade in the atmosphere by reaction with 

photochemically-produced hydroxyl radicals and has a half-life estimated to be between 3.5 

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minutes and 1.3 days. Similar to the Human Health risk assessment, no refinements were needed 

to the non-target risk assessment developed in the Aliphatic Alcohols RED (Case No. 4004), 

which concluded the following: 

• Aliphatic alcohols are categorized as "practically non-toxic" to birds on acute oral and 

dietary bases. 

• Acute oral mammalian toxicity data indicate that the aliphatic alcohols are "practically 

non-toxic" to mammals on an acute oral basis. 

• Available toxicity data indicate that aliphatic alcohols are "practically non-toxic" to 

honey bees and not toxic to terrestrial plant species. 

• Previously submitted data and open literature studies suggest that the aliphatic alcohols 

are "slightly" to "moderately" toxic to freshwater fish. 

The new use of 1-octanol indoors does not present an increased ecological risk to the already 

registered use as a tobacco sucker control agent. 1-0ctanol will be applied in indoor storage 

facilities. Once applied, if 1-octanol is released into the outside air via ventilation systems, 

environmental fate data and information indicate that the chemical will degrade rapidly. 

3. Alternatives 

1-0ctanol can be used alone or alongside currently registered biochemical or conventional sprout 

inhibitors; 1-octanol can be an important component of an Integrated Pest Management (IPM) 

system. The use of this biochemical sprout inhibitor is expected to displace and reduce the 

amount of conventional active ingredients required for this purpose. Growers may prefer to use 

1-octanol as a viable alternative to conventional sprout inhibitors because 1-octanol has an 

established exemption from the requirement of a tolerance (no limitations) for stored root and 

tuber crops, indicating that it is safe. Conventional sprout inhibitors generally have tolerances 

and may result in residues of concern on root and tuber crops. 

4. Benefits and Public Comments 

By definition alone, biochemicals are favorable when compared to currently registered 

conventional alternatives because biochemicals are naturally-occurring substances (or substances 

structurally-similar and functionally identical to naturally-occurring substances) with a history of 

exposure to humans and the environment demonstrating minimal toxicity and a non-toxic mode 

of action to the target pest(s). Benefits of biochemical pesticides as compared to conventional 

pesticides typically include lower toxicity profiles for humans and non-target organisms, and 

faster degradation in the environment. As outlined above, 1-octanol is a viable alternative to 

conventional sprout inhibitors containing a low toxicity profile and half-life of less than two 

days. 

On January 14, 2015, EPA published a Notice of Receipt in the Federal Register ofthree 

applications for registration of 1-octanol for first food use indoors on stored root and tuber 

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vegetables and announced a public comment period of 30 days. No comments were received in 

response to this Notice of Receipt. 

On August 1, 2014, EPA published a Notice of Filing in the Federal Register announcing the 

receipt of the initial filing of the 1-octanol petition by D-I-1-4, Inc., under the Federal Food, 

Drug and Cosmetic Act (FFDCA) requesting the establishment of an exemption from the 

requirement of a tolerance for residues of 1-octanol, applied post-harvest to stored potatoes and 

other sprouting root and tuber crops. This publication also announced a public comment period 

of 30 days; no comments were received on the FFDCA Notice of Filing 

5. Regulatory Decision 

The aliphatic alcohol database is comprised of 680 studies and is considered>to be complete. The 

proposed food use of 1-octanol is well supported by this database. In considering the assessed 

risk to human health and the environment, the Agency concludes that 1-octanol meets the 

regulatory standard under the Federal Insecticide, 'Fungicide and Rodenticide Act (FIFRA). 

There are no outstanding data requirements for this biochemical. Therefore, the EPA is granting 

the unconditional registration of the 1-octanol first food use under Section 3(c)(5) ofFIFRA. 

Three products will be registered. "1,4ZAP Teehnical" is a manufacturing-use product; 

"1,4PEEP" and "1,4ZAP are end-use products (EPs). "1 ,4ZAP Technical" and "1,4ZAP" contain 

1-octanol as their sole active ingredient. "1 ,4PEEP" contains the active ingredient 1,4-

dimethylnapththalene in addition to 1-octanol. Application of these products can be made any 

time after the crop is placed in an indoor storage area. The application rate is up to 10 pounds of 

active ingredient per 50,000 lbs crop, which is equivalent to 200 ppm on a product to crop basis. 

Crops may be retreated as necessary for effective control, but application must not exceed 800 

ppm during the storage season. 

The risk assessment supporting this decision can be found in the regulatory docket (Document 

ID: EPA-HQ-OPP-2.014-0885-0002). 

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