Page 2 of 5 

### 1. Background

On August 16, 2013, the U.S. Environmental Protecti on 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 ingred ient first registered on April 2, 1980, and reregistered in March, 2007. There will be three new products sold under the trade names “1,4PEEP,” “1,4ZAP Technical,” and “1,4ZAP. ” 1-Octanol, or octyl al cohol, 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 m ode of action to the target pest(s). It is a linear saturated aliphatic alcohol containing eight carbons and ha s been previously summarized in the Reregistration Eligibility Decision (RED) for Aliphatic Alcohols, List D, Case No. 4004,

available at: http://www.epa.gov/pesticides/reregis tration/REDs/aliphatic_alcohols_red.pdf . Case 4004 consists of four active ingredients, all classifi ed as straight chain a liphatic alcohols with 6

to 16 carbon atoms in the chain. Three of these active ingredients, 1-octanol, 1-decanol and a mixture of aliphatic alcohols described as “fatty alcohols,” are used as plant growth regulators on tobacco. The fourth, 1-dodecanol (a lso known as lauryl alcohol), is registered as a Lepidopteran pheromone/sex attractant in pear and apple orchards.

1-Octanol functions as a plant growth regulator (PGR) by counter acting 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., intende d for use to inhibit sp routing on stored root and tuber vegetables post-harvest, signify the fi rst pesticide active ingr edient 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 spro uting 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 applic ation, 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 dete rmine 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 com pound 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 fo r 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 comm unicate essential limitations and mitigations that are necessary for public safety. In fact, the pestic ide law has a provision whic h indicates that it is a violation to use a pesticide in a wa y that conflicts with the label.

1 1-Octanol was classified as a biochemical pesticide by EPA’s Office of Pesticide Programs (OPP) Biochemical Classification Committee (BCC) on July 3, 2012.Page 3 of 5 

### 2.1 Assessment of Risk to Human Health

EPA requires a wide range of studies in order to assess a pesticide. Fo r 6 to 16 carbon aliphatic alcohols (case 4004), the database of studies requir ed to support the assessm ent of risk to human health from pesticidal non-food use is comp lete. For 1-octanol in particular, adequate data/information has been received by the Agen cy to support the assessm ent of risk to human

health for the use of th is active ingredient on root and tuber vegetables post-har vest (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 submit ted indicate that 1-octano l is not genotoxic. A developmental toxicity study (subchronic) reve aled increased saliva tion (maternal) at 1,000 milligrams 1-octanol per kilogram body weight (m g/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 half-lif e of this substance and the classification of the pesticid e: a plant growth regulator in tended for use before long-term storage. EPA concludes that 1-octanol ha s no subchronic toxic effects and is not a developmental toxicant. There ar e no known effects of 1-octanol on endocrine systems via oral, dermal, or inhalation routes of exposure. Furt hermore, EPA has not found 1-octanol to share a common mechanism of toxicity with any other substances, and 1-octano l does not appear to produce a toxic metabolite pr oduced by other substances.

Given the low likelihood of adve rse effects on humans, more re fined estimates of acute and chronic dietary risk were not necessary for 1-oc tanol. 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 pesticid e active ingredient on tob acco. Furthermore, human exposure to 1-octanol via dietary exposure to pe sticide-treated commodities, such as root and tuber vegetables, is unlikely. Residues on food comm odities 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 dr inking water is not expected because use of 1- octanol as an active ingredient will be approve d for application indoors only (root and tuber vegetables in storage facilities).

For more information, please refer to the documen t entitled, “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 1-Octanol (M arch 13, 2015),” which can be found in Docket ID EPA-HQ-OPP-2014-0353 (Documen t ID: EPA-HQ-OPP-2014-0353-0003).



### 2.2 Assessment of Ecological Risk

The battery of tests required to assess the envi ronmental fate and ecological effects of 1-octanol is complete. 1-Octanol is volatile and is expected to degrade in the atmosphere by reaction with photochemically-produced hydroxyl radicals and ha s a half-life estimated to be between 3.5Page 4 of 5 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 Alc ohols RED (Case No. 4004), which concluded the following:

 Aliphatic alcohols are categorized as “practic ally non-toxic” to birds on acute oral and dietary bases.

 Acute oral mammalian toxicity da ta indicate that the aliphatic alcohols are “practically

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

 Available toxicity data indi cate that aliphatic alcohols ar e “practically non-toxic” to honey bees and not toxic to te rrestrial 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 suck er control agent. 1-Octanol 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 indica te that the chemical will degrade rapidly.



### 3. Alternatives

1-Octanol can be used alone or alongside currently registered bi ochemical or conventional sprout inhibitors; 1-octanol can be an important compone nt of an Integrated Pest Management (IPM) system. The use of this biochemical sprout inhi bitor is expected to displace and reduce the amount of conventional active ingr edients required for this purpose. Growers may prefer to use

1-octanol as a viable alternative to conventiona l 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 inhib itors generally have tolerances and may result in residues of c oncern 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 ar e naturally-occurring subs tances (or substances structurally-similar and functionally identical to naturally-occurring substanc es) with a history of exposure to humans and the environment demons trating minimal toxicity and a non-toxic mode of action to the target pest(s). Benefits of bi ochemical pesticides as compared to conventional pesticides typically include lower toxicity pr ofiles for humans and non-target organisms, and faster degradation in the environment. As outli ned above, 1-octanol is a viable alternative to conventional sprout inhibitors c ontaining a low toxicity profile and half-life of less than two days.

On January 14, 2015, EPA published in the Federa l Register a Notice of Receipt of three applications for registration of 1-octanol for first food use i ndoors on stored root and tuberPage 5 of 5 vegetables and announced a public comment peri od of 30 days. No comme nts were received in response to this Notice of Receipt.

On August 1, 2014, EPA published a Notice of Fili ng 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-octano l, 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.

EPA announced (in Docket ID: EPA-HQ-OPP- 2014-0885) the proposed decision of the unconditional registration of 1-octanol for use as an indoor sprout inhi bitor on root and tuber crops post-harvest on April 9, 2015, and held a pub lic comment period for 15 days, closing April 23, 2015, at 11:59 pm. The announcement included this draft Decision Document and the draft product labels for “1,4PEEP” (EPA File Sym bol 67727-L), “1,4ZAP Technical” (EPA File Symbol 67727-A), and “1,4ZAP (EPA File Symb ol 67727-T). No comments were received during this public comment period.



### 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 co nsidering the assessed risk to human health and the environment, the Agency concludes that 1-octanol meets the regulatory standard under the Federal Insecticid e, Fungicide and Rode nticide Act (FIFRA). There are no outstanding data requirements for th is biochemical. Therefore, the EPA is granting the unconditional registration of th e 1-octanol first food use under S ection 3(c)(5) of FIFRA.

Three products will be registered. “1,4ZAP Technical” 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” c ontains 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 applic ation rate is up to 10 pounds of active ingredient per 50,000 lbs cr op, which is equivalent to 2 00 ppm on a product to crop basis. Crops may be retreated as necessary for effectiv e control, but applica tion 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-2014-0885-0002).