# 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 20151. Background On August 16, 2013, the U.S. Environmental Protection A g ency ("EPA") received an application from D-I-1-4, Inc., a division of 1 ,4-Group, Inc., for the re g istration of a first food use of 1- octanol (CAS Number 111-87-5), an old biochemical activ e 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 oc tyl alcohol, is classified as a biochemical pesticide 1 based on its history of exposur e to humans and the environment demonstrating minimal toxicity and its non-toxic mode of action to th e t arget pest(s). It is a linear saturated aliphatic alcohol containing eight carbons and has been previously summarized in the Reregistrat i on Eligibility Decision (RED) for Alipha tic Al co hols, Li st 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 s traight 1: hain aliPh atic alcohols with 6 to 16 carbon atoms in the chain. Three ofthese acti ve i ngredients, "1-octanol, 1- dec anol and a mixture of alipha ti c alcohols described as "fatty alcohols, " are l,lse d as plant growt h re gulators on tobacco. The fourth, 1-dodecanol (also known as laury l a l cohol), is egistered as a :Cepidopteran pheromone / sex attractant in pear and apple orchards.

1-0ctanol functions as a plan t growth regu lator (PGR) by counteract ing the effects of e t hylene (ripening) and thus decreasing suckers in to bacco and sprouting in root and tuber crops. The three new products put forth by D-I-1-4, Inc., i ntended for use to i nhibit sprouting on stored root

and tuber vegetables post-harvest , signi fy the f rrst pesticide active r "li gredient food-use for an aliphatic alcohol. D - I-1-4, Inc., has requested t hat 40 CF R part 180 be amended by establishing an exemption from the requirement o f a toleran ce for res id u es of 1-octanol applied post-harvest to stored potatoes an d other sprouting root and tub er cro ps. A copy of the petition is available in Docket ID E PA-HQ-OP P - 2014-035 3 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 t he 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 wi t h the proposed use of the product. Risk assessments are developed to evaluate the environmental fate of the compound as well as how it m i ght affect a wide range of non-target organisms including humans, terrestr i al 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 ha s a p r ovision 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 of P est icide Program s (OPP) Biochemical Classificati o n Committee (BCC) on July 3, 2012. P age 2 of5

### 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 ofrisk 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 ofrisk 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 indicat e that 1-octanol is not genotoxic
. A developmenta l toxicity study (subchronic) revealed increased salivation (matern al) at 1 ,000 milligrams 1-octanol per kilogram body weight (mg{k g); however, the Agency does not consider this to be an adverse effect because the effect occ urs at a very high dose, a much higher dose than the level at which humans are likely to be exposed, given -the 1i hlf

-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 to xic effects and is not a developmental toxicant. There are no known ef fects of 1

-octanol on endocrine systems via oral, dermal , or inhalation routes ofexposure . Furthermore, EPA has not found 1

- octanol to share a common mechanism of toxicity with any oth er 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 ofacute and chronic dietary risk were not**~ecessar y**  for 1-octanol. Humans are currently exposed to 1-octanol through its natural occur rence in ce rtain 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 pest icide

-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 ofhumans 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-H Q

-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 Page 3 ofSminutes and 1.3 days. Similar to the H uman Health risk assessment , no refinements were needed to the non-target r i s k assessment developed in the Aliphatic Alcohols RED (Case No . 4004) , which co n cluded the following:

• Aliphatic alcoho l s are categorized as " practica ll y non - toxic" to birds on acute oral and dietary bases. • Acute oral mammalian toxicity data indicate that the aliphatic alcoho l s are "practically non - toxic " to mammals on an acute oral b as is. • Available toxicity data indicate that a l iphatic alcohols are " pr actica ll y non-toxic " to honey bees and not toxic to terrestria l plant species. • P r eviously submitted data and open literature studies su gges t th at the aliphatic alcohols a r e "slightly " to " moderately" toxic to freshwater fis h . The new u se of 1-octanol indoors does not present an in cr eased eco l ogical r i sk to the a l ready registered use as a tobacco sucker control agent. 1-0 ct anol will be applied in i nd o or storage

facilities. Once applied , if 1-octanol is released int o th e outside ai r via ventilation syste ms , environmental fate data and information indicate that the chemical wi ll degrade rap i dly. 3. Alternatives

1 -0ctano l can be used a l one or a l ongside currently r eg i ste r ed b ioch e mical or co n ve n t i ona l sprout inhibito r s; 1 - octano l can be an important comp onent of an Inte grated Pest Management (IPM) system. The use of thi s b i och emi cal sprout inhibi to r is expec t e d to disp l ace and reduce t h e amount of conventional ac t ive i n gred ients requir e d for this purpose. Growers may prefer to use 1-octano l as a viable alternative to co nventional sprout i nhibitors becau s e 1-octanol has an established exemption from the req uirement of a to leran ce (no limitation s ) for stored root and tuber crops , indicatin g tha t it is saf e . Conve n tiona l s p rout inhibitors generally have tolerances

and may resu lt in residues of conce rn on root and tuber crops.

4. Benefits and Public Comments By definitio n alone , biochemical s are favo r able when com p ared to currently registered conventional a l ternatives beca use biochemicals are naturally

- occurring s ubstances (o r substance s s tructurally

- simila r and functi onally identica l t o naturally-occurring substances) with a history of exposure to humans and the environment demon s trating minimal toxicity and a non-toxic mod e of action to the target pest(s). Benefits of biochemical pesticides as compared to conventional pest i c i des typica ll y include lowe r toxicity profiles for humans and n on-target organisms, and faster deg r a d ation in the environment. As outlined above, 1 -octano l i s a viab l e alte rn at i ve to conventional sprout inhibitors containing a low toxicity profi l e and ha l f-life of less than two days. On January 14 , 2015 , EPA published a N otice of Receipt in the Federal Register ofthree applications for registration o f 1-octanol for fir s t food use indoors on s tored root and tuber Page 4 of5vegetables 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 ofFiling in the Federal Register announcing the receipt ofthe 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 ofa tolerance for residues of 1-octanol, applied post-harvest to stored potatoes and other sprouting root and t uber crops. This publication also announced a public comment period of 30 days; no comments were received on the FFDCA Notice ofFiling 

### 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 cons idering 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 ofthe 1-octanol first food use under Section 3(c)(5) ofFIFRA. Three products will be registered. "1,4ZAP Teehnical" is a manufa cturing-use product; "1,4PEEP" and "1,4ZAP are end-use products (EPs). "1 ,4ZAP Technica l" and "1,4ZAP" contain 1-octanol as their sole active ingredient. "1 ,4PEEP" contains the active ingredient 1,4- dimethylnapththalene in addition to 1-octan ol. Application ofthese 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 support ing 

### this decision can be found in the regulatory docket (Document ID: EPA-HQ-OPP-2.014-08 85-0002)
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