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## Alkyl Amine Hydrochloride Notice of Registration Review Case Closure

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## Alkyl Amine Hydrochloride Notice of Registration Review Case Closure February 2013

Case Number 3051

Approved by:

# ~lb&W)~ Susan Lewis Acting Director, Antimicrobials Division

Date:

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### Table of Contents 1 Introduction

................................ ................................ ................................ ............................. 4 2 Background Information

................................ ................................ ................................ ......... 5 3 Registration Review Case Closure

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## 1 Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency) based on sci entific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as polic ies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. 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 change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 CF R 155.40. The Agency will consider benefits information and data as required by FIFRA. The public pha se of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a r egistration review decision.

Pursuant to 40 CFR Part 155.50, the Agency formally initiated registration review for a lkyl amine hydrochloride (Case 3051) in December 2007

. The following timeline highlights significant events that have occurred during th e registration review of a lkyl amine hydrochloride :

December 12 , 2007

– Publication of the a lkyl amine hydrochloride Summary Document

, including the P reliminary W ork P lan and human health and ecological scoping documents in the docket (EPA

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- day public comment period. The Agency received one public comment that did not affect the Preliminary Work Plan. June 19 , 200 8

– Publication of the a lkyl amine hydrochloride Final Work Plan and the Agency’s response to the public comments receiv ed during the 90

- day comment period on the a lkyl amine hydrochloride S ummary Document

. No modifications were made to the Final Work Plan from the Preliminary Work Plan based on the public comments received. August 17, 2011

– Issuance of the a lkyl amine hyd rochloride data call

- in (DCI). After the Data Call

- In (GDCI

- 069152

- 1010) was issued on August 17, 2011 as part of the registration review process for alkyl amine hydrochloride, the technical and end

- use product registrant International Specialty Products i nformed the Agency that they were requesting to voluntarily cancel all of their alkyl amine hydrochloride product registrations. These were the last remaining products registered in the U.S. containing alkyl amine hydrochloride. February 2 9 , 2012

– Publish ed a Notice of Receipt of request to voluntarily cancel certain pesticide registrations containing alkyl amine hydrochloride in the Federal Register (77Docket Number: EPA

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5 FR 12299) (FRL

- 9336

- 2)

. No comments were received during the 18 0

- day comment period. October 17, 2012

– Published the P roduct C ancellation O rder for certain pesticide registrations containing a lkyl amine hydrochloride in the Federal Register (77 FR 63829) (FRL

- 9365

- 9).


## 2 Background Information

Alkyl amine hydrochloride (derived from fatty acids of coconut oil) is an antimicrobial pesticide which was previously registered for material preservative use, but for which all registrations have been cancelled as discussed below.

After the issuance of t he alkyl amine hydrochloride data call

- in (GDCI

- 069152

- 1010) on August 17, 2011, the sole technical and end

- use product registrant International Specialty Products informed the Agency that it was requesting to voluntarily cancel all of its alkyl amine hydr ochloride product registrations. These were the last remaining products registered in the U.S. containing alkyl amine hydrochloride. Following publication of a Federal Register notice announcing receipt of those requests and the end of the public comment p eriod, the Agency issued the product cancellation order on October 17, 2012 for all alkyl amine hydrochloride product registrations. (Copies of those notices are included in the docket for this registration review.) Existing stocks provisions include d in the order allow the registrant to sell and distribute alkyl amine hydrochloride products (EPA Reg. Nos. 1529

- 29 and 1529

- 30) until October 17, 2013. Persons other than the registrant may continue to sell, distribute, and use alkyl amine hydrochloride products until exhausted, provided that such sale, distribution, and use is consistent with the terms of the previously approved labeling on, or that accompanied, the cancelled products.


## 3 Registration Review Case Closure

As stated in the Alkyl Amine Hydroch loride Preliminary Work Plan and Final Work Plan , the Agency had intended to revise the existing risk assessments for alkyl amine hydrochloride as part of registration review. However, due to the cancellation order issued affecting all remaining alkyl amin e hydrochloride product registrations in the United States, the Agency has found that it is not necessary to complete new risk assessments for alkyl amine hydrochloride and is, therefore, closing the registration review case for alkyl amine hydrochloride p ursuant to 40 CFR § 155.42(c), which provides that the Agency ''will close a registration review case if all products in the case are cancelled. " The voluntary cancellations of the last remaining alkyl amine hydrochloride product registrations became effective on October 17, 2012, and hence all of the products in the alkyl amine hydrochloride case are cancelled. The effective date for the end of the existing stocks provision included in the cancellation order for the last alkyl amine hydrochloride prod ucts registered for use in the U.S. is October 17, 2013.

The Agency does not expect the current risks associated with alkyl amine hydrochloride use to differ from those identified during the alkyl amine hydrochloride reregistration process. The existing st ocks sales and distribution deadlines included in the October 17, 2012 cancellation order ensure that alkyl amine hydrochloride sale, distribution, and use will decline andDocket Number: EPA

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6 eventually cease entirely in the United States in the future. During this interim p eriod, the Agency believes that existing stocks of alkyl amine hydrochloride products may be used until depleted without causing unreasonable risk to human health and the environment.

Pursuant to 40 CFR § 155.42(c), the Agency is closing the registration review case for alkyl amine hydrochloride, thus concluding the alkyl amine hydrochloride registration review, for the

reasons discussed above.