Docket Number: EPA-HQ-OPP-2007-1039

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Alkyl Amine Hydrochloride 

Notice of Registration Review Case Closure

February 2013
Docket Number: EPA-HQ-OPP-2007·1 039 

www.regulations.gov 

Alkyl Amine Hydrochloride 

Notice of Registration Review Case Closure 

February 2013 

Case Number 3051 

Approved by: 

Susan 

~lb&W)~ Lewis 

Acting Director, Antimicrobials Division 

Date: 

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Docket Number: EPA-HQ-OPP-2007-1039

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Table of Contents

1 Introduction............................................................................................................................. 4

2 Background Information......................................................................................................... 5

3 Registration Review Case Closure.......................................................................................... 5
Docket Number: EPA-HQ-OPP-2007-1039

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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 scientific 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 policies 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 CFR 155.40. The Agency 

will consider benefits information and data as required by FIFRA. The public phase 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 registration review decision. 

Pursuant to 40 CFR Part 155.50, the Agency formally initiated registration review for alkyl 

amine hydrochloride (Case 3051) in December 2007. The following timeline highlights 

significant events that have occurred during the registration review of alkyl amine hydrochloride:

December 12, 2007 – Publication of the alkyl amine hydrochloride Summary Document, 

including the Preliminary Work Plan and human health and ecological scoping 

documents in the docket (EPA-HQ-OPP-2007-1039) for a 90-day public comment 

period. The Agency received one public comment that did not affect the Preliminary 

Work Plan.

June 19, 2008 – Publication of the alkyl amine hydrochloride Final Work Plan and the 

Agency’s response to the public comments received during the 90-day comment period 

on the alkyl amine hydrochloride Summary 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 alkyl amine hydrochloride 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 informed 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 29, 2012 – Published a Notice of Receipt of request to voluntarily cancel certain 

pesticide registrations containing alkyl amine hydrochloride in the Federal Register (77 
Docket Number: EPA-HQ-OPP-2007-1039

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FR 12299) (FRL-9336-2). No comments were received during the 180-day comment 

period.

October 17, 2012 – Published the Product Cancellation Order for certain pesticide 

registrations containing alkyl 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 the 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 

hydrochloride 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 period, 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 included 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 Hydrochloride 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 amine 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 pursuant 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 products 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 stocks sales and distribution deadlines included in the October 17, 2012 cancellation 

order ensure that alkyl amine hydrochloride sale, distribution, and use will decline and 
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eventually cease entirely in the United States in the future. During this interim period, 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.