Docket Number: EPA-HQ-OPP-2008-0879

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Table of Contents

1 Introduction............................................................................................................................. 3

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

3 Registration Review Case Closure.......................................................................................... 4
Docket Number: EPA-HQ-OPP-2008-0879

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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 U.S. 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://www2.epa.gov/pesticide-reevaluation.

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 2-

((hydroxymethyl)- amino)ethanol also known as HMAE (case # 3070, PC code 099001) in 

December 2008. The following timeline highlights significant events that have occurred during 

the registration review of HMAE:

 December 19, 2008 – Publication of the HMAE Summary Document, including the 

Preliminary Work Plan and human health and ecological scoping documents in the 

docket (EPA-HQ-OPP-2008-0879) for a 90-day public comment period. During this time 

the agency received one public comment that did not affect the Preliminary Work Plan.

 June 30, 2009 – Publication of the HMAE Final Work Plan and the agency’s response to 

the public comment received during the 90-day comment period on the HMAE Summary 

Document. No modifications were made to the Final Work Plan from the Preliminary 

Work Plan based on the one public comment received.

 May 9, 2012 – Issuance of the HMAE Data Call-In Notice (DCI). After the Data Call-In 

Notice (GDCI-099001-1076) was issued on May 9, 2012 as part of the registration 

review process for HMAE, the sole HMAE registrant informed the agency that it was

requesting to voluntarily cancel its sole HMAE product registration; this was the last 

remaining product registered in the U.S. containing HMAE.

 April 11, 2014 – EPA Published a Notice of Receipt of Requests to Voluntarily Cancel 

Certain Pesticide Registrations in the Federal Register (79 FR 20200) (FRL-9908-81), 

which included, among other products, the only active U.S. registration for HMAE, EPA 

Reg. No. 5383-68, TROYSAN 174P. No comments pertaining to HMAE or TROYSAN 

174P were received during the 180-day comment period.
Docket Number: EPA-HQ-OPP-2008-0879

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 December 17, 2014 – EPA Published the Product Cancellation Order for certain 

pesticide registrations, which included, among other products, the only active U.S. 

registration for HMAE, TROYSAN 174P in the Federal Register (79 FR 75149) (FRL9920-12).

2 Background Information

2-((hydroxymethyl)- amino)ethanol, also known as HMAE, is an antimicrobial formaldehyde 

releasing pesticide that was first registered in April 1975. HMAE was previously registered for use as 

manufacturing in-process preservatives and as in-can preservatives of caulks, sealants, grouts, 

lattices, resin emulsions, adhesives, spackling, ready-mixed wallboard compounds, pigment 

dispersions, joint cements, cutting oils, drilling additives, and ready-mixed cements. All HMAE 

product registrations have been cancelled as discussed below.

After the issuance of the HMAE Data Call-In Notice (GDCI-099001-1076) on May 9, 2012, the 

only technical and end-use product registrant, Troy Chemical Corporation informed the agency 

that it was requesting to voluntarily cancel its sole remaining HMAE product registration (EPA 

Reg. No. 5383-68, TROYSAN 174P). This was the last remaining product containing HMAE as 

an active ingredient registered in the United States. Following publication of a Federal Register 

Notice announcing receipt of the request and the end of the public comment period, the agency 

issued the product cancellation order on December 17, 2014 for the last remaining HMAE 

product registration. Existing stocks provisions included in the cancellation order allow the 

registrant to sell and distribute existing stocks of its HMAE product (EPA Reg. No. 5383-68) 

until December 17, 2015. Persons other than the registrant may continue to sell, distribute, and 

use HMAE 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 HMAE Preliminary Work Plan and Final Work Plan, the agency had intended to 

revise the existing risk assessments for HMAE as part of registration review. However, due to 

the cancellation order issued cancelling all remaining HMAE product registrations in the U.S., 

the agency has found that it is not necessary to complete new risk assessments for HMAE and is, 

therefore, closing the registration review case for HMAE 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 cancellation of the last remaining HMAE product registration became 

effective on December 17, 2014, and it is subject to the existing stocks provision set forth in the 

cancellation order. Hence all of the products in the HMAE case are cancelled.

The existing stocks sales and distribution deadlines included in the December 17, 2014

cancellation order ensure that HMAE sale, distribution, and use will decline and eventually cease 

entirely in the U.S. in the future. During this interim period, the agency believes that existing 

stocks of HMAE products may be used until depleted without causing unreasonable risk to 

human health and the environment.
Docket Number: EPA-HQ-OPP-2008-0879

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Pursuant to 40 CFR § 155.42(c), the agency is closing the registration review case for HMAE, 

thus concluding the HMAE registration review, for the reasons discussed above.