Docket Number: EPA

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### Table of Contents 1 Introduction

................................ ................................ ................................ ............................. 3 2 Background Information

................................ ................................ ................................ ......... 4 3 Re gistration Review Case Closure

................................ ................................ .......................... 4Docket Number: EPA

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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 a gency) based on scientific d ata 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 p ractices 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 regis tration review program, the a gency 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 a gency 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 a gency 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
a gency ’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 a gency formally initiated registration review for 2

- ((hydroxymethyl)

- amino)ethanol also known as HMAE (c ase # 3070 , PC code 099001 ) in December 200 8

. 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

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- 0879 ) for a 90

- day publ ic comment period. During this time t he a gency received one public comment that did not affect the Preliminary Work Plan.

 June 30 , 200 9

– Publication of the HMAE Final Work Plan and the a gency’s response to the public comment received during the 90

- day comment period on the HMAE S ummary Document

. No modifications were made to the Final Work Plan from the Preliminary Work Plan based on the one public comment received.

 May 9 , 201 2

– Issuance of the HMAE D ata C all

- I n 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 a gency 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 N otice of Receipt of R equest s to Voluntarily Cancel Certain Pesticide R egistrations in the Federal Register (79 FR 20200 ) (FRL

- 9908

- 8 1 ) , 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

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www.regulations.gov

4  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 ) (FRL

9920

- 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, sealan ts, 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 bel ow.
After the issuance of the HMAE D ata C all

- I n Notice (GDCI

- 099001

- 1076 ) on May 9 , 201 2 , the only technical and end

- use product registrant , Troy Chemical Corporation informed the a gency that it was requesting to voluntarily cancel its sole remaining HMAE product registration (EPA R eg . 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 N otice announcing receipt of th e request an d the end of the public comment period, the a gency 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. N o. 5383

- 68 ) until December 17 , 201 5 . Persons other than the registrant may continue to sell, distribute, and
use HMAE products until exhausted, provided that s uch 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 a gency h ad 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 a gency 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 a gency ''will close a registration review case if al l 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 th e 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 a gency 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

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www.regulations.gov

5 Pursuant to 40 CFR § 155.42(c), the a gency is closing t he registration review case for HMAE , thus concluding the HMAE registration review, for the reasons discussed above.