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Response to Comments on the 

Proposed Ethylene Glycol Ethers (Glymes) Significant New Use Rule (SNUR) 

RIN 2070-AJ52

Prepared by the Existing Chemicals Branch,

Office of Pollution Prevention and Toxics,

Office of Chemical Safety and Pollution Prevention

U.S. Environmental Protection Agency

November 2014
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Table of Contents

A. Introduction

B. Scope of the Rule

C. Ongoing Uses

D. General Clarifications

E. Economic Issues

References
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A. Introduction

This document contains a summary of the comments received by EPA in response to the 

TSCA section 5(a)(2) proposed Significant New Use Rule (SNUR) entitled “Glymes; Proposed 

Significant New Use Rule” (76 FR 133, July 12, 2011) along with EPA’s responses to those 

comments. The proposed rule and comments are available in EPA’s public docket and e-docket 

for the final test rule under Docket No. EPA–HQ–OPPT–2009-0767. EPA received comments 

from industry, including: 

 The Alliance of Automobile Manufacturers 

 American Coatings Association 

 American Chemistry Council 

 The Boeing Company 

 Global Automakers, Inc. 

 Novolyte Technologies 

 The Rechargeable Battery Association 

 Technology Sciences Group Inc. 

 West Kern Water 
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B. Scope of Rule

1. Scope of Ethylene glycol ethers category 

Comment 1: One commenter contends that the term glymes, while technically correct, is a less 

well-known term for these ethylene glycol ethers. The commenter asserts it may not have been 

clear to many what chemicals are subject to this rulemaking.

Response 1: EPA disagrees that it was unclear what chemical substances were the subjects of 

the proposed SNUR. Even if an individual manufacturer or processor were unfamiliar with the 

term EPA used to designate the category (“glymes”), all of the chemical substances proposed to 

be included in the SNUR were also individually identified by their Chemical Abstracts Service 

Registry Number (CASRN), Chemical Abstracts (CA) Index Name, and ethylene glycol ether 

common name. Notice of the proposal was adequate; there were several ways in which 

stakeholders could have determined which chemical substances were the subjects of the 

proposal. However, to increase clarity, EPA will list the “ethylene glycol ether” name instead of 

the name “glymes” to characterize the chemicals subject to this SNUR.

Comment 2: One commenter contends that while the ethylene glycol ethers are structurally 

similar, they vary in molecular weight, in the number of ethylene glycol groups, and in the length 

of the terminal alkyl groups. The commenter asserts that the presence of characteristics, such as 

longer terminal alkyl groups and more ethylene glycol groups act to reduce the developmental 

and reproductive toxicity of the higher molecular weight ethylene glycol ethers, as compared to 

the lower molecular weight ethylene glycol ethers. The commenter states that there is a decrease 

in ethylene glycol ether toxicity with increasing terminal alkyl length and/or increasing ethylene 

glycol groups, and that the category should be limited to monoglyme, diglyme and ethylglyme. 

Another commenter contends that the category should be limited based on a consideration of 

metabolism. The commenter contends that the category should be limited to monoglyme, 

diglyme, ethyl diglyme and triglyme because only these will be metabolized in the body to 

chemical substances that have toxicity characteristics of ethylene glycol monomethyl ether and 

ethylene glycol monoethyl ether. The commenter contends that none of the other ethylene glycol 
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ethers exhibit developmental or reproductive toxicity similar to that of these four chemical 

substances. 

Response 2: A specific evaluation of hazard is not required by TSCA section 5(a)(2) to issue a 

SNUR. Nonetheless, EPA has based this SNUR in part on considerations of toxicity, so toxicity 

considerations are relevant in this instance. 

EPA believes that based on both toxicity data and structure-activity relationships (Refs.

1-4) ethylene glycol ethers that consist of 1, 2 or 3 glycol ether groups and terminal alkyl groups 

of 1 to 4 carbons can be anticipated to cause developmental and reproductive toxicity and/or 

hemolytic toxicity. Based on these same data and structure-activity relationships, EPA agrees 

with commenters that chemical substances with more than 3 repeating glycol ether units should 

not be included in the category because the toxicity of such substances is dissimilar from the 

remaining members of the category. Therefore, EPA removed seven of the proposed category 

members from the final rule. 

While there is evidence that the toxicity is reduced going from methyl to butyl ether and 

with increasing number of ethylene glycol groups, toxicity is still observed (Refs. 3, 4). Indeed, 

data provided by one commenter demonstrate the developmental toxicity of six of the seven 

ethylene glycol ethers (Ref. 5). Among the seven substances subject to the final SNUR, EPA 

disagrees that the relevant evidence establishes sufficient variation in degree of toxicity to cull 

any further substances from the group. Differing doses at which toxicity occurs does not equate 

with lack of toxicity. Thus, EPA disagrees with the commenter that the category should be 

further limited to only those chemicals which induce toxicity at the lowest doses. Inclusion in 

the category is appropriately predicated on similarity of toxicity. (EPA notes also that the 

commenters’ individual lists are not in agreement with respect to ethylene glycol ethers that they 

consider to be the most developmentally toxic, and that there is only partial overlap between 

these two lists.)

Further, ethylene glycol ethers cause adverse effects in addition to reproductive and 

developmental toxicity. Data for other toxic effects of ethylene glycol ethers with terminal alkyl 

groups of one to four carbons do not indicate a trend toward decreasing toxicity with increasing 

alkyl chain length (Ref. 4). Hemolysis has been reported in varying degrees for ethylene glycol 
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ethers of one to five carbons in the alkyl chains (Ref. 4). Hemolysis is associated with chain 

length, and a chain length of four carbons causes this type of toxicity at the lowest dose (Ref. 4).

One commenter contends that “the lower glymes that are generally considered to be toxic 

following repeated exposure are: monoglyme, diglyme and ethylglyme. The higher glymes that 

are less toxic following repeated exposure are triglyme, tetraglyme, polyglyme, ethyldiglyme and 

butyldiglyme” (Ref. 5). EPA disagrees that molecular weight can be appropriately applied, by 

itself, to establish which substances are sufficiently similar to be included in the SNUR. EPA 

notes that some level of variation within chemical categories is inevitable when placing similar 

chemicals into groups, and therefore, variation is expected. The similarity in the toxicity of the 

chemical substances that are the subject of this SNUR is not primarily based on molecular 

weight but as discussed above is based on both toxicity data and structure-activity relationships 

(Refs. 1-4). Ethylene glycol ethers that consist of 1, 2 or 3 glycol ether groups and terminal alkyl 

groups of 1 to 4 carbons can be anticipated to cause developmental and reproductive toxicity 

and/or hemolytic toxicity. Based on these toxicity considerations, EPA notes that it did, in fact 

remove some of the higher molecular weight ethylene glycol ethers from the final rule. But EPA 

disagrees that varying molecular weight, in itself, should be a deciding factor in eliminating a 

chemical substance from a category of similar chemical substances. While the commenter 

provides limited data on developmental and reproductive toxicity, they provide no data with 

respect to other toxicity endpoints of concern (including toxicity to blood and blood forming 

organs, and potential for gene mutation) and the commenter does not speculate on possible 

similarities or differences among the chemical substances with respect to these endpoints (Ref. 

5).

Comment 3: Several commenters contend that the ethylene glycol ether category is too broad. 

While the chemical substances in the category are similar because they have one or more 

repeating glycol ether groups and terminal alkyl chains, structural similarity is not sufficient to 

predict toxicity. One commenter further states that structural similarities alone should not be the 

basis for toxicity determinations, risk assessment and subsequent regulation.
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Response 3: EPA acknowledges the commenters’ assertions that the category of ethylene glycol 

ethers in the proposed SNUR was too broad, and is finalizing this SNUR for only seven of the 

original 14 chemicals. 

The commenters’ remaining arguments (about the relevance of structural similarities to 

risk assessment, and subsequent regulation) are premature. This SNUR is not based on risk 

assessment, and it does not establish that subsequent regulation of the ethylene glycol ethers 

would be necessary in the event EPA receives a significant new use notice after promulgating 

this rule. 

While EPA did consider toxicity in deciding to focus on these chemical substances, under 

TSCA section 5(a)(2), EPA is neither required to determine that a particular new use of any 

chemical substance presents, nor even that it may present, an unreasonable risk to human health 

or the environment. Rather, EPA issues a SNUR for a particular new use of a substance if it has 

reason to anticipate that the use would raise significant questions related to potential exposure, so 

that it should have an opportunity to review the use before such use could occur. EPA bases this 

judgment on a consideration of all relevant factors, including the specific factors identified at 

section 5(a)(2). EPA considered similarities in toxicity and potential toxicity among these 

chemical substances, similarities in uses and considered the extent to which the significant new 

uses that are the subject of this SNUR could result in changes to the processing of these chemical 

substances and the type, duration and magnitude of exposures to these chemicals.

2. Metabolites

Comment 4: One commenter suggests that ethylene glycol dimethyl ether, diethylene glycol 

dimethyl ether, diethylene glycol diethyl ether, and triethylene glycol dimethyl ether are known 

to metabolize to Ethylene glycol methyl ether (EGME) and Ethylene glycol ethyl ether (EGEE). 

The commenter states that because these four short chain ethylene glycol ethers have toxicity 

profiles similar to the recognized toxic metabolites EGME and EGEE, they should be the only 

ethylene glycol ethers included in the SNUR. Another commenter identified ethylene glycol 

dimethyl ether, diethylene glycol dimethyl ether, and ethylene glycol diethyl ether as the only 

ethylene glycol ethers that have the potential to metabolize to EGEE and EGME.
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Response 4: As previously discussed, the ethylene glycol ethers included in this SNUR have 

similar toxic properties, including reproductive, developmental and hemolytic toxicity. 

Regardless of what metabolite any of the seven the ethylene glycol ethers metabolize into, the 

chemicals themselves are known to display similar toxicological properties. 

Comment 5: One commenter stated that the accepted use of diethylene glycol monoethyl ether 

(DEGEE) and diethylene glycol monobutyl ether (DEGBE), as inert ingredients in pesticides 

used on agricultural crops “supports the position that there is not a significant concern for 

potential toxicity of these chemicals.” The commenter asserts that DEGEE and DEGBE are 

identified as the metabolites of diethylene glycol diethyl ether and diethylene glycol dibutyl 

ether, respectively.

Response 5: EPA does not believe that the issuance of tolerance exemptions for DEGEE and 

DEGBE indicates that the agency should therefore have no concern for future uses of diethylene 

glycol diethyl ether or diethylene glycol dibutyl ether. 

As an initial matter, EPA is not issuing a SNUR for DEGEE or DEGBE, and the agency 

has no data to indicate that for all uses of diethylene glycol diethyl ether and diethylene glycol 

dibutyl ether, these chemicals’ hazards relate solely to their potential to degrade into DEGEE and 

DEGBE, respectively. 

Even if this were known to be true, the risk assessments for pesticide inert ingredients are 

very specific to agriculture and the issuance of an exemption from the requirement of tolerance 

when the chemical is used as a pesticide inert ingredient does not negate potential exposures of

concern for other uses. 

Furthermore, SNURs are issued based on EPA’s reasonable anticipation that the future 

emergence of certain new uses would raise significant questions related to potential exposure, 

which EPA should have an opportunity to review before such use could occur. Even if EPA 

could extrapolate that all ongoing uses of diethylene glycol diethyl ether and diethylene glycol 

dibutyl ether are “safe” (as defined under section 408(b)(2)(A)(ii) of the Federal Food, Drug, and 

Cosmetic Act) from these tolerance exemptions with regard to consumer uses, that would not 

resolve the broader question of whether it is reasonable to anticipate that the emergence of non-
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pesticidal new uses would raise significant exposure-related questions that EPA should have an 

advance opportunity to review.

The hazard for diethylene glycol diethyl ether or diethylene glycol dibutyl ether has been 

demonstrated, independent of possible metabolites; thus, issuing this SNUR does not present an 

inconsistency with the previously-issued tolerance exemptions of two potential metabolites as 

pesticide inerts. The tolerance exemptions for DEGEE and DEGBE focus almost specifically on 

“anticipated dietary exposures” to these substances. This rule reflects the Agency’s interest in 

receiving notice of non-pesticidal significant new uses of diethylene glycol diethyl ether or 

diethylene glycol dibutyl ether (among the other ethylene glycol ethers subject to the rule).

C. Ongoing Uses 

1. Uses

Comment 6: Two commenters request clarification on whether automobiles are considered 

consumer products. These commenters point to the definition of consumer product at section 

3(a)(5) of the Consumer Product Safety Act (CPSA), which excludes motor vehicles. These 

commenters contend that the EPA definition at 40 CFR 721.3 should be clarified to be consistent

with CPSA and exclude motor vehicles.

Response 6: CPSA is a different statute from TSCA. For purposes of significant new use rules 

issued pursuant to TSCA, consumer product is defined at 40 CFR 721.3 as “...a chemical 

substance that is directly, or as part of a mixture, sold or made available to consumers for their 

use in or around a permanent or temporary household or residence, in or around a school, or in 

recreation.” This is the pertinent regulatory text and it contains no exclusion for automobiles.

However, EPA would not consider ethylene glycol ethers to have been “sold or made 

available to consumers for their use” merely because they have been sold or made available to 

automobile manufacturers or commercial auto service establishments (for their use in 

manufacturing or maintaining customers’ motor vehicles). By contrast, ethylene glycol ethers 

that are sold or made available to a consumer, for the consumer’s own use in maintaining his or 
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her own motor vehicle (e.g., as part of an aftermarket brake fluid) would fall within the 

definition of “consumer product.”

Comment 7: One commenter asks that EPA clarify the status of brake fluid contained in a new 

or used motor vehicle at point of sale.

Response 7: EPA would not consider an ethylene glycol ether to have been “sold or made 

available to consumers for their use,” merely because it has been made available to motor vehicle 

manufacturers (as part of a brake fluid mixture for their use in manufacturing customers’ motor 

vehicles) or used car dealers. By contrast, ethylene glycol ethers that are sold or made available 

to a consumer, for the consumer’s own use in maintaining his or her own motor vehicle (e.g., as 

part of an aftermarket brake fluid) would fall within the definition of “consumer product.”

Comment 8: One commenter requested that EPA clarify how aftermarket components are 

addressed in this rulemaking.

Response 8: An aftermarket component is any product offered for sale or installation in or on a 

motor vehicle after such vehicle has left the manufacturer's production line. Use in an 

aftermarket component would qualify as use in a consumer product if the chemical substances in 

an aftermarket component are “sold or made available to consumers for their use in or around a 

permanent or temporary household or residence, in or around a school, or in recreation.” 40 

CFR 721.3.

Comment 9: Two commenters request that EPA modify the listed ongoing use for monoethylene 

glycol dimethyl ether (monoglyme) listed in the proposed rule - “any use in a consumer product 

except in electrolyte solution in sealed lithium batteries” to “any use in a consumer product 

except in electrolyte solutions for primary and secondary sealed lithium batteries” - because this 

would clarify that the ongoing use of ethylene glycol dimethyl ether is in all primary and 

secondary batteries.
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Response 9: For purposes of defining the scope of the significant new use, EPA has determined 

that the use of ethylene glycol ethers in sealed lithium batteries (whether primary or secondary) 

is not use in a consumer product. An ethylene glycol ether is not being “sold or made available 

to consumers for their use,” 40 CFR 721.3, merely because it is contained in the electrolyte of 

sealed lithium batteries, which are themselves used by consumers. With this clarification, EPA 

is finalizing the significant new use for monoethylene glycol dimethyl ether as “any use in a 

consumer product.”

Comment 10: One commenter asked EPA to consider whether the scope of the SNUR should be 

narrowed to “do-it-yourself” uses, to the extent that motor vehicle equipment is considered a 

“consumer product.” The commenter draws a comparison to a SNUR EPA issued for 2,3,3,3-

tetrafluoro-1-propene (75 FR 65987), in which the scope of the SNUR relating to consumer 

products is limited to “distribution in commerce of products intended for use by a consumer for 

the purpose of servicing, maintenance, and disposal involving the substance.” 

Response 10: EPA considered the TSCA section 5(a)(2) factors and the exposure scenarios for 

both 1-Propene, 2,3,3,3-tetrafluoro- and the ethylene glycol ethers SNURs. The exposure 

concerns and potential use patterns for these chemicals subject to each of the rules, respectively, 

are different enough the EPA does not believe that the specific scope limitation (i.e., to “do-ityourself” use as “a refrigerant in motor vehicle air conditioning system in new passenger cars 

and vehicles”) from the 1-Propene, 2,3,3,3-tetrafluoro- SNUR would be an appropriate model for 

this rule.

Furthermore, the existing definition of “consumer product” already allows for a 

distinction to be drawn between circumstances in which a chemical substance is being “sold or 

made available” to consumers for their own use, and circumstances in which the chemical 

substance is being “sold or made available” for use by other persons (e.g., by motor vehicle 

manufacturers, commercial auto service establishments, or used car dealers). See Responses to 

Comments 6 and 7.

Comment 11: Several commenters identified commercial and/or industrial ongoing uses of

ethylene glycol ethers to be excluded from the final SNUR. These commenters also indicated 
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that the ongoing status of some of the uses that EPA excluded from the proposed rule (on the 

grounds of their status as ongoing uses) could not be confirmed. 

Response 11: In order to adequately characterize the ongoing uses of ethylene glycol ethers, 

EPA updated the original use document prepared for the proposed rule (Ref. 6) based on publicly 

submitted comments and data from the 2012 Chemical Data Reporting (CDR). The agency 

reviewed the original sources of use data from the 2009 Use document (Ref. 6) and compared 

that data to the publicly submitted comments and 2012 CDR data to determine the ongoing uses 

that should be listed in the final rule (Refs. 7, 8, and 9). 

For the chemical diethylene glycol dimethyl ether, EPA proposed that use “as a solvent in 

printing inks for consumer use” would not be covered by the SNUR. This listing was based on 

data from one company’s website, conversations with a technical contact from the company, and 

a list of chemicals the Printers National Environmental Assistance Center (PNEAC) created in 

1996 identifying possible components of printing inks (Refs. 6, 7, and 9). After reviewing 2012 

CDR data and comments submitted on the proposed rule, EPA was informed, by the same 

company that identified the use pre-proposal, that there are in fact, no ongoing consumer uses of 

diethylene glycol dimethyl ether (Ref. 10). In light of the company’s updated statements in 

public comments indicating that diethylene glycol dimethyl ether is not used in consumer 

products, EPA does not believe that the use is ongoing. Thus, in the final rule such use is 

included within the scope of the SNUR. 

Commenters identified several ongoing consumer uses of diethylene glycol dibutyl ether

that EPA listed in the final rule: use as a component of inks, and coatings and adhesives. The 

use of diethylene glycol dibutyl ether as a component in soldering compounds was also identified 

by one commenter as an ongoing consumer use. Therefore, in the final rule such uses were 

removed from the scope of the significant new use.

Commenters identified several ongoing consumer uses of diethylene glycol diethyl ether

that EPA listed in the final rule: use as a component of inks, coatings and adhesives, and as a 

component of paint/graffiti removers. Therefore, in the final rule such uses were removed from 

the scope of the significant new use. Two other commenters identified a number of other uses of 

diethylene glycol diethyl ether in the context of automobile manufacture (Ref. 9). EPA does not 
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consider those ongoing uses to be consumer uses and therefore there was no need to further 

narrow the scope of the significant new use in response.

Comment 12: One commenter suggests that ethylene glycol ethers are lower toxicity 

replacements for other hazardous solvents and have beneficial uses in consumer products. 

Through promulgating this ruling, EPA is assigning an unfair and negative connotation to 

ethylene glycol ethers. 

Response 12: EPA has concerns about potential exposures that could result from significant new 

uses of these chemicals in consumer and other products. The agency maintains an interest in 

being informed of significant new uses of these seven chemicals so that it can effectively 

evaluate and address potential risks related to new uses before they arise. However, it is not the 

purpose of this rule to curtail ongoing uses, and all confirmed ongoing uses of the listed ethylene 

glycol ethers were excluded from the scope of this rule. If EPA were to receive notice of 

significant new uses of the listed ethylene glycol ethers, EPA retains its discretion to evaluate the 

benefits of the proposed use, with consideration of the potential substitutes available, at that 

time. 

2. Industrial Uses

 

Comment 13: One commenter criticized EPA for including in the proposal certain references to 

paint industry uses that it characterized as “anecdotal.” The commenter stated that their inquiries 

into ongoing uses “fail to demonstrate any widespread use.” The commenter faulted EPA for not 

developing more and better information on patterns of actual use and suggested that the record of 

ongoing use was inadequate.

Response 13: The comment reflects a misunderstanding of the relevance of evidence of an 

ongoing use in the development of a SNUR. Since SNURs cannot cover ongoing uses, evidence 

of ongoing industry use would actually support removing such use from a SNUR. Evidence of 

ongoing use is not itself a basis to establish a SNUR for such use. 
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EPA believes that for the purposes of this rule, the use information EPA relied on was 

appropriate. The agency relied on a variety of sources, including personal communications with 

manufacturers, the 2006 Inventory Update Reporting (IUR) rule, business periodicals, and other 

sources listed in the proposal. EPA also provided the public with an opportunity to confirm uses 

listed in the proposal and inform the agency of any other ongoing uses through the notice and 

comment period. EPA made changes to the regulatory language to clarify the ongoing uses that 

are not subject to this SNUR. 

Comment 14: One commenter is concerned that this action could restrict the availability of these 

chemicals for the industry because manufacturers might stop or reduce productions of ethylene 

glycol ethers. The commenter indicated that if EPA is going to take action through a formal 

authority or through less formal means, the agency should consider “foreseeable collateral 

impacts” of the decision and provide both importers and manufacturers sufficient time to make 

the necessary process changes and adjustments. 

Response 14: EPA understands that some companies may decide not to use chemicals for which 

one or more potential uses have been identified as significant new uses. However, based on 

information provided by trade organizations and companies, EPA focused the scope of this 

SNUR primarily on uses of ethylene glycol ethers in consumer products. EPA does not have 

information to indicate that a SNUR alone, particularly where the significant new uses are 

primarily consumer uses, has impacted the availability of the chemical by industrial users.

Furthermore, EPA does not have data to indicate whether or not the issuance of a SNUR will 

affect the availability of the chemical(s) substance(s) subject to the rule. While the commenter 

asserts that this will have an adverse impact, the commenter provides no data to support this 

assertion. This SNUR does not apply to ongoing uses and applies only to new consumer uses for 

6 of the ethylene glycol ethers, and any consumer or industrial use for one of the ethylene glycol 

ethers. In issuing a SNUR, EPA considers a variety of factors, as well as public comments 

received. While not required by TSCA section 5(a)(2) to consider hazard, it is often an 

important consideration, including for these ethylene glycol ethers.
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C. General Clarifications 

1. Articles

Comment 15: One commenter said EPA should clearly state that the import certification 

requirements do not apply to regulated chemicals contained in articles.

Response 15: Import certification requirements do not apply to the import of a chemical 

substance as part of an article, unless EPA has specifically required such import certification, in 

the rule. (See 19 CFR 12.119.) This rule does not extend TSCA section 13 import certification 

requirements to importers of articles.

2. Imports & Exports

Comment 16: One commenter requested clarification of whether imports from other countries 

are subject to the rule and suggested that in the future EPA should propose rules so that all 

imported and exported goods are subject to the same requirements. 

Response 16: While the import of listed ethylene glycol ethers as part of an article would not 

trigger SNUN requirements, see 40 CFR 721.45(f), persons who import listed ethylene glycol 

ethers in non-article form would be subject to the rule. Such importers would be subject to the 

SNUR requirements, like domestic manufacturers. See TSCA section 3, which defines 

manufacture to include importing. 

With respect to equity between imported and exported goods, EPA notes that when 

chemical substances are domestically manufactured solely for export, and they are properly 

labeled as such, they are entirely exempt from SNURs, unless EPA makes an additional riskbased determination under TSCA section 12(a)(2). EPA has not made a section 12(a)(2) 

determination for the listed ethylene glycol ethers.

D. Economic Issues 

1. Negative impact on industry
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Comment 17: One commenter believes that there will be a significant adverse economic impact 

on existing businesses, including a substantial number of small entities (referred to as a 

“significant economic impact on a substantial number of small entities or “SISNOSE”). Further, 

the commenter questions EPA’s reliance on the Agency’s determination in 62 FR 42691 

(Modification of Significant New Use Rules for Certain Substances, August 8, 1997) that 

“proposed and final SNURs are not expected to have a [SISNOSE],” and claims that EPA did 

not consider the effects of the rule on existing businesses. The commenter states that “small 

business customers will be compelled to consider alternatives to ethylene glycol ethers if the 

proposed SNUR becomes a rule – resulting in costly process changes, reduction in product 

efficacy and loss of sales.”

Response 17: EPA reaffirms its position in the Economic Analysis (EA) of the proposed SNUR 

that the rule will have no SISNOSE (Ref. 11). The commenter did not provide any information to 

substantiate their claim that the proposed rule will have a significant impact on a substantial 

number of small businesses. The final SNUR is intended to apply only to new consumer uses of 

six ethylene glycol ethers, and any use of one ethylene glycol ether. EPA was able to confirm 

existing consumer uses for four ethylene glycol ethers and excluded these uses from the SNUR 

requirements. 

EPA disagrees that this rule obliges businesses to use more expensive substitutes, and has 

no data to indicate that more expensive alternatives would be a result of the rule. Significant 

new use notices will not be required of manufacturers or processors respecting any of the 

ongoing uses of the ethylene glycol ethers. While it is possible that some manufacturers and 

processors, who might otherwise have expanded manufacturing or processing ethylene glycol 

ethers into new uses, may prefer to employ other substances for such purposes, there are 

currently no data sources to indicate the extent of such an effect. Furthermore, manufacturers and 

processors of ethylene glycol ethers who intend to distribute the substances in commerce, for the 

existing uses that are excluded from the scope of this rule, need only document one of the 

following respecting the person to whom they distribute the chemical: that they have notified the

recipient of such chemicals about the SNUR, that knowledge of the SNUR has been otherwise 

acquired by the recipient, or that the recipient is unable to undertake significant new uses. Of 
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these three alternatives, the first may be accomplished by simply annotating an MSDS. 40 CFR 

721.5(a)(2). EPA estimates the associated burden to be about one hour of a technical employee's 

time or $64.38 per manufacturer or processor per chemical. 

EPA generally evaluates the impact on firms by measuring estimated costs as a 

percentage of per-firm revenue, using one percent and three percent impact thresholds. As stated 

above, EPA estimated the annualized cost of a SNUN submission (i.e., labor plus fee) to be 

approximately $1,040, for small firms (Ref. 11). Small firms submitting one SNUN would 

therefore need a maximum revenue of $104,000 to have a cost impact greater than one percent of 

their revenue (Ref. 11). In addition, given the low likelihood that small firms will even submit a 

SNUN, EPA does not expect SNUN submissions to have an impact of greater than 1 percent on a 

substantial number of small firms. As stated in EPA’s Final Guidance for EPA Rulewriters: 

Regulatory Flexibility Act, for the purposes of a SISNOSE classification, EPA generally 

considers more than 20 percent of small firms subject to the rule having an impact of greater than 

one percent of revenue to be a substantial number of firms affected. 

Comment 18: One commenter claims to have received negative web publicity as a result of the 

proposed SNUR, and that these effects on their business have not been quantified. 

Response 18: The commenter did not provide an analytical basis or information to assess these 

impacts. EPA believes it is not possible to accurately predict or model the demand effects of any 

publicity related to the SNUR. 

Comment 19: One commenter claims that, many of the ethylene glycol ethers that are used in 

production facilities are necessary to meet safety standards and that substitutes are not always 

available. They believe that the development of substitutes and the replacement of ethylene 

glycol ethers for certain uses can take years.

Response 19: EPA disagrees that this rule obliges businesses to use more expensive substitutes 

for existing uses of ethylene glycol ethers, and has no data to indicate that more expensive 

alternatives would be a result of the rule. See Response to Comment 16. 
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References: 

1. US EPA. “Glymes; Proposed Significant New Use Rule.” 76 FR 40850, July 12, 2011.

2. US EPA. “TSCA New Chemicals Program (NCP) Chemical Categories.” Last revised, 

August 2010, pages 68 – 69. 

http://www.epa.gov/oppt/newchems/pubs/npcchemicalcategories.pdf

3. US EPA. “Glycol Ethers Category; Toxic Chemical Release Reporting; Community 

Right-To-Know.” 58 FR 36180, July 6, 1993. 

4. US EPA. “Glycol Ethers Category; Toxic Chemical Release Reporting; Community 

Right-To-Know.” 59 FR 34386, July 5, 1994. 

5. Novolyte Technologies. “Attachment 1: Categorization of Glymes Based on Toxicology 

and Structural Characteristics.” October 12, 2011, pages 1-21. 

6. Wilson, Kimberly; Tome, Alice; and Narayan, Tulika, Abt Associates, Inc. 

“Memorandum to EPA, Nishkam Agarwal, ‘Actual and Potential Uses of Fourteen 

Selected Glymes.’” September 9, 2009. 

7. Sese, Jason, and Kurt Rindfusz, Eastern Research Group, Inc. “Memorandum to EPA, 

Greg Macek, ‘Potential Updates to Table 1 of the July 12, 2011 Proposed SNUR for the 

‘Glymes’ Category Chemicals.’” May 31, 2013.

8. Sese, Jason and Kurt Rindfusz, Eastern Research Group, Inc. “Memorandum to EPA, 

Greg Macek and Maj’d El-Zoobi, ‘Glymes SNUR – Method Used to Identify Existing 

Consumer Uses.’” May 31, 2013. 

9. Sese, Jason and Kurt Rindfusz, Eastern Research Group, Inc. “Memorandum to EPA, 

Greg Macek, ‘Analysis of Potential Uses in the ‘Glymes’ Chemical Category.’” May 31, 

2013.

10. Novolyte Technologies. “Comments Presented by Novolyte Technologies before the 
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United States Environmental Protection Agency: Proposed Significant New Use Rule on 

Glymes.” October 12, 2011, pages 1-7.

11. US EPA. “Economic Analysis of the Significant New Use Rule for Seven Ethylene 

Glycol Ethers.” Prepared by Nishkam Agarwal and Abt Associates Inc. September 30, 

2013.