1 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 201 42 Table of Contents

A. Introduction

B. Scope of the Rule

C. Ongoing Uses

D. General Clarifications

E. Economic Issues

References3

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 Water4

B. Scope of Rule

1. Scope of Eth ylene 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 pro posed 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 seve ral 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 subje ct 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 asse rts 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 molecul ar 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 b e 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 glycol5

ethers exhibit developmental or repr oductive 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 tox icity
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

- ac tivity 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 (Re fs

. 3, 4). Indeed, data provided by one commenter demonstrate the developmental toxicity of six of the seve n ethylene glycol ethers (Ref. 5 ). Among the seven substances subject to the final SNUR , EPA disagrees that the relevant evidence establishes suffi cient 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 onl y 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 ether s 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 glycol6

ethers o f 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, ethyld iglyme and butyldiglyme” (Ref. 5 ). EPA disagrees that m olecular 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

- activ ity 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
chemica l 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 blo od forming organs, and potential for gene mutation) and the commenter does not speculate on possible similarities or differences among the chemical substances with re spect 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.7

Response 3 : EPA acknowledges the commenters’ assertions that the category of ethylene glycol
eth ers in the proposed SNUR wa s 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 prematu re. 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 consi der 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 hum an healt h
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 be fore such use could occur. EPA bases this judgment on a consideration of all relevant factors, including the specific factors i dentified at section 5(a)(2). EPA considered similarities in toxicity and potential toxicity among these chemical substances, s imilarities 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 ether s have toxicity profiles similar to the recognized toxic metabolites EGME and EGEE, they should be the only ethylene glycol ether s inclu ded in the SNUR. Another commenter identified ethylene glycol dimethyl ether
, diethylene glycol dimethyl ether , and ethylene glycol diethyl ether as the only ethylene glycol ether s that have the potential to metabolize to EGEE and EGME.8

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 int o, the
chemicals themselves are known to display similar toxicological properties.

Comment 5 : One commenter state d 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 to xicity 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 toleranc e exemption s 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, t he 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 be fore such use c ould 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 th e emergence of non

-9

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, indepe ndent 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

. T he tolerance exemptions for DEGEE and DEGBE focus almost specifical ly on “anticipated dietary exposures” to these substance s . This rule reflects the A gency ’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. Use s

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 or10

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 mono ethylene 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

exc ept 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.11

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 batter ies, 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 commente r 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 dr aws 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 product s is limited to “distribution in commerce of products intended for use by a consumer for the purpose of servicing, maintenance, and disposal in volving 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. T he 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

- it

yourself” 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 che mical 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 c ommercial and/or industrial ongoing uses of ethylene glycol ethers to be excluded from the final SNUR. These commenters also indicated12

that the ongoing status of some of the uses that EPA excluded from the proposed rule (on the grounds of their status as o ngoing 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 da ta from the 2012 Chemical Data Reporting (CDR). The agency reviewed the original sources of use data fro m 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 b e 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 2 012 CDR data and comments submitted on the proposed rule, EPA was informed
, by the same company that identified the use pre

- proposal, that t here 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 d iethylene glycol dibutyl ether that EPA listed in the final rule: use as a component of inks, and coatings and adhesives. The
use of d iethylene glycol dibutyl ether as a component in soldering compounds was als o 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 d iethylene glycol diethyl ether
that EPA liste d 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 numbe r of other uses of
d iethylene glycol diethyl ether in the context of automobile manufacture (Ref. 9). EPA does not13

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 1 2 : One commenter suggests that ethylene glycol ether s 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 ether s.

Response 1 2 : 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 o ngoing uses of the listed ethylene glycol ethers were excluded from the scope of this r ule. If EPA were to receive notice of significa nt 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 1 3 : One commenter criticized EPA for including in the proposal certain references to paint industry uses that it characterized as “anecdotal.” The commenter s tated that their inquiries into ongoing uses “fail to demo nstra te any widespread use.” The commenter faulted EPA for not developing more and better information on patterns of actual us e and suggested that the record of ongoing use was inadequate.

Response 1 3 : 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 f or such use.14

EPA believes that fo r the purposes of this rule, the use information EPA relied on was appropriate . The agency relied on a variety of sources, includi ng personal communications with manufacturers, the 2006 Inventory Update Reporting (IUR) ru le, 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 chan ges to the regulatory language to clarify the ongoing uses that are not subject to this SNUR.

Comment 1 4 : 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 consid er “foreseeable collateral impacts” of the decision and provide both importers and manufacturers sufficient time to make the necessary process changes and adjustments.

Response 1 4 : 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 wheth er 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 comment s 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.15

C. General Clarifications
1. Articles

Comment 1 5 : O ne commenter said EPA should clearly state that the import certification requirements do not apply to regulated chemicals contained in articles

.

Response 1 5 : Import certification requirement s 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 impor ters of articles.

2. Imports & Exports

Comment 1 6 : One commenter requested clarification of whether imports from other countries are subject to the rule and suggested that in the future EPA should pro pose rules so that all imported and exported goods a re subject to the same requirements.

Response 1 6 : W hile 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 not es 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 risk

based determination under TSCA section 12(a)(2). EPA has not made a section 12(a)(2)
det ermination for the listed ethylene glycol ethers

.

D. Economic Issues

1. Negative impact on industry16

Comment 1 7 : 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”). Furth er, 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 di d 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 change s, reduction in product efficacy and loss of sales .”

Response 1 7 : 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
substantia te 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 e thers , and any use of one ethylene glycol ether

. EPA was able to confirm existing consumer uses for four ethylene glycol ethers and ex cluded 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 , m ay prefer to employ other substances for such purposes, there are currently no data sources to indicate the extent of such an effect. Furthermore, m anufacturer s 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 c hemical: that they have notif ied 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. Of17

these three alternatives, the fi rst 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 s mall 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 1 8 : 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.

Re s ponse 1 8 : The commenter did not provide an analytical basis or informa tion 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 1 9 : O ne 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 ether s for certain uses can take years

.

Respon se 1 9 : 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 16.18

References:
1. US EPA. “Glymes; Proposed Significant New Use R ule.” 76 FR 40850, July 12, 2011

.
2. US EPA. “TSCA New Chemicals Program (NCP) Chemical Categories.” Last revised,
August 20 10 , 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; Com munity
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 As sociates, 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 Use s.’” 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 the19

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
G lycol Ethers

. ” Prepared by Nishkam Agarwal and Abt Associates Inc. September 30
, 2013.