Significant New Use Rules: Glymes
This Proposed Rule document was issued by the Environmental Protection Agency (EPA)
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
Glymes; Proposed Significant New Use Rule
Environmental Protection Agency (EPA).
EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the 14 glymes identified in this proposed rule. This action would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Comments must be received on or before September 12, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2009-0767, by one of the following methods:
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2009-0767. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov ore-mail. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) atRm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
For Further Information Contact
For technical information contact: Amy Breedlove, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 202-564-9823; e-mail address: firstname.lastname@example.org.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture, import, or process the chemicals listed in Unit III.A. Potentially affected entities may include, but are not limited to:
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after August 11, 2011 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit confidential business information (CBI) to EPA through regulations.gov ore-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a redacted copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments, remember to:
i. Identify the document by docket ID number and other identifying information (subject heading,Federal Registerdate and page number).
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal
viii. Make sure to submit your comments by the comment period deadline identified.
A. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” Since on-going uses are by definition, not new, they are identified and excluded from the SNUR. EPA must make the determination of a “significant new use” by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). The relevant factors to be considered are:
Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit VII., the general SNUR provisions are found at 40 CFR Part 721, Subpart A.
Section 26(c) of TSCA (15 U.S.C. 2625(c)) authorizes EPA to take action under other sections of TSCA with respect to categories of chemical substances.
B. Why is the agency taking this action?
EPA has concerns about the 14 glymes listed in this SNUR, all of which have similar chemical structures. EPA is concerned about the reproductive and/or developmental toxicity of monoglyme, diglyme, and ethylglyme and believes that individuals could suffer adverse effects from their use. In addition, EPA has concerns about the remaining 11 glymes due to the lack of available use, exposure, and toxicity information. Currently, exposure to monoglyme in lithium batteries is very limited since the batteries are sealed. The amount of exposure to diglyme in printing inks is less certain, but any additional use would increase the existing exposure to the chemical. Ethylglyme currently has no consumer uses but has been found in water sources, its production level appears to be increasing, and given its toxicity, EPA would be concerned if this chemical substance became prevalent in consumer products. EPA further believes that the use of any of these chemical substances in consumer products, beyond the limited, on-going current uses, could significantly increase the magnitude and duration of exposure to humans and the environment over that which would otherwise exist and that such increase should not occur without opportunity for EPA review. Finally, for pentaethylene glycol dibutyl ether and butyltriglyme, which presently show no reported production to the IUR or any ongoing uses, EPA believes that any use of these chemical substances could be a significant increase in the magnitude and duration of exposure to humans and the environment over that which currently exist.
On March 18, 2008, EPA published risk based prioritization related documents on monoglyme and diglyme (Refs. 1, 2, 3, and 4), which indicated that it appeared these two chemical substances are used in consumer products and also indicated EPA's concerns about the potential health effects of these two chemical substances. Studies on monoglyme and diglyme indicate adverse health effects concerning reproductive and developmental toxicity, as well as on blood and blood-forming organs. Studies on ethylglyme show developmental toxicity as well as potential for gene mutation. Several manufacturers initially responded that, with the exception of monoglyme use in sealed lithium batteries, there are no consumer uses. Follow up contact with manufacturers revealed some additional potential consumer uses and raised questions about some of the other uses. For monoglyme, diglyme, and ethylglyme, as well as the remaining 11 chemicals, the level of toxicity is uncertain and/or the type and extent of the use of the chemical substance is unclear. EPA is proposing to issue this SNUR to require notification prior to any new manufacturing, importing, or processing of these chemicals for consumer uses (with specified exceptions), or in some cases all uses. EPA intends to continue to monitor production, use and other relevant information on the subject substances and, where appropriate, initiate further action.
EPA previously published a SNUR on November 29, 2005, (70 FR 71401), (FRL-7740-7), on a major metabolite of monoglyme, 2-methoxyethanol (2-ME), CASRN 109-86-4, requiring notice to the Agency before 2-ME is used in a consumer product (40 CFR 721.10001) (Ref. 5).
III. Significant New Use Determination
A. What chemicals are included in this SNUR?
The proposed category of glymes to be regulated by this SNUR consists of the 14 chemical substances shown in Table 1 and Table 2. Specifically, the designated significant new use for the glymes chemicals in Table 1 of this unit would be “use in a consumer product,” with the exception of the ongoing uses which are the excluded uses listed under “Proposed Excluded Consumer Uses,” and where the designated significant new use for the chemicals in Table 2 would be “any use.” “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.”
While hazard data are only currently available for 3 of the 14 chemical substances in this category (see Unit IV.D.), EPA is proposing to designate significant new uses for all 14 chemical substances listed in Tables 1 and 2 on the basis of the available information. Consistent with its authority under TSCA section 26(c), EPA is proposing to make all 14 chemical substances subject to the significant new use rule based on similarities in the molecular structures, physical and chemical properties, uses, and potential uses of the chemical substances in the category. EPA acknowledges that there are differences in the ongoing uses of the 14 chemical substances, and has accounted for those differences by varying the proposed significant new use designations for the chemical substances, as shown in Tables 1 and 2. Nonetheless, EPA believes that the chemicals are sufficiently similar such that it is appropriate, for purposes of this SNUR, to act on them together. EPA solicits public comment on the scope of the chemical substances to be subject to this SNUR. Specifically, whether any of the chemical substances included in the category are sufficiently dissimilar from the rest that they should be removed from the category, or whether any additional chemical substances are sufficiently similar that they should be added to the category.
B. What relevant factors were considered for this SNUR?
To develop its preliminary determination of what would constitute a significant new use of the glymes listed in Table 1 and Table 2, EPA considered relevant information about the toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA and Unit II.A. of this proposed SNUR.
The latest information available to EPA, which is summarized in Unit IV. of this SNUR, indicates that based on historical production levels of five of these chemicals, any production or commencement of Inventory Update Reporting (IUR) reporting would be considered a significant change. For the two chemicals which currently do not appear to be in production or use, commencement of production for any use could result in a significant increase in the type and form of exposure to both humans and the environment. For the seven chemicals which currently do not have ongoing consumer uses, any commencement of use in a consumer product would change the type of exposure to humans from indirect to direct exposure and the form of exposure from primarily inhalation to both inhalation and skin exposure.
EPA believes that any shift from a status of no uses in a consumer product to any use in a consumer product would increase the magnitude and duration of exposure to consumers than would otherwise exist since use of a consumer product could result in more frequent, direct, and longer exposures than the infrequent or indirect exposures that currently exist. Additional workers are also likely to be exposed, as is the surrounding environment at manufacturing or processing sites, due to possible increases in releases which could contribute additional glymes into the environment. Finally, EPA believes that any changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, or disposal of these glymes could contribute to the type, form, magnitude and duration of exposure to humans and the environment.
Based on these relevant factors, EPA has preliminarily determined that the manufacture, import, or processing of ethyldiglyme, butyldiglyme, tetraethylene glycol dibutyl ether, ethylglyme, tetraethylene glycol diethyl ether, pentaethylene glycol diethyl ether, and polyethylene glycol dibutyl ether for any use in a consumer product is a significant new use. EPA has also primarily determined that the manufacture, import, or processing of monoglyme, diglyme, triglyme, tetraglyme, polyglyme for any use in a consumer product, other than for the ongoing uses listed in Table 1, is a significant new use. In addition, EPA has primarily determined that the manufacture, import, or processing of pentaethylene glycol dibutyl ether and butyltriglyme for any use is a significant new use.
C. What are EPA objectives for this SNUR?
EPA wants to achieve the following objectives with regard to the significant new use(s) that are designated in this proposed rule:
1. EPA would receive notice of any person's intent to manufacture, import, or process the glymes listed in Table 1 and Table 2 for the described significant new uses before that activity begins.
2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing or processing of the glymes listed in Table 1 and Table 2 for the described significant new uses.
3. EPA would be able to regulate prospective uses of the glymes listed in Table 1 and Table 2 before the described significant new uses of the chemical substance occur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.
IV. Summary of Relevant Available Information on the Glymes
A. What are the ongoing uses of these chemicals?
1. Known Ongoing Uses of Glymes. To identify the ongoing consumer uses of these glymes, as well as potential industrial uses, EPA used information submitted under the 2006 IUR rule, contacted manufacturers, searched business periodicals, and searched other available sources. Monoglyme is used in consumer products in electrolyte solutions for sealed lithium batteries. Industrial uses include printed circuit board manufacturing; in reactions with strong bases; in mixtures where solvent separation and recovery is necessary; as an inert special solvent; and as a solvent in pharmaceutical production (Ref. 6, p. 9).
Diglyme is used as a solvent in printing inks for consumer products and industrially as a solvent in a variety of processes (Ref. 6, p. 10).
Triglyme is used in consumer products in consumer brake fluids, as a solvent in consumer adhesives, as a component of consumer paint and graffiti removers and in consumer paints. Industrial uses includegeneration of chemicals, use as a reaction solvent, and use as a binding agent in porcelain powders (Ref. 6, p. 11).
Tetraglyme is used in consumer products as a solubilizing agent for consumer printing inks, as a coalescing agent in consumer paints, and as an HFC/CFC lubricant which may be used in consumer air conditioners. Industrial uses include use as a solubilizing agent in textiles and plastics, as a dye fixation additive for cotton textiles, as a fungicide process solvent, and as a gas scrubbing agent (Ref. 6, p. 12).
Polyglyme is used in consumer paint strippers. Industrial uses include use as special, high boiling solvents for chemical reactions, use as a solubilizing agent for plastic, textile, and paper processes, and use as a gas scrubbing agent (Ref. 6, p. 13).
Ethyldiglyme, butyldiglyme, tetraethylene glycol dibutyl ether, ethylglyme, tetraethylene glycol diethyl ether, pentaethylene glycol diethyl ether, and polyethylene glycol dibutyl ether, have no known uses in consumer products. Industrial uses of these glymes can include use: as a high-boiling solvent for nitrocellulose, resins, and lacquers; as a solubilizer in organic synthesis; as a solvent in the production of plastic resins and compounds, rubber chemicals; as a solvent for conductive printing ink; in the production of printed circuit etchants; in the preparation of and reaction with Grignard reagents; in metal extractions; as a solvent in pharmaceutical syntheses; in the production of coatings; and as a gas scrubbing liquid (Ref. 6, pp. 14-19).
The chemicals listed in Table 2, pentaethylene glycol dibutyl ether and butyltriglyme, have no known uses (Ref. 6, p. 19).
2. Potential for Other Ongoing Uses of Glymes. In order to ascertain if there are any ongoing uses of these glymes, EPA used information submitted under the IUR rule, contacted manufacturers, searched business periodicals, and searched other available sources. In some instances, EPA could confirm the existence of an ongoing use in a consumer product from the information reviewed. In other instances, the results of EPA's search were unclear, and EPA could not confirm whether certain reported consumer product uses were actual ongoing uses.
Therefore, EPA is requesting public comment on whether any of the additional unconfirmed uses listed in this unit are actual, ongoing uses in a consumer product, and whether there are any other ongoing uses in a consumer product of the chemicals listed in Table 1. For pentaethylene glycol dibutyl ether and butyltriglyme, EPA is requesting public comment on whether there are any ongoing uses at all (consumer or industrial). EPA does not anticipate that it will add additional exclusions to the final rule, beyond those listed in Table 1, except where public comment adequately substantiates the existence of a claimed additional ongoing use.
B. What are the estimated production levels of these chemicals?
The 2006 IUR regulation required manufacturers and importers of certain chemical substances included on the TSCA Chemical Substance Inventory to report site and manufacturing information for chemicals manufactured (including imported) in amounts of 25,000 pounds or greater at a single site. For monoglyme and diglyme, EPA expects that current production levels will continue. For triglyme and ethylglyme, predicting future production is infeasible, although ethylglyme production appears to be increasing. For ethyldiglyme, butyldiglyme, and tetraglyme, EPA expects that production will remain at the previous levels. Production of pentaethylene glycol diethyl ether appears to be steadily increasing. For polyglyme, EPA expects that production will continue to decrease and/or remain the same. For tetraethylene glycol dibutyl ether, tetraethylene glycol diethyl ether, polyethylene glycol dibutyl ether, pentaethylene glycol dibutyl ether, and butyltriglyme, EPA expects that production of these chemical substances, if any, will remain below reporting levels. Previous IUR reporting rules required that chemicals produced at amounts of 10,000 pounds or greater be reported. Table 3 summarizes 2006 and prior year IUR data for the 14 glymes. The projected trends are based on the IUR data from 1986-2006. The projections may not be precise since the IUR data does not reflect 100% of chemicals and their production and requirements for reporting have varied over time.
C. What are the potential routes and sources of exposure for these chemicals?
The following are summaries of the potential routes and sources of exposure for these chemicals considering ongoing current uses. More detailed information can be found in the Exposure Characterization documents for monoglyme and diglyme (Refs. 1, 2) and in the description of ethylglyme in the Hazardous Substances Data Bank (Ref. 7).
1. Potential exposures to the environment, consumers, and general population. The exposures described in this unit reflect the actual and/or potential indirect exposures to the environment, consumers, and the general population resulting from ongoing industrial and commercial uses of these glymes. Consumer uses, however, also potentially allow for the direct exposure to skin from product handling and more immediate inhalation exposures resulting from proximity to the product. However, little to no data is available for those types of use scenarios.
Monoglyme, diglyme, ethyldiglyme, triglyme, butyldiglyme, and ethylglyme are included in the category of chemicals reported as “certain glycol ethers” under the ID number N230 in the Toxics Release Inventory (TRI) (Ref. 8). The total release reported to the TRI in 2007 from all reporting sites was 18,476,420 pounds. This total includes air releases of 16,416,033 pounds from on-site fugitive and point sources, in addition to on-site water releases of 87,035 pounds. Most of the remaining volume of release was deep-well injected, sent to land treatment, transferred for energy recovery or transferred to a Publicly Owned Treatment Works (POTW). Release information about the individual glymes within the larger glycol ether category is not known (Ref. 9). Manufacturers, importers, or processors are required to report releases of chemicals on the TRI when total manufacturing, imports or processing by a facility equals 25,000 pounds/year for the chemicals combined.
Ethylglyme was found in the US EPA Office of Water Storage and Retrieval (STORET) database indicating potential environmental exposure since this chemical substance was found in ground water and/or surface water (Ref. 9).
Monitoring data indicate that the general population may be exposed to diglyme and ethyldiglyme via inhalation of vehicle exhaust and ingestion of contaminated drinking water (Refs. 10 and 11). Diglyme was listed as a contaminant found in drinking water (Ref. 10).
Diglyme has been detected in diluted vehicle exhaust from a light-duty truck using different fuel types (Ref. 10).
Industrial manufacture and processing may result in the release of glymes to the environment through various waste streams (Ref. 10). Diglyme, ethyldiglyme, and ethylglyme have been found at measurable concentrations in industrial wastewater treatment systems (Refs. 10, 11, and 7). Wastewater treatment systems discharge to either surface waters or publicly owned treatment works. Either of these two discharge options could result in exposures for the general population and the environment to these chemicals.
Ethyldiglyme has been qualitatively detected in drinking water from Cincinnati, OH; in ground water from the Hipps Road Landfill in Jacksonville, FL; in trench leachates from Maxey Flats, KY and West Valley, NY low-level radioactive waste disposal sites and in advanced waste treatment water from Lake Tahoe, CA, Pomona, CA, and Blue Plains, Washington, DC (Ref. 11).
Ethylglyme has been detected in western Cleveland, OH wastewater influents at 140 μg/L and it was identified in Chicago Central water works water (treated and untreated) at2 μg/L (Ref. 7).
Monitoring data for ethylglyme indicates that the general population may be exposed to the chemical substance through releases from manufacturing facilities. The general population can then be exposed via inhalation of ambient air, ingestion of drinking water, and dermal contact with these substances and other products containing these chemicals. Evidence of releases from industrial manufacturing and processing is demonstrated by concentrations of 400 milligrams per liter (mg/L) of diglyme which have been found in activated sludge from the waste treatment facility of the industry producing the chemical substance(Ref. 7).
For the remaining chemicals in Table 1 or Table 2, little or no release information was found.
EPA's Source Ranking Databank (Ref. 12) shows metal polish and polishing cloths and papers as containing ethylglyme. Most of the entries in this databank for consumer products are from the late 1990s and therefore may not still be current. If ethylglyme is stillfound in these products, however, there is potential that consumers and children might be exposed to this chemical substance from these consumer products. Furthermore, production of ethylglyme appears to be increasing.
Based on IUR data and communications with manufacturers, EPA believes that monoglyme is used as a component of lithium batteries and diglyme is used in printing inks, both of which are consumer applications of monoglyme. It is believed that disposal of the lithium batteries containing monoglyme and paper with printing inks containing diglyme could present the potential for release of these chemicals to environmental media and subsequent exposure to humans and ecological receptors.
2. Potential occupational exposure. Occupational exposure to these chemicals may occur through inhalation and dermal contact at workplaces where the chemicals are produced or used. Monoglyme, diglyme, ethylglyme, ethyldiglyme, triglyme, and tetraethylene glycol diethyl ether all have vapor pressures high enough to potentially result in significant exposures to workers if they are near the chemical substance (Refs. 1, 2, 9, and 13). Based on IUR data, ethyldiglyme, butyldiglyme, tetraglyme, pentaethylene glycol diethyl ether, and polyglyme are manufactured in liquid forms, and worker exposures through dermal contact are possible (Ref. 13).
These chemicals do not have Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) (Refs. 1, 2, and 9). Ferro Corporation, in their publications, recommended a Threshold Limit Value (TLV) for glycol ethers of 5 parts per million (ppm) (Time Weighted Average (TWA)) with a Short Term Exposure Limit (STEL) of 25 ppm. The 15-minute STEL should not be achieved more than 4 times in 8 hours. For women of child-bearing potential, Ferro recommended a TLV of 1 ppm with a STEL of 5 ppm (Ref. 14).
Based on the 2006 IUR reports, the maximum total number of potentially exposed industrial workers to monoglyme and ethylglyme during manufacturing and industrial processing and use is less than 100 each, and the maximum total number of workers likely to be exposed to diglyme was between 100 and 999 workers. There may, however, be additional potentially exposed industrial workers who are not included in these estimates since not all production volume may have been accounted for in the IUR (production below 25,000 pounds at a site does not have to be reported to the IUR), and commercial workers may be exposed as well (Refs. 1, 2, and 15).
D. What are the potential health effects of these chemicals?
The following are summaries of the potential health effects of these chemicals considering ongoing current uses. More detailed information can be found in the Hazard Characterization documents for monoglyme and diglyme (Refs. 3, 4) and in the description of ethylglyme in the Hazardous Substances Data Bank (Ref. 7).
Toxicology studies in laboratory animals have shown that exposure to monoglyme results in hemolytic effects (destruction of red blood cells), and developmental and reproductive toxicity. The acute toxicity of monoglyme is low via oral, dermal and inhalation routes of exposure. Monoglyme's chronic adverse health effects generally fall into the moderate to high hazard range based on the classification ranges used in the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). The potential toxicity from repeated exposure to monoglyme was assessed using a major metabolite, 2-methoxyethanol (CASRN 109-86-4). Oral 90-day studies of 2-methoxyethanol in rats and mice showed testicular degeneration and adverse effects on the process of blood cell formation. The lowest observed adverse effect level (LOAEL) in rats was 70 milligrams/kilograms (mg/kg)-day; the LOAEL in mice was 300 mg/kg-day. An oral prenatal developmental toxicity study of monoglyme in rats showed fetal mortality at doses as low as 60 mg/kg-day, and edema at doses as low as 30 mg/kg-day. An oral prenatal developmental toxicity study of monoglyme in mice showed reduced fetal body weight and increased skeletal defects at 250 mg/kg-day. Available data also suggest that monoglyme has the potential to be genotoxic (Ref. 3).
Toxicology studies in laboratory animals have shown that exposure to diglyme results in hemolytic effects (destruction of red blood cells), and developmental and reproductive toxicity. The acute toxicity of diglyme to rats via the oral and inhalation routes of exposure is low. The chronic adverse health effects of diglyme generally fall into the moderate to high hazard range based on the classification ranges used in the GHS. The toxicity profile following repeated exposures to diglyme is similar to the profile for monoglyme. Rats showed testicular degeneration and hemolytic effects following inhalation exposure to diglyme for two weeks at concentrations as low as 0.6 mg/L-day; a NOAEL was not established. An inhalation dominant-lethal study in rats showed a reduced pregnancy rate at 5.5 mg/L-day (5.5 ppm in air). An oral prenatal developmental toxicity study in mice showed effects on fetal growth and viability, and an increase in malformations at 125 mg/kg-day; the NOAEL was 62.5 mg/kg-day. In vitro gene mutation and in vivo chromosomal aberration tests were negative (Ref. 4).
Toxicology studies in laboratory animals have shown that exposure to ethylglyme results in developmental toxicity. The acute toxicity of ethylglyme is low in rats. Oral prenatal developmental toxicity studies of ethylglyme in mice and rabbits showed a significant decrease in fetal body weight and viability, and a significant increase in malformations; the NOAEL for developmental toxicity was 50 mg/kg-day in mice and 25 mg/kg-day in rabbits (Ref. 7), both falling into the high chronic hazard range based on the GHS.
Based on a review of the literature, there is insufficient information available to arrive at any health effects related conclusions for the remaining chemicals in Table 1 or Table 2.
V. Alternatives Considered for This SNUR
Before proposing this SNUR, EPA considered promulgating a TSCA section 8(a) reporting rule for these glymes. Under a TSCA section 8(a) rule, EPA could, among other things, generally require persons to report information to the Agency when they intend to manufacture, import, or process a listed chemical substance for a specific use or any use. However, for these glymes, the use of TSCA section 8(a) rather than SNUR authority would have several limitations. First, if EPA was to require reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human and environmental hazards and exposures associated with the proposed significant new use and, if necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit the activity before it begins. In addition, EPA may not receive important information from small businesses, because such firms generally are exempt from TSCA section 8(a) reporting requirements. In view of the level of health and environmental concerns about monoglyme, diglyme, and ethylglyme if used for the proposed significant new use, and the lack of information to be able to judge exposure for the remaining glymes, EPA believes that a TSCA section 8(a) rule for thissubstance would not meet EPA's regulatory objectives.
VI. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule
As discussed in theFederal Registerof April 24, 1990 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substance(s) that would be regulated through this proposed rule, if finalized, would have to cease any such activity before the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under section 721.45(h), that person would be considered to have met the requirements of the final SNUR for those activities.
VII. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in theFederal Registerits reasons for not taking action.
Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. There are two exceptions: i. development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and ii. development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters include data that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture, import, processing, use, distribution in commerce, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use. SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this chemical.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from the significant new uses of the chemical substances.
2. Potential benefits of the chemical substances.
3. Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
IX. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in accordance with the procedures set forth in 40 CFR 721.25 and 720.40.
Readers are reminded that EPA published a final rule at 75 FR 773 on January 6, 2010, (FRL-8794-5) that established standards and requirements for the use of the electronic-PMN(e-PMN) software and EPA's Central Data Exchange (CDX) to electronically submit these notices. The Agency is introducing electronic reporting via CDX using the e-PMN in three phases over a two-year period. The effective date of the rule was April 6, 2010. During the first year following the effective date of the final rule, submissions will be permitted via CDX, optical disc, or paper. After April 6, 2011, paper submissions will no longer be accepted. After April 6, 2012, all submissions will be required to be submitted electronically via CDX. Regardless of the delivery method, after April 6, 2010, EPA requires that all submissions be generated using the new e-PMN software. For additional information and instructions go to: http://www.epa.gov/opptintr/newchems//epmn/epmn-index.htm. Until April 6, 2012, SNUNs may still be mailed to the Environmental Protection Agency, OPPT Document Control Office (7407M), 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers, importers, and processors of the chemical substances included in this proposed rule. While most businesses are subject to a$2,500 user fee required by 40 CFR 700.45(b)(2)(iii), small businesses with annual sales of less than $40 million when combined with those of the parent company (if any) are subject to a reduced user fee of $100 (40 CFR 700.45(b)(1)). The costs of submission of SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in this proposed SNUR. Furthermore, EPA believes that the expense of submitting a notice (approximately $6,000 plus the user fee) is unlikely to discourage innovations of high potential value. EPA's complete economic analysis is available in the public docket for this proposed rule (Ref. 16).
B. Export Notification
Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 707, subpart D, exporters must notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5. For persons exporting a substance the subject of a SNUR, a one-time notice must be provided for the first export or intended export to a particular country. EPA estimates the one-time cost to be approximately $937 per exporter including mailing costs. The total costs of export notification will vary by chemical, depending on the number of required notifications (i.e., the number of countries to which the chemical substance is exported). Because EPA is unable to make an estimate of the likely number of export notifications for the chemicals covered in this proposed SNUR, a total export notification cost is not available.
XI. Request for Public Comment
EPA welcomes comment on all aspects of this proposed rule. In addition, EPA is particularly interested in receiving stakeholder input on a number of issues that were identified for public comment earlier in this proposed rule. Please provide comments on the following issues:
1. Scope of the chemical substances to be subject to this SNUR. While hazard data are only currently available for 3 of the 14 chemical substances in the glymes chemical category identified in this proposed rule (see Unit IV.D.), EPA is proposing to designate significant new uses for all 14 chemical substances listed in Tables 1 and 2 in Unit III.A. on the basis of the available information. As discussed in Unit III.A. of this document, EPA believes that the chemicals are sufficiently similar such that it is appropriate, for purposes of this SNUR and consistent with TSCA section 26(c), to act on them together. However, EPA would be interested in hearing whether any of the chemical substances included in the category are sufficiently dissimilar from the rest such that they should be removed from the category, or whether any additional chemical substances are sufficiently similar such that they should be added to the category.
2. Ongoing uses. EPA solicits comment on whether any of the additional unconfirmed uses listed in this proposed rule are actual ongoing uses in a consumer product, and whether there are any other ongoing uses in a consumer product of the chemicals listed in Table 1 in Unit III.A. For pentaethylene glycol dibutyl ether and butyltriglyme, EPA is soliciting comment on whether there are any ongoing uses at all (consumer or industrial). In providing comments on ongoing uses, it would be most helpful if you provide sufficient information for EPA to adequately substantiate the existence of a claimed additional ongoing use.
The following is a list of the documents that are specifically referenced in this proposed rule and placed in the public docket that was established under Docket ID No. EPA-HQ-OPPT-2009-0767. The docket includes information considered by EPA in developing this proposed rule. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the public docket, regardless of whether these referenced documents are physically located in the public docket.
1. US EPA. Screening-Level Exposure Characterization of High Production Volume Chemicals: 1,2-Dimethoxyethane(CAS No. 110-71-4), [9th CI Name: Ethane, 1,2-dimethoxy-]. March 2008, page 21. http://www.epa.gov/chemrtk/hpvis/rbp/Monoglyme.110714.Web.SupportDocs.31408.pdf.
2. US EPA. Screening-Level Exposure Characterization of High Production Volume Chemicals: Diglyme(CAS No. 111-96-6), [9th CI Name: Bis(2-methoxyethyl) Ether]. March 2008, page 16. http://www.epa.gov/chemrtk/hpvis/rbp/Diglyme.111966.Web.SupportDocs.031808.pdf.
3. US EPA. Screening-Level Hazard Characterization of High Production Volume Chemicals: 1,2-Dimethoxyethane (CAS No. 110-71-4), [9th CI Name: Ethane, 1,2-dimethoxy-]. February 2008, page 6. http://www.epa.gov/chemrtk/hpvis/rbp/Monoglyme.110714.Web.SupportDocs.31408.pdf.
4. US EPA. Screening-Level Hazard Characterization of High Production Volume Chemicals: Diglyme (CAS No. 111-96-6), [9th CI Name: Bis(2-methoxyethyl) Ether]. February 2008, page 6. http://www.epa.gov/chemrtk/hpvis/rbp/Diglyme.111966.Web.SupportDocs.031808.pdf
5. US EPA. “2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 2-methoxyethanol acetate; Significant New Use Rule.” 70 FR 71401. November 29, 2005.
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. Hazardous Substances Data Bank (HSDB). Entry for Ethylene glycol diethyl ether, CASRN 629-14-1. Accessed on October 30, 2009. http://toxnet.nlm.nih.gov.
8. US EPA. TRI Web site. http://www.epa.gov/ttn/atw/glycol2000.pdf.
9. US EPA. Exposure Characterization for Ethylglyme. November 6, 2009.
10. Hazardous Substances Data Bank (HSDB). Hazardous Substances Data Bank. Entry for diglyme. Accessed October 30, 2009. http://toxnet.nlm.nih.gov.
11. Hazardous Substances Data Bank (HSDB). Entry for CASRN 112-36-7. Accessed on October 28, 2009. http://toxnet.nlm.nih.gov.
12. The Source Ranking Database is an EPA database that performs a systematic screening-level review of over 12,000 potential indoor pollution sources to identify high-priority product and material categories for further evaluation. It can also identify the products that have contained a specific chemical. May 1997. http://www.epa.gov/oppt/exposure/pubs/srd_apdx.pdf.
13. US EPA. Physical-Chemical Properties and Fate Characterization: Glycol Ethers. Washington, DC: U.S. EPA/OPPT/EETD/EAB. August 2009.
14. Ferro Corporation. 1,2-Dimethoxyethane US EPA HPV Challenge Program Submission. December 2001, pages 7-8 of 93.
15. US EPA. IUR database search results for number of workers exposed to ethylglyme, http://cfpub.epa.gov/iursearch/2006_iur_natlcheminfo.cfm?id=3975. Accessed on October 21, 2009.
16. US EPA. Economic Analysis of the Proposed Significant New Use Rule for 14 Glymes. Washington, DC: U.S. EPA/OPPT/EETD/EPAB. January 12, 2010.
XIII. Statutory and Executive Order Reviews
A. Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has designated this a “significant regulatory action” under section 3(f) of the Executive Order. Accordingly, this action was submitted to OMB for review under Executive Order 12866 and any changes made in response to OMB recommendations have been documented in the docket for this rulemaking as required by section 6(a)(3)(E) of the Executive Order.
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in Title 40 of the CFR, after appearing in theFederal Register, are listed in 40 CFR, part 9, and included on the related collection instrument, or form, if applicable. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 110 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
C. Small Entity Impacts
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., the Agency hereby certifies that this action will not have a significant adverse economic impact on a substantial number of small entities. Under RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined in accordance with RFA section 601 as:
1. A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201.
2. A small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since this proposed SNUR would require a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted, only one appears to be from a small entity in response to any SNUR. Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, EPA has determined that this regulatory action would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538.
This action would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).
F. Tribal Implications
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly or uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this proposed rule.
G. Children's Health Protections
This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
H. Affect on Energy Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.
I. Technical Standards
Because this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15U.S.C. 272 note), does not apply to this action.
J. Environmental Justice
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: June 30, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
Part 721 Amended
1. The authority citation for part 721 continues to read as follows:
15 U.S.C. 2604, 2607, and 2625(c).
2. Add § 721.10229 to subpart E to read as follows:
Chemical substances and significant new uses subject to reporting. The chemical substances identified in Table 1 are subject to reporting under this section for the significant new uses described in Table 1, Column 3 “Significant New Use.”
[FR Doc. 2011-17084 Filed 7-11-11; 8:45 am]
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Oct 12 2011, at 11:59 PM ET
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Date Posted: Jul 12, 2011
RIN: Not Assigned
CFR: 40 CFR Part 721
Federal Register Number: 2011-17084
Alliance of Automobile Manufacturers comments on Proposed SNUR on GLYMES.
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