EPA Proposes Significant New Use Rules for 37 Chemicals and Nanomaterials

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TSCA/SNUR/Nanotechnology:

Background

Continuing its robust exercise of its expansive TSCA authority, EPA last week released proposed Significant New Use Rules (“SNURs”) under TSCA for 37 chemicals, including 14 nanoengineered carbon compounds. The SNURs cover a wide range of uses, including the manufacture, processing, and import of adhesives, coatings, colorants, lubricants, chemical intermediates, etc., and result from premanufacture notice (“PMN”) submissions from as long ago as 2000. For almost half of the affected chemicals, the SNURs essentially codify protective measures already required under existing consent orders; the rest are largely based on PMN use scenarios.

EPA has already determined that 17 of the substances addressed by the proposed rule “may present an unreasonable risk of injury to human health or environment” and thus are subject to risk-based consent orders under TSCA § 5(e). The proposed SNURs for these substances adopt certain safety precautions already required by the consent orders. For example, for certain chemicals, workers would be required to wear specified respirators unless air monitoring shows that the substance is actually present in concentrations lower than the New Chemical Exposure Limit (“NCEL”). The NCEL provisions, already incorporated in the § 5(e) consent orders, were established by EPA “to provide adequate protection to human health” and modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs). Users who wish to pursue the NCEL alternative to the respirator requirement would have to request permission to do so under 40 CFR § 721.30 (“EPA approval of alternative control measures.”) EPA anticipates approving such requests under the same conditions already present in the consent orders.

The other 20 substances covered by the new SNURs are not subject to § 5(e) consent orders. These “non-5(e) SNURs” cover certain changes from the use scenarios described in the PMNs which could result in increased exposure, per 40 CFR § 721.170(c)(2).

In addition to personal protective equipment, the SNURs impose various standard use restrictions on the chemicals, such as prohibiting manufacture in the U.S., limiting use to conditions specified in existing consent orders, and banning release to water. EPA also recommends various types of toxicity testing to better characterize the new chemicals’ environmental effects.

Regulatory actions flowing from SNURs

Upon promulgation of the SNURs, any users of the affected substances will be required to determine whether they must submit a Significant New Use Notification (“SNUN”) to EPA 90 days prior to engaging in one of the designated “new uses.” On receipt of the SNUN, EPA may take further regulatory action under TSCA § 5(e), 5(f), 6 or 7, or otherwise publish a notice in the Federal Register explaining its reasons for not taking action.

In addition, EPA’s proposal of the SNURs triggers export notification requirements under TSCA § 12(b). Any exporter or intended exporter of the affected chemicals must notify EPA of the first export or intended export to a particular country, unless the substance is present at certain low concentrations that qualify for the de minimus exemption. If and when the SNURs are finalized, importers of the affected substances must also certify their compliance the SNURs.

EPA is accepting comments on the proposed SNURs through April 26, 2013.

Naming nanoscale materials and other CBI concerns

In the proposed SNURs, EPA identifies nanoengineered carbon compounds based on generic structural terms in order to protect the confidential chemical identities of the substances. EPA uses terms like, for example, “single-walled carbon nanotube” (or “SWCNT”), along with PMN numbers to identify the substances for inclusion in the TSCA Inventory.

The nomenclature developed by EPA is further described in a document, “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature,” which should be available soon under the docket number EPA–HQ–OPPT–2012–0727. It is likely to be similar to or the same as the identically-named document published with the SNUR finalized in 2011 for a substance named as “multi-walled carbon nanotubes.”

If an intended user is uncertain whether its chemicals are subject to the new SNURs, EPA advises contacting the agency or obtaining a written determination under the bona fide procedures in 40 CFR § 721.11. Since production volume limits and certain other uses detailed in the proposed SNURs may also be claimed as CBI, users may not know whether their intended production volumes constitute a significant new use. The bona fide procedures also apply to such cases. If, after evaluating detailed submissions on the intended use, EPA finds that the user has a bona fide intent to manufacture, produce, or import the substance, the agency will advise whether the intended use would qualify as a significant new use.

EPA Proposes TSCA SNUR for Certain Perfluorinated Chemicals

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TSCA:

On August 8, 2012, EPA signed a proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) to:

  • Require companies to report 90 days in advance of all new uses of long-chain perfluoroalkyl carboxylic (LCPFAC) chemicals as part of carpets or to treat carpets, including the import of new carpet containing LCPFACs;
  • Add seven perfluoroalkyl sulfonate (PFAS) chemicals to the existing PFAS SNUR (40 CFR 721.9582), and amend that SNUR to include “processing” in the definition of significant new use for PFAS chemicals.

The following is a link to the pre-publication copy of the proposed SNUR:

http://www.epa.gov/oppt/pfoa/pubs/PrePublication_LCPFC-SNUR_NPRM_2012-08-07.pdf

Comments on the proposed SNUR are due 60 days after the SNUR is published in the Federal Register. For more information, see EPA’s website

EPA Issues Testing Rules and a Significant New Use Rule for HPV Chemicals

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TSCA/HPV Chemical Testing:

On October 21, 2011, utilizing its authority under the Toxic Substances Control Act (TSCA), 15 U.S.C. §2601 et seq., EPA published two Federal Register notices announcing testing rules for certain high production volume (HPV) chemicals as well as significant new use rules (SNURs) for other HPV chemicals.  HPV chemicals are those with a production/import volume equal to or greater than 1 million pounds (lbs) per year.  The first notice promulgates a final testing rule for 15 HPV chemicals.  The second notice adopts an innovative approach to regulating HPV chemicals, proposing a testing rule for 23 HPV chemicals and a SNUR for 22 others, along with an alternative proposal to regulate any of the 23 chemicals via a SNUR should public comments indicate a testing rule is unecessary.  Additional details about the rules and the affected chemicals are provided below.

Final Test Rule

The first notice promulgates a final rule under section 4(a)(1)(B) that requires manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 HPV chemicals.  (As a general matter, only certain manufacturers/importers actually perform testing required under section 4.)  The chemicals are part of the so-called “Third Group of Unsponsored HPV Chemicals (HPV3),” a group of 29 chemicals for which no manufacturer or importer accepted the “challenge” to make publicly available health and environmental effects data under the voluntary High Production Volume Challenge Program launched in 1998.  The rule will be effective on November 21, 2011.

According to EPA, there are insufficient data to reasonably determine or predict the effects on human health or the environment from the manufacture, distribution in commerce, processing, use, or disposal of these chemicals, or from any combination of these activities.  Thus, the Agency concluded that testing is needed.  Data developed under this final rule supposedly will provide EPA with critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and to take appropriate action.

EPA’s action affects more persons than those who are required to perform testing.  Persons who export or intend to export any of the chemicals in any form (e.g., as byproducts, impurities, components of Class 2 chemical substances, etc.) included in the final rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D.  Export notification is generally not required for articles, as provided by 40 CFR 707.60(b).  Section 12(b) of TSCA states, in part, that any person who exports or intends to export to a foreign country a chemical for which the submission of data is required under TSCA section 4 must notify EPA of such export or intent to export.  EPA in turn will notify the government of the importing country of the Agency’s regulatory action with respect to the chemical.

The following chemicals are the subject of this final rule:

CAS

Number

Name

98-09-9

Benzenesulfonyl chloride

98-56-6

Benzene, 1-chloro-4-(trifluoromethyl)-

111-44-4

Ethane, 1,1′-oxybis[2-chloro-.

127-68-4

Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)

515-40-2

Benzene, (2-chloro-1,1-dimethylethyl)-

2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)

5026-74-4

2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester

25321-41-9

Benzenesulfonic acid, dimethyl-

52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)

68082-78-0

Lard, oil, Me esters

68442-60-4

Acetaldehyde, reaction products with formaldehyde, by-products from

68610-90-2

2-Butenedioic acid (2E)-, di-C8-18-alkyl esters

70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-

72162-15-3

1-Decene, sulfurized

Proposed Test Rule and SNUR

The proposed test rule, adopted pursuant to section 4(a)(1)(B) of TSCA, would require manufacturers, importers, and processors of 23 HPV chemicals to develop screening-level health, environmental, and fate data, based on the potential for substantial exposures of workers and consumers to these chemicals. The proposed significant new use rule (SNUR), adopted pursuant to section 5(a)(2), would require persons to file a “significant new use” notice (SNUN) with EPA prior to manufacturing, importing, or processing any of a separate group of 22 chemicals for (1) use in a consumer product or (2) for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity.  The chemicals are part of the so-called “Fourth Group of Unsponsored HPV Chemicals (HPV4).”  Public comments are due by January 19, 2012.

EPA’s use of two rules is an innovative approach to regulating this group of 45 HPV chemicals.  If successful, the Agency may use the same approach to regulating future HPV chemicals (i.e., those designated HPV in in 2012 and beyond).  According to EPA, it is proposing the two actions together because the Agency believes they are complementary and will best ensure these HPV chemicals are adequately evaluated.  For example, if EPA receives comments on this proposal sufficient to establish that one of the 23 chemicals proposed for testing is not used in a way that meets the substantial exposure criteria in section 4(a)(1)(B), but information received indicates that the chemical meets the criteria for the SNUR, EPA intends to include the chemical in the final SNUR rather than the test rule, without further public notice and comment.  According to the Agency, simply removing such a chemical from the test rule, without including it in the SNUR, would not provide a regulatory mechanism for timely notification to EPA in the event of changed circumstances that would likely justify the issuance of a test rule for the chemical.  EPA also states that, if public comment on these proposed actions is sufficient to establish that any of the uses to be covered for the 22 chemical substances proposed in the SNUR are, in fact, on-going, yet such comments also establish that there is already substantial exposure to the chemical substance, EPA intends to review the status of the chemical and, as warranted, take appropriate steps to promulgate a test rule rather than a SNUR for the chemical.

The 23 chemicals subject to the test rule, and for which the SNUR is an option, are the following:

CAS Number

Name

56-40-6

Glycine

67-72-1

Ethane, 1,1,1,2,2,2-hexachloro-

78-00-2

Plumbane, tetraethyl-

95-14-7

1H-Benzotriazole

118-48-9

2H-3,1-Benzoxazine-2,4(1H)-dione

128-44-9

1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt (1:1)

928-72-3

Glycine, N-(carboxymethyl)-, sodium salt (1:2)

1809-19-4

Phosphonic acid, dibutyl ester

25377-73-5

2,5-Furandione, 3-(dodecen-1-yl)dihydro-

26544-38-7

2,5-Furandione, dihydro-3-(tetrapropenyl)-

27859-58-1

Butanedioic acid,2-(tetrapropenyl)-

28777-98-2

2,5-Furandione, dihydro-3-(octadecen-1-yl)-

29385-43-1

1H-Benzotriazole, 6(or75)-methyl-.

32072-96-1

2,5-Furandione, 3-(hexadecen-1-yl)dihydro-

61789-73-9

Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides

64665-57-2

1H-Benzotriazole, 6(or7)-methyl-, sodium salt

68131-13-5

Naphthenic acids, reaction products with diethylenetriamine

68153-60-6

Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates

68424-85-1

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

68442-77-3

2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.

68607-28-3

Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides

68909-18-2

Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides

69834-17-9

Benzene, decylphenoxy-

The 22 chemicals subject to the SNUR, and for which a future test rule is an option, are the following:

CAS Number

Name

98-16-8

Benzenamine, 3-(trifluoromethyl)-

100-53-8

Benzenemethanethiol

104-91-6

Phenol, 4-nitroso-

110-03-2

2,5-Hexanediol, 2,5-dimethyl-

124-63-0

Methanesulfonyl chloride

142-30-3

3-Hexyne-2,5-diol, 2,5-dimethyl-

460-00-4

Benzene, 1-bromo-4-fluoro-

542-92-7

1,3-Cyclopentadiene

553-26-4

4,4′-Bipyridine

8007-45-2

Tar, coal

28106-30-1

Benzene, ethenylethyl-

35203-06-6

Benzenamine, 2-ethyl-6-methyl-N-methylene-

35203-08-8

Benzenamine, 2,6-diethyl-N-methylene-

37734-45-5

Carbonochloridothioic acid, S-(phenylmethyl) ester

37764-25-3

Acetamide, 2,2-dichloro-N,N-di-2-propen-1-yl-

61789-72-8

Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides

61790-13-4

Naphthenic acids, sodium salts

65996-91-0

Distillates (coal tar), upper

68308-01-0

Tail gas (petroleum), cracked distillate hydrotreater stripper

68478-20-6

Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free.

68526-82-9

Alkenes, C6-10, hydroformylation products, highboiling

68909-77-3

Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. Residues

Similar to the final rule discussed above, EPA’s action affects more persons than those who are required to perform testing or submit SNUNs.  Once the rule became final, exporters of the chemicals subject to the final test rule would be subject to the export notification requirements in section 12(b).  However, exporters of chemicals subject to the proposed SNUR became subject to those requirements upon publication of this proposed rule.

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Readers interested in following EPA’s innovative approach to regulating HPV should look for future posts on this topic, here at the Green Chemistry Law Report.