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.