USEPA issued a final rule ordering manufacturers and importers of 19 chemicals used to make a wide range of products to conduct laboratory studies to provide basic health and environmental effects information about those chemicals. Manufacturers of the chemicals would have to submit study results from their research to USEPA by March 2012.
By February 7, 2011, manufacturers must state their intent to test the chemical(s) they produce or submit an exemption application.
If manufacturers of the 19 chemicals fail comply with the regulation, other manufacturers—such as those that produce the chemicals as byproducts of their manufacturing process, as impurities in other chemicals, or that process the chemicals— could be required to provide the data. However, at this time the regulations do not extend to entities other than those manufacturing the 19 chemicals. There will be a later Federal Register notice specifying the chemicals and tests needed if none of the traditional manufacturers notify the agency of its intent to conduct the required tests.
This is the second final test rule stemming from the voluntary High Production Volume (HPV) Challenge Program initiated in 1998 when Vice President Gore challenged manufacturers of chemicals made in or imported into the United States in volumes of 1 million pounds or more—high production volume (HPV) chemicals—to voluntarily make basic health and environmental effects data on those compounds publicly available.
According to EPA, as of June 2007, companies agreed to provide data on more than 2,200 HPV chemicals through EPA's program and an international counterpart managed by the Organization for Economic Cooperation and Development (OECD). The rule issued today targets the 19 chemicals for which data was not voluntarily provided - called “orphan” chemicals.
It is expected that additional, similar rules for other chemicals will be forthcoming this year.
The 19 chemicals subject to the final test rule are:
• acetaldehyde (CAS No. 75-07-0);
• 1,3 propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester), (CAS No.78-11-5);
• 9,10-anthracenedione (CAS No. 84-65-1);
• 1H, 3H-benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone (CAS No. 89-32-7);
• 2,4-hexadienoic acid, (E,E), (CAS No. 110-44-1);
• phenol, 4, 4'-methylenebis[2,6-bis(1,1-dimethylethyl), (CAS No. 118-82-1);
• diphenylmethanone (CAS No. 119-61-9);
• ethanedioic acid (CAS No. 144-62-7);
• methanesulfinic acid, hydroxy-, monosodium salt (CAS No.149-44-0);
• phosphorochloridothioic acid, O, O-diethyl ester (CAS No. 2524-04-1);
• 1, 3, 5-triazine-1,3,5(2H,4H,6H)-triethanol (CAS No. 4719-04-4);
• D-erythro-hex-2-enonic acid, gamma.-lactone, monosodium salt (CAS No. 6381-77-7);
• D-gluco-heptonic acid, monosodium salt, (2.xi.), (CAS No. 31138-65-5);
• C.I. Leuco Sulphur Black 1 (CAS No. 66241-11-0);
• castor oil, sulfated, sodium salt (CAS No. 68187-76-8);
• castor oil, oxidized (CAS No. 68187-84-8);
• benzenediamine, ar,ar-diethyl-ar-methyl (CAS No. 68479-98-1);
• alkenes, C12-24, chloro (CAS No. 68527-02-6); and
• hydrocarbons, C >4 (CAS No. 68647-60-9).