Earth Justice recently filed a citizen suit petition under TSCA asking the USEPA to regulate the chemical substances and mixtures used for oil and gas exploration and production ("E&P"). They seek to have manufacturers and processors of E&P chemicals conduct testing of all chemical substances and mixtures, submit existing health and safety studies and identify chemicals and mixtures used during E&P. The petition can be found here.
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).
On Friday, August 13th USEPA published its proposed IUR Modifications rule in the Federal Register, beginning a 60-day comment period. We previously discussed the prepublication notice of this coming rule.
According to USEPA’s statement:
The proposal delineates a number of improvements for 2011 reporting, including requiring electronic reporting via the e-IURweb of all IUR data, making reporting easier and more accessible to all potential reporters. The proposal would also modify the reporting of manufacturing, processing and use data for most chemicals and would make changes to specific data elements, including the addition of other production volume data that would require production volume for all years since the 2006 reporting year. It would also require a greater amount of substantiation for confidential business information claims. Data collected under the final rule would provide improved information for both EPA and the public so they can better identify and, where appropriate, take steps to manage risks associated with TSCA chemical substances. Read the fact sheet.
Note to inorganic chemical manufacturers: Inorganic chemicals are no longer partially exempt from the IUR rule. The partial exemption was a one-time exemption for 2006 reporting only
USEPA has published a pre-publication notice of a proposed rule amendment to TSCA's Inventory Update Reporting (IUR) rule, promulgated under Section 8(a) of TSCA. The IUR rule requires manufacturers (including importers) of certain chemical substances to report information about the manufacturing, processing and use of those chemicals. The proposed changes include:
The long-awaited proposed revisions to TSCA were introduced in the U.S. House and Senate last week. As expected, these proposals, referred to as the “Safe Chemicals Act of 2010” in the Senate and as the “Toxic Chemicals Safety Act of 2010” in the House, contain numerous similarities to REACH. For example, the precautionary principle will apply, manufacturers will need to submit data on each chemical produced and its use, the EPA will be required to prioritize chemicals based on risk, the EPA will be expected to address high risk chemicals quickly. Chemical information submitted will be publically available, the scope of confidential business information will be significantly narrowed, and there is a focus on using safer alternatives to chemicals of concern.
On February 19, 2010, the USEPA proposed a rule to revise the procedures for developing Enforceable Consent Agreements ("ECA") to generate test data under TSCA. The rule would generally apply to those who manufacture or process chemical substances. ECAs are legally enforceable agreements entered into with USEPA wherein a manufacturer or processor of chemical substances agrees to conduct specific testing on a chemical substance to fill an USEPA data need (without requiring EPA to first make a risk determination under TSCA Section 4). The proposed rule is intended to shorten the average time to complete negotiations for ECAs and to use deadlines to terminate negotiations for ECAs if not completed.
The Senate Committee on Environment & Public Works heard testimony yesterday on improving the framework for assessing and managing chemical risks under the Toxic Substances Control Act (TSCA). Written statements of the witnesses, including from the Administrator of U.S. EPA, can be found here.
U.S. EPA just announced core principles that outline the President’s goals for Congressional reform of the Toxic Substances Control Act (TSCA):
These are certainly very broad principles. However, the tone of these principles and the comments supporting same signal that the President supports revisions to TSCA that will make it look more like REACH than like an updated version of TSCA. One of the more detailed goals specifically calls for stricter requirements before information can be deemed confidential, an inability to treat data “relevant to health and safety” as confidential, and an increased ability for the EPA to share such information with other governments. The actual draft legislation is currently expected to be introduced next month.
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