Archive for the ‘Toxic Substances Control Act’ Category

EPA Initiates Proposed Rulemaking Process to Obtain Fracking Fluid Data

Photo by dmott9. Some rights reserved.

On November 23, 2011 the EPA issued a letter partially granting a petition from the environmental group Earthjustice requesting disclosure and evaluation of the fluids and chemicals used in hydraulic fracturing under the Toxic Substances Control Act (TSCA).

Earthjustice had submitted the petition in August 2011 on behalf of more than 100 public health, environmental, and “good government” groups requesting that the EPA “adopt a rule under TSCA section 4 [15 USC 2603], requiring that manufacturers and processors of E&P Chemicals (defined in the petition as “chemical substances and mixtures used in oil and gas exploration or production” – ed.) conduct toxicity testing of all E&P Chemicals and identify all chemical substances and mixtures tested.” The petition also asked for the “promulgation of a rule under TSCA section 8 [15 USC 2607], requiring maintenance and submission of various records related to E&P Chemicals, calling in records of allegations of significant adverse reactions to E&P Chemicals, and requiring submission of all existing health and safety studies related to E&P Chemicals.”

Earlier in November, the EPA provided an initial response to the petition in which they denied the TSCA section 4 request, as the petition did not “set forth sufficient facts to support the assertion that it is ‘necessary to issue’ the requested TSCA section 4 rule, as required by TSCA section 21(b)(1).”

However, as stated in the November 24 letter, the EPA “has now decided to partially grant the TSCA section 8(a) and section 8(d) requests in the petition,” because they “believe there is value in initiating a proposed rulemaking process using TSCA authorities to obtain data on chemical substances and mixtures used in hydraulic fracturing.”

Hogan Lovells and K&L Gates have more.

EPA Chips Away at Confidential Business Information

Photo by puamelia. Some rights reserved.

You can now know precisely which chemicals were administered to which laboratory rats and rabbits!

In what they are calling an “unprecedented” action, the EPA yesterday announced that they have made public the identities of more than 150 previously confidential chemicals mentioned in 100+ health and safety studies.

Under Section 8(e) of the Toxic Substances Control Act (15 U.S.C. §2607(e)), companies that manufacture, process, or distribute chemicals are required to provide notices to the EPA immediately if they learn that any of their chemical substances present a “substantial risk of injury to health or the environment.” While such reports would understandably reference the chemicals under scrutiny, Section 14 of the TSCA (15 U.S.C. §2613) allows said companies to omit the name of the chemical in the public version of these reports (and other types of studies) if they “believe” that information is “entitled to confidential treatment.” (Not a particularly stringent rule, eh?)

Over a year ago, the EPA began to ramp up their fight against unwarranted Confidential Business Information (CBI) claims, beginning in January of 2010, with the publication of new guidance outlining updated practices for reviewing submissions under section 8(e) for CBI claims “of chemical identities listed on the public portion of the TSCA Chemical Substances Inventory.” The guidance was followed by another Federal Register Notice in which the EPA announced that they would generally “deny a confidentiality claim for chemical identity” in health and safety studies. The new practices were intended to increase transparency by making “more health and safety information available to the public.”

Around the same time, the Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention sent a letter to industry trade associations, challenging them “to reduce the voluminous claims” of CBI that the industry has made. While such letters prompted some companies to voluntarily initiate declassifications of CBI, not all companies were eager to do so. In February of 2011, the EPA notified five companies that their previous CBI claims were “clearly not entitled to confidential treatment under § 14 of TSCA,” and that the EPA intended to make the information public.

In March 2011, the EPA began to declassify CBI in health and safety studies published on the EPA’s website. As of June 8, 2011, more than 100 studies had received the declassification treatment – you can see those studies here.

While the reports often contain the original language requesting confidential treatment (“Disclosure of product composition would be of benefit to competitors and would harm our Company’s ability to enable sell end products made utilizing the material whose composition is being claimed as confidential.”Report #8EHQ-92-4171), they have since been updated – by the addition of a few pages at the beginning of the document – and rescanned to indicate the declassification in some manner. (“After reconsidering the substance of the referenced TSCA 8(e) submission, Rhodia Inc. hereby agrees to declassify from confidential business information to public information all of the bracketed information identified in and redacted from the Public Notice Copy of this filing.” Report #8EHQ-91-1708)

(PETA members may want to refrain from browsing the studies, which go into detail about the administration of said declassified chemicals into various animals’ eyes. What really kills me is one such narrative emphasizing that “the test article was instilled into the eye by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited.” (emphasis added) Regardless of how gently the lid was handled, it didn’t stop the “blistering of eyelid” by said “test article.”)

Nanomaterials: More Than a Nano-Threat?

The National Institute for Occupational Safety and Health (NIOSH, a part of the Centers for Disease Control) will be accepting comments until February 18, 2011, on its draft “Current Intelligence Bulletin” regarding occupational exposure to carbon nanotubes and nanofibers.*

Photo by TED-43. Some rights reserved.

Though, as the bulletin reports, there are currently no reported “adverse health effects in workers producing or using carbon nanotubes (CNT) or carbon nanofibers (CNF),” some studies on rodents have shown effects such as “the early onset and persistence of pulmonary fibrosis […] in CNT-exposed animals,” “reduced lung clearance in rats exposed to low mass concentrations of CNT,” and “acute pulmonary inflammation and interstitial fibrosis […] in mice exposed to CNF.”

It is because of such findings that NIOSH is proposing a recommended exposure limit (REL) of 7 μg/m3 elemental carbon (EC) as an 8-hour time-weighted average. The bulletin goes on to make additional recommendations for dealing with CNT and CNF in the workplace, such as how to store and handle the materials, as well how to clean areas where such materials are used. You can read a succinct summary of the draft in this Fulbright & Jaworski briefing.

But NIOSH isn’t the only agency worried about nanomaterials. According to the EPA, many nanoscale materials are regarded as “chemical substances” under the Toxic Substances Control Act (TSCA). The EPA has been working towards comprehensive regulation of nanomaterials under TSCA, using a “four-pronged approach” that is detailed here.

In fact, only a few months ago, the EPA published a final rule in the federal register requiring anyone intending to manufacture, import, or process either multi- or single-walled carbon nanotubes to notify the EPA at least 90 days before commencing such activities. This pre-manufacture notification (one of the aforementioned four prongs) gives the EPA an opportunity to determine whether the proposed use should be prohibited or limited, as “these chemical substances may be hazardous to human health and the environment.”


* Nanomaterials are generally defined as structures sized between 1 to 100 nanometers**

** A nanometer is equal to only one billionth of a meter

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