EPA Publicly Discloses More Chemical Identities Claimed Confidential under TSCA

TSCA/CBI:

On June 8, 2011, EPA announced the public disclosure of the identities of more than 150 chemicals contained in 104 health and safety studies that had been claimed confidential under the Toxic Substances Control Act (TSCA).  For those 104 studies, the chemical identity will no longer be redacted, or kept from public view.  According to EPA, the chemicals at issue are used in dispersant formulations and consumer products such as air fresheners, non-stick and stain resistant materials, fire resistant materials, nonylphenol compounds, perfluorinated compounds, and lead.  This latest development is another demonstration of EPA’s commitment to increasing transparency under the Toxic Substances Control Act (TSCA) by making publicly available more information about chemical hazards.

Readers will recall that, in 2010, EPA challenged industry to declassify voluntarily unwarranted claims of confidential business information (CBI).  EPA also issued new guidance outlining plans to deny CBI claims for chemical identity in health and safety studies under TSCA.  Based on this guidance, EPA notified a number of companies in February 2011 that it had determined that their CBI claims were not eligible for confidential treatment under TSCA and that EPA intended to make the information public.  (See related posts here and here.)   The health and safety studies included in the lastest disclosure  include some declassified by EPA and other voluntary declassifications by companies in response to EPA’s challenge.

In addition to these actions, EPA over the past several months has taken a number of other steps to make chemical information more readily available.  EPA provided the public, for the first time ever, with free access to the consolidated TSCA Inventory on the EPA and Data.Gov websites.  EPA also launched a new chemical data access tool that gives the public the ability electronically to search EPA’s database of more than 10,000 health and safety documents on a wide range of chemicals that they may come in contact with every day. (See related post here.)  More information about EPA’s transparency initiative under TSCA is avaialble here.

EU Environmental Groups Sue ECHA to Force the Disclosure of Companies Manufacturing or Importing Chemicals on the “SIN List”

REACh:

On May 9, 2011, two EU environmental groups, the International Chemical Secretariat (ChemSec) and ClientEarth, announced that they had initiated a lawsuit against the European Chemicals Agency (ECHA).  The groups filed the lawsuit in the General Court of the EU with the goal of forcing ECHA to publicly disclose the names of companies manufacturing or importing chemicals currently listed on ChemSec’s so-called “Substitute It Now!” list or “SIN List.”  The groups also seek volume information.  ChemSec and ClientEarth want the names and volume information so that they can pressure ECHA and the companies to substitute the chemicals for ones that supposedly are “safer.”  The groups submitted their initial request on December 1, 2010, and after a series of escalating and more formal requests, ECHA issued its final denial on March 7, 2011.  Now, in response to the lawsuit, ECHA has announced that it will release some of the information.  A spokesperson for the groups says that they intend to pursue the case in light of ECHA’s inadequate response.  Additional details are set out below.

ECHA received the names and volume information when the companies submitted their registration dossiers in partial fulfillment of their obligations under the regulation, “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh).  For readers less familiar with the regulation of chemicals, REACh is the primary EU chemical control law.  It applies to most chemicals, except for those used in pharmaceuticals, pesticides, or other products regulated under different EU laws.  Companies that manufacture or import nonexempt chemicals in the EU above 1 metric ton per year are required to submit a registration dossier to ECHA.  The dossier includes certain data and other information about the chemical, its uses, as well as the manufacturer or importer.  ECHA and the EU countries (called Member States) review the dossier to decide whether a chemical should be banned or its use limited through the so-called restriction or authorization processes established under REACh.  Additional testing or other information may also be requested.

The SIN List is an inventory of chemicals that ChemSec developed.  Chemicals on the list purportedly meet the criteria established under REACh for identifying Substances of Very High Concern (SVHC).  SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which expressly contemplates substitution of such chemicals for those that are “safer.”

The lawsuit is currently pending before the General Court of the European Union.  The General Court handles cases filed by private individuals, companies and some organizations, and cases relating to competition law (antitrust for American readers).  The General Court provides the first level of judicial review.  Afterwards, a case can be appealed to the European Court of Justice.  The Court of Justice interprets EU law to ensure the law is applied consistently in all EU countries.  The Court of Justice also settles legal disputes between EU governments and EU institutions.  Individuals, companies, or organizations can also bring cases before the Court if they feel their rights have been infringed by an EU institution.  The Court of Justice has one judge per EU country.

A copy of the legal compliant, called an Application for Annulment, is available here.  In it, ChemSec and ClientEarth include numerous allegations challenging the substantive basis and procedures ECHA used in delaying its response and ultimately denying the groups’ request.  A discussion of the legal principles set out in the complaint and an evaluation of the merits of the allegations are beyond the scope of this post.  However, they may be reviewed more closely in a subsequent post.

In response to the lawsuit, ECHA announced on May 11, 2011, that it will begin to publish certain information from the registration dossier contained in the safety data sheet (SDS), including company names.  In addition to the company’s name, ECHA said that it will also make further elements contained in the SDS publicly available such as the REACH registration number and whether the substance meets some of the SVHC criteria.  However, ECHA noted that companies will be able to keep the information confidential, provided that a valid justification is given and accepted by ECHA.   According to the agency, providing this information will require significant revisions to ECHA’s databases so it is currently unable to commit to releasing the information in the immediate future.  ChemSec and ClientEarth have stated publicly that they find ECHA’s response inadequate and plan to proceed with their lawsuit.

Design for the Environment–EPA’s Safer Product Labeling Program

Green Chemistry/Design for the Environment:

Readers interested in EPA’s Safer Product Labeling Program may want to look through the list of products now authorized to carry EPA’s Design for the Environment (DfE) label.  The list is available here.

On April 20, in anticipation of Earth Day, EPA announced that 2,500 products are now approved to carry the DfE label, including all-purpose cleaners, laundry and dishwasher detergents, drain line maintainers, and car and boat care products. DfE-labeled products do not contain known chemicals of potential concern, like carcinogens, reproductive or developmental toxicants. Even minor product components, like dyes and fragrances, are screened for safety.  In fact, according to EPA, before allowing the DfE logo to be used on a product label, the Agency conducts a scientific evaluation to ensure that candidate products are formulated from the safest possible ingredients.  The Agency’s press release explains that “[t]he DfE label means that EPA has screened each ingredient for potential human health and environmental effects and that the product contains only ingredients that, in EPA’s scientific opinion, pose the least concern among chemicals in their class.”

EPA also announced that DfE labeled products will soon be required to disclose their ingredients (other than trade secrets) to consumers. In addition, new DfE-approved products will need to meet additional life-cycle requirements such as sustainable packaging and limits on volatile organic compounds.  The new disclosure and life-cycle requirements will be phased in for existing DfE products, but some companies are already moving to comply with those standards.

Instructions on the application process for DfE labeling are available here.

Click here for the DfE home page.

Leading Consumer Products Companies Explain How and Why They Share Chemical Data Along the Supply Chain

Green Chemistry/Sustainable Supply Chain Management:

The Green Chemistry and Commerce Council (GC3) recently published a report titled, Meeting Customers’ Needs for Chemical Data: A Guidance Document for Suppliers.  The Guidance Document is designed to improve supply chain communication between suppliers and their customers concerning chemical identities and health and safety data.  In the report, leading companies such as HP, Johnson & Johnson, Method, Nike, SC Johnson, and Wal-Mart explain why they want such data and how they interact with their suppliers to obtain it. 

Readers unfamiliar with GC3 should know that it is a business-to-business forum for members to discuss and share information and experiences relating to the advancement of green chemistry, design for the environment, and sustainable supply chain management.  GC3, which began in 2005, is a project of Lowell Center for Sustainable Production at the University of Massachusetts Lowell.  GC3 prepared the Guidance Document with two goals in mind: “(1) to advance the efforts of companies trying to obtain the chemical data needed for regulatory and corporate sustainability programs and in response to market demands, and (2) to advance the efforts of suppliers to provide chemical data needed by their customers.”

The Guidance Document is a response to the growing demand for increased transparency concerning chemical-related data. Companies attempting to bring “green” or “safer” products to the market need chemical identity and health and safety data at the product design phase.  Access to this information enables them to evaluate and manage market, regulatory, and tort liability risks, as well as respond to requests from their customers, including consumers, wanting more information.

The Guidance Document should prove helpful to suppliers less familiar with the trend toward greater transparency, the rationale supporting it, and the techniques used to sustain it.  The document explains why fabricators and formulators are requesting chemical data, what chemical data are being sought, how suppliers can benefit from sharing data, why Material Safety Data Sheets (MSDS) often provide inadequate data, how companies are handling confidential business information, how fabricators and formulators collect data from their suppliers and what they are doing with the data, and where suppliers can obtain the data being requested.  In addition to describing the chemical data collection practices of different companies, the Guidance Document also provides customizable letters and forms that companies can use to facilitate their communications. 

More information about GC3 is available here.

EPA Denies Protection for Chemical Identities in TSCA 8(e) Reports

TSCA:

As part of EPA’s initiative to increase transparency under the Toxic Substances Control Act (TSCA), on February 10, 2011, the Agency sent a letter to five companies informing them that the identities of 14 chemicals contained in certain health and safety studies were ineligible for protection from public disclosure.  The studies are “substantial risk” reports that the companies submitted to EPA to fulfill their obligations under section 8(e) of TSCA (15 U.S.C. § 2607(e)).  Readers will recall that substantial risk reports disclose information that reasonably supports the conclusion that a chemical substance or mixture (collectively “chemicals”) presents a substantial risk of injury to health or the environment.  EPA reasons that the public has a right to know the identities of chemicals posing such risks.  In contrast, industry frequently contends that disclosure of identities could reveal commercially valuable information about formulations or manufacturing processes.  To stop the disclosure of the identities of its chemicals, a company would need to initiate a legal challenge within 30 days of receiving the Agency’s February letter.

The letters comprise the Agency’s first serious attempt to implement a new transparency policy announced on January 21, 2010.  (The scope of the policy was subsequently expanded in May 2010.)  As announced in January, EPA will deny Confidential Business Information (CBI) protection for the identities of chemicals included in section 8(e) reports when those chemicals are listed on the public version of the TSCA Inventory.  EPA contends that substantial risk reports are a type of health and safety study, as defined under section 3(6) of TSCA (15 U.S.C. § 2602(6)) and the regulations at 40 C.F.R. § 2.306(a)(3).  The Agency also asserts that a chemical’s identity is either part of a health and safety study or the data included within such study, as explained in various TSCA regulations such as those at 40 C.F.R. § 716.3; § 720.3(k).  And because section 14(b)(1) of TSCA (15 U.S.C. § 2613(b)(1)) “does not prohibit disclosure of” health and safety studies (and their data) concerning chemicals offered for commercial distribution, EPA concludes that a chemical’s identity would be eligible for disclosure when it is listed on the public version of the TSCA Inventory and it is the subject of a substantial risk report.

According to EPA’s letter, the chemicals fit squarely within the Agency’s policy.  Each of the chemicals is currently listed on the public version of the TSCA Inventory of “existing” substances.  (The Inventory is EPA’s official list of chemicals that can be lawfully imported or manufactured for commercial distribution without first submitting a premanufacture notice under section 5 of TSCA – the public version lists those chemicals whose identities are not confidential.)  And each of them supposedly was the subject of a substantial risk report.

However, section 14(b)(1) prohibits disclosure of data from health and safety studies when such disclosure would reveal “processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release [would disclose] the portion of the mixture comprised by any of the chemical substances in the mixture.”  These exceptions are designed to prevent the disclosure of trade secrets and other sensitive business information.  EPA’s letter seems to anticipate this objection from the companies, noting “that the [chemical] identity itself, as well as any information that might be derived from it about processes or portions, has already been disclosed” and therefore neither exception applies.

Whether the companies will seek judicial review remains to be seen.  Many challenged CBI claims are withdrawn, and judicial review is expensive.  If the companies seek judicial review, they may challenge EPA’s statutory interpretion or its conclusion that neither disclosure exception applies.  (If a challenge(s) is brought, look for a future blog post discussing the various arguments.)

Regardless of whether there’s a challenge, the Agency’s decision is somewhat controversial – applauded by some and criticized by others.  Unless there’s a successful legal challenge or some other restraint imposed, look for EPA’s continued release of unredacted substantial risk reports and possibly other health and safety studies.  The Agency has clearly signalled its intention to increase the amount of publicly-available information concerning chemical risks.  When balancing commercial interests against environmental and health interests, EPA’s current administration plans to favor the latter at the expense of the former, raising the question:  “Could a better balance be achieved?”  Perhaps – EPA could release the reports with a descriptive generic name in lieu of the chemical’s specific name, a practice the Agency’s used elsewhere under TSCA.