Tag Archive for: CBI

DTSC Requests Public Comment on Another Draft of the Green Chemistry Regulations

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California Green Chemistry Regulations:

The saga of California’s nascent Green Chemistry program continues. Last week, the Department of Toxic Substances Control (DTSC) released the revised text (PDF) of its proposed Safer Consumer Product Regulations. The comment period for the revisions started on January 29 and closes on February 28, 2013.

Notably, the revised rules significantly pare down the list of potential Chemicals of Concern (COCs), which are now referred to as “Candidate Chemicals,” from over 3,000 to approximately 1,200. The Candidate Chemicals  are drawn from lists of substances which exhibit one or more hazard trait. The revisions also clarify that the list of Priority Products to be regulated will be developed and updated through the Administrative Procedure Act rulemaking process.

In addition, DTSC modified the applicability of upfront exemptions for certain products, providing an exemption for products already regulated by other laws that provide comparable health and environmental protections. However, products which are manufactured, stored, or transported through California solely for use outside of the state, or used in California solely for the manufacture of non-consumer products will no longer be exempted, although these factors will be considered in the product prioritization process.

Requirements for the certification and accreditation of assessors involved in developing Alternatives Analyses (AA) have been relaxed in favor of a public review and comment process for AA reports, a choice that seems likely to increase the administrative burden and place confidential business information at greater risk. The scope of evaluating economic impacts for AA reports has also been limited to “a monetized comparison of public health and environmental costs, and costs to governmental agencies and nonprofit organizations that manage waste, oversee environmental cleanup and restoration efforts, and/or are charged with protecting natural resources, water quality, and wildlife.”

Finally, DTSC’s ability to make regulatory responses has been further refined and clarified. For example, the revised proposal requires DTSC to provide notice (with accompanying public comment period) of its proposed regulatory response determination no later than 90 days after it issues a notice of compliance or disapproval for a submitted AA report. The revised proposal also limits the agency’s ability to impose certain regulatory responses on manufacturers only, and not on retailers or importers.

More details on the revised proposed regulations, including how to submit comments and a comprehensive summary of changes from the agency’s last proposal, are available on the DTSC’s website.

EPA Assistant Administrator Steve Owens Resigns

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EPA Administration/Chemical Regulation:

On Tuesday, October 25, 2011, the Environmental Protection Agency (EPA) announced the resignation of Assistant Administrator Steve Owens.  Readers will recall that President Obama appointed Mr. Owens the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), which is the office implementing the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Pollution Prevention Act, and other federal laws concerning chemicals management.  November 30, 2011, will be Mr. Owens’ last day in office before returning home to Arizona where he previously served as the Director of the Arizona Department of Environmental Quality.  It is unclear at this time who will assume Mr. Owen’s responsibilities and what effect his departure will have on EPA’s various chemicals management initiatives.

Mr. Owens served the EPA during a two-year period in which Congress, the courts, and various stakeholders engaged in vigorous debate and litigation over the appropriate regulation of chemicals in the United States.  In a 2010 brown-bag session (available on podcast), sponsored by the American Bar Association’s Pesticides, Chemical Regulation, and Right-to-Know Committee, Mr. Owens discussed many of the initiatives the Agency was undertaking and some of the challenges it faced as it participated and attempted to shape the debate. 

In a letter to EPA staff announcing his resignation, Mr. Owens said:

“I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.
 
As many of you know, my family has remained in Arizona while I have been working at EPA headquarters in Washington. Although I have been able to get home to see my family periodically, I have essentially been away from them for more than two years. After a lot of hard thinking, we have decided that it is time for me to come home. My wife needs her husband; my sons need their father; and I need them.
 
While I am very happy that I will be back with my family, I will miss all of you greatly. It has been a true privilege to work with so many incredibly talented and dedicated people who are doing so much to protect the health and safety of the American people and our environment.
 
I am extremely grateful to Lisa Jackson for her wonderful friendship and the remarkable vision and leadership she provides to this Agency. We are truly fortunate that she is EPA’s Administrator.
 
As I said earlier, I will continue working alongside you all through November 30. Administrator Jackson will share additional information about the transition process shortly.
 
In closing, let me thank you so much for the friendship and support you have given me during my time at EPA. Please know how much I appreciate you and all that you are doing for our country.”

 

EPA Publicly Discloses More Chemical Identities Claimed Confidential under TSCA

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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.

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

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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. 

TSCA CBI – New Practices Adopted at EPA While Further Changes Are Debated in Congress

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TSCA, TSCA Reform: 

Confidential Business Information (CBI) continues to be a focal point of the debates over improving implementation of the current version of TSCA, as well as amending the statute.  Here’s a short update on where those debates currently stand.

EPA Adopts New Practices under TSCA

On May 27, 2009, EPA announced in a Federal Register notice that the Agency will begin a “general practice” of reviewing CBI claims for chemical identities in health and safety studies and related data, submitted under TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B.  According to the notice, “Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” If the chemical identity does not clearly reveal mixture portions or process information, EPA is unlikely to find the information eligible for confidential treatment.  EPA will apply its new practice to both newly submitted and existing claims, beginning August 25, 2010. 

Stakeholders supporting or opposing this new practice are likely to submit comments to the Agency in advance of the August implementation.

Congressional Debate over the Bills to Modernize TSCA

Both the Senate and House bills would revise and narrow the protections for CBI.  The bills would require all CBI claims to be justified up front.  EPA would have to review the claims within a prescribed time period.  Only those that withstood the review – applying standards that EPA would adopt within one year of enactment of the legislation – would be eligible for protection.  Approved claims would receive protection for up to five years. 

Similar to the current version of Section 14, the bills would not allow “the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Nonetheless, the chemical industry remains concerned about the negative impact the new CBI provisions would have on innovation, jobs, and the U.S. industry’s general competitiveness.   ICIS reports that the CEOs from 30 different chemical companies planned to meet this past Wednesday with 50 different members of Congress or their staff to discuss the bills, and the CBI provisions concerning chemical identities were on the top of their list of concerns. 

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Watch for future postings as the debates over CBI evolve.

 

EPA Expands Public Access to Information on Chemicals

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TSCA:

On May 17, EPA issued a press release, announcing that it had added more than 6,300 chemicals and 3,800 facilities, regulated under the Toxic Substances Control Act (TSCA), to the public database known as Envirofacts.   The Agency said its action further demonstrated Administrator Lisa Jackson’s commitment to increasing public access to information on chemicals.   

The Envirofacts database is available on EPA’s website.  The database is designed to provide information on facility activities that may affect air, water, and land in the United States.   Included in the database is information such as facility name and address, aerial imagery, maps, and links to other records such as those available on the Agency’s Enforcement Compliance History Online (ECHO) database, which provides inspection and compliance reports.

In the press release, EPA stated that it has conducted a series of efforts to increase public access to chemical information including reducing confidentiality claims by industry and making the public portion of the TSCA inventory available for free on its website.  EPA supposedly intends to take additional actions in the months ahead to further increase the amount of information available to the public.  Additional details regarding EPA’s plans are available here.

I plan to continue following and reporting on EPA’s public-access initiative, as well as the confidential business information (CBI) provisions in the Congressional bills proposing to modify TSCA.  Stay tuned for future postings here at The Green Chemistry Law Report!