EDF Health

Selected tag(s): Confidential Business Information (CBI)

D.C. Circuit Affirms Public’s Right to Know about Chemicals in Use under Reformed Law

By Richard Denison / Published: April 26, 2019

Court strongly rebukes Trump EPA’s unlawful attempts to scale back transparency requirements

(April 26, 2019 – Washington, D.C.) Today, the U.S. Court of Appeals for the D.C. Circuit delivered a strong rebuke to the Trump Environmental Protection Agency’s (EPA) implementation of the nation’s chemical safety law, protecting key aspects of the public’s right to know about the toxic chemicals in our homes, schools, and workplaces.

The Court agreed with EDF that EPA had failed to require companies to show that the identities of their chemicals cannot be reverse-engineered in order to claim them confidential under the Toxic Substances Control Act (TSCA).

The Court remanded the rule back to EPA to require that companies make this showing to claim confidentiality.  The Court also affirmed that other key TSCA requirements apply to confidentiality claims despite EPA’s failure to include them in its regulations.

“This decision is a significant win for public disclosure and a strong affirmation by the Court of the public’s right to know about the chemicals to which we all are or may be exposed. The Court ruled that EPA must require companies to provide real substantiation for their claims for confidentiality – and that EPA had failed to do so in the rule we challenged,” said Robert Stockman, Senior Attorney at Environmental Defense Fund.  “EPA will now have to require significantly more evidence from companies before they can conceal the identities of chemicals they make and sell.  As a result, fewer such claims will be allowed and workers, consumers and the public will gain access to more information about those chemicals.”

In the case, EDF v. EPA (D.C. Cir. 17-1201), EDF aimed to ensure that EPA upholds the requirements set forth in the reformed Toxic Substances Control Act (TSCA) to maximize transparency and public knowledge about which chemicals are currently in use by narrowing the grounds for asserting confidentiality claims and requiring more scrutiny of them.  The Court affirmed that these requirements apply despite EPA’s failure to incorporate them into its regulation.

“A key goal of the reformed chemical safety law is to make more information public about the chemicals we’re exposed to at home, in our workplaces and schools, and through our environment.” said Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. “While the Trump EPA has taken every opportunity to skirt its responsibility and conceal information that the public has a right to know, the Court’s decision today affirms that the law trumps those efforts.”

On some issues, the Court gave deference to EPA in interpreting the law as it did:  EPA’s decision to delay assigning “unique identifiers” to certain chemicals with confidential chemical identities; and its decision to exempt chemicals made only for export from the law’s Inventory notification requirement.  Finally, the Court unfortunately ruled that EPA could in its discretion allow any manufacturer or processor to make a claim for the confidentiality of a chemical, regardless of whether that company had previously made such a claim.  While EDF does not agree with the Court’s characterization of our position, the Court cited the Chevron standard that provides agencies with considerable deference.

For more background on the decision, see the bullets below.  For more information on this and other lawsuits challenging EPA’s implementation of TSCA, see: https://www.edf.org/health/tsca-case-resources. Read More »

Posted in Health policy, TSCA reform / Also tagged , , | Comments are closed

The Trump EPA’s latest TSCA gift to the chemical industry is illegal and the height of hypocrisy

By Richard Denison / Published: December 4, 2018

Richard Denison, Ph.D., is a Lead Senior Scientist.

‘Tis the season for giving, but it’s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry.  The latest one I’ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); it exposes this EPA’s two-facedness when it comes to making public the information EPA relies on in making regulatory decisions that affect our health and our environment.[pullquote]EPA’s failure to make health and safety studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.[/pullquote]

First some background.  It has been a long time since EPA has proposed a rule to require testing to determine the hazards of a chemical; the last time was way back in 2011.  (That proposed rule was never finalized.  And despite Congress’ major expansion of EPA’s authority to require testing when reforming TSCA in 2016, EPA has steadfastly refused to even consider use of that new authority.)

The American Chemistry Council (ACC) filed comments opposing the 2011 proposed rule.  As I blogged about at the time, ACC insisted that, instead of calling on its members to provide the health and safety data sought through the proposed rule, EPA should seek to get it from the European Chemicals Agency (ECHA). ACC asserted that ECHA likely had already received the requested data under the European Union’s (EU) REACH Regulation.  I noted that’s not as easy as it sounds, because the chemical industry itself has thrown up major roadblocks to such inter-governmental data sharing.  But here’s the rub:  ACC further argued that, should EPA succeed in obtaining the health and safety data submitted to ECHA, EPA could and should deny public access to those data – despite the fact that TSCA clearly prohibits EPA from withholding health and safety studies.  ACC added that the public should make do with mere summaries of the studies, summaries that were prepared by the companies making the subject chemicals.

At the time, EPA was having none of this.  It indicated that if necessary it could use, and was considering using, its subpoena authority under section 11(c) of TSCA to get the studies from the companies that had submitted them to ECHA; see pages 16-17 of this 2013 report from the Government Accountability Office (GAO).

That was then.  Now, with a former ACC senior official essentially running the TSCA office at EPA, the agency is virtually following ACC’s script.   Read More »

Posted in Health policy, Industry influence, TSCA reform / Also tagged , , | Comments are closed

EPA practices are hindering transparency and public confidence in TSCA’s new chemicals program

By Richard Denison / Published: April 23, 2018

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 1               Part 2               Part 3               Part 4

This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA’s Docket Center.  For most of these chemicals, EPA made a determination that they are “not likely to present unreasonable risk” under the Toxic Substances Control Act (TSCA), which greenlights their entry into commercial production.

In our previous post we demonstrated EPA is not complying with a number of provisions under TSCA that require the agency to make public the premanufacture notices (PMNs), notices of commencement (NOCs), and information that is submitted with them.  In this post we look further into how, through these failures and others, EPA has impeded meaningful transparency in the new chemicals program.

As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (see, e.g., TSCA § 14(b)).  Even in EPA’s original (1983) regulations establishing the new chemicals review program, EPA recognized that “[p]ublic participation cannot be effective unless meaningful information is made available to the interested persons” (see here p. 21737).  Among the many flaws of the original TSCA, however, was the law’s inability to ensure EPA delivered the promised transparency when it came to both information EPA receives and the agency’s decisions on new chemicals.

The amendments to TSCA in 2016 were meant, in part, to expand public access to information about both chemicals and agency decisions, and in doing so increase public confidence.  For instance, under § 26, EPA must now make available to the public “all notices, determinations, findings, rules, consent agreements, and orders.”  And under § 5, EPA must now make an affirmative determination on new chemicals, which under § 26 must be made public.  These changes, in addition to the original TSCA provisions, clearly envision a robust program under which the public is able to readily access non-confidential information on new chemicals and information on EPA’s decisions about them.  [pullquote]Coupled with the policy changes EPA has made, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform – and hide as much of it from public view as possible.[/pullquote]

As implemented, however, a number of features of the new chemicals program severely hamper the ability of the public to understand EPA’s decision-making or engage in the new chemicals program.  In addition to the failings we have discussed in previous posts in this series, this post will address several others:

  • the convoluted and fragmented public information “system” EPA has created for PMNs;
  • the failure of EPA to provide access to agency-generated health and safety information on PMN substances; and
  • EPA’s failure to publish Notices of Commencement (NOCs) and EPA’s determinations on confidentiality claims for specific chemical identity in those NOCs.

Read More »

Posted in Health policy, TSCA reform / Also tagged , , , | Comments are closed

EDF comments fault EPA for deviating from the law in proposal for states and health professionals’ CBI access

By Richard Denison / Published: April 17, 2018

Richard Denison, Ph.D., is a Lead Senior Scientist.

One of the key reforms to the Toxic Substances Control Act (TSCA) made by 2016’s Lautenberg Act was the expansion of who can access confidential business information (CBI) submitted by companies to EPA.  The old law largely limited access to federal government employees and contractors.  Congress recognized the enormous value such information could provide to officials at other levels of government and to health providers and environmental officials treating or responding to chemical releases and exposures.  It therefore mandated that EPA expand CBI access, subject to certain conditions specified in the law.

In March, a full 21 months after passage of the Lautenberg Act, EPA finally issued draft guidance documents setting forth how it intends to meet the law’s mandate to expand access to CBI.  Unfortunately, as has been the case with so many other aspects of TSCA implementation under the Trump administration, EPA got a lot of things wrong in its draft guidance documents.

Yesterday, EDF filed extensive comments raising our concerns over these serious deviations from the law and providing our recommendations for fixing them.   Read More »

Posted in Health policy, Public health, TSCA reform / Also tagged , | Comments are closed

EPA is keeping the public in the dark on premanufacture notices for new chemicals under TSCA

By Richard Denison / Published: April 2, 2018

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 1               Part 2               Part 3               Part 4

This is the third in a series of blog posts based on our frustrating, and frustrated, efforts to get information on premanufacture notifications (PMNs) for new chemicals under the Toxic Substances Control Act (TSCA).  The saga began when we requested from the EPA Docket Center the public files on 69 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the TSCA, as amended in 2016 by the Lautenberg Act.  This series of posts analyzes and describes what we did, and did not, get from the Docket Center, to which EPA staff pointed us when we raised the fact that such files are not available on EPA’s website or at www.regulations.gov, despite EPA regulations requiring they be.

TSCA and EPA’s regulations contain a number of provisions that, if reliably implemented, would give the public better access to, or at least a better understanding of, the information EPA receives on new chemicals.  This includes mandates that EPA:

  • publish in the Federal Register EPA’s receipt of new chemical PMNs (TSCA § 5(d)(2));
  • make all PMNs and Significant New Use Notices (SNUNs) publicly available (TSCA § 5(d)(1));
  • make all information submitted with the notices available to the public (TSCA § 5(b)(3) and 40 C.F.R. § 720.95); and
  • make the public files electronically available (40 C.F.R. §§ 700.17(b)(1), 720.95).

EPA has repeatedly committed to increasing the transparency of its new chemicals program.  Unfortunately, our review of the PMN files we received has revealed massive gaps and inconsistencies in the information EPA does provide to the public, and all too often we are finding that EPA has entirely failed to comply with the law and its own regulations.  These failings are on top of efforts by the agency to actively hide information on new chemicals that it had made public for decades.

This post will focus on failings of EPA’s new chemicals program when it comes to transparency and compliance with TSCA and its own regulations with respect to the PMNs EPA receives for new chemicals.  These failings make it virtually impossible for the public to gain any understanding of, or play any meaningful role in, EPA’s review of new chemicals under TSCA.   Read More »

Posted in Health policy, TSCA reform / Also tagged , , , | Comments are closed

EDF files Opening Brief in legal challenge to EPA’s Inventory Notification Rule

By EDF Blogs / Published: March 7, 2018

Late yesterday, EDF filed our Opening Brief in our case challenging EPA’s Inventory Notification Rule.  The Brief was filed with the U.S. Court of Appeals for the District of Columbia Circuit.

Our Brief argues in favor of the public’s right to know.  Among other arguments, it explains that EPA erred by allowing companies to assert “Confidential Business Information” (CBI) claims that do not meet the law’s requirements.  As a result, EPA will be concealing information about chemicals, particularly information about specific chemical identities, in violation of the public’s right to know.  EDF also filed our two-volume Addendum supporting EDF’s standing to pursue this lawsuit.  The Addendum proves that EDF uses this kind of information to study and communicate to the public about chemicals and to advocate for measures to protect public health.

EPA’s response brief in the case is due to the Court on May 21, 2018.

 

Posted in Health policy, TSCA reform / Also tagged , | Comments are closed