EDF Health

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

No justification: Substantiations for rampant new chemical CBI claims are deficient or lacking altogether

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

We recently started a series of blog posts describing what we did, and did not, get from the EPA Docket Center when we requested the public files on about 70 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the Toxic Substances Control Act (TSCA), as amended in 2016 by the Lautenberg Act.  To continue our series, we address in this post EPA’s pervasive failure to require companies to adequately substantiate Confidential Business Information (CBI) claims, and its own apparent failure to review such claims, despite clear requirements to do so under § 14 of TSCA. 

Twenty months after passage of the Lautenberg Act, we simply must ask:  When will EPA start carrying out its new responsibilities on CBI claims – which includes compelling companies to comply with the law?

First, to provide some context, let us address a question we were asked based on our first post: whether the PMN situation we are describing is any worse now than it was pre-Lautenberg Act.  We suspect it is not necessarily worse.  However, the purpose of the reforms to CBI in the Lautenberg Act was to fix these problems, by requiring substantiation and EPA review of most CBI claims, including those asserted in premanufacture notifications (PMNs) submitted for new chemicals.  By and large it appears this is simply not happening, 20 months after the law passed and those provisions took effect.

Few of the PMN public files we received included any substantiations, despite massive assertions of CBI claims that require substantiation; instead, companies simply redacted the information.  In addition, nearly all of those submissions that do include a substantiation document are wholly inadequate, routinely claiming information as CBI that is not eligible for nondisclosure or failing to provide justification for information that may be eligible.  The violations are so egregious that they indicate EPA is failing to conduct even a cursory review of the claims and redactions.   Read More »

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EPA’s appalling failure to provide public access to public data on TSCA new chemicals

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

At last month’s public meeting held by EPA to discuss changes it is making to its new chemical review program, the issue of public access to information about those chemicals and EPA’s review of them featured prominently.  This post describes EDF’s recent exasperating attempt to gain access to information that the Toxic Substances Control Act (TSCA) and EPA’s own regulations require be made public.

We blogged recently about how EPA is now hiding its tracks when it comes to the outcomes of its initial reviews of new chemicals.  This post details another way in which EPA is cutting the public out of the new chemicals review process.

EDF has repeatedly informed EPA that the agency’s regulations (see here and here) require EPA to promptly make premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets.  One regulation states: “All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.”  The other regulation states that public files are to be made available in the electronic docket posted at http://www.regulations.gov.

Despite the clear requirements for electronic access, EPA acknowledged at its December 6 meeting that it has not provided such access.  It then stated that “[s]anitized PMNs and their attachments can be requested directly from the EPA Docket Center.”  So we decided to try getting these materials by that route.

On December 13, 2017, EDF sent a letter to the EPA Docket Center requesting electronic versions of the sanitized Pre-Manufacturing Notices (PMNs), any health and safety studies, and any other supporting documentation associated with each chemical substance for which, between the law’s passage on June 22, 2016, and the date of our request, EPA had made a finding:

  • under § 5(g), in accordance with § 5(a)(3)(C), that the new chemical substance is “not likely to present an unreasonable risk of injury to health or the environment;” or
  • in accordance with §§ 5(a)(3)(A) and 5(f), that the new chemical substance “presents an unreasonable risk of injury to health or environment.”

We received a CD from the docket center two weeks later, on December 26, 2017. The CD contained file folders for 67 PMNs; a week later we requested additional file folders for two PMNs that received “not likely” findings around the time of our first request, and subsequently received a second CD.

We have been reviewing these materials.  This post is the first in a series that will describe what we got – and didn’t get.   Read More »

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Known knowns and known unknowns: Getting an accurate, transparent and up-to-date TSCA chemical inventory

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

A major reform of the Toxic Substances Control Act (TSCA) made by last year’s Lautenberg Act was to set in motion a process to ensure that EPA (and the public, to the maximum extent practicable) know how many and which chemicals are actually in use today, and to ensure that the identities of any active chemicals that are not publicly disclosed constitute actual trade secrets.

In January, EPA took its first step to implement this reform by issuing its proposed rule for Inventory notification.  The public comment period on this proposed rule closed recently.  EDF submitted extensive comments, which are available here.

The Inventory notification requirements of TSCA as amended by the Lautenberg Act, specified under sections 8(b)(4)(A)(i) and 8(b)(4)(B)(ii), have two interlocked purposes:

  1. to ensure EPA has a full and current list of all chemical substances on the TSCA Inventory that are actively being made and processed – paramount to many other aspects of the law, especially the prioritization and risk evaluation provisions of section 6 and, more generally, in providing an up-to-date understanding of the magnitude of chemical production and use within the scope of TSCA relevant to long-term planning and resource allocation; and
  2. to ensure that the only active chemicals not identified by name on the Inventory are those whose identities are actual trade secrets, by requiring reassertion, substantiation and EPA review of any prior confidential business information (CBI) claims a company has made and seeks to retain to protect its chemicals’ identities from public disclosure on the updated Inventory.

Many of EDF’s comments are aimed at ensuring that EPA’s proposed rule serves both purposes and is fully in compliance with the law.  In contrast, many comments received from industry interests would pit the first objective against the second and do so in ways that would not comply with what the law requires.   Read More »

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Getting it up front: EPA clarifies substantiation requirements for CBI claims under the new TSCA

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

The Environmental Protection Agency (EPA) is publishing a notice in tomorrow’s Federal Register affirming that the Lautenberg Act requires upfront substantiation of all confidential business information (CBI) claims submitted under the Toxic Substances Control Act (TSCA), except for certain claims that the law exempts from substantiation requirements.

While EPA initially took a narrower approach on an interim basis in the flurry of activity following last June’s passage of the Lautenberg Act, today’s notice supersedes that earlier approach and clarifies the upfront substantiation requirement.

In today’s notice, EPA notes the strong support for its clarification in the statute itself as well as in the legislative history in both Houses of Congress leading up to its final passage.

This clarification hopefully won’t be controversial:  A broad swath of stakeholders have voiced support for the upfront substantiation requirement and have noted that it is a key reform made by the new law.

In November the American Alliance for Innovation (AAI) sent a letter to EPA Administrator McCarthy signed by more than 60 trade associations – including the American Chemistry Council, the Society of Chemical Manufacturers and Affiliates, the American Cleaning Institute, the American Petroleum Institute and the Consumer Specialty Products Association – noting that under the Lautenberg Act “[c]laims for CBI protection must be accompanied by an upfront substantiation.”

And back in 2013, the American Chemistry Council provided responses to questions for the record posed by then-Congressman Henry Waxman that stated that “[i]mprovements to the CBI provisions in a modernized TSCA should include … [r]equiring upfront substantiation of the CBI claim.”  The same response letter noted that:  “The American Chemistry Council and its members support up-front substantiation of CBI claims.”

Importantly, EPA’s notice makes clear that the substantiation requirement applies to all non-exempt CBI claims made since passage of the law last June, although EPA is providing an exceedingly generous length of time for companies to comply.

Given the law’s 90-day deadline for EPA review of CBI claims, there are strong policy reasons for requiring upfront substantiation of CBI claims:

  • First, EPA’s own experience based on recent chemical reporting it has required demonstrates that requiring upfront substantiation reduces the number of CBI claims asserted. That means fewer claims EPA has to review and a greater likelihood that claims are only asserted for information that warrants protection.
  • Second, when those reviews are conducted, EPA will already have the information it needs to review the claim instead of having to request it from the company, wasting precious days or weeks of the 90-day review period.
Posted in EPA, Health Policy, TSCA Reform / Also tagged | Comments are closed

Separating fact from fancy in the TSCA Inventory reset mandated by the Lautenberg Act

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

A key reform under the Lautenberg Act is the requirement that the Environmental Protection Agency (EPA) generate an accurate, up-to-date list of all chemicals in active commerce.  This is to be accomplished by promulgating a rule to do a full “reset” of the TSCA Inventory that distinguishes between active and inactive chemicals.  It is necessary because the 85,000 chemicals on that Inventory represent a cumulative listing of all chemicals that have been in commerce at some point since its establishment in 1979, but no doubt includes many that are not now in commerce.

I have blogged previously about why it is important that EPA and the public know how many and which chemicals are in use today in the U.S.  Among other reasons, it is essential that we understand the magnitude of the task that awaits EPA under the new TSCA, with respect to prioritization, risk evaluation, risk management, and substantiation and review of confidential business information (CBI) claims.  That has implications for the pace of the program and the resources EPA will need to do its job, which extends ultimately to reviewing the safety of all chemicals in commerce.

EDF provided EPA with our comments on what should be included in EPA’s upcoming rule establishing the Inventory reset.  Unfortunately, comments on that rule received from some in industry indicate that they are seeking to limit the Inventory reset in ways that are not allowed under the new law and are short-sighted or even counterproductive to the purpose of the reset.  I provide a critique here of three of those proposed limitations.   Read More »

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Compromise that strengthens, not weakens, TSCA is the key to getting a new law

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

My recent blog post about the public’s right to know the names of chemicals in health and safety studies brought a response from the Vice President for Government and Public Relations at the Society of Chemical Manufacturers and Affiliates (SOCMA), a trade association of specialty chemical firms.

The response devotes considerable space to arguing for something we don’t oppose:  why it’s important for a company to be able to protect information relating to the process by which a chemical is made.  We have no quarrel with that:  EDF has never sought to change the provision of TSCA that precludes EPA from disclosing such information, even in the context of a health and safety study.  That provision is preserved in both the Senate and House bills, and that has been and remains acceptable to us.

Let me be crystal clear:  EDF has not sought to alter TSCA’s requirement that EPA withhold the identity of a chemical even in a health and safety study if revealing that identity would reveal process information.

What we do strongly oppose, however, is the effort to expand TSCA’s exclusion so as to allow a company always to hide from the public the identity of the chemical in a health and safety study – even where knowing that chemical’s name would not reveal the process used to make it.  That is exactly what the provision in the House TSCA reform bill that SOCMA is pressing for would do.

This would be a major weakening of current TSCA that would severely limit the public’s right to know about health and environmental impacts of chemicals in use today.

SOCMA’s response argues this would be okay for two reasons:  First, EPA will know the chemical’s identity, so no one else needs to know.  And second, the public should be content with a “generic” name.  Let me briefly address each of these arguments.   Read More »

Posted in Health Policy, TSCA Reform / Also tagged | Comments are closed