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.  

As detailed in EDF’s submitted comments, the law is quite straightforward in what it requires in the Inventory notification process:

  • Each manufacturer must, within 6 months of promulgation of this final rule, notify EPA of each chemical on the current TSCA Inventory that it has manufactured during the 10 years preceding the new law’s date of enactment (which are then deemed to be “active” chemicals). [Section 8(b)(4)(A)(i)]
  • If the manufacturer wishes to continue to protect from disclosure the identity of its active chemical on the updated Inventory, it must include a request to do so in its notification to EPA. [Section 8(b)(4)(B)(ii)]  This option is limited, of course, only to chemicals that are currently on the confidential portion of the Inventory.
  • EPA can require chemical processors to do the same. [Section 8(b)(4)(A)(i)]

The first requirement of the law – that each manufacturer must notify EPA of each active chemical it manufactures – is not only intended to serve the first objective of Inventory notification;  it is essential to achieving the second objective of ensuring that chemical identities that are not or are no longer trade secrets are not hidden from the public.

Some industry interests are arguing for two approaches, neither of which is allowed under the law and both of which would preclude the Inventory notification process from achieving its second key objective.  Each of these proposals is discussed below.

“One and done” is wrong and dumb

Some in the industry are pushing for an approach they have dubbed “one and done.”

Two big problems.  First, the proposal would have EPA rewrite the law’s requirement that each manufacturer notify EPA of its active chemical, to instead allow that once one company has notified EPA of a chemical, no other company need do so.  TSCA Section 8(b)(4)(A)(i) states (emphases added):

(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Clearly this provision requires each manufacturer of a substance on the Inventory to notify EPA if it has been manufacturing it recently.  Nothing in this language allows for a subset of such manufacturers to file notices.

Second, the industry’s proposal won’t work in practice and likely won’t be desirable even to them.  Recall that part of the notice a manufacturer must file is a reassertion of any existing claim to protect from disclosure the identity of a chemical the company wishes to maintain; see section 8(b)(4)(B)(ii).  Such CBI claims and the basis for them are, of course, specific to the company asserting a claim.  If the Inventory notification process for a chemical could stop after the first notice is received, that could well mean that only that first notifier’s CBI claim would be asserted – and even then only if that notifier had an existing claim and wished to reassert it.  Under this scenario, requests to maintain existing CBI claims originating with other manufacturers of that same chemical might well not be received by EPA.

In this context, the law is clear that the identity of any active chemical for which no requests are received through the Inventory notification process to renew an existing CBI claim must be disclosed to the public [section 8(b)(4)(B)(iv)]:

(B) CONFIDENTIAL CHEMICAL SUBSTANCES.—In promulgating a rule under subparagraph (A), the Administrator shall—

(iv) move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list.

I suspect that is not an outcome those in industry urging EPA to stop the Inventory notification process for a chemical after receipt of the first notice would be pleased with.

To try to address this problem that “one and done” would create, one industry commenter seeks to demand that EPA go through an additional, convoluted process that is not in the law at all, in order to ensure that “all potentially affected manufacturers and processors have had a full opportunity to reassert CBI claims” and that “if an ‘early’ notifier decides to waive an existing CBI claim, that action cannot itself prejudice subsequent notifiers or deprive them of an opportunity to reassert a claim.”

This tries to shift to EPA a burden that the law clearly places on companies.  And it begs the question why EPA should have to provide “all potentially affected manufacturers and processors” yet another “full opportunity to reassert CBI claims” when they just chose not to take up the opportunity afforded them under the law and EPA’s proposed rule to do so via the Inventory notification process.

In sum, the new law is clear that all manufacturers must notify EPA of their active manufacture of a chemical, and that, unless one or more of those companies reassert any existing CBI claims at that time (and those claims are later reviewed and found to be warranted), the identity of that chemical is to be made public.

CBI claims are company-specific and can’t be “borrowed” by other companies

Some 17,000 chemical identities on the Inventory are confidential at present, denying the public the ability to know the full range of chemicals being made and used in the U.S.  In enacting the Inventory notification provisions, Congress wanted EPA not only to update the Inventory to identify chemicals in active commerce, but also to require EPA to retrospectively review this large backlog of CBI claims to ensure that if the public is to continue to be denied access to some chemical identities, they are limited only to those that actually warrant protection from disclosure.

Congress did not intend for the Inventory notification process to be a means by which companies could assert new CBI claims for chemical identity.  The intent was to provide a means for EPA to review already existing chemical identity claims to determine if they are still warranted.

Consistent with this Congressional intent, the language of the law expressly provides only for requests under the Inventory notification process to “maintain an existing claim,” not to assert a new one; see section 8(b)(4)(B)(ii).  Because CBI claims are company-specific, it should not be possible for a company to seek to “maintain” a claim it did not make.

Unfortunately, EPA has proposed to allow a company to request to maintain a CBI claim for chemical identity through the Inventory notification that it had not asserted.  Industry interests have supported this approach in their comments.  EDF strongly disagrees:  we believe this approach is not allowed by law, and it would clearly frustrate achieving the second objective of the Inventory notification process.  In our comments, we argue that EPA’s final Inventory notification rule needs to specifically state that no company that had not previously asserted a CBI claim for the identity of a chemical substance can request that such a claim be maintained through the Inventory notification process.

None of this is to say that a company cannot at any point assert a new claim for CBI protection of the identity of a chemical on the confidential portion of the Inventory.  The law clearly provides for that to be done – but only through the procedures and requirements of section 14.  EPA should make clear that any new claim to protect the identity of a chemical must be asserted and addressed as laid out in section 14.

This is not a trivial distinction:  Among other differences, the section 14 process would require EPA to review such a claim within 90 days, rather than the potentially much longer timeframe provided under section 8(b)(4)(B), (C) and (D).  The much longer period (5-7 years) provided under the new law for EPA review of pre-existing CBI claims for chemical identity was an acknowledgment of the large number of such claims potentially requiring review; compounding that problem by allowing new claims to be asserted and then reviewed under the review plan would run entirely counter to the intent of this provision of the law.

Section 14 of the Lautenberg Act provides ample means to meet the needs EPA identifies in its rationale for its proposed approach:

A number of manufacturers and processors may legitimately benefit from the confidential status of a specific chemical identity, and the initial claimant may no longer exist.  EPA does not believe that Congress intended for specific confidential chemical identities to be disclosed without providing the opportunity for manufacturers and processors to make a request that the identities should remain confidential simply because the original claimants no longer manufacture the chemical substances.

Section 14 provides a clear and direct “opportunity for manufacturers and processors to make a request that the identities should remain confidential.”  Any company seeking to “legitimately benefit from the confidential status of a specific chemical identity” can do so simply by asserting a CBI claim for that chemical identity through the means provided under the Lautenberg Act, i.e., in conformance with the procedures and requirements delineated in section 14.  To do so, there is no need for a company to seek to identify the original or any other claimant.

 

In contrast to both of these proposals embraced by industry, the most straightforward approach is also the one that comports with the law.

This entry was posted in Health Policy, TSCA Reform and tagged , , . Bookmark the permalink. Both comments and trackbacks are currently closed.
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