EDF Health

Selected tag(s): prioritization

EDF comments at EPA’s public meeting on identifying chemicals for prioritization stress legal requirements and urge adoption of sound and fair policies

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

EPA held a public meeting today on “Approaches to Identifying Potential Candidate Chemicals for Prioritization” under last year’s reforms made to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.

EPA provided brief opportunities for stakeholders to provide comments.  Four of us from EDF gave oral comments at the meeting.  Below we provide links to those comments in written form and briefly describe them (in the order in which they were presented).

EDF Senior Attorney Robert Stockman’s comments argue that, under the law, EPA:

  • must use its broad information-gathering authorities under section 4, 8 and 11 of TSCA to collect all “reasonably available information” to inform the prioritization process;
  • should exercise those authorities in the processes leading up to and including prioritization; and
  • should start immediately to develop additional information on chemicals in its Work Plan.

EDF Project Manager Lindsay McCormick’s comments:

  • stress the need to use its information-gathering authorities to develop experimental data early in the prioritization process;
  • caution against over-reliance on voluntary information submissions;
  • urge EPA to avoid implanting a bias toward information-rich chemicals; and
  • remind EPA of its obligations to make full health and safety studies and underlying data publicly available.

My comments:

  • stress that the law sets a higher bar for low-priority than for high-priority designations;
  • urge EPA to identify only small numbers of low-priority candidates at a time;
  • caution EPA not to identify categories of chemicals as candidates for low-priority designations; and
  • argue EPA should consider ensuring a minimum set of hazard data is available for candidates.

EDF Senior Scientist Dr. Jennifer McPartland’s comments point to serious limitations and critical caveats relating to some of EPA’s proposed approaches for identifying candidates, including:

  • Canadian Categorization and Chemicals Management Plan;
  • Safer Choice Ingredient List; and
  • Functional category approaches.
Posted in EPA, Health Policy, Health Science, TSCA Reform / Also tagged | Comments are closed

More questions for EPA on identifying chemicals for prioritization under TSCA

Lindsay McCormick is a Project Manager.  

When EPA finalized its framework prioritization rule under TSCA last June, the agency deleted its proposed approach to identifying potential candidate chemicals for prioritization.  EDF had supported EPA’s initial proposed rule, and EPA’s decision to delay this process to allow for additional stakeholder engagement tracks closely with the comments chemical industry groups submitted on that proposed rule.

EPA is now holding a public meeting on December 11th to discuss its proposed approaches and get input from stakeholders.  As with the upcoming meeting on new chemical reviews, EPA is accepting questions ahead of the meeting.

In response, EDF submitted a number of questions to the agency on Monday, relating to our concerns in the following areas:

  • EPA’s stated intention to significantly exceed its statutory minimum of designating 20 low-priority chemicals within the law’s specified timeframe.
  • EPA’s passive approach to utilizing its new authorities to fill data gaps on chemicals before they enter the prioritization and risk evaluation processes.
  • The need to ensure transparency with respect to health and safety studies and underlying data used by EPA to identify candidate chemicals for prioritization.
  • Specific concerns regarding EPA’s proposed approaches, including to utilize Canada’s Chemicals Management Plan as a model and to use EPA’s Safer Chemicals Ingredient List (SCIL) as a basis for identifying low-priority chemicals.

Read our full list of questions here for more details.

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

Getting the framework right for the new TSCA: EDF comments filed on key EPA proposed rules

Richard Denison, Ph.D.is a Lead Senior Scientist.  Lindsay McCormick is a Project Manager.  Jennifer McPartland, Ph.D., is a Senior Scientist.

Environmental Defense Fund (EDF) filed extensive comments yesterday on the Environmental Protection Agency’s (EPA) proposals for the two most central “framework” rules mandated by last year’s Lautenberg Act amendments to the Toxic Substances Control Act (TSCA).

Our comments address these proposed rules:

Both sets of comments address many different provisions of the proposed rules.  EDF indicated our strong support for many aspects of the proposals, but urged changes to a number of provisions that we cannot support as proposed.  In addition, we identified provisions we believe need to be added to EPA’s rules to be consistent with or meet the requirements of the Lautenberg Act.

EDF emphasized how vital it is for EPA to meet its June 22, 2017, statutory deadline for promulgating these rules.  Because they establish processes that will require several years to begin to yield decisions on specific chemicals, delays in promulgating them in final form so that the processes can commence in the timeframe Congress intended will only serve to undermine public confidence in the new law, counter business interests to restore confidence in the chemicals marketplace, and hamper EPA’s ability to carry out its new mandates.  This is especially the case, given EPA’s appropriate recognition in both proposed rules that it will need to initiate measures as soon as possible to ensure that sufficient information will be available to inform prioritization and risk evaluation decisions.

As discussed in more detail in the comments, EDF strongly supports EPA’s decision not to codify specific scientific policies, procedures and guidance in these rules.  To do so would not be consistent with the law and would more generally represent bad policy.  EDF also agreed with EPA’s proposal not to define in its rules complex, science policy-laden terms such as “weight of the scientific evidence,” “best available science,” and “unreasonable risk.”  These concepts are best elaborated on in guidance and policy statements and best understood in the context of specific decisions on chemical substances.

Some other highlights from each set of EDF’s comments follow.   Read More »

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EDF files comments on three TSCA rules EPA is developing

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

Yesterday was the deadline for stakeholders to file written comments on three rules EPA is now developing, as required under the new Toxic Substances Control Act (TSCA as amended by the Lautenberg Act).  EPA is moving quickly to get input on these rules, which it intends to propose in December in order to stay on track to finalize the rules by June of next year, as mandated under the new law.

The solicitation of written comments follows public meetings EPA held on August 9, 10 and 11 to get input from stakeholders on these rules, at which dozens of stakeholders provided oral comments.  Those meetings were the first EPA public meetings since the Lautenberg Act was signed into law on June 22.

The three rules (and associated docket numbers) on which EPA solicited comments are:

  • Risk-Based Prioritization Procedural Rule, which will set forth the process and criteria EPA will use to prioritize chemicals in commerce. Docket EPA-HQ-OPPT-2016-0399
  • Risk Evaluation Procedural Rule, which will set forth the process EPA will use to conduct risk evaluations of high-priority and industry-requested chemicals. Docket EPA-HQ-OPPT-2016-0400
  • Rule Establishing Fees for the Administration of TSCA, which will detail how EPA will collect fees from companies to defray the costs of administering core activities under the new law. Docket EPA-HQ-OPPT-2016-0401

EDF filed comments yesterday on all three rules, available here, here and here.

Several of the key recommendations from each of our comments follow.   Read More »

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

Links to essential reading on Senate and House TSCA reform legislation

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

[UPDATE 2/26/16:  Updated versions of (1) our detailed side-by-side comparison of Senate and House bills — now with bill section references — and (2) our 5-part series have been posted below.]

On December 17, 2015, the full Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, the Lautenberg Act), which would amend the nearly 40-year-old Toxic Substances Control Act (TSCA).

The House of Representatives already passed its TSCA reform bill in June, the TSCA Modernization Act of 2015, H.R. 2576.

Next up in the New Year will be efforts to reconcile these two bills.  In anticipation of this, I am posting here updated analyses of the two bills that examine how and to what extent they would address key flaws in TSCA.  These analyses include:

  • brief and detailed side-by-sides of TSCA and the two bills,
  • a comparison of how the bills deal with the contentious issue of preemption of state authority,
  • a comparison of how well the bills meet the Administration’s principles for TSCA reform, and
  • an earlier blog post on the importance of understanding which chemicals are in use today.

All of these materials (including this post) are available at blogs.edf.org/health.

ANALYSES:

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New Draft of House Chemical Safety Bill Falls Short; EDF Calls on All Sides to Redouble Effort

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

Release in response to today's House Environment and Economy Subcommittee hearing on a revised discussion draft of the Chemicals in Commerce Act (CICA)

Today’s hearing makes clear that the discussion draft has made progress but still falls far short of legislation that will fix the fundamental flaws of the current law, according to Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. He urged all sides to keep the bipartisan process moving forward in both houses of Congress.

“While bipartisan discussions have yielded a number of substantial improvements to address serious concerns with the original draft, the most problematic provisions remain virtually untouched,” Denison said. “The goal now should be to keep the conversations going.”

Examples of progress include giving the Environmental Protection Agency (EPA) authority to require testing where data are insufficient for prioritization purposes; incorporation of deadlines for agency action to assess and address risks of high-priority chemicals; and less prescriptive and onerous information quality and evaluation requirements.

Sections of the draft pose major concerns and fail to strike a fair and reasonable balance. Examples include the sweeping preemption of state authority for chemicals never subject to a thorough EPA safety review; overly broad allowances for companies to mask the identity of chemicals even long after market entry; and a failure to ensure that conditions placed on new chemicals apply to all companies making or using them.

“We’re optimistic that solutions are at hand that address the needs of all stakeholders, but it is going to take a redoubling of effort by all sides to get there,” he said.

 

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