EDF Health

Selected tag(s): Prioritization

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: November 22, 2023

Quote from FDA Commissioner Robert Califf, MD. "I want to throw in chemical safety as another really, really important area for the future—for humankind, really—and where science is evolving rapidly."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Industry influence, Public health, Regulation / Also tagged , | Authors: , / Comments are closed

EDF joins Opening Brief in legal challenge to EPA’s Prioritization and Risk Evaluation Rules

By EDF Blogs / Published: April 17, 2018

Late yesterday, EDF joined fourteen other Petitioners in filing an Opening Brief in our case challenging EPA’s Prioritization Rule and Risk Evaluation Rule.  The Brief was filed with the U.S. Court of Appeals for the Ninth Circuit.

Our Brief argues that the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Act, requires EPA to comprehensively evaluate a chemical’s hazards and exposures arising from all of its “conditions of use,” a term defined under TSCA as encompassing the chemical’s entire lifecycle from manufacturing and processing to use and disposal.  EPA is then to make a holistic determination of whether the chemical presents an unreasonable risk of injury to human health or the environment, including to potentially exposed or susceptible subpopulations.  EPA’s Rules violate this requirement because EPA asserts unfettered discretion to exclude known or reasonably foreseen exposures and conditions of use from consideration, thereby ignoring potentially important contributors to a chemical’s overall risk.  As a result, the Rules threaten to leave the public—especially vulnerable groups like children, pregnant women, and workers—as well as the environment inadequately protected from the potential risks posed by the thousands of chemicals to which we are exposed every day.

EPA’s response brief in the case is due to the Court on July 5, 2018.  As this litigation proceeds, you can find more information – including all significant legal documents – on EDF’s website.

 

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

EDF files comments on EPA’s approaches to the process under TSCA formerly known as pre-prioritization

By Lindsay McCormick / Published: January 29, 2018

Lindsay McCormick, is a Project Manager.

Last week, EDF filed detailed comments to the Environmental Protection Agency (EPA) on the approaches it has presented for identifying potential candidates for prioritization under TSCA.

EDF believes the purpose of prioritization is to provide an orderly, transparent process for EPA to use in working its way through the huge backlog of chemicals needing risk reviews and to provide an accountable means by which EPA decides which chemicals need full risk evaluations and which have ample information at the time of the prioritization decision indicating they can be set aside absent new information.  Our comments argue for a simple process for identifying potential candidates for prioritization that:

  • is not overly formalized or regimented;
  • ensures sufficient information is available or will be developed in a timely manner to inform prioritization, and subsequently risk evaluations, through robust and early use of EPA’s section 4, 8 and 11 information-generation and information-gathering authorities;
  • proceeds at an incremental pace to build trust and gain experience, and preserve balance between high- and low-priority designations; and
  • allows EPA to routinely meet deadlines for making priority designations and completing risk evaluations on high-priority substances.

In light of these objectives, EDF recommends using an augmented TSCA Work Plan approach to identify potential high-priority candidates. The earlier methodology would need to be updated to incorporate statutory requirements not previously included – or not sufficiently addressed (e.g., exposure to children) – and to integrate new information.

We also believe EPA could use the Safer Choice Ingredient List (SCIL) as a starting point for identifying a comparable number of low-priority candidates.  However, EDF does not believe that the presence of a chemical on the SCIL list alone is at all sufficient for designating it as low-priority.  Rather, the SCIL list may help EPA identify a select number of candidates, which would need to undergo a much more robust evaluation to determine whether they meet the strict statutory requirements for low-priority designations.

For additional detail, check out our full comments.

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

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

By / Published: December 11, 2017

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

More questions for EPA on identifying chemicals for prioritization under TSCA

By Lindsay McCormick / Published: November 29, 2017

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 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

By / Published: March 21, 2017

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 »

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