EDF Health

A closer look at FDA’s “Closer to Zero” plan to reduce for heavy metals in children’s food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 21, 2021

Tom Neltner, J.D. is the Chemicals Policy Director.

This month, the Food and Drug Administration (FDA) released its “Closer to Zero” action plan to reduce exposure to heavy metals in foods for babies and young children. The plan, released in response to a recent House of Representatives Committee on Oversight and Reform report and the introduction of the Baby Food Safety Act in both the House and the Senate, is a step forward since it commits the agency to specific actions and general deadlines for the first time. However, there is room for improvement, specifically the agency should:

  1. Explicitly consider the cumulative effect of heavy metals on neurodevelopment when setting limits.
  2. Move up deadlines for draft action levels for arsenic and cadmium;
  3. Be consistent in messaging that there is no safe level of lead in children’s blood;
  4. Define what “as low as possible” and “children’s food” means as soon as possible;
  5. Be transparent by posting testing data quickly; and
  6. Add milestones for compliance verification with action levels and preventive controls.

Read More »

Posted in FDA, Food, Lead, Public health / Tagged , , , , , | Comments are closed

Lead pipes are in the news – Here’s why that matters

By Sam Lovell / Published: April 19, 2021

Sam Lovell, Communications Manager. 

“How many of you know, when you send your child to school, the fountain they’re drinking out of is not fed by a lead pipe?”

That stark question was posed by President Biden in a briefing following the announcement of the American Jobs Plan. The President’s historic infrastructure package includes $45 billion to fully replace lead pipes across the country. This has caused a surge of attention nationally on the problem of lead pipes, as administration officials and members of Congress voice support of the plan and local media outlets report on the implications of the investment.

And this attention is well-placed: across the country, an estimated 9.2 million lead service lines still provide water to US homes – putting children at risk of lead exposure and permanent harm to their brain development. While this has been an issue for far too long, this recent momentum – with the inclusion of funding in the American Jobs Plan and in several bills moving in both the House of Representatives and the Senate – is a promising sign that action is near.

Read More »

Posted in Drinking water, Lead, Public health / Tagged , , , , | Authors: / Comments are closed

The damage done, Part 2: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

By / Published: April 9, 2021

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

Part 2 of a 2-part series (see Part 1 here)

Last week’s announcement by EPA about improvements it is making to EPA’s reviews of new chemicals under the Toxic Substances Control Act (TSCA) indicated it will begin by reversing two of the most damaging policy changes the Trump EPA made to the program:

Under the Trump EPA policies being reversed, at least 425 new chemicals were granted unfettered market access despite potential risks or insufficient information.

  • EPA will cease avoiding issuance of the binding orders TSCA requires to address potential risk or insufficient information:
    “EPA will stop issuing determinations of ‘not likely to present an unreasonable risk’ based on the existence of proposed SNURs [Significant New Use Rules]. Rather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks. Going forward, when EPA’s review leads to a conclusion that one or more uses may present an unreasonable risk, or when EPA lacks the information needed to make a safety finding, the agency will issue an order to address those potential risks.”
  • EPA will cease assuming workers are adequately protected from chemical exposures absent binding requirements on employers:
    “EPA now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. Where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are adequately protected under OSHA’s worker protection standards and updated Safety Data Sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA section 5(e) order, as appropriate.”

If you want the details on what was wrong with these policies – legally, scientifically, and health-wise – see EDF’s comments submitted to the agency last year and a summary of them here.

It’s no accident that these two policies were prioritized for reversal.  As I discuss below, each had massive adverse impact on the rigor and outcome of EPA’s reviews of new chemicals.  The result was that the Trump EPA allowed many hundreds of new chemicals to enter commerce under no or insufficient conditions.  It did this by:  1) illegally restricting its review to only the intended uses of a new chemical selected by its maker, hence failing to follow TSCA’s mandate to identify and assess reasonably foreseen uses of the chemicals; and 2) dismissing significant risks to workers that its own reviews identified, despite TSCA’s heightened mandate to protect workers.  Read More »

Posted in Health policy, TSCA reform, Worker safety / Tagged , , , | Authors: / Comments are closed

The damage done, Part 1: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

By / Published: April 8, 2021

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

Part 1 of a 2-part series (see Part 2 here)

With last week’s announcement by EPA that it intends to reverse two of the most damaging policy changes the Trump EPA made to EPA’s reviews of new chemicals under the Toxic Substances Control Act (TSCA), there is hope that going forward EPA’s reviews will once again conform to TSCA’s requirements and better protect workers, consumers, the public and the environment.

Predictably, the chemical industry and its phalanx of law firms – who demanded and embraced the Trump EPA’s policy reversals – have been howling loudly, doing their best impressions of Chicken Little.  They predict huge backlogs and economic calamity of all sorts, including an end to American innovation, and their lawyers are already threatening legal action – a clever way to drum up business, no doubt.

The fact is that EPA spends scarce resources reviewing hundreds of new chemicals every year that their manufacturers are not serious about – and often not in any hurry about – commercializing.  And industry then uses any delays in those reviews to argue that the review process is too rigorous and demand that it be scaled back.

But facts are stubborn things.

In this first post I’ll look at a few reasons why the industry’s new round of fear-mongering is not based in fact.  And in a second post I’ll look at the decisions on new chemicals made under the Trump EPA to shed more light on the real reason why industry is upset:  It just may have lost the inside track that yielded such high dividends in the form of flawed approvals of hundreds of new chemicals.  Or, as one prominent industry attorney bluntly said recently in a related context, “the good days are over, quite frankly.”  Read More »

Posted in Health policy, Industry influence, TSCA reform / Tagged , , | Authors: / Comments are closed

At all costs: Failings of Trump EPA’s proposed TSCA fee rule

By Lindsay McCormick / Published: April 7, 2021

Lindsay McCormick, Program Manager and Richard Denison, Ph.D., Lead Senior Scientist

When Congress reformed the Toxic Substances Control Act (TSCA) in 2016, it authorized EPA to require companies to pay fees to help defray the agency’s costs of administering this extensive new law.  EPA finalized the first “fee rule” in 2018 to establish the payment framework.  Under TSCA, EPA is to adjust the fees every three years both to account for inflation and to ensure it is recouping the authorized portion of agency costs to implement the law.

Therefore, developing an accurate estimate of the agency’s costs to implement TSCA is critical.  Not only does this provide the baseline by which to establish industry fees (as EPA is to set the fees so as to recoup 25% of its program costs), but it should serve as a north star to identify the true resource needs to lawfully implement TSCA.

Recent reports by the Government Accountability Office and EPA’s Office of Inspector General found that EPA’s ability to assess and manage chemicals regressed over recent years due to lack of workforce or workload planning to ensure the agency can carry out its duties.  Both reports recognize the greatly increased scope of work under amended TSCA, and EPA’s failure to translate that into additional staff and resource needs.  Establishing a robust, accurate budget for administering TSCA is the first step to rectifying this problem.

Despite the alarm bells rung by these two watchdogs, the Trump EPA’s proposed revised fee rule seems to have lost sight of Congress’ purpose in expanding EPA’s fee authority.  The proposed rule invokes a new purpose entirely divorced from TSCA: to reduce asserted burdens on industry – without regard to the impacts that will have on EPA’s ability to implement the law or on ensuring health and environmental protection from chemical exposures.  As a result, EPA underestimated its costs and proposed fees such that, if finalized, would push an undue portion of its costs onto the taxpayer.

Below we summarize the major concerns about the fee rule proposal that we detailed in our comments submitted to the agency late last month. Read More »

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

Re-visioning TSCA: Address the cumulative impacts of chemical exposures

By / Published: April 1, 2021

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

Part 4 of a 4-part series – see Part 1, Part 2, and Part 3 here

This series of blog posts is looking ahead toward opportunities to advance a more robust and holistic vision for implementing the Toxic Substances Control Act (TSCA) as reformed in 2016.

We discussed in the preceding installments of this series the importance of ensuring that combined exposures to a chemical from multiple sources and the greater exposures and susceptibilities of certain groups are accounted for.  But it is critical to also recognize that many other factors influence the impacts chemical exposures have on our health.  This final installment in our series will discuss how TSCA can and should take into account all of these factors – that is, account for cumulative impacts.

Read More »

Posted in Health policy, Health science, TSCA reform / Tagged , | Authors: / Comments are closed