EDF Health

EDF asks judge to rule on legality of FDA rule allowing companies to secretly decide on chemicals in our food

Tom Neltner, J.D.is Chemicals Policy Director

At the end of March, EDF, represented jointly by counsel from Earthjustice and the Center for Food Safety (CFS), asked a federal district court judge to decide as a matter of law that the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) regulation is unlawful. The GRAS Rule allows food manufacturers to make secret safety determinations for chemicals added to food without notifying FDA or the public and to use such chemicals. If the judge agrees to our request, this would vacate the rule. Two years ago, EDF and others challenged the legality of the GRAS Rule in the Federal District Court for the Southern District of New York. Last September, the court ruled that plaintiffs EDF and the CFS have standing, setting the stage for a decision on the merits of the case.

In the Motion for Summary Judgment, we identify the following four ways in which FDA violated the law in the GRAS Rule. FDA has until May 28 to respond to our motion.

  1. FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food.

When Congress enacted the Federal Food Drug and Cosmetic Act (FFDCA) of 1938, it gave FDA the responsibility to ensure the nation’s food is safe and free from harmful substances. To implement this responsibility, it provided the agency broad authority to adopt necessary regulations.

Unfortunately, in the GRAS Rule, instead of fulfilling its responsibility to keep food safe, FDA formally and unlawfully outsourced its responsibility to the regulated entities themselves – namely, for-profit additive manufacturers – allowing them to decide for themselves, in secret, whether the chemical substances they have manufactured can be added to food. This unlawful delegation – made without express statutory authorization – makes it all but impossible for FDA to fulfill its obligations under the FFDCA.

As a result, the GRAS Rule impermissibly allows regulated, private companies with obvious conflicts of interest to self-certify the use of their chemical additives as GRAS without notifying FDA. This is not a case where FDA is seeking legitimate outside input to gather factual information or advice and make policy recommendations. Here, FDA retains no oversight over these secret GRAS determinations that directly affect the safety of our food and thus render it impossible for the agency to fulfill its statutory mandate to keep our food safe.

By delegating its authority in the GRAS Rule, the agency violated Constitutional principles, the FFDCA, and the Administrative Procedures Act (APA). The rule effectively insulates the agency from democratic accountability for food safety decisions and denies citizens their right to seek judicial review of decisions about the safety of substances that may be added to food.

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Posted in FDA, Food, GRAS, Industry Influence / Tagged , , | Leave a comment

How toxic is oilfield wastewater? New paper highlights gaps in our understanding.

This post originally was published on the Energy Exchange Blog.

By Cloelle Danforth and Nichole Saunders.

Jennifer McPartland contributed to this post.

Collaborative research is a critical element for identifying unforeseen risks associated with using the oil industry’s wastewater outside the oilfield. That’s the recommendation of a new peer-reviewed paper accepted this week in the Journal of Integrated Environmental Assessment and Management (IEAM).

The paper comes at a crucial moment for the oil and gas industry, which generates some 900 billion gallons of salty, chemical-filled water (also called produced water) each year. Traditionally, companies dispose of this wastewater deep underground where it is less likely to cause contamination. But economics and water scarcity are forcing questions about other ways to treat, reuse and even repurpose this wastewater. In fact, the Environmental Protection Agency (EPA) will release a report very soon that could make it more common for companies to discharge their wastewater into rivers and streams.

The IEAM paper outlines the conclusions of a multi-day toxicity workshop where experts from the oil and gas industry, academia, government and the environmental community collectively identified key knowledge gaps associated with this waste stream and determined tools, technologies and methods needed to help close those gaps.

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Posted in Environment, Health Science, Public Health / Tagged | Leave a comment

Latest available national data shows increase in blood lead levels for at least 2 million kids

Tom Neltner, J.D.Chemicals Policy Director

In February, the Centers for Disease Control and Prevention (CDC) released a report summarizing the biomonitoring data from its National Health and Nutrition Examination Survey (NHANES). Given EDF’s focus on protecting children from lead exposure, we went straight to the most recent blood lead monitoring results. The results are disturbing. As shown in Figure 1 below, after years of progress, in 2015-16 the blood lead levels (BLLs) of more than 2 million young children[1] increased:

  • Average child BLL: 48% BLL decrease from 2007-8 to 2013-14 but only a 3% decrease in 2015-16.
  • 75th percentile BLL (75% of children are below this level): 51% decrease from 2007-8 to 2013-14 but a 2% increase in 2015-16.
  • 90th percentile BLL: 51% decrease from 2007-8 to 2013-14 but an 18% increase in 2015-16.
  • 95th percentile BLL: 45% decrease from 2007-8 to 2013-14 but a 23% increase in 2015-16.

As with the smaller uptick in 2007-08 (which may have been related to the housing crises), it may only be short-term setback, nonetheless it bears careful examination.

Even more disturbing is the Trump Administration’s response to this information. The Administration:

  • Ignored the data in the rosy picture of progress it painted in its recent Lead Action Plan; and
  • Appears to be repeating mistakes of the past by proposing to slash CDC’s childhood lead poisoning prevention budget in half.

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Posted in EPA, Health Policy, lead / Tagged , | Leave a comment

Wheeler piles on more deception trying to defend EPA’s corrupt actions on formaldehyde

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

In a series of recent hearings Environmental Protection Agency (EPA) Administrator Andrew Wheeler has sought to justify his and his agency’s corrupt decisions to kill off a health assessment of formaldehyde done by career scientists in the agency’s science arm (IRIS) and resurrect it under the control of conflicted political appointees.

Once again, the Trump EPA is elevating private interests over the public interest – and offering up deceptions to try to obfuscate and cover up its real intent.

Recall that under Wheeler’s and his predecessor’s leadership, a draft of the IRIS assessment, ready since fall 2017 for release for public comment and peer review, has been suppressed.  Also recall that EPA leadership ran a phony priority-setting process last fall under the direction of yet another conflicted political appointee in order to claim that the IRIS formaldehyde assessment is no longer a priority for the agency.  Aspects of this scheme were highlighted in a recent report of Congress’ Government Accountability Office (GAO).  Finally, recall that a scant few weeks after that pronouncement, EPA declared last month that it intends to name formaldehyde a “high-priority substance” under TSCA.

Now to the next installment in this corrupt scheme:  Read More »

Posted in EPA, Health Policy, Industry Influence / Tagged | Leave a comment

EDF analysis: Lead service lines in Illinois communities

Tom Neltner, J.D.Chemicals Policy Director

Building statewide, comprehensive inventories of lead service lines (LSLs) in community water systems (CWSs) is a critical part of any effort to eliminate lead pipes. With a solid inventory, states can conduct a credible needs assessment and engage the public in supporting community efforts to replace LSLs.

In January 2017, the Illinois legislature passed a law designed to reduce children’s exposure to lead in drinking water. It included a requirement that CWSs submit annual reports to Illinois Environmental Protection Agency (IEPA) regarding a “water distribution system material inventory” by April of each year. EDF sees Illinois’s approach to developing an inventory as a model to be considered by other states because it:

  • Requires all CWS to report (unlike Indiana which had a well-designed one-time voluntary survey but only a 57% response);
  • Covers the entire service line (unlike California which ignored the portion of the service line on private property); and
  • Requires annual updates to track progress, especially in reducing the number of service lines with unknown materials (unlike Michigan which requires updates only every five-years).

In August 2018, IEPA released a summary of the first year submissions and has updated it several times. IEPA indicated that 95% of CWSs submitted reports and provided totals of each type of piping material reported with 414,895 LSLs and 1,504,748 of unknown material. At the time, the agency did not provide information on what each CWS reported.

Making totals public is important but does little to engage the public in understanding what the information means for their community. But earlier this week, IEPA published an online tool, which allows residents to search for their water system and download the data for individual reports of the types of materials currently reported by their water system.  EDF also received the information pursuant to a Freedom of Information request. Click here to see the data for all the CWSs in a spreadsheet. We also used an EPA database to identify the 84 CWSs that did not comply with the law.

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Posted in Drinking Water, lead, Public Health / Tagged , , , | Comments are closed

PART 3: Busting more industry-perpetrated myths about new chemicals and worker protection under TSCA

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

Part 1          Part 2         Part 3

I have been blogging in the last few weeks about myths the chemical industry is perpetrating about the adequacy and legality of the Environmental Protection Agency’s (EPA) recent reviews of the risks that chemicals just entering the market may present to workers.  In this post, I address another such myth that, unfortunately, EPA has swallowed hook, line, and sinker.  This myth was laid out by one of the industry witnesses at the March 13 House Energy & Commerce Committee hearing on EPA’s failures to protect workers from chemical risks.

One wonders when EPA will start doing what Congress told it to do, first in 1976 and then again, with renewed vigor in 2016:  Protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

I’ll get to this third myth in a moment.  But let me first try to crystallize what is at stake in this debate.  While the Toxic Substances Control Act (TSCA) has always given EPA authority to regulate workplace risks, the 2016 amendments to TSCA strengthened EPA’s authority and mandate to protect workers.  TSCA now expressly identifies workers as a “potentially exposed or susceptible subpopulation.”  See the definition of that term in paragraph 12 here.  TSCA then requires EPA to identify and assess potential risks to such subpopulations when reviewing both new and existing chemicals.  Finally, it requires EPA to use its TSCA authorities to impose restrictions on any chemical found to present an “unreasonable risk” – which is TSCA’s health standard – to any such subpopulation.

In a word, TSCA requires EPA to protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

Both before and after the 2016 TSCA amendments, the chemical industry has sought to compel or convince EPA not to regulate workplaces under TSCA, and instead to defer to OSHA.  Industry wants this because OSHA’s authority and capacity are severely limited and its legal requirements for regulating toxic substances (“health standards” in OSHA parlance) allow vastly greater risks to workers than do TSCA’s (see my previous post).

Sadly, under the Trump EPA, industry is getting its wish.  At industry’s urging, EPA is acting in a manner that is wholly contrary to TSCA – and is less health-protective than even under TSCA before the 2016 reforms.

Now let’s get back to more myth-busting.   Read More »

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform, Uncategorized, Worker Safety / Tagged , , , | Comments are closed