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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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 »

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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 »

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PART 2: 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

This post shows why the chemical industry has been so anxious to convince EPA to defer to OSHA rather than regulate worker risks from new chemicals under TSCA.

I started blogging last week about myths the chemical industry is perpetrating when it comes to EPA’s review of the risks new chemicals may present to workers.  In this post, I address another such myth, one that the industry promotes to argue why the Environmental Protection Agency (EPA) can and should defer to the Occupational Safety and Health Administration (OSHA) in addressing the risks posed by new chemicals under the Toxic Substances Control Act (TSCA).  This myth was on full display at last week’s House Energy & Commerce Committee hearing on EPA’s failures to protect workers from chemical risks.

Myth #2:  OSHA regulations provide ample protection of workers from any exposures to new chemicals EPA is reviewing under TSCA.   Read More »

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PART 1: Busting 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

This week the House Energy & Commerce Committee held a hearing on EPA’s failures to protect workers from chemical risks.  It featured a number of compelling testimonies from worker representatives:  auto workers, firefighters, teachers, and farmworkers.  It also featured testimony from a former Occupational Safety and Health Administration (OSHA) official, who made the case for why it is so critical that the Environmental Protection Agency (EPA) comply with the mandates and use the enhanced authorities Congress gave the agency under the Toxic Substances Control Act (TSCA) to protect workers exposed to chemicals.  He detailed why OSHA is unable to do so, describing OSHA as “outmatched” and having “exhausted its capacity” in the face of decades of severe budget cuts and limited legal authority.

The chemical industry is perpetuating damaging myths about worker protection at EPA and OSHA, which have unfortunately taken a firm hold in the Trump EPA.

Unfortunately, the hearing also included testimonies from two chemical industry representatives who painted a highly deceptive picture of what EPA has done to protect workers under the new TSCA and the adequacy of OSHA regulations regarding chemical risks in the workplace and the extent of compliance with them.  This and future posts will address the damaging myths these witnesses are perpetuating, which have unfortunately taken a firm hold in the Trump EPA.

Myth #1:  EPA is committed to protecting workers when reviewing new chemicals under TSCA.   Read More »

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GAO affirms the Trump EPA’s political manipulation of the IRIS formaldehyde assessment

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

I blogged last month about the Trump EPA’s corrupt actions to bury the long-awaited assessment of the carcinogen formaldehyde conducted by the agency’s Integrated Risk Information System (IRIS) program.  That post cited an article in the Wall Street Journal that noted a forthcoming report by Congress’ Government Accountability Office (GAO) that was expected to expose the suspect process used by conflicted political appointees at EPA to prevent public release and completion of that scientific assessment over the past 15 months.  We also noted disturbing indications that EPA intends to redo the assessment of formaldehyde under the Toxic Substances Control Act (TSCA), under the control of political appointees who came to EPA directly from the chemical industry’s main trade association and while there led its efforts to undermine IRIS.

GAO confirms in spades the concerted efforts by the agency’s political leadership to fabricate a rationale for abandoning the formaldehyde assessment, which has been ready for public and peer review since the fall of 2017.

GAO’s report is out, and yesterday it featured prominently at a Senate hearing at which top GAO officials testified.  That testimony confirms in spades the recounting in our earlier blog post of the concerted efforts by the agency’s political leadership to fabricate a rationale for abandoning the formaldehyde assessment, which has been ready for public and peer review since the fall of 2017.

In the wake of the GAO report, Senator Carper and other members of Congress from both houses have sent a letter to EPA Administrator Andrew Wheeler calling on him to complete the formaldehyde assessment and release documents pertaining to potential ethical and scientific integrity policy violations by EPA political appointees.

I won’t further rehash our earlier post, but will simply post a key excerpt from the hearing, an exchange between Senator Tom Carper (DE) and Mark Gaffigan, Managing Director for Natural Resources and Environment at GAO.  I’ll highlight some key passages in which GAO describes what its investigation found.

EXCERPT FROM YESTERDAY’S GAO TESTIMONY   Read More »

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