Monthly Archives: October 2019

Without a food safety overhaul for additives, the innovative food craze could spiral out of control

Tom Neltner, J.D.Chemicals Policy Director

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At an FDA-sponsored conference, EDF proposed a new path forward to ensure innovative food ingredients are safe by overhauling how food additives are regulated today.

[/pullquote]Every day brings reports of new ingredients that food innovators around the world have developed to meet consumer demands for a healthier and more sustainable food supply. The innovations range from new ways to extract useful additives from existing sources such as algae to bioengineering to make novel ingredients like sweeteners or proteins that can be grown in a tank instead of on a farm.

At EDF, we encourage innovation that helps communities and the environment thrive, especially in the face of the threats posed by climate change. However, an innovator’s bold claims, especially those involving food safety, must be closely scrutinized before the additive hits the marketplace. Given the potential for harm to consumers, we cannot simply take a company’s assertion of safety at face value – there must be transparency and the Food and Drug Administration (FDA) must provide an independent review.

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

EPA’s just-released methylene chloride draft risk evaluation: Some important context

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

After more than a month’s delay, EPA today released its draft risk evaluation for methylene chloride.  Running to 725 pages (not counting more than a dozen supplemental files), it will take some time to digest.  But here are some initial observations that provide context for those of you who will be looking closer.

First, methylene chloride is a very nasty chemical.  It has killed a lot of people.  It causes cancer.  Short- and long-term exposure to it is tied to liver effects, immune system effects, nervous system effects, and reproductive/developmental effects.

So it shouldn’t be surprising that EPA’s draft – even coming from an administration not known to be overly worried about the risks of chemicals – has found that most industrial, commercial and consumer uses of methylene chloride present unreasonable risks.

For example, EPA found that workers using methylene chloride-based paint strippers face high risks.  Of course, we knew that already:  EPA identified those risks more than five years ago, and proposed to ban those uses.  This EPA decided it had to do it all over again – which means that thousands of workers have continued to be unnecessarily exposed to this deadly chemical.  And it will be even more years before we get back to where we were before EPA took its mulligan.

So the good news is that EPA seems to be acknowledging that methylene chloride presents high enough risks to warrant regulation under the Toxic Substances Control Act (TSCA).

The bad news is that EPA is dramatically underestimating the magnitude of methylene chloride’s risks – by pulling the same tricks it has for other chemicals among the first 10 it is evaluating under TSCA:

  • EPA once again ignores all exposures and risks to the general population by falsely assuming those exposures and risks are eliminated by actions it has taken or could take under other laws. That means ignoring over 4 million pounds of methylene chloride annually released to air, water and land.  See this backgrounder for the details and why this EPA assumption about methylene chloride is deeply flawed.
  • EPA once again grossly understates risks to workers:
    • EPA assumes that workers will always wear fully effective personal protective equipment (respirators and gloves) to make many of the risks it identifies go away – and to grossly understate the magnitude of the unreasonable risks it does find.
    • EPA once again finds a cancer risk to workers unreasonable only if it exceeds a level of 1 in 10,000 – which is 100 times higher a risk than warrants regulation under TSCA to protect workers and other vulnerable subpopulations.
    • For occupational non-users (ONUs), EPA has once again failed to identify unreasonable risks for the most highly exposed, and hence most vulnerable, workers unless it finds that the majority of workers also face unreasonable risks.

These are just a few initial observations based on our reading of EPA’s opus so far.

So while it’s somewhat encouraging that this new draft risk evaluation has found many more risks than previous drafts, we can already tell the draft falls far short of adequately describing the risks presented by methylene chloride.

Stay tuned.

Posted in Health policy, Health science, Public health, Regulation, TSCA reform, Worker safety / Tagged , , | Comments are closed

EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

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Posted in Emerging science, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: / Comments are closed

Another EPA risk evaluation grossly understates risks, this time of 1-bromopropane

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

On Friday EDF filed detailed comments with the Environmental Protection Agency (EPA) critical of its draft risk evaluation for the carcinogenic solvent, 1-bromopropane (or 1-BP).  As was the case with 1,4-dioxane, EPA has grossly understated the risks from exposure to this chemical, for both cancer and non-cancer health effects.  EPA has also inappropriately dismissed human studies that show neurological effects at 1-BP exposures lower than EPA assumed to be safe.

While the draft risk evaluation did find that some uses of 1-BP present unreasonable risks, even in those cases it understated the extent of the risk – which, if not ameliorated, means that any regulation it subsequently promulgates will be under-protective.

EPA has also abdicated its responsibility under the Toxic Substances Control Act (TSCA) to identify and evaluate the risks the chemical presents to consumers and the general population by excluding from its risk evaluation conditions of use and exposures that are known or reasonably foreseen.  EPA has not met its mandatory duty under TSCA to thoroughly identify and evaluate the risks to vulnerable subpopulations.  EPA has utterly failed to utilize the enhanced authorities Congress granted it in 2016 to ensure that it has or obtains robust information on 1-BP’s uses, hazards and exposures, resulting in serious information and analytic gaps and deficiencies that severely undermine the scientific quality of its risk evaluation.

Below we list major concerns that EDF addressed in our comments (with references to the corresponding section of the comments).  Read More »

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Latest federal data on lead in food suggests progress made in 2016 was fleeting

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

The Food and Drug Administration’s (FDA) Total Diet Study (TDS) is an important source of data for both the agency and the public to estimate exposure, track trends, and set priorities for chemical contaminants in food. EDF analyzed TDS data for samples the agency collected from 2003-2013 in our 2017 report to reveal that lead in food was a hidden health threat. In follow-up blogs using TDS data from 2014-2016, we reported that overall trends for detectable rates of lead appeared to be on the decline, especially in 2016. In our analysis, we summarized that the trends were both good news and bad news for children because there were stubbornly high rates of detectable lead in baby food teething biscuits, arrowroot cookies, carrots, and sweet potatoes.

In this blog, we analyze the latest lead in food TDS data, released by FDA in August, and we take a new look at the trends. Overall, the 2017 data reversed the progress in 2016, largely driven by the percent of samples[1] with detectable lead in prepared meals nearly doubling from 19% to 39%. The good news is that fruit juices continued their dramatic and steady drop in samples with detectable lead, from 67% in 2016 to 11% in 2017. When we compared results for baby foods to similar samples of regular fruits and vegetables, the most notable finding was that baby carrots and peeled and boiled carrots had significantly lower detection rates than baby food carrot puree. Additionally, we were surprised to find that 83 of 84 samples of canned fruit had detectable levels of lead.

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Next TSCA chemical peer reviews and draft risk evaluations to be delayed. You’ll never guess why.

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

We’re hearing that EPA has cancelled the next meeting of its Scientific Advisory Committee on Chemicals (SACC), which was scheduled for October 21-25.  The SACC is conducting peer reviews of EPA’s draft risk evaluations of the first 10 chemicals to undergo safety reviews under the Toxic Substances Control Act (TSCA).

Word is that the panel was to use its October meeting to peer-review the draft risk evaluations for methylene chloride and N-methylpyrrolidone (NMP).  But release of those drafts has been delayed, leaving insufficient time for the SACC to review them before the meeting.

We’re also hearing why release of the drafts has fallen behind.  The drafts were on track for release late last month, but apparently were blocked based on objections about at least the draft risk evaluation for methylene chloride.  The objections were lodged by Dr. Nancy Beck.  Read More »

Posted in EPA, Health policy, Health science, Industry influence, TSCA reform / Tagged , | Read 1 Response