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Selected tag(s): Exposure and hazard

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Health science, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Also tagged , , , , | Authors: , / Comments are closed

New Draft of House Chemical Safety Bill Falls Short; EDF Calls on All Sides to Redouble Effort

By Richard Denison / Published: April 29, 2014

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

Release in response to today’s House Environment and Economy Subcommittee hearing on a revised discussion draft of the Chemicals in Commerce Act (CICA)

Today’s hearing makes clear that the discussion draft has made progress but still falls far short of legislation that will fix the fundamental flaws of the current law, according to Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. He urged all sides to keep the bipartisan process moving forward in both houses of Congress.

“While bipartisan discussions have yielded a number of substantial improvements to address serious concerns with the original draft, the most problematic provisions remain virtually untouched,” Denison said. “The goal now should be to keep the conversations going.”

Examples of progress include giving the Environmental Protection Agency (EPA) authority to require testing where data are insufficient for prioritization purposes; incorporation of deadlines for agency action to assess and address risks of high-priority chemicals; and less prescriptive and onerous information quality and evaluation requirements.

Sections of the draft pose major concerns and fail to strike a fair and reasonable balance. Examples include the sweeping preemption of state authority for chemicals never subject to a thorough EPA safety review; overly broad allowances for companies to mask the identity of chemicals even long after market entry; and a failure to ensure that conditions placed on new chemicals apply to all companies making or using them.

“We’re optimistic that solutions are at hand that address the needs of all stakeholders, but it is going to take a redoubling of effort by all sides to get there,” he said.

 

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

The perverting of prioritization: How a good idea for TSCA reform went bad – and how to save it

By Richard Denison / Published: April 22, 2014

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

For years, the concept of prioritization as an element of TSCA reform has enjoyed support from a broad array of stakeholders.  The number of chemicals in active commerce is large, if uncertain:  surely less than the 85,000 listed on the TSCA Inventory, but still in the tens of thousands. That sheer number demands that EPA develop and apply a process to decide where to start and how to sequence the enormous task of reviewing the safety of those chemicals. 

There has also been widespread agreement that EPA should make an initial pass using available information to identify three groups of chemicals:  a) those that present significant hazard or exposure potential or both; b) those for which existing information doesn’t raise such concerns; and c) those that need more information to determine their level of concern.

As conceived, prioritization was to be a low-stakes proposition for the various stakeholders, simply the means to get the new system up and running.  Prioritization decisions would not be final actions; rather, they were expressly designed to minimize dispute, and would be barred from legal challenge.  Chemicals identified as high priority and in need of immediate scrutiny would get a more thorough assessment before any decision as to whether they posed significant risk and required a regulatory response.  Chemicals identified as low-priority would be so designated provisionally based on less than a thorough assessment, and could be revisited if and when new information arose.  And chemicals lacking sufficient information to be prioritized would be subject to further data collection and generation, and then funneled back into the prioritization process.

These concepts are well-established both in the outcomes of industry-NGO negotiations and in heavily negotiated provisions of the more recent incarnations of the Safe Chemicals Act.

But then some folks got greedy.  Read More »

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

Unnerving developments in the state of the evidence on developmental neurotoxicity

By Rachel Shaffer / Published: February 18, 2014

Rachel Shaffer is a research assistant.

Seven years ago, leading children’s environmental health experts Philippe Grandjean and Philip Landrigan published a groundbreaking review that identified five chemicals prevalent in the environment—lead, methylmercury, polychlorinated biphenyls (PCBs), arsenic, and toluene—as developmental neurotoxicants. In their follow-up review released last week, they have added six more chemicals—manganese, fluoride, polybrominated diphenyl ethers (PBDEs), chlorpyrifos, DDT, and tetrachloroethylene (PERC)—to this list. The implications of early-life exposures to these common compounds, say the authors?  A “global silent pandemic of neurodevelopmental toxicity.”  Read More »

Posted in Emerging science, Health policy, Health science / Also tagged , , , , | Read 2 Responses

A full month after West Virginia spill, many questions linger … along with the chemical’s distinctive odor

By Richard Denison / Published: February 9, 2014

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

Today marks exactly a month since what is now said to be 10,000 gallons of “crude MCHM” – mixed with what was later found to have included other chemicals – spilled into West Virginia’s Elk River, contaminated 1,700 miles of piping in the water distribution system for nine counties, and disrupted the lives of hundreds of thousands of the state’s residents. 

Despite declining levels of the chemical in the water being fed into the distribution system, late this past week five area schools were closed due to detection of the distinctive licorice-like odor of MCHM and multiple reports of symptoms such as eye irritation, nausea and dizziness among students and staff.

The latest sampling data (for February 7 and 8) at locations such as area fire hydrants and hospitals and at schools shows that MCHM is at non-detect levels (<10 parts per billion) in most samples, but the chemical is still being detected in a minority of the samples despite extensive flushing.  Despite repeated calls to do so, officials appear to have yet to conduct any sampling of taps in residents’ homes.

This past week also featured a press conference by state and federal officials seeking to explain their response to the spill (a video of the entire press conference is available in four parts here; it’s worth watching).  [UPDATE 3/29/14:  As this link no longer works, here are updated links to Part 1, Part 2, Part 3 and Part 4 of the press conference.]

Today’s Charleston Gazette features the latest in a long series of outstanding front-line reports by Ken Ward, Jr., and his colleagues, who have closely followed every twist and turn of both the spill and the government’s response to it.  Today’s article makes clear the extent to which federal officials were winging it in the hours and days after the spill was discovered as they rushed to set a “safe” level for MCHM in tap water.

In this post I’ll delve a little deeper into CDC’s rush to set the “safe” level and the many ways in which CDC inadequately accounted for major data gaps and uncertainties.  I’ll end by saying what I think CDC should have done instead.  Read More »

Posted in Environment, Health policy, Health science / Also tagged , | Read 2 Responses

Should we be holding our breath waiting for more information on risks of the chemical spilled in West Virginia?

By Richard Denison / Published: January 30, 2014

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

A hearing held yesterday by the West Virginia Legislature’s Joint Legislative Oversight Commission on State Water Resources created quite a stir, when a witness – West Virginia Environmental Quality Board vice-chairman Scott Simonton – said that the human carcinogen formaldehyde had been detected in several water samples drawn from a Charleston, WV, restaurant, and that people in the area affected by the January 9 spill could be expected to have inhaled the chemical, which he identified as a likely breakdown product of the spilled material, crude MCHM.  See stories in the Charleston Gazette and USA Today.

State officials and the West Virginia American Water company were quick to call Simonton’s claims “unfounded” and “misleading and irresponsible,” respectively.  The controversy led even the American Chemistry Council – which has laid low ever since the spill – to quickly issue its first statement related to the spill through its Formaldehyde Panel.

While experts are noting that data are insufficient to identify the spill as the source of any formaldehyde detected in the water samples, this new kerfuffle does point to yet another major data gap on crude MCHM.

The one part-per-million (1 ppm) “safe” level state and federal officials set was based on limited data from studies in which rats were exposed to crude or pure MCHM through oral ingestion.  Absolutely no data are available on the chemical with respect to exposure through inhalation.  Yet officials did not hesitate to tell residents the 1 ppm level would be safe not only for drinking the water, but also for bathing and showering.

(It’s curious that the Eastman Chemical Company apparently performed no inhalation studies on crude or pure MCHM, given that Eastman said its motivation for the studies it did perform was to understand risks to workers in industrial settings, and its safety data sheet for crude MCHM prominently notes the potential for health concerns for workers from inhalation.)

[UPDATE 1/31/14:  This morning, Eastman posted an updated version of its Q&A document on its website (linked to in the above paragraph), and took down the earlier version.  Here is the original version, the updated version dated 1/31/14, and a redline comparison of the two versions.]

Clearly the material that spilled is volatile – that’s why people can smell it.  Taking a hot shower in such water means that people would clearly be exposed via inhalation of the vapor; how much exposure would occur has not been ascertained.  But in the absence of any data as to toxicity of the chemical via inhalation, there is simply no scientific basis on which to say or imply that showering in water contaminated at 1 ppm level was OK.

Chemicals can be more or less toxic by inhalation than by ingestion, with one study finding inhalation to be the more toxic route for half of the chemicals examined and oral ingestion to be the more toxic route for the other half.  Benzene, for example, is estimated to be several hundred times more toxic by inhalation than by ingestion, while inhalation of chloroform is estimated to be about 25-fold lower in toxicity than it is by ingestion.

What such comparisons indicate is that extrapolating from data on oral toxicity to predict inhalation toxicity – which is effectively what government officials did in this case – is about as accurate as flipping a coin.

Posted in Environment, Health policy, Health science / Also tagged , , | Read 3 Responses