EDF Health

Did your kids have a hyper holiday? Why those vibrantly colored treats need a warning label

Terry Hyland, Communications Manager

Many parents have experienced that foreboding sense of what might come next as they watch their child indulge in a decadent treat at a holiday gathering or birthday party. All that sugar means things are about to get a little crazy, right?

While sugar has its own issues, perhaps the source of that burst of hyperactivity is another ingredient: the synthetic dyes that brighten many of our sweet treats, and many of the not-so-sweet ones too.

Last year, California government scientists at the Office of Environmental Health Hazard Assessment (OEHHA) released a report finding that commonly used synthetic food dyes can lead to hyperactivity and other neurobehavioral problems in children, with some reacting very strongly to relatively small amounts of colorants. Children’s exposure is also higher compared to adults.

That stands to reason. According to OEHHA, the most common food items associated with food dye exposures include icings, fruit-flavored and juice drinks, sodas, and breakfast cereals. And it is not only the more than 6 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) that may be particularly sensitive to synthetic dyes; kids without pre-existing behavioral disorders can also be affected. Read More »

Also posted in FDA, Food / Tagged , | Read 1 Response

Industry-requested risk evaluation for D4 under TSCA: EPA has improved its scoping approach, but must go further

Lauren Ellis, Research Analyst, Environmental Health

Earlier this week, EDF submitted comments to EPA on the agency’s draft scope for the manufacturer-requested risk evaluation of D4 under the Toxic Substances Control Act (TSCA). This is EPA’s first draft scope under the Biden Administration – providing an opportunity to see where improvements have been made and where challenges still exist (see EDF’s and others’ comments on the last set of draft scopes under the Trump Administration).

In our comments, we applaud the agency for developing a more comprehensive chemical risk evaluation plan than EPA provided in past scopes. For instance, in its draft scope document, EPA indicated its intent to assess exposure occurring via environmental release to capture fenceline exposures – a necessary step toward addressing environmental justice considerations under TSCA. EPA also indicated it would not assume the use of personal protective equipment (PPE) when evaluating and making determinations on potential risks to workers – a highly problematic approach taken in the past. However, the draft D4 scope also revealed areas still needing further improvement, including greater detail on how the agency will approach differential risks across the population and address combined exposures from different sources.

Last year, the Silicones Environmental, Health and Safety Center (SEHSC), on behalf of Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation, asked EPA to evaluate D4, or octamethylcyclotetrasiloxane, under TSCA’s provisions governing manufacturer-requested risk evaluations. In October 2020, EPA granted that request. Critically, when conducting manufacturer-requested risk evaluations, EPA must adhere to the same requirements under TSCA as EPA-initiated risk evaluations, including consideration of all reasonably available information and use of the best available science.

D4 is a high production cyclic siloxane chemical, with an annual U.S. production volume of 750 million to 1 billion pounds. It has widespread industrial, commercial, and consumer uses, including as a reactant to make other silicone chemicals; in adhesives, paints, and plastic products; and in food packaging, personal care products (e.g., hair, skin, and nail products), over-the-counter medications (e.g., anti-gas drugs), and medical devices (e.g., breast implants).

D4 hazard, exposure, and risk has been considered by the Government of Canada and the European Chemicals Agency, among others. In 2009, a Health Canada screening assessment concluded that D4 is harmful to the environment and its biodiversity. In Europe, D4 is currently restricted in wash-off cosmetics (concentration limit of 0.1 % w/w); and recently, the European Chemicals Agency proposed further restrictions on D4 in other consumer and commercial uses due to potential risk. Notably, here in the U.S., EPA has received 39 separate “substantial risk reports” on D4 under TSCA Section 8(e), highlighting health concerns such as reproductive toxicity and immunotoxicity. Given the results of previous risk assessments on D4, and the significant number of risk reports provided to the agency, EPA must comprehensively assess the potential risk of D4 in all relevant uses to best protect public health.

Despite EPA’s movement toward a more comprehensive, public health protective approach to risk evaluation (see EDF’s Re-visioning TSCA after the Trump years blog series), the draft D4 scope highlights significant issues that remain, including:

  • Insufficient indication of specific “potentially exposed and susceptible subpopulations” that will be included in the risk evaluation;
  • Absence of a revised systematic review method and a specific systematic review protocol for D4;
  • Inadequate plan to use information authorities under TSCA to fill the extensive data gaps identified;
  • Failure to consider combined exposures to D4 in the workplace (e.g., when a worker is engaged in multiple activities involving potential exposure to D4);
  • Failure to consider combined exposures to individuals who fall into multiple receptor categories (e.g., individuals exposed to D4 in both the workplace and as resident of a fenceline community);
  • Insufficient commitment to consider relevant “background exposures” of D4 that may fall outside of TSCA’s direct regulatory authority but are relevant to evaluating risks from “TSCA uses” (e.g., exposures from food packaging, personal care products, and medical applications); and
  • Insufficient detail on how EPA plans to assess and incorporate uncertainty associated with the use of modeled or surrogate data when evaluating potential D4 risk.

EDF commends EPA for improvements made from previous scopes, and urges the agency to address the identified deficiencies in the final D4 scope.

See EDF’s comments for more detail.

Also posted in EPA, Health Policy, Public Health / Tagged , , | Comments are closed

Loosening industry’s grip on EPA’s new chemicals program

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

[I delivered a shorter version of these comments at the September 22, 2021 webinar titled “Hair on Fire and Yes Packages! How the Biden Administration Can Reverse the Chemical Industry’s Undue Influence,” cosponsored by Public Employees for Environmental Responsibility (PEER), NH Safe Water Alliance, and EDF.  A recording of the webinar will shortly be available here.  The webinar, second in a series, follows on EPA whistleblower disclosures first appearing in a complaint filed by PEER that are detailed in a series of articles by Sharon Lerner in The Intercept.]

The insularity of the New Chemicals Program – where staff only interact with industry and there is no real engagement with other stakeholders – spawns and perpetuates these industry-friendly and un-health-protective policies.

I have closely tracked the Environmental Protection Agency’s New Chemicals Program for many years.  Reluctantly, I have come to the conclusion that the program does not serve the agency’s mission and the public interest, but rather the interests of the chemical industry.  Despite the major reforms Congress made to the program in 2016 when it overhauled the Toxic Substances Control Act, the New Chemicals Program is so badly broken that nothing less than a total reset can fix the problems.

Revelations emerging through responses Environmental Defense Fund finally received to a FOIA request we made two years ago, and through the disclosures of courageous whistleblowers who did or still work in the New Chemicals Program, confirm what I have long suspected, looking in from the outside.  The program:

  • uses practices that allow the chemical industry to easily access and hold sway over EPA reviews and decisions on the chemicals they seek to bring to market;
  • has developed a deeply embedded culture of secrecy that blocks public scrutiny and accountability;
  • employs policies – often unwritten – that undermine Congress’ major reforms to the law and reflect only industry viewpoints; and
  • operates through a management system and managers, some still in place, that regularly prioritize industry’s demands for quick decisions that allow their new chemicals onto the market with no restrictions, over reliance on the best science and protection of public and worker health.

Many of the worst abuses coming to light took place during the Trump administration, and it is tempting to believe the change in administrations has fixed the problems.  It has not.  The damaging practices, culture, policies and management systems predate the last administration and laid the foundation for the abuses.  Highly problematic decisions continue to be made even in recent weeks.

I am encouraged by recent statements and actions of Dr. Michal Freedhoff, Assistant Administrator of the EPA office that oversees TSCA implementation.  They clearly are moves in the right direction.  But it is essential that the deep-rooted, systemic nature of the problem be forthrightly acknowledged and forcefully addressed.

Let me provide some examples of each of the problems I just noted.  Read More »

Also posted in EPA, Health Policy, Industry Influence, PFAS, Public Health, Regulation, TSCA Reform, Worker Safety / Tagged , | Comments are closed

Beyond paper: PFAS linked to common plastic packaging used for food, cosmetics, and much more

Tom Neltner, Chemicals Policy Director, Maricel Maffini, consultant, and Tom Bruton with Green Science Policy Institute. 

Update August 11, 21 – Added FDA’s Response to FOIA.

Results from an Environmental Protection Agency (EPA) investigation into PFAS-contaminated pesticides have much broader, concerning implications for food, cosmetics, shampoos, household cleaning products, and other consumer products, as well as recycling. This investigation, first announced earlier this year, found that fluorinated high-density polyethylene (HDPE) containers used for pesticide storage contained a mix of short and long-chain per- and polyfluorinated alkyl substances (PFAS), including PFOA, that leached into the product. From what EPA can tell, the PFAS were not intentionally added to the HDPE containers but are hypothesized to have been produced when fluorine gas was applied to the plastic.

Since EPA released its investigation, we have learned the disturbing fact that the fluorination of plastic is commonly used to treat hundreds of millions of polyethylene and polypropylene containers each year ranging from packaged food and consumer products that individuals buy to larger containers used by retailers such as restaurants to even larger drums used by manufacturers to store and transport fluids.

The process of polyethylene fluorination was approved by the Food and Drug Administration (FDA) in 1983 for food packaging to reduce oxygen and moisture migration through the plastic that would cause foods to spoil. The fluorination process forms a barrier on the plastic’s surface and it also strengthens the packaging.

Fluorination of plastic leading to the inadvertent creation of PFAS may be another reason these ‘forever chemicals’ show up in many unexpected places. This significant source of PFAS contamination needs to be addressed. Much remains to be resolved as FDA and EPA actively investigate this new source of PFAS; however, preventive steps need to be taken quickly, especially since other PFAS-free barrier materials are available as alternatives.

Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer.

Read More »

Also posted in EPA, FDA, PFAS, Regulation / Tagged , , | Comments are closed

Heart disease and adult lead exposure – the evidence grows more compelling

Tom Neltner, J.D.is Chemicals Policy Director

Two recent articles add to the already strong evidence that adult exposure to relatively low levels of lead is associated with heart disease, the leading cause of death in the United States, after COVID-19. These studies reinforce the urgent need to reduce not only children’s exposure to lead but also adult exposure through regulatory action.

A February 2021 Environmental Health Perspectives article found that blood lead levels were positively associated with prevalence of moderate to severe coronary artery stenosis (CAS), the narrowing of at least 25% of these vital arteries to the heart. The researchers studied a cohort of 2,000 Korean adults studied with no history of CAS, cardiovascular disease (CVD), or occupational exposure to lead. The vast majority of their blood lead levels were below the U.S. Center of Disease Control’s (CDC) reference level.[1] The researchers found that he severity of CAS is an important predictor for life threatening cardiovascular disease, even after adjusting for factors such as age, sex, hypertension, body mass index, regular exercise, smoking, and alcohol drinking.[2]

Read More »

Also posted in Emerging Science, lead / Tagged | Comments are closed

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

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 »

Also posted in EPA, Health Policy, TSCA Reform / Tagged | Comments are closed