EDF Health

FDA acts on fluorinated plastic packaging. What are next steps?

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) took an important step last week to protect food from PFAS contamination from plastic packaging. On August 5, the agency sent a letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles reminding them that these articles must be made under specific conditions to comply with existing regulation or otherwise the food contact articles “are not lawful.” Therefore, the food that contacted them should not be permitted for sale. The agency gave three examples of manufacturing processes that do not comply with the regulation. We flagged concerns with fluorinated plastic packaging in a July blog and applaud the agency for this action.

This significant first step needs to be followed:

  1. Investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether their products complied with the law. If not, then alert food manufacturers and retailers so they can recall the adulterated food and cosmetics.
  2. Reassess whether the process FDA approved in 1983 for fluorinating polyethylene generates PFAS and whether it should still be considered safe.

Investigate companies that provided fluorinated plastic packaging

In the letter, FDA’s Office of Food Additive Safety (OFAS) states that “available information indicates that some manufacturers of fluorinated polyethylene produce articles via alternative manufacturing methods from that stipulated in FDA’s regulation.” It identified three specific examples and says that “these alternative processes for fluorination of polyethylene are not compliant with 21 CFR § 177.1615, and are not lawful for use in food contact articles.” The three examples of unlawful manufacturing processes are:

  1. “Fluorination of polyethylene for non-food uses may occur during the fabrication or molding of the container.”
  2. “Use of fluorine gas in combination with other inert diluents such as carbon dioxide, helium, or argon.”
  3. Incorporation of oxygen into the fluorinating mixture to modify the properties of the final container.

A market search shows several brands that have in-mold fluorination of high-density polyethylene (HDPE), (here and here) and another that may use oxygen or other gases in combination with fluorine.

With the letter public, FDA’s Office of Regulatory Affairs (ORA), which handles field inspections and sampling for the agency, should ensure compliance by food manufacturers all along the supply chain. Where it finds a violation, it would manage the recall of the adulterated food.

Reassess whether the allowed use generates PFAS and should still be considered safe

About a week before FDA sent out the letter, the agency responded to our May 2021 FOIA request for the documentation that resulted in its 1983 approval of fluorinated polyethylene packaging at 21 CFR § 177.1615. The approval came in response to a 1979 food additive petition by Union Carbide.

As with most of FDA’s FOIA responses, the 233-page document has extensive redactions of health and safety information. However, two things come through clearly:

  1. Nitrogen and fluorine only: In its petition and communications with FDA, Union Carbide was inconsistent when it explained whether nitrogen was only an example of an acceptable inert gas. FDA scientists demanded clarity and the company agreed that only nitrogen would be allowed. In its recent letter, FDA reminds companies that only this condition is approved.
  2. Fluorinated organics: The petition included studies of the chemicals that migrated into a simulated food such as water or alcohol. The study evaluated the residue that remained after the food simulant was evaporated off. Union Carbide maintained that fluorine in the residue was almost entirely ionic fluorine – the kind added to toothpaste – and showed that the exposure was within tolerated levels. FDA scientists kept pushing back explaining that there was evidence the residue contained substances with a carbon-fluorine bond – a indicator of what we now refer to as PFAS. FDA finally relented, stating that “our general conclusion is that low molecular weight fluorocarbon-oxygen compounds should not be present in significant quantities.” (see page 195 of FOIA response).

We now know that levels of PFAS that were considered insignificant by FDA in the 1980s pose significant risks as evidenced by some of the agency’s recent actions. For those reasons, we reaffirm our call in our July 2021 blog and in the June 2021 citizens petition submitted by 11 organizations to FDA to reassess the safety of PFAS uses, including fluorinated polyethylene.

As part of that reassessment, FDA needs to revisit the concerns raised by the agency scientists in 1983 in light of the risks posed by PFAS. Specifically:

  • Nitrogen: In its August 5 letter, FDA states that a form of PFAS known as perfluoroalkyl carboxylic acids “can form when the fluorination of HDPE occurs in the presence of oxygen or water, but not in the presence of nitrogen.” However, the agency does not acknowledge that commercially available nitrogen contains contaminants like oxygen. Food-grade nitrogen can have as much as 10,000 parts per million (ppm) of oxygen and 55 ppm of water. These levels could well be sufficient to generate significant amounts of PFAS.
  • PFAS leaching into food: Since the amount of PFAS in food considered “significant” is dramatically lower than in 1983 when FDA made its decision, the agency needs to evaluate whether it is practical – even with the purest nitrogen – to fluorinate plastic without making PFAS.

If the agency determines that the fluorine gas treatment process creates any PFAS, the law explicitly requires that FDA evaluate safety after taking into account the cumulative effects of related substances in the diet that have related health impacts. As with virtually all of its decisions, the agency failed to do that for its 1983 approval. Given the pervasive presence of PFAS in the environment and the additional PFAS FDA authorized for use in food packaging, this type of review is even more important.

Conclusion

In summary, FDA’s August 5, 2021 letter is an important step in the effort to protect consumers from PFAS in food. Now the agency needs to investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether the products complied with the law and take action. It must also reassess the safety of the packaging even if it complies with the specific conditions in its 1983 approval.

Also posted in FDA, Food, Health Policy, PFAS, Regulation / 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 »

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

EDF submits comments for peer reviewers on EPA’s exposure, use and hazard information on five PBT chemicals

Lindsay McCormick, is a Project Manager. Richard Denison, Ph.D.is a Lead Senior Scientist.

Yesterday, EDF filed comments on several draft EPA documents that are part of the basis for developing restrictions EPA is required to impose on five persistent, bioaccumulative and toxic (PBT) chemicals under the 2016 reforms made to the Toxic Substances Control Act (TSCA).  The draft documents are to undergo peer review, and EDF’s comments raise issues we believe peer reviewers need to pay particular attention to.

As required by TSCA section 6(h), EPA last year identified five PBT chemicals (DecaBDE, HCBD, PCTP, PIP (3:1), and 2,4,6 TTBP) that meet the statutory criteria for “expedited action”: By June 22, 2019, EPA must propose a rule to restrict these five chemicals.  Last month, EPA released draft documents for peer review and public comment that summarize available hazard information and assess exposure and use of each of the five PBTs.

Our main points for consideration for the peer review committee are summarized below: Read More »

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

Monitoring our chemical exposures: Five lessons learned and what’s on the horizon

Lindsay McCormick, is a Project Manager.

Last October, a groundbreaking report concluded that diseases caused by pollution were responsible for 1 in 6 premature deaths in 2015 worldwide.  That’s 9 million deaths caused by environmental pollution – three times more than AIDS, tuberculosis, and malaria combined.

That may seem startling at first, but health outcomes are largely defined by a person’s genes and their environment.  In fact, environmental factors – like ambient and household air pollution, industrial chemicals, and common consumer products – are implicated in health impacts ranging from cancer and asthma to infertility.

Unfortunately, our ability to track an individual’s chemical exposures – also called the “chemical exposome” – lags way behind what we can measure genetically.  And without this information, it is virtually impossible to develop sound policies and evidence-based interventions to reduce harmful exposures and protect health.

But what if everyone could monitor hazardous chemical exposures? What if school children, soldiers, pregnant women, flight attendants, nail salon workers, gas attendants, and those living within just a few miles of industrial sites – or just about anyone – could understand chemical exposures in their personal environment?

This is where EDF comes in. EDF is exploring ways to catalyze development and scaling of breakthrough technologies capable of detecting an individual’s exposure to a broad spectrum of chemicals—making the invisible, visible.

Our efforts began three years ago, with a series of pilot projects in which people wore a simple silicone wristband capable of detecting over 1,400 chemicals in the environment. Today, we’re collaborating with diverse stakeholders to identify needs and opportunities for accelerating broad uptake of chemical exposure monitoring technologies. Below are five important lessons to jump-start this opportunity. Read More »

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

Podcast: How space travel affects human health

Have you ever wondered what it would be like to leave Earth?

Floating around the International Space Station and exploring new worlds may sound exciting, but space travel also poses a unique set of pretty intense health effects. Changes in gravitational force and radiation can cause physical harm to the body, while being in a small, isolated environment can take a toll on mental wellbeing. And that’s just the start of it!

Since the inception of our national and international space programs, researchers have been studying the myriad effects of spaceflight on health in hopes of developing better countermeasures as we venture farther into space.

In this episode of our podcast, we talked with Dr. Allie Anderson at the University of Colorado Boulder. Dr. Anderson describes “puffy face bird leg” syndrome (yes, that’s a thing) among other health impacts of space travel and what hot topics are keeping folks in space medicine busy.

Want more? Subscribe and listen on iTunes or Google Play, or check out Podbean to listen via desktop!

Posted in Uncategorized / Comments are closed

New EPA model enables comparison of various sources of childhood exposure to lead

Tom Neltner, J.D.is Chemicals Policy Director and Dr. Ananya Roy is Health Scientist

This week, Environmental Health Perspectives published an important article by scientists at the Environmental Protection Agency (EPA) that sheds important light on the various sources of children’s lead exposure. Led by Valerie Zaltarian, the article shares an innovative multimedia model to quantify and compare relative contributions of lead from air, soil/dust, water and food to children’s blood lead level. The model couples existing SHEDS and IEUBK models to predict blood lead levels using information on concentrations of lead in different sources, intake and gut absorption. The predicted blood lead levels compared well with observed levels in the National Health and Nutrition Evaluation Survey population. Given the variety of independent sources of lead exposure, the model provides a critical tool that public health professionals can use to set priorities and evaluate the impact of various potential standards for all children and not just those with the greatest exposure.

This peer-reviewed article builds on a draft report EPA released in January 2017 evaluating different approaches to setting a health-based benchmark for lead in drinking water. The report has provided a wealth of insight into a complicated topic. Earlier this year, we used it to show that formula-fed infants get most of their lead exposure from water and toddlers from food, while the main source of lead for the highest exposed children is soil and dust. In our February blog, we provided our assessment of a health-based benchmark for lead in drinking water and explained how public health professionals could use it to evaluate homes. The information was also critical to identifying lead in food as an overlooked, but meaningful, source of children’s exposure to lead.

The new article reaffirms the analysis in the January 2017 EPA report and highlights that evaluating source contribution to blood lead in isolation versus aggregating across all sources can lead to very different answers and priorities. A health-based benchmark for lead in drinking water could vary from 0 to 46 ppb depending on age and whether all other sources of lead are considered. For example, a health-based benchmark for infants (birth to six months old) would be 4 ppb or 13 ppb depending on whether or not you consider all sources of exposure.

Read More »

Also posted in Drinking Water, Emerging Science, EPA, Food, Health Policy, lead / Tagged , , , , , , , , | Comments are closed