EDF Health

Beyond paper, part 2: PFAS intentionally used to make plastic food packaging

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

Since 2002, FDA has authorized the use of four types of per- and polyfluorinated alkyl substances (PFAS) to make plastic food packaging, one as recently as 2016. The PFAS are allowed in plastic at levels up to 2000 parts per million (ppm); although lower than those used to greaseproof paper, these levels still contaminate food. The PFAS are added to facilitate the production of articles such as bottles and wraps. They reportedly improve polymer extrusion, reduce build-up on the injection mold, and improve surface roughness among other technical effects.

EDF submitted a Freedom of Information Act (FOIA) request for seven food contact substance notices (FCNs) that FDA has authorized. From FDA’s response[1], we learned that these PFAS can contaminate food in contact with the packaging. In one case the overall amount of the PFAS in the diet would be as high as 41 ppb (see pages 31-32 of FOIA response) – much more than is tolerated for some PFAS in drinking water.

These plastic processing aids, along with fluorinated polyethylene, are the latest additions to a growing list of sources of ‘forever chemicals’ in the diet. They join environmental contamination and greaseproofed paper and cardboard as sources that food companies must consider in order to keep PFAS out of their products and respond to consumer demand for safer food. Given the evidence, FDA needs to move forward pursuant to our June 2021 citizens petition to evaluate the safety of PFAS taking into account the cumulative effect of these chemicals in the diet from many sources.

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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.

Posted in FDA, Food, Health Policy, PFAS, Regulation, Uncategorized / Tagged , , , , | Comments are closed

Fixing America’s lead in water crisis must be a priority for Congress

Eric Jjemba, Health Legislative Intern, Joanna Slaney, Legislative Director, and Tom Neltner, Chemicals Policy Director

Last week, over 100 House members led by Representatives Paul Tonko (D-NY), Jan Schakowsky (D-IL), Daniel Kildee (D-MI), Gwen Moore (D-MI), and Henry Cuellar (D-TX) sent a letter to Speaker Nancy Pelosi asking that she prioritize funding for full lead service line (LSL) replacement in “any major infrastructure legislation moving through the chamber.” Additionally, a group of 8 medical and health associations led by the American Academy of Pediatrics sent a letter of their own urging Congressional leadership “​​to fully fund this proposed public health measure with $45 billion.” These letters highlight the broad support around treating America’s lead in water crisis as one that necessitates federal action. EDF, and many others, have advocated  for $45 billion in funding to fully replace the more than 9 million remaining LSLs in the country.

For too many families in this country, turning on the faucet for water essentially means drinking through a lead straw. This hundred year old legacy problem of LSLs impacts communities across the nation, but it disproportionately harms already overburdened communities– those that experience racial, economic, and environmental disparities together. To make sure that necessary assistance reaches those that need it most, including low-income communities, communities of color, and rural communities, the federal government needs to adequately fund full LSL replacement across the country.

EDF applauds the members of Congress and key public health organizations that are continuing to push for this investment, of which we have frequently outlined the clear and tangible benefits. Among these are:

  • Protecting health, especially for children, who are likely to have their brain development impaired by lead, contributing to learning and behavioral problems and lower IQs. While children of color and those from low-income families remain at the greatest risk of lead exposure, adults are also at risk of heart disease – even at low exposure levels. 
  • Reducing disparities by advancing equity for low-income communities and communities of color (including small and rural ones) that may lack the capacity to pursue federal funds, have not developed an inventory of their LSLs, and would not otherwise have the resources to do the work.
  • Creating good paying jobs in construction and plumbing through shovel-ready work. Most communities have a good sense of where many of the LSLs are in their water systems, meaning this work can get off the ground quickly.

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Whistleblower revelations about EPA TSCA new chemical reviews

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

[I delivered these comments at the July 28, 2021 webinar titled “Toxic Chemicals, Whistleblowers, and the Need for Reform at EPA
cosponso
red by Public Employees for Environmental Responsibility (PEER), NY PIRG, and EDF.  [A recording of the webinar is available here.]  The webinar followed on whistleblower disclosures in a complaint filed by PEER and the first in what will be a series of articles by Sharon Lerner in The Intercept detailing the allegations.]

I have long described the EPA new chemicals program as a “black box.”  For decades, it has operated almost entirely out of public view, in multiple respects:

  • Excessive confidentiality claims and withholding of information from the public have been standard operating procedures.
  • A purely bilateral mode of operating developed, where the only parties in the room are EPA and the chemical industry.
  • The inability of the public to access information and meaningfully participate has severely limited public input and scrutiny.
  • As a result, a highly insular, almost secretive program culture arose over time, one where EPA has often viewed its only stakeholders to be the companies seeking quick approval of their new chemicals.
  • In sum, private interests trumped public interests.

TSCA reform sought to address key problems

The 2016 amendments to TSCA significantly overhauled the new chemicals provisions of the then-40-year-old law, seeking to rebalance those interests to some extent:

  • EPA for the first time is required to make a safety finding for each new chemical and explain the scientific basis for its finding.
  • Lack of sufficient information in and of itself is grounds for restricting a chemical and/or requiring testing. Before, unless EPA had enough data to show potential risk, it simply dropped the chemical from further review and allowed it onto the market.
  • Companies’ ability to simply assert their submissions are confidential has been reined in in several ways.

To be sure, the amendments did not address all of the program’s problems.  For example, despite the fact that the vast majority of new chemicals lack basic safety data, requiring companies to provide a minimum set of information – as many other countries do for new chemicals – was a bridge too far in the face of massive industry opposition.  The revelations indicate this is still a big problem:  Despite TSCA’s mandate that EPA restrict or require testing of chemicals lacking sufficient information, that has not been happening.  EPA still excessively relies on estimating a new chemical’s potential risks using models and extrapolations of data from other chemicals – approaches that have serious limitations, introduce large uncertainties, and are themselves a black box.

Enter the Trump EPA – the damage done

Immediately after the 2016 reforms, there were signs that EPA was starting down a better path.  But under the last Administration that progress was quickly reversed and the worst features of the pre-reform program came roaring back.  Indeed, where the program ended up was worse than before TSCA reform.  Clearly, the new revelations vividly show that – and how far we have to go, both in implementing the reforms and in changing the disturbing culture that still pervades the program.  What strikes me about the whistleblowers’ allegations is that they all cut in industry’s favor, removing or downplaying risks the scientists had flagged.  This argues against these simply being cases of scientific disagreement and points to a systemic problem.  Read More »

Posted in Health Policy, Industry Influence, TSCA Reform, Worker Safety / Tagged , , , | Read 3 Responses

State legislation requires replacement of ¼ of the country’s lead pipes

Tom Neltner, Chemicals Policy Director

With the recent passage of excellent legislation in Illinois and New Jersey, one out of every four of the nation’s lead service lines (LSLs) is on a mandatory schedule to be fully replaced, with strict limits on partial replacement in the interim. These states now join Michigan in leading the way on replacing lead pipes– made all the more important because they have some of the highest numbers of LSLs in the country.

Both the Illinois and New Jersey laws[1] were the result of extensive negotiations between stakeholders and were passed with broad bipartisan support. We applaud the bill sponsors and the advocacy organizations that made it happen.

The most significant difference between the three state policies is their deadlines for utilities to fully replace the LSLs:

  • Illinois: range of 15 years to 50 years depending on a given utility’s number of LSLs.
  • New Jersey: 10-year deadline with an option to extend to 15 years
  • Michigan: 20-year deadline.

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Posted in Drinking Water, EPA, lead, Regulation, States / Tagged , , | Comments are closed

The science behind toxic inequities in beauty and personal care products

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

Prominent incidences of environmental injustice in the public eye are typically place-based — from lead-contaminated tap water in Flint, Michigan to smokestacks lining Cancer Alley in Louisiana. For decades, communities of color and low income communities have confronted long-standing discriminatory practices and policies around land use, housing, and related issues that result in greater exposures to pollution and toxic chemicals.

While geography is a predictor of an individual’s health and well-being, environmental injustice and environmental racism extend beyond geography to include inequities in toxic exposures like in personal care product formulations. Beauty and personal care products marketed to women of color often contain more toxic ingredients than products marketed to white women. As a result, women of color are disproportionately exposed to toxic chemicals through these products. Read More »

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