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, Uncategorized / Tagged , , , , | Comments are closed

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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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.

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Getting chemical safety back on track 5 years after TSCA reform

Five years ago, President Obama signed into law the Lautenberg Chemical Safety for the 21st Century Act, which overhauled the country’s chemical safety law to better protect people from toxic chemicals.

In a welcome change to the dismal Toxic Substances Control Act (TSCA) reform anniversaries during the Trump administration, this year we are able to highlight some signs of progress we have seen from the Biden EPA that are getting chemical safety back on track.

Though significant challenges remain and lots of work lies ahead to repair the damage done by the former administration and advance a broader vision of health protection for everyone, here are five ways the Biden administration has started to turn things around on chemical safety:

1. Naming leaders committed to scientific integrity and public health protection

With Michael Regan at the helm of EPA, the agency is already miles ahead of where it stood in the last administration. The critical position for overseeing TSCA implementation at EPA is the leader of the Office of Chemical Safety and Pollution Prevention. Fortunately, a chemist with deep experience on TSCA and other chemical issues from her time on Capitol Hill, Dr. Michal Freedhoff, has been confirmed for the role.

Both Regan and Freedhoff have made strong statements supporting a return to scientific integrity and transparency – which are critical needs to building back trust. Dr. Freedhoff specifically cited how the Trump White House forced EPA scientists to weaken their assessment of the dangerous chemical trichloroethylene, an egregious example of political interference in science-based decision-making.

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

A consequential day in the effort to prevent lead poisoning

Tom Neltner, J.D.is Chemicals Policy Director

Lead poisoning prevention advocates should mark May 14, 2021 as a consequential day in our collective efforts to protect public health. Last week, two decisions and a preliminary report were issued that lay a solid foundation for further progress. When translated into action, the decisions and report should result in significantly reduced lead exposure for children. These developments were:

  • A court ruling on lead-based paint hazard standards: The U.S. Court of Appeals for the Ninth Circuit directed the Environmental Protection Agency (EPA) to reconsider – and most likely tighten – the agency’s 2019 revisions to its lead-based paint (LBP) hazard standard that define the levels of lead in paint, dust, and soil that are dangerous. The current standards remain in place until EPA revises them to comply with the law and the court’s order. This decision has significant implications for home renovations, real estate disclosures, lead cleanups, and homeowner testing. This welcome step toward stronger protections for children was only possible thanks to Earthjustice and the petitioners that challenged EPA’s flawed rule.
  • Lowered federal elevated blood lead level: The Centers for Disease Control and Prevention’s (CDC) Lead Exposure and Prevention Advisory Committee (LEPAC) unanimously recommended that the agency lower its blood lead reference level (aka “elevated blood lead level” or EBLL) from 5 micrograms per deciliter (µg/dL) of lead in young children’s blood to 3.5 µg/dL. CDC appears ready to act on the recommendation. When it does, the decision will have significant implications for state and local health and housing agencies reacting to blood lead testing results for at-risk children and for action levels for lead in food.
  • New national survey of lead-based paint hazards: The U.S. Department of Housing and Urban Development (HUD) presented to LEPAC the preliminary results of its American Healthy Homes Survey II (AHHS-II), a long-overdue update to its 2006 survey. This survey of lead-based paint hazards serves as the basis for federal agencies to set priorities, assess impacts of policy decisions, and track progress. The results of samples taken in 2018-19 shows modest but significant progress across many demographics including African American households, government-supported households, and households in poverty – most likely an indication that the federal investment to fix low-income housing is paying off.

These actions put added urgency to President Biden’s America Jobs Plan that includes $45 billion in federal funding to fully replace the nation’s 9 million lead service lines and $213 billion for housing – both critical aspects of our nation’s infrastructure that need a lead poisoning prevention-oriented upgrade. We encourage Congress to provide at least $19 billion as part of an investment in housing to reduce lead-based paint hazards in pre-1940 housing, especially by replacing old, single-pane windows to get the combined benefits of safer and more energy efficient homes.

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California water utilities fear the unknown when it comes to lead service lines

Tom Neltner, Chemicals Policy Director.

Last month, two California trade associations submitted disconcerting comments to the Environmental Protection Agency (EPA) as the agency considers what to do with the revised Lead and Copper Rule (LCR) published in the waning days of the Trump Administration. The associations – the Association of California Water Agencies (ACWA) and the California Municipal Utilities Association (CMUA) – represent 90% of the state’s drinking water utilities.

The trade associations are asking EPA to allow water utilities to tell the agency, the state, their customers, and the public that they have no lead service lines (LSLs) even when they know it may well be false. This would seriously undermine one of the most important positive aspects of the revised LCR – the service line inventory. California’s unusual definition of a “user service line” has been a long-running problem: it does not include the portion of the service line on private property. This definition is narrower than the federal one – and even the state’s definition of an LSL that has been in place for more than a quarter century.

Under EPA’s revised LCR, utilities can only claim that they have no LSLs – and thus avoid the need to comply with the rule’s more protective sampling and corrosion control requirements for systems with LSLs – if they are confident there are no LSLs based the entire length of the service line, including the portion on private property. The two state trade associations are asking EPA to put the burden of determining the composition of this portion of the service line entirely on the customer, allowing a utility to ignore a lead pipe if the customer does not provide the information. This approach will render the inventory effectively useless and misleading.

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