EDF Health

EU gets ready to ban most BPA uses. Once again: Where’s FDA?

By EDF Blogs / Published: March 1, 2024

By Maricel Maffini, PhD, Consultant, and Tom Neltner, Executive Director, Unleaded Kids

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What’s Happening?

On February 9, 2024, the European Commission published a proposed regulation [PDF, 502KB] that would ban most uses of bisphenol A (BPA) in materials that contact food—including plastic and coatings applied to metal cans—and restrict other uses. Interested parties can comment on the draft until March 8, 2024. (You must register to comment.)

This proposed regulation is based on the 2023 European Food Safety Authority’s (EFSA) risk assessment of BPA that concluded that dietary exposures are a health concern. The proposed regulation would impact the following bisphenol-based food contact materials:

  • Plastics: Would be banned from use if made from BPA at any stage of manufacturing.1 The only exception is polysulfone resins made from a sodium salt of BPA, which are allowed for use in filtration membranes if there is no detectable migration into food.
  • Varnishes, coatings, printing inks, adhesives, ion-exchange resins, and rubbers: Use of BPA and bisphenol S (BPS)2 would be banned at any stage of manufacture. Use of BPS or other bisphenols may be authorized on a case-by-case basis. The exception to the ban is bisphenol-A diglycidyl ether (BADGE)3 made from BPA and used to make epoxy-based varnishes and coatings, which are allowed only in making materials with capacity of more than 250 liters and there is no detectable migration4 into food.
  • Recycled materials: Unintentional BPA contamination would be allowed if there is no detectable migration into food.

Why It Matters

In its 2023 reassessment, EFSA estimated that the amount of BPA that could be safely consumed daily is 20,000 times less than its 2015 estimate. Among the health problems associated with BPA exposure are harm to the immune and reproductive systems, disruption of the normal function of hormones and reduced learning and memory.

The draft rule would manage the risk of BPA uses to significantly reduce dietary exposure after considering alternatives that are technically feasible at a commercial scale.

Our Take

The European Commission’s proposed rule is an excellent example of a risk management decision that considers safety and achievability. The Commission balanced protecting human health by eliminating as many sources of BPA as fast as possible with the implementation challenges. The Commission has included transition periods to eliminate all uses of food-contact articles manufactured with BPA ranging from 18 months for final food packaging (e.g., plastics, can coating) to 10 years for repeat-use, final food contact articles used in food production equipment.

In a previous blog, we stated that Americans’ exposure to BPA from food is similar to that of Europeans. Unfortunately, FDA doesn’t share the same sense of urgency as the European Commission. While Europe is on track to ban most uses of BPA in food contact materials, FDA is failing to take action to protect our families.

EDF and our allies submitted a food additive petition [PDF, 542KB] asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022, and has not made a final decision on it, despite a 180-day statutory deadline. It is now more than 600 days overdue.

Timeline

Once the rules are finalized, compliance would be required within 18 months for most products and within 36 months for:

  • Varnishes and coatings for processed fruit, vegetable, and processed fish products.
  • Varnishes and coatings used outside of metal packaging.
  • Manufacture of repeat-use components in professional food production equipment.

The rule would also allow repeat-use, final food contact articles used in professional food production equipment to remain in service for up to 10 years.

What’s Next?

We will submit comments to the European Commission seeking clarity on some aspects of the proposal. In addition, we will continue to press FDA to make a final decision on our petition, including potentially taking legal action for unreasonable delay in responding to it.

Go Deeper

Read our blogs on BPA.

NOTES

1 The rule is inconsistent regarding status of plastics other than polysulfone. EDF will submit comments seeking clarity.

2 The Commission may expand to more bisphenols if they are added to Annex VI, Part 3 of Regulation (EC) No 1272/2008 due to their harmonized classification as category 1A or 1B “mutagenic,” “carcinogenic,” “toxic to reproduction” or category 1 “endocrine disrupting” for human health.

3 BADGE (CAS No 1675-54-3) – is a type of epoxy resin manufactured from BPA.

4 Rule defines the limit of detection as 0.01 milligram of bisphenol per kilogram of food.

Posted in BPA, EFSA, FDA / Tagged , , | Authors: / Comments are closed

FDA Acknowledged Ortho-Phthalates Could Be Grouped Into Classes For Safety, Then Punted

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 16, 2022

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

In May, FDA decided to allow continued use of nine ortho-phthalates in food packaging and processing equipment but punted on deciding whether or not using those phthalates is safe. We’ve written about the petitions that resulted in the decision, along with the agency’s decision to “abandon” the use of 19 other phthalates (here, here, here, and here). We’ve also written about how phthalates that industry and FDA say are no longer on the market are showing up in our food (here and here). Today, however, we focus on whether those nine phthalates are a class of related substances—and the implications for public health if they are.

FDA’s obligation to evaluate related chemicals as a class

FDA’s regulations state that additives “that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects.” In denying our petition, FDA acknowledged that some phthalates could be in a class of related substances. For example, FDA described studies showing that seven phthalates reduced testosterone production – an effect called antiandrogenicity – during fetal development. This caused malformation of the male reproductive system (primarily malformed genitals in male infants). The agency balked at declaring all phthalates anti-androgenic because four of them did not show that effect.[1]

But rather than move forward with a safety assessment of the use of the antiandrogenic phthalates as a class of chemicals with similar toxicity, FDA dropped the issue, implicitly sending the message the chemicals are safe. This is contrary to the agency’s obligation. When making a final decision on a food additive petition that allows the use of a substance, FDA must explicitly decide the use is safe after considering the cumulative effect of it and related substances in the diet.[2]

In contrast to FDA’s failure to act, the Consumer Product Safety Commission, responding to safety concerns, took action five years earlier and banned use of antiandrogenic phthalates in children’s products.

A phthalate scorecard: Where we stand on which phthalates can be used and their health effects

The table below provides a scorecard for the nine phthalates that remain in use. Of those substances, studies showed that seven were associated with developmental effects, including four which have antiandrogenic effects. Two phthalates were never studied for developmental effects.

Read More »

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Broken GRAS: FDA must declare abandoned uses of ortho-phthalates are not GRAS.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 25, 2022

Maricel Maffini, EDF consultant and Tom Neltner, Chemicals Policy Director

This blog is the sixth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food.

In May, FDA removed its approval for all uses of 19 ortho-phthalates (aka phthalates) and some uses for two more because it agreed with the industry petition claiming the uses had been abandoned. During the comment period when the petition was filed and again when the decision was published, Earthjustice, EDF, and others warned FDA that despite the removal of approvals, a company could still use any of the abandoned phthalates without the agency’s knowledge by determining on its own that the use was Generally Recognized as Safe (GRAS).

In its decision, FDA implicitly acknowledged that this could indeed happen. After explaining what a GRAS safety determination[1] entails and how its voluntary GRAS notification program[2] works, the agency said:

In the future, if a manufacturer wishes to establish safe conditions of use for one or more of these substances in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification prior to market entry because these intended uses were previously authorized under section 409 of the FD&C Act.[3]

Since the agency has no way of knowing that a company determined a substance’s use was GRAS or that it was actually in use, FDA’s expectation is little more than a hope. The agency’s own studies show that the abandoned phthalates show up in food and in food contact materials. Many other studies have shown the same thing, including one that found an unapproved phthalate in fast food.

Read More »

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 9, 2021

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, Food contact materials, Health policy, Regulation / Tagged , , , , | Authors: / Comments are closed

FDA accepting public comments on the safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 19, 2016

Tom Neltner, J.D., is Chemicals Policy Director.

Today, the Food and Drug Administration (FDA) announced it was accepting public comment on a food additive petition asking the agency to reconsider the safety of 30 toxic chemicals known as ortho-phthalates, which are used as additives in food packaging and handling materials.

The announcement, to be published in tomorrow’s Federal Register, comes shortly after a new study by Dr. Ami Zota published in the journal Environmental Health Perspectives found that individuals who consume large amounts of fast food have higher levels of exposure to two of the most commonly-used phthalates—diethylhexyl phthalate (DEHP) and diisononyl phthtlate (DiNP). Because the study was about fast food, final food packaging is less likely to be a major source than food handling equipment, including gloves. Read More »

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FDA agrees to reconsider safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2016

Tom Neltner, J.D., is Chemicals Policy Director.

Yesterday, the Food and Drug Administration (FDA) agreed to consider withdrawing its approvals of 30 food additives known as ortho-phthalates from use in food packaging and food handling equipment.  The chemicals are in a class of chemically- and pharmacologically-related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents to process and package food. The agency allows them to be used in cellophane, paper, paperboard, and plastics that come in contact with food. All of the chemicals were approved by the agency before 1985.  Pursuant to 21 U.S.C. 321(s), chemicals that are reasonably expected to get into food from their intentional use in materials contacting food are considered “food additives.”

FDA acted in response to a food additive petition submitted by the Natural Resources Defense Council, Center for Science in the Public Interest, Center for Environmental Health, Center for Food Safety, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, and Learning Disabilities Association of America – groups all concerned by the adverse health effects of ortho-phthalates at the levels typically seen in food.

Academic studies have linked some of these chemicals to various reproductive, developmental and endocrine health problems. In fact, every ortho-phthalate that has been studied for these types of health effects has been found to pose a risk. From lower IQ in young children to malformation of the male genital tract, the evidence of health effects in humans continues to grow. But, with more than half of the 30 chemicals lacking any published safety data, the full extent of the threat remains unclear.

Read More »

Posted in FDA, Food, Health policy, Phthalates, Regulation / Tagged , , , , , , , , , | Authors: / Comments are closed